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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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