MDedge Endocrinology

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

dbrunk@mdedge.com

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

dbrunk@mdedge.com

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

dbrunk@mdedge.com

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.

Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.

In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.

At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).

The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.

The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.

“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.

The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”

Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”

Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.

Here are the stories our MDedge editors across specialties think you need to know about today:

Pregnant women at higher risk for severe COVID-19

Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.

Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.  

CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.

“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.

Going out of business: Primary care practices at risk

In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.

Here is a sample of Dr. Frieden’s observations:

“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
 

Surge in out-of-hospital cardiac arrests

The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.

Read more.

Fenfluramine approved for Dravet syndrome

The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Pregnant women at higher risk for severe COVID-19

Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.

Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.  

CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.

“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.

Going out of business: Primary care practices at risk

In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.

Here is a sample of Dr. Frieden’s observations:

“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
 

Surge in out-of-hospital cardiac arrests

The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.

Read more.

Fenfluramine approved for Dravet syndrome

The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Pregnant women at higher risk for severe COVID-19

Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.

Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.  

CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.

“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.

Going out of business: Primary care practices at risk

In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.

Here is a sample of Dr. Frieden’s observations:

“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
 

Surge in out-of-hospital cardiac arrests

The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.

During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.

In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.

“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.

The study was published online June 19 in JAMA Cardiology.

Read more.

Fenfluramine approved for Dravet syndrome

The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.

Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.

Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.

A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.

Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.

As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.

SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.

“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.

“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.

Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.

At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.

Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”

With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”

There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.

Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.

“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.

The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.

“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.

He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”

Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.

For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.

The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”

Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”

Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.

Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”

A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.

The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.

The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall

Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”

Medscape.com

Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.

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

The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.

A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.

Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.

As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.

SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.

“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.

“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.

Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.

At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.

Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”

With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”

There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.

Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.

“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.

The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.

“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.

He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”

Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.

For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.

The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”

Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”

Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.

Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”

A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.

The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.

The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall

Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”

Medscape.com

Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.

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

The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.

A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.

Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.

As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.

SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.

“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.

“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.

Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.

At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.

Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”

With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”

There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.

Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.

“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.

The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.

“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.

He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”

Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.

For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.

The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”

Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”

Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.

Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”

A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.

The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.

The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall

Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”

Medscape.com

Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.

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