Low-cost polypill could dramatically cut heart attacks, strokes

A single tablet that contains four generically-available drugs – or ‘polypill’ – could offer an effective, low-cost way to tackle heart disease in low- and middle-income countries, says a new study.

The fixed-dose combination of aspirin, statin drug atorvastatin, diuretic hydrochlorothiazide and either an ACE inhibitor (enalapril) or angiotensin 2 receptor antagonist (valsartan) was so effective that it should be considered as a preventive therapy for people without established heart disease, according to the trial investigators.

The polypill plus health advice cut the risk of heart attacks and strokes by a third to 5.9% compared to 8.8% in a control group who received the advice alone, according to the results of the 6,800-subject PolyIran trial, which are published in The Lancet.

It’s by far the largest study of the polypill concept ever attempted, and the first to use cardiovascular outcomes as a readout rather than surrogate markers like blood pressure or cholesterol levels.

Both polypills cost just a few pence per day, say the researchers, while adherence to the treatment was high with a low rate of side effects in this patient group.

PolyIran included Iranian men and women aged over 50, 90% of whom had no cardiovascular disease at the start of the five-year study, which was led by investigators at Tehran University of Medical Sciences.

Treatment started with the enalapril combination, with the valsartan version used as a back-up for patients who developed a cough – a recognised side effect of ACE inhibitor drugs.

The use of a polypill as a simple, cost saving approach to improve medicine adherence and reduce the burden of cardiovascular disease was first proposed almost two decades ago, but this is the first strong evidence that the benefit of widespread polypill use could outweigh side effects.

Prof Reza Malekzadeh, of Tehran University said: “Our research has shown a polypill prevents heart disease in a developing country and is an important step forward in preventing heart disease.”

Drilling down into the data, the therapy reduced the risk of major cardiovascular events by around 40% in individuals without a history of cardiovascular disease and by approximately 20% in those with previous cardiovascular disease.

There was no significant difference in blood pressure between the groups, but LDL cholesterol levels dropped significantly in the polypill arm.

“A polypill strategy could also work in other countries, particularly those where cardiovascular diseases are still increasing,” commented Professor KK Cheng, director of the Institute of Applied Health Research at the University of Birmingham in the UK.

Whether the approach would be appropriate for higher-income countries remains a subject for debate, however.

Prof Jeremy Pearson, associate medical director of the British Heart Foundation (BHF), said that in the UK “as many as a third of people with high blood pressure are undiagnosed and many of those who are diagnosed aren’t managing their condition properly, even though we already have several effective medicines.”

He suggests that the biggest priority in the UK “is to identify more people who do not realise they have high blood cholesterol or high blood pressure, and to help people prescribed medications to take them as prescribed.”