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Sleepless in the pandemic

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Sleep difficulties during the COVID-19 crisis may be exacerbated by media overexposure and other factors causing fear and stress, according to findings from a large survey of French individuals.

klebercordeiro/Getty Images

“Physicians usually recommend coping with sleep disorders by exercising, going outside, avoiding screen time, and having a regular schedule – all recommendations difficult to apply during lockdown. Being forced to stay home and the ensuing boredom and loneliness may have led to increased [media exposure], especially among disadvantaged people and overexposure to media COVID-19 content may have contributed to fright and emotional distress,” Damien Leger of the Centre du Sommeil et de la Vigilance, Hôtel Dieu APHP, Université de Paris, and his colleagues wrote in the journal Sleep.

The investigators analyzed data from survey respondents about their sleep problems since the COVID-19 lockdown and other topics such as employment, daily activities, and sleep medications. The survey was part of a large research project, COCONEL, that has been developed to study the French population on a variety of behaviors and comprises 750,000 permanent panelists who respond to surveys. The survey was sent to random sample of panelists with no topic label to avoid selection bias. Of the 25,800 surveys sent, 1,005 responses were recorded.

Respondents were classified as having severe sleep problems if they reported that their daytime activities were affected or if their sleeping medications had increased since the lockdown. While 73% of respondents reported poor sleep in the 8 previous days, 25% reported severe sleep problems, and 54% reported that their sleep problems had worsened during the COVID-19 lockdown.

A media exposure score was created with a Likert scale (strongly agree, agree, disagree, strongly disagree) about media exposures of different types. The investigators also queried respondents about the degree to which they found media coverage of the pandemic provoked a fear response. Overall, 68% of respondents agreed that media images and stories about COVD-19 were frightening.

The researchers found a strong association between severe sleeping problems and a high media exposure score (risk ratio, 1.49; 95% confidence interval, 1.10-2.01; P < .05).

In addition, trepidation and fear from media exposure to COVID-19 news were also associated with severe sleep problems (RR, 1.27; 95% CI, 0.92-1.75; P < .05). “Suffering from sleep problems may have increased media use at night, and thus increased stress and/or psychological distress and reinforced sleeping problems,” the investigators wrote.

Not surprisingly, respondents with financial difficulties due to the pandemic also reported severe sleeping difficulties (RR, 1.99; 95% CI, 1.49-2.65; P < .05).

For individuals who have been treated for sleep problems, the COVID-19 pandemic may ratchet up their sleep challenges. The strongest association with severe sleep problems was found in those respondents who were already taking sleeping medications before the pandemic (RR, 2.72; 95% CI, 2.04-3.61; P < .05).

The COCONEL survey has been funded by the French and National Agency for Research, the Fondation de France, and the National Research Institute for Sustainable Development.

SOURCE: Leger D et al. Sleep. 2020, Jul 25. doi: 10.1093/sleep/zsaa125.

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Sleep difficulties during the COVID-19 crisis may be exacerbated by media overexposure and other factors causing fear and stress, according to findings from a large survey of French individuals.

klebercordeiro/Getty Images

“Physicians usually recommend coping with sleep disorders by exercising, going outside, avoiding screen time, and having a regular schedule – all recommendations difficult to apply during lockdown. Being forced to stay home and the ensuing boredom and loneliness may have led to increased [media exposure], especially among disadvantaged people and overexposure to media COVID-19 content may have contributed to fright and emotional distress,” Damien Leger of the Centre du Sommeil et de la Vigilance, Hôtel Dieu APHP, Université de Paris, and his colleagues wrote in the journal Sleep.

The investigators analyzed data from survey respondents about their sleep problems since the COVID-19 lockdown and other topics such as employment, daily activities, and sleep medications. The survey was part of a large research project, COCONEL, that has been developed to study the French population on a variety of behaviors and comprises 750,000 permanent panelists who respond to surveys. The survey was sent to random sample of panelists with no topic label to avoid selection bias. Of the 25,800 surveys sent, 1,005 responses were recorded.

Respondents were classified as having severe sleep problems if they reported that their daytime activities were affected or if their sleeping medications had increased since the lockdown. While 73% of respondents reported poor sleep in the 8 previous days, 25% reported severe sleep problems, and 54% reported that their sleep problems had worsened during the COVID-19 lockdown.

A media exposure score was created with a Likert scale (strongly agree, agree, disagree, strongly disagree) about media exposures of different types. The investigators also queried respondents about the degree to which they found media coverage of the pandemic provoked a fear response. Overall, 68% of respondents agreed that media images and stories about COVD-19 were frightening.

The researchers found a strong association between severe sleeping problems and a high media exposure score (risk ratio, 1.49; 95% confidence interval, 1.10-2.01; P < .05).

In addition, trepidation and fear from media exposure to COVID-19 news were also associated with severe sleep problems (RR, 1.27; 95% CI, 0.92-1.75; P < .05). “Suffering from sleep problems may have increased media use at night, and thus increased stress and/or psychological distress and reinforced sleeping problems,” the investigators wrote.

Not surprisingly, respondents with financial difficulties due to the pandemic also reported severe sleeping difficulties (RR, 1.99; 95% CI, 1.49-2.65; P < .05).

For individuals who have been treated for sleep problems, the COVID-19 pandemic may ratchet up their sleep challenges. The strongest association with severe sleep problems was found in those respondents who were already taking sleeping medications before the pandemic (RR, 2.72; 95% CI, 2.04-3.61; P < .05).

The COCONEL survey has been funded by the French and National Agency for Research, the Fondation de France, and the National Research Institute for Sustainable Development.

SOURCE: Leger D et al. Sleep. 2020, Jul 25. doi: 10.1093/sleep/zsaa125.

Sleep difficulties during the COVID-19 crisis may be exacerbated by media overexposure and other factors causing fear and stress, according to findings from a large survey of French individuals.

klebercordeiro/Getty Images

“Physicians usually recommend coping with sleep disorders by exercising, going outside, avoiding screen time, and having a regular schedule – all recommendations difficult to apply during lockdown. Being forced to stay home and the ensuing boredom and loneliness may have led to increased [media exposure], especially among disadvantaged people and overexposure to media COVID-19 content may have contributed to fright and emotional distress,” Damien Leger of the Centre du Sommeil et de la Vigilance, Hôtel Dieu APHP, Université de Paris, and his colleagues wrote in the journal Sleep.

The investigators analyzed data from survey respondents about their sleep problems since the COVID-19 lockdown and other topics such as employment, daily activities, and sleep medications. The survey was part of a large research project, COCONEL, that has been developed to study the French population on a variety of behaviors and comprises 750,000 permanent panelists who respond to surveys. The survey was sent to random sample of panelists with no topic label to avoid selection bias. Of the 25,800 surveys sent, 1,005 responses were recorded.

Respondents were classified as having severe sleep problems if they reported that their daytime activities were affected or if their sleeping medications had increased since the lockdown. While 73% of respondents reported poor sleep in the 8 previous days, 25% reported severe sleep problems, and 54% reported that their sleep problems had worsened during the COVID-19 lockdown.

A media exposure score was created with a Likert scale (strongly agree, agree, disagree, strongly disagree) about media exposures of different types. The investigators also queried respondents about the degree to which they found media coverage of the pandemic provoked a fear response. Overall, 68% of respondents agreed that media images and stories about COVD-19 were frightening.

The researchers found a strong association between severe sleeping problems and a high media exposure score (risk ratio, 1.49; 95% confidence interval, 1.10-2.01; P < .05).

In addition, trepidation and fear from media exposure to COVID-19 news were also associated with severe sleep problems (RR, 1.27; 95% CI, 0.92-1.75; P < .05). “Suffering from sleep problems may have increased media use at night, and thus increased stress and/or psychological distress and reinforced sleeping problems,” the investigators wrote.

Not surprisingly, respondents with financial difficulties due to the pandemic also reported severe sleeping difficulties (RR, 1.99; 95% CI, 1.49-2.65; P < .05).

For individuals who have been treated for sleep problems, the COVID-19 pandemic may ratchet up their sleep challenges. The strongest association with severe sleep problems was found in those respondents who were already taking sleeping medications before the pandemic (RR, 2.72; 95% CI, 2.04-3.61; P < .05).

The COCONEL survey has been funded by the French and National Agency for Research, the Fondation de France, and the National Research Institute for Sustainable Development.

SOURCE: Leger D et al. Sleep. 2020, Jul 25. doi: 10.1093/sleep/zsaa125.

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Postmenopausal use of estrogen alone lowers breast cancer cases, deaths

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A new follow-up study of menopausal hormone therapy found that prior use of conjugated equine estrogen (CEE) decreased both breast cancer incidence and mortality, while prior use of CEE plus medroxyprogesterone acetate (MPA) was associated with an increase in incidence.

“Prior use of CEE alone is, to our knowledge, the first pharmacologic intervention demonstrated to be associated with a statistically significantly reduction in deaths from breast cancer,” wrote Rowan T. Chlebowski, MD, PhD, of the Lundquist Institute for Biomedical Innovation in Torrance, Calif., and his coauthors. The study was published July 28 in JAMA.

To further investigate the outcomes of the Women’s Health Initiative in regard to hormone therapy and breast cancer risk, the researchers analyzed the long-term follow-up of two randomized trials that included 27,347 postmenopausal women with no prior breast cancer and negative mammograms at baseline. Their mean (SD) age was 63.4 (7.2) years. Enrollment took place from 1993 to 1998; participants were contacted for follow-up every 6 months through 2005 and annually from then on. Mortality data were gathered from follow-up and the National Death Index.

The first trial included 16,608 women with a uterus. Among these women, 8,506 received 0.625 mg/day of CEE plus 2.5 mg/day of MPA, and 8,102 received placebo. The second trial included 10,739 women who’d gotten a hysterectomy, 5,310 of whom received 0.625 mg/day of CEE alone and 5,429 of whom received placebo. The first trial ended in 2002 after a median intervention period of 5.6 years, and the second trial ended in 2004 after a period of 7.2 years.

An analysis in 2015 found that CEE alone was associated with lower risk of breast cancer and CEE plus MPA was associated with increased risk.



The current analysis confirmed that, after a median of 20.3 years of follow-up, and with mortality data now available for more than 98% of participants, CEE alone was associated with fewer cases of breast cancer (238 cases, annualized rate 0.30%), compared with placebo (296 cases, annualized rate 0.37%; hazard ratio 0.78; 95% confidence interval, 0.65-0.93; P = .005).

Furthermore, CEE alone was also associated with lower mortality (30 deaths, annualized mortality rate 0.031%), compared with placebo (46 deaths, annualized mortality rate 0.046%; HR 0.60; 95% CI, 0.37-0.97; P = .04).

By comparison, CEE plus MPA was linked with more cases of breast cancer (584 cases, annualized rate 0.45%) than placebo (447 cases, annualized rate 0.36%; HR 1.28; 95% CI, 1.13-1.45; P < .001). In regard to mortality, there was no statistically significant difference between CEE plus MPA (71 deaths, annualized mortality rate 0.045%) and placebo (53 deaths, annualized mortality rate 0.035%; HR 1.35; 95% CI, 0.94-1.95; P = .11).

“The big thing to think about is estrogen alone reducing breast cancer mortality by 40%,” said Dr. Chlebowski in an interview. “None of the other interventions, including tamoxifen, had any change on mortality. This should change the way we look at breast cancer prevention, though we might have to be a little creative about it. I think you have to be a little away from menopause for it to reduce breast cancer. But we wanted to start that debate.

“On the other hand,” he said, “a woman takes estrogen plus progestin and when you look at that curve, it’s staying about 25% increased. You take it for 5.6 years and the increase continues through 20 years, so you’re maybe buying a lifetime of increase in breast cancer by taking estrogen plus progestin for 5 years.”

He also highlighted the comprehensiveness of the mortality data, noting that “when you hook up to the National Death Index, they find 98% of all deaths in the United States. That’s really remarkable; you retain the whole power of the randomization. It means our data, between the death index and our follow-up of participants, is essentially complete.”

 

 

Use of hormone therapy, and decoding the outcomes, remains ‘complex’

Decades after the data were gathered from the Women’s Health Initiative clinical trials, they continue to assist researchers and patients alike, wrote Christina A. Minami, MD, of Brigham and Women’s Hospital in Boston and Rachel A. Freedman, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

That said, in regard to the findings of this latest analysis, “many questions still remain on whether (and how) a hormone therapy intervention that occurred many years earlier may continue to affect breast cancer risk and mortality at 20 years,” they wrote. They noted that it’s “impossible” to isolate how exposure to certain therapies can impact long-term outcomes, and that a high percentage of patients who discontinued the drugs during each trial muddy the waters even further.

“Decisions to initiate these medications remain complex,” they added, emphasizing that breast cancer risk is just one of many factors that physicians must consider when considering hormone therapy for their patients.

Dr. Chlebowski and his coauthors acknowledged their study’s limitations, including the use of very specifically administered and formulated dosages making their findings “not necessarily generalizable to other preparations.” In addition, they noted the significant percentage of patients – 54% with CEE alone and 42% with CEE plus MPA – who discontinued drug usage during their respective trials.

The Women’s Health Initiative is supported by the National Institutes of Health and the Department of Health and Human Services. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various government organizations, foundations, and pharmaceutical companies. The editorial’s authors reported no conflicts of interest.

SOURCE: Chlebowski RT et al. JAMA. 2020 Jul 28. doi: 10.1001/jama.2020.9482.

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A new follow-up study of menopausal hormone therapy found that prior use of conjugated equine estrogen (CEE) decreased both breast cancer incidence and mortality, while prior use of CEE plus medroxyprogesterone acetate (MPA) was associated with an increase in incidence.

“Prior use of CEE alone is, to our knowledge, the first pharmacologic intervention demonstrated to be associated with a statistically significantly reduction in deaths from breast cancer,” wrote Rowan T. Chlebowski, MD, PhD, of the Lundquist Institute for Biomedical Innovation in Torrance, Calif., and his coauthors. The study was published July 28 in JAMA.

To further investigate the outcomes of the Women’s Health Initiative in regard to hormone therapy and breast cancer risk, the researchers analyzed the long-term follow-up of two randomized trials that included 27,347 postmenopausal women with no prior breast cancer and negative mammograms at baseline. Their mean (SD) age was 63.4 (7.2) years. Enrollment took place from 1993 to 1998; participants were contacted for follow-up every 6 months through 2005 and annually from then on. Mortality data were gathered from follow-up and the National Death Index.

The first trial included 16,608 women with a uterus. Among these women, 8,506 received 0.625 mg/day of CEE plus 2.5 mg/day of MPA, and 8,102 received placebo. The second trial included 10,739 women who’d gotten a hysterectomy, 5,310 of whom received 0.625 mg/day of CEE alone and 5,429 of whom received placebo. The first trial ended in 2002 after a median intervention period of 5.6 years, and the second trial ended in 2004 after a period of 7.2 years.

An analysis in 2015 found that CEE alone was associated with lower risk of breast cancer and CEE plus MPA was associated with increased risk.



The current analysis confirmed that, after a median of 20.3 years of follow-up, and with mortality data now available for more than 98% of participants, CEE alone was associated with fewer cases of breast cancer (238 cases, annualized rate 0.30%), compared with placebo (296 cases, annualized rate 0.37%; hazard ratio 0.78; 95% confidence interval, 0.65-0.93; P = .005).

Furthermore, CEE alone was also associated with lower mortality (30 deaths, annualized mortality rate 0.031%), compared with placebo (46 deaths, annualized mortality rate 0.046%; HR 0.60; 95% CI, 0.37-0.97; P = .04).

By comparison, CEE plus MPA was linked with more cases of breast cancer (584 cases, annualized rate 0.45%) than placebo (447 cases, annualized rate 0.36%; HR 1.28; 95% CI, 1.13-1.45; P < .001). In regard to mortality, there was no statistically significant difference between CEE plus MPA (71 deaths, annualized mortality rate 0.045%) and placebo (53 deaths, annualized mortality rate 0.035%; HR 1.35; 95% CI, 0.94-1.95; P = .11).

“The big thing to think about is estrogen alone reducing breast cancer mortality by 40%,” said Dr. Chlebowski in an interview. “None of the other interventions, including tamoxifen, had any change on mortality. This should change the way we look at breast cancer prevention, though we might have to be a little creative about it. I think you have to be a little away from menopause for it to reduce breast cancer. But we wanted to start that debate.

“On the other hand,” he said, “a woman takes estrogen plus progestin and when you look at that curve, it’s staying about 25% increased. You take it for 5.6 years and the increase continues through 20 years, so you’re maybe buying a lifetime of increase in breast cancer by taking estrogen plus progestin for 5 years.”

He also highlighted the comprehensiveness of the mortality data, noting that “when you hook up to the National Death Index, they find 98% of all deaths in the United States. That’s really remarkable; you retain the whole power of the randomization. It means our data, between the death index and our follow-up of participants, is essentially complete.”

 

 

Use of hormone therapy, and decoding the outcomes, remains ‘complex’

Decades after the data were gathered from the Women’s Health Initiative clinical trials, they continue to assist researchers and patients alike, wrote Christina A. Minami, MD, of Brigham and Women’s Hospital in Boston and Rachel A. Freedman, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

That said, in regard to the findings of this latest analysis, “many questions still remain on whether (and how) a hormone therapy intervention that occurred many years earlier may continue to affect breast cancer risk and mortality at 20 years,” they wrote. They noted that it’s “impossible” to isolate how exposure to certain therapies can impact long-term outcomes, and that a high percentage of patients who discontinued the drugs during each trial muddy the waters even further.

“Decisions to initiate these medications remain complex,” they added, emphasizing that breast cancer risk is just one of many factors that physicians must consider when considering hormone therapy for their patients.

Dr. Chlebowski and his coauthors acknowledged their study’s limitations, including the use of very specifically administered and formulated dosages making their findings “not necessarily generalizable to other preparations.” In addition, they noted the significant percentage of patients – 54% with CEE alone and 42% with CEE plus MPA – who discontinued drug usage during their respective trials.

The Women’s Health Initiative is supported by the National Institutes of Health and the Department of Health and Human Services. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various government organizations, foundations, and pharmaceutical companies. The editorial’s authors reported no conflicts of interest.

SOURCE: Chlebowski RT et al. JAMA. 2020 Jul 28. doi: 10.1001/jama.2020.9482.

A new follow-up study of menopausal hormone therapy found that prior use of conjugated equine estrogen (CEE) decreased both breast cancer incidence and mortality, while prior use of CEE plus medroxyprogesterone acetate (MPA) was associated with an increase in incidence.

“Prior use of CEE alone is, to our knowledge, the first pharmacologic intervention demonstrated to be associated with a statistically significantly reduction in deaths from breast cancer,” wrote Rowan T. Chlebowski, MD, PhD, of the Lundquist Institute for Biomedical Innovation in Torrance, Calif., and his coauthors. The study was published July 28 in JAMA.

To further investigate the outcomes of the Women’s Health Initiative in regard to hormone therapy and breast cancer risk, the researchers analyzed the long-term follow-up of two randomized trials that included 27,347 postmenopausal women with no prior breast cancer and negative mammograms at baseline. Their mean (SD) age was 63.4 (7.2) years. Enrollment took place from 1993 to 1998; participants were contacted for follow-up every 6 months through 2005 and annually from then on. Mortality data were gathered from follow-up and the National Death Index.

The first trial included 16,608 women with a uterus. Among these women, 8,506 received 0.625 mg/day of CEE plus 2.5 mg/day of MPA, and 8,102 received placebo. The second trial included 10,739 women who’d gotten a hysterectomy, 5,310 of whom received 0.625 mg/day of CEE alone and 5,429 of whom received placebo. The first trial ended in 2002 after a median intervention period of 5.6 years, and the second trial ended in 2004 after a period of 7.2 years.

An analysis in 2015 found that CEE alone was associated with lower risk of breast cancer and CEE plus MPA was associated with increased risk.



The current analysis confirmed that, after a median of 20.3 years of follow-up, and with mortality data now available for more than 98% of participants, CEE alone was associated with fewer cases of breast cancer (238 cases, annualized rate 0.30%), compared with placebo (296 cases, annualized rate 0.37%; hazard ratio 0.78; 95% confidence interval, 0.65-0.93; P = .005).

Furthermore, CEE alone was also associated with lower mortality (30 deaths, annualized mortality rate 0.031%), compared with placebo (46 deaths, annualized mortality rate 0.046%; HR 0.60; 95% CI, 0.37-0.97; P = .04).

By comparison, CEE plus MPA was linked with more cases of breast cancer (584 cases, annualized rate 0.45%) than placebo (447 cases, annualized rate 0.36%; HR 1.28; 95% CI, 1.13-1.45; P < .001). In regard to mortality, there was no statistically significant difference between CEE plus MPA (71 deaths, annualized mortality rate 0.045%) and placebo (53 deaths, annualized mortality rate 0.035%; HR 1.35; 95% CI, 0.94-1.95; P = .11).

“The big thing to think about is estrogen alone reducing breast cancer mortality by 40%,” said Dr. Chlebowski in an interview. “None of the other interventions, including tamoxifen, had any change on mortality. This should change the way we look at breast cancer prevention, though we might have to be a little creative about it. I think you have to be a little away from menopause for it to reduce breast cancer. But we wanted to start that debate.

“On the other hand,” he said, “a woman takes estrogen plus progestin and when you look at that curve, it’s staying about 25% increased. You take it for 5.6 years and the increase continues through 20 years, so you’re maybe buying a lifetime of increase in breast cancer by taking estrogen plus progestin for 5 years.”

He also highlighted the comprehensiveness of the mortality data, noting that “when you hook up to the National Death Index, they find 98% of all deaths in the United States. That’s really remarkable; you retain the whole power of the randomization. It means our data, between the death index and our follow-up of participants, is essentially complete.”

 

 

Use of hormone therapy, and decoding the outcomes, remains ‘complex’

Decades after the data were gathered from the Women’s Health Initiative clinical trials, they continue to assist researchers and patients alike, wrote Christina A. Minami, MD, of Brigham and Women’s Hospital in Boston and Rachel A. Freedman, MD, of the Dana-Farber Cancer Institute in Boston, in an accompanying editorial.

That said, in regard to the findings of this latest analysis, “many questions still remain on whether (and how) a hormone therapy intervention that occurred many years earlier may continue to affect breast cancer risk and mortality at 20 years,” they wrote. They noted that it’s “impossible” to isolate how exposure to certain therapies can impact long-term outcomes, and that a high percentage of patients who discontinued the drugs during each trial muddy the waters even further.

“Decisions to initiate these medications remain complex,” they added, emphasizing that breast cancer risk is just one of many factors that physicians must consider when considering hormone therapy for their patients.

Dr. Chlebowski and his coauthors acknowledged their study’s limitations, including the use of very specifically administered and formulated dosages making their findings “not necessarily generalizable to other preparations.” In addition, they noted the significant percentage of patients – 54% with CEE alone and 42% with CEE plus MPA – who discontinued drug usage during their respective trials.

The Women’s Health Initiative is supported by the National Institutes of Health and the Department of Health and Human Services. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various government organizations, foundations, and pharmaceutical companies. The editorial’s authors reported no conflicts of interest.

SOURCE: Chlebowski RT et al. JAMA. 2020 Jul 28. doi: 10.1001/jama.2020.9482.

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Real-world data show SGLT2 inhibitors for diabetes triple DKA risk

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Sodium-glucose cotransporter 2 (SGLT2) inhibitors used for the treatment of type 2 diabetes, and for heart failure, are associated with a nearly threefold increased risk for diabetic ketoacidosis (DKA), according to a new large database analysis.

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The findings, which include data on the use of three different SGLT2 inhibitors in Canada and the United Kingdom and suggest a class effect, were published online July 27 in Annals of Internal Medicine by Antonios Douros, MD, PhD, of McGill University and the Centre for Clinical Epidemiology, Lady Davis Institute, Montreal, and colleagues.

“Our results provide robust evidence that SGLT2 inhibitors are associated with an increased risk for DKA. Of note, increased risks were observed in all molecule-specific analyses, with canagliflozin [Invokana, Janssen] showing the highest effect estimate,” they noted.

And because the beneficial effects of SGLT2 inhibitors in the prevention of cardiovascular and renal disease will probably increase their uptake in the coming years, “Physicians should be aware of DKA as a potential adverse effect,” Dr. Douros and colleagues wrote.
 

Analysis “generally confirms what has already been published”

Asked for comment, Simeon I. Taylor, MD, PhD, professor of medicine at the University of Maryland, Baltimore, said that the study “generally confirms what has already been published” on the topic. He noted that overall “the risk of SGLT2 inhibitor–induced ketoacidosis is quite low in type 2 diabetes, perhaps on the order of 1 episode per 1000 patient-years.”

However, Dr. Taylor cautioned: “Published evidence suggests that the risk of DKA is increased if patients are unable to eat,” such as when hospitalized patients are not permitted to eat.

“In that setting, it is probably prudent to discontinue an SGLT2 inhibitor. Also, it may be prudent not to prescribe SGLT2 inhibitors to patients with a history of DKA,” he added.

Dr. Taylor also advised: “Although not necessarily supported by this publication, I think that caution should be exercised in prescribing SGLT2 inhibitors to insulin-dependent type 2 diabetes patients. ... Some late-stage type 2 diabetes patients may have severe insulin deficiency, and their physiology may resemble that of a type 1 diabetes patient.”

Dr. Taylor has previously advised against using SGLT2 inhibitors altogether in patients with type 1 diabetes.
 

Increased DKA risk seen across all SGLT2 inhibitors

The study involved electronic health care databases from seven Canadian provinces and the United Kingdom, from which 208,757 new users of SGLT2 inhibitors were propensity-matched 1:1 to new dipeptidyl peptidase-4 (DPP-4) inhibitor users.

Of those taking an SGLT2 inhibitor, 42.3% took canagliflozin, 30.7% dapagliflozin (Farxiga/Forxiga, AstraZeneca), and 27.0% empagliflozin (Jardiance, Boehringer Ingelheim).

Over a mean 0.9-year follow-up, 521 patients were hospitalized with DKA, for an overall incidence rate of 1.41 per 1,000 person-years.

The rate with SGLT2 inhibitors, 2.03 per 1,000 person-years, was nearly three times that seen with DPP-4 inhibitors, at 0.75 per 1,000 person-years, a significant difference (hazard ratio, 2.85).

By individual SGLT2 inhibitor, the hazard ratios compared with DPP-4 inhibitors were 1.86 for dapagliflozin, 2.52 for empagliflozin, and 3.58 for canagliflozin, all statistically significant. Stratification by age, sex, and incident versus prevalent user did not change the association between SGLT2 inhibitors and DKA.

Asked about the higher rate for canagliflozin, Dr. Taylor commented: “It is hard to know whether there are real and reproducible differences in the risks of DKA among the various SGLT2 inhibitors. The differences are not huge and the populations are not well matched.”

But, he noted, “If canagliflozin triggers more glucosuria, it is not surprising that it would also induce more ketosis and possibly ketoacidosis.”

He also noted that the threefold relative increase in DKA with canagliflozin versus comparators is consistent with Janssen’s data, published in 2015. 

“It is, of course, reassuring that both [randomized clinical trials] and epidemiology produce similar estimates of the risk of drug-induced adverse events. Interestingly, the incidence of DKA is approximately threefold higher in the Canadian [data] as compared to Janssen’s clinical trials.”

Dr. Taylor also pointed out that, in the Janssen studies, the risk of canagliflozin-induced DKA appeared to be higher among patients with anti-islet antibodies, which suggests that some may have actually had autoimmune (type 1) diabetes. “So the overall risk of SGLT2 inhibitor-induced DKA may depend at least in part on the mix of patients.”

In the current study, individuals who never used insulin had a greater relative increase in risk of DKA with SGLT2 inhibitors, compared with DPP-4 inhibitors, than did those who did use insulin (hazard ratios, 3.96 vs. 2.24, both compared with DPP-4 inhibitors). However, just among those taking SGLT2 inhibitors, the absolute risk for DKA was higher for those with prior insulin use (3.52 vs. 1.43 per 1,000 person-years). 

The results of sensitivity analyses were consistent with those of the primary analysis.

The study was funded by the Canadian Institutes of Health Research and supported by ICES. Dr. Douros has reported receiving a salary support award from Fonds de recherche du Quebec – sante. Dr. Taylor was previously employed at Bristol-Myers Squibb. He is currently a consultant for Ionis Pharmaceuticals and has reported receiving research support provided to the University of Maryland School of Medicine by Regeneron.

A version of this article originally appeared on Medscape.com.

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Sodium-glucose cotransporter 2 (SGLT2) inhibitors used for the treatment of type 2 diabetes, and for heart failure, are associated with a nearly threefold increased risk for diabetic ketoacidosis (DKA), according to a new large database analysis.

Boarding1Now/Thinkstock

The findings, which include data on the use of three different SGLT2 inhibitors in Canada and the United Kingdom and suggest a class effect, were published online July 27 in Annals of Internal Medicine by Antonios Douros, MD, PhD, of McGill University and the Centre for Clinical Epidemiology, Lady Davis Institute, Montreal, and colleagues.

“Our results provide robust evidence that SGLT2 inhibitors are associated with an increased risk for DKA. Of note, increased risks were observed in all molecule-specific analyses, with canagliflozin [Invokana, Janssen] showing the highest effect estimate,” they noted.

And because the beneficial effects of SGLT2 inhibitors in the prevention of cardiovascular and renal disease will probably increase their uptake in the coming years, “Physicians should be aware of DKA as a potential adverse effect,” Dr. Douros and colleagues wrote.
 

Analysis “generally confirms what has already been published”

Asked for comment, Simeon I. Taylor, MD, PhD, professor of medicine at the University of Maryland, Baltimore, said that the study “generally confirms what has already been published” on the topic. He noted that overall “the risk of SGLT2 inhibitor–induced ketoacidosis is quite low in type 2 diabetes, perhaps on the order of 1 episode per 1000 patient-years.”

However, Dr. Taylor cautioned: “Published evidence suggests that the risk of DKA is increased if patients are unable to eat,” such as when hospitalized patients are not permitted to eat.

“In that setting, it is probably prudent to discontinue an SGLT2 inhibitor. Also, it may be prudent not to prescribe SGLT2 inhibitors to patients with a history of DKA,” he added.

Dr. Taylor also advised: “Although not necessarily supported by this publication, I think that caution should be exercised in prescribing SGLT2 inhibitors to insulin-dependent type 2 diabetes patients. ... Some late-stage type 2 diabetes patients may have severe insulin deficiency, and their physiology may resemble that of a type 1 diabetes patient.”

Dr. Taylor has previously advised against using SGLT2 inhibitors altogether in patients with type 1 diabetes.
 

Increased DKA risk seen across all SGLT2 inhibitors

The study involved electronic health care databases from seven Canadian provinces and the United Kingdom, from which 208,757 new users of SGLT2 inhibitors were propensity-matched 1:1 to new dipeptidyl peptidase-4 (DPP-4) inhibitor users.

Of those taking an SGLT2 inhibitor, 42.3% took canagliflozin, 30.7% dapagliflozin (Farxiga/Forxiga, AstraZeneca), and 27.0% empagliflozin (Jardiance, Boehringer Ingelheim).

Over a mean 0.9-year follow-up, 521 patients were hospitalized with DKA, for an overall incidence rate of 1.41 per 1,000 person-years.

The rate with SGLT2 inhibitors, 2.03 per 1,000 person-years, was nearly three times that seen with DPP-4 inhibitors, at 0.75 per 1,000 person-years, a significant difference (hazard ratio, 2.85).

By individual SGLT2 inhibitor, the hazard ratios compared with DPP-4 inhibitors were 1.86 for dapagliflozin, 2.52 for empagliflozin, and 3.58 for canagliflozin, all statistically significant. Stratification by age, sex, and incident versus prevalent user did not change the association between SGLT2 inhibitors and DKA.

Asked about the higher rate for canagliflozin, Dr. Taylor commented: “It is hard to know whether there are real and reproducible differences in the risks of DKA among the various SGLT2 inhibitors. The differences are not huge and the populations are not well matched.”

But, he noted, “If canagliflozin triggers more glucosuria, it is not surprising that it would also induce more ketosis and possibly ketoacidosis.”

He also noted that the threefold relative increase in DKA with canagliflozin versus comparators is consistent with Janssen’s data, published in 2015. 

“It is, of course, reassuring that both [randomized clinical trials] and epidemiology produce similar estimates of the risk of drug-induced adverse events. Interestingly, the incidence of DKA is approximately threefold higher in the Canadian [data] as compared to Janssen’s clinical trials.”

Dr. Taylor also pointed out that, in the Janssen studies, the risk of canagliflozin-induced DKA appeared to be higher among patients with anti-islet antibodies, which suggests that some may have actually had autoimmune (type 1) diabetes. “So the overall risk of SGLT2 inhibitor-induced DKA may depend at least in part on the mix of patients.”

In the current study, individuals who never used insulin had a greater relative increase in risk of DKA with SGLT2 inhibitors, compared with DPP-4 inhibitors, than did those who did use insulin (hazard ratios, 3.96 vs. 2.24, both compared with DPP-4 inhibitors). However, just among those taking SGLT2 inhibitors, the absolute risk for DKA was higher for those with prior insulin use (3.52 vs. 1.43 per 1,000 person-years). 

The results of sensitivity analyses were consistent with those of the primary analysis.

The study was funded by the Canadian Institutes of Health Research and supported by ICES. Dr. Douros has reported receiving a salary support award from Fonds de recherche du Quebec – sante. Dr. Taylor was previously employed at Bristol-Myers Squibb. He is currently a consultant for Ionis Pharmaceuticals and has reported receiving research support provided to the University of Maryland School of Medicine by Regeneron.

A version of this article originally appeared on Medscape.com.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors used for the treatment of type 2 diabetes, and for heart failure, are associated with a nearly threefold increased risk for diabetic ketoacidosis (DKA), according to a new large database analysis.

Boarding1Now/Thinkstock

The findings, which include data on the use of three different SGLT2 inhibitors in Canada and the United Kingdom and suggest a class effect, were published online July 27 in Annals of Internal Medicine by Antonios Douros, MD, PhD, of McGill University and the Centre for Clinical Epidemiology, Lady Davis Institute, Montreal, and colleagues.

“Our results provide robust evidence that SGLT2 inhibitors are associated with an increased risk for DKA. Of note, increased risks were observed in all molecule-specific analyses, with canagliflozin [Invokana, Janssen] showing the highest effect estimate,” they noted.

And because the beneficial effects of SGLT2 inhibitors in the prevention of cardiovascular and renal disease will probably increase their uptake in the coming years, “Physicians should be aware of DKA as a potential adverse effect,” Dr. Douros and colleagues wrote.
 

Analysis “generally confirms what has already been published”

Asked for comment, Simeon I. Taylor, MD, PhD, professor of medicine at the University of Maryland, Baltimore, said that the study “generally confirms what has already been published” on the topic. He noted that overall “the risk of SGLT2 inhibitor–induced ketoacidosis is quite low in type 2 diabetes, perhaps on the order of 1 episode per 1000 patient-years.”

However, Dr. Taylor cautioned: “Published evidence suggests that the risk of DKA is increased if patients are unable to eat,” such as when hospitalized patients are not permitted to eat.

“In that setting, it is probably prudent to discontinue an SGLT2 inhibitor. Also, it may be prudent not to prescribe SGLT2 inhibitors to patients with a history of DKA,” he added.

Dr. Taylor also advised: “Although not necessarily supported by this publication, I think that caution should be exercised in prescribing SGLT2 inhibitors to insulin-dependent type 2 diabetes patients. ... Some late-stage type 2 diabetes patients may have severe insulin deficiency, and their physiology may resemble that of a type 1 diabetes patient.”

Dr. Taylor has previously advised against using SGLT2 inhibitors altogether in patients with type 1 diabetes.
 

Increased DKA risk seen across all SGLT2 inhibitors

The study involved electronic health care databases from seven Canadian provinces and the United Kingdom, from which 208,757 new users of SGLT2 inhibitors were propensity-matched 1:1 to new dipeptidyl peptidase-4 (DPP-4) inhibitor users.

Of those taking an SGLT2 inhibitor, 42.3% took canagliflozin, 30.7% dapagliflozin (Farxiga/Forxiga, AstraZeneca), and 27.0% empagliflozin (Jardiance, Boehringer Ingelheim).

Over a mean 0.9-year follow-up, 521 patients were hospitalized with DKA, for an overall incidence rate of 1.41 per 1,000 person-years.

The rate with SGLT2 inhibitors, 2.03 per 1,000 person-years, was nearly three times that seen with DPP-4 inhibitors, at 0.75 per 1,000 person-years, a significant difference (hazard ratio, 2.85).

By individual SGLT2 inhibitor, the hazard ratios compared with DPP-4 inhibitors were 1.86 for dapagliflozin, 2.52 for empagliflozin, and 3.58 for canagliflozin, all statistically significant. Stratification by age, sex, and incident versus prevalent user did not change the association between SGLT2 inhibitors and DKA.

Asked about the higher rate for canagliflozin, Dr. Taylor commented: “It is hard to know whether there are real and reproducible differences in the risks of DKA among the various SGLT2 inhibitors. The differences are not huge and the populations are not well matched.”

But, he noted, “If canagliflozin triggers more glucosuria, it is not surprising that it would also induce more ketosis and possibly ketoacidosis.”

He also noted that the threefold relative increase in DKA with canagliflozin versus comparators is consistent with Janssen’s data, published in 2015. 

“It is, of course, reassuring that both [randomized clinical trials] and epidemiology produce similar estimates of the risk of drug-induced adverse events. Interestingly, the incidence of DKA is approximately threefold higher in the Canadian [data] as compared to Janssen’s clinical trials.”

Dr. Taylor also pointed out that, in the Janssen studies, the risk of canagliflozin-induced DKA appeared to be higher among patients with anti-islet antibodies, which suggests that some may have actually had autoimmune (type 1) diabetes. “So the overall risk of SGLT2 inhibitor-induced DKA may depend at least in part on the mix of patients.”

In the current study, individuals who never used insulin had a greater relative increase in risk of DKA with SGLT2 inhibitors, compared with DPP-4 inhibitors, than did those who did use insulin (hazard ratios, 3.96 vs. 2.24, both compared with DPP-4 inhibitors). However, just among those taking SGLT2 inhibitors, the absolute risk for DKA was higher for those with prior insulin use (3.52 vs. 1.43 per 1,000 person-years). 

The results of sensitivity analyses were consistent with those of the primary analysis.

The study was funded by the Canadian Institutes of Health Research and supported by ICES. Dr. Douros has reported receiving a salary support award from Fonds de recherche du Quebec – sante. Dr. Taylor was previously employed at Bristol-Myers Squibb. He is currently a consultant for Ionis Pharmaceuticals and has reported receiving research support provided to the University of Maryland School of Medicine by Regeneron.

A version of this article originally appeared on Medscape.com.

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MIS-C is a serious immune-mediated response to COVID-19 infection

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One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

Dr. Melissa Hazen

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.1 The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. 2 Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Dr. Kevin G. Friedman

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

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One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

Dr. Melissa Hazen

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.1 The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. 2 Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Dr. Kevin G. Friedman

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

Dr. Melissa Hazen

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.1 The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. 2 Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Dr. Kevin G. Friedman

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

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Physician recruitment drops by 30% because of pandemic

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As a result of the coronavirus pandemic and its financial impact, the number of physician recruitment searches conducted by Merritt Hawkins has dropped by 30% since March 31, the firm reported.

“Rather than having many practice opportunities to choose from, physicians now may have to compete to secure practice opportunities that meet their needs,” the authors wrote in Merritt Hawkins’ report on the impact of COVID-19.

Most of the report concerns physician recruitment from April 1, 2019, to March 31, 2020. The data were mostly derived from searches that Merritt Hawkins conducted before the effects of the pandemic was fully felt.

Family medicine was again the most sought-after specialty, as it has been for the past 14 years. But demand for primary care doctors – including family physicians, internists, and pediatricians – leveled off, and average starting salaries for primary care doctors dropped during 2019-2020. In contrast, the number of searches conducted for nurse practitioners (NPs) and physician assistants (PAs) increased by 54%, and their salaries increased slightly.

To explain the lackluster prospects for primary care before the pandemic, the authors cited research showing that patients were turning away from the traditional office visit model. At the same time, there was a rise in visits to NPs and PAs, including those in urgent care centers and retail clinics.

As a result of decreased demand for primary care physicians and the rising prevalence of telehealth, Merritt Hawkins expects primary care salaries to drop overall. With telehealth generating a larger portion of revenues, “it is uncertain whether primary care physicians will be able to sustain levels of reimbursement that were prevalent pre-COVID even at such time as the economy is improved and utilization increases,” the authors reported.

Demand for specialists was increasing prior to the COVID-19 crisis, partly as a result of the aging of the population. Seventy-eight percent of all searches were for medical specialists, compared with 67% 5 years ago. However, the pandemic has set back specialist searches. “Demand and compensation for specialists also will change as a result of COVID-19 in response to declines in the volume of medical procedures,” according to the authors.

In contrast, the recruitment of doctors who are on the front line of COVID-19 care is expected to increase. Among the fields anticipated to be in demand are emergency department specialists, infectious disease specialists, and pulmonology/critical care physicians. Travis Singleton, executive vice president of Merritt Hawkins, said in an interview that this trend is already happening and will accelerate as COVID-19 hot spots arise across the country.

Specialists in different fields received either higher or lower offers than during the previous year. Starting salaries for noninvasive cardiologists, for example, dropped 7.3%; gastroenterologists earned 7.7% less; and neurologists, 6.9% less. In contrast, orthopedic surgeons saw offers surge 16.7%; radiologists, 9.3%; and pulmonologists/critical care specialists, 7.7%.

Physicians were offered salaries plus bonuses in three-quarters of searches. Relative value unit–based production remained the most common basis for bonuses. Quality/value-based metrics were used in computing 64% of bonuses – up from 56% the previous year – but still determined only 11% of total physician compensation.
 

 

 

Pandemic outlook

Whereas health care helped drive the U.S. economy in 2018-2019, the pace of job growth in health care has decreased since March. As a result of the pandemic, health care spending in the United States declined by 18% in the first quarter of 2020. Physician practice revenue dropped by 55% during the first quarter, and many small and solo practices are still struggling.

In a 2018 Merritt Hawkins survey, 18% of physicians said they had used telehealth to treat patients. Because of the pandemic, that percentage jumped to 48% in April 2020. But telehealth hasn’t made up for the loss of patient revenue from in-office procedures, tests, and other services, and it still isn’t being reimbursed at the same level as in-office visits.

With practices under severe financial strain, the authors explained, “A majority of private practices have curtailed most physician recruiting activity since the virus emerged.”

In some states, many specialty practices have been adversely affected by the suspension of elective procedures, and specialty practices that rely on nonessential procedures are unlikely to recruit additional physicians.
 

One-third of practices could close

The survival of many private practices is now in question. “Based on the losses physician practices have sustained as a result of COVID-19, some markets could lose up to 35% or more of their most vulnerable group practices while a large percent of others will be acquired,” the authors wrote.

Hospitals and health systems will acquire the bulk of these practices, in many cases at fire-sale prices, Mr. Singleton predicted. This enormous shift from private practice to employment, he added, “will have as much to do with the [physician] income levels we’re going to see as the demand for the specialties themselves.”

Right now, he said, Merritt Hawkins is fielding a huge number of requests from doctors seeking employment, but there aren’t many jobs out there. “We haven’t seen an employer-friendly market like this since the 1970s,” he noted. “Before the pandemic, a physician might have had five to 10 jobs to choose from. Now it’s the opposite: We have one job, and 5 to 10 physicians are applying for it.”

Singleton believes the market will adjust by the second quarter of next year. Even if the pandemic worsens, he said, the system will have made the necessary corrections and adjustments “because we have to start seeing patients again, both in terms of demand and economics. So these doctors will be in demand again and will have work.”
 

Contingent employment

Although the COVID-related falloff in revenue has hit private practices the hardest, some employed physicians have also found themselves in a bind. According to a Merritt Hawkins/Physicians Foundation survey conducted in April, 21% of physicians said they had been furloughed or had taken a pay cut.

Mr. Singleton views this trend as part of hospitals’ reassessment of how they’re going to deal with labor going forward. To cope with utilization ebbs and flows in response to the virus, hospitals are now considering what the report calls a “contingent labor/flex staffing model.”

Under this type of arrangement, which some hospitals have already adopted, physicians may no longer work full time in a single setting, Mr. Singleton said. They may be asked to conduct telehealth visits on nights and weekends and work 20 hours a week in the clinic, or they may have shifts in multiple hospitals or clinics.

“You can make as much or more on a temporary basis as on a permanent basis,” he said. “But you have to be more flexible. You may have to travel or do a different scope of work, or work in different settings.”

A version of this article originally appeared on Medscape.com.

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As a result of the coronavirus pandemic and its financial impact, the number of physician recruitment searches conducted by Merritt Hawkins has dropped by 30% since March 31, the firm reported.

“Rather than having many practice opportunities to choose from, physicians now may have to compete to secure practice opportunities that meet their needs,” the authors wrote in Merritt Hawkins’ report on the impact of COVID-19.

Most of the report concerns physician recruitment from April 1, 2019, to March 31, 2020. The data were mostly derived from searches that Merritt Hawkins conducted before the effects of the pandemic was fully felt.

Family medicine was again the most sought-after specialty, as it has been for the past 14 years. But demand for primary care doctors – including family physicians, internists, and pediatricians – leveled off, and average starting salaries for primary care doctors dropped during 2019-2020. In contrast, the number of searches conducted for nurse practitioners (NPs) and physician assistants (PAs) increased by 54%, and their salaries increased slightly.

To explain the lackluster prospects for primary care before the pandemic, the authors cited research showing that patients were turning away from the traditional office visit model. At the same time, there was a rise in visits to NPs and PAs, including those in urgent care centers and retail clinics.

As a result of decreased demand for primary care physicians and the rising prevalence of telehealth, Merritt Hawkins expects primary care salaries to drop overall. With telehealth generating a larger portion of revenues, “it is uncertain whether primary care physicians will be able to sustain levels of reimbursement that were prevalent pre-COVID even at such time as the economy is improved and utilization increases,” the authors reported.

Demand for specialists was increasing prior to the COVID-19 crisis, partly as a result of the aging of the population. Seventy-eight percent of all searches were for medical specialists, compared with 67% 5 years ago. However, the pandemic has set back specialist searches. “Demand and compensation for specialists also will change as a result of COVID-19 in response to declines in the volume of medical procedures,” according to the authors.

In contrast, the recruitment of doctors who are on the front line of COVID-19 care is expected to increase. Among the fields anticipated to be in demand are emergency department specialists, infectious disease specialists, and pulmonology/critical care physicians. Travis Singleton, executive vice president of Merritt Hawkins, said in an interview that this trend is already happening and will accelerate as COVID-19 hot spots arise across the country.

Specialists in different fields received either higher or lower offers than during the previous year. Starting salaries for noninvasive cardiologists, for example, dropped 7.3%; gastroenterologists earned 7.7% less; and neurologists, 6.9% less. In contrast, orthopedic surgeons saw offers surge 16.7%; radiologists, 9.3%; and pulmonologists/critical care specialists, 7.7%.

Physicians were offered salaries plus bonuses in three-quarters of searches. Relative value unit–based production remained the most common basis for bonuses. Quality/value-based metrics were used in computing 64% of bonuses – up from 56% the previous year – but still determined only 11% of total physician compensation.
 

 

 

Pandemic outlook

Whereas health care helped drive the U.S. economy in 2018-2019, the pace of job growth in health care has decreased since March. As a result of the pandemic, health care spending in the United States declined by 18% in the first quarter of 2020. Physician practice revenue dropped by 55% during the first quarter, and many small and solo practices are still struggling.

In a 2018 Merritt Hawkins survey, 18% of physicians said they had used telehealth to treat patients. Because of the pandemic, that percentage jumped to 48% in April 2020. But telehealth hasn’t made up for the loss of patient revenue from in-office procedures, tests, and other services, and it still isn’t being reimbursed at the same level as in-office visits.

With practices under severe financial strain, the authors explained, “A majority of private practices have curtailed most physician recruiting activity since the virus emerged.”

In some states, many specialty practices have been adversely affected by the suspension of elective procedures, and specialty practices that rely on nonessential procedures are unlikely to recruit additional physicians.
 

One-third of practices could close

The survival of many private practices is now in question. “Based on the losses physician practices have sustained as a result of COVID-19, some markets could lose up to 35% or more of their most vulnerable group practices while a large percent of others will be acquired,” the authors wrote.

Hospitals and health systems will acquire the bulk of these practices, in many cases at fire-sale prices, Mr. Singleton predicted. This enormous shift from private practice to employment, he added, “will have as much to do with the [physician] income levels we’re going to see as the demand for the specialties themselves.”

Right now, he said, Merritt Hawkins is fielding a huge number of requests from doctors seeking employment, but there aren’t many jobs out there. “We haven’t seen an employer-friendly market like this since the 1970s,” he noted. “Before the pandemic, a physician might have had five to 10 jobs to choose from. Now it’s the opposite: We have one job, and 5 to 10 physicians are applying for it.”

Singleton believes the market will adjust by the second quarter of next year. Even if the pandemic worsens, he said, the system will have made the necessary corrections and adjustments “because we have to start seeing patients again, both in terms of demand and economics. So these doctors will be in demand again and will have work.”
 

Contingent employment

Although the COVID-related falloff in revenue has hit private practices the hardest, some employed physicians have also found themselves in a bind. According to a Merritt Hawkins/Physicians Foundation survey conducted in April, 21% of physicians said they had been furloughed or had taken a pay cut.

Mr. Singleton views this trend as part of hospitals’ reassessment of how they’re going to deal with labor going forward. To cope with utilization ebbs and flows in response to the virus, hospitals are now considering what the report calls a “contingent labor/flex staffing model.”

Under this type of arrangement, which some hospitals have already adopted, physicians may no longer work full time in a single setting, Mr. Singleton said. They may be asked to conduct telehealth visits on nights and weekends and work 20 hours a week in the clinic, or they may have shifts in multiple hospitals or clinics.

“You can make as much or more on a temporary basis as on a permanent basis,” he said. “But you have to be more flexible. You may have to travel or do a different scope of work, or work in different settings.”

A version of this article originally appeared on Medscape.com.

As a result of the coronavirus pandemic and its financial impact, the number of physician recruitment searches conducted by Merritt Hawkins has dropped by 30% since March 31, the firm reported.

“Rather than having many practice opportunities to choose from, physicians now may have to compete to secure practice opportunities that meet their needs,” the authors wrote in Merritt Hawkins’ report on the impact of COVID-19.

Most of the report concerns physician recruitment from April 1, 2019, to March 31, 2020. The data were mostly derived from searches that Merritt Hawkins conducted before the effects of the pandemic was fully felt.

Family medicine was again the most sought-after specialty, as it has been for the past 14 years. But demand for primary care doctors – including family physicians, internists, and pediatricians – leveled off, and average starting salaries for primary care doctors dropped during 2019-2020. In contrast, the number of searches conducted for nurse practitioners (NPs) and physician assistants (PAs) increased by 54%, and their salaries increased slightly.

To explain the lackluster prospects for primary care before the pandemic, the authors cited research showing that patients were turning away from the traditional office visit model. At the same time, there was a rise in visits to NPs and PAs, including those in urgent care centers and retail clinics.

As a result of decreased demand for primary care physicians and the rising prevalence of telehealth, Merritt Hawkins expects primary care salaries to drop overall. With telehealth generating a larger portion of revenues, “it is uncertain whether primary care physicians will be able to sustain levels of reimbursement that were prevalent pre-COVID even at such time as the economy is improved and utilization increases,” the authors reported.

Demand for specialists was increasing prior to the COVID-19 crisis, partly as a result of the aging of the population. Seventy-eight percent of all searches were for medical specialists, compared with 67% 5 years ago. However, the pandemic has set back specialist searches. “Demand and compensation for specialists also will change as a result of COVID-19 in response to declines in the volume of medical procedures,” according to the authors.

In contrast, the recruitment of doctors who are on the front line of COVID-19 care is expected to increase. Among the fields anticipated to be in demand are emergency department specialists, infectious disease specialists, and pulmonology/critical care physicians. Travis Singleton, executive vice president of Merritt Hawkins, said in an interview that this trend is already happening and will accelerate as COVID-19 hot spots arise across the country.

Specialists in different fields received either higher or lower offers than during the previous year. Starting salaries for noninvasive cardiologists, for example, dropped 7.3%; gastroenterologists earned 7.7% less; and neurologists, 6.9% less. In contrast, orthopedic surgeons saw offers surge 16.7%; radiologists, 9.3%; and pulmonologists/critical care specialists, 7.7%.

Physicians were offered salaries plus bonuses in three-quarters of searches. Relative value unit–based production remained the most common basis for bonuses. Quality/value-based metrics were used in computing 64% of bonuses – up from 56% the previous year – but still determined only 11% of total physician compensation.
 

 

 

Pandemic outlook

Whereas health care helped drive the U.S. economy in 2018-2019, the pace of job growth in health care has decreased since March. As a result of the pandemic, health care spending in the United States declined by 18% in the first quarter of 2020. Physician practice revenue dropped by 55% during the first quarter, and many small and solo practices are still struggling.

In a 2018 Merritt Hawkins survey, 18% of physicians said they had used telehealth to treat patients. Because of the pandemic, that percentage jumped to 48% in April 2020. But telehealth hasn’t made up for the loss of patient revenue from in-office procedures, tests, and other services, and it still isn’t being reimbursed at the same level as in-office visits.

With practices under severe financial strain, the authors explained, “A majority of private practices have curtailed most physician recruiting activity since the virus emerged.”

In some states, many specialty practices have been adversely affected by the suspension of elective procedures, and specialty practices that rely on nonessential procedures are unlikely to recruit additional physicians.
 

One-third of practices could close

The survival of many private practices is now in question. “Based on the losses physician practices have sustained as a result of COVID-19, some markets could lose up to 35% or more of their most vulnerable group practices while a large percent of others will be acquired,” the authors wrote.

Hospitals and health systems will acquire the bulk of these practices, in many cases at fire-sale prices, Mr. Singleton predicted. This enormous shift from private practice to employment, he added, “will have as much to do with the [physician] income levels we’re going to see as the demand for the specialties themselves.”

Right now, he said, Merritt Hawkins is fielding a huge number of requests from doctors seeking employment, but there aren’t many jobs out there. “We haven’t seen an employer-friendly market like this since the 1970s,” he noted. “Before the pandemic, a physician might have had five to 10 jobs to choose from. Now it’s the opposite: We have one job, and 5 to 10 physicians are applying for it.”

Singleton believes the market will adjust by the second quarter of next year. Even if the pandemic worsens, he said, the system will have made the necessary corrections and adjustments “because we have to start seeing patients again, both in terms of demand and economics. So these doctors will be in demand again and will have work.”
 

Contingent employment

Although the COVID-related falloff in revenue has hit private practices the hardest, some employed physicians have also found themselves in a bind. According to a Merritt Hawkins/Physicians Foundation survey conducted in April, 21% of physicians said they had been furloughed or had taken a pay cut.

Mr. Singleton views this trend as part of hospitals’ reassessment of how they’re going to deal with labor going forward. To cope with utilization ebbs and flows in response to the virus, hospitals are now considering what the report calls a “contingent labor/flex staffing model.”

Under this type of arrangement, which some hospitals have already adopted, physicians may no longer work full time in a single setting, Mr. Singleton said. They may be asked to conduct telehealth visits on nights and weekends and work 20 hours a week in the clinic, or they may have shifts in multiple hospitals or clinics.

“You can make as much or more on a temporary basis as on a permanent basis,” he said. “But you have to be more flexible. You may have to travel or do a different scope of work, or work in different settings.”

A version of this article originally appeared on Medscape.com.

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Laurent Duvernay-Tardif, MD, the only medical doctor on a current NFL roster, has become the first player to opt out of the 2020 NFL season, citing concerns over risk for COVID-19.

Canadian-born Duvernay-Tardif, right guard for the Kansas City Chiefs, announced on Twitter on July 24 what he called “one of the most difficult decisions I have had to make in my life.”

“There is no doubt in my mind the Chiefs’ medical staff have put together a strong plan to minimize the health risks associated with COVID-19, but some risks will remain,” he posted.

“Being at the frontline during this offseason has given me a different perspective on this pandemic and the stress it puts on individuals and our healthcare system. I cannot allow myself to potentially transmit the virus in our communities simply to play the sport that I love. If I am to take risks, I will do it caring for patients.”

According to CNN, Duvernay-Tardif, less than 3 months after helping the Chiefs win the Super Bowl in February, began working at a long-term care facility near Montreal in what he described as a “nursing role.”

Duvernay-Tardif wrote recently in an article for Sports Illustrated that he has not completed his residency and is not yet licensed to practice.

“My first day back in the hospital was April 24,” Duvernay-Tardif wrote. “I felt nervous the night before, but a good nervous, like before a game.”

Duvernay-Tardif has also served on the NFL Players’ Association COVID-19 task force, according to Yahoo News .

A spokesperson for Duvernay-Tardif told Medscape Medical News he was unavailable to comment about the announcement.

Starting His Dual Career

Duvernay-Tardif, 29, was drafted in the sixth round by the Chiefs in 2014.

According to Forbes , he spent 8 years (2010-2018) pursuing his medical degree while still playing college football for McGill University in Montreal. Duvernay-Tardif played offensive tackle for the Redmen and in his senior year (2013) won the Metras Trophy as most outstanding lineman in Canadian college football.

He explained in a previous Medscape interview how he managed his dual career; as a doctor he said he would like to focus on emergency medicine:

“I would say that at around 16-17 years of age, I was pretty convinced that medicine was for me,” he told Medscape.

“I was lucky that I didn’t have to do an undergrad program,” he continued. “In Canada, they have a fast-track program where instead of doing a full undergrad before getting into medical school, you can do a 1-year program where you can do all your physiology and biology classes all together.

“I had the chance to get into that program, and that’s how I was able to manage football and medicine at the same time. There’s no way I could have finished my med school doing part-time med school like I did for the past 4 years.”

ESPN explained the opt-out option: “According to an agreement approved by both the league and the union on [July 24], players considered high risk for COVID-19 can earn $350,000 and an accrued NFL season if they choose to opt out of the 2020 season. Players without risk can earn $150,000 for opting out. Duvernay-Tardif was scheduled to make $2.75 million this season.”

The danger of COVID-19 in professional sports has already been seen in Major League Baseball.

According to USA Today, the Miami Marlins have at least 14 players and staff who have tested positive for COVID-19, and major league baseball Commissioner Rob Manfred must decide whether to further delay the shortened season, cancel it, or allow it to continue.

MLB postponed the Marlins’ home opener July 27 against the Baltimore Orioles as well as the New York Yankees game in Philadelphia against the Phillies.

COVID-19 also shut down professional, college, high school, and recreational sports throughout much of the country beginning in March.

 

 

Medicine, Football Intersect

In the previous Medscape interview, Duvernay-Tardif talked about how medicine influenced his football career.

“For me, medicine was really helpful in the sense that I was better able to build a routine and question what works for me and what doesn’t. It gave me the ability to structure my work in order to optimize my time and to make sure that it’s pertinent.

“Another thing is the psychology and the sports psychology. I think there’s a little bit of a stigma around mental health issues in professional sports and everywhere, actually. I think because of medicine, I was more willing to question myself and more willing to use different tools in order to be a better football player.”
 

A version of this article first appeared on Medscape.com.

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Laurent Duvernay-Tardif, MD, the only medical doctor on a current NFL roster, has become the first player to opt out of the 2020 NFL season, citing concerns over risk for COVID-19.

Canadian-born Duvernay-Tardif, right guard for the Kansas City Chiefs, announced on Twitter on July 24 what he called “one of the most difficult decisions I have had to make in my life.”

“There is no doubt in my mind the Chiefs’ medical staff have put together a strong plan to minimize the health risks associated with COVID-19, but some risks will remain,” he posted.

“Being at the frontline during this offseason has given me a different perspective on this pandemic and the stress it puts on individuals and our healthcare system. I cannot allow myself to potentially transmit the virus in our communities simply to play the sport that I love. If I am to take risks, I will do it caring for patients.”

According to CNN, Duvernay-Tardif, less than 3 months after helping the Chiefs win the Super Bowl in February, began working at a long-term care facility near Montreal in what he described as a “nursing role.”

Duvernay-Tardif wrote recently in an article for Sports Illustrated that he has not completed his residency and is not yet licensed to practice.

“My first day back in the hospital was April 24,” Duvernay-Tardif wrote. “I felt nervous the night before, but a good nervous, like before a game.”

Duvernay-Tardif has also served on the NFL Players’ Association COVID-19 task force, according to Yahoo News .

A spokesperson for Duvernay-Tardif told Medscape Medical News he was unavailable to comment about the announcement.

Starting His Dual Career

Duvernay-Tardif, 29, was drafted in the sixth round by the Chiefs in 2014.

According to Forbes , he spent 8 years (2010-2018) pursuing his medical degree while still playing college football for McGill University in Montreal. Duvernay-Tardif played offensive tackle for the Redmen and in his senior year (2013) won the Metras Trophy as most outstanding lineman in Canadian college football.

He explained in a previous Medscape interview how he managed his dual career; as a doctor he said he would like to focus on emergency medicine:

“I would say that at around 16-17 years of age, I was pretty convinced that medicine was for me,” he told Medscape.

“I was lucky that I didn’t have to do an undergrad program,” he continued. “In Canada, they have a fast-track program where instead of doing a full undergrad before getting into medical school, you can do a 1-year program where you can do all your physiology and biology classes all together.

“I had the chance to get into that program, and that’s how I was able to manage football and medicine at the same time. There’s no way I could have finished my med school doing part-time med school like I did for the past 4 years.”

ESPN explained the opt-out option: “According to an agreement approved by both the league and the union on [July 24], players considered high risk for COVID-19 can earn $350,000 and an accrued NFL season if they choose to opt out of the 2020 season. Players without risk can earn $150,000 for opting out. Duvernay-Tardif was scheduled to make $2.75 million this season.”

The danger of COVID-19 in professional sports has already been seen in Major League Baseball.

According to USA Today, the Miami Marlins have at least 14 players and staff who have tested positive for COVID-19, and major league baseball Commissioner Rob Manfred must decide whether to further delay the shortened season, cancel it, or allow it to continue.

MLB postponed the Marlins’ home opener July 27 against the Baltimore Orioles as well as the New York Yankees game in Philadelphia against the Phillies.

COVID-19 also shut down professional, college, high school, and recreational sports throughout much of the country beginning in March.

 

 

Medicine, Football Intersect

In the previous Medscape interview, Duvernay-Tardif talked about how medicine influenced his football career.

“For me, medicine was really helpful in the sense that I was better able to build a routine and question what works for me and what doesn’t. It gave me the ability to structure my work in order to optimize my time and to make sure that it’s pertinent.

“Another thing is the psychology and the sports psychology. I think there’s a little bit of a stigma around mental health issues in professional sports and everywhere, actually. I think because of medicine, I was more willing to question myself and more willing to use different tools in order to be a better football player.”
 

A version of this article first appeared on Medscape.com.

Laurent Duvernay-Tardif, MD, the only medical doctor on a current NFL roster, has become the first player to opt out of the 2020 NFL season, citing concerns over risk for COVID-19.

Canadian-born Duvernay-Tardif, right guard for the Kansas City Chiefs, announced on Twitter on July 24 what he called “one of the most difficult decisions I have had to make in my life.”

“There is no doubt in my mind the Chiefs’ medical staff have put together a strong plan to minimize the health risks associated with COVID-19, but some risks will remain,” he posted.

“Being at the frontline during this offseason has given me a different perspective on this pandemic and the stress it puts on individuals and our healthcare system. I cannot allow myself to potentially transmit the virus in our communities simply to play the sport that I love. If I am to take risks, I will do it caring for patients.”

According to CNN, Duvernay-Tardif, less than 3 months after helping the Chiefs win the Super Bowl in February, began working at a long-term care facility near Montreal in what he described as a “nursing role.”

Duvernay-Tardif wrote recently in an article for Sports Illustrated that he has not completed his residency and is not yet licensed to practice.

“My first day back in the hospital was April 24,” Duvernay-Tardif wrote. “I felt nervous the night before, but a good nervous, like before a game.”

Duvernay-Tardif has also served on the NFL Players’ Association COVID-19 task force, according to Yahoo News .

A spokesperson for Duvernay-Tardif told Medscape Medical News he was unavailable to comment about the announcement.

Starting His Dual Career

Duvernay-Tardif, 29, was drafted in the sixth round by the Chiefs in 2014.

According to Forbes , he spent 8 years (2010-2018) pursuing his medical degree while still playing college football for McGill University in Montreal. Duvernay-Tardif played offensive tackle for the Redmen and in his senior year (2013) won the Metras Trophy as most outstanding lineman in Canadian college football.

He explained in a previous Medscape interview how he managed his dual career; as a doctor he said he would like to focus on emergency medicine:

“I would say that at around 16-17 years of age, I was pretty convinced that medicine was for me,” he told Medscape.

“I was lucky that I didn’t have to do an undergrad program,” he continued. “In Canada, they have a fast-track program where instead of doing a full undergrad before getting into medical school, you can do a 1-year program where you can do all your physiology and biology classes all together.

“I had the chance to get into that program, and that’s how I was able to manage football and medicine at the same time. There’s no way I could have finished my med school doing part-time med school like I did for the past 4 years.”

ESPN explained the opt-out option: “According to an agreement approved by both the league and the union on [July 24], players considered high risk for COVID-19 can earn $350,000 and an accrued NFL season if they choose to opt out of the 2020 season. Players without risk can earn $150,000 for opting out. Duvernay-Tardif was scheduled to make $2.75 million this season.”

The danger of COVID-19 in professional sports has already been seen in Major League Baseball.

According to USA Today, the Miami Marlins have at least 14 players and staff who have tested positive for COVID-19, and major league baseball Commissioner Rob Manfred must decide whether to further delay the shortened season, cancel it, or allow it to continue.

MLB postponed the Marlins’ home opener July 27 against the Baltimore Orioles as well as the New York Yankees game in Philadelphia against the Phillies.

COVID-19 also shut down professional, college, high school, and recreational sports throughout much of the country beginning in March.

 

 

Medicine, Football Intersect

In the previous Medscape interview, Duvernay-Tardif talked about how medicine influenced his football career.

“For me, medicine was really helpful in the sense that I was better able to build a routine and question what works for me and what doesn’t. It gave me the ability to structure my work in order to optimize my time and to make sure that it’s pertinent.

“Another thing is the psychology and the sports psychology. I think there’s a little bit of a stigma around mental health issues in professional sports and everywhere, actually. I think because of medicine, I was more willing to question myself and more willing to use different tools in order to be a better football player.”
 

A version of this article first appeared on Medscape.com.

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Diary of a rheumatologist who briefly became a COVID hospitalist

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When the coronavirus pandemic hit New York City in early March, the Hospital for Special Surgery leadership decided that the best way to serve the city was to stop elective orthopedic procedures temporarily and use the facility to take on patients from its sister institution, NewYork–Presbyterian Hospital.

As in other institutions, it was all hands on deck. We have hospitalists that are accustomed to managing postsurgical care and internists familiar with preop surgical clearances. But they needed more help, and soon, other internal medicine subspecialists were asked to volunteer, including rheumatologists and primary care sports medicine doctors.

As a rheumatologist, it had been well over 10 years since I had last done any inpatient work. I was filled with trepidation, but I was also excited to dive in.
 

April 4:

Feeling very unmoored. I am in unfamiliar territory, and it’s terrifying. There are so many things that I no longer know how to do. Thankfully, the hospitalists are gracious, extremely supportive, and helpful.

My N95 doesn’t fit well. It’s never fit — not during residency or fellowship, not in any job I’ve had, and not today. The lady fit-testing me said she was sorry, but the look on her face said, “I’m sorry, but you’re going to die.”
 

April 7:

We don’t know how to treat coronavirus. I’ve sent some patients home, others I’ve sent to the ICU. Thank goodness for treatment algorithms from leadership, but we are sorely lacking good-quality data.

Our infectious disease doctor doesn’t think hydroxychloroquine works at all; I suspect he is right. The guidance right now is to give hydroxychloroquine and azithromycin to everyone who is sick enough to be admitted, but there are methodologic flaws in the early enthusiastic preprints, and so far, I’ve not noticed any demonstrable benefit.

The only thing that seems to be happening is that I am seeing more QT prolongation — not something I previously counseled my rheumatology patients on.
 

April 9:

The patients have been, with a few exceptions, alone in the room. They’re not allowed to have visitors and are required to wear masks all the time. Anyone who enters their rooms is fully covered up so you can barely see them. It’s anonymous and dehumanizing.

We’re instructed to take histories by phone in order to limit the time spent in each room. I buck this instruction; I still take histories in person because human contact seems more important now than ever.

Except maybe I should be smarter about this. One of my patients refuses any treatment, including oxygen support. She firmly believes this is a result of 5G networks — something I later discovered was a common conspiracy theory. She refused to wear a mask despite having a very bad cough. She coughed in my face a lot when we were chatting. My face with my ill-fitting N95 mask. Maybe the fit-testing lady’s eyes weren’t lying and I will die after all.
 

April 15:

On the days when I’m not working as a hospitalist, I am still doing remote visits with my rheumatology patients. It feels good to be doing something familiar and something I’m actually good at. But it is surreal to be faced with the quotidian on one hand and life and death on the other.

I recently saw a fairly new patient, and I still haven’t figured out if she has a rheumatic condition or if her symptoms all stem from an alcohol use disorder. In our previous visits, she could barely acknowledge that her drinking was an issue. On today’s visit, she told me she was 1½ months sober.

I don’t know her very well, but it was the happiest news I’d heard in a long time. I was so beside myself with joy that I cried, which says more about my current emotional state than anything else, really.
 

April 21:

On my panel of patients, I have three women with COVID-19 — all of whom lost their husbands to COVID-19, and none of whom were able to say their goodbyes. I cannot even begin to imagine what it must be like to survive this period of illness, isolation, and fear, only to be met on the other side by grief.

Rheumatology doesn’t lend itself too well to such existential concerns; I am not equipped for this. Perhaps my only advantage as a rheumatologist is that I know how to use IVIG, anakinra, and tocilizumab.

Someone on my panel was started on anakinra, and it turned his case around. Would he have gotten better without it anyway? We’ll never know for sure.
 

April 28:

Patients seem to be requiring prolonged intubation. We have now reached the stage where patients are alive but trached and PEGed. One of my patients had been intubated for close to 3 weeks. She was one of four people in her family who contracted the illness (they had had a dinner party before New York’s state of emergency was declared). We thought she might die once she was extubated, but she is still fighting. Unconscious, unarousable, but breathing on her own.

Will she ever wake up? We don’t know. We put the onus on her family to make decisions about placing a PEG tube in. They can only do so from a distance with imperfect information gleaned from periodic, brief FaceTime interactions — where no interaction happens at all.
 

May 4:

It’s my last day as a “COVID hospitalist.” When I first started, I felt like I was being helpful. Walking home in the middle of the 7 PM cheers for healthcare workers frequently left me teary eyed. As horrible as the situation was, I was proud of myself for volunteering to help and appreciative of a broken city’s gratitude toward all healthcare workers in general. Maybe I bought into the idea that, like many others around me, I am a hero.

I don’t feel like a hero, though. The stuff I saw was easy compared with the stuff that my colleagues in critical care saw. Our hospital accepted the more stable patient transfers from our sister hospitals. Patients who remained in the NewYork–Presbyterian system were sicker, with encephalitis, thrombotic complications, multiorgan failure, and cytokine release syndrome. It’s the doctors who took care of those patients who deserve to be called heroes.

No, I am no hero. But did my volunteering make a difference? It made a difference to me. The overwhelming feeling I am left with isn’t pride; it’s humility. I feel humbled that I could feel so unexpectedly touched by the lives of people that I had no idea I could feel touched by.
 

 

 

Postscript:

My patient Esther [name changed to hide her identity] died from COVID-19. She was MY patient — not a patient I met as a COVID hospitalist, but a patient with rheumatoid arthritis whom I cared for for years.

She had scleromalacia and multiple failed scleral grafts, which made her profoundly sad. She fought her anxiety fiercely and always with poise and panache. One way she dealt with her anxiety was that she constantly messaged me via our EHR portal. She ran everything by me and trusted me to be her rock.

The past month has been so busy that I just now noticed it had been a month since I last heard from her. I tried to call her but got her voicemail. It wasn’t until I exchanged messages with her ophthalmologist that I found out she had passed away from complications of COVID-19.

She was taking rituximab and mycophenolate. I wonder if these drugs made her sicker than she would have been otherwise; it fills me with sadness. I wonder if she was alone like my other COVID-19 patients. I wonder if she was afraid. I am sorry that I wasn’t able to say goodbye.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medical College and an attending physician at Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center in New York City. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a columnist for this rheumatology publication, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.

A version of this article originally appeared on Medscape.com. This article is part of a partnership between Medscape and Hospital for Special Surgery.

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When the coronavirus pandemic hit New York City in early March, the Hospital for Special Surgery leadership decided that the best way to serve the city was to stop elective orthopedic procedures temporarily and use the facility to take on patients from its sister institution, NewYork–Presbyterian Hospital.

As in other institutions, it was all hands on deck. We have hospitalists that are accustomed to managing postsurgical care and internists familiar with preop surgical clearances. But they needed more help, and soon, other internal medicine subspecialists were asked to volunteer, including rheumatologists and primary care sports medicine doctors.

As a rheumatologist, it had been well over 10 years since I had last done any inpatient work. I was filled with trepidation, but I was also excited to dive in.
 

April 4:

Feeling very unmoored. I am in unfamiliar territory, and it’s terrifying. There are so many things that I no longer know how to do. Thankfully, the hospitalists are gracious, extremely supportive, and helpful.

My N95 doesn’t fit well. It’s never fit — not during residency or fellowship, not in any job I’ve had, and not today. The lady fit-testing me said she was sorry, but the look on her face said, “I’m sorry, but you’re going to die.”
 

April 7:

We don’t know how to treat coronavirus. I’ve sent some patients home, others I’ve sent to the ICU. Thank goodness for treatment algorithms from leadership, but we are sorely lacking good-quality data.

Our infectious disease doctor doesn’t think hydroxychloroquine works at all; I suspect he is right. The guidance right now is to give hydroxychloroquine and azithromycin to everyone who is sick enough to be admitted, but there are methodologic flaws in the early enthusiastic preprints, and so far, I’ve not noticed any demonstrable benefit.

The only thing that seems to be happening is that I am seeing more QT prolongation — not something I previously counseled my rheumatology patients on.
 

April 9:

The patients have been, with a few exceptions, alone in the room. They’re not allowed to have visitors and are required to wear masks all the time. Anyone who enters their rooms is fully covered up so you can barely see them. It’s anonymous and dehumanizing.

We’re instructed to take histories by phone in order to limit the time spent in each room. I buck this instruction; I still take histories in person because human contact seems more important now than ever.

Except maybe I should be smarter about this. One of my patients refuses any treatment, including oxygen support. She firmly believes this is a result of 5G networks — something I later discovered was a common conspiracy theory. She refused to wear a mask despite having a very bad cough. She coughed in my face a lot when we were chatting. My face with my ill-fitting N95 mask. Maybe the fit-testing lady’s eyes weren’t lying and I will die after all.
 

April 15:

On the days when I’m not working as a hospitalist, I am still doing remote visits with my rheumatology patients. It feels good to be doing something familiar and something I’m actually good at. But it is surreal to be faced with the quotidian on one hand and life and death on the other.

I recently saw a fairly new patient, and I still haven’t figured out if she has a rheumatic condition or if her symptoms all stem from an alcohol use disorder. In our previous visits, she could barely acknowledge that her drinking was an issue. On today’s visit, she told me she was 1½ months sober.

I don’t know her very well, but it was the happiest news I’d heard in a long time. I was so beside myself with joy that I cried, which says more about my current emotional state than anything else, really.
 

April 21:

On my panel of patients, I have three women with COVID-19 — all of whom lost their husbands to COVID-19, and none of whom were able to say their goodbyes. I cannot even begin to imagine what it must be like to survive this period of illness, isolation, and fear, only to be met on the other side by grief.

Rheumatology doesn’t lend itself too well to such existential concerns; I am not equipped for this. Perhaps my only advantage as a rheumatologist is that I know how to use IVIG, anakinra, and tocilizumab.

Someone on my panel was started on anakinra, and it turned his case around. Would he have gotten better without it anyway? We’ll never know for sure.
 

April 28:

Patients seem to be requiring prolonged intubation. We have now reached the stage where patients are alive but trached and PEGed. One of my patients had been intubated for close to 3 weeks. She was one of four people in her family who contracted the illness (they had had a dinner party before New York’s state of emergency was declared). We thought she might die once she was extubated, but she is still fighting. Unconscious, unarousable, but breathing on her own.

Will she ever wake up? We don’t know. We put the onus on her family to make decisions about placing a PEG tube in. They can only do so from a distance with imperfect information gleaned from periodic, brief FaceTime interactions — where no interaction happens at all.
 

May 4:

It’s my last day as a “COVID hospitalist.” When I first started, I felt like I was being helpful. Walking home in the middle of the 7 PM cheers for healthcare workers frequently left me teary eyed. As horrible as the situation was, I was proud of myself for volunteering to help and appreciative of a broken city’s gratitude toward all healthcare workers in general. Maybe I bought into the idea that, like many others around me, I am a hero.

I don’t feel like a hero, though. The stuff I saw was easy compared with the stuff that my colleagues in critical care saw. Our hospital accepted the more stable patient transfers from our sister hospitals. Patients who remained in the NewYork–Presbyterian system were sicker, with encephalitis, thrombotic complications, multiorgan failure, and cytokine release syndrome. It’s the doctors who took care of those patients who deserve to be called heroes.

No, I am no hero. But did my volunteering make a difference? It made a difference to me. The overwhelming feeling I am left with isn’t pride; it’s humility. I feel humbled that I could feel so unexpectedly touched by the lives of people that I had no idea I could feel touched by.
 

 

 

Postscript:

My patient Esther [name changed to hide her identity] died from COVID-19. She was MY patient — not a patient I met as a COVID hospitalist, but a patient with rheumatoid arthritis whom I cared for for years.

She had scleromalacia and multiple failed scleral grafts, which made her profoundly sad. She fought her anxiety fiercely and always with poise and panache. One way she dealt with her anxiety was that she constantly messaged me via our EHR portal. She ran everything by me and trusted me to be her rock.

The past month has been so busy that I just now noticed it had been a month since I last heard from her. I tried to call her but got her voicemail. It wasn’t until I exchanged messages with her ophthalmologist that I found out she had passed away from complications of COVID-19.

She was taking rituximab and mycophenolate. I wonder if these drugs made her sicker than she would have been otherwise; it fills me with sadness. I wonder if she was alone like my other COVID-19 patients. I wonder if she was afraid. I am sorry that I wasn’t able to say goodbye.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medical College and an attending physician at Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center in New York City. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a columnist for this rheumatology publication, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.

A version of this article originally appeared on Medscape.com. This article is part of a partnership between Medscape and Hospital for Special Surgery.

When the coronavirus pandemic hit New York City in early March, the Hospital for Special Surgery leadership decided that the best way to serve the city was to stop elective orthopedic procedures temporarily and use the facility to take on patients from its sister institution, NewYork–Presbyterian Hospital.

As in other institutions, it was all hands on deck. We have hospitalists that are accustomed to managing postsurgical care and internists familiar with preop surgical clearances. But they needed more help, and soon, other internal medicine subspecialists were asked to volunteer, including rheumatologists and primary care sports medicine doctors.

As a rheumatologist, it had been well over 10 years since I had last done any inpatient work. I was filled with trepidation, but I was also excited to dive in.
 

April 4:

Feeling very unmoored. I am in unfamiliar territory, and it’s terrifying. There are so many things that I no longer know how to do. Thankfully, the hospitalists are gracious, extremely supportive, and helpful.

My N95 doesn’t fit well. It’s never fit — not during residency or fellowship, not in any job I’ve had, and not today. The lady fit-testing me said she was sorry, but the look on her face said, “I’m sorry, but you’re going to die.”
 

April 7:

We don’t know how to treat coronavirus. I’ve sent some patients home, others I’ve sent to the ICU. Thank goodness for treatment algorithms from leadership, but we are sorely lacking good-quality data.

Our infectious disease doctor doesn’t think hydroxychloroquine works at all; I suspect he is right. The guidance right now is to give hydroxychloroquine and azithromycin to everyone who is sick enough to be admitted, but there are methodologic flaws in the early enthusiastic preprints, and so far, I’ve not noticed any demonstrable benefit.

The only thing that seems to be happening is that I am seeing more QT prolongation — not something I previously counseled my rheumatology patients on.
 

April 9:

The patients have been, with a few exceptions, alone in the room. They’re not allowed to have visitors and are required to wear masks all the time. Anyone who enters their rooms is fully covered up so you can barely see them. It’s anonymous and dehumanizing.

We’re instructed to take histories by phone in order to limit the time spent in each room. I buck this instruction; I still take histories in person because human contact seems more important now than ever.

Except maybe I should be smarter about this. One of my patients refuses any treatment, including oxygen support. She firmly believes this is a result of 5G networks — something I later discovered was a common conspiracy theory. She refused to wear a mask despite having a very bad cough. She coughed in my face a lot when we were chatting. My face with my ill-fitting N95 mask. Maybe the fit-testing lady’s eyes weren’t lying and I will die after all.
 

April 15:

On the days when I’m not working as a hospitalist, I am still doing remote visits with my rheumatology patients. It feels good to be doing something familiar and something I’m actually good at. But it is surreal to be faced with the quotidian on one hand and life and death on the other.

I recently saw a fairly new patient, and I still haven’t figured out if she has a rheumatic condition or if her symptoms all stem from an alcohol use disorder. In our previous visits, she could barely acknowledge that her drinking was an issue. On today’s visit, she told me she was 1½ months sober.

I don’t know her very well, but it was the happiest news I’d heard in a long time. I was so beside myself with joy that I cried, which says more about my current emotional state than anything else, really.
 

April 21:

On my panel of patients, I have three women with COVID-19 — all of whom lost their husbands to COVID-19, and none of whom were able to say their goodbyes. I cannot even begin to imagine what it must be like to survive this period of illness, isolation, and fear, only to be met on the other side by grief.

Rheumatology doesn’t lend itself too well to such existential concerns; I am not equipped for this. Perhaps my only advantage as a rheumatologist is that I know how to use IVIG, anakinra, and tocilizumab.

Someone on my panel was started on anakinra, and it turned his case around. Would he have gotten better without it anyway? We’ll never know for sure.
 

April 28:

Patients seem to be requiring prolonged intubation. We have now reached the stage where patients are alive but trached and PEGed. One of my patients had been intubated for close to 3 weeks. She was one of four people in her family who contracted the illness (they had had a dinner party before New York’s state of emergency was declared). We thought she might die once she was extubated, but she is still fighting. Unconscious, unarousable, but breathing on her own.

Will she ever wake up? We don’t know. We put the onus on her family to make decisions about placing a PEG tube in. They can only do so from a distance with imperfect information gleaned from periodic, brief FaceTime interactions — where no interaction happens at all.
 

May 4:

It’s my last day as a “COVID hospitalist.” When I first started, I felt like I was being helpful. Walking home in the middle of the 7 PM cheers for healthcare workers frequently left me teary eyed. As horrible as the situation was, I was proud of myself for volunteering to help and appreciative of a broken city’s gratitude toward all healthcare workers in general. Maybe I bought into the idea that, like many others around me, I am a hero.

I don’t feel like a hero, though. The stuff I saw was easy compared with the stuff that my colleagues in critical care saw. Our hospital accepted the more stable patient transfers from our sister hospitals. Patients who remained in the NewYork–Presbyterian system were sicker, with encephalitis, thrombotic complications, multiorgan failure, and cytokine release syndrome. It’s the doctors who took care of those patients who deserve to be called heroes.

No, I am no hero. But did my volunteering make a difference? It made a difference to me. The overwhelming feeling I am left with isn’t pride; it’s humility. I feel humbled that I could feel so unexpectedly touched by the lives of people that I had no idea I could feel touched by.
 

 

 

Postscript:

My patient Esther [name changed to hide her identity] died from COVID-19. She was MY patient — not a patient I met as a COVID hospitalist, but a patient with rheumatoid arthritis whom I cared for for years.

She had scleromalacia and multiple failed scleral grafts, which made her profoundly sad. She fought her anxiety fiercely and always with poise and panache. One way she dealt with her anxiety was that she constantly messaged me via our EHR portal. She ran everything by me and trusted me to be her rock.

The past month has been so busy that I just now noticed it had been a month since I last heard from her. I tried to call her but got her voicemail. It wasn’t until I exchanged messages with her ophthalmologist that I found out she had passed away from complications of COVID-19.

She was taking rituximab and mycophenolate. I wonder if these drugs made her sicker than she would have been otherwise; it fills me with sadness. I wonder if she was alone like my other COVID-19 patients. I wonder if she was afraid. I am sorry that I wasn’t able to say goodbye.

Karmela Kim Chan, MD, is an assistant professor at Weill Cornell Medical College and an attending physician at Hospital for Special Surgery and Memorial Sloan Kettering Cancer Center in New York City. Before moving to New York City, she spent 7 years in private practice in Rhode Island and was a columnist for this rheumatology publication, writing about the challenges of starting life as a full-fledged rheumatologist in a private practice.

A version of this article originally appeared on Medscape.com. This article is part of a partnership between Medscape and Hospital for Special Surgery.

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Hypertension medication adjustment less likely with polypill

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A secondary analysis of a major study of polypill therapy for hypertension found that patients who don’t reach blood pressure targets are less likely to have their medications adjusted if they’re on fixed-dose combination therapy.

Dr. Nelson Wang

However, hypertension patients on low-dose, triple-pill combination therapy are more likely to achieve blood pressure control than are those on usual care.

The secondary analysis of Triple Pill vs. Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) was published online in JAMA Cardiology (2020 Jul 22. doi: 10.1001/jamacardio.2020.2739). The trial randomized 700 patients with hypertension in Sri Lanka to triple-pill fixed-dose combination (FDC) therapy or usual care during February 2016–May 2017, with follow-up ending in October 2017.

A greater proportion of FDC patients reached target BP by the end of the study compared with usual care, 70% vs. 55%. However, the study found that therapeutic inertia – the failure to intensify therapy in nonresponsive patients – was more common in the FDC group at 6- and 12-week follow-up: 87% vs. 64% and 90% vs. 65%, respectively; both differences were significant different at P < .001).

The once-daily FDC pill contained telmisartan 20 mg, amlodipine 2.5 mg; and chlorthalidone 12.5 mg.

“Using a triple low-dose combination blood-pressure pill reduced the need to uptitrate BP therapy as more patients are at target, but doctors were less likely to uptitrate with triple-pill therapy when it was needed,” lead author Nelson Wang, MD, a research fellow at the George Institute for Global Health in suburban Sydney, said in an interview.

“Overall, there were fewer treatment inertia episodes in the triple-pill group than in the usual care group, but this was driven by the fact that fewer triple-pill patients needed uptitration when coming to their follow-up visits,” Dr. Wang added.

The analysis found that clinicians who prescribed triple-pill FDC used 23 unique drug treatment regimens per 100 treated patients compared with 54 different regiments with usual care (P < .001). “There was a large simplification in care,” Dr. Wang said of the FDC approach.

Dr. Wang and colleagues called for greater efforts to address therapeutic inertia, particularly with FDC therapies, and suggested potential strategies consisting of patient education, incentives for appropriate treatment adjustments, and feedback mechanisms and reminders for physicians.

“There may also be a need for more dosage options with the FDC triple pill to allow physicians to intensify therapy without fear of overtreatment and adverse drug effects,” they wrote.

In an accompanying editorial (JAMA Cardiol. 2020 Jul 22. doi: 10.1001/jamacardio.2020.2693), Ann Marie Navar, MD, PhD, associate professor of cardiology at Duke Clinical Research Institute, Durham, N.C., noted that initiating treatment with FDC therapy doesn’t preclude a more personalized approach for patients who don’t achieve their BP target. “The real choice now is the choice of initial treatment,” she wrote, adding that future treatment guidelines should consider extending an FDC-first approach to patients with less severe levels of hypertension.

Dr. Ann Marie Navar

“The study showed there’s room for a both a population-based fixed-drug combination approach and a personalized approach to how we think about hypertension management with fixed-dose therapy,” she said in an interview. “It’s not a one-and-done situation.”

Dr. Wang has no financial relationships to disclose. Study coauthors received funding from the Australian National Health and Medical Research Council and the U.K. National Institute for Health Research. Dr. Navar has no relevant financial relationships to report.

SOURCE: Wang N et al. JAMA Cardiol. 2020. doi: 10.1001/jamacardio.2020.2739.

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A secondary analysis of a major study of polypill therapy for hypertension found that patients who don’t reach blood pressure targets are less likely to have their medications adjusted if they’re on fixed-dose combination therapy.

Dr. Nelson Wang

However, hypertension patients on low-dose, triple-pill combination therapy are more likely to achieve blood pressure control than are those on usual care.

The secondary analysis of Triple Pill vs. Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) was published online in JAMA Cardiology (2020 Jul 22. doi: 10.1001/jamacardio.2020.2739). The trial randomized 700 patients with hypertension in Sri Lanka to triple-pill fixed-dose combination (FDC) therapy or usual care during February 2016–May 2017, with follow-up ending in October 2017.

A greater proportion of FDC patients reached target BP by the end of the study compared with usual care, 70% vs. 55%. However, the study found that therapeutic inertia – the failure to intensify therapy in nonresponsive patients – was more common in the FDC group at 6- and 12-week follow-up: 87% vs. 64% and 90% vs. 65%, respectively; both differences were significant different at P < .001).

The once-daily FDC pill contained telmisartan 20 mg, amlodipine 2.5 mg; and chlorthalidone 12.5 mg.

“Using a triple low-dose combination blood-pressure pill reduced the need to uptitrate BP therapy as more patients are at target, but doctors were less likely to uptitrate with triple-pill therapy when it was needed,” lead author Nelson Wang, MD, a research fellow at the George Institute for Global Health in suburban Sydney, said in an interview.

“Overall, there were fewer treatment inertia episodes in the triple-pill group than in the usual care group, but this was driven by the fact that fewer triple-pill patients needed uptitration when coming to their follow-up visits,” Dr. Wang added.

The analysis found that clinicians who prescribed triple-pill FDC used 23 unique drug treatment regimens per 100 treated patients compared with 54 different regiments with usual care (P < .001). “There was a large simplification in care,” Dr. Wang said of the FDC approach.

Dr. Wang and colleagues called for greater efforts to address therapeutic inertia, particularly with FDC therapies, and suggested potential strategies consisting of patient education, incentives for appropriate treatment adjustments, and feedback mechanisms and reminders for physicians.

“There may also be a need for more dosage options with the FDC triple pill to allow physicians to intensify therapy without fear of overtreatment and adverse drug effects,” they wrote.

In an accompanying editorial (JAMA Cardiol. 2020 Jul 22. doi: 10.1001/jamacardio.2020.2693), Ann Marie Navar, MD, PhD, associate professor of cardiology at Duke Clinical Research Institute, Durham, N.C., noted that initiating treatment with FDC therapy doesn’t preclude a more personalized approach for patients who don’t achieve their BP target. “The real choice now is the choice of initial treatment,” she wrote, adding that future treatment guidelines should consider extending an FDC-first approach to patients with less severe levels of hypertension.

Dr. Ann Marie Navar

“The study showed there’s room for a both a population-based fixed-drug combination approach and a personalized approach to how we think about hypertension management with fixed-dose therapy,” she said in an interview. “It’s not a one-and-done situation.”

Dr. Wang has no financial relationships to disclose. Study coauthors received funding from the Australian National Health and Medical Research Council and the U.K. National Institute for Health Research. Dr. Navar has no relevant financial relationships to report.

SOURCE: Wang N et al. JAMA Cardiol. 2020. doi: 10.1001/jamacardio.2020.2739.

A secondary analysis of a major study of polypill therapy for hypertension found that patients who don’t reach blood pressure targets are less likely to have their medications adjusted if they’re on fixed-dose combination therapy.

Dr. Nelson Wang

However, hypertension patients on low-dose, triple-pill combination therapy are more likely to achieve blood pressure control than are those on usual care.

The secondary analysis of Triple Pill vs. Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) was published online in JAMA Cardiology (2020 Jul 22. doi: 10.1001/jamacardio.2020.2739). The trial randomized 700 patients with hypertension in Sri Lanka to triple-pill fixed-dose combination (FDC) therapy or usual care during February 2016–May 2017, with follow-up ending in October 2017.

A greater proportion of FDC patients reached target BP by the end of the study compared with usual care, 70% vs. 55%. However, the study found that therapeutic inertia – the failure to intensify therapy in nonresponsive patients – was more common in the FDC group at 6- and 12-week follow-up: 87% vs. 64% and 90% vs. 65%, respectively; both differences were significant different at P < .001).

The once-daily FDC pill contained telmisartan 20 mg, amlodipine 2.5 mg; and chlorthalidone 12.5 mg.

“Using a triple low-dose combination blood-pressure pill reduced the need to uptitrate BP therapy as more patients are at target, but doctors were less likely to uptitrate with triple-pill therapy when it was needed,” lead author Nelson Wang, MD, a research fellow at the George Institute for Global Health in suburban Sydney, said in an interview.

“Overall, there were fewer treatment inertia episodes in the triple-pill group than in the usual care group, but this was driven by the fact that fewer triple-pill patients needed uptitration when coming to their follow-up visits,” Dr. Wang added.

The analysis found that clinicians who prescribed triple-pill FDC used 23 unique drug treatment regimens per 100 treated patients compared with 54 different regiments with usual care (P < .001). “There was a large simplification in care,” Dr. Wang said of the FDC approach.

Dr. Wang and colleagues called for greater efforts to address therapeutic inertia, particularly with FDC therapies, and suggested potential strategies consisting of patient education, incentives for appropriate treatment adjustments, and feedback mechanisms and reminders for physicians.

“There may also be a need for more dosage options with the FDC triple pill to allow physicians to intensify therapy without fear of overtreatment and adverse drug effects,” they wrote.

In an accompanying editorial (JAMA Cardiol. 2020 Jul 22. doi: 10.1001/jamacardio.2020.2693), Ann Marie Navar, MD, PhD, associate professor of cardiology at Duke Clinical Research Institute, Durham, N.C., noted that initiating treatment with FDC therapy doesn’t preclude a more personalized approach for patients who don’t achieve their BP target. “The real choice now is the choice of initial treatment,” she wrote, adding that future treatment guidelines should consider extending an FDC-first approach to patients with less severe levels of hypertension.

Dr. Ann Marie Navar

“The study showed there’s room for a both a population-based fixed-drug combination approach and a personalized approach to how we think about hypertension management with fixed-dose therapy,” she said in an interview. “It’s not a one-and-done situation.”

Dr. Wang has no financial relationships to disclose. Study coauthors received funding from the Australian National Health and Medical Research Council and the U.K. National Institute for Health Research. Dr. Navar has no relevant financial relationships to report.

SOURCE: Wang N et al. JAMA Cardiol. 2020. doi: 10.1001/jamacardio.2020.2739.

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Delaying denosumab dose boosts risk for vertebral fractures

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Delaying doses of denosumab after the first injection dramatically boosts the risk that patients with osteoporosis will suffer vertebral fractures, a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.

doble-d/Getty Images

The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.

“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.

Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.

Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”

For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).

The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).

Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).

“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”

In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.

The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”

In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”

The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”

Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.

The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.

Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.

The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
 

SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.

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Delaying doses of denosumab after the first injection dramatically boosts the risk that patients with osteoporosis will suffer vertebral fractures, a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.

doble-d/Getty Images

The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.

“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.

Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.

Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”

For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).

The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).

Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).

“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”

In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.

The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”

In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”

The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”

Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.

The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.

Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.

The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
 

SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.

 

Delaying doses of denosumab after the first injection dramatically boosts the risk that patients with osteoporosis will suffer vertebral fractures, a new study confirms. Physicians say they are especially concerned about the risk facing patients who are delaying the treatment during the coronavirus pandemic.

doble-d/Getty Images

The recommended doses of denosumab are at 6-month intervals. Patients who delayed a dose by more than 16 weeks were nearly four times more likely to suffer vertebral fractures, compared with those who received on-time injections, according to the study, which was published in Annals of Internal Medicine.

“Because patients who used denosumab were at high risk for vertebral fracture, strategies to improve timely administration of denosumab in routine clinical settings are needed,” wrote the study authors, led by Houchen Lyu, MD, PhD, of National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation at General Hospital of Chinese PLA in Beijing.

Denosumab, a human monoclonal antibody, is used to reduce bone loss in osteoporosis. The manufacturer of Prolia, a brand of the drug, recommends it be given every 6 months, but the study reports that it’s common for injections to be delayed.

Researchers have linked cessation of denosumab to higher risk of fractures, and Dr. Lyu led a study published earlier this year that linked less-frequent doses to less bone mineral density improvement. “However,” the authors of the new study wrote, “whether delaying subsequent injections beyond the recommended 6-month interval is associated with fractures is unknown.”

For their new study, researchers retrospectively analyzed data from 2,594 patients in the U.K. 45 years or older (mean age, 76; 94% female; 53% with a history of major osteoporotic fracture) who began taking denosumab between 2010 and 2019. They used a design that aimed to emulate a clinical trial, comparing three dosing intervals: “on time” (within 4 weeks of the recommended 6-month interval), “short delay” (within 4-16 weeks) and “long delay” (16 weeks to 6 months).

The study found that the risk of composite fracture over 6 months out of 1,000 was 27.3 for on-time dosing, 32.2 for short-delay dosing, and 42.4 for long-delay dosing. The hazard ratio for long-delay versus on-time was 1.44 (95% confidence interval, 0.96-2.17; P = .093).

Vertebral fractures were less likely, but delays boosted the risk significantly: Over 6 months, it grew from 2.2 in 1,000 (on time) to 3.6 in 1,000 (short delay) and 10.1 in 1,000 (long delay). The HR for long delay versus on time was 3.91 (95% CI, 1.62-9.45; P = .005).

“This study had limited statistical power for composite fracture and several secondary end points ... except for vertebral fracture. Thus, evidence was insufficient to conclude that fracture risk was increased at other anatomical sites.”

In an accompanying editorial, two physicians from the University of Minnesota, Minneapolis, noted that the study is “timely and relevant” since the coronavirus pandemic may disrupt dosage schedules more than usual. While the study has limitations, the “findings are consistent with known denosumab pharmacokinetics and prior studies of fracture incidence after denosumab treatment discontinuation, wrote Kristine E. Ensrud, MD, MPH, who is also of Minneapolis VA Health Care System, and John T. Schousboe, MD, PhD, who is also of HealthPartners Institute.

The editorial authors noted that, in light of the pandemic, “some organizations recommend temporary transition to an oral bisphosphonate in patients receiving denosumab treatment for whom continued treatment is not feasible within 7 to 8 months of their most recent injection.”

In an interview, endocrinologist and osteoporosis specialist Ethel Siris, MD, of Columbia University, New York, said many of her patients aren’t coming in for denosumab injections during the pandemic. “It’s hard enough to get people to show up every 6 months to get their shot when things are going nicely,” she said. “We’re talking older women who may be on a lot of other medications. People forget, and it’s difficult for the office to constantly remind some of them to get their shots at an infusion center.”

The lack of symptoms is another challenge to getting patients to return for doses, she said. “In osteoporosis, the only time something hurts is if you break it.”

Since the pandemic began, many patients have been avoiding medical offices because of fear of getting the coronavirus.

The new research is helpful because it shows that patients are “more likely to fracture if they delay,” Dr. Siris noted. The endocrinologist added that she has successfully convinced some patients to give themselves subcutaneous injections in the abdomen at home.

Dr. Siris said she has been able to watch patients do these injections on video to check their technique. Her patients have been impressed by “how easy it is and delighted to have accomplished it,” she said.

The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors, commentary authors, and Dr. Siris report no relevant disclosures.
 

SOURCE: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.

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Key clinical point: Patients with osteoporosis who delay denosumab doses are at much higher risk for vertebral fractures.

Major finding: Over 6 months, the risk of vertebral fractures grew from 2.2 in 1,000 (on-time doses) to 10.1 in 1,000 (delay of more than 16 weeks) – a hazard ratio of 3.91 (confidence interval, 1.62 to 9.45; P = .005).

Study details: Retrospective analysis of 2,594 patients in the U.K. 45 years or older who began taking denosumab between 2010 and 2019.

Disclosures: The study was funded by the National Institutes of Health China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation. The study authors report no relevant disclosures.

Source: Lyu H et al. Ann Intern Med. 2020 Jul 28. doi: 10.7326/M20-0882.

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Cleaner data confirm severe COVID-19 link to diabetes, hypertension

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Further refinement of data from patients hospitalized worldwide for COVID-19 disease showed a 12% prevalence rate of patients with diabetes in this population and a 17% prevalence rate for hypertension.

Irina Shatilova/Getty Images

These are lower rates than previously reported for COVID-19 patients with either of these two comorbidities, yet the findings still document important epidemiologic links between diabetes, hypertension, and COVID-19, said the study’s authors.

A meta-analysis of data from 15,794 patients hospitalized because of COVID-19 disease that was drawn from 65 carefully curated reports published from December 1, 2019, to April 6, 2020, also showed that, among the hospitalized COVID-19 patients with diabetes (either type 1 or type 2), the rate of patients who required ICU admission was 96% higher than among those without diabetes and mortality was 2.78-fold higher, both statistically significant differences.

The rate of ICU admissions among those hospitalized with COVID-19 who also had hypertension was 2.95-fold above those without hypertension, and mortality was 2.39-fold higher, also statistically significant differences, reported a team of researchers in the recently published report.

The new meta-analysis was notable for the extra effort investigators employed to eliminate duplicated patients from their database of COVID-19 patients included in various published reports, a potential source of bias that likely introduced errors into prior meta-analyses that used similar data. “We found an overwhelming proportion of studies at high risk of data repetition,” the report said. Virtually all of the included studies were retrospective case studies, nearly two-thirds had data from a single center, and 71% of the studies included only patients in China.

“We developed a method to identify reports that had a high risk for repetitions” of included patients, said Fady Hannah-Shmouni, MD, a senior author of the study. “We also used methods to minimize bias, we excluded certain patients populations, and we applied a uniform definition of COVID-19 disease severity,” specifically patients who died or needed ICU admission, because the definitions used originally by many of the reports were very heterogeneous, said Dr. Hannah-Shmouni, principal investigator for Endocrine, Genetics, and Hypertension at the National Institute of Child Health and Human Development.



Despite the effort to eliminate case duplications, the analysis remains subject to additional confounders, in part because of a lack of comprehensive patient information on factors such as smoking, body mass index, socioeconomic status, and the specific type of diabetes or hypertension a patient had. “Even with these limitations, we were able to show that the prevalence of hypertension and diabetes is elevated in patients with COVID-19, that patients with diabetes have increased risk for both death and ICU admissions, and that there is the potential for reverse causality in the reporting of hypertension as a risk factor for COVID-19,” Dr. Hannah-Shmouni said in an interview. “We believe the explosion of data that associated hypertension and COVID-19 may be partially the result of reverse causality.”

One possible example of this reverse causality is the overlap between hypertension and age as potential risk factors for COVID-19 disease or increased infection severity. People “older than 80 frequently develop severe disease if infected with the novel coronavirus, and 80% of people older than 80 have hypertension, so it’s not surprising that hypertension is highly prevalent among hospitalized COVID-19 patients,” but this “does not imply a causal relationship between hypertension and severe COVID-19; the risk of hypertension probably depends on older age,” noted Ernesto L. Schiffrin, MD, a coauthor of the study, as well as professor of medicine at McGill University and director of the Hypertension and Vascular Research Unit at the Lady Davis Institute for Medical Research, both in Montreal. “My current opinion, on the basis of the totality of data, is that hypertension does not worsen [COVID-19] outcomes, but patients who are elderly, obese, diabetic, or immunocompromised are susceptible to more severe COVID-19 and worse outcomes,” said Dr. Schiffrin in an interview.

The new findings show “there is certainly an interplay between the virus, diabetes, and hypertension and other risk factors,” and while still limited by biases, the new findings “get closer” to correctly estimating the COVID-19 risks associated with these comorbidities,” Dr. Hannah-Shmouni said.

The connections identified between COVID-19, diabetes, and hypertension mean that patients with these chronic diseases should receive education about their COVID-19 risks and should have adequate access to the drugs and supplies they need to control blood pressure and hyperglycemia. Patients with diabetes also need to be current on vaccinations to reduce their risk for pneumonia. And recognition of the heightened COVID-19 risk for people with these comorbidities is important among people who work in relevant government agencies, health care workers, and patient advocacy groups, he added.

The study received no commercial funding. Dr. Hannah-Shmouni and Dr. Schiffrin had no disclosures.

SOURCE: Barrera FJ et al. J Endocn Soc. 2020 July 21. doi: 10.1210/jendso/bvaa102.

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Further refinement of data from patients hospitalized worldwide for COVID-19 disease showed a 12% prevalence rate of patients with diabetes in this population and a 17% prevalence rate for hypertension.

Irina Shatilova/Getty Images

These are lower rates than previously reported for COVID-19 patients with either of these two comorbidities, yet the findings still document important epidemiologic links between diabetes, hypertension, and COVID-19, said the study’s authors.

A meta-analysis of data from 15,794 patients hospitalized because of COVID-19 disease that was drawn from 65 carefully curated reports published from December 1, 2019, to April 6, 2020, also showed that, among the hospitalized COVID-19 patients with diabetes (either type 1 or type 2), the rate of patients who required ICU admission was 96% higher than among those without diabetes and mortality was 2.78-fold higher, both statistically significant differences.

The rate of ICU admissions among those hospitalized with COVID-19 who also had hypertension was 2.95-fold above those without hypertension, and mortality was 2.39-fold higher, also statistically significant differences, reported a team of researchers in the recently published report.

The new meta-analysis was notable for the extra effort investigators employed to eliminate duplicated patients from their database of COVID-19 patients included in various published reports, a potential source of bias that likely introduced errors into prior meta-analyses that used similar data. “We found an overwhelming proportion of studies at high risk of data repetition,” the report said. Virtually all of the included studies were retrospective case studies, nearly two-thirds had data from a single center, and 71% of the studies included only patients in China.

“We developed a method to identify reports that had a high risk for repetitions” of included patients, said Fady Hannah-Shmouni, MD, a senior author of the study. “We also used methods to minimize bias, we excluded certain patients populations, and we applied a uniform definition of COVID-19 disease severity,” specifically patients who died or needed ICU admission, because the definitions used originally by many of the reports were very heterogeneous, said Dr. Hannah-Shmouni, principal investigator for Endocrine, Genetics, and Hypertension at the National Institute of Child Health and Human Development.



Despite the effort to eliminate case duplications, the analysis remains subject to additional confounders, in part because of a lack of comprehensive patient information on factors such as smoking, body mass index, socioeconomic status, and the specific type of diabetes or hypertension a patient had. “Even with these limitations, we were able to show that the prevalence of hypertension and diabetes is elevated in patients with COVID-19, that patients with diabetes have increased risk for both death and ICU admissions, and that there is the potential for reverse causality in the reporting of hypertension as a risk factor for COVID-19,” Dr. Hannah-Shmouni said in an interview. “We believe the explosion of data that associated hypertension and COVID-19 may be partially the result of reverse causality.”

One possible example of this reverse causality is the overlap between hypertension and age as potential risk factors for COVID-19 disease or increased infection severity. People “older than 80 frequently develop severe disease if infected with the novel coronavirus, and 80% of people older than 80 have hypertension, so it’s not surprising that hypertension is highly prevalent among hospitalized COVID-19 patients,” but this “does not imply a causal relationship between hypertension and severe COVID-19; the risk of hypertension probably depends on older age,” noted Ernesto L. Schiffrin, MD, a coauthor of the study, as well as professor of medicine at McGill University and director of the Hypertension and Vascular Research Unit at the Lady Davis Institute for Medical Research, both in Montreal. “My current opinion, on the basis of the totality of data, is that hypertension does not worsen [COVID-19] outcomes, but patients who are elderly, obese, diabetic, or immunocompromised are susceptible to more severe COVID-19 and worse outcomes,” said Dr. Schiffrin in an interview.

The new findings show “there is certainly an interplay between the virus, diabetes, and hypertension and other risk factors,” and while still limited by biases, the new findings “get closer” to correctly estimating the COVID-19 risks associated with these comorbidities,” Dr. Hannah-Shmouni said.

The connections identified between COVID-19, diabetes, and hypertension mean that patients with these chronic diseases should receive education about their COVID-19 risks and should have adequate access to the drugs and supplies they need to control blood pressure and hyperglycemia. Patients with diabetes also need to be current on vaccinations to reduce their risk for pneumonia. And recognition of the heightened COVID-19 risk for people with these comorbidities is important among people who work in relevant government agencies, health care workers, and patient advocacy groups, he added.

The study received no commercial funding. Dr. Hannah-Shmouni and Dr. Schiffrin had no disclosures.

SOURCE: Barrera FJ et al. J Endocn Soc. 2020 July 21. doi: 10.1210/jendso/bvaa102.

Further refinement of data from patients hospitalized worldwide for COVID-19 disease showed a 12% prevalence rate of patients with diabetes in this population and a 17% prevalence rate for hypertension.

Irina Shatilova/Getty Images

These are lower rates than previously reported for COVID-19 patients with either of these two comorbidities, yet the findings still document important epidemiologic links between diabetes, hypertension, and COVID-19, said the study’s authors.

A meta-analysis of data from 15,794 patients hospitalized because of COVID-19 disease that was drawn from 65 carefully curated reports published from December 1, 2019, to April 6, 2020, also showed that, among the hospitalized COVID-19 patients with diabetes (either type 1 or type 2), the rate of patients who required ICU admission was 96% higher than among those without diabetes and mortality was 2.78-fold higher, both statistically significant differences.

The rate of ICU admissions among those hospitalized with COVID-19 who also had hypertension was 2.95-fold above those without hypertension, and mortality was 2.39-fold higher, also statistically significant differences, reported a team of researchers in the recently published report.

The new meta-analysis was notable for the extra effort investigators employed to eliminate duplicated patients from their database of COVID-19 patients included in various published reports, a potential source of bias that likely introduced errors into prior meta-analyses that used similar data. “We found an overwhelming proportion of studies at high risk of data repetition,” the report said. Virtually all of the included studies were retrospective case studies, nearly two-thirds had data from a single center, and 71% of the studies included only patients in China.

“We developed a method to identify reports that had a high risk for repetitions” of included patients, said Fady Hannah-Shmouni, MD, a senior author of the study. “We also used methods to minimize bias, we excluded certain patients populations, and we applied a uniform definition of COVID-19 disease severity,” specifically patients who died or needed ICU admission, because the definitions used originally by many of the reports were very heterogeneous, said Dr. Hannah-Shmouni, principal investigator for Endocrine, Genetics, and Hypertension at the National Institute of Child Health and Human Development.



Despite the effort to eliminate case duplications, the analysis remains subject to additional confounders, in part because of a lack of comprehensive patient information on factors such as smoking, body mass index, socioeconomic status, and the specific type of diabetes or hypertension a patient had. “Even with these limitations, we were able to show that the prevalence of hypertension and diabetes is elevated in patients with COVID-19, that patients with diabetes have increased risk for both death and ICU admissions, and that there is the potential for reverse causality in the reporting of hypertension as a risk factor for COVID-19,” Dr. Hannah-Shmouni said in an interview. “We believe the explosion of data that associated hypertension and COVID-19 may be partially the result of reverse causality.”

One possible example of this reverse causality is the overlap between hypertension and age as potential risk factors for COVID-19 disease or increased infection severity. People “older than 80 frequently develop severe disease if infected with the novel coronavirus, and 80% of people older than 80 have hypertension, so it’s not surprising that hypertension is highly prevalent among hospitalized COVID-19 patients,” but this “does not imply a causal relationship between hypertension and severe COVID-19; the risk of hypertension probably depends on older age,” noted Ernesto L. Schiffrin, MD, a coauthor of the study, as well as professor of medicine at McGill University and director of the Hypertension and Vascular Research Unit at the Lady Davis Institute for Medical Research, both in Montreal. “My current opinion, on the basis of the totality of data, is that hypertension does not worsen [COVID-19] outcomes, but patients who are elderly, obese, diabetic, or immunocompromised are susceptible to more severe COVID-19 and worse outcomes,” said Dr. Schiffrin in an interview.

The new findings show “there is certainly an interplay between the virus, diabetes, and hypertension and other risk factors,” and while still limited by biases, the new findings “get closer” to correctly estimating the COVID-19 risks associated with these comorbidities,” Dr. Hannah-Shmouni said.

The connections identified between COVID-19, diabetes, and hypertension mean that patients with these chronic diseases should receive education about their COVID-19 risks and should have adequate access to the drugs and supplies they need to control blood pressure and hyperglycemia. Patients with diabetes also need to be current on vaccinations to reduce their risk for pneumonia. And recognition of the heightened COVID-19 risk for people with these comorbidities is important among people who work in relevant government agencies, health care workers, and patient advocacy groups, he added.

The study received no commercial funding. Dr. Hannah-Shmouni and Dr. Schiffrin had no disclosures.

SOURCE: Barrera FJ et al. J Endocn Soc. 2020 July 21. doi: 10.1210/jendso/bvaa102.

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