RT’s Three Key Takeaways:
- Tirzepatide achieved a imply apnea-hypopnea index discount of as much as 63% (about 30 fewer occasions per hour), assembly all main and key secondary endpoints in two section 3 scientific trials.
- The drug was efficient in decreasing the apnea-hypopnea index in sufferers who have been and weren’t utilizing optimistic airway strain remedy over a 52-week remedy interval.
- Along with enhancing sleep apnea signs, tirzepatide led to a imply physique weight discount of round 20% from baseline within the research contributors. Primarily based on these outcomes Lilly plans to submit these knowledge for international regulatory evaluations.
Eli Lilly introduced that its weight-loss drug Zepbound (tirzepatide) lowered the severity of obstructive sleep apnea (OSA) by as much as 63% in adults with OSA and weight problems, assembly all main and key secondary endpoints in two section 3 scientific trials.
The injection meaningfully improved sleep apnea signs in these with moderate-to-severe OSA and weight problems with and with out optimistic airway strain (PAP) remedy within the SURMOUNT-OSA trials.
Primarily based on these outcomes, Lilly plans to undergo the US Meals and Drug Administration (FDA) and different international regulatory businesses starting mid-year. The FDA accredited Zepbound injection final November for continual weight administration in adults with weight problems or chubby with at the least one weight-related situation. Lilly acquired FDA Quick Monitor designation for moderate-to-severe OSA and weight problems.
“OSA impacts 80 million adults within the US, with greater than 20 million dwelling with moderate-to-severe OSA. Nevertheless, 85% of OSA instances go undiagnosed and due to this fact untreated,” says Jeff Emmick, MD, PhD, senior vice chairman of product improvement at Lilly, in a launch. “Addressing this unmet want head-on is crucial, and whereas there are pharmaceutical therapies for the extreme sleepiness related to OSA, tirzepatide has the potential to be the primary pharmaceutical remedy for the underlying illness.”
SURMOUNT-OSA Examine 1
SURMOUNT-OSA research 1 evaluated tirzepatide in adults with moderate-to-severe OSA and weight problems who weren’t on optimistic airway strain (PAP) remedy for 52 weeks.
For the efficacy estimandi, at 52 weeks, tirzepatide led to a imply apnea-hypopnea index (AHI) discount from baseline of 27.4 occasions per hour in comparison with a imply AHI discount from baseline of 4.8 occasions per hour for placebo.
In key secondary outcomes, tirzepatide led to a imply AHI discount from baseline of 55% in comparison with 5% from baseline for placebo; tirzepatide additionally led to a imply physique weight discount of 18.1% from baseline, in comparison with 1.3% from baseline for placebo.
SURMOUNT-OSA Examine 2
SURMOUNT-OSA research 2 evaluated tirzepatide in adults with moderate-to-severe OSA and weight problems who have been on and deliberate to proceed to make use of PAP remedy for 52 weeks.
On this inhabitants for the efficacy estimand, at 52 weeks, tirzepatide led to a imply AHI discount from baseline of 30.4 occasions per hour in comparison with a imply AHI discount from baseline of 6 occasions per hour for placebo.
In key secondary outcomes, tirzepatide led to a imply AHI discount from baseline of 62.8% in comparison with 6.4% from baseline for placebo; tirzepatide additionally led to a imply physique weight discount of 20.1% from baseline, in comparison with 2.3% from baseline for placebo.
Weight Loss Noticed Throughout the Research
The load loss noticed at 52 weeks with tirzepatide (10 mg and 15 mg) throughout the 2 research was almost 20% in a affected person inhabitants that was comprised of roughly 70% males, who’re identified to attain much less weight reduction with incretin remedy than females.
Topline Outcomes
| SURMOUNT-OSA Examine 1 – Members Not on PAP Remedy | ||
| Efficacy Estimand Outcomes at 52 Weeks |
Therapy-Routine Estimand Outcomes at 52 Weeks | |
| Main Endpoint – Change in AHI from Baseline | ||
| Tirzepatide* | -27.4 | -25.3 |
| Placebo | -4.8 | -5.3 |
| Secondary Endpoint – P.c Change in AHI from Baseline | ||
| Tirzepatide* | -55.0 % | -50.7 % |
| Placebo | -5.0 % | -3.0 % |
| Secondary Endpoint – P.c Change in Physique Weight from Baseline | ||
| Tirzepatide* | -18.1 % | -17.7 % |
| Placebo | -1.3 % | -1.6 % |
| SURMOUNT-OSA Examine 2 Members Used PAP Remedy | ||
| Efficacy Estimand Outcomes at 52 Weeks |
Therapy-Routine EstimandResults at 52 Weeks | |
| Main Endpoint – Change in AHI from Baseline | ||
| Tirzepatide* | -30.4 | -29.3 |
| Placebo | -6.0 | -5.5 |
| Secondary Endpoint – P.c Change in AHI from Baseline | ||
| Tirzepatide* | -62.8 % | -58.7 % |
| Placebo | -6.4 % | -2.5 % |
| Secondary Endpoint – P.c Change in Physique Weight from Baseline | ||
| Tirzepatide* | -20.1 % | -19.6 % |
| Placebo | -2.3 % | -2.3 % |
The SURMOUNT-OSA trials will probably be introduced throughout a symposium on the American Diabetes Affiliation’s 84th Scientific Classes on June 21 at 3:45 pm ET and submitted to a peer-reviewed journal.
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