FDA Approves First Drug for Obstructive Sleep Apnea with Obesity: Daily Dose

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On December 20, 2024, we reported on on the US FDA approval of tirzepatide (Zepbound; Eli Lilly and Company) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

The approval

Tirzepatide is the first and only prescription medication indicated for adults with moderate-to-severe OSA who also have obesity. Tirzepatide is indicated to be used alongside a reduced-calorie diet and increased physical activity.

The approval was supported by results from the SURMOUNT-OSA phase 3 clinical trial that evaluated the efficacy and safety of tirzepatide in 2 patient populations: adults with moderate-to-severe OSA and obesity who were unable or unwilling to use positive airway pressure (PAP) therapy (Study 1), and those who were using and planned to remain on PAP therapy during the trial (Study 2). The primary objective of both studies was to determine whether tirzepatide was superior to placebo in changing the apnea-hypopnea index (AHI) from baseline at 52 weeks.

The data showed that tirzepatide was approximately 5 times more effective than placebo in reducing breathing disruptions among patients not on PAP therapy, lowering their AHI by an average of 25 events per hour compared with 5 events per hour for placebo. In patients on PAP therapy, tirzepatide lowered the AHI by 29 events per hour compared with 6 events per hour for placebo. After 1 year, up to 50% of adults receiving tirzepatide experienced remission or mild, nonsymptomatic OSA compared with significantly fewer patients in the placebo group.

Patients also experienced substantial weight loss, averaging 45 lb (18% of baseline body weight) for those not on PAP therapy and 50 lb (20%) for those on PAP therapy, versus 4 lb (2%) and 6 lb (2%) for placebo, respectively.

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