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CHOLESTEROL-LOWERING DRUGS HAVE PENETRATED ONE-THIRD TO ONE- HALF OF INDICATED POPULATION -- NHANES III; CHD PATIENTS SHOULD BE TARGETED, ATP II REPORT SUGGESTS

Executive Summary

Cholesterol-lowering drugs are currently being used by between one-third and one-half of patients for whom they are recommended under the newly released ATP II cholesterol treatment report, National Center for Health Statistics Director Manning Feinleib, MD, told a press conference June 15 in Washington, D.C. Feinleib based his estimate on an analysis of the first phase of NCHS' third National Health and Nutrition Examination Survey (NHANES III). The press conference was called to unveil the National Heart Lung & Blood Institute's Adult Treatment Panel II report on "Detection, Evaluation and Treatment of High Blood Cholesterol in Adults." About 12.7 mil. adult Americans are candidates for drug therapy under ATP II, Feinleib estimated. "Although precise estimates are hard to pin down, about...4 to 6 mil. U.S. adults are currently taking cholesterol-lowering drugs." Results of NHANES III indicate that 29% of American adults, or 52 mil. people based on the 1990 population, have elevated low- density lipoprotein levels that meet the ATP II guidelines for initiating dietary treatment, Feinleib said. Assuming that dietary changes will produce "an average 10% decline in LDL cholesterol levels," he said, "about 7% of all adults, or approximately 12.7 mil. Americans, might be candidates for cholesterol-lowering drugs." NHLBI National Cholesterol Education Program Coordinator James Cleeman, MD, noted that the 12.7 mil. potential patient population is "an outside estimate," since "some patients will have other diseases" which contraindicate drug use. The NHANES III data was collected between 1988-1991 based on standardized medical examinations of about 8,000 people representative of the total U.S. adult population. The trial is ongoing, with data collection expected to continue into 1994. The survey shows that drug therapy may be helping to reduce average cholesterol levels in the U.S., Feinleib said. "Since 1960, cholesterol levels declined in every age-sex group" by 6%- 8%, Feinleib said. Between 1978-1990, average cholesterol levels in the U.S. dropped 4% from 213 mg/dL to 205 mg/dL. "The decline in LDL levels may be due to a number of factors," Feinleib said, "such as: changes in the consumption of saturated fat and dietary cholesterol; the use of lipid-lowering drugs; hormone use; changes in obesity; and changes in physical activity." He added that "we hope to have more answers on this when dietary intake and other data from NHANES III become available." The public release of the ATP II guidelines comes one year after ATP II Chairman Scott Grundy, MD/PhD, outlined a draft version of the document before the NCEP Coordinating Committee ("The Pink Sheet" June 22, 1992, p. 12). A summary of the report as well as data from the NHANES III study were published in the June 16 issue of the Journal of the American Medical Association. In comparison to the ATP I report published in 1988, ATP II appears to encourage more aggressive drug therapy in patients with established coronary heart disease or other risk factors while adopting a more conservative approach to younger patients who have elevated LDLs but are otherwise at low risk for CHD. The NHANES III survey concluded that there are about 11 mil. Americans with elevated cholesterol who already have CHD. Of these, about 4 mil. would be candidates for drug therapy, Feinleib said. "Nowhere near that number are getting treatment now," Cleeman said. "With coronary disease patients, there really is under use" of drugs. NCEP "will encourage physicians and other health professionals to use these guidelines to target coronary patients and others at high risk of CHD for aggressive treatment," Cleeman added. The ATP II report recommends reducing LDLs in patients with CHD disease to below 100 mg/dL (or reducing total cholesterol below 160 mg/dL). ATP I had recommended a level of 130 mg/dL for LDLs or 200 mg/dL for total cholesterol. "This change will affect several million Americans," Grundy said. On the other hand, among younger patients with no established CHD, "drug therapy should be delayed and diet modification used instead," Grundy said. "This delay in drug therapy especially holds for men younger than age 35 and for premenopausal women," he added. "An exception is" patients whose "LDL is over 220 mg/dL, which corresponds in most people to a total cholesterol of over 300 mg/dL." As Grundy reported in 1992, the ATP report's concern with aggressive treatment in younger patients relates to the absence of long-term evidence of a mortality benefit in treating patients with no existing CHD. "The reduction in CHD risk may not outweigh the risk of adverse effects of long-term drug therapy or the inconvenience and costs," the report states. In choosing drug therapy, the report advises physicians to take into account triglyceride levels. For patients with elevated LDL and triglycerides less than 200 mg/dL, the report recommends bile-acid sequestrants, HMG-CoA reductase inhibitors and nicotinic acid. For patients with elevated LDL and triglycerides between 200 and 400 mg/dL, the report recommends nicotinic acid, HMG-CoA reductase inhibitors and gemfibrozil (Warner-Lambert's Lopid and generics). "Combination therapy in many cases will increase effectiveness of cholesterol lowering, reduce cost, increase compliance and reduce side effects," the report states. Nicotinic acid was deemed a "drug of choice" for prevention of CHD by a February 1992 National Institutes of Health "Consensus Development Conference on Triglyceride, High Density Lipoprotein and Coronary Heart Disease" ("The Pink Sheet" March 2, 1992, p. 10). "All patients taking nicotinic acid to alter serum lipids should be closely monitored by trained health professionals, because of the potential toxicity accompanying the high doses required for efficacy," the ATP II report states. "Self-medication with nicotinic acid should be discouraged." "The principal drawback of nicotinic acid is its frequent bothersome side effects," the report says. "This document recommends that crystalline nicotinic acid be used first, and that consideration be given to sustained-release preparations only under special circumstances." For younger patients, the report favors treatment with bile- acid sequestrants, such as cholestyramine (Bristol-Myers Squibb's Questran) and colestipol (Upjohn's Colestid), over HMG-CoA inhibitors, such as lovastatin (Merck's Mevacor), simvastatin (Merck's Zocor) and pravastatin (BMS' Pravachol). With the HMG-CoA inhibitors, the report states, "long-term safety data are limited and exposure over many years starting in young adulthood may carry adverse effects that are not yet recognized. Therefore, bile-acid sequestrants are preferred to statins for primary prevention in men younger than 45 years and in women below age 55." The "disadvantages of the sequestrants are inconvenience of administration and frequent gastrointestinal symptoms," the report states. "All three available statins appear to have similar efficacy when administered at the recommended doses and times," the report says. "However, extensive direct comparisons are not available." Estrogen therapy is suggested as a possible alternative for postmenopausal women with elevated LDLs. However, the report adds, "in spite of seemingly favorable effects of estrogen use on CHD risk observed in the epidemiologic and nonrandomized prospective studies...it has not been proven unequivocally that estrogen replacement reduces CHD risk in postmenopausal women." Finally, the report states, "although the current role of probucol [Marion Merrell Dow's Lorelco] in treatment of high serum cholesterol is difficult to define, there is considerable interest in the possibility that probucol reduces CHD risk through mechanisms other than cholesterol lowering."
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