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A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial.
Curr Med Res Opin. 2001; 17(1):43-50.CM

Abstract

OBJECTIVE

At higher doses, simvastatin has been shown to produce significantly greater increases in high-density lipoprotein (HDL) cholesterol and apolipoprotein (apo) A-I than atorvastatin. To extend and confirm these findings, a 36-week, randomized, double-blind, dose-titration study was performed in 826 hypercholesterolemic patients to compare the effects of simvastatin and atorvastatin on HDL cholesterol, apo A-I, and clinical and laboratory safety. PRIMARY HYPOTHESIS: Simvastatin, across a range of doses, will be more effective than atorvastatin at raising HDL cholesterol and apo A-I levels.

METHODS

A total of 826 hypercholesterolemic patients were enrolled in this double-blind, randomized, parallel, 36-week, dose-escalation study. Patients randomized to simvastatin received 40 mg/day for the first 6 weeks, 80 mg/day for the next 6 weeks, and remained on 80 mg/day for the final 24 weeks. Patients randomized to atorvastatin received 20 mg/day for the first 6 weeks, 40 mg/day for the next 6 weeks, and 80 mg/day for the remaining 24 weeks.

RESULTS

During the first 12 weeks of the study, simvastatin increased HDL cholesterol and apo A-I more than the comparative doses of atorvastatin, while producing slightly lower reductions in low-density lipoprotein (LDL) cholesterol and triglycerides. At the maximal dose comparison, simvastatin 80 mg and atorvastatin 80 mg, the HDL cholesterol and apo A-I differences favoring simvastatin were larger than at the lower doses. In addition, at the maximal dose comparison, the incidence of drug-related clinical adverse experiences was approximately two-fold higher with atorvastatin 80 mg than with simvastatin 80 mg (23 versus 12%, p < 0.001), due predominantly to a greater incidence of gastrointestinal symptoms with atorvastatin (10 versus 3%, p < 0.001). The incidence of clinically significant alanine aminotransferase elevations was also higher with atorvastatin 80 mg than with simvastatin 80 mg (3.8 versus 0.5%, p < 0.010), especially in women (6.0 versus 0.6%).

CONCLUSIONS

At the doses compared in this study, simvastatin led to greater increases in HDL cholesterol and apo A-I levels than atorvastatin. At the maximum dose comparison, there were fewer drug-related gastrointestinal symptoms and clinically significant aminotransferase elevations with simvastatin.

Authors+Show Affiliations

Division of Endocrinology, Diabetes, & Clinical Nutrition (L465), Oregon Health Sciences University, 3181 S.W. Sam Jackson Park Road, Portland, Oregon 97201, USA. illingwo@ohsu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11464446

Citation

Illingworth, D R., et al. "A Comparison of Simvastatin and Atorvastatin Up to Maximal Recommended Doses in a Large Multicenter Randomized Clinical Trial." Current Medical Research and Opinion, vol. 17, no. 1, 2001, pp. 43-50.
Illingworth DR, Crouse JR, Hunninghake DB, et al. A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. Curr Med Res Opin. 2001;17(1):43-50.
Illingworth, D. R., Crouse, J. R., Hunninghake, D. B., Davidson, M. H., Escobar, I. D., Stalenhoef, A. F., Paragh, G., Ma, P. T., Liu, M., Melino, M. R., O'Grady, L., Mercuri, M., & Mitchel, Y. B. (2001). A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. Current Medical Research and Opinion, 17(1), 43-50.
Illingworth DR, et al. A Comparison of Simvastatin and Atorvastatin Up to Maximal Recommended Doses in a Large Multicenter Randomized Clinical Trial. Curr Med Res Opin. 2001;17(1):43-50. PubMed PMID: 11464446.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial. AU - Illingworth,D R, AU - Crouse,J R,3rd AU - Hunninghake,D B, AU - Davidson,M H, AU - Escobar,I D, AU - Stalenhoef,A F, AU - Paragh,G, AU - Ma,P T, AU - Liu,M, AU - Melino,M R, AU - O'Grady,L, AU - Mercuri,M, AU - Mitchel,Y B, AU - ,, PY - 2001/7/24/pubmed PY - 2002/1/5/medline PY - 2001/7/24/entrez SP - 43 EP - 50 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 17 IS - 1 N2 - OBJECTIVE: At higher doses, simvastatin has been shown to produce significantly greater increases in high-density lipoprotein (HDL) cholesterol and apolipoprotein (apo) A-I than atorvastatin. To extend and confirm these findings, a 36-week, randomized, double-blind, dose-titration study was performed in 826 hypercholesterolemic patients to compare the effects of simvastatin and atorvastatin on HDL cholesterol, apo A-I, and clinical and laboratory safety. PRIMARY HYPOTHESIS: Simvastatin, across a range of doses, will be more effective than atorvastatin at raising HDL cholesterol and apo A-I levels. METHODS: A total of 826 hypercholesterolemic patients were enrolled in this double-blind, randomized, parallel, 36-week, dose-escalation study. Patients randomized to simvastatin received 40 mg/day for the first 6 weeks, 80 mg/day for the next 6 weeks, and remained on 80 mg/day for the final 24 weeks. Patients randomized to atorvastatin received 20 mg/day for the first 6 weeks, 40 mg/day for the next 6 weeks, and 80 mg/day for the remaining 24 weeks. RESULTS: During the first 12 weeks of the study, simvastatin increased HDL cholesterol and apo A-I more than the comparative doses of atorvastatin, while producing slightly lower reductions in low-density lipoprotein (LDL) cholesterol and triglycerides. At the maximal dose comparison, simvastatin 80 mg and atorvastatin 80 mg, the HDL cholesterol and apo A-I differences favoring simvastatin were larger than at the lower doses. In addition, at the maximal dose comparison, the incidence of drug-related clinical adverse experiences was approximately two-fold higher with atorvastatin 80 mg than with simvastatin 80 mg (23 versus 12%, p < 0.001), due predominantly to a greater incidence of gastrointestinal symptoms with atorvastatin (10 versus 3%, p < 0.001). The incidence of clinically significant alanine aminotransferase elevations was also higher with atorvastatin 80 mg than with simvastatin 80 mg (3.8 versus 0.5%, p < 0.010), especially in women (6.0 versus 0.6%). CONCLUSIONS: At the doses compared in this study, simvastatin led to greater increases in HDL cholesterol and apo A-I levels than atorvastatin. At the maximum dose comparison, there were fewer drug-related gastrointestinal symptoms and clinically significant aminotransferase elevations with simvastatin. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/11464446/A_comparison_of_simvastatin_and_atorvastatin_up_to_maximal_recommended_doses_in_a_large_multicenter_randomized_clinical_trial_ L2 - https://medlineplus.gov/cholesterolmedicines.html DB - PRIME DP - Unbound Medicine ER -