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Incidence of muscle symptoms in placebo arm among statin-intolerant patients : systematic review with meta-analysis
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As estatinas são uma classe de fármacos frequentemente utilizados na prevenção cardiovascular, eventos adversos associados ao uso de estatinas, denominados como intolerância a estatinas, são a causa mais comum de baixa adesão terapêutica, o que se repercute num risco cardiovascular aumentado. Esta revisão sistemática tem como objetivo estimar a incidência de sintomas musculares em pacientes com história de intolerância a estatina quando se encontram sob placebo. Esta revisão sistemática inclui estudos controlados e randomizados, incluindo pacientes com história de intolerância a estatinas que receberam placebo, publicados até Março de 2022 em CENTRAL, MEDLINE, PsycINFO, EMBASE. O outcome primário foi a incidência de eventos adversos musculares. Foi realizada uma meta-análise de efeitos aleatórios para agrupar os dados. Resultados foram apresentados sob a forma de percentagem, com intervalos de confiança de 95%, limitados entre 0 e 100% devido a transformação de dados. No total foram incluídos 7 estudos com 1131 participantes a receberem placebo. A incidência de eventos musculares adversos agregada foi de 23.03% (95% CI 11.35-37.10%), e a descontinuação devido a eventos musculares foi de 8.44% (95% CI 4.32-14.21%). Em pacientes previamente rotulados como intolerantes a estatinas, quase um quarto apresenta tais sintomas quando se encontra sob placebo, o que sugere que este não são relacionados com estatinas e, portanto, estes doentes iriam beneficiar de uma terapêutica com estatinas otimizada.
Statins are a class of drugs highly used in cardiovascular prevention; statin-associated adverse events, referred to as statin intolerance, are the most significant cause of low adherence, translating into a higher cardiovascular risk. This systematic review aims to estimate the incidence of muscle adverse events in patients with a history of statin intolerance once receiving a placebo. This systematic review included all randomized control trial studies, enrolling patients with a history of statin intolerance that received a placebo, published until March 2022 in CENTRAL, MEDLINE, PsycINFO, EMBASE. The primary outcome was the incidence of muscle-related adverse events, and the secondary outcome was discontinuation due to muscle-related adverse events. A random-effects meta-analysis was performed to pool data. Results are presented in percentages, with 95% confidence intervals, limited between 0 and 100% due to the data transformation. Overall, 7 studies with 1131 patients receiving placebo were included. The pooled analysis of muscle adverse events incidence was 23.03% (95% CI 11.35–37.10%), and discontinuation due to adverse muscle events was 8.44% (95% CI 4.32–14.21%). In patients previously labeled statin-intolerant, almost a quarter exhibit such symptoms when receiving a placebo, suggesting these are not statin-related and would therefore still benefit from optimal statin therapy.
Statins are a class of drugs highly used in cardiovascular prevention; statin-associated adverse events, referred to as statin intolerance, are the most significant cause of low adherence, translating into a higher cardiovascular risk. This systematic review aims to estimate the incidence of muscle adverse events in patients with a history of statin intolerance once receiving a placebo. This systematic review included all randomized control trial studies, enrolling patients with a history of statin intolerance that received a placebo, published until March 2022 in CENTRAL, MEDLINE, PsycINFO, EMBASE. The primary outcome was the incidence of muscle-related adverse events, and the secondary outcome was discontinuation due to muscle-related adverse events. A random-effects meta-analysis was performed to pool data. Results are presented in percentages, with 95% confidence intervals, limited between 0 and 100% due to the data transformation. Overall, 7 studies with 1131 patients receiving placebo were included. The pooled analysis of muscle adverse events incidence was 23.03% (95% CI 11.35–37.10%), and discontinuation due to adverse muscle events was 8.44% (95% CI 4.32–14.21%). In patients previously labeled statin-intolerant, almost a quarter exhibit such symptoms when receiving a placebo, suggesting these are not statin-related and would therefore still benefit from optimal statin therapy.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2022
Palavras-chave
Intolerância a estatinas Placebo Sintomas musculares Revisão sistemática Meta-análise Cardiologia