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IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in

Vanessa Selak1, C Raina Elley, Sue Crengle

  • 1Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142, New Zealand. v.selak@ctru.auckland.ac.nz

Contemporary Clinical Trials
|July 23, 2011
PubMed

Insights

A polypill strategy improved medication adherence and cardiovascular health in high-risk individuals. This fixed-dose combination pill offers a promising approach to managing cardiovascular disease (CVD) and reducing health disparities.

Area of Science:

  • Cardiovascular medicine
  • Pharmacology
  • Public health

Background:

  • Cardiovascular disease (CVD) significantly impacts life expectancy, particularly for indigenous Māori in New Zealand.
  • Current guidelines recommend aspirin, blood pressure, and lipid-lowering therapies for high-risk individuals, but adherence and prescribing rates are suboptimal.
  • This leads to persistent high rates of CVD events.

Purpose of the Study:

  • To evaluate if a fixed-dose combination polypill improves medication prescribing and adherence compared to usual care.
  • To assess the polypill's effectiveness in lowering blood pressure and improving lipid profiles over 12 months.
  • To address cardiovascular health disparities in high-risk populations, including Māori.

Main Methods:

  • An open-label, randomized controlled trial (IMPACT) involving 600 participants (300 Māori) with previous CVD events or high CVD risk.
  • Comparison of a once-daily polypill (aspirin, simvastatin, lisinopril, plus a diuretic or beta-blocker) against usual care.
  • Primary outcomes: medication adherence, changes in systolic blood pressure and LDL cholesterol at 12 months.

Main Results:

  • The study aims to determine if the polypill strategy leads to better adherence and improved cardiovascular risk factors.
  • Secondary outcomes include analysis of other lipids, medication dispensing patterns, adherence barriers, adverse events, quality of life, and prescriber acceptance.
  • Trial registration: ACTRN12606000067572.

Conclusions:

  • The polypill strategy is being investigated as a means to enhance adherence to guideline-recommended cardiovascular medications.
  • This approach may offer a more effective method for reducing blood pressure and improving lipid profiles in high-risk individuals.
  • The study seeks to contribute to reducing the burden of cardiovascular disease and health inequities.
Abstract

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