Drug development Therapy
Under development by Pfizer, torcetrapib is a member of the cholesteryl ester transfer protein (CETP) inhibitor class of drugs that is designed to boost blood levels of high-density lipoprotein (HDL), often described as “good cholesterol”. The company was exploring the potential to combine torcetrapib with its top selling statin Lipitor (atorvastatin) as an improved treatment for dyslipidaemia.
The combination of torcetrapib and Lipitor (atorvastatin) was in pivotal phase III trials involving about 15, 000 patients, which were expected to run for at least two years. However, Pfizer was forced to stop the trials early after an independent safety board discovered an imbalance in the incidence of cardiovascular events and death in the two treatment arms (combination therapy versus atorvastatin alone). Further clinical evaluation of torcetrapib has ceased bringing to an end the development of a drug that Pfizer had hoped to submit for regulatory approval in 2007.
Despite this significant setback, Pfizer still has other combination therapies in its development pipeline for treatment of cardiovascular disease (CVD). They include Caduet, a combination of Lipitor and the anti-hypertensive agent Norvasc, and the ACAT inhibitor avasimbe. These products, designed to expand Pfizer's CVD franchise, are part of a new approach to regulating blood plasma levels that goes beyond statin control.
DYSLIPIDAEMIA AND THE BURDEN OF CARDIOVASCULAR DISEASE
"The company was exploring the potential to combine torcetrapib with its top selling statin Lipitor (atorvastatin) as an improved treatment for dyslipidaemia."
Coronary heart disease (CHD), the physical manifestation of atherosclerosis, is a major cause of death and disability. Of the 17 million deaths that occur from CVD in the world each year, CHD is a significant contributor.
Atherosclerosis is a pathological process in which arteries supplying the heart become progressively narrowed by the build up of fatty material in the artery wall. Known as atherosclerotic plaques, they lead to narrowing or stenosis of the artery lumen so restricting blood flow to the heart. A lack of oxygen supply to the heart leads to adverse clinical consequences such as angina, heart attack (myocardial infarction) and sudden cardiac death.
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Each new drug or therapy cost billions of dollars to develop? Is this the same FDA that causes the vast majority of developed drugs to fail?
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