People are much more likely to take heart medicines if they're combined in one pill, according to a late-breaking clinical trial presented at the American Heart Association's Scientific Sessions 2012.
"This is the first time the impact of a fixed-dose, combination strategy has been tested in people with cardiovascular disease," said Simon Thom, M.D., F.R.C.P., lead author of the study and professor of cardiovascular medicine and pharmacology at Imperial College London, U.K.
"People who have suffered heart attacks or strokes or those at high risk of such problems need to take preventive medications, including antiplatelet drugs (such as aspirin), cholesterol-lowering and blood pressure-lowering drugs. But the reality is that large numbers of people in this high-risk category get out of the habit of taking the recommended medications," Thom said. "This happens for a variety of reasons; some of which may be corrected by a single, simple, fixed dose combination pill - a combination known as a 'polypill.'"
There has been uncertainty about a fixed dose combination strategy for cardiovascular disease prevention. While many physicians have anticipated that adherence might be improved, reduced flexibility in adjusting dosages and numbers of individual agents could have offset the benefits of simplicity.
Alice Stanton, lead Irish Investigator, Co-author and Professor of Molecular and Cellular Therapeutics at RCSI, Dublin, commented. "This trial showed improvements in adherence being paralleled by improvements in blood pressure and cholesterol, despite the control group in the trial being treated much better than average."
Typically, in high-income countries such as the United States only about 50 percent of people take all the needed cardiovascular medications. In low- and middle-income countries, only 5 percent to 20 percent do.
Researchers studied whether changing the delivery of several medications into one fixed-dose, combination pill might improve adherence and, therefore, improve blood pressure and cholesterol control. The researchers followed more than 2,000 men and women (average age 62) with cardiovascular disease in Europe and India for an average 15 months. Half of the participants were given a combination pill of aspirin, a cholesterol-lowering agent (statin) and two blood pressure-lowering drugs. The other half took their medications as usual, with multiple pills and doses.
Researchers noted that the group taking a single pill improved adherence by a third and had improved blood pressure and cholesterol levels compared to those taking multiple pills. The findings also likely apply to Americans, Stanton said. "We deliberately chose two quite different settings - Western Europe and India, with half the patients from each region, although the trial did include well-treated populations in both locations. Seeing broadly similar findings in each region suggests generalizability"
Similar trials are being conducted in Australia and New Zealand.