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Indian heart disease patients benefit from polypill in major international trial

Media release: 
04/09/2013

Indian patients were much more likely to take preventive medicines if they are combined in one pill, according to the first trial of the polypill in patients with cardiovascular disease.

The trial involved a thousand patients from India and a thousand from Europe, and was published today in the Journal of the American Medical Association.

Taking aspirin, cholesterol-lowering and blood pressure-lowering drugs long-term more than halves heart attack and stroke recurrence. However, most patients in India and elsewhere do not take all recommended preventive medications long-term. This leaves tens of millions of people undertreated.

In the first study to test the impact of a fixed-dose combination pill – called a polypill – in people with cardiovascular disease, 2,004 participants in the UK, Ireland, the Netherlands and India were randomly assigned either the polypill, or their normal combination of medicines.

After an average of 15 months’ follow-up, the proportion of participants in the polypill group who were taking medications regularly was a third higher than in the group receiving usual care. The polypill group also had lower blood pressure and cholesterol measurements.

Professor Vivekanand Jha, Executive Director, The George Institute for Global Health India said: “The reality is that large numbers of people who have already suffered heart attacks or strokes either don’t receive these medications or get out of the habit of taking them. The findings of this study suggest that providing them in a single pill is a helpful preventative step.”

Professor D Prabhakaran, Executive Director, Centre for Chronic Disease Control India said: “These results show that the polypill is a viable strategy for heart attack and stroke survivors, especially those who currently do not receive all recommended preventive treatments.

Professor Prabhakaran said the new findings dispelled several myths about the polypill: “Despite the use of older medications and fixed doses, the polypill group had improved blood pressure and cholesterol levels simply because they took recommended medications more regularly. Also there were no differences whatsoever in diet or exercise patterns.” He also noted that the trial participants were almost universally eager to adopt the polypill if it were made available.

“While the World Health Organisation and many others have noted the potential benefits and cost savings of such an approach for over a decade, this is the first trial to show these benefits directly.”

“This study is an example of Indian innovation and international collaboration and is the first study of its kind to show the potential benefits and cost savings of such an approach to prevention to stroke and heart disease

The polypills used in the study were developed by Dr Reddy’s Ltd, Hyderabad. The late Dr Anji Reddy gave the green light to the development, seeing an opportunity to provide an affordable, convenient treatment package to patients in India and elsewhere.

Most of the patients in the study had already had a heart attack or stroke; the rest were at high risk on the basis of risk factors such as blood pressure, cholesterol and smoking.

Heart disease is a leading cause of premature death and disability in India, in both urban and rural populations, and is growing at epidemic proportions.

The largest-ever study of deaths in India recently showed that heart disease caused 1 in 4 deaths among adults aged 25-69 years. Heart disease rates are now higher in India than in the West.

The study was funded by the EU’s Seventh Framework Programme for Research.