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SNOT-22 may help identify patients with undiagnosed OSA
CORONADO, CALIF. – results from a retrospective analysis demonstrated.
“We know based on experience and prior studies that there is significant overlap in symptoms for obstructive sleep apnea and chronic rhinosinusitis [CRS], which are two common conditions in the general population,” one of the study authors, David W. Jang, MD, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Therefore, it is important to identify patients with undiagnosed OSA who may present to the physician with nose- and sinus-related symptoms.”
Dr. Jang, assistant professor of rhinology and endoscopic skull surgery in the department of surgery at Duke University, Durham, N.C., and his colleagues conducted a 3-year retrospective analysis of 165 adults who presented with a rhinologic chief complaint and completed the SNOT-22 survey. The researchers compared SNOT-22 survey results between patients with untreated OSA confirmed on polysomnography without chronic rhinosinusitis and a control group of CRS patients. A chi-square test with Bonferroni correction was used for analysis.
Of the 165 patients, 41 met criteria for untreated OSA, based on a mean apnea-hypopnea index of 29.3, while 124 were included in the CRS control group. Sleep and psychological domain scores were not significantly different between the two groups, although patients in the OSA group were more likely to choose a sleep-related symptom as their most important complaint (MIC) (P less than .001). As for the cardinal symptoms of CRS, nasal discharge and loss of smell were significantly higher in the CRS group (P less than .001), while facial pain and nasal obstruction were not significantly different (P = .117 and P = .198, respectively). Facial pain and nasal obstruction were the most common MICs in the rhinologic domain for OSA patients; thick nasal discharge and postnasal discharge were the most common MICs reported by patients in the CRS group.
“It was surprising that, for the cardinal symptoms of CRS, only two of the four were significantly worse for the CRS group and predictive of CRS [nasal discharge and loss of smell],” Dr. Jang said. “Nasal obstruction and facial pain scores were similar between the two groups. Also, there was no significant difference in each of the sleep-related questions when comparing the CRS and OSA groups.”
He concluded that the findings further underscore the “significant overlap in symptoms between CRS and OSA. The SNOT-22 questionnaire may help identify patients with undiagnosed OSA.”
Dr. Jang acknowledged certain limitations of the study, including its retrospective design and relatively small sample size. He reported receiving research funding from Olympus.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.
CORONADO, CALIF. – results from a retrospective analysis demonstrated.
“We know based on experience and prior studies that there is significant overlap in symptoms for obstructive sleep apnea and chronic rhinosinusitis [CRS], which are two common conditions in the general population,” one of the study authors, David W. Jang, MD, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Therefore, it is important to identify patients with undiagnosed OSA who may present to the physician with nose- and sinus-related symptoms.”
Dr. Jang, assistant professor of rhinology and endoscopic skull surgery in the department of surgery at Duke University, Durham, N.C., and his colleagues conducted a 3-year retrospective analysis of 165 adults who presented with a rhinologic chief complaint and completed the SNOT-22 survey. The researchers compared SNOT-22 survey results between patients with untreated OSA confirmed on polysomnography without chronic rhinosinusitis and a control group of CRS patients. A chi-square test with Bonferroni correction was used for analysis.
Of the 165 patients, 41 met criteria for untreated OSA, based on a mean apnea-hypopnea index of 29.3, while 124 were included in the CRS control group. Sleep and psychological domain scores were not significantly different between the two groups, although patients in the OSA group were more likely to choose a sleep-related symptom as their most important complaint (MIC) (P less than .001). As for the cardinal symptoms of CRS, nasal discharge and loss of smell were significantly higher in the CRS group (P less than .001), while facial pain and nasal obstruction were not significantly different (P = .117 and P = .198, respectively). Facial pain and nasal obstruction were the most common MICs in the rhinologic domain for OSA patients; thick nasal discharge and postnasal discharge were the most common MICs reported by patients in the CRS group.
“It was surprising that, for the cardinal symptoms of CRS, only two of the four were significantly worse for the CRS group and predictive of CRS [nasal discharge and loss of smell],” Dr. Jang said. “Nasal obstruction and facial pain scores were similar between the two groups. Also, there was no significant difference in each of the sleep-related questions when comparing the CRS and OSA groups.”
He concluded that the findings further underscore the “significant overlap in symptoms between CRS and OSA. The SNOT-22 questionnaire may help identify patients with undiagnosed OSA.”
Dr. Jang acknowledged certain limitations of the study, including its retrospective design and relatively small sample size. He reported receiving research funding from Olympus.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.
CORONADO, CALIF. – results from a retrospective analysis demonstrated.
“We know based on experience and prior studies that there is significant overlap in symptoms for obstructive sleep apnea and chronic rhinosinusitis [CRS], which are two common conditions in the general population,” one of the study authors, David W. Jang, MD, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Therefore, it is important to identify patients with undiagnosed OSA who may present to the physician with nose- and sinus-related symptoms.”
Dr. Jang, assistant professor of rhinology and endoscopic skull surgery in the department of surgery at Duke University, Durham, N.C., and his colleagues conducted a 3-year retrospective analysis of 165 adults who presented with a rhinologic chief complaint and completed the SNOT-22 survey. The researchers compared SNOT-22 survey results between patients with untreated OSA confirmed on polysomnography without chronic rhinosinusitis and a control group of CRS patients. A chi-square test with Bonferroni correction was used for analysis.
Of the 165 patients, 41 met criteria for untreated OSA, based on a mean apnea-hypopnea index of 29.3, while 124 were included in the CRS control group. Sleep and psychological domain scores were not significantly different between the two groups, although patients in the OSA group were more likely to choose a sleep-related symptom as their most important complaint (MIC) (P less than .001). As for the cardinal symptoms of CRS, nasal discharge and loss of smell were significantly higher in the CRS group (P less than .001), while facial pain and nasal obstruction were not significantly different (P = .117 and P = .198, respectively). Facial pain and nasal obstruction were the most common MICs in the rhinologic domain for OSA patients; thick nasal discharge and postnasal discharge were the most common MICs reported by patients in the CRS group.
“It was surprising that, for the cardinal symptoms of CRS, only two of the four were significantly worse for the CRS group and predictive of CRS [nasal discharge and loss of smell],” Dr. Jang said. “Nasal obstruction and facial pain scores were similar between the two groups. Also, there was no significant difference in each of the sleep-related questions when comparing the CRS and OSA groups.”
He concluded that the findings further underscore the “significant overlap in symptoms between CRS and OSA. The SNOT-22 questionnaire may help identify patients with undiagnosed OSA.”
Dr. Jang acknowledged certain limitations of the study, including its retrospective design and relatively small sample size. He reported receiving research funding from Olympus.
The meeting was jointly sponsored by the Triological Society and the American College of Surgeons.
REPORTING FROM THE TRIOLOGICAL CSM
Key clinical point: Obstructive sleep apnea (OSA) should be suspected in patients with sleep dysfunction as their primary complaint without the significant nasal drainage and anosmia that characterizes chronic rhinosinusitis.
Major finding: Sleep and psychological domain scores on the SNOT-22 were not significantly different between patients with chronic rhinosinusitis and those with OSA, although OSA patients were more likely to choose a sleep-related symptom as their most important complaint (P less than .001).
Study details: A retrospective analysis of 165 adults who presented with a rhinologic chief complaint and completed the SNOT-22 survey.
Disclosures: Dr. Jang reported receiving research funding from Olympus.
New study determines factors that can send flu patients to the ICU
Numerous independent factors – including a history of obstructive/central sleep apnea syndrome (OSAS/CSAS) or myocardial infarction, along with a body mass index greater than 30 g/m2 – could be related to ICU admission and subsequent high mortality rates in influenza patients, according to an analysis of patients in the Netherlands who were treated during the influenza epidemic of 2015-2016.
Along with determining these factors, lead author M.C. Beumer, of Radboud University Medical Center, the Netherlands, and his coauthors found that “coinfections with bacterial, fungal, and viral pathogens developed more often in patients who were admitted to the ICU.” The study was published in the Journal of Critical Care.
The coauthors reviewed 199 influenza patients who were admitted to two medical centers in the Netherlands during October 2015–April 2016. Of those patients, 45 (23%) were admitted to the ICU, primarily because of respiratory failure, and their mortality rate was 17/45 (38%) versus an overall mortality rate of 18/199 (9%).
Compared with patients in the normal ward, patients admitted to the ICU more frequently had a history of OSAS/CSAS (11% vs. 3%; P = .03) and MI (20% vs. 6%; P = .007), along with a BMI higher than 30 g/m2 (30% vs. 15%; P = .04) and dyspnea as a symptom (77% vs. 48%,; P = .001). In addition, more ICU-admitted patients had influenza A rather than influenza B, compared with those not admitted (87% vs. 66%; P = .009).
Pulmonary coinfections – including bacterial, fungal, and viral pathogens – were also proportionally higher among the 45 ICU patients (56% vs. 20%; P less than .0001). The most common bacterial pathogens were Staphylococcus aureus (11%) and Streptococcus pneumoniae (7%) while Aspergillus fumigatus (18%) and Pneumocystis jirovecii (7%) topped the fungal pathogens.
Mr. Beumer and his colleagues noted potential limitations of their work, including the selection of patients from among the “most severely ill” contributing to an ICU admission rate that surpassed the 5%-10% described elsewhere. They also admitted that their study relied on a “relatively small sample size,” focusing on one seasonal influenza outbreak. However, “despite the limited validity,” they reiterated that “the identified factors may contribute to a complicated disease course and could represent a tool for early recognition of the influenza patients at risk for a complicated disease course.”
The authors reported no conflicts of interest.
SOURCE: Beumer MC et al. J Crit Care. 2019;50:59-65.
.
Numerous independent factors – including a history of obstructive/central sleep apnea syndrome (OSAS/CSAS) or myocardial infarction, along with a body mass index greater than 30 g/m2 – could be related to ICU admission and subsequent high mortality rates in influenza patients, according to an analysis of patients in the Netherlands who were treated during the influenza epidemic of 2015-2016.
Along with determining these factors, lead author M.C. Beumer, of Radboud University Medical Center, the Netherlands, and his coauthors found that “coinfections with bacterial, fungal, and viral pathogens developed more often in patients who were admitted to the ICU.” The study was published in the Journal of Critical Care.
The coauthors reviewed 199 influenza patients who were admitted to two medical centers in the Netherlands during October 2015–April 2016. Of those patients, 45 (23%) were admitted to the ICU, primarily because of respiratory failure, and their mortality rate was 17/45 (38%) versus an overall mortality rate of 18/199 (9%).
Compared with patients in the normal ward, patients admitted to the ICU more frequently had a history of OSAS/CSAS (11% vs. 3%; P = .03) and MI (20% vs. 6%; P = .007), along with a BMI higher than 30 g/m2 (30% vs. 15%; P = .04) and dyspnea as a symptom (77% vs. 48%,; P = .001). In addition, more ICU-admitted patients had influenza A rather than influenza B, compared with those not admitted (87% vs. 66%; P = .009).
Pulmonary coinfections – including bacterial, fungal, and viral pathogens – were also proportionally higher among the 45 ICU patients (56% vs. 20%; P less than .0001). The most common bacterial pathogens were Staphylococcus aureus (11%) and Streptococcus pneumoniae (7%) while Aspergillus fumigatus (18%) and Pneumocystis jirovecii (7%) topped the fungal pathogens.
Mr. Beumer and his colleagues noted potential limitations of their work, including the selection of patients from among the “most severely ill” contributing to an ICU admission rate that surpassed the 5%-10% described elsewhere. They also admitted that their study relied on a “relatively small sample size,” focusing on one seasonal influenza outbreak. However, “despite the limited validity,” they reiterated that “the identified factors may contribute to a complicated disease course and could represent a tool for early recognition of the influenza patients at risk for a complicated disease course.”
The authors reported no conflicts of interest.
SOURCE: Beumer MC et al. J Crit Care. 2019;50:59-65.
.
Numerous independent factors – including a history of obstructive/central sleep apnea syndrome (OSAS/CSAS) or myocardial infarction, along with a body mass index greater than 30 g/m2 – could be related to ICU admission and subsequent high mortality rates in influenza patients, according to an analysis of patients in the Netherlands who were treated during the influenza epidemic of 2015-2016.
Along with determining these factors, lead author M.C. Beumer, of Radboud University Medical Center, the Netherlands, and his coauthors found that “coinfections with bacterial, fungal, and viral pathogens developed more often in patients who were admitted to the ICU.” The study was published in the Journal of Critical Care.
The coauthors reviewed 199 influenza patients who were admitted to two medical centers in the Netherlands during October 2015–April 2016. Of those patients, 45 (23%) were admitted to the ICU, primarily because of respiratory failure, and their mortality rate was 17/45 (38%) versus an overall mortality rate of 18/199 (9%).
Compared with patients in the normal ward, patients admitted to the ICU more frequently had a history of OSAS/CSAS (11% vs. 3%; P = .03) and MI (20% vs. 6%; P = .007), along with a BMI higher than 30 g/m2 (30% vs. 15%; P = .04) and dyspnea as a symptom (77% vs. 48%,; P = .001). In addition, more ICU-admitted patients had influenza A rather than influenza B, compared with those not admitted (87% vs. 66%; P = .009).
Pulmonary coinfections – including bacterial, fungal, and viral pathogens – were also proportionally higher among the 45 ICU patients (56% vs. 20%; P less than .0001). The most common bacterial pathogens were Staphylococcus aureus (11%) and Streptococcus pneumoniae (7%) while Aspergillus fumigatus (18%) and Pneumocystis jirovecii (7%) topped the fungal pathogens.
Mr. Beumer and his colleagues noted potential limitations of their work, including the selection of patients from among the “most severely ill” contributing to an ICU admission rate that surpassed the 5%-10% described elsewhere. They also admitted that their study relied on a “relatively small sample size,” focusing on one seasonal influenza outbreak. However, “despite the limited validity,” they reiterated that “the identified factors may contribute to a complicated disease course and could represent a tool for early recognition of the influenza patients at risk for a complicated disease course.”
The authors reported no conflicts of interest.
SOURCE: Beumer MC et al. J Crit Care. 2019;50:59-65.
.
FROM THE JOURNAL OF CRITICAL CARE
Key clinical point:
Major finding: Flu patients in the ICU more frequently had a history of obstructive/central sleep apnea syndrome (11% vs. 3%; P = .03) and MI (20% vs. 6%; P = .007), compared with non-ICU flu patients.
Study details: A retrospective cohort study of 199 flu patients who were admitted to two academic hospitals in the Netherlands.
Disclosures: The authors reported no conflicts of interest.
Source: Beumer MC et al. J Crit Care. 2019; 50:59-65.
FDA approves 0.5-mL Fluzone Quadrivalent vaccine in young children
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.
according to Sanofi Pasteur, the vaccine’s manufacturer.
FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.
This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.
In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.
“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.
Find the full press release on the Sanofi website.
Prescribed opioids increase pneumonia risk in patients with, without HIV
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
Prescribed opioids were associated with an increase in community-acquired pneumonia in patients with and without HIV infection, according to results of a large database study.
People living with HIV (PLWH) appeared to have a greater community-acquired pneumonia (CAP) risk at lower opioid doses and particularly with immunosuppressive opioids compared with uninfected patients, although the difference was not significant, E. Jennifer Edelman, MD, of Yale University, New Haven, Conn., and her colleagues wrote in JAMA Internal Medicine.
The researchers performed a nested case-control study comprising 25,392 participants (98.9% men; mean age, 55 years) in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Dr. Edelman and her colleagues compared the characteristics of 4,246 CAP cases with those of 21,146 uninfected controls in the sample. They also compared cases and controls by HIV status. They ran bivariate and multivariate analysis to estimate odds ratios for CAP risk associated with opioid exposure. In addition, the researchers ran models stratified by HIV status and formally checked for an interaction between prescribed opioid characteristics and HIV status.
In unadjusted logistic regression, prescribed opioids were associated with increased odds of CAP, with the greatest risk observed with currently prescribed opioids, compared with past prescribed opioids or no opioids.
Prescribed opioids remained associated with CAP in the adjusted models for past unknown or nonimmunosuppressive (adjusted OR, 1.24; 95% confidence interval, 1.09-1.40) and past immunosuppressive opioid use (aOR, 1.42; 95% CI, 1.21-1.67).
For currently prescribed opioids, nonimmunosuppressive or unknown, the aOR was 1.23 (95% CI, 1.03-1.48). For currently prescribed immunosuppressive opioids, the aOR was 3.18 (95% CI, 2.44-4.14).
The researchers also found evidence of a dose-response effect such that currently prescribed high-dose opioids were associated with the greatest CAP risk, followed by medium- and then by low-dose opioids, whether immunosuppressive or not.
With regard to the effect of HIV status in stratified, adjusted analyses, CAP risk tended to be greater among PLWH with current prescribed opioids, especially immunosuppressive opioids, compared with uninfected patients. However, the overall interaction term for opioid × HIV status was not significant (P = .36).
Although the researchers stated that a limitation of their study was an inability to prove causality or rule out respiratory depression (vs. immunosuppression) as the cause of the increased CAP risk, “the observed effects of opioid immunosuppressive properties and CAP risk lend support to our hypothesis that opioids have clinically relevant immunosuppressive properties.”
Dr. Edelman and her colleagues cited several limitations. For example, they were not able to determine whether patients took their prescribed medications appropriately and assess whether the patients took nonmedically prescribed opioids. Also, because men made up such a large portion of the study population, it is unclear whether the results are generalizable to women.
Nevertheless, the study “adds to growing evidence of potential medical harms associated with prescribed opioids,” they wrote.
“Health care professionals should be aware of this additional CAP risk when they prescribe opioids, and future studies should investigate the effects of opioids prescribed for longer durations and on other immune-related outcomes,” wrote Dr. Edelman and her colleagues. “Understanding whether mitigating the risk of prescribed opioids for CAP is possible by using a lower dose and nonimmunosuppressive opioids awaits further study.”
However, without such data, when prescribed opioids are warranted, physicians should attempt to modify other factors known to affect CAP risk, including smoking and lack of vaccination, Dr. Edelman and her colleagues concluded.
Several U.S. government agencies and Yale University provided funding for the study. The authors reported that they had no conflicts.
SOURCE: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Prescribed opioids, especially those with immunosuppressive properties, are associated with increased community-acquired pneumonia risk.
Major finding: For currently prescribed immunosuppressive opioids, the adjusted odds ratio for community-acquired pneumonia was 3.18 (95% confidence interval, 2.44-4.14).
Study details: A nested case-control study of 25,392 patients in the Veterans Aging Cohort Study from Jan. 1, 2000, through Dec. 31, 2012.
Disclosures: Funding was provided by a variety of government organizations and Yale University, New Haven, Conn. The authors reported that they had no conflicts.
Source: Edelman EJ et al. JAMA Intern Med. 2019 Jan 7. doi: 10.1001/jamainternmed.2018.6101.
COPD linked to higher in-hospital death rates in patients with PAD
A growing body of evidence suggests that, along with other vascular beds, smoking and chronic obstructive pulmonary disease (COPD) affect the arteries of the lower limbs in terms of the development of peripheral arterial disease (PAD), reported Karsten Keller, MD, of the Johannes Gutenberg-University Mainz (Germany) and his colleagues.
This provided the rationale for their large database analysis of inpatients with concomitant COPD and PAD. They found that the additional presence of COPD was associated with increased in-hospital mortality in patients with PAD.
“Our data suggest that COPD increased the mortality of PAD patients by the factor 1.2-fold,” they wrote in Respiratory Medicine. “Unexpectedly, this increase was not driven by [myocardial infarction] as the life-threatening acute presentation of [coronary artery disease], but rather related to an increased risk for [pulmonary embolism] and a higher coprevalence of cancer.”
Dr. Keller and his colleagues inspected the German inpatient national database based on ICD codes. They identified 5,611,827 adult inpatients (64.8% men) diagnosed with PAD between January 2005 and December 2015, and of those, 13.6% also were coded for COPD. Overall, 277,894 PAD patients (5.0%) died in the hospital, Dr. Keller and his colleagues wrote.
The all-cause, in-hospital mortality was significantly higher in PAD patients with COPD, compared with those without COPD (6.5% vs. 4.7%, respectively; P less than .001), and cardiovascular events comprising pulmonary embolism (PE), deep vein thrombosis (DVT), and myocardial infarction (MI) occurred more often in coprevalence with PAD and COPD than in PAD without COPD.
In PAD patients, COPD was an independent predictor of in-hospital death (odds ratio, 1.16; 95% confidence interval, 1.15-1.17; P less than .001) as well as an independent predictor for PE (OR, 1.44; 95% CI, 1.40-1.49; P less than .001).
Overall, PAD patients with COPD were of similar age as (73 years), but stayed slightly longer in the hospital than (9 vs. 8 days), those without COPD. PAD patients without COPD revealed more often cardiovascular risk factors like essential arterial hypertension and diabetes, but the prevalence of cardiovascular diseases such as coronary artery disease and heart failure were more often found in PAD patients with COPD. In addition, cancer and renal insufficiency also were more common in PAD patients with COPD, according to the authors.
“Remarkably, PAD patients with COPD showed more frequently lower PAD stages than those without COPD. Especially, PAD stage IV was more prevalent in PAD patients without COPD (19.6% vs. 13.8%; P less than 0.001),” the authors stated. In addition, amputations were more often performed in PAD patients without COPD.
Dr. Keller and his colleagues had the following conclusions regarding the clinical implications of their study: “I) PAD patients with long-standing tobacco use might benefit from COPD screening and treatment. II) PAD patients with additional COPD should be monitored more intensively, and the treatment for COPD should be optimized. III) COPD increases the risk for PE, and it is critical not to overlook this life-threatening disease. IV) MI and PE are important causes of in-hospital death in PAD patients with and without COPD.”
The German Federal Ministry of Education and Research funded the study, and the authors reported having no conflicts.
SOURCE: Keller K et al. Respir Med. 2019 Feb;147:1-6.
A growing body of evidence suggests that, along with other vascular beds, smoking and chronic obstructive pulmonary disease (COPD) affect the arteries of the lower limbs in terms of the development of peripheral arterial disease (PAD), reported Karsten Keller, MD, of the Johannes Gutenberg-University Mainz (Germany) and his colleagues.
This provided the rationale for their large database analysis of inpatients with concomitant COPD and PAD. They found that the additional presence of COPD was associated with increased in-hospital mortality in patients with PAD.
“Our data suggest that COPD increased the mortality of PAD patients by the factor 1.2-fold,” they wrote in Respiratory Medicine. “Unexpectedly, this increase was not driven by [myocardial infarction] as the life-threatening acute presentation of [coronary artery disease], but rather related to an increased risk for [pulmonary embolism] and a higher coprevalence of cancer.”
Dr. Keller and his colleagues inspected the German inpatient national database based on ICD codes. They identified 5,611,827 adult inpatients (64.8% men) diagnosed with PAD between January 2005 and December 2015, and of those, 13.6% also were coded for COPD. Overall, 277,894 PAD patients (5.0%) died in the hospital, Dr. Keller and his colleagues wrote.
The all-cause, in-hospital mortality was significantly higher in PAD patients with COPD, compared with those without COPD (6.5% vs. 4.7%, respectively; P less than .001), and cardiovascular events comprising pulmonary embolism (PE), deep vein thrombosis (DVT), and myocardial infarction (MI) occurred more often in coprevalence with PAD and COPD than in PAD without COPD.
In PAD patients, COPD was an independent predictor of in-hospital death (odds ratio, 1.16; 95% confidence interval, 1.15-1.17; P less than .001) as well as an independent predictor for PE (OR, 1.44; 95% CI, 1.40-1.49; P less than .001).
Overall, PAD patients with COPD were of similar age as (73 years), but stayed slightly longer in the hospital than (9 vs. 8 days), those without COPD. PAD patients without COPD revealed more often cardiovascular risk factors like essential arterial hypertension and diabetes, but the prevalence of cardiovascular diseases such as coronary artery disease and heart failure were more often found in PAD patients with COPD. In addition, cancer and renal insufficiency also were more common in PAD patients with COPD, according to the authors.
“Remarkably, PAD patients with COPD showed more frequently lower PAD stages than those without COPD. Especially, PAD stage IV was more prevalent in PAD patients without COPD (19.6% vs. 13.8%; P less than 0.001),” the authors stated. In addition, amputations were more often performed in PAD patients without COPD.
Dr. Keller and his colleagues had the following conclusions regarding the clinical implications of their study: “I) PAD patients with long-standing tobacco use might benefit from COPD screening and treatment. II) PAD patients with additional COPD should be monitored more intensively, and the treatment for COPD should be optimized. III) COPD increases the risk for PE, and it is critical not to overlook this life-threatening disease. IV) MI and PE are important causes of in-hospital death in PAD patients with and without COPD.”
The German Federal Ministry of Education and Research funded the study, and the authors reported having no conflicts.
SOURCE: Keller K et al. Respir Med. 2019 Feb;147:1-6.
A growing body of evidence suggests that, along with other vascular beds, smoking and chronic obstructive pulmonary disease (COPD) affect the arteries of the lower limbs in terms of the development of peripheral arterial disease (PAD), reported Karsten Keller, MD, of the Johannes Gutenberg-University Mainz (Germany) and his colleagues.
This provided the rationale for their large database analysis of inpatients with concomitant COPD and PAD. They found that the additional presence of COPD was associated with increased in-hospital mortality in patients with PAD.
“Our data suggest that COPD increased the mortality of PAD patients by the factor 1.2-fold,” they wrote in Respiratory Medicine. “Unexpectedly, this increase was not driven by [myocardial infarction] as the life-threatening acute presentation of [coronary artery disease], but rather related to an increased risk for [pulmonary embolism] and a higher coprevalence of cancer.”
Dr. Keller and his colleagues inspected the German inpatient national database based on ICD codes. They identified 5,611,827 adult inpatients (64.8% men) diagnosed with PAD between January 2005 and December 2015, and of those, 13.6% also were coded for COPD. Overall, 277,894 PAD patients (5.0%) died in the hospital, Dr. Keller and his colleagues wrote.
The all-cause, in-hospital mortality was significantly higher in PAD patients with COPD, compared with those without COPD (6.5% vs. 4.7%, respectively; P less than .001), and cardiovascular events comprising pulmonary embolism (PE), deep vein thrombosis (DVT), and myocardial infarction (MI) occurred more often in coprevalence with PAD and COPD than in PAD without COPD.
In PAD patients, COPD was an independent predictor of in-hospital death (odds ratio, 1.16; 95% confidence interval, 1.15-1.17; P less than .001) as well as an independent predictor for PE (OR, 1.44; 95% CI, 1.40-1.49; P less than .001).
Overall, PAD patients with COPD were of similar age as (73 years), but stayed slightly longer in the hospital than (9 vs. 8 days), those without COPD. PAD patients without COPD revealed more often cardiovascular risk factors like essential arterial hypertension and diabetes, but the prevalence of cardiovascular diseases such as coronary artery disease and heart failure were more often found in PAD patients with COPD. In addition, cancer and renal insufficiency also were more common in PAD patients with COPD, according to the authors.
“Remarkably, PAD patients with COPD showed more frequently lower PAD stages than those without COPD. Especially, PAD stage IV was more prevalent in PAD patients without COPD (19.6% vs. 13.8%; P less than 0.001),” the authors stated. In addition, amputations were more often performed in PAD patients without COPD.
Dr. Keller and his colleagues had the following conclusions regarding the clinical implications of their study: “I) PAD patients with long-standing tobacco use might benefit from COPD screening and treatment. II) PAD patients with additional COPD should be monitored more intensively, and the treatment for COPD should be optimized. III) COPD increases the risk for PE, and it is critical not to overlook this life-threatening disease. IV) MI and PE are important causes of in-hospital death in PAD patients with and without COPD.”
The German Federal Ministry of Education and Research funded the study, and the authors reported having no conflicts.
SOURCE: Keller K et al. Respir Med. 2019 Feb;147:1-6.
FROM RESPIRATORY MEDICINE
Key clinical point:
Major finding: All-cause, in-hospital mortality was significantly higher in PAD patients with COPD, compared with those without (6.5% vs. 4.7%; P less than 0.001).
Study details: Database analysis of 5.6 million German PAD inpatients stratified for COPD.
Disclosures: The German Federal Ministry of Education and Research funded the study, and the authors reported having no conflicts.
Source: Keller K et al. Respir Med. 2019 Feb;147:1-6.
Flu activity down for second consecutive week
The second week of the new year brought a second straight week of declining activity for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) was 3.1% for the week ending Jan. 12, 2019, down from 3.5% the previous week but still above the national baseline level of 2.2%, the CDC’s influenza division reported Jan. 18.
Activity was also down at the state level. There were 4 states – Colorado, Kentucky, New Jersey, and New Mexico – at level 10 on the CDC’s 1-10 scale for ILI activity, compared with 10 the week before, and a total of 9 were in the high range from 8 to 10, compared with 15 the previous week, data from the influenza division show.
Reports of total influenza deaths, which lag a week behind other measures, continue to rise: 111 for the week ending Jan. 5, although reporting is only 72% complete. There were 89 deaths during the previous week, with reporting 82% complete so far. Total flu-related deaths among children are up to 19 for the 2018-2019 season after three more were reported during the week ending Jan. 12, the CDC said. Influenza deaths from the comparable weeks of the much more severe 2017-2018 season were 1,163 for all ages and 10 for children.
The second week of the new year brought a second straight week of declining activity for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) was 3.1% for the week ending Jan. 12, 2019, down from 3.5% the previous week but still above the national baseline level of 2.2%, the CDC’s influenza division reported Jan. 18.
Activity was also down at the state level. There were 4 states – Colorado, Kentucky, New Jersey, and New Mexico – at level 10 on the CDC’s 1-10 scale for ILI activity, compared with 10 the week before, and a total of 9 were in the high range from 8 to 10, compared with 15 the previous week, data from the influenza division show.
Reports of total influenza deaths, which lag a week behind other measures, continue to rise: 111 for the week ending Jan. 5, although reporting is only 72% complete. There were 89 deaths during the previous week, with reporting 82% complete so far. Total flu-related deaths among children are up to 19 for the 2018-2019 season after three more were reported during the week ending Jan. 12, the CDC said. Influenza deaths from the comparable weeks of the much more severe 2017-2018 season were 1,163 for all ages and 10 for children.
The second week of the new year brought a second straight week of declining activity for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) was 3.1% for the week ending Jan. 12, 2019, down from 3.5% the previous week but still above the national baseline level of 2.2%, the CDC’s influenza division reported Jan. 18.
Activity was also down at the state level. There were 4 states – Colorado, Kentucky, New Jersey, and New Mexico – at level 10 on the CDC’s 1-10 scale for ILI activity, compared with 10 the week before, and a total of 9 were in the high range from 8 to 10, compared with 15 the previous week, data from the influenza division show.
Reports of total influenza deaths, which lag a week behind other measures, continue to rise: 111 for the week ending Jan. 5, although reporting is only 72% complete. There were 89 deaths during the previous week, with reporting 82% complete so far. Total flu-related deaths among children are up to 19 for the 2018-2019 season after three more were reported during the week ending Jan. 12, the CDC said. Influenza deaths from the comparable weeks of the much more severe 2017-2018 season were 1,163 for all ages and 10 for children.
FDA approves Adacel for repeat Tdap vaccinations
The Food and Drug Administration has approved the expanded use of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccinations 8 years or more after the first vaccination in people aged 10-64 years.
The expanded indication was based on results of a randomized, controlled trial, published in the Journal of the Pediatric Infectious Diseases Society, in which more than 1,300 adults aged 18-64 years received either Adacel or a Td (tetanus-diphtheria) vaccine 8-12 years after receiving a previous dose of Adacel.
Over the course of the study, no significant difference in adverse event incidence was observed between groups. Injection-site reaction was the most common adverse event during the study, occurring in 87.7% of those who received Adacel and 88.0% of those who received the Td vaccine. Other common adverse events associated with Adacel include headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.
“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity. The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules,” said David P. Greenberg, MD, regional medical head North America at Sanofi Pasteur, in the press release.
Find the full press release on the Sanofi website.
The Food and Drug Administration has approved the expanded use of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccinations 8 years or more after the first vaccination in people aged 10-64 years.
The expanded indication was based on results of a randomized, controlled trial, published in the Journal of the Pediatric Infectious Diseases Society, in which more than 1,300 adults aged 18-64 years received either Adacel or a Td (tetanus-diphtheria) vaccine 8-12 years after receiving a previous dose of Adacel.
Over the course of the study, no significant difference in adverse event incidence was observed between groups. Injection-site reaction was the most common adverse event during the study, occurring in 87.7% of those who received Adacel and 88.0% of those who received the Td vaccine. Other common adverse events associated with Adacel include headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.
“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity. The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules,” said David P. Greenberg, MD, regional medical head North America at Sanofi Pasteur, in the press release.
Find the full press release on the Sanofi website.
The Food and Drug Administration has approved the expanded use of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccinations 8 years or more after the first vaccination in people aged 10-64 years.
The expanded indication was based on results of a randomized, controlled trial, published in the Journal of the Pediatric Infectious Diseases Society, in which more than 1,300 adults aged 18-64 years received either Adacel or a Td (tetanus-diphtheria) vaccine 8-12 years after receiving a previous dose of Adacel.
Over the course of the study, no significant difference in adverse event incidence was observed between groups. Injection-site reaction was the most common adverse event during the study, occurring in 87.7% of those who received Adacel and 88.0% of those who received the Td vaccine. Other common adverse events associated with Adacel include headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.
“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity. The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules,” said David P. Greenberg, MD, regional medical head North America at Sanofi Pasteur, in the press release.
Find the full press release on the Sanofi website.
Lower grip strength associated with worse health outcomes
Background: Previous studies have shown that lower muscle function is associated with increased mortality; however, studies have not been able to fully examine associations with age and disease-specific mortality.
Study design: Prospective, population-based study.
Setting: Large population cohort in the United Kingdom (UK Biobank).
Synopsis: The UK Biobank population included 502,293 individuals, aged 40-69 years, recruited during April 2007–December 2010, with grip strength data available. Mean follow-up was 7.1 years for all-cause and disease-specific mortality. Cox proportional hazard models were used to report hazard ratios (HR) per 5-kg decrease in grip strength and were controlled for multiple sociodemographic and lifestyle factors. A lower grip strength was found to correlate with all-cause mortality (HR, 1.16 in women; HR, 1.20 in men) as well as incidence of and mortality from cardiovascular disease, respiratory disease, and cancer. Hazard ratios were higher among younger age groups with similar lower grip strength. The use of grip strength also improved the prediction of an office-based mortality risk score from cardiovascular disease.
Bottom line: Grip strength is a useful and easy-to-obtain measurement that is associated with all-cause and disease-specific morbidity and can be used to improve the prediction of an office-based risk score.
Citation: Celis-Morales CA et al. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all-cause mortality: Prospective cohort study of half a million UK Biobank participants. BMJ. 2018;361:k1651.
Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
Background: Previous studies have shown that lower muscle function is associated with increased mortality; however, studies have not been able to fully examine associations with age and disease-specific mortality.
Study design: Prospective, population-based study.
Setting: Large population cohort in the United Kingdom (UK Biobank).
Synopsis: The UK Biobank population included 502,293 individuals, aged 40-69 years, recruited during April 2007–December 2010, with grip strength data available. Mean follow-up was 7.1 years for all-cause and disease-specific mortality. Cox proportional hazard models were used to report hazard ratios (HR) per 5-kg decrease in grip strength and were controlled for multiple sociodemographic and lifestyle factors. A lower grip strength was found to correlate with all-cause mortality (HR, 1.16 in women; HR, 1.20 in men) as well as incidence of and mortality from cardiovascular disease, respiratory disease, and cancer. Hazard ratios were higher among younger age groups with similar lower grip strength. The use of grip strength also improved the prediction of an office-based mortality risk score from cardiovascular disease.
Bottom line: Grip strength is a useful and easy-to-obtain measurement that is associated with all-cause and disease-specific morbidity and can be used to improve the prediction of an office-based risk score.
Citation: Celis-Morales CA et al. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all-cause mortality: Prospective cohort study of half a million UK Biobank participants. BMJ. 2018;361:k1651.
Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
Background: Previous studies have shown that lower muscle function is associated with increased mortality; however, studies have not been able to fully examine associations with age and disease-specific mortality.
Study design: Prospective, population-based study.
Setting: Large population cohort in the United Kingdom (UK Biobank).
Synopsis: The UK Biobank population included 502,293 individuals, aged 40-69 years, recruited during April 2007–December 2010, with grip strength data available. Mean follow-up was 7.1 years for all-cause and disease-specific mortality. Cox proportional hazard models were used to report hazard ratios (HR) per 5-kg decrease in grip strength and were controlled for multiple sociodemographic and lifestyle factors. A lower grip strength was found to correlate with all-cause mortality (HR, 1.16 in women; HR, 1.20 in men) as well as incidence of and mortality from cardiovascular disease, respiratory disease, and cancer. Hazard ratios were higher among younger age groups with similar lower grip strength. The use of grip strength also improved the prediction of an office-based mortality risk score from cardiovascular disease.
Bottom line: Grip strength is a useful and easy-to-obtain measurement that is associated with all-cause and disease-specific morbidity and can be used to improve the prediction of an office-based risk score.
Citation: Celis-Morales CA et al. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all-cause mortality: Prospective cohort study of half a million UK Biobank participants. BMJ. 2018;361:k1651.
Dr. Marr is assistant professor of medicine and an academic hospitalist, University of Utah, Salt Lake City.
INPULSIS-ON: Nintedanib shows manageable long-term safety for IPF
For patients with showed acceptable safety and tolerability and might have slowed disease progression, according to the results of the open-label INPULSIS-ON trial.
No new safety signals were identified among patients who continued nintedanib or switched from placebo to the medication after completing one of the two 52-week phase 3 INPULSIS trials, reported Bruno Crestani, MD, of H
Idiopathic pulmonary fibrosis has had a poor prognosis – before antifibrotic therapy became available in the United States, median survival after diagnosis was estimated at 3-5 years, the researchers noted. Patients often die or deteriorate because of acute declines in respiratory function, often from unknown causes. Nintedanib (Ofev) is an intracellular tyrosine kinase inhibitor first approved for idiopathic pulmonary fibrosis in the United States in 2014, based on the results of the replicate randomized, placebo-controlled, double-blind, phase 3 INPULSIS trials, in which nintedanib (150 mg twice daily) was usually tolerable, showed an acceptable overall toxicity profile, and significantly lessened the annual rate of decline in forced vital capacity (FVC), compared with placebo.
Because idiopathic pulmonary fibrosis has a chronic trajectory, data on long-term safety and efficacy were clearly desirable. “Results from the open-label extension of the [foundational] phase 2 TOMORROW trial [also] identified no new safety signals and suggested an effect of nintedanib on slowing the progression of idiopathic pulmonary fibrosis beyond 52 weeks; however, only 35 patients treated with nintedanib 150 mg twice daily entered the extension study,” Dr. Crestani and his associates noted.
The open-label INPULSIS-ON extension trial included 734 patients, which was 91% of the population that completed the INPULSIS trials. A total of 59% patients in the open-label trial continued nintedanib while the rest switched to nintedanib from placebo. When considering both cohorts, the median duration of exposure to nintedanib was 44.7 months (range, 1.9-68.3 months).
Rates of major adverse cardiovascular events were 2.4 per 100 person-years of drug exposure among treatment initiators and 3.6 per 100 person-years among continuers, the researchers reported. Rates of bleeding were 6.7 and 8.4 events per 100 person-years, respectively, while rates of myocardial infarction, using the broadest possible definition, were 0.7 and 1.3 events per 100 person-years, respectively. The most common adverse event was diarrhea, with 60.1 and 71.2 events per 100 person-years among treatment initiators and continuers, respectively. In all, 10% of treatment initiators and 5% of continuers stopped nintedanib because of diarrhea. A total of 14% of treatment initiators and 12% of continuers stopped treatment because they experienced progression of idiopathic pulmonary fibrosis, making this adverse event the most common reason to stop treatment.
The adjusted annual rate of decline in FVC was −135.1 mL overall, –145 mL in nintedanib continuers, and –119.7 mL in nintedanib initiators, which resembled the findings of the INPULSIS trials, the researcher said. They added that the difference in FVC decline between INPULSIS-ON nintedanib initiators and continuers does not seem clinically meaningful, especially given that the average FVC decline in the INPULSIS placebo group was −223.5 mL per year, and the minimal clinically important difference in FVC is thought to be 2%-6% predicted, a difference of at least 75 mL-80 mL.
Boehringer Ingelheim funded the study. Dr. Crestani disclosed grants and personal fees from Boehringer Ingelheim and Roche, grants from Apellis and MedImmune, and personal fees from AstraZeneca and Sanofi.
SOURCE: Crestani B et al. Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600(18)30339-4.
The study provides “invaluable safety data, including a very low incidence of cardiovascular events” among patients who received long-term nintedanib therapy for idiopathic pulmonary fibrosis, wrote Athol U. Wells, MD, in an editorial published alongside the study.
But the efficacy data were substantially more problematic, he said. “At first sight, the data seem to show that treatment benefits are sustained during long-term follow-up. However, this finding applied to patients completing 4 years of treatment. Approximately 70% of patients discontinued nintedanib [during the open-label extension trial].”
Death, probable treatment failure, or adverse events unrelated to idiopathic pulmonary fibrosis accounted for 62% of withdrawals from this study, and the investigators did not present FVC trends for these patients, he noted. This makes it difficult to know whether bias affected the efficacy results. Long-term stability or slow progression was seen in 30%-40% of patients, exceeding results from previous IPF cohorts, but “this finding, although encouraging, is clearly non-definitive.”
The mortality data also were problematic because the trial excluded patients with major comorbidities and severe disease, and the researchers only tracked vital status for 6 weeks after patients withdrew from INPULSIS-ON, he said. “One cannot help but feel that a major opportunity was lost in this study and, equally, in the pirfenidone extension study. An intention-to-treat study design would have provided invaluable long-term efficacy data and should be prioritized in future.”
Dr. Wells is with Royal Brompton Hospital in London. He disclosed personal fees from Boehringer Ingelheim, Intermune/Roche, Bayer, Actelion, and Raffo, outside the submitted work (Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600[18]30385-0).
The study provides “invaluable safety data, including a very low incidence of cardiovascular events” among patients who received long-term nintedanib therapy for idiopathic pulmonary fibrosis, wrote Athol U. Wells, MD, in an editorial published alongside the study.
But the efficacy data were substantially more problematic, he said. “At first sight, the data seem to show that treatment benefits are sustained during long-term follow-up. However, this finding applied to patients completing 4 years of treatment. Approximately 70% of patients discontinued nintedanib [during the open-label extension trial].”
Death, probable treatment failure, or adverse events unrelated to idiopathic pulmonary fibrosis accounted for 62% of withdrawals from this study, and the investigators did not present FVC trends for these patients, he noted. This makes it difficult to know whether bias affected the efficacy results. Long-term stability or slow progression was seen in 30%-40% of patients, exceeding results from previous IPF cohorts, but “this finding, although encouraging, is clearly non-definitive.”
The mortality data also were problematic because the trial excluded patients with major comorbidities and severe disease, and the researchers only tracked vital status for 6 weeks after patients withdrew from INPULSIS-ON, he said. “One cannot help but feel that a major opportunity was lost in this study and, equally, in the pirfenidone extension study. An intention-to-treat study design would have provided invaluable long-term efficacy data and should be prioritized in future.”
Dr. Wells is with Royal Brompton Hospital in London. He disclosed personal fees from Boehringer Ingelheim, Intermune/Roche, Bayer, Actelion, and Raffo, outside the submitted work (Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600[18]30385-0).
The study provides “invaluable safety data, including a very low incidence of cardiovascular events” among patients who received long-term nintedanib therapy for idiopathic pulmonary fibrosis, wrote Athol U. Wells, MD, in an editorial published alongside the study.
But the efficacy data were substantially more problematic, he said. “At first sight, the data seem to show that treatment benefits are sustained during long-term follow-up. However, this finding applied to patients completing 4 years of treatment. Approximately 70% of patients discontinued nintedanib [during the open-label extension trial].”
Death, probable treatment failure, or adverse events unrelated to idiopathic pulmonary fibrosis accounted for 62% of withdrawals from this study, and the investigators did not present FVC trends for these patients, he noted. This makes it difficult to know whether bias affected the efficacy results. Long-term stability or slow progression was seen in 30%-40% of patients, exceeding results from previous IPF cohorts, but “this finding, although encouraging, is clearly non-definitive.”
The mortality data also were problematic because the trial excluded patients with major comorbidities and severe disease, and the researchers only tracked vital status for 6 weeks after patients withdrew from INPULSIS-ON, he said. “One cannot help but feel that a major opportunity was lost in this study and, equally, in the pirfenidone extension study. An intention-to-treat study design would have provided invaluable long-term efficacy data and should be prioritized in future.”
Dr. Wells is with Royal Brompton Hospital in London. He disclosed personal fees from Boehringer Ingelheim, Intermune/Roche, Bayer, Actelion, and Raffo, outside the submitted work (Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600[18]30385-0).
For patients with showed acceptable safety and tolerability and might have slowed disease progression, according to the results of the open-label INPULSIS-ON trial.
No new safety signals were identified among patients who continued nintedanib or switched from placebo to the medication after completing one of the two 52-week phase 3 INPULSIS trials, reported Bruno Crestani, MD, of H
Idiopathic pulmonary fibrosis has had a poor prognosis – before antifibrotic therapy became available in the United States, median survival after diagnosis was estimated at 3-5 years, the researchers noted. Patients often die or deteriorate because of acute declines in respiratory function, often from unknown causes. Nintedanib (Ofev) is an intracellular tyrosine kinase inhibitor first approved for idiopathic pulmonary fibrosis in the United States in 2014, based on the results of the replicate randomized, placebo-controlled, double-blind, phase 3 INPULSIS trials, in which nintedanib (150 mg twice daily) was usually tolerable, showed an acceptable overall toxicity profile, and significantly lessened the annual rate of decline in forced vital capacity (FVC), compared with placebo.
Because idiopathic pulmonary fibrosis has a chronic trajectory, data on long-term safety and efficacy were clearly desirable. “Results from the open-label extension of the [foundational] phase 2 TOMORROW trial [also] identified no new safety signals and suggested an effect of nintedanib on slowing the progression of idiopathic pulmonary fibrosis beyond 52 weeks; however, only 35 patients treated with nintedanib 150 mg twice daily entered the extension study,” Dr. Crestani and his associates noted.
The open-label INPULSIS-ON extension trial included 734 patients, which was 91% of the population that completed the INPULSIS trials. A total of 59% patients in the open-label trial continued nintedanib while the rest switched to nintedanib from placebo. When considering both cohorts, the median duration of exposure to nintedanib was 44.7 months (range, 1.9-68.3 months).
Rates of major adverse cardiovascular events were 2.4 per 100 person-years of drug exposure among treatment initiators and 3.6 per 100 person-years among continuers, the researchers reported. Rates of bleeding were 6.7 and 8.4 events per 100 person-years, respectively, while rates of myocardial infarction, using the broadest possible definition, were 0.7 and 1.3 events per 100 person-years, respectively. The most common adverse event was diarrhea, with 60.1 and 71.2 events per 100 person-years among treatment initiators and continuers, respectively. In all, 10% of treatment initiators and 5% of continuers stopped nintedanib because of diarrhea. A total of 14% of treatment initiators and 12% of continuers stopped treatment because they experienced progression of idiopathic pulmonary fibrosis, making this adverse event the most common reason to stop treatment.
The adjusted annual rate of decline in FVC was −135.1 mL overall, –145 mL in nintedanib continuers, and –119.7 mL in nintedanib initiators, which resembled the findings of the INPULSIS trials, the researcher said. They added that the difference in FVC decline between INPULSIS-ON nintedanib initiators and continuers does not seem clinically meaningful, especially given that the average FVC decline in the INPULSIS placebo group was −223.5 mL per year, and the minimal clinically important difference in FVC is thought to be 2%-6% predicted, a difference of at least 75 mL-80 mL.
Boehringer Ingelheim funded the study. Dr. Crestani disclosed grants and personal fees from Boehringer Ingelheim and Roche, grants from Apellis and MedImmune, and personal fees from AstraZeneca and Sanofi.
SOURCE: Crestani B et al. Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600(18)30339-4.
For patients with showed acceptable safety and tolerability and might have slowed disease progression, according to the results of the open-label INPULSIS-ON trial.
No new safety signals were identified among patients who continued nintedanib or switched from placebo to the medication after completing one of the two 52-week phase 3 INPULSIS trials, reported Bruno Crestani, MD, of H
Idiopathic pulmonary fibrosis has had a poor prognosis – before antifibrotic therapy became available in the United States, median survival after diagnosis was estimated at 3-5 years, the researchers noted. Patients often die or deteriorate because of acute declines in respiratory function, often from unknown causes. Nintedanib (Ofev) is an intracellular tyrosine kinase inhibitor first approved for idiopathic pulmonary fibrosis in the United States in 2014, based on the results of the replicate randomized, placebo-controlled, double-blind, phase 3 INPULSIS trials, in which nintedanib (150 mg twice daily) was usually tolerable, showed an acceptable overall toxicity profile, and significantly lessened the annual rate of decline in forced vital capacity (FVC), compared with placebo.
Because idiopathic pulmonary fibrosis has a chronic trajectory, data on long-term safety and efficacy were clearly desirable. “Results from the open-label extension of the [foundational] phase 2 TOMORROW trial [also] identified no new safety signals and suggested an effect of nintedanib on slowing the progression of idiopathic pulmonary fibrosis beyond 52 weeks; however, only 35 patients treated with nintedanib 150 mg twice daily entered the extension study,” Dr. Crestani and his associates noted.
The open-label INPULSIS-ON extension trial included 734 patients, which was 91% of the population that completed the INPULSIS trials. A total of 59% patients in the open-label trial continued nintedanib while the rest switched to nintedanib from placebo. When considering both cohorts, the median duration of exposure to nintedanib was 44.7 months (range, 1.9-68.3 months).
Rates of major adverse cardiovascular events were 2.4 per 100 person-years of drug exposure among treatment initiators and 3.6 per 100 person-years among continuers, the researchers reported. Rates of bleeding were 6.7 and 8.4 events per 100 person-years, respectively, while rates of myocardial infarction, using the broadest possible definition, were 0.7 and 1.3 events per 100 person-years, respectively. The most common adverse event was diarrhea, with 60.1 and 71.2 events per 100 person-years among treatment initiators and continuers, respectively. In all, 10% of treatment initiators and 5% of continuers stopped nintedanib because of diarrhea. A total of 14% of treatment initiators and 12% of continuers stopped treatment because they experienced progression of idiopathic pulmonary fibrosis, making this adverse event the most common reason to stop treatment.
The adjusted annual rate of decline in FVC was −135.1 mL overall, –145 mL in nintedanib continuers, and –119.7 mL in nintedanib initiators, which resembled the findings of the INPULSIS trials, the researcher said. They added that the difference in FVC decline between INPULSIS-ON nintedanib initiators and continuers does not seem clinically meaningful, especially given that the average FVC decline in the INPULSIS placebo group was −223.5 mL per year, and the minimal clinically important difference in FVC is thought to be 2%-6% predicted, a difference of at least 75 mL-80 mL.
Boehringer Ingelheim funded the study. Dr. Crestani disclosed grants and personal fees from Boehringer Ingelheim and Roche, grants from Apellis and MedImmune, and personal fees from AstraZeneca and Sanofi.
SOURCE: Crestani B et al. Lancet Respir Med. 2018 Sep 14. doi: 10.1016/S2213-2600(18)30339-4.
FROM THE LANCET RESPIRATORY MEDICINE
Key clinical point: Nintedanib showed manageable safety and tolerability and might have helped conserve forced vital capacity during long-term use for the treatment of IPF.
Major finding: No new safety signals were found over up to 68 months of treatment.
Study details: Open-label extension study of nintedanib initiation or continuation in 734 patients with idiopathic pulmonary fibrosis (median drug exposure 44.7 months; range, 11.9-68.3 months).
Disclosures: Boehringer Ingelheim funded the study. Dr. Crestani disclosed grants and personal fees from Boehringer Ingelheim and Roche, grants from Apellis and MedImmune, and personal fees from AstraZeneca and Sanofi.
Source: Crestani B et al. Lancet Respir Med. 2018 Sep 14.
Lung screening complications costly, more prevalent than in trial setting
The real-world rate of is substantially higher than in clinical trials, a study suggests.
Those complications related to low-dose computed tomography (LDCT) screening are potentially costly, according to the analysis of commercial and Medicare claims data for nearly 350,000 individuals.
While tentative, these results emphasize the need to discuss the risk of adverse events and their costs as part of the shared decision-making process between physicians and patients, researchers said in a report on their study in JAMA Internal Medicine.
“As the number of individuals seeking lung cancer screening with LDCT increases, so too will the number of individuals undergoing invasive diagnostic procedures as a results of abnormal findings,” said Jinhai Huo, MD, PhD, of the department of health services research, management, and policy at the University of Florida, Gainesville.
The retrospective cohort study included 174,702 individuals who underwent an invasive diagnostic procedure related to lung cancer screening and 169,808 control subjects.
All individuals studied were between 55 and 77 years old, the targeted age range for lung cancer screening specified by the Centers for Medicare & Medicaid Services.
Complication rates were about twice as high as they were in the landmark National Lung Screening Trial (NLST), both for a younger cohort of individuals aged 55-64 years, and an older Medicare age group of individuals aged 65 to 77 years, Dr. Huo and coinvestigators reported.
The estimated rate of complications was 22.0% (95% confidence interval, 21.7%-22.7%) in the younger age group, and even higher in the older age group, at 23.8% (95% CI, 23.0%-24.6%), according to investigators. By contrast, complication rates in the NLST were 9.8% and 8.5% for younger and older age cohorts, respectively.
The cost of managing postprocedural complications was higher than the cost of the diagnostic procedures, investigators said.
Mean costs ranged from $6,320 for minor complications to $56,845 for major complications, they reported.
The most common invasive diagnostic procedure in the study cohort was cytology test or biopsy in 26.1%, followed by bronchoscopy in 25.6%, according to study data. Another 5.4% underwent thoracic surgery.
In a previous Medicare advisory committee meeting, some experts expressed concern that complication rates in settings outside of the NLST would be higher than what was reported in that study, Dr. Huo and coauthors noted in their report.
“Our findings echoed this concern,” they said in a discussion of their results.
Dr. Huo and coauthors reported no conflicts of interest related to the research, which was supported in part by grants or fellowships from the University of Texas MD Anderson Cancer Center, the University of Florida, the National Cancer Institute, and the National Institutes of Health.
SOURCE: Huo J et al. JAMA Intern Med. 2019 Jan 14.
“The conversations that are occurring about lung cancer screening are woefully inadequate and do not discuss harms,” wrote Rita F. Redberg, MD, in an editorial note. Shared decision-making visits were made mandatory prior to lung cancer screening by the Centers for Medicare & Medicaid Services. That decision was made because of an evidence review suggesting a “low likelihood” that benefits of lung cancer screening would exceed harms in the Medicare population, Dr. Redberg wrote. Despite that, most Medicare beneficiaries are not having the required visit for shared decision making before they undergo the CT scan.
“It is likely that patients’ decisions not to undergo low-dose computed tomography for lung cancer screening are driven by the high false-positive rate, high chance of incidental findings, and subsequent need for invasive procedures, and small chance of benefit,” she said in her comment.
Shared decision-making visits are also rarely happening in the privately insured population, as shown in previous research, Dr. Redberg noted.
She reported no conflicts of interest related to her Editor’s Note, which appears in JAMA Internal Medicine (2019 Jan 14).
Dr. Redberg is with the department of medicine, University of California, San Francisco.
“The conversations that are occurring about lung cancer screening are woefully inadequate and do not discuss harms,” wrote Rita F. Redberg, MD, in an editorial note. Shared decision-making visits were made mandatory prior to lung cancer screening by the Centers for Medicare & Medicaid Services. That decision was made because of an evidence review suggesting a “low likelihood” that benefits of lung cancer screening would exceed harms in the Medicare population, Dr. Redberg wrote. Despite that, most Medicare beneficiaries are not having the required visit for shared decision making before they undergo the CT scan.
“It is likely that patients’ decisions not to undergo low-dose computed tomography for lung cancer screening are driven by the high false-positive rate, high chance of incidental findings, and subsequent need for invasive procedures, and small chance of benefit,” she said in her comment.
Shared decision-making visits are also rarely happening in the privately insured population, as shown in previous research, Dr. Redberg noted.
She reported no conflicts of interest related to her Editor’s Note, which appears in JAMA Internal Medicine (2019 Jan 14).
Dr. Redberg is with the department of medicine, University of California, San Francisco.
“The conversations that are occurring about lung cancer screening are woefully inadequate and do not discuss harms,” wrote Rita F. Redberg, MD, in an editorial note. Shared decision-making visits were made mandatory prior to lung cancer screening by the Centers for Medicare & Medicaid Services. That decision was made because of an evidence review suggesting a “low likelihood” that benefits of lung cancer screening would exceed harms in the Medicare population, Dr. Redberg wrote. Despite that, most Medicare beneficiaries are not having the required visit for shared decision making before they undergo the CT scan.
“It is likely that patients’ decisions not to undergo low-dose computed tomography for lung cancer screening are driven by the high false-positive rate, high chance of incidental findings, and subsequent need for invasive procedures, and small chance of benefit,” she said in her comment.
Shared decision-making visits are also rarely happening in the privately insured population, as shown in previous research, Dr. Redberg noted.
She reported no conflicts of interest related to her Editor’s Note, which appears in JAMA Internal Medicine (2019 Jan 14).
Dr. Redberg is with the department of medicine, University of California, San Francisco.
The real-world rate of is substantially higher than in clinical trials, a study suggests.
Those complications related to low-dose computed tomography (LDCT) screening are potentially costly, according to the analysis of commercial and Medicare claims data for nearly 350,000 individuals.
While tentative, these results emphasize the need to discuss the risk of adverse events and their costs as part of the shared decision-making process between physicians and patients, researchers said in a report on their study in JAMA Internal Medicine.
“As the number of individuals seeking lung cancer screening with LDCT increases, so too will the number of individuals undergoing invasive diagnostic procedures as a results of abnormal findings,” said Jinhai Huo, MD, PhD, of the department of health services research, management, and policy at the University of Florida, Gainesville.
The retrospective cohort study included 174,702 individuals who underwent an invasive diagnostic procedure related to lung cancer screening and 169,808 control subjects.
All individuals studied were between 55 and 77 years old, the targeted age range for lung cancer screening specified by the Centers for Medicare & Medicaid Services.
Complication rates were about twice as high as they were in the landmark National Lung Screening Trial (NLST), both for a younger cohort of individuals aged 55-64 years, and an older Medicare age group of individuals aged 65 to 77 years, Dr. Huo and coinvestigators reported.
The estimated rate of complications was 22.0% (95% confidence interval, 21.7%-22.7%) in the younger age group, and even higher in the older age group, at 23.8% (95% CI, 23.0%-24.6%), according to investigators. By contrast, complication rates in the NLST were 9.8% and 8.5% for younger and older age cohorts, respectively.
The cost of managing postprocedural complications was higher than the cost of the diagnostic procedures, investigators said.
Mean costs ranged from $6,320 for minor complications to $56,845 for major complications, they reported.
The most common invasive diagnostic procedure in the study cohort was cytology test or biopsy in 26.1%, followed by bronchoscopy in 25.6%, according to study data. Another 5.4% underwent thoracic surgery.
In a previous Medicare advisory committee meeting, some experts expressed concern that complication rates in settings outside of the NLST would be higher than what was reported in that study, Dr. Huo and coauthors noted in their report.
“Our findings echoed this concern,” they said in a discussion of their results.
Dr. Huo and coauthors reported no conflicts of interest related to the research, which was supported in part by grants or fellowships from the University of Texas MD Anderson Cancer Center, the University of Florida, the National Cancer Institute, and the National Institutes of Health.
SOURCE: Huo J et al. JAMA Intern Med. 2019 Jan 14.
The real-world rate of is substantially higher than in clinical trials, a study suggests.
Those complications related to low-dose computed tomography (LDCT) screening are potentially costly, according to the analysis of commercial and Medicare claims data for nearly 350,000 individuals.
While tentative, these results emphasize the need to discuss the risk of adverse events and their costs as part of the shared decision-making process between physicians and patients, researchers said in a report on their study in JAMA Internal Medicine.
“As the number of individuals seeking lung cancer screening with LDCT increases, so too will the number of individuals undergoing invasive diagnostic procedures as a results of abnormal findings,” said Jinhai Huo, MD, PhD, of the department of health services research, management, and policy at the University of Florida, Gainesville.
The retrospective cohort study included 174,702 individuals who underwent an invasive diagnostic procedure related to lung cancer screening and 169,808 control subjects.
All individuals studied were between 55 and 77 years old, the targeted age range for lung cancer screening specified by the Centers for Medicare & Medicaid Services.
Complication rates were about twice as high as they were in the landmark National Lung Screening Trial (NLST), both for a younger cohort of individuals aged 55-64 years, and an older Medicare age group of individuals aged 65 to 77 years, Dr. Huo and coinvestigators reported.
The estimated rate of complications was 22.0% (95% confidence interval, 21.7%-22.7%) in the younger age group, and even higher in the older age group, at 23.8% (95% CI, 23.0%-24.6%), according to investigators. By contrast, complication rates in the NLST were 9.8% and 8.5% for younger and older age cohorts, respectively.
The cost of managing postprocedural complications was higher than the cost of the diagnostic procedures, investigators said.
Mean costs ranged from $6,320 for minor complications to $56,845 for major complications, they reported.
The most common invasive diagnostic procedure in the study cohort was cytology test or biopsy in 26.1%, followed by bronchoscopy in 25.6%, according to study data. Another 5.4% underwent thoracic surgery.
In a previous Medicare advisory committee meeting, some experts expressed concern that complication rates in settings outside of the NLST would be higher than what was reported in that study, Dr. Huo and coauthors noted in their report.
“Our findings echoed this concern,” they said in a discussion of their results.
Dr. Huo and coauthors reported no conflicts of interest related to the research, which was supported in part by grants or fellowships from the University of Texas MD Anderson Cancer Center, the University of Florida, the National Cancer Institute, and the National Institutes of Health.
SOURCE: Huo J et al. JAMA Intern Med. 2019 Jan 14.
FROM JAMA INTERNAL MEDICINE
Key clinical point: The risk of complications following lung cancer screening is higher in a real-world setting as compared with the landmark National Lung Screening Trial (NLST).
Major finding: Estimated complication rates were 22.0%-23.8%, compared with 8.5%-9.8% in the NLST.
Study details: A retrospective cohort study including 174,702 individuals who underwent an invasive diagnostic procedure related to lung cancer screening and 169,808 controls.
Disclosures: Authors reported no conflicts of interest. The research was supported in part by grants or fellowships from the University of Texas MD Anderson Cancer Center, the University of Florida, the National Cancer Institute, and the National Institutes of Health.
Source: Huo J et al. JAMA Intern Med. 2019 Jan 14.