Trial begins of polypill that could prevent heart attacks and strokes
The first trial among the over 50s in the UK of the “polypill”, a daily tablet combining several low-dose drugs that could protect against heart attacks and strokes, is being launched this month.
The idea was proposed by two British professors in 2003. Prof Sir Nicholas Ward and Prof Malcolm Law, from the Wolfson Institute of Preventive Medicine at Queen Mary, University of London, suggested in a paper in the British Medical Journal that a pill combining low doses of several drugs to bring down cholesterol and blood pressure could save lives.
Ward and Law wrote in their paper: “The polypill strategy could largely prevent heart attacks and stroke if taken by everyone aged 55 and older and everyone with existing cardiovascular disease. It would be acceptably safe and with widespread use would have a greater impact on the prevention of disease in the western world than any other single intervention.” Richard Smith, then BMJ editor, said it was possibly “more than 50 years since we published something as important as these papers”.
The idea has gained currency and is being explored by more than one team of researchers. While some scientists are investigating a pill they christened the “red heart”, which they hope will cut heart disease deaths among those already known to be at risk in Asia, the Wolfson researchers continue to focus on the original concept.
They hope the trial, which begins this month, will pave the way for a pill which anybody over 50 in the UK will be able to obtain at low cost from a pharmacy within a couple of years.
One of the researchers conducting the trial at the Wolfson Institute, Dr David Wald, said: “The polypill has the potential to be a daily preventive method against heart attacks and strokes, just as the contraceptive pill is a daily preventive method to avoid an unwanted pregnancy. This trial is a step towards making access to the polypill a reality.”
The pill is being made by the Indian generics company Cipla. All components are out of patent and therefore can be copied and are cheap. It contains simvastatin to lower cholesterol and three drugs at half the standard dose to reduce blood pressure – losartan, hydrochlorthiazide and amlodopine.
Unlike the red heart, which is intended for people who have already suffered heart problems, the polypill does not contain aspirin as originally envisaged by Ward and Law in 2003. Aspirin is known to protect against heart attacks and stroke, and trials recently showed there were more than 20% fewer deaths from certain common cancers in people who took a daily low dose of aspirin.
But the Wolfson team want to minimise potential side-effects to make the pill safe for everyone to take, and aspirin has been shown to sometimes cause stomach bleeding.
Wald said: “By offering the polypill on the basis of age alone, prevention is greatly simplified and the population receiving the polypill are not medicalised, because they do not have to become patients to receive it.”
The trial will include 100 people, selected on the basis of age alone, who will take the pill for 12 weeks and a placebo for 12 weeks, without knowing which one is which. They will be monitored for the effects on their blood pressure and cholesterol levels. At the end of the 24 weeks, all will be given the polypill for a further two years to help assess the long-term benefits.
Because the drugs which make up the polypill are all well-known and are often taken together, even if not in a single tablet, there would not have to be the usual long licensing process to get the polypill on the market.
Within 18 months or two years, the researchers hope it may be universally available, although they still envisage that it may be prescribed by a pharmacist, rather than sold over the counter.
Tags: BMJ, Doctors, Heart Disease, NHS Deaths, polypills, preventable crisis, Strokes