| ORLANDO, Florida
ORLANDO, Florida Bundling three older blood-pressure medicines, a cholesterol-lowering drug and aspirin into a single pill shows promise as a way to reduce heart disease, new research showed on Monday.
A 2,053-patient, Indian clinical trial marked the largest study to evaluate such a "polypill" and test whether it leads to meaningful changes in heart risk factors, according to researchers presenting the study at the American College of Cardiology scientific meeting in Orlando.
"Before this study, there were no data about whether it was even possible to put five active ingredients into a single pill, in terms of feasibility, the bioavailability of different agents and possible interactions," said Salim Yusuf of the Population Health Research Institute at McMaster University, which presented the data. "We found that it works."
Cardiologists have theorized about using polypills for years to prevent heart disease -- and its potential has been aided by the fact that many heart drugs have lost patent protection and are available as generics.
Based on the reduction in risk factors seen in the trial, Yusuf projected the polypill could reduce heart disease by 60 percent and stroke by 50 percent.
The pill was well-tolerated and showed no evidence of problems with the increasing number of active components. In fact, the effects of some ingredients counteracted side effects of others, Yusuf said.
The polypill in the study was manufactured by privately held Cadila Pharmaceuticals of India, which also sponsored the study. Cadila's polypill is a capsule, with the brand name, Polycap.
It incorporated low doses of three blood-pressure drugs from different classes -- thiazide, atenolol and ramipril -- as well as the statin cholesterol-lowering drug Zocor and aspirin.
Dr. Udho Thadani, a professor of medicine at The University of Oklahoma Health Sciences Center, said cardiac patients are often juggling several medicines so reducing their pill load could help them stay on their drugs while also potentially saving money.
"I think it will be great for compliance and also bring the cost down," said Thadani, who was attending the cardiology conference.
Participants in the Indian study were randomized to the polypill or one of eight other arms which included one of the individual medicines or combinations of them. They were 45 to 80 years old without heart disease but with at least one risk factor for developing cardiovascular problems.
While the pill proved as good as its individual components in lowering blood pressure and heart rates, it fell slightly short of lowering bad LDL cholesterol as much as Zocor alone.
The authors of the study, also published in the journal Lancet, described the cholesterol difference as borderline significance.
Yusuf said the study would help inform the design of larger, more definitive studies as well as developing appropriate combinations.
Michael Ross, president of Cadila's U.S. division, said the company had not yet determined its next step for developing its polypill, but was pleased the formulation could work.
"We're just very excited about the outcome of the study," Ross said.
(Reporting by Lewis Krauskopf; editing by Gunna Dickson)