Efeitos cardiovasculares do liraglutido no mundo real: análise da transportabilidade do ensaio LEADER

O que aconteceu

Appropriate use of recently approved type 2 diabetes treatments depends on the external validity of landmark randomized clinical trials (RCTs) in real-world populations that may differ from trial participants. This study transported effect estimates from the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, a placebo-controlled RCT of liraglutide on cardiovascular outcomes, onto real-world cohorts within the Veterans Affairs (VA) healthcare system. Risk differences (RDs) in survival outcomes, approximated using pseudo-observations of individual survival probabilities, were estimated with augmented inverse probability weighting after balancing baseline characteristics between RCT and target samples using approximate balancing weights. Transported effects of liraglutide compared with placebo on major adverse cardiovascular events (MACE) and all-cause mortality in veterans (VA-weighted LEADER) were larger than, though statistically consistent with, the treatment effects observed in LEADER: MACE RD at 3 years of 4.6% (95% CI, 2.2, 7.0) in VA-weighted LEADER vs 1.6% (0.3, 2.9) in LEADER; all-cause mortality RD at 3 years of 2.9% (0.8, 5.1) in VA-weighted LEADER vs 0.9% (-0.1, 1.9) in LEADER. These estimates of the effects of liraglutide in veterans with diabetes provide real-world evidence that can guide diabetes treatment decisions and formulary policies for a high-risk population underrepresented in RCTs.

Trecho mantido em inglês: a tradução automática não passou na conferência de números.