Expanded clinical evaluation of lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8,245 patients with moderate hypercholesterolemia

Article Abstract:

The Expanded Clinical Evaluation of Lovastatin (EXCEL) Study was designed to test the efficacy of lovastatin, a drug that lowers low-density-lipoprotein (LDL) cholesterol in the blood of patients with moderate hypercholesterolemia (high blood cholesterol). The study also examined dosage levels and duration of treatment for evidence of adverse effects. Researchers from 362 clinical sites took part, recording data from 8,245 patients with moderately elevated cholesterol. Four dosage levels of lovastatin and a placebo were tested for 48 weeks. Lovastatin effected changes in all lipid and lipoprotein levels, with LDL cholesterol lowered by 24 to 40 percent, according to dosage of the drug. High-density-lipoprotein (HDL) cholesterol increased by 6.6 to 9.5 percent; increased levels of HDL cholesterol appear to reduce the risk of heart disease. Triglycerides decreased by 10 to 19 percent, and the ratio of LDL-cholesterol to HDL-cholesterol also decreased. All dosage levels of lovastatin were well tolerated, causing few side effects. The most common side effect was constipation. Because these patients had only moderately elevated cholesterol levels, many were able to lower their cholesterol levels adequately through diet and use of lovastatin alone. Four out of five patients without coronary heart disease (or two or more coronary heart disease risk factors) were able to meet the guidelines of the National Cholesterol Education Program (NCEP) by taking only 20 mg of lovastatin daily, the lowest dosage level studied, and the most frequently prescribed dosage. It should be noted that at the beginning of the study, some of these lower-risk patients did not exceed the LDL cholesterol level defined by NCEP as requiring drug therapy. Higher dosages of lovastatin, and perhaps a second drug as well, may be needed for higher-risk patients to achieve recommended levels of LDL cholesterol. Patients with kidney disease, and those taking gemfibrozil or niacin (to lower cholesterol) or cyclosporine (an immunosuppressant) were excluded, therefore no adverse effects caused by kidney failure or drug interactions could be determined. It is concluded that for patients with moderately elevated cholesterol, lovastatin is highly effective and produces few side effects. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Dosage and administration, Hypercholesterolemia

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Effectiveness of low-dose lovastatin in lowering serum cholesterol

Article Abstract:

The effectiveness of the drug lovastatin for lowering blood levels of cholesterol was assessed in patients with type IIa or IIb hyperlipoproteinemia, or increased blood levels of lipoproteins. Lovastatin inhibits an enzyme called 3-hydroxy-3-methylglutaryl coenzyme A reductase, and has been shown to reduce cholesterol levels when given at doses between 10 and 80 milligrams (mg) per day. However, there are no studies examining the effectiveness of a low dose of lovastatin, 20 mg per day, given for longer than six weeks. In this study, the 56 patients had disease of the coronary arteries, the major blood vessels supplying the heart, and were treated with low-dose lovastatin. Their lipid levels were measured at the start of the study, and 6, 12, 18, and 24 weeks after the start of treatment with 20 mg lovastatin. Treatment with lovastatin decreased total cholesterol level by 26 percent and triglyceride levels by 12 percent, whereas high-density lipoprotein (HDL) levels increased by 7.6 percent. Increases in the HDL level are thought to lower the risk of heart disease. Two patients were withdrawn from the study because of abnormal liver function and muscle weakness. The greatest decrease in total cholesterol level was measured six weeks after the start of lovastatin treatment. These findings show that lovastatin decreases total cholesterol levels in patients with type IIa and type IIb hyperlipoproteinemia without causing severe side effects. However, the long-term safety and effectiveness of lovastatin therapy should be investigated. (Consumer Summary produced by Reliance Medical Information, Inc.)

Measurement, Blood cholesterol, Anticholesteremic agents, Hyperlipoproteinemia

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