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Strength plus aerobics equals fitness for obese older adults
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Physical performance measures increased by 21% in obese older adults who followed a combination aerobic and resistance exercise routine for weight management, based on data form 141 participants. The findings were published May 17 in the New England Journal of Medicine.
The combination plan scores improved significantly more than either an aerobic exercise or resistance exercise plan (14%), wrote Dennis T. Villareal, MD, professor in the division of diabetes, endocrinology and metabolism at Baylor College of Medicine, Houston, and his colleagues (N Engl J Med. 2017 May 18;376[20]:1943-55).
The researchers randomized 40 adults to each of four interventions: aerobic exercise, resistance exercise, combination aerobic/resistance, and control. A total of 141 participants completed the study, and baseline demographic characteristics were similar among the groups.
Overall, among members of the combination group, scores on the Physical Performance Test showed the greatest increase from baseline to 6 months (from 28 to 33 points), compared with the aerobic group (29 to 33 points) and the resistance group (29 to 33 points).
Peak oxygen consumption was significantly higher at the end of the training period than at baseline in the combination and aerobic groups, compared with the resistance group (with increases of 17%, 18%, and 8% increase, respectively). Strength was significantly higher in the combination and resistance groups than in the aerobic group (18%, 19%, and 4% increase, respectively). Both decreases in both lean body mass and bone mineral density were significantly less in the combination and resistance groups, compared with the aerobic group.
Body weight decreased by approximately 9% from baseline in all three exercise groups, but no significant change was noted in the control group.
Adverse events “were relatively few and consistent with coexisting medical conditions,” the researchers said. Exercise-related adverse events included knee, back, and hip pain in the combination group; falling, shoulder pain, and back pain in the aerobic group; and shoulder pain, knee pain, and atrial fibrillation in the resistance group.
The study was limited in part by factors including the physical ability of the study population, which may not represent obese older adults in general, the researchers said. However, “our findings support that the recommendation by the American Heart Association and American College of Sports Medicine to combine aerobic exercise with resistance exercise for overall health extends to obese older adults undertaking weight loss,” they noted.
The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Combining aerobic and resistance exercise was significantly more effective for improving physical function in obese older adults.
Major finding: Physical performance test scores improved by 21% from baseline for obese adults in a combination exercise program vs. 14% for those in either an aerobic-only or resistance-only exercise program.
Data source: The data came from a randomized trial of 141 obese adults aged 65 years and older.
Disclosures: The study was supported by grants from the National Institutes of Health. The researchers had no financial conflicts to disclose.
USPSTF discourages postmenopausal hormone therapy for prevention
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.
The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.
After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.
The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.
Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.
However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).
Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.
The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.
Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.
View the recommendations online at uspreventiveservicestaskforce.org.
Mycobacteria subset plagues pulmonary patients
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
Nontuberculous mycobacteria accounts for an increasing percentage of pulmonary disease, and nonsurgical treatment alone has not shown effectiveness, according to data from a meta-analysis of 24 studies and 1,224 patients. The study results were published online in Chest.
Data on therapeutic successes in cases of nontuberculosis mycobacteria (NTM)–related pulmonary disease are limited, in particular for those species not related to the Mycobacterium avium complex (non-MAC), wrote Roland Diel, MD, of University Medical Hospital Schleswig-Holstein, Germany, and his colleagues.
In particular, non-MAC species Mycobacterium xenopi (MX), Mycobacterium abscessus, Mycobacterium malmoense, and Mycobacterium kansasii (MK) were addressed in the studies, which included 16 retrospective chart reviews, 5 randomized trials, and 3 prospective, nonrandomized studies (Chest 2017. doi: 10.1016/j.chest.2017.04.166).
Treatment success was measured by rates of sputum culture conversion (SCC).
Overall, the average proportion of SCC for patients with M. abscessus was 41% after subtraction for posttreatment relapses, but reached 70% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with MX, and 54% for those with M. malmoense.
Treatment success ranged from 9% to 73% for M. xenopi patients, but all-cause mortality was 69%. Of note, a 100% success rate was noted in M. kansasii patients using a three-drug TB regimen of isoniazid, rifampicin, and ethambutol, or with a combination of ethambutol, rifampicin, and clarithromycin, the researchers noted.
The percentage of SCC in 55 patients with lung resection and either MX or M. abscessus was considered high at 76%.
The study findings were limited by the diverse definitions of treatment success and by the variety of treatments and “an optimal multidrug treatment cannot be derived from the few studies and has yet to be determined,” the researchers said. In the absence of optimal drug therapy, functional and quality of life elements deserve greater consideration when evaluating outcomes in patients with non-MAC NTM pulmonary disease, they added.
Dr. Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
FROM CHEST
Key clinical point: An optimal multidrug treatment has not yet been found for patients with nontuberculosis mycobacteria (NTM)–related pulmonary disease.
Major finding: The average proportion of sputum culture conversion (SCC) for patients with M. abscessus was 42% after subtraction for posttreatment relapses, but reached 79% for subspecies M. massiliense in macrolide-containing treatments. The average proportion of SCC was 80% for patients with M. kansasii, 32% for those with M. xenopi, and 54% for those with M. malmoense.
Data source: A meta-analysis of 24 studies and 1,224 patients.
Disclosures: Dr. Roland Diel reported receiving lecturing and/or consulting fees from Insmed and Riemser.
In pyoderma gangrenosum, cyclosporine is cost effective for large lesions
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
, based on data from a multicenter, randomized trial published online in the British Journal of Dermatology.
In the STOP-GAP trial, researchers recruited 112 adults with pyoderma gangrenosum and similar baseline demographics. The patients were randomized to receive cyclosporine or prednisolone and were assessed at 6 weeks and 6 months. The researchers also collected quality of life data and cost and resource information.
Healing rates within 6 months were approximately 47% for the cyclosporine and prednisolone groups. Adverse reactions were similar between the two groups at 68% and 66%, respectively.
“Having found no difference for a range of objective and patient-reported outcomes, the trialists concluded that treatment decisions for individual patients should be guided by the different side effect profiles of the two drugs and patient preference,” wrote James M. Mason, MD, of the University of Warwick (England), and his colleagues. Compared with prednisolone, cyclosporine reduced the costs of treatment by 1,100 British pounds, the researchers noted. However, most of that cost savings was seen in patients with lesions of 20 cm2 or greater; the decreased cost for these patients averaged 5,310 British pounds. The cost savings were 1,007 British pounds for patients with lesions less than 20 cm2 (Br J Dermatol. 2017. doi: 10.1111/bjd.15561). “These differences were driven by the pattern of hospitalization, which predominantly occurred in patients receiving prednisolone and may be linked to the occurrence of serious adverse events,” the researchers wrote.
Quality of life was assessed using the EuroQol questionnaire and the Dermatology Life Quality Index.
No significant differences were noted between the two treatments in terms of quality of life scores, although there was a slight increase in quality of life scores among cyclosporine-treated patients over the 24-week follow-up period.
The findings were limited by incomplete data and the use of a base case analysis to complete the gaps, the researchers said. However, the results suggest that cyclosporine may be a cost-effective strategy for patients with larger lesions; no clear advantage was seen for cyclosporine vs. prednisolone treatment in patients with smaller lesions.
The study was supported in part by a grant from the National Institute for Health Research. The researchers had no financial conflicts to disclose.
Key clinical point: Approximately 50% of ulcers in pyoderma gangrenosum patients healed by 6 months on either cyclosporine or prednisolone, but cyclosporine cost less for patients with larger lesions.
Major finding: Cyclosporine was associated with an average cost reduction of 5,310 British pounds for pyoderma gangrenosum patients with lesions 20 cm2 or larger.
Data source: A cost-effectiveness analysis of the STOP-GAP randomized trial of adults with pyoderma gangrenosum.
Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by a grant from the National Institute for Health Research.
Novel robotic camera photographs colon
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
A novel robotically driven capsule successfully navigated a colon in a pig model in 100% of 30 retroflexion maneuvers, setting the stage for further study of robotics in colonoscopy. The data were presented at the annual Digestive Disease Week.
Although capsule technology has expanded exploration of the GI tract, current capsules are limited by passive movement and lack therapeutic capability, said Keith L. Obstein, MD, of Vanderbilt University in Nashville, Tenn.
The researchers developed a capsule with an 18-mm head and interior permanent magnets designed to be automatically controlled by an external robotic arm in difficult areas.
“Retroflexion is a common but mechanically complex maneuver during colonoscopy, and therefore serves as an excellent subject for autonomous control,” the researchers noted.
Logistically, the capsule is soft-tethered after it is introduced through the rectum, which allows the potential for therapeutic procedures such as biopsies and polyp removal. In addition, the use of an external magnet to pull the robot with the tether may reduce the pressure on the colon that typically created when a physician pushes the colonoscope from behind. Therefore, use of a robotic capsule may help reduce patients’ discomfort and make them more amenable to the procedure, Dr. Obstein said.
In the study, an endoscopist performed the first retroflexion with a standard colonoscope at 15 cm from the anal sphincter, and these parameters were used to set the robotic system for autonomous retroflexion at 15 cm from the anal sphincter.
The success rate was 100% for both the standard endoscope and the automatically controlled robot for each of 30 maneuvers. The average time for a robotic maneuver was 12 seconds, and no leaks or histologic abnormalities were noted.
Studies to evaluate additional control algorithms are in progress, and the robot capsule may be ready for human trials in 2018, Dr. Obstein said.
This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: An 18-mm magnetized capsule colonoscope successfully navigated a pig colon, and researchers are planning human trials for 2018.
Major finding: An automated robot capsule successfully completed 30 retroflexion maneuvers in a pig colon with an average time of 12 seconds.
Data source: The data come from a test of 30 maneuvers.
Disclosures: This study was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992. Dr. Obstein had no relevant financial conflicts to disclose.
Enzyme tablet eases pain of gluten consumption
CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.
The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.
The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.
After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.
By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.
Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.
AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.
The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.
The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.
After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.
By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.
Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.
AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Gluten-sensitive patients were able to tolerate small amounts of gluten after consuming an enzyme supplement derived from Aspergillus niger as part of a meal in a randomized, placebo-controlled trial of 18 adults. The data were presented at the annual Digestive Disease Week.
The enzyme, A. niger-derived prolyl endoprotease (AN-PEP), has demonstrated the ability to degrade gluten into nonimmunogenic compounds in vivo in healthy subjects, according to Julia König, PhD, of the School of Medical Sciences, Örebro (Sweden) University and her colleagues. The researchers tested the enzyme at two separate doses in 18 adults with self-reported gluten sensitivity.
The participants’ gastric and duodenal content was sampled several times over 180 minutes and analyzed for gluten epitopes using an enzyme-linked immunosorbent assay test. Participants also completed questionnaires after each day of testing.
After taking the enzyme in conjunction with the gluten, stomach gluten content averaged 31 microg x min/mL in the high-dose and low-dose enzyme patients (P = 0.001 for both doses), compared with 281 microg x min/mL in the placebo patients.
By the time the gluten reached the duodenum, the average levels had dropped to 12 microg x min/mL in the high-dose patients (P = 0.019) and 8 microg x min/mL in the low-dose patients (P = 0.015), compared with an average of 65 microg x min/mL in the placebo patients.
Overall, the enzyme was well tolerated by the patients, the researchers said. However, Dr. König emphasized that the enzyme tablet is meant to help avoid symptoms when gluten-sensitive patients encounter small amounts of gluten, and these patients should still follow a gluten-free diet.
AN-PEP is available in the United States in supplement form under several names and is manufactured by the Dutch company DSM. The AN-PEP enzyme used in the study was provided by DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: Consuming an enzyme tablet simultaneously with small amounts of gluten may reduce discomfort in gluten-sensitive individuals.
Major finding: On average, gluten levels in the stomach after enzyme consumption were 31 microg x min/mL in both high- and low-dose groups, vs. 281 microg x min/mL in a placebo group.
Data source: A randomized, placebo-controlled trial of 18 gluten-sensitive adults.
Disclosures: The enzyme used in the study, AN-PEP, was provided by the Dutch company DSM, but the company provided no other support. Dr. König had no relevant financial conflicts to disclose.
Genetic test predicts cirrhosis outcomes
CHICAGO – Cirrhosis patients with the rs738409 CG/GG genotype experienced worse outcomes, including a slower recovery of encephalopathy, ascites, and bilirubin, compared with those without this CG/GG genotype, based on data from a prospective study. The findings were presented at the annual Digestive Disease Week.
Most patients with hepatitis C virus–associated cirrhosis do well after treatment with direct-acting antiviral agents to achieve a sustained virologic response, according to Winston Dunn, MD, of Kansas University Medical Center, Kansas City, and his colleagues.
However, patients with decompensated cirrhosis may have a range of outcomes, and, to help predict treatment success, Dr. Dunn and his colleagues examined the possible genetic role of the rs738409 Single Nucleotide Polymorphism of Patatin-like Phospholipase Domain Containing 3 gene.
The researchers assessed 30 adults with Child-Pugh (CPT) Class B or C cirrhosis caused by HCV infection who underwent interferon-free, direct-acting antiviral therapy and achieved sustained virologic response. They collected DNA from each patient using a cheek swab. The study population included 16 patients with a CC genotype, 11 with CG, and 3 with GG.
They measured changes in CPT scores and Model for End-Stage Liver Disease (MELD) scores from before DAA treatment to 12 weeks after treatment. Baseline scores were similar among all patients, as were demographic characteristics, although patients with the rs738409 CC genotype averaged a higher body-mass index 35 kg/m2, vs. 29 kg/m2 (P = 0.03).
After 12 weeks, 13 of 16 patients with the CC genotype (81 %) had improved CPT scores, and 8 patients (50%) had improved MELD scores by at least 1 point. None had worsened CPT or MELD scores. By contrast, 5 of 14 patients with CG/GG genotype (36%) had improved CPT scores, and 4 (29%) had improved MELD scores by at least 1 point; 3 patients (21%) had worsened CPT scores and 4 (29%) had worsened MELD scores by at least 1 point.
Overall, patients in the CG/GG groups showed a 1.7-point higher delta CPT score and a 2.3-point higher delta MELD score after adjusting for confounding variables, compared with patients with CC after adjusting for confounding variables.
The study findings were limited by small numbers and prospective design, and the genetic test is not yet widely available, Dr. Dunn said. However, “Our results will help target patients for liver transplant evaluation based on individual genetic risk factors,” the researchers said.
The study was funded by the Frontiers Pilot and Collaborative Studies Funding Program. Dr. Dunn had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Cirrhosis patients with the rs738409 CG/GG genotype experienced worse outcomes, including a slower recovery of encephalopathy, ascites, and bilirubin, compared with those without this CG/GG genotype, based on data from a prospective study. The findings were presented at the annual Digestive Disease Week.
Most patients with hepatitis C virus–associated cirrhosis do well after treatment with direct-acting antiviral agents to achieve a sustained virologic response, according to Winston Dunn, MD, of Kansas University Medical Center, Kansas City, and his colleagues.
However, patients with decompensated cirrhosis may have a range of outcomes, and, to help predict treatment success, Dr. Dunn and his colleagues examined the possible genetic role of the rs738409 Single Nucleotide Polymorphism of Patatin-like Phospholipase Domain Containing 3 gene.
The researchers assessed 30 adults with Child-Pugh (CPT) Class B or C cirrhosis caused by HCV infection who underwent interferon-free, direct-acting antiviral therapy and achieved sustained virologic response. They collected DNA from each patient using a cheek swab. The study population included 16 patients with a CC genotype, 11 with CG, and 3 with GG.
They measured changes in CPT scores and Model for End-Stage Liver Disease (MELD) scores from before DAA treatment to 12 weeks after treatment. Baseline scores were similar among all patients, as were demographic characteristics, although patients with the rs738409 CC genotype averaged a higher body-mass index 35 kg/m2, vs. 29 kg/m2 (P = 0.03).
After 12 weeks, 13 of 16 patients with the CC genotype (81 %) had improved CPT scores, and 8 patients (50%) had improved MELD scores by at least 1 point. None had worsened CPT or MELD scores. By contrast, 5 of 14 patients with CG/GG genotype (36%) had improved CPT scores, and 4 (29%) had improved MELD scores by at least 1 point; 3 patients (21%) had worsened CPT scores and 4 (29%) had worsened MELD scores by at least 1 point.
Overall, patients in the CG/GG groups showed a 1.7-point higher delta CPT score and a 2.3-point higher delta MELD score after adjusting for confounding variables, compared with patients with CC after adjusting for confounding variables.
The study findings were limited by small numbers and prospective design, and the genetic test is not yet widely available, Dr. Dunn said. However, “Our results will help target patients for liver transplant evaluation based on individual genetic risk factors,” the researchers said.
The study was funded by the Frontiers Pilot and Collaborative Studies Funding Program. Dr. Dunn had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Cirrhosis patients with the rs738409 CG/GG genotype experienced worse outcomes, including a slower recovery of encephalopathy, ascites, and bilirubin, compared with those without this CG/GG genotype, based on data from a prospective study. The findings were presented at the annual Digestive Disease Week.
Most patients with hepatitis C virus–associated cirrhosis do well after treatment with direct-acting antiviral agents to achieve a sustained virologic response, according to Winston Dunn, MD, of Kansas University Medical Center, Kansas City, and his colleagues.
However, patients with decompensated cirrhosis may have a range of outcomes, and, to help predict treatment success, Dr. Dunn and his colleagues examined the possible genetic role of the rs738409 Single Nucleotide Polymorphism of Patatin-like Phospholipase Domain Containing 3 gene.
The researchers assessed 30 adults with Child-Pugh (CPT) Class B or C cirrhosis caused by HCV infection who underwent interferon-free, direct-acting antiviral therapy and achieved sustained virologic response. They collected DNA from each patient using a cheek swab. The study population included 16 patients with a CC genotype, 11 with CG, and 3 with GG.
They measured changes in CPT scores and Model for End-Stage Liver Disease (MELD) scores from before DAA treatment to 12 weeks after treatment. Baseline scores were similar among all patients, as were demographic characteristics, although patients with the rs738409 CC genotype averaged a higher body-mass index 35 kg/m2, vs. 29 kg/m2 (P = 0.03).
After 12 weeks, 13 of 16 patients with the CC genotype (81 %) had improved CPT scores, and 8 patients (50%) had improved MELD scores by at least 1 point. None had worsened CPT or MELD scores. By contrast, 5 of 14 patients with CG/GG genotype (36%) had improved CPT scores, and 4 (29%) had improved MELD scores by at least 1 point; 3 patients (21%) had worsened CPT scores and 4 (29%) had worsened MELD scores by at least 1 point.
Overall, patients in the CG/GG groups showed a 1.7-point higher delta CPT score and a 2.3-point higher delta MELD score after adjusting for confounding variables, compared with patients with CC after adjusting for confounding variables.
The study findings were limited by small numbers and prospective design, and the genetic test is not yet widely available, Dr. Dunn said. However, “Our results will help target patients for liver transplant evaluation based on individual genetic risk factors,” the researchers said.
The study was funded by the Frontiers Pilot and Collaborative Studies Funding Program. Dr. Dunn had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: Genotyping patients with advanced cirrhosis from HCV could help predict improvement and determine fitness for liver transplants.
Major finding: The rs738409 CG/GG genotype was associated with a 1.7-point higher delta CPT score, a 2.3 -point higher delta MELD score, and slower recovery of encepholpathy, ascites, and bilirubin, compared with those without this CG/GG genotype.
Data source: A prospective study of 35 adults with cirrhosis caused by HCV infection.
Disclosures: The study was funded by the Frontiers Pilot and Collaborative Studies Funding Program.
Endoscopic weight loss surgery cuts costs, side effects
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Obese patients who underwent endoscopic sleeve gastroplasty had significantly fewer complications and shorter hospital stays than did those who had laparoscopic sleeve gastrectomy or laparoscopic band placement, according to results from a study of 278 adults. The data were presented at the annual Digestive Disease Week®.
Overall, 1% of patients who underwent endoscopic sleeve gastroplasty (ESG) experienced adverse events, compared with 8% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 9% of those who underwent laparoscopic band placement (LAGB).
ESG, which reduces gastric volume by use of an endoscopic suturing system of full-thickness sutures through the greater curvature of the stomach, is becoming a popular weight-loss procedure for patients with a body mass index greater than 30 kg/m2 who are poor candidates for laparoscopic surgery or who would prefer a less invasive procedure, according to Reem Z. Sharaiha, MD, of Cornell University, New York.
Dr. Sharaiha and her colleagues randomized 91 patients to ESG, 120 to LSG, and 67 to LAGB. Patient demographic characteristics, including age, gender, and diabetes, were similar among the three groups. However, patients in the LSG group had a higher average BMI than did the LAGB and ESG groups (47.3 kg/m2, 45.7 kg/m2, and 38.8 kg/m2, respectively). In addition, the incidence of hypertension, and hyperlipidemia was significantly higher in each of the surgical groups compared to the ESG group (P less than .01).
The average postprocedure hospital stay was 0.13 days for ESG patients compared with 3.09 days for LSG patients and 1.68 days for LAGB patients. ESG also had the lowest cost of the three procedures, averaging $12,000 for the procedure compared to $22,000 for LSG and $15,000 for LAGB.
After 1 year, patients in the LSG group had the greatest percentage of total body weight loss (29.3%), followed by ESG patients (17.6%), and LAGB patients (14.5%). Rates of leaks, pulmonary embolism events, and 90-day readmission were not significantly different among the groups.
The study results do not imply that ESG will replace either LAGB or LSG for weight loss, Dr. Sharaiha noted, but the results suggest that ESG is a viable option for some patients.
Dr. Sharaiha had no relevant financial conflicts to disclose.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
FROM DDW
Key clinical point: Endoscopic sleeve gastroplasty is a viable option for patients seeking weight loss but wishing to avoid major surgery.
Major finding: After 1 year, 1% of patients who underwent endoscopic sleeve gastroplasty experienced adverse events, compared with 8% of laparoscopic sleeve gastrectomy patients, and 9% of laparoscopic band placement patients.
Data source: A randomized trial of 278 obese adults who underwent one of three weight loss procedures.
Disclosures: Dr. Sharaiha had no relevant financial conflicts to disclose.
Twice-daily tofacitinib induces ulcerative colitis remission
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
“Pharmacokinetic results in the OCTAVE trials did not indicate a decrease in plasma tofacitinib concentrations during the course of treatment at any given dose in individual patients. These results are consistent with the previously established physicochemical characteristics and clearance mechanisms of tofacitinib,” noted William J. Sandborn, MD, of the University of California, San Diego, and his colleagues.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
AGA Resource
AGA offers materials to help you manage patients with Crohn’s disease and ulcerative colitis, and integrate patient education into your practice, including multimedia publications that are accessible and informative. Learn more at http://www.gastro.org/ibd
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
“Pharmacokinetic results in the OCTAVE trials did not indicate a decrease in plasma tofacitinib concentrations during the course of treatment at any given dose in individual patients. These results are consistent with the previously established physicochemical characteristics and clearance mechanisms of tofacitinib,” noted William J. Sandborn, MD, of the University of California, San Diego, and his colleagues.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
AGA Resource
AGA offers materials to help you manage patients with Crohn’s disease and ulcerative colitis, and integrate patient education into your practice, including multimedia publications that are accessible and informative. Learn more at http://www.gastro.org/ibd
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
“Pharmacokinetic results in the OCTAVE trials did not indicate a decrease in plasma tofacitinib concentrations during the course of treatment at any given dose in individual patients. These results are consistent with the previously established physicochemical characteristics and clearance mechanisms of tofacitinib,” noted William J. Sandborn, MD, of the University of California, San Diego, and his colleagues.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
AGA Resource
AGA offers materials to help you manage patients with Crohn’s disease and ulcerative colitis, and integrate patient education into your practice, including multimedia publications that are accessible and informative. Learn more at http://www.gastro.org/ibd
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Tofacitinib, a JAK inhibitor, was a significantly more effective induction and maintenance therapy for patients with moderate to severe ulcerative colitis compared with placebo.
Major finding: Tofacitinib dosed at 10 mg twice daily yielded a remission rate of 41% at 52 weeks, compared with 11% in a placebo group.
Data source: The OCTAVE series of three randomized trials totaled approximately 1,500 adults with moderate to severely active ulcerative colitis.
Disclosures: The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies, including Pfizer.
Twice-daily tofacitinib induces ulcerative colitis remission
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
In addition, rates of mucosal healing were greater in the tofacitinib group than in the placebo group at 8 weeks and 52 weeks.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
“This report is the culmination of an international effort,” over a 4-year period, wrote Sonia Friedman, MD, of Harvard University in an accompanying editorial.
“This study has all the elements of a high-quality trial: a large, international cohort of patients and investigators; reasonable enrollment criteria that would apply to many of my own patients with moderate-to-severe ulcerative colitis; rigorous and unbiased scoring for response, remission, and mucosal healing; fair adjudication of adverse events; and meticulous reporting of all meaningful outcomes and laboratory test results,” she said. Tofacitinib has proven its efficacy – its exact role will be determined by additional research, she noted.
“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and ... identify the specific subsets of patients who will most likely benefit from this new therapy,” Dr. Friedman emphasized (N. Engl. J. Med. 2017;376:1792-3).
Dr. Friedman is affiliated with Harvard University, Boston, Mass., and Brigham and Women’s Hospital Center for Crohn’s and Colitis, Chestnut Hill, Mass. She disclosed receiving personal fees from Boston University.
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
In addition, rates of mucosal healing were greater in the tofacitinib group than in the placebo group at 8 weeks and 52 weeks.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
A 10-mg dose of tofacitinib twice daily was significantly more effective than placebo for inducing remission in ulcerative colitis patients, based on data from a group of three randomized trials totaling approximately 1,500 adults. The findings were published online May 3 in the New England Journal of Medicine (2017;376:1723-36).
The series of OCTAVE trials (Oral Clinical Trials for Tofacitinib in Ulcerative Colitis) included adults with moderately to severely active ulcerative colitis (UC). Patients were randomized to 10 mg of tofacitinib, 5 mg tofacitinib, or placebo. The studies were conducted over a 4-year period, at 144 sites for OCTAVE 1, 169 sites for OCTAVE 2, and 297 sites for OCTAVE Sustain.
In both OCTAVE 1 and OCTAVE 2, the remission rates at 8 weeks were significantly higher in the 10-mg tofacitinib groups, compared with the placebo groups (18.5% vs. 8.2%, respectively; 16.6% vs. 3.6%, respectively). The rate of remission at 52 weeks was significantly higher in the 5-mg and 10-mg tofacitinib groups (34.3% and 40.6%, respectively) than in the placebo group (11.1%) in the OCTAVE Sustain trial.
In addition, rates of mucosal healing were greater in the tofacitinib group than in the placebo group at 8 weeks and 52 weeks.
In the OCTAVE 1 trial, serious adverse events occurred in 4.2% and 8.0% of patients in the 10-mg and placebo groups, respectively. In the OCTAVE 2 trial, they occured in 3.4% and 4.1% of the 10-mg and placebo groups, respectively. The rate of serious adverse events in the OCTAVE Sustain trial was 5.1%, 5.6%, and 6.6% in the 10-mg, 5-mg, and placebo groups, respectively. Tofacitinib was associated with increased lipid levels, as well as higher rates of overall infection and herpes zoster infection, compared with placebo.
The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies including Pfizer.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Tofacitinib, a JAK inhibitor, was a significantly more effective induction and maintenance therapy for patients with moderate to severe ulcerative colitis compared with placebo.
Major finding: Tofacitinib dosed at 10 mg twice daily yielded a remission rate of 41% at 52 weeks, compared with 11% in a placebo group.
Data source: The OCTAVE series of three randomized trials totaled approximately 1,500 adults with moderate to severely active ulcerative colitis.
Disclosures: The study was supported by Pfizer. Lead author Dr. Sandborn and several coauthors disclosed financial relationships with multiple companies, including Pfizer.