Comparison of the efficacy and tolerability of simvastatin and atorvastatin in the treatment of hypercholesterolemia

Clinical Cardiology - Tập 23 Số 9 - Trang 682-688 - 2000
Cesar S. Recto1, Stefan Acosta2, Adrian S. Dobs3
1Philippine Heart Center, Quezon City, Philippines
2Service of Endocrinology, Hospital de San Jose, Santafe de Bogota, Colombia
3Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

Tóm tắt

AbstractBackground: Simvastatin and atorvastatin are effective statins for treating hypercholesterolemia.Hypothesis: The study was undertaken to compare the efficacy and tolerability of simvastatin 20 and 40 mg/day and atorvastatin 10 and 20 mg/day.Methods: In this multinational, open‐label, crossover study, 258 patients with primary hypercholesterolemia were randomized after 4 weeks of diet plus placebo to once‐daily administration of a starting dose sequence of simvastatin (20 mg) or atorvastatin (10 mg), or a higher dose sequence of simvastatin (40 mg) or atorvastatin (20 mg) for 6 weeks. Patients were then switched after a 1‐week washout to the corresponding starting or higher dose of the alternate drug for a second 6‐week period. The primary endpoint was the mean percent change from baseline to Week 6 in low‐density lipoprotein (LDL) cholesterol; percent changes from baseline in total cholesterol, high‐density lipoprotein cholesterol, triglycerides, and apolipoprotein B were also compared. Safety was assessed through adverse experiences and laboratory measurements.Results: Both statins produced statistically significant improvements in all measured plasma lipids and lipoproteins. The main treatment comparison showed no statistically significant difference in changes in LDL cholesterol and triglycerides, whereby the overall effects were comparable when doses of 20 mg and 40 mg of simvastatin were compared with atorvastatin 10 mg and 20 mg. The mean percent reductions for LDL cholesterol from baseline to Week 6 ranged from 35–42% for the entire study cohort. An LDL cholesterol level ≤ 130 mg/dl (3.4 mmol/l) was achieved in approximately 70% of patients treated with both drugs in this study. Simvastatin and atorvastatin were well tolerated at the doses studied.Conclusion: In patients with hypercholesterolemia, the most commonly used doses of simvastatin and atorvastatin produced similar changes in LDL cholesterol and achieved an LDL cholesterol level ≤ 130 mg/dl (3.4 mmol/l) in a similar number of patients. Both statins were well tolerated.

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Tài liệu tham khảo

10.1056/NEJM199502233320807

Anderson KM, 1987, Cholesterol and mortality 30 years of follow‐up from the Framingham study, J Am Med Assoc, 257, 2176, 10.1001/jama.1987.03390160062027

10.1136/bmj.303.6797.276

National Cholesterol Education Program Expert Panel, 1993, Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II), J Am Med Assoc, 269, 3015, 10.1001/jama.1993.03500230097036

Mingworth DR, 1988, Long‐term experience with HMG CoA reductase inhibitors in the therapy of hypercholesterolemia, Atheroscler Rev, 18, 161

ZOCOR™ (simvastatin) tablets, 1998, Product information

Scandinavian Simvastatin Survival Study Group, 1994, Randomised trial of cholesterol lowering in 4,444 patients with coronary heart disease: Scandinavian Simvastatin Survival Study (4S), Lancet, 344, 1383

Pedersen TR, 1998, Extended follow‐up of patients in the Scandinavian Simvastatin Survival Study (4S) shows increased survival benefit of simvastatin therapy (abstr), Circulation, 98, I

10.1016/S0140-6736(94)92082-6

10.1161/01.ATV.15.5.678

10.1016/S0021-9150(96)06052-2

Friedewald WT, 1977, Estimation of the concentration of low‐density lipoprotein cholesterol in plasma, without use of preparative ultracentrif uge, Clin Chem, 18, 499, 10.1093/clinchem/18.6.499

BestJ DartA Hamilton CraigI JerumsG NicholsonG SullivanD TallisG WestM d'EmdenM BraesP:A One Year Study Comparing Atorvastatin and Simvastatin in Patients with Hypercholesterolemia. 66th Congress of the European Atherosclerosis Society July1996

1993, Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II), J Am Med Assoc, 23, 3015

10.1056/NEJM198006193022503

10.1016/0002-8703(86)90296-6

10.1161/01.ATV.11.1.2

10.1016/S0002-9149(98)00041-1

10.1093/eurheartj/15.suppl_3.255

10.1016/0021-9150(91)90202-E

10.1016/0002-9149(93)90601-8