New Delhi, Dec. 7: A cocktail of four drugs to prevent heart attacks and locked for the first time into a single pill by an Indian company will soon undergo clinical trials in eight countries, company officials and researchers announced today.
The four-in-one polypill, developed by Hyderabad-based Dr Reddy’s Laboratories, contains aspirin, a cholesterol-lowering drug, and two other medicines that lower the blood pressure.
Polypills that contain two or three drugs that lower cholesterol and blood pressure are routinely prescribed by doctors in many countries. This is the first four-in-one drug.
Medical researchers said they expect the drug to prevent first heart attacks in people who are at risk as well as lower the risk of repeat events in people who have already suffered heart attacks.
A clinical trial of the polypill to determine its efficacy in lowering the risk of second heart attacks has been under way in 11 centres across the country, Satish Reddy, the managing director of Dr Reddy’s Laboratories, said.
Although all four drugs have been prescribed by doctors for years to patients to lower their risk of suffering heart attacks, combining the four medicines into a single pill is expected to be more effective. “We hope to launch this product for secondary prevention sometime during the second half of next year,” Reddy said.
The international trial, led by Anthony Rodgers at the University of Auckland in New Zealand, will examine the efficacy of the drug to prevent even first heart attacks.
“Research shows that people with chronic diseases like heart disease only take half their medications,” Rodgers said.
“This creates a gap in treatment which can have serious consequences for some patients.”
“Although each of the four drugs has been used for years, the safety and efficacy of the combined form will have to be established,” M. Venkateswarlu, drugs controller-general of India said.
The international trial will recruit 600 patients from India, New Zealand, Australia, Brazil, China, South Africa, the UK and the US.
The trial will aim at finding out how effective the polypill will be in lowering cholesterol and blood pressure and thus reduce the risk of heart attacks and strokes.
Researchers say combining multiple drugs into a single pill can be tricky because drugs may interact among themselves or with other components of the pill which may alter their efficacy.