Tuesday, August 14, 2007

 

polypil

In the next few months a New Zealand-led clinical trial begins for a pill claimed by two British researchers to have the potential for “a greater impact on the prevention of disease in the Western world than any other known intervention”.

The case for the ‘polypill’ – a super-drug that combines four common medicines used to treat heart disease – was outlined in the British Medical Journal in 2003 in an issue the editor described as perhaps the most important it had published in 50 years.

The two researchers suggested the polypill could reduce cardiovascular disease by more than 80 percent.

The trial of the effectiveness of the polypill, made by the Indian-based global pharmaceutical company Dr Reddy’s, will be led by the New Zealand-based University of Auckland’s Professor Anthony Rodgers, a recognised world leader in clinical trials.

The trial, to start in the second quarter of 2007, will involve about 600 people from New Zealand, India, Australia, Brazil, China, South Africa, the United Kingdom and the United States who have a raised risk of having a heart attack or a stroke.

The global trial will attempt to confirm that the polypill medicines are safe and tolerable when taken together and are still effective when combined in one fixed-dose pill.

Dr Reddy’s’ Chief Operating Officer, Satish Reddy, says there are two notable aspects of the New Zealand-India collaboration, the first being the outstanding clinical development expertise and global credibility Professor Rodgers and his team bring to the project, and secondly, the commitment to making medicine affordable.

Professor Rodgers’ team is an example of New Zealand’s significant clinical trials’ capability. The calibre of New Zealand investigators and clinicians is rated highly internationally, costs are competitive and both ethics and regulatory standards are high.

All the medicines in the polypill – aspirin, a statin to lower cholesterol and two blood pressure drugs – are already widely used. They are also no longer covered by patents, so the polypill will be cheap to produce and at a few dollars a month will be more affordable in developing countries.

The medicines also treat several related conditions and combining them may benefit people who can’t afford regular visits to the doctor.

Professor Rodgers says the four medicines will potentially be much more effective when taken in one pill.

“Research shows that people with chronic diseases like heart disease only take half their medications.”

He says people forget or feel well so don’t take their pills, but this creates a gap in their treatment that can have serious consequences.

“We hope the polypill will provide an easier and more practical way to take the medications," says Professor Rodgers.

The World Health Organization says about 17 million people die prematurely from heart disease and stroke each year and most of those deaths occur in low/middle-income countries.

The Health Research Council of New Zealand has invested NZ$350,000 to support overall co-ordination of the trial and recruitment in New Zealand. Dr Reddy’s will invest NZ$7.5 million in developing the polypill and providing supplies for clinical trials globally.

If the first trial is successful, a full-scale one is planned involving up to 5000 people with a moderate risk of heart disease. This trial will confirm the pill’s ability to prevent heart attacks and strokes.

For more information, please contact:

michelle.sullivan@investmentnz.govt.nz

+64 9 966 9205



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