Trials on cheap heart 'polypill' to begin

A CHEAP “polypill” that combines several heart medications is due to start trials in Ireland later this year.

The single pill contains aspirin as well as drugs to lower blood pressure and cholesterol, and is designed to lower the risk of heart attack and stroke.

The planned research study will include some 330 patients from Ireland and is to link in with trials looking at about 6,000 patients worldwide, according to Alice Stanton, associate professor of molecular and cellular therapeutics at the Royal College of Surgeons in Ireland.

The 30-month trial, which is funded by the European Commission, will compare treatment with the inexpensive combined pill and with standard medication regimes in people at high risk of heart attack or stroke.

“This trial is going to address the question of whether blood pressure and cholesterol is better controlled with a polypill, because there are both financial savings and compliance savings,” said Prof Stanton, who noted that the single pill was relatively inexpensive and easy to take.

“The projected cost for this polypill in the Western world is going to be €10 per month and the current cost of those medications prescribed individually is in excess of €100 per month. So there could be huge savings for both the country and for individuals.”

The planned study will recruit patients who have already had a heart attack or stroke or are at high risk of having one. Medication in the polypill can have side effects, so it would be inappropriate to prescribe it for people at low cardiovascular risk, said Prof Stanton.

But she expects benefits for patients already at risk: “We have to prove it, but we think it’s very likely that the cheaper polypill will be at least as good if not better for both the blood pressure control and the cholesterol control.”

The protocol for the polypill trial will be submitted to the Irish Medicines Board and to an ethics committee next month.

“We anticipate approvals by the end of April, and hence formal recruitment can only commence in May,” said Prof Stanton.

“However, we would be very happy for people who might be interested in participating in the trial to make contact with us by phone or by e-mail. Then once we have all approvals in place, we will re-contact them and provide approved full participant information sheets.”

• For more information contact the Adapt Centre, RCSI Clinical Research Centre, Beaumont Hospital, at 01-8092862 or e-mail adapt@beaumont.ie