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A multi-centre, randomised, double-blind 14-week extension study examining the long-term safety and efficacy profile of the ezetimibe/simvastatin combination tablet.
Int J Clin Pract. 2007 Sep; 61(9):1469-80.IJ

Abstract

The objective of this study was to compare the efficacy and safety profile of ezetimibe/simvastatin (EZE/SIMVA) tablet and SIMVA monotherapy. This was an extension study of a randomised, double-blind, placebo-controlled study in patients with primary hypercholesterolaemia. Protocol-compliant patients who completed the 12-week base study were eligible to enter a randomised, double-blind, 14-week extension study and were administered 1 of 8 daily treatments: EZE/SIMVA 10/10-, 10/20-, 10/40- or 10/80-mg, or SIMVA 10-, 20-, 40- or 80-mg. Patients receiving these treatments during the base study remained on the same treatment in the extension. Patients administered placebo or EZE 10-mg monotherapy during the base study were re-randomised to EZE/SIMVA 10/10 mg or SIMVA 80 mg. The primary analysis was mean per cent change in low-density lipoprotein cholesterol (LDL-C) from baseline to extension study end-point. Mean changes from baseline in LDL-C of -38.8% and -53.7% were observed for pooled SIMVA and pooled EZE/SIMVA respectively. The between treatment difference of -14.9% (95% confidence interval: -16.4, -13.3) was statistically significant (p < 0.001). The incremental LDL-C lowering effect of EZE/SIMVA compared with the corresponding dose of SIMVA alone was consistent across the dose range (p < 0.001 for each between-group comparison). More patients receiving EZE/SIMVA than SIMVA achieved LDL-C concentrations < 100 mg/dl and < 70 mg/dl (p < 0.001 for both goals). EZE/SIMVA was generally well tolerated with a safety profile similar to SIMVA monotherapy. There were no significant between-group differences in the incidences of clinically significant elevations in liver transaminase or creatine kinase levels. In conclusion, EZE/SIMVA had a comparable safety and tolerability profile and was more efficacious than SIMVA monotherapy for up to 6 months.

Authors+Show Affiliations

Lipid Clinic, Rikshospitalet, Oslo, Norway. liv.ose@rikshospitalet.noNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17655686

Citation

Ose, L, et al. "A Multi-centre, Randomised, Double-blind 14-week Extension Study Examining the Long-term Safety and Efficacy Profile of the Ezetimibe/simvastatin Combination Tablet." International Journal of Clinical Practice, vol. 61, no. 9, 2007, pp. 1469-80.
Ose L, Johnson-Levonas A, Reyes R, et al. A multi-centre, randomised, double-blind 14-week extension study examining the long-term safety and efficacy profile of the ezetimibe/simvastatin combination tablet. Int J Clin Pract. 2007;61(9):1469-80.
Ose, L., Johnson-Levonas, A., Reyes, R., Lin, J., Shah, A., Tribble, D., & Musliner, T. (2007). A multi-centre, randomised, double-blind 14-week extension study examining the long-term safety and efficacy profile of the ezetimibe/simvastatin combination tablet. International Journal of Clinical Practice, 61(9), 1469-80.
Ose L, et al. A Multi-centre, Randomised, Double-blind 14-week Extension Study Examining the Long-term Safety and Efficacy Profile of the Ezetimibe/simvastatin Combination Tablet. Int J Clin Pract. 2007;61(9):1469-80. PubMed PMID: 17655686.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multi-centre, randomised, double-blind 14-week extension study examining the long-term safety and efficacy profile of the ezetimibe/simvastatin combination tablet. AU - Ose,L, AU - Johnson-Levonas,A, AU - Reyes,R, AU - Lin,J, AU - Shah,A, AU - Tribble,D, AU - Musliner,T, AU - ,, Y1 - 2007/07/26/ PY - 2007/7/28/pubmed PY - 2007/11/1/medline PY - 2007/7/28/entrez SP - 1469 EP - 80 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 61 IS - 9 N2 - The objective of this study was to compare the efficacy and safety profile of ezetimibe/simvastatin (EZE/SIMVA) tablet and SIMVA monotherapy. This was an extension study of a randomised, double-blind, placebo-controlled study in patients with primary hypercholesterolaemia. Protocol-compliant patients who completed the 12-week base study were eligible to enter a randomised, double-blind, 14-week extension study and were administered 1 of 8 daily treatments: EZE/SIMVA 10/10-, 10/20-, 10/40- or 10/80-mg, or SIMVA 10-, 20-, 40- or 80-mg. Patients receiving these treatments during the base study remained on the same treatment in the extension. Patients administered placebo or EZE 10-mg monotherapy during the base study were re-randomised to EZE/SIMVA 10/10 mg or SIMVA 80 mg. The primary analysis was mean per cent change in low-density lipoprotein cholesterol (LDL-C) from baseline to extension study end-point. Mean changes from baseline in LDL-C of -38.8% and -53.7% were observed for pooled SIMVA and pooled EZE/SIMVA respectively. The between treatment difference of -14.9% (95% confidence interval: -16.4, -13.3) was statistically significant (p < 0.001). The incremental LDL-C lowering effect of EZE/SIMVA compared with the corresponding dose of SIMVA alone was consistent across the dose range (p < 0.001 for each between-group comparison). More patients receiving EZE/SIMVA than SIMVA achieved LDL-C concentrations < 100 mg/dl and < 70 mg/dl (p < 0.001 for both goals). EZE/SIMVA was generally well tolerated with a safety profile similar to SIMVA monotherapy. There were no significant between-group differences in the incidences of clinically significant elevations in liver transaminase or creatine kinase levels. In conclusion, EZE/SIMVA had a comparable safety and tolerability profile and was more efficacious than SIMVA monotherapy for up to 6 months. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/17655686/A_multi_centre_randomised_double_blind_14_week_extension_study_examining_the_long_term_safety_and_efficacy_profile_of_the_ezetimibe/simvastatin_combination_tablet_ L2 - https://doi.org/10.1111/j.1742-1241.2007.01402.x DB - PRIME DP - Unbound Medicine ER -