Medication-Attributable Adverse Events in Heart Failure Trials

Autor: Josephine Harrington, Gregg C. Fonarow, Muhammad Shahzeb Khan, Adrian Hernandez, Stefan Anker, Michael Böhm, Stephen J. Greene, G. Michael Felker, Muthiah Vaduganathan, Javed Butler
Rok vydání: 2023
Předmět:
Zdroj: JACC Heart Fail
ISSN: 2213-1779
DOI: 10.1016/j.jchf.2022.11.026
Popis: BACKGROUND: Initiation and up-titration of guideline-directed medical therapies (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains suboptimal, in part due to concerns regarding tolerability and adverse events (AE). OBJECTIVES: To compare rates of adverse events in patients randomized to GDMT medication vs placebo in a meta-analysis of landmark cardiovascular outcomes trials. METHODS: We assessed rates of reported AE in 17 landmark HFrEF clinical trials across each class of GDMT in the placebo and intervention arms. The overall rates of AE for each drug class, the absolute difference in frequency in AEs between the placebo and intervention arms, and the odds of each AE according based on randomization strata were calculated. RESULTS: AE were reported commonly in trials across each class of GDMT, with 75-85% of participants reporting at least one AE. There was no significant difference in the frequency of AE between the intervention and placebo arms, except for angiotensin converting enzyme (ACE) inhibitors (87.0% [85.0-88.8%] vs 82.0% [79.8-84.0%], absolute difference +5% with intervention, P
Databáze: OpenAIRE