Potential of Polypill Intervention in Stroke and Cognitive Impairment Prevention,reveals PROMOTE Study

The PROMOTE study, sponsored by the Program of Support for Institutional Development for the Unified Health System (PROADI-SUS) of the Hospital Moinhos de Vento in partnership with the Ministry of Health of Brazil, was conducted by a collaborative team of researchers from different Institutions, led by Professor Sheila Cristina Ouriques Martins.

The study was designed to prove the World Stroke Organisation’s concept of a comprehensive intervention approach in primary prevention to “Cut Stroke in Half”, conceived by former World Stroke Organisation President Michael Brainin from Austria, and Professor Valery Feigin from New Zealand. The intervention is based on lifestyle modification utilising the Stroke Riskometer and a polypill containing anti-hypertensive and statin for patients at low to moderate risk of stroke, a population that currently has no recommendation for medication use. The main study will explore the efficacy of intervention in reducing the incidence of stroke and cognitive impairment in this population. The polypill regimen comprised valsartan 80mg, amlodipine 5mg, and rosuvastatin 10mg.

PROMOTE is a Phase III, randomised, double-blinded, placebo-controlled clinical trial recruiting participants aged 50-75 years without a history of hypertension, diabetes, stroke, or cardiovascular disease, yet presenting systolic blood pressure (SBP) levels between 120- 139mmHg and at least one lifestyle risk factor (including an unhealthy diet, sedentarism, obesity or smoking). This pilot study aimed to assess the feasibility of this strategy implementation, the tolerability of this new polypill, and the potential impact of this integrated intervention, including as the main outcome a target reduction in 2.5mmHg in SBP and improvement in 0.4 points in the Life’s Simple 7 score over a 9-month period. Participants underwent a 28-day run-in phase to evaluate adherence and tolerance to the polypill regimen. Primary Health Care Units in southern Brazil were randomised into clusters to implement Stroke Riskometer-guided lifestyle modification or provide standard care, while individual participants were allocated to the polypill or placebo.