Shannon Aymes

Neuropsychiatric adverse events do not increase significantly in smokers treated with either varenicline or bupropion, a large cohort study shows.

Both bupropion and varenicline have been tied to long-term smoking cessation in observational studies and randomized trials. However, concerns about adverse neuropsychiatric events, including aggression and suicidality, have been raised. Furthermore, data are limited on the safety of the medications in smokers with known psychiatric conditions.

©pmphoto/iStockphoto.com

At the request of the Food and Drug Administration, Dr. Robert M. Anthenelli and his colleagues conducted a randomized, double-blind, triple-dummy, placebo- and active-controlled trial to assess bupropion and varenicline in motivated smokers with and without psychiatric diagnoses for 12 weeks. The efficacy endpoint in the multinational trial, called the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), was abstinence for 9-12 weeks. The primary endpoint was adverse neuropsychiatric events, reported Dr. Anthenelli of the psychiatry department at the University of California, San Diego.

In total, 8,144 participants were randomized to either a nonpsychiatric (n = 4,028) or a psychiatric (n = 4,116) cohort. Men made up 44% of the study population, and the average age was 46.5 years. Most participants were white (82%) and American (52%). The psychiatric cohort included participants with diagnoses of primary mood disorders, anxiety and psychotic disorders, and borderline personality disorders, and 49% reported treatment with a psychotropic medication (Lancet. 2016 Apr 22. doi: 10.1016/S0140-6736).

Overall, the incidence of neuropsychiatric adverse events was similar in the bupropion (4.5%), varenicline (4.0%), nicotine patch (3.9%), and the placebo (3.7%) groups. However, more neuropsychiatric events were reported in the psychiatric cohort than the nonpsychiatric cohort (5.8% versus 2.1%, P less than .0001). Likewise, the psychiatric cohort reported moderate and severe neuropsychiatric adverse events more often in the bupropion group (6.7% versus 2.2%), varenicline (6.5% versus 1.3%), nicotine patch (5.2% versus 2.5%), and placebo groups (4.9% versus 2.4%) than the nonpsychiatric cohort.

In the nonpsychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were –1.28 (95% confidence interval, –2.40 to –0.15) for varenicline vs. placebo and –0.08 (95% CI, –1.37 to 1.21) for bupropion vs. placebo. In the psychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were 1.59 (95% CI, -0.42 to 3.59) for varenicline-placebo and 1.78 (95% CI, -0.24 to 3.81) for bupropion-placebo.

Rates of abstinence were higher in the participants who received varenicline, compared with placebo (OR, 3.61; 95% CI, 3.07-4.24), bupropion (OR, 1.75; 95% CI, 1.52-2.01), and the nicotine patch (OR, 1.68; 95% CI, 1.46-1.93).

The most common adverse events reported included abnormal dreams, headache, insomnia, and nausea.

Dr. Anthenelli and his associates noted several limitations. For example, participants in the psychiatric cohort were stable or in remission; they were restricted to particular psychiatric diagnoses; and participants with current substance abuse or risk for suicide were excluded.

However, they said the EAGLES trial results provide “further evidence that varenicline and bupropion can be used safely by psychiatrically stable smokers,” they wrote. “Although varenicline appears to be the most effective single pharmacotherapy available, all of the first-line medications – varenicline, bupropion, and nicotine patch – are efficacious, compared with placebo.”

The authors report relationships with several pharmaceutical companies, including Pfizer and GlaxoSmithKline. The study was funded by Pfizer and GlaxoSmithKline.

Neuropsychiatric adverse events do not increase significantly in smokers treated with either varenicline or bupropion, a large cohort study shows.

Both bupropion and varenicline have been tied to long-term smoking cessation in observational studies and randomized trials. However, concerns about adverse neuropsychiatric events, including aggression and suicidality, have been raised. Furthermore, data are limited on the safety of the medications in smokers with known psychiatric conditions.

©pmphoto/iStockphoto.com

At the request of the Food and Drug Administration, Dr. Robert M. Anthenelli and his colleagues conducted a randomized, double-blind, triple-dummy, placebo- and active-controlled trial to assess bupropion and varenicline in motivated smokers with and without psychiatric diagnoses for 12 weeks. The efficacy endpoint in the multinational trial, called the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), was abstinence for 9-12 weeks. The primary endpoint was adverse neuropsychiatric events, reported Dr. Anthenelli of the psychiatry department at the University of California, San Diego.

In total, 8,144 participants were randomized to either a nonpsychiatric (n = 4,028) or a psychiatric (n = 4,116) cohort. Men made up 44% of the study population, and the average age was 46.5 years. Most participants were white (82%) and American (52%). The psychiatric cohort included participants with diagnoses of primary mood disorders, anxiety and psychotic disorders, and borderline personality disorders, and 49% reported treatment with a psychotropic medication (Lancet. 2016 Apr 22. doi: 10.1016/S0140-6736).

Overall, the incidence of neuropsychiatric adverse events was similar in the bupropion (4.5%), varenicline (4.0%), nicotine patch (3.9%), and the placebo (3.7%) groups. However, more neuropsychiatric events were reported in the psychiatric cohort than the nonpsychiatric cohort (5.8% versus 2.1%, P less than .0001). Likewise, the psychiatric cohort reported moderate and severe neuropsychiatric adverse events more often in the bupropion group (6.7% versus 2.2%), varenicline (6.5% versus 1.3%), nicotine patch (5.2% versus 2.5%), and placebo groups (4.9% versus 2.4%) than the nonpsychiatric cohort.

In the nonpsychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were –1.28 (95% confidence interval, –2.40 to –0.15) for varenicline vs. placebo and –0.08 (95% CI, –1.37 to 1.21) for bupropion vs. placebo. In the psychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were 1.59 (95% CI, -0.42 to 3.59) for varenicline-placebo and 1.78 (95% CI, -0.24 to 3.81) for bupropion-placebo.

Rates of abstinence were higher in the participants who received varenicline, compared with placebo (OR, 3.61; 95% CI, 3.07-4.24), bupropion (OR, 1.75; 95% CI, 1.52-2.01), and the nicotine patch (OR, 1.68; 95% CI, 1.46-1.93).

The most common adverse events reported included abnormal dreams, headache, insomnia, and nausea.

Dr. Anthenelli and his associates noted several limitations. For example, participants in the psychiatric cohort were stable or in remission; they were restricted to particular psychiatric diagnoses; and participants with current substance abuse or risk for suicide were excluded.

However, they said the EAGLES trial results provide “further evidence that varenicline and bupropion can be used safely by psychiatrically stable smokers,” they wrote. “Although varenicline appears to be the most effective single pharmacotherapy available, all of the first-line medications – varenicline, bupropion, and nicotine patch – are efficacious, compared with placebo.”

The authors report relationships with several pharmaceutical companies, including Pfizer and GlaxoSmithKline. The study was funded by Pfizer and GlaxoSmithKline.

Neuropsychiatric adverse events do not increase significantly in smokers treated with either varenicline or bupropion, a large cohort study shows.

Both bupropion and varenicline have been tied to long-term smoking cessation in observational studies and randomized trials. However, concerns about adverse neuropsychiatric events, including aggression and suicidality, have been raised. Furthermore, data are limited on the safety of the medications in smokers with known psychiatric conditions.

©pmphoto/iStockphoto.com

At the request of the Food and Drug Administration, Dr. Robert M. Anthenelli and his colleagues conducted a randomized, double-blind, triple-dummy, placebo- and active-controlled trial to assess bupropion and varenicline in motivated smokers with and without psychiatric diagnoses for 12 weeks. The efficacy endpoint in the multinational trial, called the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), was abstinence for 9-12 weeks. The primary endpoint was adverse neuropsychiatric events, reported Dr. Anthenelli of the psychiatry department at the University of California, San Diego.

In total, 8,144 participants were randomized to either a nonpsychiatric (n = 4,028) or a psychiatric (n = 4,116) cohort. Men made up 44% of the study population, and the average age was 46.5 years. Most participants were white (82%) and American (52%). The psychiatric cohort included participants with diagnoses of primary mood disorders, anxiety and psychotic disorders, and borderline personality disorders, and 49% reported treatment with a psychotropic medication (Lancet. 2016 Apr 22. doi: 10.1016/S0140-6736).

Overall, the incidence of neuropsychiatric adverse events was similar in the bupropion (4.5%), varenicline (4.0%), nicotine patch (3.9%), and the placebo (3.7%) groups. However, more neuropsychiatric events were reported in the psychiatric cohort than the nonpsychiatric cohort (5.8% versus 2.1%, P less than .0001). Likewise, the psychiatric cohort reported moderate and severe neuropsychiatric adverse events more often in the bupropion group (6.7% versus 2.2%), varenicline (6.5% versus 1.3%), nicotine patch (5.2% versus 2.5%), and placebo groups (4.9% versus 2.4%) than the nonpsychiatric cohort.

In the nonpsychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were –1.28 (95% confidence interval, –2.40 to –0.15) for varenicline vs. placebo and –0.08 (95% CI, –1.37 to 1.21) for bupropion vs. placebo. In the psychiatric cohort, the risk differences for moderate and severe neuropsychiatric adverse events were 1.59 (95% CI, -0.42 to 3.59) for varenicline-placebo and 1.78 (95% CI, -0.24 to 3.81) for bupropion-placebo.

Rates of abstinence were higher in the participants who received varenicline, compared with placebo (OR, 3.61; 95% CI, 3.07-4.24), bupropion (OR, 1.75; 95% CI, 1.52-2.01), and the nicotine patch (OR, 1.68; 95% CI, 1.46-1.93).

The most common adverse events reported included abnormal dreams, headache, insomnia, and nausea.

Dr. Anthenelli and his associates noted several limitations. For example, participants in the psychiatric cohort were stable or in remission; they were restricted to particular psychiatric diagnoses; and participants with current substance abuse or risk for suicide were excluded.

However, they said the EAGLES trial results provide “further evidence that varenicline and bupropion can be used safely by psychiatrically stable smokers,” they wrote. “Although varenicline appears to be the most effective single pharmacotherapy available, all of the first-line medications – varenicline, bupropion, and nicotine patch – are efficacious, compared with placebo.”

The authors report relationships with several pharmaceutical companies, including Pfizer and GlaxoSmithKline. The study was funded by Pfizer and GlaxoSmithKline.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

Mental health symptoms and severity differed across a cohort of lesbian, gay, bisexual, and questioning (LGBQ) adolescents, highlighting the need to consider behavioral health separately for each group.

Lesbian, gay, or bisexual youth demonstrate higher rates of depression, anxiety, self-harm, and suicidal ideation than do youth who identify as heterosexual, several studies have reported. Youth who identify as “unsure” or “questioning” are at an even higher risk of suicidality, depression, and victimization than their LGB counterparts.

With a lack of research focusing on the subgroup of youth identifying as questioning or bisexual, Annie Shearer and her colleagues at Drexel University in Philadelphia sought to assess the behavioral health of heterosexual and LGBQ youth in a large primary care sample (J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.02.005).

The cohort included 2,513 youth aged 14-24 years, with 61% female. Same sex attraction was reported in 2%, attraction to both sexes was reported in 4%, attraction to the opposite sex was reported by 92%, and unsure sexuality preferences were reported in 2%.

The study was conducted using a Web-based screening tool, the Behavioral Health Screen owned by the Children’s Hospital of Philadelphia, in 10 primary care offices in semiurban and rural communities. Deidentified data were collected on demographics, social factors, medical history, and psychiatric factors including depression, anxiety, substance use, suicidality, and trauma.

An analysis of the data demonstrated females identifying as questioning or bisexual had higher scores for traumatic distress, anxiety, and depression than did their heterosexual peers; there were no differences among lesbian, bisexual, or questioning females in these areas. Female youth in those three sexual minority groups had significantly higher lifetime suicide scores. Bisexual females reported higher scores for current suicide as well as substance abuse.

Male participants identifying as bisexual or gay reported significantly higher scores for traumatic distress and depression, with gay participants reporting higher anxiety scores. Bisexual male youth had significantly higher lifetime suicide scores. There did not appear to be a higher risk for questioning males. There were no differences between the groups in terms of current suicide or substance use scores.

Study limitations included the complex nature of sexuality and the self-reported nature of the data, the investigators noted.

“Our findings underscore the willingness of sexual minority youth to disclose the same-sex attractions in PC [primary care] settings,” the authors concluded. “Medical providers should in turn be receptive to this information and engage youth in conversations about these issues, particularly in contexts where the same-sex or bisexual attractions are stigmatized.”

“Although sexual orientation does not cause mental illness,” clinicians should be aware of the association between LGBQ status and mental health, Ms. Shearer and her colleagues said.

The study was funded by a grant from the Substance Abuse and Mental Health Services Administration. Coauthor Guy Diamond, Ph.D., reported potential royalty payments if the Behavioral Health Screen is made public.

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

GI-Logic – AbStats™ system

In collaboration with the UCLA gastroenterology department and the UCLA Wireless Health Institute, GI-Logic developed the AbStats™ system to provide continuous telemetry monitoring of the gastrointestinal tract function. With sensors placed on the patient’s abdomen, telemetry is employed to record and analyze vibrations of the digestive tract. Although there is a wide number of applications being considered, one focus has been on the ability of the AbStats™ system to evaluate postoperative ileus. Clinical studies suggest that this tool can signal when patients can resume eating, including distinguishing between suitability for solid foods relative to a liquid diet.

“The AbStats™ system is being studied in a number of chronic GI conditions and will allow clinic physicians a tool to monitor patient conditions and therapeutic impact of both drugs and interventional therapies. The AbStats™ system was recently cleared by the Food and Drug Administration and will be launching in selective centers in May of 2016,” noted Ken Beres, vice president of marketing and business development at GI Logic.

“The system will allow for care teams to for the first time use objective data to guide the feeding and pharmacological management of patients to both improve outcomes and reduce health care expenses.”

The sharks agreed that this tool has potential clinical utility, but there was also general consensus that more data are needed to confirm that it has value from an economic perspective. They suggested that studies are needed to show how the tool alters clinical decisions in a way that saves money or improves outcomes. Dr. Pasricha suggested, “You have to prove that you are not just another layer of diagnosis,” but are providing information that leads to improved patient care.

GI Therapies – TAGS™

The transabdominal gastrointestinal stimulation (TAGS™) device was developed by GI Therapies as a noninvasive tool for the treatment of chronic constipation. The TAGS™ device, which sends small electric pulses to promote peristaltic contractions, was tested in a small pilot study of six women with gastroparesis and chronic constipation. All five patients who required nutritional support (total parenteral nutrition or enteral feedings) at the start of the study were no longer requiring nutritional support after 3-4 months.

GI Therapies is looking to conduct a larger, sham-controlled trial to investigate the use of TAGS™ for the treatment of symptoms of gastroparesis, according to Dr. David Fischer, a principal at GI Therapies, who noted that current therapeutic options for the treatment of gastroparesis, which is a relatively common problem, are “very limited.” He indicated that interest in alternatives to the current array of pharmacologic therapies “is substantial.”

The sharks agreed that gastroparesis is a common and challenging clinical complaint, and they also encouraged the plans to conduct a well-controlled trial using a sham device. However, there was also consensus that patient selection will be critical to efforts to demonstrate a positive outcome, as placebo responses are substantial and not all forms of gastroparesis may respond to this form of electrical stimulation. Several sharks, including Mr. Tinkham, suggested that the developers should already be considering what type of company might be most interested in acquiring this device if clinical studies confirm benefit.

Wake Forest Institute for Regenerative Medicine – BioSphincter™

Using autologous enteric neural progenitor and smooth muscle cells, Khalil N Bitar, Ph.D., AGAF, was able to bioengineer innervated internal anal sphincters, which have been successfully implanted into rabbits after a sphincterectomy. In these experimental studies, sustained continence was restored over a follow-up of 12 months.

“Fecal incontinence, the inability to control bowel movements allowing stool to leak unexpectedly from the rectum, afflicts 6.6 million people in the United States. The true prevalence is thought to be much higher, but is underreported due to social factors. Fecal incontinence represents the second leading cause of institutionalization in the elderly,” Dr. Bitar noted.

“Using autologous cell sources, bioengineered internal anal sphincter, BioSphincter™ is a unique regenerative medicine solution to reinstate function in the anorectum, restoring both smooth muscle and intrinsic neural components, resulting in continence. This regenerative medicine approach to reinstate physiological function to treat fecal incontinence using BioSphincter is promising for translation into clinical practice,” Dr. Bitar added.

The sharks were enthusiastic. Although Dr. Bitar was faced with a barrage of questions about the logistics of harvesting muscle and neuroendocrine cells to create an effective implantable sphincter, they suggested that this could provide a major advance in a condition for which there are now very few options. However, they noted that enthusiasm must be tempered by the relatively early clinical development and the likelihood of many potential hurdles to overcome. Of those intrigued, Mr. Pierce initially questioned whether this approach could be adequately protected as intellectual property from competitors but was reassured by Dr. Bitar’s description of the patentable aspects of the bioengineering.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

GI-Logic – AbStats™ system

In collaboration with the UCLA gastroenterology department and the UCLA Wireless Health Institute, GI-Logic developed the AbStats™ system to provide continuous telemetry monitoring of the gastrointestinal tract function. With sensors placed on the patient’s abdomen, telemetry is employed to record and analyze vibrations of the digestive tract. Although there is a wide number of applications being considered, one focus has been on the ability of the AbStats™ system to evaluate postoperative ileus. Clinical studies suggest that this tool can signal when patients can resume eating, including distinguishing between suitability for solid foods relative to a liquid diet.

“The AbStats™ system is being studied in a number of chronic GI conditions and will allow clinic physicians a tool to monitor patient conditions and therapeutic impact of both drugs and interventional therapies. The AbStats™ system was recently cleared by the Food and Drug Administration and will be launching in selective centers in May of 2016,” noted Ken Beres, vice president of marketing and business development at GI Logic.

“The system will allow for care teams to for the first time use objective data to guide the feeding and pharmacological management of patients to both improve outcomes and reduce health care expenses.”

The sharks agreed that this tool has potential clinical utility, but there was also general consensus that more data are needed to confirm that it has value from an economic perspective. They suggested that studies are needed to show how the tool alters clinical decisions in a way that saves money or improves outcomes. Dr. Pasricha suggested, “You have to prove that you are not just another layer of diagnosis,” but are providing information that leads to improved patient care.

GI Therapies – TAGS™

The transabdominal gastrointestinal stimulation (TAGS™) device was developed by GI Therapies as a noninvasive tool for the treatment of chronic constipation. The TAGS™ device, which sends small electric pulses to promote peristaltic contractions, was tested in a small pilot study of six women with gastroparesis and chronic constipation. All five patients who required nutritional support (total parenteral nutrition or enteral feedings) at the start of the study were no longer requiring nutritional support after 3-4 months.

GI Therapies is looking to conduct a larger, sham-controlled trial to investigate the use of TAGS™ for the treatment of symptoms of gastroparesis, according to Dr. David Fischer, a principal at GI Therapies, who noted that current therapeutic options for the treatment of gastroparesis, which is a relatively common problem, are “very limited.” He indicated that interest in alternatives to the current array of pharmacologic therapies “is substantial.”

The sharks agreed that gastroparesis is a common and challenging clinical complaint, and they also encouraged the plans to conduct a well-controlled trial using a sham device. However, there was also consensus that patient selection will be critical to efforts to demonstrate a positive outcome, as placebo responses are substantial and not all forms of gastroparesis may respond to this form of electrical stimulation. Several sharks, including Mr. Tinkham, suggested that the developers should already be considering what type of company might be most interested in acquiring this device if clinical studies confirm benefit.

Wake Forest Institute for Regenerative Medicine – BioSphincter™

Using autologous enteric neural progenitor and smooth muscle cells, Khalil N Bitar, Ph.D., AGAF, was able to bioengineer innervated internal anal sphincters, which have been successfully implanted into rabbits after a sphincterectomy. In these experimental studies, sustained continence was restored over a follow-up of 12 months.

“Fecal incontinence, the inability to control bowel movements allowing stool to leak unexpectedly from the rectum, afflicts 6.6 million people in the United States. The true prevalence is thought to be much higher, but is underreported due to social factors. Fecal incontinence represents the second leading cause of institutionalization in the elderly,” Dr. Bitar noted.

“Using autologous cell sources, bioengineered internal anal sphincter, BioSphincter™ is a unique regenerative medicine solution to reinstate function in the anorectum, restoring both smooth muscle and intrinsic neural components, resulting in continence. This regenerative medicine approach to reinstate physiological function to treat fecal incontinence using BioSphincter is promising for translation into clinical practice,” Dr. Bitar added.

The sharks were enthusiastic. Although Dr. Bitar was faced with a barrage of questions about the logistics of harvesting muscle and neuroendocrine cells to create an effective implantable sphincter, they suggested that this could provide a major advance in a condition for which there are now very few options. However, they noted that enthusiasm must be tempered by the relatively early clinical development and the likelihood of many potential hurdles to overcome. Of those intrigued, Mr. Pierce initially questioned whether this approach could be adequately protected as intellectual property from competitors but was reassured by Dr. Bitar’s description of the patentable aspects of the bioengineering.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.

BOSTON – Several innovators had the opportunity to present their novel technologies to a five-person “shark tank” panel – two entrepreneurs, a practicing physician, a venture capitalist, and a businessman – at the 2016 AGA Tech Summit.

After the innovators explained why they expected their products to fill an unmet need, the “sharks” probed for weaknesses and offered advice on what data were needed to confirm a viable advantage over existing options.

“These presentations offer a glimpse into what innovators are working on to improve the practice of gastroenterology,” said Michael L. Kochman, M.D., AGAF, one of the “sharks,” who is chair of the AGA Center for GI Innovation and Technology, which sponsored the summit.

“This ‘shark tank’ is a perfect illustration of what the AGA Center for GI Innovation and Technology is all about – we’re here to help move the field forward and discuss what’s next for the care of patients with digestive disorders.”

In addition to Dr. Kochman, the panel comprised Jay Pasricha, M.D., professor of medicine at Johns Hopkins University, who has been involved in several start-ups; Thomas Shehab, MD, a trained gastroenterologist who is now a principal at Arboretum Ventures; Mr. Brian Tinkham, a founder of Beacon Endoscopic and now vice president, New Technologies, GI Solutions, at Medtronic; and Mr. David Pierce, senior vice president at Boston Scientific.

Amenity Health – MedCline™

Amenity Health developed MedCline™ based on the work of Dr. Carl Melcher, as a positional therapy for nocturnal acid reflux in patients with GERD refractory to pharmacologic treatment. As a component of the GERD treatment plan, MedCline™ is a sleeping device designed to raise the torso and facilitate left-side positioning, both of which have been shown to reduce the risk of nocturnal gastroesophageal reflux disease (GERD). Currently, there are five published studies assessing MedCline™ for nocturnal reflux.

“With so many patients still having nighttime reflux even on daily PPIs and growing concerns of long-term side effects of these medications, it’s a perfect time to bring an effective, nonpharmacological treatment to market like MedCline,™” noted Aaron Clark, COO and co-inventor, at Amenity Health.

MedCline

“We are happy to be offering both patients and physicians a much-needed treatment alternative for nocturnal GERD and are grateful to our research partners for their studies showing that MedCline™ is far more effective at treating nocturnal GERD than bed wedges or propping up the head of the bed,” Mr. Clark said. “We now hope to garner the support of the professional societies and payers to help make MedCline™ more accessible to patients who are in desperate need of nighttime relief.”

All of the sharks agreed that the team at Amenity Health should focus on marketing this device to patients, rather than physicians. Expressing some skepticism about the prospects for third-party reimbursement, all agreed that a direct-to-consumer marketing strategy is needed even if the company can generate more data showing value, such as decreased use of pharmacologic therapy. When told by Mr. Clark that the plan was to market to both physicians and patients, Dr. Pasricha cautioned, “I would require a higher level of evidence [than what was so far presented] before I would recommend it to patients.”

BioInnovate Ireland – Microwave ablation of varices

According to Jonathan Bouchier-Hayes, BSc, MBA, at BioInnovate, current strategies for the treatment of gastroesophageal varices have several limitations. Endoscopic banding, in particular, which is commonly used, requires two to four treatments over several weeks and is associated with a high risk of recurrence. BioInnovate proposes a microwave energy solution integrated into a standard endoscope. By inducing coagulation, the aim of microwave energy is to treat gastroesophageal varices in a single procedure. The advantage of microwave therapy is that it appears to preserve the mucosal layer, reducing the risk of complications associated with endoscopic banding and providing a reduced risk of recurrence. In the experimental studies conducted so far, the fibrosis produced by microwave energy also proved to be a barrier for recurrence. Mr. Bouchier-Hayes believes that the reduction in rebleeding and recurrence will make this approach cost effective. Clinical trials have not yet been initiated.

Several sharks implied that the disadvantages of endoscopic banding, which is widely performed and associated with a relatively low rate of complications, might be less of a concern than was in Mr. Bouchier-Hayes’ analysis of the unmet need, but they were intrigued with this concept if clinical development includes studies that show a cost advantage over current options. To invest, Dr. Shehab reported that he would require a detailed understanding of the specific clinical trials that were planned from which a “go or no-go” decision would be made for further development. Others agreed that it is not just efficacy but economic viability that will be important as development proceeds.

GI-Logic – AbStats™ system

In collaboration with the UCLA gastroenterology department and the UCLA Wireless Health Institute, GI-Logic developed the AbStats™ system to provide continuous telemetry monitoring of the gastrointestinal tract function. With sensors placed on the patient’s abdomen, telemetry is employed to record and analyze vibrations of the digestive tract. Although there is a wide number of applications being considered, one focus has been on the ability of the AbStats™ system to evaluate postoperative ileus. Clinical studies suggest that this tool can signal when patients can resume eating, including distinguishing between suitability for solid foods relative to a liquid diet.

“The AbStats™ system is being studied in a number of chronic GI conditions and will allow clinic physicians a tool to monitor patient conditions and therapeutic impact of both drugs and interventional therapies. The AbStats™ system was recently cleared by the Food and Drug Administration and will be launching in selective centers in May of 2016,” noted Ken Beres, vice president of marketing and business development at GI Logic.

“The system will allow for care teams to for the first time use objective data to guide the feeding and pharmacological management of patients to both improve outcomes and reduce health care expenses.”

The sharks agreed that this tool has potential clinical utility, but there was also general consensus that more data are needed to confirm that it has value from an economic perspective. They suggested that studies are needed to show how the tool alters clinical decisions in a way that saves money or improves outcomes. Dr. Pasricha suggested, “You have to prove that you are not just another layer of diagnosis,” but are providing information that leads to improved patient care.

GI Therapies – TAGS™

The transabdominal gastrointestinal stimulation (TAGS™) device was developed by GI Therapies as a noninvasive tool for the treatment of chronic constipation. The TAGS™ device, which sends small electric pulses to promote peristaltic contractions, was tested in a small pilot study of six women with gastroparesis and chronic constipation. All five patients who required nutritional support (total parenteral nutrition or enteral feedings) at the start of the study were no longer requiring nutritional support after 3-4 months.

GI Therapies is looking to conduct a larger, sham-controlled trial to investigate the use of TAGS™ for the treatment of symptoms of gastroparesis, according to Dr. David Fischer, a principal at GI Therapies, who noted that current therapeutic options for the treatment of gastroparesis, which is a relatively common problem, are “very limited.” He indicated that interest in alternatives to the current array of pharmacologic therapies “is substantial.”

The sharks agreed that gastroparesis is a common and challenging clinical complaint, and they also encouraged the plans to conduct a well-controlled trial using a sham device. However, there was also consensus that patient selection will be critical to efforts to demonstrate a positive outcome, as placebo responses are substantial and not all forms of gastroparesis may respond to this form of electrical stimulation. Several sharks, including Mr. Tinkham, suggested that the developers should already be considering what type of company might be most interested in acquiring this device if clinical studies confirm benefit.

Wake Forest Institute for Regenerative Medicine – BioSphincter™

Using autologous enteric neural progenitor and smooth muscle cells, Khalil N Bitar, Ph.D., AGAF, was able to bioengineer innervated internal anal sphincters, which have been successfully implanted into rabbits after a sphincterectomy. In these experimental studies, sustained continence was restored over a follow-up of 12 months.

“Fecal incontinence, the inability to control bowel movements allowing stool to leak unexpectedly from the rectum, afflicts 6.6 million people in the United States. The true prevalence is thought to be much higher, but is underreported due to social factors. Fecal incontinence represents the second leading cause of institutionalization in the elderly,” Dr. Bitar noted.

“Using autologous cell sources, bioengineered internal anal sphincter, BioSphincter™ is a unique regenerative medicine solution to reinstate function in the anorectum, restoring both smooth muscle and intrinsic neural components, resulting in continence. This regenerative medicine approach to reinstate physiological function to treat fecal incontinence using BioSphincter is promising for translation into clinical practice,” Dr. Bitar added.

The sharks were enthusiastic. Although Dr. Bitar was faced with a barrage of questions about the logistics of harvesting muscle and neuroendocrine cells to create an effective implantable sphincter, they suggested that this could provide a major advance in a condition for which there are now very few options. However, they noted that enthusiasm must be tempered by the relatively early clinical development and the likelihood of many potential hurdles to overcome. Of those intrigued, Mr. Pierce initially questioned whether this approach could be adequately protected as intellectual property from competitors but was reassured by Dr. Bitar’s description of the patentable aspects of the bioengineering.

Dark Canyon Labs – DCL-101 colonoscopy preparation

In an effort to make the colonoscopy preparation process more tolerable, Dark Canyon Labs has developed a novel preparation designed to avoid the bad taste of current options while preserving efficacy. Currently, bowel preps combine polyethylene glycol (PEG) solutions with salts to achieve the cathartic effect. The PEG is tasteless but the salts are not. The concept of the novel prep is to administer the PEG in the usual liquid form but deliver the salts by capsule, avoiding the bad taste. Once the PEG and capsules reach the stomach, they mix and reform the same concentration of a standard prep.

The product as currently formulated reproduces the electrolyte composition of GoLYTELY®. Rather than 4 liters of the typical preps, the patient takes 2 liters of solution along with 48 capsules, according to Dr. Dale Bachwich, cofounder and chief medical officer of Dark Canyon Laboratories and a practicing gastroenterologist.

“A better colonoscopy prep benefits everyone – patients, physicians, endoscopy centers, payers, and society,” said Dr. Bachwich, who presented several sets of data demonstrating that patients far preferred the tasteless prep despite the 48-capsule requirement. Like standard bowel preps, the new formulation can be taken in single or split doses.

The sharks, who were given a taste test in which they compared the liquid portion of the new bowel prep to a conventional prep, agreed that the new prep was relatively tasteless and could provide a large advantage over current formulations despite the large pill burden. However, there was unanimous agreement that the purported advantages, including greater compliance and fewer canceled colonoscopies due to inadequate prep, need to be demonstrated in a well-controlled trial, particularly if the novel bowel preparation has a higher price. Mr. Pierce said that there is a potential value proposition for the advantages Dr. Bachwich outlined, but objective supportive evidence is needed.

The prevalence of undiagnosed diabetic retinopathy was 25% and that of sight-threatening diabetic retinopathy was 19% of an inpatient population of patients with diabetes, compared with the general population; researchers identified several barriers to ophthalmic care.

Diabetic retinopathy and sight-threatening diabetic retinopathy are estimated at a prevalence of 28.5% and 4.4%, respectively. In contrast, there is little research in to the prevalence of undiagnosed diabetic retinopathy or sight-threatening diabetic retinopathy in higher risk inpatients.

Dr. Jessica Kovarik, who at the time of this research was with the UPMC Eye Center at the University of Pittsburgh, and her associates sought to identify the prevalence of undiagnosed diabetic retinopathy among inpatients with established diabetes as well as barriers to diabetic retinopathy examinations and treatment.

They conducted a cross-sectional analysis of diabetic patients admitted to an urban teaching hospital in Pittsburgh. Digital funduscopic images were obtained to determine the presence and severity of diabetic retinopathy and macular edema. Questionnaires assessed barriers to ophthalmic examinations and demographics (BMJ Open Diab Res Care. 2016;4:e000164 [doi: 10.1136/bmjdrc-2015-000164]).

In total, 113 patients were eligible and 5 were excluded from analysis of diabetic retinopathy prevalence due to an inability to take images or poor-quality images.

Among the patients, 61 were women, 83 were white, and 34 were aged 50-60 years. Most had health insurance (89%) and an ophthalmologist (64%), and most understood that diabetic retinopathy affects vision (91%). Further, patients reported a history of type 2 diabetes (96%), hypertension (85%), hyperlipidemia (68%), renal disease (25%), peripheral vascular disease (55%), and coronary artery disease (52%).

Among those who had not had a dilated funduscopic examination within a year, barriers to screening examination included transportation issues, physical disability, too many appointments or being too sick, cost, lack of time or priority, or no visual impairment. Forty percent reported having an eye examination within the year and 5% reported never having an eye examination.

The investigators identified 7 patients with clinically significant macular edema (6%), 13 with proliferative diabetic retinopathy (12%), and 1 with severe (1%), 14 with moderate (13%), and 16 with mild nonproliferative diabetic retinopathy (15%). Overall, 44% of the patients had diabetic retinopathy, with 25% previously undiagnosed. Further, sight-threatening diabetic retinopathy was found in 19%, with 3.7% previously undiagnosed.

Finally, after multivariable analysis, a longer duration of diabetes (odds ratio, 1.08 per year; 95% confidence interval, 1.014-1.147; P =.017) and renal disease (OR, 3.86; 95% CI, 1.22-12.27; P =.022) was associated with diabetic retinopathy. Further, of the 17 patients admitted with osteomyelitis or a nonhealing diabetic ulcer, 15 (88.2%) had diabetic retinopathy.

“Curiously, most inpatients in our population (91%) are aware of the ocular complications of diabetes, and many (64%) do have ophthalmologists (more than any other subspecialty listed), yet only a minority (40%) of patients are getting the recommended standard of care screening examinations. Barriers that are unique to this high-risk population may explain this disparity,” the authors wrote.

The study was funded by the National Institutes of Health, Eye and Ear Foundation of Pittsburgh, Clinical and Translational Science Institute, the University of Pittsburgh, and a grant from Research to Prevent Blindness. One of the researchers, Dr. Jann Johnston, reported speaking for Medtronic, Lilly, and Sanofi.

The prevalence of undiagnosed diabetic retinopathy was 25% and that of sight-threatening diabetic retinopathy was 19% of an inpatient population of patients with diabetes, compared with the general population; researchers identified several barriers to ophthalmic care.

Diabetic retinopathy and sight-threatening diabetic retinopathy are estimated at a prevalence of 28.5% and 4.4%, respectively. In contrast, there is little research in to the prevalence of undiagnosed diabetic retinopathy or sight-threatening diabetic retinopathy in higher risk inpatients.

Dr. Jessica Kovarik, who at the time of this research was with the UPMC Eye Center at the University of Pittsburgh, and her associates sought to identify the prevalence of undiagnosed diabetic retinopathy among inpatients with established diabetes as well as barriers to diabetic retinopathy examinations and treatment.

They conducted a cross-sectional analysis of diabetic patients admitted to an urban teaching hospital in Pittsburgh. Digital funduscopic images were obtained to determine the presence and severity of diabetic retinopathy and macular edema. Questionnaires assessed barriers to ophthalmic examinations and demographics (BMJ Open Diab Res Care. 2016;4:e000164 [doi: 10.1136/bmjdrc-2015-000164]).

In total, 113 patients were eligible and 5 were excluded from analysis of diabetic retinopathy prevalence due to an inability to take images or poor-quality images.

Among the patients, 61 were women, 83 were white, and 34 were aged 50-60 years. Most had health insurance (89%) and an ophthalmologist (64%), and most understood that diabetic retinopathy affects vision (91%). Further, patients reported a history of type 2 diabetes (96%), hypertension (85%), hyperlipidemia (68%), renal disease (25%), peripheral vascular disease (55%), and coronary artery disease (52%).

Among those who had not had a dilated funduscopic examination within a year, barriers to screening examination included transportation issues, physical disability, too many appointments or being too sick, cost, lack of time or priority, or no visual impairment. Forty percent reported having an eye examination within the year and 5% reported never having an eye examination.

The investigators identified 7 patients with clinically significant macular edema (6%), 13 with proliferative diabetic retinopathy (12%), and 1 with severe (1%), 14 with moderate (13%), and 16 with mild nonproliferative diabetic retinopathy (15%). Overall, 44% of the patients had diabetic retinopathy, with 25% previously undiagnosed. Further, sight-threatening diabetic retinopathy was found in 19%, with 3.7% previously undiagnosed.

Finally, after multivariable analysis, a longer duration of diabetes (odds ratio, 1.08 per year; 95% confidence interval, 1.014-1.147; P =.017) and renal disease (OR, 3.86; 95% CI, 1.22-12.27; P =.022) was associated with diabetic retinopathy. Further, of the 17 patients admitted with osteomyelitis or a nonhealing diabetic ulcer, 15 (88.2%) had diabetic retinopathy.

“Curiously, most inpatients in our population (91%) are aware of the ocular complications of diabetes, and many (64%) do have ophthalmologists (more than any other subspecialty listed), yet only a minority (40%) of patients are getting the recommended standard of care screening examinations. Barriers that are unique to this high-risk population may explain this disparity,” the authors wrote.

The study was funded by the National Institutes of Health, Eye and Ear Foundation of Pittsburgh, Clinical and Translational Science Institute, the University of Pittsburgh, and a grant from Research to Prevent Blindness. One of the researchers, Dr. Jann Johnston, reported speaking for Medtronic, Lilly, and Sanofi.

The prevalence of undiagnosed diabetic retinopathy was 25% and that of sight-threatening diabetic retinopathy was 19% of an inpatient population of patients with diabetes, compared with the general population; researchers identified several barriers to ophthalmic care.

Diabetic retinopathy and sight-threatening diabetic retinopathy are estimated at a prevalence of 28.5% and 4.4%, respectively. In contrast, there is little research in to the prevalence of undiagnosed diabetic retinopathy or sight-threatening diabetic retinopathy in higher risk inpatients.

Dr. Jessica Kovarik, who at the time of this research was with the UPMC Eye Center at the University of Pittsburgh, and her associates sought to identify the prevalence of undiagnosed diabetic retinopathy among inpatients with established diabetes as well as barriers to diabetic retinopathy examinations and treatment.

They conducted a cross-sectional analysis of diabetic patients admitted to an urban teaching hospital in Pittsburgh. Digital funduscopic images were obtained to determine the presence and severity of diabetic retinopathy and macular edema. Questionnaires assessed barriers to ophthalmic examinations and demographics (BMJ Open Diab Res Care. 2016;4:e000164 [doi: 10.1136/bmjdrc-2015-000164]).

In total, 113 patients were eligible and 5 were excluded from analysis of diabetic retinopathy prevalence due to an inability to take images or poor-quality images.

Among the patients, 61 were women, 83 were white, and 34 were aged 50-60 years. Most had health insurance (89%) and an ophthalmologist (64%), and most understood that diabetic retinopathy affects vision (91%). Further, patients reported a history of type 2 diabetes (96%), hypertension (85%), hyperlipidemia (68%), renal disease (25%), peripheral vascular disease (55%), and coronary artery disease (52%).

Among those who had not had a dilated funduscopic examination within a year, barriers to screening examination included transportation issues, physical disability, too many appointments or being too sick, cost, lack of time or priority, or no visual impairment. Forty percent reported having an eye examination within the year and 5% reported never having an eye examination.

The investigators identified 7 patients with clinically significant macular edema (6%), 13 with proliferative diabetic retinopathy (12%), and 1 with severe (1%), 14 with moderate (13%), and 16 with mild nonproliferative diabetic retinopathy (15%). Overall, 44% of the patients had diabetic retinopathy, with 25% previously undiagnosed. Further, sight-threatening diabetic retinopathy was found in 19%, with 3.7% previously undiagnosed.

Finally, after multivariable analysis, a longer duration of diabetes (odds ratio, 1.08 per year; 95% confidence interval, 1.014-1.147; P =.017) and renal disease (OR, 3.86; 95% CI, 1.22-12.27; P =.022) was associated with diabetic retinopathy. Further, of the 17 patients admitted with osteomyelitis or a nonhealing diabetic ulcer, 15 (88.2%) had diabetic retinopathy.

“Curiously, most inpatients in our population (91%) are aware of the ocular complications of diabetes, and many (64%) do have ophthalmologists (more than any other subspecialty listed), yet only a minority (40%) of patients are getting the recommended standard of care screening examinations. Barriers that are unique to this high-risk population may explain this disparity,” the authors wrote.

The study was funded by the National Institutes of Health, Eye and Ear Foundation of Pittsburgh, Clinical and Translational Science Institute, the University of Pittsburgh, and a grant from Research to Prevent Blindness. One of the researchers, Dr. Jann Johnston, reported speaking for Medtronic, Lilly, and Sanofi.