RT’s Three Key Takeaways:
- FDA Approval: The FDA has authorised Zepbound (tirzepatide) as the primary prescription treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and weight problems.
- OSA Symptom Reduction: Zepbound decreased respiration interruptions by a median of 25-29 occasions per hour, with as much as 50% of sufferers experiencing remission or gentle OSA signs after one 12 months.
- Weight Loss Outcomes: Sufferers on Zepbound misplaced a median of 18-20% of their physique weight, equal to 45-50 kilos, highlighting its twin profit for enhancing OSA signs and addressing weight problems.
Eli Lilly and Firm introduced the US Meals and Drug Administration (FDA) authorised Zepbound (tirzepatide) as the primary and solely prescription medication for adults with moderate-to-severe obstructive sleep apnea (OSA) and weight problems.
Zepbound might assist adults with moderate-to-severe obstructive sleep apnea and weight problems enhance their sleep problem. It must be used with a reduced-calorie weight loss program and elevated bodily exercise.
“Too usually, OSA is dismissed as ‘simply loud night breathing’—but it surely’s way over that,” says Julie Flygare, JD, president and CEO of Undertaking Sleep, in a launch. “It’s essential to know OSA signs and know that therapies can be found, together with new choices like Zepbound. We hope this can spark extra significant conversations between sufferers and well being care suppliers and in the end result in higher well being outcomes.”
Scientific Trial Outcomes
This approval was primarily based on outcomes from the SURMOUNT-OSA part 3 scientific trials, which evaluated Zepbound (10 mg or 15 mg) for the therapy of moderate-to-severe OSA in adults with weight problems, with and with out optimistic airway stress (PAP) remedy over the course of a 12 months.
Zepbound was about 5 instances more practical than placebo in decreasing respiration disruptions in adults not on PAP remedy, resulting in 25 fewer respiration disruptions per hour with Zepbound and 5 with placebo.
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In adults on PAP remedy, Zepbound led to 29 fewer respiration disruptions per hour in comparison with six with placebo. After one 12 months, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP remedy skilled remission or gentle, non-symptomatic OSA, in comparison with 16% and 14% on placebo, respectively.
Along with improved OSA signs, adults on Zepbound misplaced a median of 45 kilos (18%) of their physique weight, whereas adults on Zepbound with PAP remedy misplaced a median of fifty lbs (20%) of their physique weight, in comparison with 4 kilos (2%) and 6 kilos (2%) on placebo, respectively.
“As we speak, many instances of OSA go undiagnosed and untreated, leaving tens of millions in danger for severe well being penalties,” says Patrik Jonsson, govt vp, and president of Lilly Cardiometabolic Well being and Lilly USA, in a launch. “Zepbound is the primary treatment that considerably improves moderate-to-severe OSA and aids in long-term weight reduction in adults with weight problems. Practically half of scientific trial sufferers noticed such enhancements that they now not had signs related to OSA, marking a vital step ahead in decreasing the burden of this illness and its interconnected well being challenges.”
That is the second indication within the US for Zepbound in simply over a 12 months, following the FDA approval for adults with weight problems or obese who even have weight-related medical issues in November 2023.
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