Have you seen this new addition on DNAP's web page(s)? Statins
Hypercholesterolemic and dyslipidemic patients are at increased risk for atherosclerotic vascular (heart) disease. Currently, these patients are prescribed medications, nicknamed "statins", to ameliorate this risk. Statins function to decrease cholesterol levels by inhibiting a key enzyme (HMG-Co enzyme A reductase) in the cholesterol pathway. According to the National Heart, Lung, and Blood Institute's National Cholesterol Education Program, high cholesterol is one of the key risk factors for heart disease. Heart disease is the number one cause of death for both men and women in the United States, and more than 90 million American adults, or about 50 percent of the population, have elevated blood cholesterol levels. A study published in the New England Journal of Medicine in September 1998 says heart disease deaths have declined steadily over the last 30 years, decreasing by 10.3 percent between 1990 and 1994 alone. This improvement is largely attributable to better prevention of heart disease through the wide-spread use of statins.
Notwithstanding the efficacy of this class of drugs, individual patients respond differently to statins based on a variety of inter-individual genetic and environmental differences. About 2%-5% of patients are discontinued from statin treatment due to adverse experiences including hepatocellular toxicity (indicated by elevated serum levels of certain liver enzymes), and more rarely, Rhabdomyolysis with acute renal failure. In fact, it is recommended that physicians monitor this toxicity by performing liver function tests prior to, and at 12 weeks following, both the initiation of therapy and any elevation of dose, and periodically thereafter.
As a recent Time magazine article points out, statins may potentially serve as a useful preveltative tool to reduce the risk of heart disease in the general, healthy population. A key impediment for the expansion of the statin market in this way is the danger posed by adverse events associated with use of these drugs. For example, the long term affects of hepatocellular injury is not clearly understood.
Diagnomics products could potentially help reduce the risk associated with the use of statins in the general population. The Statin project we are conducting is expected to result in several "diagnomics" test solutions for routine patient pre-screening prior to statin prescription. Based on the prevalence of dyslipidemia and hypercholesteremia in the population, such a product could enjoy a market in excess of several billion dollars in the near future.
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