TIPS-3 RCT Results: Does a Combined Polypill Plus Aspirin Reduce Cardiovascular Events in Patients at Increased Risk?
BACKGROUND AND PURPOSE:
Yusuf et al. (NEJM, 2020) evaluated the efficacy and safety of the polypill alone (containing lipid-lowering and blood-pressure–lowering medications), aspirin alone, and the combination of polypill plus aspirin for the reduction of cardiovascular events among people at increased risk
Patients were assigned to intervention using a 2-by-2-by-2 factorial design
Polypill vs placebo
Aspirin vs placebo
Polypill + aspirin vs double placebo
For polypill alone and polypill + aspirin interventions
Composite of the following: Major cardiovascular events (including) death from cardiovascular causes, stroke, and myocardial infarction, plus heart failure, resuscitated cardiac arrest, and arterial revascularization
For aspirin alone
Death from cardiovascular causes | Myocardial infarction | Stroke
5713 participants were randomized
Mean follow-up: 4.6 years
LDL levels and systolic blood pressure were lower with the polypill and the combination therapy vs placebo
LDL cholesterol level: Lower by 19.0 mg per deciliter (0.50 mmol per liter)
Systolic blood pressure: Lower by 5.9 mm Hg
There were no significant differences in the primary outcome for the following
Polypill vs placebo
Polypill: 4.4% incidence
Hazard ratio (HR) 0.79 (95% CI, 0.63 to 1.00)
Aspirin vs placebo
HR 0.86 (95% CI, 0.67 to 1.10)
The primary outcome occurred in fewer patients in the combined treatment
Combined vs double placebo
HR 0.69 (95% CI, 0.50 to 0.97)
The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups
Use of combination therapy with polypill (statin plus three blood-pressure–lowering drugs) plus aspirin resulted in a 31% lower relative risk of cardiovascular events in a primary-prevention population at intermediate risk
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