Prescribed use of cholesterol-lowering drugs in the United States, 1978 through 1988

Article Abstract:

Evidence from many sources suggests that when blood cholesterol levels are lowered the risk of coronary heart disease also decreases. Coronary heart disease (CHD) affects the coronary arteries, which supply blood to the heart muscle. Health professionals now emphasize the importance of reducing fats in the diet as a means of reducing blood cholesterol. However, when cholesterol levels (especially low-density lipoprotein cholesterol levels) remain elevated, cholesterol-lowering drugs are prescribed. To understand more about the use of these drugs, trends in the outpatient use of eight commonly prescribed cholesterol-lowering agents were studied for the 10-year period of 1978 to 1988. Data on the number of prescriptions was obtained by analyzing two pharmaceutical marketing databases, which record the amounts and types of drugs prescribed and dispensed by physicians and pharmacies, respectively. Results showed that 4.4 million prescriptions for cholesterol-lowering drugs were filled in 1978, 2.6 million in 1983, and 13 million in 1988. This fivefold increase between 1983 and 1988 is largely due to the introduction of two drugs, gemfibrozil and lovastatin. Some medications, formerly used against diarrhea and other conditions, also came into use as cholesterol-lowering agents. Fifty-four percent of the patients using cholesterol-lowering drugs were 60 years or older, and more than one-third were between 40 and 59. Internists were responsible for approximately 40 percent of the prescriptions and cardiologists for about 13 percent. Cholesterol-lowering drugs were prescribed primarily in doctors' offices or over the telephone. It appears that public awareness of the dangers of high blood cholesterol are reflected in prescribing practices. However, clinical trails of these medications, for the most part, did not study patients over 60 years of age, who now consume 54 percent of cholesterol-lowering drugs. It is not certain whether findings from these drug studies can be extrapolated to an older population or whether using these drugs will decrease the risk of CHD and related illnesses in persons over 60 years of age. People with high cholesterol levels constitute a large market for this mode of drug therapy. Monitoring the development of CHD during subsequent years will permit researchers to assess the long-term effects of cholesterol-lowering drugs. (Consumer Summary produced by Reliance Medical Information, Inc.)

Research, Evaluation

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Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy

Article Abstract:

Two drugs used to lower the levels of lipids (fats) in the blood are lovastatin and gemfibrozil, but evidence suggests that combining these two agents may produce serious side effects. Because the Food and Drug Administration (FDA) has received several reports of rhabdomyolysis (destruction of skeletal muscle) in patients who were taking these drugs, a broader investigation of the issue was initiated. Data regarding adverse reactions from combined doses of lovastatin and gemfibrozil from spontaneous reports to the FDA's Division of Epidemiology and Surveillance; foreign reports; and other sources, and were evaluated to determine the prevalence and characteristics of these reactions. Results showed that for the period from mid-1987 to mid-1988 there were 63 reports of adverse muscle reactions in people who took lovastatin without other lipid-reducing drugs. Average levels of creatine kinase (CK) (a product of muscle breakdown that is significantly elevated in rhabdomyolysis) were 465 units per liter for these patients, with 17 patients having CK levels above 1,000 units per liter. Three had severe rhabdomyolysis (CK of more than 10,000 units per liter), and one of the three had renal failure. Five reports of adverse muscle reactions to gemfibrozil alone were received (average CK 740 units per liter), with one case of severe myopathy (muscle disease) and rhabdomyolysis. CK levels for the 12 patients with adverse muscle reactions who were taking both drugs were considerably higher, with a median CK level of 15,250. Three case studies are presented in detail. Evaluation of a situation such as this is difficult, since it is hard to know the extent adverse drug reactions are underreported to the FDA. Possible physiological mechanisms that could cause muscle degeneration are discussed. In summary, combined therapy with lovastatin and gemfibrozil is not recommended from either a therapeutic or a safety standpoint. These drugs are, individually, intended for use by specified patient groups only; their combined use cannot be justified. (Consumer Summary produced by Reliance Medical Information, Inc.)

Causes of, Complications and side effects, Hyperlipidemia, Gemfibrozil, Lovastatin, Rhabdomyolysis

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Cholesterol and coronary heart disease in older adults: no easy answers

Article Abstract:

Doctors should discuss the uncertain benefits of cholesterol-lowering therapy with elderly patients before measuring blood cholesterol. Research published in 1995 revealed that total cholesterol levels are a poor indicator of coronary heart disease (CHD) risk in the elderly. The duration of high blood cholesterol increases the risk of CHD. Because cholesterol levels decrease in the elderly, a single cholesterol screening underestimates the duration of high cholesterol levels and CHD risk. Clinical trials are needed to assess the benefits of cholesterol-lowering therapy on people older than age 65. Doctors should limit cholesterol testing to elderly patients who are likely to benefit from treatment. Life expectancy, the presence of other CHD risk factors, the quality of life, and patient preferences determine appropriate candidates for intervention.

Health aspects, Care and treatment, Editorial, Aged patients, Elderly patients

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