(2) whether his Department plans to make available to people over the age of 55 years a polypill combining statins with other medicines to reduce the risk of circulatory diseases. [R]
The Department has not commissioned and evaluated the effects of the use of polypills. However, there are at least three phase I or II studies under way:
At Imperial, Neil Poulter and Simone Thorn are already involved in a primary prevention trial of a Polypill (simvastatin 20 mg, hydrochlorothiazide 12.5 mg, lisinopril 10 mg, aspirin 75mg) cost ~ 1 dollar/month. The collaboration is being led by Anthony Rodgers in Auckland and includes centres in Brazil, United States of America, the Netherlands, India, Australia, United Kingdom (our centre here at St. Mary’s-Imperial) and New Zealand. The pill has been made by Dr. Reddy’s which is a big generic pharmaceutical company in India. The project is supported by the Wellcome Trust, the New Zealand medical research council and by other local organisations in the participating countries (for us—the British Heart Foundation). The pilot phase has started-the first patient was evaluated here in London last week—this is a 12-week pilot to test tolerability, safety and efficacy. Towards the end of next year they hope to proceed to the main morbidity and mortality trial that will include five-7,000 patients over three-five years. The project is quite well summarised in a recent Guardian article:
www.guardian.co.uk/society/2008/sep/29/health.medicalresearch
Dr. Rodgers has been working with Dr. Reddy since about 2000 and the technical problems of Galenic formulation for a four component cardiovascular Polypill (the Red Heart Pill) have been solved. This Polypill has been approved by several regulatory authorities (including the UK and the Medicines and Healthcare products Regulatory Agency)—hence the primary prevention trial described above.
The University of Birmingham and Tehran University of Medical Sciences have completed a randomised controlled trial of a four component polypill in approximately 500 men aged 50 to 79 and women aged 55 to 79. This is a pilot study, with the aim of starting a fully powered clinical trial if this is successful. The Polypill consists of aspirin, a statin, an angiotensin converting enzyme inhibitor, and a thiazide diuretic. The aim is essentially to look at compliance and determine the effects of treatment on blood pressure and lipid concentrations. Recruitment began in 2006 in Golestan (northeast Iran), and follow-up was completed earlier this year. They proposed to submit for publication soon. This is led by Tom Marshall, senior lecturer in public health University of Birmingham, on behalf of Fatemeh Malekzadeh Akram Pourshams, Mina Gharravi, Afshin Aslani, Alireza Nateghi, Mansoor Rastegarpanah, Masoud Khoshnia, G. Neil Thomas, Bagher Larijani, Reza Malekzadeh, K. K. Cheng.
Trial in Madrid, Spain—Secondary Prevention study—a three-component polypill, which comprises aspirin, a statin and an angiotensin converting enzyme (ACE) inhibitor (which helps lower blood pressure), for secondary prevention in patients who have already suffered an acute myocardial infarction. The project is a private-public venture with Ferrer-Internacional, which is a Spanish pharmaceutical company based in Barcelona with experience in the development and launching of international projects. The new formulation will be available in 2010.
The Department has met the original Polypill authors on a number of occasions. The initial conclusions were that this type of approach would be more suitable in developing countries rather than in more sophisticated healthcare systems such as ours where tailored therapy is more the norm.
The Department is currently exploring how to reassess this issue in the light of fresh interest in the topic.