Amy Karon

Risk of interval colorectal cancer (CRC) more than doubled when average withdrawal times during routine colonoscopy were less than 6 minutes, investigators reported in the October issue of Gastroenterology.

The results reinforce current guidelines that set a withdrawal time of at least 6 minutes as a quality indicator for screening colonoscopy, said Dr. Aasma Shaukat at the Minneapolis Veterans Affairs Health Care System and her associates. “Focusing quality-improvement efforts on withdrawal time [less] than 6 minutes would likely have the most impact,” although rates of interval CRC were “lowest and relatively constant” when withdrawal times were at least 8 minutes, the investigators said.

©Eraxion/thinkstockphotos.com

Short scope withdrawal times are known to decrease adenoma detection rates, but their impact on risk of interval CRC had not been examined before, the investigators said. Their retrospective, multicenter, community-based study included 76,810 colonoscopies performed by 51 endoscopists in and near Minneapolis and St. Paul between 2004 and 2009. Follow-up time was 5.5 years or until cancer diagnosis (Gastroenterology 2015 June 5 [doi: 10.1053/j.gastro.2015.06.001]) .

Patients of endoscopists whose withdrawal times averaged less than 6 minutes had a 2.3-fold higher rate of interval CRC, compared with patients whose physicians took at least 6 minutes to withdraw the scope (incidence rate ratio, 2.3; 95% confidence interval, 1.5-3.4; P less than .0001), even after they had accounted for age, sex, and quality of preparation for colonoscopy, the researchers reported. Every extra minute of withdrawal time also led to a 3.6% rise in the chances of detecting an adenoma (95% CI, 2.4%-4.8%; P less than .0001). Physicians whose adenoma detection rates averaged at least 25% had somewhat lower interval CRC rates among their patients than did those whose adenoma detection rates (ADRs) were less than 25%, although the difference was not significant. Adjusting for ADRs also did not alter the link between withdrawal time and risk of interval CRC, but restricting the analysis to 2007 and later weakened the association slightly (IRR, 2.0; 95% CI; 1.0-3.9; P = .04). Finally, patients who were aged 60-69 years had interval CRCs almost three times more often than did younger patients, and patients who were at least 70 years old had 6.2 times the frequency of interval CRCs, compared with the youngest age group, the investigators reported.The researchers designed the study around the 6-minute withdrawal time threshold because of current guidelines but found “no obvious cut point for defining poor quality for screening colonoscopies,” they said. Although the patient sample represented the community-based target population for screening programs, the study had some limitations, the investigators added. For example, they used 2007 withdrawal times for the years 2004-2006 because they lacked data for those years, and as a result, they could have overestimated the association between withdrawal time and risk of interval CRC, they said. They also would have missed any cancer cases diagnosed in other states and could not distinguish between cancers diagnosed because of symptoms and those that were first detected on screening colonoscopy, they noted.

A Veterans Affairs Career Development program and the Center for Chronic Disease Outcomes Research funded the study. The authors reported having no conflicts of interest.

Risk of interval colorectal cancer (CRC) more than doubled when average withdrawal times during routine colonoscopy were less than 6 minutes, investigators reported in the October issue of Gastroenterology.

The results reinforce current guidelines that set a withdrawal time of at least 6 minutes as a quality indicator for screening colonoscopy, said Dr. Aasma Shaukat at the Minneapolis Veterans Affairs Health Care System and her associates. “Focusing quality-improvement efforts on withdrawal time [less] than 6 minutes would likely have the most impact,” although rates of interval CRC were “lowest and relatively constant” when withdrawal times were at least 8 minutes, the investigators said.

©Eraxion/thinkstockphotos.com

Short scope withdrawal times are known to decrease adenoma detection rates, but their impact on risk of interval CRC had not been examined before, the investigators said. Their retrospective, multicenter, community-based study included 76,810 colonoscopies performed by 51 endoscopists in and near Minneapolis and St. Paul between 2004 and 2009. Follow-up time was 5.5 years or until cancer diagnosis (Gastroenterology 2015 June 5 [doi: 10.1053/j.gastro.2015.06.001]) .

Patients of endoscopists whose withdrawal times averaged less than 6 minutes had a 2.3-fold higher rate of interval CRC, compared with patients whose physicians took at least 6 minutes to withdraw the scope (incidence rate ratio, 2.3; 95% confidence interval, 1.5-3.4; P less than .0001), even after they had accounted for age, sex, and quality of preparation for colonoscopy, the researchers reported. Every extra minute of withdrawal time also led to a 3.6% rise in the chances of detecting an adenoma (95% CI, 2.4%-4.8%; P less than .0001). Physicians whose adenoma detection rates averaged at least 25% had somewhat lower interval CRC rates among their patients than did those whose adenoma detection rates (ADRs) were less than 25%, although the difference was not significant. Adjusting for ADRs also did not alter the link between withdrawal time and risk of interval CRC, but restricting the analysis to 2007 and later weakened the association slightly (IRR, 2.0; 95% CI; 1.0-3.9; P = .04). Finally, patients who were aged 60-69 years had interval CRCs almost three times more often than did younger patients, and patients who were at least 70 years old had 6.2 times the frequency of interval CRCs, compared with the youngest age group, the investigators reported.The researchers designed the study around the 6-minute withdrawal time threshold because of current guidelines but found “no obvious cut point for defining poor quality for screening colonoscopies,” they said. Although the patient sample represented the community-based target population for screening programs, the study had some limitations, the investigators added. For example, they used 2007 withdrawal times for the years 2004-2006 because they lacked data for those years, and as a result, they could have overestimated the association between withdrawal time and risk of interval CRC, they said. They also would have missed any cancer cases diagnosed in other states and could not distinguish between cancers diagnosed because of symptoms and those that were first detected on screening colonoscopy, they noted.

A Veterans Affairs Career Development program and the Center for Chronic Disease Outcomes Research funded the study. The authors reported having no conflicts of interest.

Risk of interval colorectal cancer (CRC) more than doubled when average withdrawal times during routine colonoscopy were less than 6 minutes, investigators reported in the October issue of Gastroenterology.

The results reinforce current guidelines that set a withdrawal time of at least 6 minutes as a quality indicator for screening colonoscopy, said Dr. Aasma Shaukat at the Minneapolis Veterans Affairs Health Care System and her associates. “Focusing quality-improvement efforts on withdrawal time [less] than 6 minutes would likely have the most impact,” although rates of interval CRC were “lowest and relatively constant” when withdrawal times were at least 8 minutes, the investigators said.

©Eraxion/thinkstockphotos.com

Short scope withdrawal times are known to decrease adenoma detection rates, but their impact on risk of interval CRC had not been examined before, the investigators said. Their retrospective, multicenter, community-based study included 76,810 colonoscopies performed by 51 endoscopists in and near Minneapolis and St. Paul between 2004 and 2009. Follow-up time was 5.5 years or until cancer diagnosis (Gastroenterology 2015 June 5 [doi: 10.1053/j.gastro.2015.06.001]) .

Patients of endoscopists whose withdrawal times averaged less than 6 minutes had a 2.3-fold higher rate of interval CRC, compared with patients whose physicians took at least 6 minutes to withdraw the scope (incidence rate ratio, 2.3; 95% confidence interval, 1.5-3.4; P less than .0001), even after they had accounted for age, sex, and quality of preparation for colonoscopy, the researchers reported. Every extra minute of withdrawal time also led to a 3.6% rise in the chances of detecting an adenoma (95% CI, 2.4%-4.8%; P less than .0001). Physicians whose adenoma detection rates averaged at least 25% had somewhat lower interval CRC rates among their patients than did those whose adenoma detection rates (ADRs) were less than 25%, although the difference was not significant. Adjusting for ADRs also did not alter the link between withdrawal time and risk of interval CRC, but restricting the analysis to 2007 and later weakened the association slightly (IRR, 2.0; 95% CI; 1.0-3.9; P = .04). Finally, patients who were aged 60-69 years had interval CRCs almost three times more often than did younger patients, and patients who were at least 70 years old had 6.2 times the frequency of interval CRCs, compared with the youngest age group, the investigators reported.The researchers designed the study around the 6-minute withdrawal time threshold because of current guidelines but found “no obvious cut point for defining poor quality for screening colonoscopies,” they said. Although the patient sample represented the community-based target population for screening programs, the study had some limitations, the investigators added. For example, they used 2007 withdrawal times for the years 2004-2006 because they lacked data for those years, and as a result, they could have overestimated the association between withdrawal time and risk of interval CRC, they said. They also would have missed any cancer cases diagnosed in other states and could not distinguish between cancers diagnosed because of symptoms and those that were first detected on screening colonoscopy, they noted.

A Veterans Affairs Career Development program and the Center for Chronic Disease Outcomes Research funded the study. The authors reported having no conflicts of interest.

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Brodalumab met all primary endpoints against its first-in-class rival, ustekinumab, and against placebo in two phase III trials of more than 3,700 patients with moderate to severe plaque psoriasis, investigators reported in the New England Journal of Medicine.

The results of the two studies, AMAGINE-2 and AMAGINE-3, were published on Sept. 30 (N Eng J Med. 2015;373:1318-28).

“The data for brodalumab are the best data we’ve seen. It literally is twice as effective at achieving PASI [Psoriasis Area Severity Index] 100 as ustekinumab, which is a spectacular drug,” lead investigator Dr. Mark Lebwohl said in an interview. “More than two-thirds of patients achieved PASI 90. We’ve never seen data like this before,” said Dr. Lebwohl, professor and chairman of the department of dermatology at Icahn School of Medicine at Mount Sinai, New York.

Dermatologists and patients have closely followed brodalumab, an investigational interleukin-17 receptor A inhibitor, which, in March 2015, was reported to have doubled the PASI 100 response rate of ustekinumab in the AMAGINE-2 trial. But 2 months later, Amgen pulled funding and ended its partnership with AstraZeneca on the biologic in the wake of suicides of two patients who had recently completed brodalumab treatment. At the time, Amgen stated that it was concerned that brodalumab would receive restrictive labeling related to suicidal ideation and behavior. An Amgen spokeswoman on Sept. 29 declined to elaborate.

On Sept. 1, however, Valeant Pharmaceuticals announced that it was partnering with AstraZeneca to continue with plans to develop and commercialize brodalumab and that regulatory submissions in the United States and the European Union were planned for the 4th quarter of 2015.

In the interview, Dr. Lebwohl said he did not know of a mechanism by which blocking the IL-17 receptor might increase the risk of depression or suicide. “But psoriasis is certainly associated with depression,” he added. “Two out of more than 3,700 patients committed suicide over more than a year, and that could certainly be attributable to the depression associated with the underlying skin disease.”

AMAGINE-2 and AMAGINE-3 were replicate phase III, double-blind, randomized, controlled trials of 3,712 patients with moderate to severe plaque psoriasis. In the two studies, week 12 PASI 75 rates were about 85% with 210 mg of brodalumab, about 68% for 140 mg of brodalumab, and 6%-8% for placebo (P less than .001). Moreover, week 12 PASI 100 response rates with 210 mg of brodalumab were 37% and 44%, compared with 19% and 22% for ustekinumab (P less than .001), the investigators reported.

Median time to PASI 75 on 210 mg of brodalumab was 4 weeks – about twice as fast as for ustekinumab. Rates of static Physician’s Global Assessment (sPGA) scores of 0 or 1 (clear or almost clear skin) also were significantly higher for brodalumab, compared with placebo (P less than .001).

Mild to moderate candidiasis was more common during induction of brodalumab, compared with ustekinumab or placebo, underscoring the role of interleukin-17A in microbial surveillance, Dr. Lebwohl and his associates pointed out. They estimated that 1-1.3 serious infections occurred for every 100 patient-years of exposure to brodalumab, through 52 weeks.

The investigators reported but did not comment on the suicides, stating only that the study populations were large enough to assess common adverse events but “may have been inadequate for the detection of rare adverse events, which would require longer follow-up of large numbers of patients to provide a full understanding of the safety profile of brodalumab.”

Ustekinumab is marketed as Stelara.

Amgen funded the AMAGINE-2 and AMAGINE-3 studies. Dr. Lebwohl reported having received grant support from Amgen, AbbVie, Janssen Biotech, UCB Pharma, Pfizer, Celgene, Eli Lilly, and Novartis outside the submitted work. Twenty-four coauthors reported grant support or personal fees from Amgen, Abbvie, Merck, Janssen, and several other pharmaceutical companies. The other investigators declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Self-reported psoriasis more than doubled the odds of major depression, even after accounting for demographic factors and comorbidities, reported the authors of a study that used data from the National Health and Nutrition Examination Survey.

In addition, depressive symptoms adversely affected the work and social lives of psoriasis patients in this first-in-kind study, said Dr. Brandon Cohen and his associates of the department of dermatology, New York University. “The risk of major depression was not associated with the self-reported degree of psoriasis. Therefore, our study supports that all patients with psoriasis, regardless of severity, are at risk for depressive symptoms and may benefit from depression screening,” they wrote. The study was published online on Sept. 30 in JAMA Dermatology (2015 Sep 30. doi: 10.1001/jamadermatol.2015.3605).

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis is known to increase the risk of major depression, as well as anxiety disorders, substance abuse, and suicidal ideation. To better understand whether disease severity or comorbidities affect the psoriasis-depression link, the researchers analyzed self-reported health data from 12,382 individuals who had responded to the National Health and Nutrition Examination Survey between 2009 and 2012. The investigators defined major depression as a score of at least 10 on the 27-point Patient Health Questionnaire-9 (PHQ-9). Psoriasis was self-reported, and some psoriasis patients were also asked to rate the severity of their skin disease.

After adjusting for factors such as age, sex, race, and history of myocardial infarction, stroke, and diabetes, the 351 individuals with psoriasis had more than twice the odds of major depression, compared with respondents without psoriasis (odds ratio, 2.09; 95% confidence interval, 1.41-3.11; P less than .001). Furthermore, the average PHQ-9 score among psoriasis patients was significantly higher than that among other respondents (4.54 vs. 3.22; P less than .001).

Neither severity of skin disease nor history of MI or stroke affected the relationship between psoriasis and depression. “The psychiatric burden of psoriasis may be more closely tied to patients’ perception of the social response to their appearance than objective disease severity,” the investigators said. They noted that as far as they know, this is the first study to use a nationally representative sample of patients to evaluate the association between psoriasis and major depression.

The investigators reported no funding sources and declared no competing interests.

Children who received at least 274 mg of metformin for any reason grew about 1 cm more than controls, authors of a meta-analysis reported online in JAMA Pediatrics.

The relative increase “may appear small, [but] is likely underestimated, given that many studies were of short duration and included older adolescents, potentially after epiphyseal growth plate closure,” wrote Nicholas Kuzik of the University of Alberta in Edmonton, Canada, and his associates. “It is possible that longer treatment periods or treatments concentrated at times of greater growth may lead to even greater height changes,” the researchers added.

Metformin has been increasingly used off label for children and adolescents who have impaired glucose tolerance, nonalcoholic fatty liver disease, obesity, or polycystic ovary syndrome, the investigators noted. Their meta-analysis included 10 randomized controlled trials of 562 such patients who were 8 to almost 16 years old. A total of 59% of children were female and body mass index ranged from 18.4 to 41 (JAMA Pediatr. 2015 Sept. 28. doi: 10.1001/jamapediatrics.2015.2186).

Height gains did not statistically differ between groups when the researchers analyzed all 10 studies together. The 1-cm greater average increase with metformin, compared with controls (95% confidence interval, 0.0 to 2.0 cm) applied only to the five studies that used the highest cumulative doses of at least 274 mg. Metformin conferred no relative gains in height for the five trials that used lower cumulative doses of 91-186 mg. The lower-dose studies also involved 3-6 months of treatment, compared with 6-48 months for the high-dose trials, said Mr. Kuzik and his associates.

Metformin affects several factors that mediate growth, including sex hormones, insulin or insulin-like growth factor 1, and adenosine monophosphate–activated protein kinase, the investigators noted. They recommended longer-term studies of younger children.

The investigators declared no funding sources or competing interests.

Children who received at least 274 mg of metformin for any reason grew about 1 cm more than controls, authors of a meta-analysis reported online in JAMA Pediatrics.

The relative increase “may appear small, [but] is likely underestimated, given that many studies were of short duration and included older adolescents, potentially after epiphyseal growth plate closure,” wrote Nicholas Kuzik of the University of Alberta in Edmonton, Canada, and his associates. “It is possible that longer treatment periods or treatments concentrated at times of greater growth may lead to even greater height changes,” the researchers added.

Metformin has been increasingly used off label for children and adolescents who have impaired glucose tolerance, nonalcoholic fatty liver disease, obesity, or polycystic ovary syndrome, the investigators noted. Their meta-analysis included 10 randomized controlled trials of 562 such patients who were 8 to almost 16 years old. A total of 59% of children were female and body mass index ranged from 18.4 to 41 (JAMA Pediatr. 2015 Sept. 28. doi: 10.1001/jamapediatrics.2015.2186).

Height gains did not statistically differ between groups when the researchers analyzed all 10 studies together. The 1-cm greater average increase with metformin, compared with controls (95% confidence interval, 0.0 to 2.0 cm) applied only to the five studies that used the highest cumulative doses of at least 274 mg. Metformin conferred no relative gains in height for the five trials that used lower cumulative doses of 91-186 mg. The lower-dose studies also involved 3-6 months of treatment, compared with 6-48 months for the high-dose trials, said Mr. Kuzik and his associates.

Metformin affects several factors that mediate growth, including sex hormones, insulin or insulin-like growth factor 1, and adenosine monophosphate–activated protein kinase, the investigators noted. They recommended longer-term studies of younger children.

The investigators declared no funding sources or competing interests.

Children who received at least 274 mg of metformin for any reason grew about 1 cm more than controls, authors of a meta-analysis reported online in JAMA Pediatrics.

The relative increase “may appear small, [but] is likely underestimated, given that many studies were of short duration and included older adolescents, potentially after epiphyseal growth plate closure,” wrote Nicholas Kuzik of the University of Alberta in Edmonton, Canada, and his associates. “It is possible that longer treatment periods or treatments concentrated at times of greater growth may lead to even greater height changes,” the researchers added.

Metformin has been increasingly used off label for children and adolescents who have impaired glucose tolerance, nonalcoholic fatty liver disease, obesity, or polycystic ovary syndrome, the investigators noted. Their meta-analysis included 10 randomized controlled trials of 562 such patients who were 8 to almost 16 years old. A total of 59% of children were female and body mass index ranged from 18.4 to 41 (JAMA Pediatr. 2015 Sept. 28. doi: 10.1001/jamapediatrics.2015.2186).

Height gains did not statistically differ between groups when the researchers analyzed all 10 studies together. The 1-cm greater average increase with metformin, compared with controls (95% confidence interval, 0.0 to 2.0 cm) applied only to the five studies that used the highest cumulative doses of at least 274 mg. Metformin conferred no relative gains in height for the five trials that used lower cumulative doses of 91-186 mg. The lower-dose studies also involved 3-6 months of treatment, compared with 6-48 months for the high-dose trials, said Mr. Kuzik and his associates.

Metformin affects several factors that mediate growth, including sex hormones, insulin or insulin-like growth factor 1, and adenosine monophosphate–activated protein kinase, the investigators noted. They recommended longer-term studies of younger children.

The investigators declared no funding sources or competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.

Rigorous studies have not linked testosterone replacement therapy to heart attack or stroke, and the decision to prescribe testosterone replacement therapy should be based on a full diagnostic work-up – not the underlying cause of hypogonadism, according to a new position statement from the American Association of Clinical Endocrinologists.

The statement challenges several aspects of a recent Food and Drug Administration safety announcement warning about “possible” increased risks of heart attack and stroke with testosterone replacement therapy (TRT) and approving its use only for testicular, pituitary, or brain disorders that cause low testosterone, not for age-associated hypogonadism.

In fact, AACE rejoined, randomized controlled trials have lacked the power to assess whether TRT increases the chances of cardiovascular events or death. Data linking TRT to cardiovascular problems come from a few retrospective studies, the “major flaws” of which limit their ability to assess risk. “Large-scale prospective randomized controlled trials on testosterone therapy, focusing on cardiovascular benefits and risks, are clearly needed. As with therapeutics in general, common sense, experience, and an individualized approach are recommended” (Endocr Pract. 2015;21:1066-73).

The benefits and risks of TRT in age-associated hypogonadism remain uncertain, according to both the FDA and AACE. Until better studies are available, AACE recommends that clinicians consider TRT for men with signs and symptoms that are consistent with hypogonadism, regardless of cause, and who have at least two “unequivocally low” testosterone levels in samples drawn before 10 a.m.

Clinicians also should educate patients about the possible cardiovascular risks of TRT, should be “extra cautious” when considering TRT for symptomatic elderly men with low testosterone levels, and should avoid TRT entirely in frail elderly men “until better outcome data are available,” AACE also recommended. Furthermore, clinicians should avoid TRT for patients with uncontrolled or poorly controlled heart failure, a history of heart attack or cerebrovascular accident within the past 6 months, an individual or family history of a procoagulant state, or an individual history of thromboembolism, AACE stated.

Although TRT can improve some cardiovascular risk factors by promoting muscle gain and fat loss, decreasing insulin resistance, and potentially reversing metabolic syndrome, it remains unclear whether low testosterone is a marker of cardiovascular illness or a causal factor, AACE noted. Replacement therapy is most likely to benefit men with very low testosterone levels, not those whose levels are just below normal, according to AACE.

The American Urological Association has echoed several recommendations from AACE, emphasizing in its own statement that “testosterone therapy in the absence of hypogonadism is inappropriate” and calling for more federal and industry funding for studies of the indications, benefits, and risks of approved treatments for hypogonadism as well as studies of new potential therapies. “Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, and patients should be so informed,” noted the statement from the AUA, which was last updated in August 2015.

The AACE Reproductive Endocrinology Scientific Committee listed the following disclosures: first author Dr. Neil Goodman reported serving on the AbbVie speaker bureau for AndroGel and senior author Dr. Glenn Cunningham reported receiving research support from Abbvie, having served on advisory panels for Abbvie, Apricus, Clarus Therapeutics, Endo Pharma, and Lilly and having consulted for Clarus Therapeutics, Endo Pharma, Ferring, Purdue Pharma, and Repros Therapeutics. Two other coauthors declared financial relationships with Abbvie, GlaxoSmithKline, Merck, Sanofi-Aventies, and a number of other pharmaceutical companies. The other two coauthors declared no competing interests.