Core Viewpoint - Tirzepatide, developed by Eli Lilly, is a dual agonist for GIP and GLP-1 receptors, recently approved by the FDA for weight loss under the brand name Zepbound™ and previously for type 2 diabetes as Mounjaro™. It is noted as the most effective weight loss drug currently available, having set multiple records in clinical trials for weight reduction [2]. Summary by Sections FDA Approval and Indications - Tirzepatide received FDA approval in November 2023 for weight loss and has also been approved for type 2 diabetes treatment. It has now gained a third indication for moderate to severe obstructive sleep apnea (OSA) in adults, as announced by the NMPA in China [2]. Clinical Trial Results - The SURMOUNT-OSA trial demonstrated that Tirzepatide significantly reduced the apnea-hypopnea index (AHI) and body weight in patients with moderate to severe OSA and obesity. In a 52-week treatment period, patients lost an average of 20% of their body weight, and AHI decreased by an average of 27 times per hour [2][7][11]. Efficacy Metrics - In the SURMOUNT-OSA study, patients treated with Tirzepatide experienced a 55% reduction in AHI compared to a 5% reduction in the placebo group. The average weight loss in the Tirzepatide group was 18.1%, while the placebo group saw only a 1.3% reduction [8][9]. Safety Profile - The overall safety of Tirzepatide in the SURMOUNT-OSA studies was consistent with previous trials, with gastrointestinal issues being the most commonly reported adverse events, generally mild to moderate in severity [12]. Market Potential - The success of the SURMOUNT-OSA trials indicates a significant advancement in addressing the unmet clinical need for OSA treatment, positioning Tirzepatide as a potential first pharmacological therapy for this condition [12]. Demographics of Study Participants - Approximately 70% of participants in the studies were male, with evidence suggesting that Tirzepatide may have a more pronounced weight loss effect in females [11].
受打鼾困扰的人有救了:最强减肥药替尔泊肽,在中国获批治疗阻塞性睡眠呼吸暂停