Dr. Reddy's, the Indian pharma giant has decided to join hands with the University of Auckland, New Zealand to begin Global trials of a new fixed dose combination or "polypills" to prevent strokes and heart attacks.
The polypill will combine four drugs- aspirin, statin(to reduce cholesterol) and two drugs to prevent hypertension. The trial will check the reliability of the pill when it comes to safety and its effectiveness when consumed as one pill.
Investments of Dr. Reddy's in the trial would come up to $7.5 million, and The Health Research Council, New Zealand has invested U.S. $241,055.
Dr. Reddy's has initiated the trial six months ago, Satish Reddy, COO and managing director of Dr. Reddy's said, "Since all medicines in the polypill are already prescribed to heart attack patients, we don't anticipate any problem with polypill trial."
Anyway, the plan of having a global trial will assess the success of using the polypill in different populations. The trial will begin by the second quarter of 2007, and would involve 600 people from five continents.
Apart from people from India and New Zealand, the other countries involved in the global trial would be South Africa, China, Australia, Brazil, the United Kingdom and the United States.
It took three years for the drug company to formulate this pill. Mr.Reddy's claims this pill to be "single most important initiative of the decade" by his firm. He also said, "We should be able to introduce the drug for secondary indication [prescriptions to stroke/heart attack patients] by mid-2007."
Affordability of the polypill
The cost of this pill is taken to prime importance since it is to be used in developing countries. Dr.Reddy's assured, "Our intention is to see that one month's medication costs less than Rs. 100 [U.S. $2.20]. The combination is not going to bring us big money, but it will help the patients as they get all four pills combined."
Trials at Global Level
Professor Anthony Rodgers working at the University of Auckland's, belonging to the clinical trials research unit is going to lead the trial. He has been an advisory to WHO and is also a world-renowned clinical trial expert.
Prof. Rodgers claims that this combined pill will prove to be more effective than four medicines. He said, "Research shows that people with chronic diseases, like heart disease, take only half their medications, they forget, or they feel well, so think they don't need to take their pills. However, that creates a gap in their treatment, which can have serious consequences for some patients."
Thus he believes that this oil is a more practical and easy solution to cardiac ailments.
Prof. Rodgers said that the first trial would involve 5000 people moderately prone to cardiac ailments. He said, "The first trial will confirm whether the polypill lowers blood pressure and cholesterol, if it goes ahead, this second trial would confirm the pill's ability to prevent heart attacks and strokes."