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Polypill could slash heart disease and stroke risk

By Lilian Anekwe

A polypill combining five different cardiovascular drugs can act as a potent agent for primary prevention of heart disease and stroke without raising the risk of side-effects, a new trial reports.

The study in 2,053 patients with one cardiovascular risk factor but no established disease found the pill could strongly drive down blood pressure and reduce cholesterol.

As a result, the polypill could be expected to cut the risk of heart disease by as much as a third and stroke by a quarter, researchers said.

Their results, published online by The Lancet and presented at the American College of Cardiology conference this week, will reignite debate over whether a polypill should be introduced in the UK for primary prevention.

A polypill has been mooted since the UK's Professor Nick Wald and Professor Malcolm Law combined a statin, aspirin, three types of blood pressure-lowering drug and folic acid and found the new medicine reduced rates of heart attack and stroke by more than 80%.

That proposal floundered on concerns over the patents of the drugs included, but the latest polypill - branded the Polycap by its Indian manufacturer - combines five generic drugs.

A Polycap capsule contains three antihypertensives – hydrochlorothiazide 12.5mg, atenolol 50 mg and ramipril 5mg – with simvastatin 20mg and aspirin 100mg.

The trial, conducted in India, randomised patients to the Polycap or either aspirin, simvastatin or hydrochlorthiazide alone, or two blood-pressure-lowering drugs, three blood-pressure-lowering drugs, or three blood-pressure-lowering drugs plus aspirin.

The Polycap reduced systolic blood pressure by 2.2 mmHg and diastolic blood pressure by 1.3 mmHg compared with patients on three anti-hypertensives.

Combined treatment also reduced LDL cholesterol by 0.70 mmol/L, slightly less than the 0.83 mmol/l reduction with simavastatin alone. Tolerability was similar in all groups.

Study leader Dr Salim Yusuf, director of cardiology at McMaster University in Hamilton, Canada, said: ‘The reductions in blood pressure could lead to a 24% risk reduction in heart disease and a 33% reduction in strokes in individuals with average blood pressure.

‘On the basis of the more modest lowering of LDL cholesterol, a 27% risk reduction in heart disease and an 8% risk reduction in stroke can be projected.'

Dr David Wald, consultant cardiologist at the Wolfson Institute of Preventive Medicine and coordinator of the polypill prevention programme, said the study supported the original predictions made by Wald and Law in 2003:

‘It's an impressive study. But 12 months is not long enough to measure tolerability. In trials, patients put up with side effects they would not in the real world, so rates of discontinuation could be a problem.'

Dr Terry McCormack, former chair of the Primary Care Cardiovascular Society and a GP in Whitby, North Yorkshire, said: ‘I can see advantages for compliance. But it's a blanket way of doing things, not tailored to individual patients.'

Aspirin is one of 5 drugs contained in the polypill

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