Coronary atherosclerosis is a leading cause of cardiovascular mortality, and high serum cholesterol is a major factor in the development of coronary atherosclerosis. Cholesterol and triglycerides circulate in the bloodstream as part of lipoprotein complexes which can be separated into HDL (high-density lipoprotein), IDL (intermediate-density lipoprotein), LDL (low-density lipoprotein), and VLDL (very-low-density lipoprotein) fractions. Increased levels of total cholesterol (total-C) and LDL-cholesterol (LDL-C) are associated with atherosclerosis and development of cardiovascular disease, while increased levels of HDL-C decrease cardiovascular risk.
Patients with a risk of coronary artery disease mortality can benefit from cholesterol reduction. Cholesterol levels can be reduced with diet, exercise and drugs, thus slowing the progression of atherosclerosis and reducing the risk of myocardial infarction. After 5 years, a 10% reduction in LDL-C results in a decrease in ischaemic heart disease of up to 50%. The HMG-CoA reductase inhibitors ("statins") are a group of drugs that slow the progression of coronary artery disease and induce regression of atherosclerotic lesions in these patients. Mortality from coronary and non-coronary causes are both reduced. HMG-CoA reductase inhibitors include lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin and cerivastatin.
Atorvastatin has been described as the most effective statin drug yet, reducing LDL cholesterol by up to 60% at its highest 80 mg dose, compared to simvastatin at 40%. Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase, the enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin is indicated in primary hypercholesterolemia and other lipid disorders. It is more potent on a milligram per milligram basis than other agents of the class. In clinical studies, atorvastatin provided significantly greater reductions of LDL-cholesterol at its starting dose of 10 mg per day than once-daily doses of simvastatin 10 mg, pravastatin 10 and 20 mg, lovastatin 20 and 40 mg and fluvastatin 20 and 40 mg. Atorvastatin is well tolerated, with a safety profile similar to simvastatin. Adverse reactions are usually mild and transient.
Statins are one of the fastest growing drug categories in the market today and are the most-prescribed class of cholesterol-lowering agents. According to IMS, statins accounted for 87.9% of the cholesterol and triglyceride market in 1999, up from the 1998 figure of 87.1%. IMS data involving 13 leading countries worldwide showed that among pharma products, the atorvastatin brand Lipitor had climbed to fourth place in January 1999 and was likely to overtake the third placed product, Prozac (fluoxetine) soon. Further growth is expected since only a third of the patients who are candidates for these drugs in the U.S. actually take them, and in a developing country like India, this figure will be even less. In the coming years, more patients will be diagnosed with high levels of cholesterol through better screening, and lipid-lowering therapy will be employed more aggressively. The total market for statins in India is Rs 49 crore and is growing at 81 per cent (ORG MAT March 2000). Presently, simvastatin is the leading molecule, but in the short time since its launch, atorvastatin sales have amounted to Rs 5.2 crore.
With an estimated 45 million patients suffering from coronary artery disease in India and the number expected to increase over the next 20 years, it is apparent that the statins such as atorvastatin will play an important role in controlling morbidity and mortality.
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This article was published in Pharma Business 16th June 2000.
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