A fixed-dose combination treatment developed by Pfizer, Caduet, can reduce the risk that patients with high-blood pressure and elevated blood cholesterol go on to suffer a fatal cardiovascular event in half, according to data from the JEWEL clinical programme.
Caduet, which combines Pfizer’s top-selling cholesterol-lowering drug atorvastatin with its calcium antagonist amlodipine, was found to reduce the risk of a fatal cardiovascular event, such as a heart attack or stroke, by 29% to 52% across the countries participating in the studies.
The new data is good news for Pfizer, which was forced to withdraw its application to market Caduet in 12 European countries last November, because some regulatory authorities were not convinced that its efficacy had been demonstrated.
European guidelines recommend routine use of statin therapy in patients with high blood pressure who have other risk factors for cardiovascular disease, and Pfizer said that Caduet can achieve this as a monotherapy. Around 50% of patients with high blood pressure also have elevated cholesterol, according to Professor Richard Hobbs of the University of Birmingham in the UK, who chaired the steering committee for one of the JEWEL studies.
In the two studies which made up the JEWEL programme, 51% and 63% of patients met their treatment targets for both cholesterol and blood pressure. This is a significant result, according to Pfizer, because historical data suggest that just 9% of patients with both risk factors meet targets using current treatment strategies.
Caduet was held up as an important new product for Pfizer on its launch in June 2004, as it gears up to defend its lucrative $2.5 billion US franchise for amlodipine – sold as Norvasc - that is due to lose patent protection in the US market in 2007.
But critics have suggested that Caduet is a marketing rather than medical innovation, and sales uptake has been slow. Last year, Caduet's worldwide sales reached just $186 million, a tiny fraction of Norvasc's $3.68 billion turnover and the $12.2 billion achieved by Lipitor, although there signs of acceleration in the fourth quarter.
The JEWEL results were presented during an oral plenary session at the annual meeting of the European Society of Hypertension (ESH) in Madrid, Spain, yesterday.