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Vivus Inc Announces Study Finds Improvements In Patients With Obstructive Sleep Apnea Treated With Phentermine And Topiramate Extended-Release Capsules


Monday, 12 Nov 2012 07:00am EST 

Vivus Inc announced that a study published in the journal SLEEP (2012; 35(11):1529-1539) found that patients with moderate to severe obstructive sleep apnea (OSA) taking phentermine and topiramate extended-release capsules achieved significant improvements in key measures of OSA and cardiovascular risk factors along with weight loss during the 28-week trial. OSA is a chronic and potentially serious sleep disorder in which breathing is abnormally shallow ("hypopnea") or stops altogether ("apnea") for at least 10 seconds. These In the study recently reported in SLEEP, 45 obese adults who were not using PAP were randomized to placebo or treatment with phentermine and topiramate extended-release capsules for 28 weeks. Both groups received intensive lifestyle modification counseling. The primary endpoint was change in the apnea-hypopnea index (AHI), a measure of the average number of breathing interruptions per hour during sleep. An AHI of 5-15 is considered mild, 15-30 moderate, and severe if >30. The average AHI at baseline in both treatment groups was about 45, indicating that, on average, subjects had severe OSA at the beginning of the study. By the end of the study, the number of apnea-hypopnea events in the phentermine and topiramate extended-release capsules group was reduced from an average of 44 events per hour (severe) to 14 events per hour (mild) at Week 28. The placebo-adjusted LS mean change Week 28 was -14.9 (p=0.0084). 

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21 Jul 2014