Cheap 'Polypill' deals with heart disease and stroke

The 'Polypill' is a single pill which combines a range of drugs that protect against heart disease and stroke and was first considered a number of years ago as a cost effective way to significantly reduce the death toll from cardiovascular disease. But progress has been hampered by the reluctance of pharmaceutical companies to embark on a project involving inexpensive drugs which offered little financial incentive.

Now a team funded by the Wellcome Trust in London, UK, and the British Heart Foundation, and led by Professor Anthony Rodgers at the University of Auckland, New Zealand, has begun recruiting 700 volunteers in six countries for a pilot trial of a Polypill manufactured by Dr. Reddy's of Hyderabad, India.

The single, cheap tablet - the Red Heart Pill - combining the blood-thinner aspirin, a cholesterol-lowering statin, an ACE inhibitor and a thiazide to lower blood pressure, which protect against heart disease and stroke - have already begun pilot trials in human volunteers in Britain.

The Red Heart Pill costs just $1 (70 cents) for a month's supply and is aimed at reducing the risk of heart disease and stroke in poor and rich countries alike.

Dr. Simon Thom of Imperial College London, who is leading the UK trials, says its use will vary around the world but he believes in distributing the pill "almost blind" to everyone over 55 in the developing world.

He says in countries where people have better access to doctors and drugs, the one-size-fits-all approach is unlikely to be adopted and suggests instead that over-55s could be put on one of several different polypills containing varying doses of the drugs, depending on their health needs.

The pill promises to halve the cardiovascular risk and the British trial is just part of a larger international trial of the polypill on 700 volunteers - if successful larger clinical trials involving up to 7,000 people are planned for 2009.

Experts say combining four drugs in one pill is no easy task and can present challenges for formulation, delivery and testing and human trials will monitor for interactions between the drugs, but they say all the component drugs have a good safety record.

Trials of the 'Polypill' led by Associate Professor Patel are about to begin in Sydney involving 400 people who are healthy but have an increased chance of developing heart disease over the next five years because of their age, smoking or weight.

The study will establish whether the pill lowers participants' blood pressure and cholesterol over a three-month period, compared to a placebo.