MELBOURNE – A polypill combining aspirin, simvastatin, and two antihypertensive drugs has shown a significant improvement in adherence as well as reductions in blood pressure and LDL cholesterol in patients with existing heart disease, according to data from a large international multicenter trial.
The Single Pill to Avert Cardiovascular Events (SPACE) project – a randomized, open-label, controlled trial in 3,140 patients – showed a 43% increase in patient adherence to their medication at 12 months.
Data presented at the World Congress of Cardiology 2014 showed the polypill also led to a statistically significant 2.8–mm Hg drop in systolic blood pressure and 0.1 mmol/L decline in LDL cholesterol.
Presenter and epidemiologist Dr. Ruth Webster said adherence was one of three primary outcomes of the analysis, which included data from three separately run but coordinated trials in Australia, New Zealand, Europe, and India.
Courtesy Bianca Nogrady
Dr. Ruth Webster
"In high-income countries, about 50% of people who should be taking their medications take them, and in lower-middle income countries, 90% of people don’t take their medications," said Dr. Webster, international coordinator for the SPACE collaboration and research fellow at The George Institute for Global Health.
"An estimated 100 million people worldwide should be taking these drugs but aren’t, so in that context even small improvements in blood pressure and LDL cholesterol will have a massive impact globally," Dr. Webster said at the meeting sponsored by the World Heart Federation.
Dr. Webster also pointed out that while the blood pressure and LDL cholesterol gains were modest, they were achieved against a control population receiving the usual care, not an untreated population.
The polypill was consistently associated with improvements in adherence across the different study populations, although subgroup analysis revealed a fourfold increase in adherence at 12 months among patients who weren’t taking their prescribed medications at baseline.
"If you’re struggling to take all your medications or you don’t have access to them ... then this could be a huge help in bridging that evidence-practice gap," Dr. Webster told the conference attendees.
The SPACE project trials enrolled individuals with pre-existing cardiovascular disease or who were at high risk (at least 15% over 5 years) but had not had a primary event. Around two-thirds of patients in both arms had a history of coronary heart disease, approximately 14% had a history of cerebrovascular disease, and just over one-third had diabetes.
The polypill, which was prescribed in the primary care setting, contained 75 mg aspirin, 40 mg simvastatin, 10 mg lisinopril, and either 50 mg atenolol or 12.5 mg hydrochlorothiazide.
Commenting on the study, Dr. Sidney C. Smith Jr. said it was not unusual to see patients come into hospital with as many as twelve different medications.
"In coronary artery disease, we know that the use of three to four key medications – aspirin, statins, ACE inhibitors and beta-blockers – may reduce future events by as much as 70% ... and yet study after study using current pills and therapy is showing that a minority of patients are taking all four medications," said Dr. Smith.
"That has led to the idea that if we could combine all these medications into one tablet, it just might have a huge impact," Dr. Smith said.
While polypills are not yet available on the market in the United States and other major markets, Dr. Webster said it was anticipated that some might become available within a couple of years.
The SPACE collaboration studies are all publicly funded, and the coordinating centre was partly funded by an unrestricted education grant from Dr. Reddy’s Laboratories (Hyderabad, India), which also supplied the polypill (Red Heart Pill) used in the study. The George Institute has since negotiated an exclusive global license for the rights to the polypill used in the study.