Analysis of SCORE and PRIDE studies shows semaglutide results in improved functional outcomes, health-related quality of life and CV events

Analysis of the SCORE and PRIDE studies shows semaglutide results in improved functional outcomes, health-related quality of life and CV events, according to presentations at the American College of Cardiology Annual Scientific Session and Expo.

The observational SCORE study assessed treatment with semaglutide 2.4 mg and the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease (CVD).

Compared with non-users, semaglutide 2.4 mg use was associated with a significantly lower risk of revised MACE-3 composite endpoint (heart attack, stroke, or all-cause death) by 57% (HR: 0.43; 95% CI: 0.31-0.61; p<0.001). Revised MACE-3 occurred in 42 (0.45%) of the 9,321 patients in the semaglutide 2.4 mg group and 175 (0.94%) of the 18,642 patients in the non-user group. The mean follow-up duration was 7.1 months for semaglutide users and 6.4 months for non-users.

Compared with non-users, semaglutide 2.4 mg use was associated with a significantly lower risk of revised MACE-5 composite endpoint (heart attack, stroke, hospitalization for heart failure (HF), evidence of a coronary revascularization procedure, or all-cause death) by 45% (HR: 0.55; 95% CI: 0.43-0.70; p<0.001). Revised MACE-5 occurred in 88 (0.94%) of the 9,321 patients in the semaglutide 2.4 mg group and 288 (1.54%) of 18,642 patients in the non-user group.

SCORE results were consistent across a variety of CV endpoints, including death. Compared with non-users, semaglutide 2.4 mg use was also associated with significantly lower risk of hospitalization for HF, CV-related death and all-cause death.

STRIDE trial

STRIDE is a phase 3b trial investigating the effects of once-weekly Ozempic (semaglutide) injection 1 mg in adults with type 2 diabetes and early-stage symptomatic peripheral artery disease (PAD).

The double-blind, randomised, placebo-controlled STRIDE trial, which enrolled 792 adults with type 2 diabetes and symptomatic PAD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 13% superior improvement in maximum walking distance (estimated treatment ratio [ETR] vs placebo, 1.13; 95% confidence interval [CI], 1.06 to 1.21; p=0.0004) and a clinically meaningful median treatment difference of 26.4 meters (95% CI, 11.8 to 40.9; approximately 87 feet, or about a third the length of an American football field) on a 12% incline, compared to placebo at 52 weeks.

The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance (ETR vs placebo 1.11; 95% CI, 1.03 to 1.20; p=0.0046) and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) (estimated treatment difference vs placebo 1.00; 95% CI, 0.48 to 1.52; p=0.011) at 52 weeks.

Serious adverse events (SAEs) were reported in 74 (19%) participants in the semaglutide arm and 78 (20%) participants in the placebo arm, and SAEs that were possibly/probably treatment-related occurred in 5 (1%) and 6 (2%) participants, respectively. The most frequent SAE across both groups was serious gastrointestinal events (2 [1%] vs 3 [1%]). SAEs leading to permanent treatment discontinuation of semaglutide or placebo were reported in 11 (2.8%) and 13 (3.3%) participants in the semaglutide and placebo groups, respectively. SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related.

Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic to the FDA. A decision is anticipated in 2025.