In 2012, Dr. Renli Qiao, FCCP, won the D. Robert McCaffree, MD, Master FCCP Humanitarian Award for his critical work with village doctors in rural China. Because medical schools in China are located in larger metropolitan areas where graduates are likely to stay, medical resources are unevenly distributed across the country. Physicians with shortened medical education often staff rural hospitals, and smaller villages usually house a single village doctor with a high-school diploma and 3-6 months of medical training.

Inspired by his work with the China California Heart Watch (CCHW), Dr. Qiao created a program to train rural medical professionals so that their efforts would have a sustaining impact on the care that residents of these villages receive. Volunteer physicians traveled through as many villages on foot to spend several days in each village where they would see about 250 villagers a day. In these villages, the doctors were also able to perform heart examinations for hundreds of children in the village schools. The team observed that although hypertension is the leading cause of death in China and the antihypertensive drugs are relatively affordable, there is a high incidence of hypertension, and up to 95% of patients with hypertension were never diagnosed or treated.

Realizing the need to train doctors on the importance of preventive care, early diagnoses, and treatment of hypertension, Dr. Qiao led the initiative to educate thousands of doctors in the Yunnan province. His model involved 2-day seminars and included participatory workshops, lectures, group collaboration, and the dissection of clinical cases.

Dr. Qiao’s effort not only improved the lives of thousands of patients but also achieved a lasting model to educate rural doctors. He is now aiding in the China-CHEST PCCM program efforts to establish PCCM as a subspecialty in China.

In 2012, Dr. Renli Qiao, FCCP, won the D. Robert McCaffree, MD, Master FCCP Humanitarian Award for his critical work with village doctors in rural China. Because medical schools in China are located in larger metropolitan areas where graduates are likely to stay, medical resources are unevenly distributed across the country. Physicians with shortened medical education often staff rural hospitals, and smaller villages usually house a single village doctor with a high-school diploma and 3-6 months of medical training.

Inspired by his work with the China California Heart Watch (CCHW), Dr. Qiao created a program to train rural medical professionals so that their efforts would have a sustaining impact on the care that residents of these villages receive. Volunteer physicians traveled through as many villages on foot to spend several days in each village where they would see about 250 villagers a day. In these villages, the doctors were also able to perform heart examinations for hundreds of children in the village schools. The team observed that although hypertension is the leading cause of death in China and the antihypertensive drugs are relatively affordable, there is a high incidence of hypertension, and up to 95% of patients with hypertension were never diagnosed or treated.

Realizing the need to train doctors on the importance of preventive care, early diagnoses, and treatment of hypertension, Dr. Qiao led the initiative to educate thousands of doctors in the Yunnan province. His model involved 2-day seminars and included participatory workshops, lectures, group collaboration, and the dissection of clinical cases.

Dr. Qiao’s effort not only improved the lives of thousands of patients but also achieved a lasting model to educate rural doctors. He is now aiding in the China-CHEST PCCM program efforts to establish PCCM as a subspecialty in China.

In 2012, Dr. Renli Qiao, FCCP, won the D. Robert McCaffree, MD, Master FCCP Humanitarian Award for his critical work with village doctors in rural China. Because medical schools in China are located in larger metropolitan areas where graduates are likely to stay, medical resources are unevenly distributed across the country. Physicians with shortened medical education often staff rural hospitals, and smaller villages usually house a single village doctor with a high-school diploma and 3-6 months of medical training.

Inspired by his work with the China California Heart Watch (CCHW), Dr. Qiao created a program to train rural medical professionals so that their efforts would have a sustaining impact on the care that residents of these villages receive. Volunteer physicians traveled through as many villages on foot to spend several days in each village where they would see about 250 villagers a day. In these villages, the doctors were also able to perform heart examinations for hundreds of children in the village schools. The team observed that although hypertension is the leading cause of death in China and the antihypertensive drugs are relatively affordable, there is a high incidence of hypertension, and up to 95% of patients with hypertension were never diagnosed or treated.

Realizing the need to train doctors on the importance of preventive care, early diagnoses, and treatment of hypertension, Dr. Qiao led the initiative to educate thousands of doctors in the Yunnan province. His model involved 2-day seminars and included participatory workshops, lectures, group collaboration, and the dissection of clinical cases.

Dr. Qiao’s effort not only improved the lives of thousands of patients but also achieved a lasting model to educate rural doctors. He is now aiding in the China-CHEST PCCM program efforts to establish PCCM as a subspecialty in China.

The Lung Association of Saskatchewan has conferred its highest award on Dr. Darcy Marciniuk, FCCP. The Lifetime Achievement Award recognizes 25 years of outstanding service by Dr. Marciniuk to improving respiratory health in Saskatchewan. Dr. Marciniuk is currently associate vice president of research (Acting) at the University of Saskatchewan, Canada, in addition to continuing to serve as professor of medicine in the division of respirology, critical care, and sleep medicine.

Dr. Marciniuk led the development of both respiratory services and chronic disease management in general in the Saskatoon Health Region, which is now spreading to the province as a whole. He began the LiveWell program that started with respiratory health and was used as a model to expand the chronic disease management program to other health areas. He was a leader in the development of the Lung Health Institute and is currently spearheading the establishment of a respiratory research center at the University of Saskatchewan. He has done extensive research in the area of chronic obstructive pulmonary disease, for which he is nationally and internationally recognized with more than 100 peer-reviewed publications. Dr. Marciniuk is currently a leader in the CHEST initiative to develop a national respirology training program in China, which is being implemented in collaboration with the Chinese government.

CHEST congratulates Dr. Marciniuk on this prestigious honor.

The Lung Association of Saskatchewan has conferred its highest award on Dr. Darcy Marciniuk, FCCP. The Lifetime Achievement Award recognizes 25 years of outstanding service by Dr. Marciniuk to improving respiratory health in Saskatchewan. Dr. Marciniuk is currently associate vice president of research (Acting) at the University of Saskatchewan, Canada, in addition to continuing to serve as professor of medicine in the division of respirology, critical care, and sleep medicine.

Dr. Marciniuk led the development of both respiratory services and chronic disease management in general in the Saskatoon Health Region, which is now spreading to the province as a whole. He began the LiveWell program that started with respiratory health and was used as a model to expand the chronic disease management program to other health areas. He was a leader in the development of the Lung Health Institute and is currently spearheading the establishment of a respiratory research center at the University of Saskatchewan. He has done extensive research in the area of chronic obstructive pulmonary disease, for which he is nationally and internationally recognized with more than 100 peer-reviewed publications. Dr. Marciniuk is currently a leader in the CHEST initiative to develop a national respirology training program in China, which is being implemented in collaboration with the Chinese government.

CHEST congratulates Dr. Marciniuk on this prestigious honor.

The Lung Association of Saskatchewan has conferred its highest award on Dr. Darcy Marciniuk, FCCP. The Lifetime Achievement Award recognizes 25 years of outstanding service by Dr. Marciniuk to improving respiratory health in Saskatchewan. Dr. Marciniuk is currently associate vice president of research (Acting) at the University of Saskatchewan, Canada, in addition to continuing to serve as professor of medicine in the division of respirology, critical care, and sleep medicine.

Dr. Marciniuk led the development of both respiratory services and chronic disease management in general in the Saskatoon Health Region, which is now spreading to the province as a whole. He began the LiveWell program that started with respiratory health and was used as a model to expand the chronic disease management program to other health areas. He was a leader in the development of the Lung Health Institute and is currently spearheading the establishment of a respiratory research center at the University of Saskatchewan. He has done extensive research in the area of chronic obstructive pulmonary disease, for which he is nationally and internationally recognized with more than 100 peer-reviewed publications. Dr. Marciniuk is currently a leader in the CHEST initiative to develop a national respirology training program in China, which is being implemented in collaboration with the Chinese government.

CHEST congratulates Dr. Marciniuk on this prestigious honor.

FROM CIRCULATION: CARDIOVASCULAR QUALITY OUTCOMES

Insufficient evidence exists to routinely recommend surgical closure of the left atrial appendage, either surgically or with a LAA exclusion device, for patients who have atrial fibrillation, a large data review has concluded.

None of the devices so far examined is more effective than oral anticoagulation therapy in reducing AF-related stroke risk, but they appear to be riskier, with up to 1 in 15 patients experiencing a serious adverse event during or after percutaneous placement, North Noelck, MD, and his colleagues wrote (Circ Cardiovasc Qual Outcomes. 2016 Jul 12. doi: 10.1161/CIRCOUTCOMES.115.002539).

Surgical studies, which also have found no benefit, are poor in quality and provide no strong data in favor of any technique, wrote Dr. Noelck of Oregon Health and Science University, Portland.

The meta-analysis comprised 13 studies of the benefits and risks of percutaneous LAA exclusion and 7 of the benefits and harms of surgical LAA closure.

The team found “limited evidence” that one device, the Watchman (Boston Scientific), may be an effective alternative to long-term oral anticoagulation treatment in some patients. But the Watchman was also associated with “significant, procedural-related harms,” in almost 11% of patients in one large study, PROTECT-AF. These included pericardial effusions with and without associated tamponade, bleeding, device thrombus, and device embolization. However, the benefit conferred by the device appeared marginal. Neither PROTECT-AF nor the subsequent PREVAIL studies of the Watchman found that it conferred significant clinical benefit above the comparator arm of warfarin therapy. Indeed, in PREVAIL, a composite outcome of death, ischemic/hemorrhagic stroke, or systemic embolism occurred in 5.2% of the device group and in 2.9% of the warfarin group.

Three randomized studies and two observational studies examined surgical LAA closure relative to usual medical care. The authors said the randomized studies were underpowered to show clinical benefit. Neither of the observational studies showed significant advantages in stroke-free survival, but the team noted, “data such as information about anticoagulation use among the groups [were] lacking.”

“Overall, there is insufficient evidence to support the routine use of surgical LAA exclusion to reduce stroke risk or the future need for anticoagulant therapy,” wrote Dr. Noelck and his coinvestigators. However, they said, several ongoing studies “should add substantively to this body of evidence during the next several years.”

The study was funded by the Department of Veterans Affairs. None of the authors had any relevant financial disclosure.

[email protected]

FROM CIRCULATION: CARDIOVASCULAR QUALITY OUTCOMES

Insufficient evidence exists to routinely recommend surgical closure of the left atrial appendage, either surgically or with a LAA exclusion device, for patients who have atrial fibrillation, a large data review has concluded.

None of the devices so far examined is more effective than oral anticoagulation therapy in reducing AF-related stroke risk, but they appear to be riskier, with up to 1 in 15 patients experiencing a serious adverse event during or after percutaneous placement, North Noelck, MD, and his colleagues wrote (Circ Cardiovasc Qual Outcomes. 2016 Jul 12. doi: 10.1161/CIRCOUTCOMES.115.002539).

Surgical studies, which also have found no benefit, are poor in quality and provide no strong data in favor of any technique, wrote Dr. Noelck of Oregon Health and Science University, Portland.

The meta-analysis comprised 13 studies of the benefits and risks of percutaneous LAA exclusion and 7 of the benefits and harms of surgical LAA closure.

The team found “limited evidence” that one device, the Watchman (Boston Scientific), may be an effective alternative to long-term oral anticoagulation treatment in some patients. But the Watchman was also associated with “significant, procedural-related harms,” in almost 11% of patients in one large study, PROTECT-AF. These included pericardial effusions with and without associated tamponade, bleeding, device thrombus, and device embolization. However, the benefit conferred by the device appeared marginal. Neither PROTECT-AF nor the subsequent PREVAIL studies of the Watchman found that it conferred significant clinical benefit above the comparator arm of warfarin therapy. Indeed, in PREVAIL, a composite outcome of death, ischemic/hemorrhagic stroke, or systemic embolism occurred in 5.2% of the device group and in 2.9% of the warfarin group.

Three randomized studies and two observational studies examined surgical LAA closure relative to usual medical care. The authors said the randomized studies were underpowered to show clinical benefit. Neither of the observational studies showed significant advantages in stroke-free survival, but the team noted, “data such as information about anticoagulation use among the groups [were] lacking.”

“Overall, there is insufficient evidence to support the routine use of surgical LAA exclusion to reduce stroke risk or the future need for anticoagulant therapy,” wrote Dr. Noelck and his coinvestigators. However, they said, several ongoing studies “should add substantively to this body of evidence during the next several years.”

The study was funded by the Department of Veterans Affairs. None of the authors had any relevant financial disclosure.

[email protected]

FROM CIRCULATION: CARDIOVASCULAR QUALITY OUTCOMES

Insufficient evidence exists to routinely recommend surgical closure of the left atrial appendage, either surgically or with a LAA exclusion device, for patients who have atrial fibrillation, a large data review has concluded.

None of the devices so far examined is more effective than oral anticoagulation therapy in reducing AF-related stroke risk, but they appear to be riskier, with up to 1 in 15 patients experiencing a serious adverse event during or after percutaneous placement, North Noelck, MD, and his colleagues wrote (Circ Cardiovasc Qual Outcomes. 2016 Jul 12. doi: 10.1161/CIRCOUTCOMES.115.002539).

Surgical studies, which also have found no benefit, are poor in quality and provide no strong data in favor of any technique, wrote Dr. Noelck of Oregon Health and Science University, Portland.

The meta-analysis comprised 13 studies of the benefits and risks of percutaneous LAA exclusion and 7 of the benefits and harms of surgical LAA closure.

The team found “limited evidence” that one device, the Watchman (Boston Scientific), may be an effective alternative to long-term oral anticoagulation treatment in some patients. But the Watchman was also associated with “significant, procedural-related harms,” in almost 11% of patients in one large study, PROTECT-AF. These included pericardial effusions with and without associated tamponade, bleeding, device thrombus, and device embolization. However, the benefit conferred by the device appeared marginal. Neither PROTECT-AF nor the subsequent PREVAIL studies of the Watchman found that it conferred significant clinical benefit above the comparator arm of warfarin therapy. Indeed, in PREVAIL, a composite outcome of death, ischemic/hemorrhagic stroke, or systemic embolism occurred in 5.2% of the device group and in 2.9% of the warfarin group.

Three randomized studies and two observational studies examined surgical LAA closure relative to usual medical care. The authors said the randomized studies were underpowered to show clinical benefit. Neither of the observational studies showed significant advantages in stroke-free survival, but the team noted, “data such as information about anticoagulation use among the groups [were] lacking.”

“Overall, there is insufficient evidence to support the routine use of surgical LAA exclusion to reduce stroke risk or the future need for anticoagulant therapy,” wrote Dr. Noelck and his coinvestigators. However, they said, several ongoing studies “should add substantively to this body of evidence during the next several years.”

The study was funded by the Department of Veterans Affairs. None of the authors had any relevant financial disclosure.

[email protected]

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here.

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here.

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here.

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here

[email protected]

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here

[email protected]

The incidence of human papillomavirus–associated cancers is increasing in the United States, but many of these cases could be prevented by the HPV vaccine, investigators from the Centers for Disease Control and Prevention report.

Between 2008 and 2012 the incidence of HPV-associated cancers was 11.7/100,000 persons, up from 10.8/100,000 persons during the previous 4-year period, according to data from population-based cancer registries. An average of 38,793 HPV-associated cancers were diagnosed in the most recent period, 30,700 (79%) of which can be attributed to HPV. Of those, 28,500 cancers are of HPV types that are preventable with the 9-valent HPV vaccine, reported Laura J. Viens, MD, and her associates.

©xrender/Thinkstock

Among the HPV-associated cancers, an average of 11,7771 cervical cancer cases were diagnosed each year. Rates of cervical cancer per 100,000 persons were higher among blacks (9.2) than among whites (7.1), and among Hispanics (9.7) than non-Hispanics (7.1).

“Increasing [HPV] vaccination coverage could decrease the cancer incidence and disparities in the United States,” the investigators concluded.

Find the full report from Morbidity and Mortality Weekly Report here

[email protected]

Irinotecan plus cisplatin is no better than paclitaxel plus carboplatin for women with ovarian clear cell carcinoma, according to an international study led by Japanese investigators.

Clear cell carcinoma (CCC) accounts for approximately 10% of epithelial ovarian cancers (EOCs) in Europe and the United States, but is more prevalent in Asia; In Japan CCC accounts for 24% of all EOCs.

In the first phase III, CCC-specific clinical trial, 667 women with stage I to IV CCC were randomized to receive one of two treatment regimens: irinotecan at a dose of 60 mg/m² on days 1, 8, and 15 plus cisplatin at 60 mg/m² on day 1 every 4 weeks for six cycles (n = 332) or paclitaxel at a dose of 175 mg/m² plus carboplatin on day 1 every 3 weeks for six cycles (n = 335).

Japanese women made up 93.5% of the study population, the median age was 53 years, and 6.4% of patients had stage I cancer. Median follow-up time was 44.3 months.

No difference was found between the groups in progression-free or overall survival, Toru Sugiyama, MD, of Iwate Medical University, Morioka, Japan, and associates reported (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.66.9010).

Both regimens were well tolerated, though the toxicity profiles were different, investigators wrote.

Overall, 72% of patients received all six cycles of their respective chemotherapy treatments. Two-year progression-free survival rates were 73.0% (95% confidence interval, 67.7%-77.5%) among patients receiving irinotecan plus cisplatin, 77.6% (95% CI, 72.4%-81.9%) among patients receiving paclitaxel plus carboplatin, and were not significantly different (HR, 1.17; 95% CI, 0.87-1.58; P = .30).

There was also no significant difference in overall survival between the two treatment arms.

In subgroup analyses, there was no significant difference in progression-free or overall survival by disease stage or tumor size.

Grade 3 or 4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia were the most common adverse events among women receiving irinotecan plus cisplatin. Grade 3 or 4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain were the most common adverse events among women receiving paclitaxel plus carboplatin. No treatment-related deaths occurred in either treatment arm.

This study was funded by the Japanese Gynecologic Oncology Group. Dr. Sugiyama and 18 other investigators had no disclosures to report. Six investigators reported serving in advisory roles for or receiving financial compensation or honoraria from multiple companies.

[email protected]

On Twitter @jessnicolecraig

Irinotecan plus cisplatin is no better than paclitaxel plus carboplatin for women with ovarian clear cell carcinoma, according to an international study led by Japanese investigators.

Clear cell carcinoma (CCC) accounts for approximately 10% of epithelial ovarian cancers (EOCs) in Europe and the United States, but is more prevalent in Asia; In Japan CCC accounts for 24% of all EOCs.

In the first phase III, CCC-specific clinical trial, 667 women with stage I to IV CCC were randomized to receive one of two treatment regimens: irinotecan at a dose of 60 mg/m² on days 1, 8, and 15 plus cisplatin at 60 mg/m² on day 1 every 4 weeks for six cycles (n = 332) or paclitaxel at a dose of 175 mg/m² plus carboplatin on day 1 every 3 weeks for six cycles (n = 335).

Japanese women made up 93.5% of the study population, the median age was 53 years, and 6.4% of patients had stage I cancer. Median follow-up time was 44.3 months.

No difference was found between the groups in progression-free or overall survival, Toru Sugiyama, MD, of Iwate Medical University, Morioka, Japan, and associates reported (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.66.9010).

Both regimens were well tolerated, though the toxicity profiles were different, investigators wrote.

Overall, 72% of patients received all six cycles of their respective chemotherapy treatments. Two-year progression-free survival rates were 73.0% (95% confidence interval, 67.7%-77.5%) among patients receiving irinotecan plus cisplatin, 77.6% (95% CI, 72.4%-81.9%) among patients receiving paclitaxel plus carboplatin, and were not significantly different (HR, 1.17; 95% CI, 0.87-1.58; P = .30).

There was also no significant difference in overall survival between the two treatment arms.

In subgroup analyses, there was no significant difference in progression-free or overall survival by disease stage or tumor size.

Grade 3 or 4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia were the most common adverse events among women receiving irinotecan plus cisplatin. Grade 3 or 4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain were the most common adverse events among women receiving paclitaxel plus carboplatin. No treatment-related deaths occurred in either treatment arm.

This study was funded by the Japanese Gynecologic Oncology Group. Dr. Sugiyama and 18 other investigators had no disclosures to report. Six investigators reported serving in advisory roles for or receiving financial compensation or honoraria from multiple companies.

[email protected]

On Twitter @jessnicolecraig

Irinotecan plus cisplatin is no better than paclitaxel plus carboplatin for women with ovarian clear cell carcinoma, according to an international study led by Japanese investigators.

Clear cell carcinoma (CCC) accounts for approximately 10% of epithelial ovarian cancers (EOCs) in Europe and the United States, but is more prevalent in Asia; In Japan CCC accounts for 24% of all EOCs.

In the first phase III, CCC-specific clinical trial, 667 women with stage I to IV CCC were randomized to receive one of two treatment regimens: irinotecan at a dose of 60 mg/m² on days 1, 8, and 15 plus cisplatin at 60 mg/m² on day 1 every 4 weeks for six cycles (n = 332) or paclitaxel at a dose of 175 mg/m² plus carboplatin on day 1 every 3 weeks for six cycles (n = 335).

Japanese women made up 93.5% of the study population, the median age was 53 years, and 6.4% of patients had stage I cancer. Median follow-up time was 44.3 months.

No difference was found between the groups in progression-free or overall survival, Toru Sugiyama, MD, of Iwate Medical University, Morioka, Japan, and associates reported (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.66.9010).

Both regimens were well tolerated, though the toxicity profiles were different, investigators wrote.

Overall, 72% of patients received all six cycles of their respective chemotherapy treatments. Two-year progression-free survival rates were 73.0% (95% confidence interval, 67.7%-77.5%) among patients receiving irinotecan plus cisplatin, 77.6% (95% CI, 72.4%-81.9%) among patients receiving paclitaxel plus carboplatin, and were not significantly different (HR, 1.17; 95% CI, 0.87-1.58; P = .30).

There was also no significant difference in overall survival between the two treatment arms.

In subgroup analyses, there was no significant difference in progression-free or overall survival by disease stage or tumor size.

Grade 3 or 4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia were the most common adverse events among women receiving irinotecan plus cisplatin. Grade 3 or 4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain were the most common adverse events among women receiving paclitaxel plus carboplatin. No treatment-related deaths occurred in either treatment arm.

This study was funded by the Japanese Gynecologic Oncology Group. Dr. Sugiyama and 18 other investigators had no disclosures to report. Six investigators reported serving in advisory roles for or receiving financial compensation or honoraria from multiple companies.

[email protected]

On Twitter @jessnicolecraig

The combination of all-trans­-retinoic acid (ATRA) and arsenic trioxide continues to show advantages over ATRA and chemotherapy as first-line therapy for patients with low- or intermediate-risk acute promyelocytic leukemia (APL), investigators report.

The final analysis of theAPL046 study, a noninferiority trial of ATRA plus arsenic trioxide (ATRA-ATO) vs. ATRA and standard chemotherapy, showed that event-free survival (EFS) and overall survival (OS) were significantly better among patients assigned to ATRA-ATO. Patients in this group also had a significantly lower cumulative incidence of relapse, reported Francesco Lo-Coco, MD, of University Tor Vergata in Rome and colleagues.

“Our results support the use of ATRA-ATO in patients with newly diagnosed APL and point to this strategy as the new standard of care for low- or intermediate-risk patients. Studies exploring the role of ATRA-ATO are warranted in other APL subsets including high-risk, pediatric, and elderly patients,” they wrote (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.67.1982).

In the trial, 276 patients with newly diagnosed APL were randomly assigned to receive either ATRA-ATO or ATRA plus chemotherapy with idarubicin, mercaptopurine, and methotrexate.

A total of 263 patients were evaluable for response to induction, including 127 assigned to ATRA-ATO and 136 assigned to ATRA-chemotherapy. Following induction, all patients assigned to ATRA-ATO and 127 assigned to chemotherapy (97%) achieved a complete remission (CR).

After a median follow-up of 40.6 months, the rate of EFS, the primary outcome, was 97.3% for ATRA-ATO vs. 80% for ATRA-chemotherapy (P less than .001). The cumulative incidences of relapse were 1.9% and 13.9%, respectively (P = .0013), and overall survival rates at 50 months were 99.2% vs. 92.6% (P = . 0073).

Hematologic toxicities were more frequent among patients assigned to chemotherapy, while liver function abnormalities occurred more often among those assigned to ATO.

One patient assigned to ATRA-ATO died while in CR, from bronchopneumonia caused by the H1N1 (influenza) virus. Five patients assigned to chemotherapy died in CR, from hemorrhagic shock, pulmonary embolism, bronchopneumonia (two patients) and secondary myelodysplastic syndrome.

Of the 17 patients who experienced relapses during follow-up, 2 assigned to ATRA-ATO had relapses at 22 and 27 months. The remaining 15 relapses were among patients assigned to ATRA-chemotherapy, occurring at a median of 14 months.

The authors noted that the superior EFS and cumulative incidence of relapse with ATRA-ATO emerged only after longer follow-up, indicating that the advantage of ATRA-ATO over ATRA-chemotherapy increases over time and that “the inclusion of ATO in the treatment of low- or intermediate-risk APL not only reduces mortality and hematologic toxicity, but also results in improved and sustained antileukemic activity.”

The study was supported by the Gruppo Italiano Malattie Ematologiche dell’Adulto Foundation; the Associazione Italiana Contro le Leucemie, Linfomi e Mieloma, Associazione Italiana per la Ricerca sul Cancro, and the German Federal Ministry of Education and Research. Dr. Lo-Coco disclosed honoraria, consulting, and speakers’ bureau activities with Teva Pharmaceutical, Lundbeck, Novartis, Baxalta, and Pfizer. Several other coauthors disclosed similar relationships.

[email protected]

The combination of all-trans­-retinoic acid (ATRA) and arsenic trioxide continues to show advantages over ATRA and chemotherapy as first-line therapy for patients with low- or intermediate-risk acute promyelocytic leukemia (APL), investigators report.

The final analysis of theAPL046 study, a noninferiority trial of ATRA plus arsenic trioxide (ATRA-ATO) vs. ATRA and standard chemotherapy, showed that event-free survival (EFS) and overall survival (OS) were significantly better among patients assigned to ATRA-ATO. Patients in this group also had a significantly lower cumulative incidence of relapse, reported Francesco Lo-Coco, MD, of University Tor Vergata in Rome and colleagues.

“Our results support the use of ATRA-ATO in patients with newly diagnosed APL and point to this strategy as the new standard of care for low- or intermediate-risk patients. Studies exploring the role of ATRA-ATO are warranted in other APL subsets including high-risk, pediatric, and elderly patients,” they wrote (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.67.1982).

In the trial, 276 patients with newly diagnosed APL were randomly assigned to receive either ATRA-ATO or ATRA plus chemotherapy with idarubicin, mercaptopurine, and methotrexate.

A total of 263 patients were evaluable for response to induction, including 127 assigned to ATRA-ATO and 136 assigned to ATRA-chemotherapy. Following induction, all patients assigned to ATRA-ATO and 127 assigned to chemotherapy (97%) achieved a complete remission (CR).

After a median follow-up of 40.6 months, the rate of EFS, the primary outcome, was 97.3% for ATRA-ATO vs. 80% for ATRA-chemotherapy (P less than .001). The cumulative incidences of relapse were 1.9% and 13.9%, respectively (P = .0013), and overall survival rates at 50 months were 99.2% vs. 92.6% (P = . 0073).

Hematologic toxicities were more frequent among patients assigned to chemotherapy, while liver function abnormalities occurred more often among those assigned to ATO.

One patient assigned to ATRA-ATO died while in CR, from bronchopneumonia caused by the H1N1 (influenza) virus. Five patients assigned to chemotherapy died in CR, from hemorrhagic shock, pulmonary embolism, bronchopneumonia (two patients) and secondary myelodysplastic syndrome.

Of the 17 patients who experienced relapses during follow-up, 2 assigned to ATRA-ATO had relapses at 22 and 27 months. The remaining 15 relapses were among patients assigned to ATRA-chemotherapy, occurring at a median of 14 months.

The authors noted that the superior EFS and cumulative incidence of relapse with ATRA-ATO emerged only after longer follow-up, indicating that the advantage of ATRA-ATO over ATRA-chemotherapy increases over time and that “the inclusion of ATO in the treatment of low- or intermediate-risk APL not only reduces mortality and hematologic toxicity, but also results in improved and sustained antileukemic activity.”

The study was supported by the Gruppo Italiano Malattie Ematologiche dell’Adulto Foundation; the Associazione Italiana Contro le Leucemie, Linfomi e Mieloma, Associazione Italiana per la Ricerca sul Cancro, and the German Federal Ministry of Education and Research. Dr. Lo-Coco disclosed honoraria, consulting, and speakers’ bureau activities with Teva Pharmaceutical, Lundbeck, Novartis, Baxalta, and Pfizer. Several other coauthors disclosed similar relationships.

[email protected]

The combination of all-trans­-retinoic acid (ATRA) and arsenic trioxide continues to show advantages over ATRA and chemotherapy as first-line therapy for patients with low- or intermediate-risk acute promyelocytic leukemia (APL), investigators report.

The final analysis of theAPL046 study, a noninferiority trial of ATRA plus arsenic trioxide (ATRA-ATO) vs. ATRA and standard chemotherapy, showed that event-free survival (EFS) and overall survival (OS) were significantly better among patients assigned to ATRA-ATO. Patients in this group also had a significantly lower cumulative incidence of relapse, reported Francesco Lo-Coco, MD, of University Tor Vergata in Rome and colleagues.

“Our results support the use of ATRA-ATO in patients with newly diagnosed APL and point to this strategy as the new standard of care for low- or intermediate-risk patients. Studies exploring the role of ATRA-ATO are warranted in other APL subsets including high-risk, pediatric, and elderly patients,” they wrote (J Clin Oncol. 2016 July 11. doi: 10.1200/JCO.2016.67.1982).

In the trial, 276 patients with newly diagnosed APL were randomly assigned to receive either ATRA-ATO or ATRA plus chemotherapy with idarubicin, mercaptopurine, and methotrexate.

A total of 263 patients were evaluable for response to induction, including 127 assigned to ATRA-ATO and 136 assigned to ATRA-chemotherapy. Following induction, all patients assigned to ATRA-ATO and 127 assigned to chemotherapy (97%) achieved a complete remission (CR).

After a median follow-up of 40.6 months, the rate of EFS, the primary outcome, was 97.3% for ATRA-ATO vs. 80% for ATRA-chemotherapy (P less than .001). The cumulative incidences of relapse were 1.9% and 13.9%, respectively (P = .0013), and overall survival rates at 50 months were 99.2% vs. 92.6% (P = . 0073).

Hematologic toxicities were more frequent among patients assigned to chemotherapy, while liver function abnormalities occurred more often among those assigned to ATO.

One patient assigned to ATRA-ATO died while in CR, from bronchopneumonia caused by the H1N1 (influenza) virus. Five patients assigned to chemotherapy died in CR, from hemorrhagic shock, pulmonary embolism, bronchopneumonia (two patients) and secondary myelodysplastic syndrome.

Of the 17 patients who experienced relapses during follow-up, 2 assigned to ATRA-ATO had relapses at 22 and 27 months. The remaining 15 relapses were among patients assigned to ATRA-chemotherapy, occurring at a median of 14 months.

The authors noted that the superior EFS and cumulative incidence of relapse with ATRA-ATO emerged only after longer follow-up, indicating that the advantage of ATRA-ATO over ATRA-chemotherapy increases over time and that “the inclusion of ATO in the treatment of low- or intermediate-risk APL not only reduces mortality and hematologic toxicity, but also results in improved and sustained antileukemic activity.”

The study was supported by the Gruppo Italiano Malattie Ematologiche dell’Adulto Foundation; the Associazione Italiana Contro le Leucemie, Linfomi e Mieloma, Associazione Italiana per la Ricerca sul Cancro, and the German Federal Ministry of Education and Research. Dr. Lo-Coco disclosed honoraria, consulting, and speakers’ bureau activities with Teva Pharmaceutical, Lundbeck, Novartis, Baxalta, and Pfizer. Several other coauthors disclosed similar relationships.

[email protected]

DENVER – Transdermal or sublingual flumazenil is well worth considering for treatment of carefully selected patients with hypersomnolence refractory to conventional wake-promoting medications, Lynn Marie Trotti, MD, said at the annual meeting of the Associated Professional Sleep Societies.

Her retrospective chart review of 153 consecutive patients treated with flumazenil (Romazicon) showed that 63% derived symptomatic benefit, and 39% of patients remained on the drug at the end of the review period, which averaged 6.8 months, reported Dr. Trotti, a neurologist and sleep scientist at Emory University in Atlanta.

©Monkey Business Images Ltd/Thinkstock

Make no mistake: This is off-label therapy. Flumazenil’s approved indication is as intravenous therapy for benzodiazepine sedation. Given orally, the drug is almost entirely eliminated on first-pass metabolism, so she and her coinvestigators had flumazenil compounded at a pharmacy in two formulations: a 6-mg sublingual lozenge and a transcutaneous lotion in a dispenser providing 3 mg of flumazenil per click of the device.

This novel therapy is supported by a plausible mechanistic rationale. Dr. Trotti and colleagues have previously shown that most patients with central hypersomnolence have abnormal potentiation of GABA-A receptors in their cerebrospinal fluid (CSF).

“Functionally speaking, it’s as though they’re producing an endogenous benzodiazepinelike substance,” she explained.

The investigators showed further that the macrolide antibiotic clarithromycin, a negative allosteric modulator of GABA-A receptors, reduced sleepiness in patients with central hypersomnolence syndromes in a randomized, double-blind, crossover trial (Ann Neurol. 2015 Sep;78[3]:454-65).

“It’s not great to use an antibiotic to treat people who don’t have a bacterial infection, so it would be really lovely if we had a GABA antagonist or negative allosteric modulator of GABA-A receptors that was not clarithromycin. And that’s where flumazenil comes into the picture,” according to Dr. Trotti.

As a requirement for receiving flumazenil at the Emory sleep disorders center, patients had to have been refractory to all conventional therapies. Indeed, they had been refractory to an average of 4.6 medications for excessive sleepiness. Also, their hypersomnolence had to have a serious impact on their daily life, for example a job at risk because of inability to drive to and from work safely. Initially, it was further required as a condition for treatment that patients had to show abnormal CSF potentiation of GABA-A receptors; however, the investigators quit requiring a CSF sample after roughly the first 100 candidates proved positive.

Dosing of the sublingual flumazenil lozenges began at one 6-mg lozenge four times daily, titrating up by adding an extra lozenge every 4-5 days until reaching a maximum of 12 per day. The lotion is rubbed on the inside of the forearm at a dose of 3 mg on each arm up to four times per day.

Among the 40 treatment responders who completed the Epworth Sleepiness Scale at baseline and after an average of 6.8 months on flumazenil, the average score improved from 15 to 10.3.

Fifty-seven patients obtained no benefit from flumazenil, 10 stopped the drug because of side effects, 3 quit because they preferred clarithromycin, 8 stopped owing to the cost, and the rest dropped the drug for an assortment of reasons, including planned pregnancy.

The most common treatment-emergent adverse events included dizziness in 13% of subjects, anxiety in 7%, and other mood disturbances in 6%.

Two serious adverse events occurred. One patient with a history of atrial fibrillation experienced a transient ischemic attack. And a patient with systemic lupus erythematous developed asymptomatic CNS lupus vasculopathy. It’s not possible to say whether these events were treatment related because the experience with chronic flumazenil therapy is so limited. After all, the drug is given for its approved indication for no longer than a few days, Dr. Trotti observed.

“This is all clinical data. Obviously I’m not suggesting that everybody should start prescribing flumazenil. That being said, we really need better treatment options,” she said.

The long-term treatment continuation rate with modafinil for hypersomnolence is about 50%, anywhere from 29% to 66% for amphetamines, 38% for clarithromycin, and 37% for pitolisant.

“If you look globally at how likely people with idiopathic hypersomnolence or narcolepsy are to get a satisfactory response to conventional therapies, probably 15%-20% do not get satisfactorily treated with what we currently have available. Prospective controlled studies of flumazenil for treatment of hypersomnolence are certainly needed, but in the absence of those data there’s at least a rationale for people who are severely affected and have nowhere else to turn to consider flumazenil,” Dr. Trotti concluded.

She reported having no financial conflicts regarding her study, supported by the National Institutes of Health.

[email protected]

DENVER – Transdermal or sublingual flumazenil is well worth considering for treatment of carefully selected patients with hypersomnolence refractory to conventional wake-promoting medications, Lynn Marie Trotti, MD, said at the annual meeting of the Associated Professional Sleep Societies.

Her retrospective chart review of 153 consecutive patients treated with flumazenil (Romazicon) showed that 63% derived symptomatic benefit, and 39% of patients remained on the drug at the end of the review period, which averaged 6.8 months, reported Dr. Trotti, a neurologist and sleep scientist at Emory University in Atlanta.

©Monkey Business Images Ltd/Thinkstock

Make no mistake: This is off-label therapy. Flumazenil’s approved indication is as intravenous therapy for benzodiazepine sedation. Given orally, the drug is almost entirely eliminated on first-pass metabolism, so she and her coinvestigators had flumazenil compounded at a pharmacy in two formulations: a 6-mg sublingual lozenge and a transcutaneous lotion in a dispenser providing 3 mg of flumazenil per click of the device.

This novel therapy is supported by a plausible mechanistic rationale. Dr. Trotti and colleagues have previously shown that most patients with central hypersomnolence have abnormal potentiation of GABA-A receptors in their cerebrospinal fluid (CSF).

“Functionally speaking, it’s as though they’re producing an endogenous benzodiazepinelike substance,” she explained.

The investigators showed further that the macrolide antibiotic clarithromycin, a negative allosteric modulator of GABA-A receptors, reduced sleepiness in patients with central hypersomnolence syndromes in a randomized, double-blind, crossover trial (Ann Neurol. 2015 Sep;78[3]:454-65).

“It’s not great to use an antibiotic to treat people who don’t have a bacterial infection, so it would be really lovely if we had a GABA antagonist or negative allosteric modulator of GABA-A receptors that was not clarithromycin. And that’s where flumazenil comes into the picture,” according to Dr. Trotti.

As a requirement for receiving flumazenil at the Emory sleep disorders center, patients had to have been refractory to all conventional therapies. Indeed, they had been refractory to an average of 4.6 medications for excessive sleepiness. Also, their hypersomnolence had to have a serious impact on their daily life, for example a job at risk because of inability to drive to and from work safely. Initially, it was further required as a condition for treatment that patients had to show abnormal CSF potentiation of GABA-A receptors; however, the investigators quit requiring a CSF sample after roughly the first 100 candidates proved positive.

Dosing of the sublingual flumazenil lozenges began at one 6-mg lozenge four times daily, titrating up by adding an extra lozenge every 4-5 days until reaching a maximum of 12 per day. The lotion is rubbed on the inside of the forearm at a dose of 3 mg on each arm up to four times per day.

Among the 40 treatment responders who completed the Epworth Sleepiness Scale at baseline and after an average of 6.8 months on flumazenil, the average score improved from 15 to 10.3.

Fifty-seven patients obtained no benefit from flumazenil, 10 stopped the drug because of side effects, 3 quit because they preferred clarithromycin, 8 stopped owing to the cost, and the rest dropped the drug for an assortment of reasons, including planned pregnancy.

The most common treatment-emergent adverse events included dizziness in 13% of subjects, anxiety in 7%, and other mood disturbances in 6%.

Two serious adverse events occurred. One patient with a history of atrial fibrillation experienced a transient ischemic attack. And a patient with systemic lupus erythematous developed asymptomatic CNS lupus vasculopathy. It’s not possible to say whether these events were treatment related because the experience with chronic flumazenil therapy is so limited. After all, the drug is given for its approved indication for no longer than a few days, Dr. Trotti observed.

“This is all clinical data. Obviously I’m not suggesting that everybody should start prescribing flumazenil. That being said, we really need better treatment options,” she said.

The long-term treatment continuation rate with modafinil for hypersomnolence is about 50%, anywhere from 29% to 66% for amphetamines, 38% for clarithromycin, and 37% for pitolisant.

“If you look globally at how likely people with idiopathic hypersomnolence or narcolepsy are to get a satisfactory response to conventional therapies, probably 15%-20% do not get satisfactorily treated with what we currently have available. Prospective controlled studies of flumazenil for treatment of hypersomnolence are certainly needed, but in the absence of those data there’s at least a rationale for people who are severely affected and have nowhere else to turn to consider flumazenil,” Dr. Trotti concluded.

She reported having no financial conflicts regarding her study, supported by the National Institutes of Health.

[email protected]

DENVER – Transdermal or sublingual flumazenil is well worth considering for treatment of carefully selected patients with hypersomnolence refractory to conventional wake-promoting medications, Lynn Marie Trotti, MD, said at the annual meeting of the Associated Professional Sleep Societies.

Her retrospective chart review of 153 consecutive patients treated with flumazenil (Romazicon) showed that 63% derived symptomatic benefit, and 39% of patients remained on the drug at the end of the review period, which averaged 6.8 months, reported Dr. Trotti, a neurologist and sleep scientist at Emory University in Atlanta.

©Monkey Business Images Ltd/Thinkstock

Make no mistake: This is off-label therapy. Flumazenil’s approved indication is as intravenous therapy for benzodiazepine sedation. Given orally, the drug is almost entirely eliminated on first-pass metabolism, so she and her coinvestigators had flumazenil compounded at a pharmacy in two formulations: a 6-mg sublingual lozenge and a transcutaneous lotion in a dispenser providing 3 mg of flumazenil per click of the device.

This novel therapy is supported by a plausible mechanistic rationale. Dr. Trotti and colleagues have previously shown that most patients with central hypersomnolence have abnormal potentiation of GABA-A receptors in their cerebrospinal fluid (CSF).

“Functionally speaking, it’s as though they’re producing an endogenous benzodiazepinelike substance,” she explained.

The investigators showed further that the macrolide antibiotic clarithromycin, a negative allosteric modulator of GABA-A receptors, reduced sleepiness in patients with central hypersomnolence syndromes in a randomized, double-blind, crossover trial (Ann Neurol. 2015 Sep;78[3]:454-65).

“It’s not great to use an antibiotic to treat people who don’t have a bacterial infection, so it would be really lovely if we had a GABA antagonist or negative allosteric modulator of GABA-A receptors that was not clarithromycin. And that’s where flumazenil comes into the picture,” according to Dr. Trotti.

As a requirement for receiving flumazenil at the Emory sleep disorders center, patients had to have been refractory to all conventional therapies. Indeed, they had been refractory to an average of 4.6 medications for excessive sleepiness. Also, their hypersomnolence had to have a serious impact on their daily life, for example a job at risk because of inability to drive to and from work safely. Initially, it was further required as a condition for treatment that patients had to show abnormal CSF potentiation of GABA-A receptors; however, the investigators quit requiring a CSF sample after roughly the first 100 candidates proved positive.

Dosing of the sublingual flumazenil lozenges began at one 6-mg lozenge four times daily, titrating up by adding an extra lozenge every 4-5 days until reaching a maximum of 12 per day. The lotion is rubbed on the inside of the forearm at a dose of 3 mg on each arm up to four times per day.

Among the 40 treatment responders who completed the Epworth Sleepiness Scale at baseline and after an average of 6.8 months on flumazenil, the average score improved from 15 to 10.3.

Fifty-seven patients obtained no benefit from flumazenil, 10 stopped the drug because of side effects, 3 quit because they preferred clarithromycin, 8 stopped owing to the cost, and the rest dropped the drug for an assortment of reasons, including planned pregnancy.

The most common treatment-emergent adverse events included dizziness in 13% of subjects, anxiety in 7%, and other mood disturbances in 6%.

Two serious adverse events occurred. One patient with a history of atrial fibrillation experienced a transient ischemic attack. And a patient with systemic lupus erythematous developed asymptomatic CNS lupus vasculopathy. It’s not possible to say whether these events were treatment related because the experience with chronic flumazenil therapy is so limited. After all, the drug is given for its approved indication for no longer than a few days, Dr. Trotti observed.

“This is all clinical data. Obviously I’m not suggesting that everybody should start prescribing flumazenil. That being said, we really need better treatment options,” she said.

The long-term treatment continuation rate with modafinil for hypersomnolence is about 50%, anywhere from 29% to 66% for amphetamines, 38% for clarithromycin, and 37% for pitolisant.

“If you look globally at how likely people with idiopathic hypersomnolence or narcolepsy are to get a satisfactory response to conventional therapies, probably 15%-20% do not get satisfactorily treated with what we currently have available. Prospective controlled studies of flumazenil for treatment of hypersomnolence are certainly needed, but in the absence of those data there’s at least a rationale for people who are severely affected and have nowhere else to turn to consider flumazenil,” Dr. Trotti concluded.

She reported having no financial conflicts regarding her study, supported by the National Institutes of Health.

[email protected]

DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

[email protected]

DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

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DENVER – Gastroesophageal reflux disease is fertile soil for medical and psychiatric comorbid conditions, with sleep disorders leading the way, Maurice M. Ohayon, MD, reported at the annual meeting of the Associated Professional Sleep Societies.

He presented a very large, longitudinal, population-based study of gastroesophageal reflux disease (GERD) and its fellow travelers. The study entailed telephone interviews with 12,218 nationally representative subjects in 8 states at time 1, and reinterviews with 10,830 of them 3 years later. The interviews were guided by Sleep-EVAL, a validated computerized diagnostic interview system.

At time 1, 10.6% of subjects reported that they were told by a physician they have GERD and/or they were taking a medication for it. At time 2 (3 years later), the prevalence had increased to 12.4%, according to Dr. Ohayon, professor of psychiatry and behavioral sciences, chief of the division of public mental health and population sciences, and director of the sleep epidemiology research center at Stanford (Calif.) University.

Chronic GERD – that is, GERD at both time points – was present in 3.9% of subjects; 6% of subjects were remitters, meaning that they had GERD at time 1 but not at time 2. Another 8.5% of the total sample had incident GERD, meaning they had GERD at time 2 but not time 1.

The prevalence of GERD rose stepwise with increasing age, from the low single digits in 18- to 34-year-olds to a peak in the 55- to 64-year-old age group, where the prevalence was 13.5% at time 1 and 17% at time 2.

GERD was significantly more common in women. At time 2, the prevalence was 10% in men and 14.4% in women.

Nocturnal awakening was the sleep disorder symptom most commonly associated with GERD. It was a complaint in 28% of subjects who never had GERD, 46% of those with GERD at time 1, and 40% of those with GERD at time 2.

Insomnia, obstructive sleep apnea, and restless legs syndrome were also significantly more common among subjects with GERD. So were musculoskeletal and connective tissue diseases, hypertension, hypercholesterolemia, and major depressive disorder.

The study was supported by the John Arrillaga Foundation and Takeda Pharmaceuticals. Dr. Ohayon reported no financial conflicts of interest.

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