Can a combination pill help heart patients?

By Genevra Pittman

Combining aspirin with cholesterol and blood pressure drugs in a single pill may encourage people to take their medication and slightly reduce their heart risks, a new study suggests.

Known as fixed-dose combinations or polypills, single pills combining multiple drugs have been proposed as a strategy to improve compliance.

"The preventive treatment of cardiovascular disease falls short of ideal. There are lots of people who've got established diseases, typically survivors of heart attacks and strokes, who are undertreated," Dr. Simon Thom, who led the study at Imperial College London, told Reuters Health.

Polypills have been used in the treatment of migraines, arthritis and HIV, but developing them for cardiovascular disease is a relatively new idea, Dr. Thom said.

Combination heart drugs are available in a few countries including India, he said, but haven't been approved by regulatory agencies in the U.S. and Europe.

Some researchers worry that a single combination pill won't address an individual person's risk factors, such as blood pressure and cholesterol levels, as effectively as a more tailored regimen of separate drugs.

There's also the concern that people who would otherwise stop taking one of their pills because of a side effect would end up going off all their medicines if they were combined in a single dose, the researchers noted.

Their study included 2,004 people in Europe and India, most with cardiovascular disease and the others at high risk due to conditions such as diabetes, high blood pressure or smoking.

Half the participants were randomly assigned to keep receiving usual treatment and the other half were assigned to take one of two combination pills, each of which included aspirin, a statin and two blood pressure-lowering drugs.

An average of 15 months later, more people on a combination pill reported having taken their medication at least four times in the prior week: 86%, vs 65 percent of those receiving usual care.

Systolic blood pressure was also slightly lower with the polypill vs usual care, at 129.2 vs 131.7 mmHg, as was LDL cholesterol, at 84.2 vs 88.4 mg/dL.

However, there was no difference in the proportion of patients who were hospitalized for heart failure or had a stroke during the study period, the researchers reported Tuesday in the Journal of the American Medical Association. Across both study groups, 85 participants had a cardiovascular event.

Katherine Carey, a pharmacy researcher who conducted a review of polypill studies at MCPHS University in Worcester, said previous trials haven't focused on the issue of adherence.

"This study did answer that really important question," Carey, who wasn't involved in the new research, told Reuters Health.

One limitation, the researchers noted, is that people in the combination pill group received their medication for free through Dr Reddy's Laboratories in India and other patients had to keep filling their prescriptions at a pharmacy as usual.

The study can't say whether that influenced how many people took their medicines regularly. However, Dr. Thom said the differences in adherence held when the researchers only looked at people in the usual care group who also had no co-pays.

He and his colleagues are working on a cost-benefit analysis of the polypills. He expects there "should be major cost savings" compared to taking multiple individual drugs, in part because the medicines included in the pill are available as generics.

But Carey said in the U.S., a company could likely market a polypill at brand-name prices, raising cost concerns.

Some of the controversy surrounding the polypill, the researchers noted, has come from the suggestion that everyone over a certain age should be taking it. A benefit of the new study, according to Carey, is that it included only people with indications for each of the individual medicines included in the pill.

"If you're looking just at patients who would be getting all of these components individually, I think it takes away that controversy and makes it more practical for use in the United States," she said.

SOURCE: http://bit.ly/15wsbwN

JAMA 2013.