Polypill Could Cut Heart Attacks And Strokes Dramatically
A randomized trial finds that giving over-50s a four-in-one "Polypill" to cut their risk of heart attack and stroke, led to large drops in blood cholesterol and blood pressure, the main causes of these two diseases. The trial's lead investigator says the expected impact of the Polypill would be to cut heart attacks and strokes, both leading causes of death worldwide, by two-thirds.
The trial, the first to test a Polypill on people selected purely on their age, was carried out at the Wolfson Institute of Preventive Medicine at Barts and The London School of Medicine & Dentistry, part of Queen Mary, University of London.
The findings were published online in the journal PLoS ONE on Wednesday.
Senior author Professor Sir Nicholas Wald, Director of the Wolfson Institute of Preventive Medicine at Queen Mary, University of London, invented the Polypill. He told the press:
"We now need public, professional and regulatory support to make the Polypill available without delay; the net benefits are too large to ignore - even if only 50 percent of people aged 50 or more took the Polypill, about 94,000 heart attacks and stroke would be prevented each year in the UK."
These new results confirm those predicted in a paper published in the BMJ in 2003. The Polypill Trial The randomized double-blind placebo-controlled crossover trial is the first to test a Polypill on participants selected on basis of age alone, without the need to have a medical exam or tests. The researchers say this sets the scene for using the treatment as a way to prevent first heart attacks and strokes in the general population.
None of the participants had a history of cardiovascular disease.
Could a once-a-day pill save thousands of lives
in the over-50s? The Polypill used in the trial is a three-layered tablet that contains three drugs (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg) for lowering blood pressure and one (simvastatin 40 mg), for reducing cholesterol. It was manufactured for the study group by Cipla, India.
The trial had two treatment periods. One where the participants took the Polypill each evening for 12 weeks, and the other where they took a placebo each evening for 12 weeks. The participants were randomly assigned to receive either the Polypill or the placebo for the first 12 weeks. Then after that, they switched to the other tablet.
84 out of 86 participants that signed up, completed both periods.
The researchers say the high level of adherence is one of the reasons the results of this trial are highly accurate and reliable.
"The four previous Polypill trials underestimated efficacy because of poor adherence to treatment in the treated group or unscheduled treatment in the control group," they write.
Another reason is the trial used a cross-over design:
"... while the other trials used a parallel group design, we used a crossover design that has greater statistical power and avoids the dilution of the estimate of effect due to participants who did not take their allocated treatments being included in the results as part of the intention-to-treat analysis," they write.
In other words, all the participants underwent both the treatment period and the placebo period and thus acted as their own controls.
The researchers measured each person's changes in blood pressure and low density lipoprotein (LDL or "bad") cholesterol at the end of each 12-week period.
The results showed that while on the Polypill, the participants experienced a 12% fall in blood pressure and 39% fall in LDL, reaching levels normally only seen in 20-year-olds.
The results were almost identical to those predicted from published estimates of the effects of the individual drugs. "Major Public Health Advance" Dr David Wald, the trial's lead investigator, is an Interventional Cardiologist with an interest in the prevention of cardiovascular disease. He told the press:
"The health implications of our results are large. If people took the Polypill from age 50, an estimated 28 percent would benefit by avoiding or delaying a heart attack or stroke during their lifetime; on average, those who benefit would gain 11 years of life without a heart attack or stroke."
He said the trial shows that the effects predicted back in the 2003 BMJ paper, can be achieved in practice.
"The expected impact on preventing what is now the world's leading cause of death is large - about a two-thirds reduction in heart attacks and strokes," said Wald.
David Taylor is Professor of Pharmaceutical and Public Health Policy at University College London. He said the Polypill should be made generally available as a matter of urgency:
"The Polypill concept is a major public health advance. This study shows that it works," he added.
"I welcome the opportunity to substantially cut my risk of having a stroke or heart attack without the disempowering fuss and bother usually required to obtain preventive medicines," said Taylor, who took part in the trial.