A polypill strategy in secondary prevention: results of the SECURE trial

Presented at the ESC congress 2022 by: Valentin Fuster, MD, PhD – New York, NY, USA

Introduction and methods

Adherence is a major problem in CVD; in post-MI patients, adherence to medication is poor. Therefore, an approach with a polypill was developed. In a previous study in 4 countries in 2000 post-MI patients (FOCUS study) was found that adherence to a polypill was significantly better than separate pills. Subsequently, a retrospective study in 14.000 post-MI patients using data of an American insurance company showed that adherence was associated with outcomes.

The SECURE study recruited 2500 patients in 113 centers across 7 European countries. These were post MI patients >65 years. Furthermore, they had to have at least one additional risk factor (diabetes, mild to moderate CKD, prior MI, prior coronary revascularization, prior stroke or age ≥75 years).

They were randomized to a polypill (aspirin 100, atorvastatin 20/40 and ramipril 2.5/5/10) or standard care. It was an open-label study. Median follow-up was 3 years.

The primary composite endpoint consisted of CV death, MI, stroke or urgent revascularization. The key secondary endpoint was CV death, MI, or stroke.

Main results

• In the group who received polypill, there were fewer events of the primary outcome (composite of CV death, MI stroke and urgent revascularization) compared to the usual care group (HR 0.76, 95%CI:0.60-0.96, non-inferiority P<0.001 and superiority P=0.02).
• The event rate of the key secondary outcome was lower in the polypill group compared to the usual care group (HR 0.70, 95%CI:0.54-0.90, P<0.005).
• Pre-specified subgroup analyses showed no difference of the treatment effect in specific groups.

Conclusion

The findings of the SECURE trial showed that treatment with a polypill containing aspirin, atorvastatin and ramipril resulted in lower CV event rate compared to usual care in patients who had a previous MI, presumably due to improved adherence.

Furthermore, use of the polypill was safe and did not result in differences in adverse events between groups.

Valentin Fuster suggested that use of polypill could be an integral part of a global strategy to improve secondary prevention.

• Our reporting is based on the information provided at the ESC Congress -

The findings of this study were simultaneously published in N Eng J Med