Trabalhos Aprovados

Semaglutide consistently reduces cardiovascular events in both male and female subjects with type 2 diabetes



Autor(es): Hramiak I; DeSouza C; Seufert J; Hansen T; Pettersson J; Thielke D; Lingvay I; Penaforte Saboia;
Apresentador(a): JAQUELLYNE GURGEL PENAFORTE SABOIA

Background and aims: Semaglutide is a GLP1 RA for once-weekly treatment of T2D. In the SUSTAIN 6 cardiovascular(CV) trial, SC semaglutide (0.5 mg and 1.0 mg) added to standard of care significantly reduced major adverse CV events (MACE: non-fatal myocardial infarction,non-fatal stroke or CV death) vs placebo over 2 years in subjects with T2D at high CV risk. This post hoc analysis assessed whether this CV risk reduction was consistent in male(M) and female(F) subjects. Materials and methods: Endpoints analysed were MACE, the individual components of the MACE endpoint, first hospitalisation due to unstable angina, first hospitalisation due to heart failure, and first revascularisation. In total, 2,002 M and 1,295 F were randomised. Results: MACE consistently occurred in fewer subjects with semaglutide vs placebo in both sexes(p=0.45 for interaction): HR 0.68 (95% CI 0.50;0.92) in M, 0.84 (95% CI 0.54;1.31) in F and 0.74 (95% CI 0.58;0.95) in the total study population. Overall, this pattern was reflected across the individual MACE components, showing lower rates with semaglutide vs placebo regardless of sex, with the exception of CV mortality in F subjects. In the overall trial population, there was no significant difference between semaglutide vs placebo for first hospitalisation due to unstable angina or heart failure: HR 0.82 (95% CI 0.47;1.44) and 1.11 (95% CI 0.77;1.61), respectively. These results were consistent in M(HR 0.66 [95% CI 0.33;1.34] and 1.18 [95% CI 0.75;1.86], respectively) and F (HR 1.17 [95% CI 0.45;3.03] and 0.93 [95% CI 0.49;1.76]) (p=0.35 and p=0.55 for interaction, respectively). Revascularisation was performed in significantly fewer subjects with semaglutide vs placebo (HR 0.65 [95% CI 0.50;0.86], p=0.003). These results were consistent in M (HR 0.60 [95% CI 0.43;0.85], p=0.0035) and F (HR 0.74 [95% CI 0.46;1.20], not statistically significant) (p=0.50 for interaction). Adverse events were reported by similar proportions of M and F across treatments. The most frequent AEs reported were gastrointestinal, with higher rates in F than in M. The proportions of subjects prematurely discontinuing treatment due to AEs were comparable for M and F. Conclusion: The semaglutide-induced risk reduction in MACE and its components vs placebo seen in SUSTAIN 6 was consistent in both M and F. Numerically lower proportions of F than M reported MACE. Semaglutide treatment effect on the risk of secondary CV endpoints was also similar in both sexes.

Palavras-chave: Semaglutide; MACE; sex

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