Abstract P445: A Randomized Controlled Trial Of A Cardiovascular Fixed-dose Combination Pill (polypill) Treatment Strategy Compared With Usual Care On Carotid Intima Media Thickness Progression In Individuals At High Risk Of Cardiovascular Disease

Abstract

Aim: The use of fixed-dose combination (FDC) pills, frequently called polypills, containing aspirin, a statin and blood pressure (BP) lowering medication may improve medication adherence and consequently reduce cardiovascular risk. Carotid intima-media thickness (CIMT) and CIMT progression have been used as surrogate measures of cardiovascular risk. This study evaluated the effect of a polypill-based treatment strategy compared to usual care on CIMT progression. Methods: A study nested within the UMPIRE trial was performed to assess whether a polypill-based treatment strategy reduces CIMT progression compared to usual care. The study was a randomized, open label, blinded endpoint clinical trial in participants with established cardiovascular disease or at equivalent high risk (estimated five year cardiovascular risk of ≥15%). Two versions of the polypill were available. These contained aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide. The choices of polypill version and the components of usual care were made at the discretion of the physician. (http://clinicaltrials.gov/show/NCT01326676). Results: In total 296 participants in the polypill group and 290 participants in the usual care group had both a baseline and follow-up CIMT scan. Allocation to a polypill compared to usual care resulted in similar levels of low-density lipoprotein (LDL)-cholesterol (mean difference: 0.0 mmol/L; 95%-confidence interval (CI): -0.1 to 0.1; p=0.41) and systolic BP (mean difference -1.7 mmHg; 95%-CI:-4.5 to 1.1; p=0.23) after a median follow-up duration of 1.00 year [IQR: 0.93 to 1.04 year]. The annualized rate of change in common CIMT in the polypill-based treatment strategy group (6.56 μm/year; standard error (SE): 4.76 μm/year) did not differ significantly from the rate of change in the usual care group (10.72 μm/year; SE: 4.76 μm/year; mean difference: -4.2 μm/year; 95%-CI: -17.0 to 8.7; p=0.53). Conclusion: This study demonstrated that a polypill-based cardiovascular treatment strategy compared to usual care did not reduce the rate of progression of common CIMT during a one year follow-up interval in a well-treated population with cardiovascular disease. Importantly, CIMT progression was not adversely effected by the polypill-based treatment strategy.