One-a-day heart polypill to be tested in new international trial

Researchers will explore whether a new, very low-cost, one-a-day combined “polypill” could reduce the risk of heart attacks, strokes, and other cardiovascular problems across the world, in a major new international trial that has just launched, as reported by Science Daily.

The new “Red Heart Pill” contains low-dose aspirin, a statin, and two blood pressure-lowering medicines in a single polypill. It is expected to be substantially cheaper than existing medications to combat cardiovascular problems, according to researchers.

Researchers are now recruiting 2,000 volunteers who are at high risk of heart attack or stroke, or who have already had such a cardiovascular event, for a 2-year trial of the Red Heart Pill. The trial, called UMPIRE (Use of a Multidrug Pill In Reducing Cardiovascular Events), launches in London and at facilities in Ireland, the Netherlands and, pending regulatory approval, India.

“The UMPIRE study is designed to evaluate whether a polypill strategy improves individuals’ continuation with indicated preventive medication,” Professor Simon Thom, the co-principal investigator of the study from the National Heart and Lung Institute at Imperial College in London, tells Formulary. “Adherence to medication [the primary end point of the trial] will be assessed by a simple questionnaire. Any differences in the medication adherence between the ‘polypill group’ and the ‘usual care group’ will be substantiated by measurement of blood pressure and cholesterol.”

There are 2 other trials with the same protocol currently running in New Zealand (IMPACT) and Australia (Kanyini-GAP), and researchers plan similar trials in China, Brazil, South Africa, and Canada, Thom said. When all trials are combined, there should be about 6,000 to 7,000 participants and “we will be counting cardiovascular events and the collective pooled data [that] should have sufficient statistical power to evaluate the effect of the polypill strategy on cardiovascular outcomes,” he told Formulary.

The researchers will investigate whether patients are more likely to stick with a preventive treatment regimen using a single, one-a-day polypill, rather than multiple tablets. The researchers will also be exploring whether the Red Heart Pill is effective at reducing blood pressure and lowering cholesterol.

If the treatment strategy is effective, the researchers plan to establish how the polypill could be made available to people on low incomes in countries like India, where 80% of healthcare is paid out of pocket and the majority of people do not currently have access to cardiovascular drugs.

In countries like the United Kingdom, where heart medications are more readily available, the researchers want to explore whether the Red Heart Pill could provide a more convenient alternative to existing medications. In the United Kingdom, the medications contained in the polypill are currently prescribed individually. Doctors recommend such preventive treatments, because they can more than halve the risk of cardiovascular events, but evidence shows that at present many people who start on these medicines do not continue to take them in the long term.

The UK arm of the trial is being conducted by Imperial College London, with patients being recruited through clinics at Imperial College Healthcare NHS Trust. The College and Trust are partners in the Academic Health Science Centre, which aims to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible.