Saturday, May 31, 2008
polypill
Polypill Progress: Clinical Testing Imminent for Three-Agent Secondary-Prevention Pill Steve Stiles Heartwire 2008. © 2008 Medscape
May 23, 2008 (Buenos Aires, Argentina) - A polypill variant containing aspirin, a statin, and an ACE inhibitor is ready to be tested in secondary-prevention studies intended to show not efficacy, which has been all but settled, but the product's pharmacodynamics and pharmacokinetics. Expected to be completed in about two years, the studies are needed to satisfy regulatory requirements that the three drugs, usually taken on separate occasions, are as potent when they are ingested at the same time, observed Dr Valentin Fuster (Mount Sinai Medical Center, NY), at a press conference here at the World Congress of Cardiology (WCC) 2008 meeting. This particular polypill--there are several varieties under development around the world for primary and secondary prevention--stems from a collaboration between the Spanish National Centre for Cardiovascular Research, for which Fuster holds the position of scientific president, and Ferrer Laboratories, a Barcelona, Spain company, according to a statement from the World Heart Federation (WHF) [1]. Fuster is the immediate past president of the Geneva, Switzerland–based organization, which sponsors the biennial WCC meeting and is a prominent backer of the three-agent pill. At the press conference (conducted in Spanish, with English translators provided by the WHF), Fuster demurred when asked to name which specific statin and ACE inhibitor are being used in the pill. Studies are also planned to test its effect on patient compliance compared with taking the three components separately, Fuster said, noting for reporters that compliance is notorious for diminishing with an increase in the amount of pills that must be taken, a key issue driving the polypill's development. He said the secondary-prevention indication is related to a requirement by the US FDA that each component of an approved multidrug pill be clinically indicated for the target population. At any rate, Fuster said through the interpreter, "I don't think I'd give aspirin to someone who doesn't need it, or any other medication that might have an antihypertensive effect. We want to make sure that every individual receiving the drug needs each of the medications contained in the polypill." The pill's introduction, planned for Spain and Latin America before it is made available elsewhere, is expected to cut the overall prevalence of secondary cardiovascular events, according to Fuster, because it should improve compliance and because a single medication is easier and less costly to distribute than three. Also, it is being developed at a greatly reduced cost compared with the usual commercial channels for drugs intended to be money makers. And, he said, the components are inexpensive, "so we will be able to go into developing countries [that have] fewer resources." The WHF statement puts the projected monthly cost of the pill at somewhere less than $10. At the press conference, Fuster said it could be as low as one or two dollars. As previously recounted by heartwire, the polypill idea was conceived by Drs Nicholas J Wald and Malcolm R Law (Wolfson Institute of Preventive Medicine, London, UK) in a controversial 2003 article in BMJ [2]. Their thesis was that a polypill containing six separate medications could reduce the prevalence of cardiovascular events by 80% if it were taken by everyone older than 55. The hypothetical pill would contain standard doses of aspirin and a statin; half doses of a thiazide, beta blocker, and ACE inhibitor; and folic acid. News outlets, primarily in the UK and British Commonwealth nations, were reporting on and around May 4 that the first samples of a polypill based on the formula of Wald and Law, minus the aspirin, had been manufactured and are now ready to be tested clinically. The London Sunday Times [3] quotes Wald: "Our mission is to make this available to everyone over 55 at an affordable price. The founders of our group would like this pill to be available to everyone for about £1 a day." The pill, according to the story, could be commercially available in the UK within two years; it will be manufactured by Cipla, "one of India’s largest pharmaceutical companies," headquartered in Mumbai. In January, 2007, heartwire reported that the Hyderabad, India drug company Dr Reddy's Laboratories had just completed enrollment of 250 patients with a history of cardiovascular events for a secondary-prevention trial of a polypill containing aspirin, lisinopril, simvastatin, and atenolol. The company was also said to be planning a larger international primary-prevention trial, of patients with cardiovascular risk factors, of a similar polypill that substitutes a thiazide diuretic for the beta blocker.
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