Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention - FOCUS

Nov 10, 2014
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Published:
01/01/2014
Date Updated:
11/10/2014
Original Posted Date:
11/10/2014
References

Description:

A polypill might increase medication adherence and thus achieve better control of cardiovascular risk factors. The aim of the current trial was to compare treatment with a polypill versus treatment with individual medications among subjects with a history of myocardial infarction.

Hypothesis:

A polypill will increase medication adherence and improve blood pressure and lipid values.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Subjects with prior myocardial infarction

    Number of enrollees: 695
    Duration of follow-up: 9 months
    Mean patient age: 64 years
    Percentage female: 20%

Exclusions:

  • Contraindication to any component of the polypill, nursing home residence, or inability to care for self

Primary Endpoints:

  • Medication adherence

Secondary Endpoints:

  • Change in blood pressure and lipid values

Drug/Procedures Used:

Subjects with prior myocardial infarction were randomized to a polypill, which consisted of aspirin 100 mg/simvastatin 40 mg/ramipril 2.5 mg or 5 mg or 10 mg (n = 350) versus the three drugs given separately (n = 345). The dose of ramipril was titrated accordingly to physician discretion.

Principal Findings:

A total of 695 patients were randomized. The mean age was 64 years, 80% were men, and 26% had diabetes.

At 9 months, medication adherence was 51% in the polypill group vs. 41% of the control group (p = 0.019).

The change in mean systolic blood pressure was -0.32 mm Hg in the polypill group vs. 0.88 mm Hg (p = 0.32).

The change in mean low-density lipoprotein (LDL) cholesterol was 5.27 mg/dl in the polypill group vs. 2.17 mg/dl (p = 0.34).

Serious adverse events occurred in 23 subjects in the polypill group vs. 21 subjects in the control group.

Interpretation:

Among subjects with prior myocardial infarction, the use of a polypill, which consisted of aspirin, statin, and an angiotensin-converting enzyme inhibitor, increased 9-month adherence compared to the three medications given separately. However, this did not translate into a significant improvement in blood pressure or lipid control.

References:

Castellano JM, Sanz G, Peñalvo JL, et al. A Polypill Strategy to Improve Adherence: Results From FOCUS Project. J Am Coll Cardiol 2014;64:2071-82.

Keywords: Lipoproteins, LDL, Medication Adherence, Myocardial Infarction, Follow-Up Studies, Secondary Prevention, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Angiotensin-Converting Enzyme Inhibitors, Risk Factors, Blood Pressure, Aspirin, Ramipril, Simvastatin, Diabetes Mellitus


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