Table 2.
Change in AHI, pAHI, body weight, and SASHB from baseline to Week 52 in this post-hoc analysis population.
| Study 1 |
Study 2 |
|||
|---|---|---|---|---|
| Tirzepatide | Placebo | Tirzepatide | Placebo | |
|
| ||||
| AHI (events/hr) at | ||||
| Baseline | 54.3 ± 2.95 | 50.9 ± 3.07 | 45.8 ± 2.42 | 53.1 ± 2.62 |
| Week 20 | 31.4 ± 1.94 | 47.6 ± 2.00 | 26.5 ± 1.97 | 43.7 ± 2.14 |
| Week 52 | 25.1 ± 2.14 | 47.6 ± 2.28 | 18.7 ± 1.98 | 43.2 ± 2.19 |
| Change in AHI (events/hr) from baseline at | ||||
| Week 20 | −21.10 ± 1.94 *** | −4.80 ± 2.00 * | −22.60 ± 1.97 *** | −5.40 ± 2.14 * |
| Week 52 | −27.40 ± 2 14 *** | −4.80 ± 2.28 * | −30.40 ± 1.98 *** | −6.00 ± 2.19 ** |
| pAHI (events/hr) at | ||||
| Baseline | 45.4 ± 3.35 | 45.4 ± 3.38 | − | − |
| Week 4 | 39.1 ± 2.02 | 41.3 ± 2.11 | − | − |
| Week 12 | 33.4 ± 2.41 | 39.9 ± 2.51 | − | − |
| Week 20 | 26.5 ± 1.76 | 37.4 ± 1.73 | − | − |
| Week 52 | 23.3 ± 2.59 | 38.5 ± 2.56 | − | − |
| Change in pAHI (events/hr) from baseline at | ||||
| Week 4 | −6.10 ± 2.02 ** | −3.90 ± 2.11 n.s. | − | − |
| Week 12 | −11.80 ± 2 41 *** | −5.30 ± 2.51 * | − | − |
| Week 20 | −18.70 ± 1 76 *** | −7.80 ± 1.73 | − | − |
| Week 52 | −21.90 ± 2.59 *** | −6.70 ± 2.56 * | − | − |
| Percent change in body weight from baseline at | ||||
| Week 4 | −2.40 ± 0 17 *** | −0.80 ± 0.16 | −3.20 ± 0.19 *** | −0.8 ± 0.19 *** |
| Week 8 | −4.80 ± 0.26 *** | −0.80 ± 0.26 | −5.80 ± 0.24 *** | −1.30 ± 0.25 *** |
| Week 12 | −7.00 ± 0.32 *** | −1.4 ± 0.32 *** | −8.30 ± 0.31 *** | −1.70 ± 0.32 *** |
| Week 16 | −9.00 ± 0 39 *** | −1.70 ± 0.39 | −10.40 ± 0.37 *** | −2.10 ± 0.39 *** |
| Week 20 | −11.00 ± 0.44 *** | −2.20 ± 0.45 | −12.60 ± 0.44 *** | −2.60 ± 0.46 *** |
| Week 24 | −12.80 ± 0.49 *** | −2.30 ± 0.50 | −14.50 ± 0.49 *** | −2.30 ± 0.52 *** |
| Week 36 | −15.90 ± 0.59 *** | −2.20 ± 0.61 | −17.80 ± 0.64 *** | −2.50 ± 0.68 *** |
| Week 48 | −17.60 ± 0.68 *** | −1.90 ± 0.71 * | −19.40 ± 0.72 *** | −2.30 ± 0.77 ** |
| Week 52 | −18.10 ± 0 71 *** | −1.30 ± 0.73 n.s. | −20.10 ± 0.73 *** | −2.30 ± 0.78 ** |
| Percent change in SASHB from baseline at | ||||
| Week 20 | −49.80 ± 3.02 *** | −13.70 ± 5.36 * | −57.30 ± 3.65 *** | −25.70 ± 6.90 ** |
| Week 52 | −67.60 ± 2.76 *** | −13.80 ± 7.88 n.s. | −76.90 ± 2.71 *** | −30.40 ± 9.04 ** |
| Percent change in WatchPAT SASHB from baseline at | ||||
| Week 4 | −6.90 ± 6.92 n.s. | −12.50 ± 6.79 n.s. | − | − |
| Week 12 | −14.10 ± 6.70 n.s. | −14.50 ± 7.03 n.s. | − | − |
| Week 20 | −33.00 ± 4.35 *** | −9.00 ± 5.84 n.s. | − | − |
| Week 52 | −41.10 ± 5.05 *** | −18.90 ± 6.90 * | − | − |
AHI, change from baseline in AHI, and percent change from baseline in body weight and in SASHB are included for this post-hoc analysis population from the SURMOUNT-OSA Study 1 and Study 2. Study 1 also includes the change from baseline in pAHI and SASHB, carried out with WatchPAT 300.
Data are LSMean ± SE for AHI, pAHI, and body weight, and Estimate ± SE for SASHB, and WatchPAT SASHB.
Data are derived from a mixed-model-for-repeated-measures analysis aligned with the efficacy estimand.
p < 0.05
p ≤ 0.010
p ≤ 0.001 represent significant changes from baseline. N.s. = not statistically significant.
AHI = number of apnea and hypopnea events during an hour of sleep; LSMean = least-squares mean; pAHI = peripheral apnea-hypopnea index; SASHB = sleep apnea-specific hypoxic burden; SE = standard error.