Clinical Effectiveness of the Cardiovascular Polypill in a Real-Life Setting in Patients with Cardiovascular Risk: The SORS Study

Arch Med Res. 2019 Jan;50(1):31-40. doi: 10.1016/j.arcmed.2019.04.001. Epub 2019 Apr 19.

Abstract

Background: The cardiovascular disease pandemic has promoted the cardiovascular polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available.

Methods: We conducted a multicentre, observational and prospective registry of a polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer polypill.

Results: At one year with the polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p <0.001), and from 89.1 mmHg to 80.4 mmHg (p <0.001) respectively. LDLc levels were significantly reduced 132.5-107.6 mg/dL (p <0.001). The 10 year Framingham cardiovascular disease risk was also reduced in the high-risk group (33.7 + 22.0 vs. 21.2 + 14.8; p <0.001) and in the intermediate risk group (23.7 + 14.8 vs. 12.7 + 11.4; p <0.001).

Conclusions: To our knowledge, the results of the current study constitute the first real life data on the impact of a polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.

Keywords: Adherence; Cardiovascular polypill; Cardiovascular risk factors; Global cardiovascular risk; High-risk primary prevention; Secondary prevention.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-Antagonists / therapeutic use*
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
  • Antihypertensive Agents / therapeutic use*
  • Blood Pressure / drug effects
  • Cardiovascular Diseases / prevention & control*
  • Cardiovascular Diseases / therapy*
  • Cholesterol / blood
  • Drug Combinations
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Male
  • Medication Adherence
  • Mexico
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Treatment Outcome

Substances

  • Adrenergic beta-Antagonists
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Drug Combinations
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Cholesterol