Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: An individual participant data meta-analysis
The Lancet Sep 02, 2021
Joseph P, Roshandel G, Gao P, et al. - In primary cardiovascular disease prevention, substantially reduced cardiovascular disease, myocardial infarction, stroke, revascularization, and cardiovascular death could be achieved with fixed-dose combination treatment strategies. These benefits consistently remained irrespective of cardiometabolic risk factors.
Researchers conducted an individual participant data meta-analysis of large randomized controlled trials (each with ≥1000 participants and ≥ 2 years of follow-up) evaluating a fixed-dose combination strategy of at least two blood pressure lowering agents plus a statin (with or without aspirin), vs a control strategy (either placebo or usual care) in a primary cardiovascular disease prevention population.
Included were three large randomized trials (TIPS-3, HOPE-3, and PolyIran), with a total of 18,162 participants.
The analyses of fixed-dose combination strategies with and without aspirin revealed significant decreases in the primary outcome (this included time to first occurrence of a composite of cardiovascular death, myocardial infarction, stroke, or arterial revascularization) and its components, with greater reductions for strategies including aspirin.
Although uncommon, gastrointestinal bleeding occurred slightly more frequently in the fixed-dose combination strategy with aspirin group vs control (0·4% vs 0·2%).
The groups had low but similar frequencies of hemorrhagic stroke, fatal bleeding, and peptic ulcer disease.
Fixed-dose combination treatment was linked with more common occurrence of dizziness.
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