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Polypill SECUREs win in secondary prevention in elderly

Presented by
Dr Valentin Fuster, Mount Sinai Health System, NY, USA
ESC 2022
Phase 3, SECURE
The 3-drug fixed-dose 'polypill' containing aspirin, ramipril, and atorvastatin prevented secondary cardiovascular events in people ≥65 years old who have previously had a myocardial infarction (MI), reducing cardiovascular mortality by 33% in this vulnerable patient population.

Findings from the EU-funded, randomised, open-label SECURE trial (NCT02596126) were presented by Dr Valentin Fuster (Mount Sinai Health System, NY, USA), and simultaneously published in the New England Journal of Medicine [1,2]. It is the first trial testing the efficacy of a fixed-dose combination polypill for secondary cardiovascular prevention in individuals ≥65 years old.

SECURE aimed to evaluate the potential benefit of the polypill as a component of a cost-effective, globally available, and comprehensive treatment strategy for secondary prevention of cardiovascular events (death from cardiovascular causes, non-fatal MI, stroke, and hospitalisation requiring revascularisation) as compared with standard therapy (the 3 components of the polypill given separately). "Although most patients initially adhere to treatment after an acute event such as an infarction, adherence drops off after the first few months. Our goal was to have an impact right from the start, and most of the patients in the study began taking a simple polypill in the first week after having a heart attack," Dr Fuster explained.

The trial randomised 2,499 patients to receive either the polypill or the usual care of 3 separate tablets. The polypill intervention contained aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The baseline characteristics were similar in each arm of the study.

The primary endpoint was a composite of 4 major cardiovascular events: death from cardiovascular causes, non-fatal MI, non-fatal stroke, and need for emergency coronary revascularisation. After a median of 36 months of follow-up, 9.5% of participants in the polypill arm and 12.7% of the usual care arm had experienced a primary outcome event, which translated to a 24% lower risk of a primary-outcome event in favour of the polypill over the 3 separate drugs (HR 0.76; 95% CI 0.60–0.96; P=0.02, see Figure). Likewise, a key secondary outcome event (composite of cardiovascular death, non-fatal type 1 MI, or non-fatal ischaemic stroke) occurred in 8.2% of the participants in the polypill arm compared with 11.7% in the usual-care arm (HR 0.70; 95% CI 0.54–0.90; P=0.005). Strikingly, for the single component cardiovascular-related death, a relative reduction of 33% in the polypill group supported a clear clinical benefit. Findings showed that participants in the polypill group had a higher level of treatment adherence than those in the control group. The improved adherence supported the earlier findings of the FOCUS study [3]; good adherence may explain the improved outcomes of those taking the polypill. The results were consistent across prespecified subgroups. Adverse events were similar between groups.

Figure: Primary endpoint analysis of SECURE, composite of CV death, MI, stroke, and urgent revascularisation [1]

"The SECURE study findings suggest that the polypill could become an integral element of strategies to prevent recurrent cardiovascular events in patients who have had a heart attack. By simplifying treatment and improving adherence, this approach has the potential to reduce the risk of recurrent cardiovascular disease and death on a global scale," concluded Dr Fuster.

  1. Fuster V, et al. A polypill strategy in secondary prevention: results of the SECURE trial. Hot Line Session 1, ESC Congress 2022, Barcelona, Spain, 26–29 August.
  2. Castellano JM et al. N Engl J Med. 2022. Online 26 Aug 2022. doi:10.1056/NEJMoa2208275.
  3. Castellano JM, et al. J Am Coll Cardiol. 2014;64(20):2071–82.


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