RICHARD J. HAVEL, M.D.; DONALD B. HUNNINGHAKE, M.D.; D. ROGER ILLINGWORTH, M.D., Ph.D.; ROBERT S. LEES, M.D.; EVAN A. STEIN, M.D., Ph.D.; JONATHAN A. TOBERT, M.B., Ph.D.; SANDRA R. BACON, R.N.; JAMES A. BOLOGNESE, M. Stat; PHILIP H. FROST, M.D.; GLENN E. LAMKIN, M.Ed.; ANN M. LEES, M.D.; ARTHUR S. LEON, M.D.; KAY GARDNER; G. JOHNSON, M.D.; M. J. MELLIES, M.D.; PATRICIA A. RHYMER, M.S.; P. TUN, M.D.
HAVEL RJ, HUNNINGHAKE DB, ILLINGWORTH DR, LEES RS, STEIN EA, TOBERT JA, et al. Lovastatin (Mevinolin) in the Treatment of Heterozygous Familial Hypercholesterolemia: A Multicenter Study. Ann Intern Med. 1987;107:609-615. doi: 10.7326/0003-4819-107-5-609
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Published: Ann Intern Med. 1987;107(5):609-615.
Study Objective: To evaluate the efficacy and tolerability of lovastatin under controlled conditions in heterozygous familial hypercholesterolemia.
Design: Randomized, double-blind, placebo-controlled, multicenter trial.
Setting: Five lipid clinics with a central laboratory and coordinating center.
Patients: 101 adult patients with heterozygous familial hypercholesterolemia.
Interventions: Patients were on a lipid-lowering diet throughout the study. After a 4-week placebo baseline period, patients were randomized to five equal treatment groups. Each group received a different sequence of placebo or lovastatin 5 to 40 mg twice daily or 20 to 40 mg once daily in the evening, during three consecutive 6-week periods.
Measurements and Main Results: The mean reductions in total plasma cholesterol and low-density lipoprotein cholesterol across the dosage ranges were 14% to 34% and 17% to 39%, respectively (p compared with zero and placebo < 0.01). High-density lipoprotein cholesterol and apolipoproteins Al and All rose slightly. Apolipoprotein B fell substantially at the higher dosage levels (-23% at 40 mg twice daily, p < 0.01), indicating a reduction in the concentration of circulating low-density lipoprotein particles. Maximum response was achieved in 4 to 6 weeks. Twice-daily dosing was slightly more efficient than once-daily dosing. Of those patients receiving 40 mg twice a day, 89% had a fall in low-density lipoprotein cholesterol of at least 20%, and 61% had a fall of at least 40%. Adverse effects attributable to lovastatin were minimal, and no patient was withdrawn from the study.
Conclusion: Lovastatin was well tolerated and effective in the treatment of familial hypercholesterolemia.
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Cardiology, Dyslipidemia, Coronary Risk Factors.
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