The once-a-day polypill contains aspirin and agents to lower blood pressure and cholesterol. These drugs are currently prescribed separately to millions of patients and are known individually to cut the risk of disease, but many experts believe that combining them into a single pill will encourage people to take the medications more reliably.
The trial tested the effectiveness and tolerability of the polypill in 378 people with raised risk of cardiovascular disease, who did not necessarily have high blood pressure or cholesterol, against a placebo. The participants came from the UK, Australia, Brazil, India, New Zealand, The Netherlands and the US. The Wellcome Trust provided the core funding for the central coordination of the trial.
The Program to Improve life and Longevity (PILL) Collaborative Group, part of a larger collaboration known as the Single Pill to Avert Cardiovascular Events (SPACE), conducted the study.
The polypill was manufactured and provided by Dr Reddy’s Ltd, Hyderabad.
‘The results show a halving in heart disease and stroke can be expected for people taking this polypill long term,’ said Professor Anthony Rodgers of The George Institute for Global Health, who led the international consortium.
‘We know from other trials that long term there would also be a 25–50% lower death rate from colon cancer, plus reductions in other major cancers, heart failure and renal failure,’ he added.
National trials of similar combination polypill treatments have previously been conducted in India, Iran and Sri Lanka, but this is the first trial to combine data from patients at international centres and the first to look reliably at the incidence of side effects against a placebo.
The authors noted that the benefits, while large, were not as massive as previous researchers have suggested, and the side effects were also not as rare as first thought. In the short term, about 1 in 6 people experienced a side effect. Most were mild, but about 1 in 20 overall stopped treatment due to side effects, indicating that treatment is best targeted to those at raised risk of disease.
Professor Simon Thom of Imperial College London, who led the UK arm of the trial, commented: ‘We now need to conduct larger trials to test whether these medicines are best provided in the form of a polypill, or as separate medicines, and whether this combination strategy improves patient adherence to cardiovascular medication.’
This polypill will be available in India soon and elsewhere within a few years.
Dr Ted Bianco, director of technology transfer at the Wellcome Trust, said: ‘Few of us would dissent from the view that prevention is better than cure in most matters medical. It is good news, indeed, to see the evidence base grow for the potential use of a new generation of combination products as a safe and affordable option in the battle against heart attack and stroke.’
The British Heart Foundation, the Health Research Council of New Zealand, the National Heart Foundation of New Zealand, the National Health and Medical Research Council of Australia and the Brazilian Ministry of Health provided additional funding for the trial.
The results are published online in PLoS One journal.