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FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity
LLYLilly(LLY) Prnewswire·2024-12-20 21:32

Core Insights - Zepbound (tirzepatide) is the first and only prescription medication approved by the FDA for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity, showing significant efficacy in reducing breathing disruptions and aiding weight loss [15][29][40] Group 1: Efficacy and Clinical Trials - The SURMOUNT-OSA phase 3 clinical trials demonstrated that Zepbound was about five times more effective than placebo in reducing breathing disruptions in adults not on positive airway pressure (PAP) therapy, leading to an average of 25 fewer breathing interruptions per hour compared to five with placebo [17] - In adults on PAP therapy, Zepbound resulted in 29 fewer breathing disruptions per hour compared to six with placebo [17] - After one year, 42% of adults on Zepbound and 50% of those on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively [17] Group 2: Weight Loss Outcomes - Adults taking Zepbound lost an average of 45 lbs (18%) of their body weight, while those on Zepbound with PAP therapy lost an average of 50 lbs (20%), compared to only 4 lbs (2%) and 6 lbs (2%) on placebo, respectively [27] - Up to 50% of adults taking Zepbound no longer had symptoms associated with OSA after one year [26] Group 3: Usage and Administration - Zepbound should be used in conjunction with a reduced-calorie diet and increased physical activity for optimal results [4][29] - The medication is administered via subcutaneous injection once a week, with a starting dose of 2.5 mg that can be increased to a maximum tolerated dose of 10 mg or 15 mg [19][10] Group 4: Safety and Side Effects - Common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, and abdominal pain, among others [34][45] - Serious side effects may include pancreatitis, depression, and potential thyroid tumors, necessitating close monitoring by healthcare providers [6][7][42]