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Grand Rounds

TIPS-3 RCT Results: Does a Combined Polypill Plus Aspirin Reduce Cardiovascular Events in Patients at Increased Risk?

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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

METHODS:

  • Double-blind, randomized, placebo-controlled trial
    • TIPS-3 (the International Polycap Study 3)
  • Participants
    • Men ≥50 years of age or older | Women ≥55 years
    • No history of CVD
    • Elevated INTERHEART Risk Score indicating intermediate or high cardiovascular risk
  • Interventions
    • Polypill: Simvastatin 40 mg | Atenolol 100 mg | Hydrochlorothiazide 25 mg | Ramipril 10 mg |
    • Aspirin: 75 mg
  • Study design
    • 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
  • Primary outcome
    • 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

RESULTS:

  • 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
      • Placebo: 5.5%
      • Hazard ratio (HR) 0.79 (95% CI, 0.63 to 1.00)
    • Aspirin vs placebo
      • Aspirin: 4.1%
      • Placebo: 4.7%
      • 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
      • Combined: 4.1%
      • Double-placebo: 5.8%
      • 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

CONCLUSION:

  • 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

Learn More – Primary Sources:

Polypill with or without Aspirin in Persons without Cardiovascular Disease

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Does Low-Dose Aspirin Reduce Risk of First Cardiovascular Events in Individuals at Moderate Risk?

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