Tags

Type your tag names separated by a space and hit enter

Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus.
Diabetes Obes Metab. 2007 Jul; 9(4):575-84.DO

Abstract

AIM

This randomized, double-blind study evaluated the efficacy of switching from atorvastatin (ATV) 10 mg to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, EZE/SIMVA 10/40 mg or doubling the dose of ATV from 10 to 20 mg in patients with type 2 diabetes (T2D).

METHODS

Eligible patients had haemoglobin A(1C)< or =10%, were aged > or =18 years and were on ATV 10 mg for > or =6 weeks before study entry. After a 4-week open-label ATV 10 mg run-in, patients were randomized to EZE/SIMVA 10/20 mg (n = 220), EZE/SIMVA 10/40 mg (n = 222) or ATV 20 g (n = 219) daily for 6 weeks.

RESULTS

Greater (p < or = 0.001) reductions in low-density lipoprotein cholesterol (LDL-C) (the primary end-point) were achieved by switching to EZE/SIMVA 10/20 mg (26.2%) or 10/40 mg (30.1%) than by doubling the dose of ATV to 20 mg (8.5%). EZE/SIMVA 10/20 mg and 10/40 mg produced greater (p < or = 0.001) reductions in total cholesterol, non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B relative to ATV 20 mg. A reduction (p < or = 0.050) in C-reactive protein was observed with EZE/SIMVA 10/40 mg vs. ATV 20 mg. Similar reductions in triglycerides were observed across the three groups, and none of the treatments produced a significant change in HDL-C. A greater (p < or = 0.001) proportion of patients achieved LDL-C <2.5 mmol/l with EZE/SIMVA 10/20 mg (90.5%) and 10/40 mg (87.0%) than with ATV 20 mg (70.4%). Both EZE/SIMVA doses were generally well tolerated, with an overall safety profile similar to ATV 20 mg.

CONCLUSIONS

EZE/SIMVA 10/20 and 10/40 mg provided greater lipid-altering efficacy than doubling the dose of ATV from 10 to 20 mg and were well tolerated in patients with T2D.

Authors+Show Affiliations

Centre de Recherché en Cardiologie, Hôpital Maisonneuve-Rosemont, Montréal, Québec, Canada. constancec@videotron.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17451425

Citation

Constance, C, et al. "Efficacy of Ezetimibe/simvastatin 10/20 and 10/40 Mg Compared With Atorvastatin 20 Mg in Patients With Type 2 Diabetes Mellitus." Diabetes, Obesity & Metabolism, vol. 9, no. 4, 2007, pp. 575-84.
Constance C, Westphal S, Chung N, et al. Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2007;9(4):575-84.
Constance, C., Westphal, S., Chung, N., Lund, M., McCrary Sisk, C., Johnson-Levonas, A. O., Massaad, R., & Allen, C. (2007). Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. Diabetes, Obesity & Metabolism, 9(4), 575-84.
Constance C, et al. Efficacy of Ezetimibe/simvastatin 10/20 and 10/40 Mg Compared With Atorvastatin 20 Mg in Patients With Type 2 Diabetes Mellitus. Diabetes Obes Metab. 2007;9(4):575-84. PubMed PMID: 17451425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg in patients with type 2 diabetes mellitus. AU - Constance,C, AU - Westphal,S, AU - Chung,N, AU - Lund,M, AU - McCrary Sisk,C, AU - Johnson-Levonas,A O, AU - Massaad,R, AU - Allen,C, Y1 - 2007/04/19/ PY - 2007/4/25/pubmed PY - 2007/12/7/medline PY - 2007/4/25/entrez SP - 575 EP - 84 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 9 IS - 4 N2 - AIM: This randomized, double-blind study evaluated the efficacy of switching from atorvastatin (ATV) 10 mg to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, EZE/SIMVA 10/40 mg or doubling the dose of ATV from 10 to 20 mg in patients with type 2 diabetes (T2D). METHODS: Eligible patients had haemoglobin A(1C)< or =10%, were aged > or =18 years and were on ATV 10 mg for > or =6 weeks before study entry. After a 4-week open-label ATV 10 mg run-in, patients were randomized to EZE/SIMVA 10/20 mg (n = 220), EZE/SIMVA 10/40 mg (n = 222) or ATV 20 g (n = 219) daily for 6 weeks. RESULTS: Greater (p < or = 0.001) reductions in low-density lipoprotein cholesterol (LDL-C) (the primary end-point) were achieved by switching to EZE/SIMVA 10/20 mg (26.2%) or 10/40 mg (30.1%) than by doubling the dose of ATV to 20 mg (8.5%). EZE/SIMVA 10/20 mg and 10/40 mg produced greater (p < or = 0.001) reductions in total cholesterol, non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B relative to ATV 20 mg. A reduction (p < or = 0.050) in C-reactive protein was observed with EZE/SIMVA 10/40 mg vs. ATV 20 mg. Similar reductions in triglycerides were observed across the three groups, and none of the treatments produced a significant change in HDL-C. A greater (p < or = 0.001) proportion of patients achieved LDL-C <2.5 mmol/l with EZE/SIMVA 10/20 mg (90.5%) and 10/40 mg (87.0%) than with ATV 20 mg (70.4%). Both EZE/SIMVA doses were generally well tolerated, with an overall safety profile similar to ATV 20 mg. CONCLUSIONS: EZE/SIMVA 10/20 and 10/40 mg provided greater lipid-altering efficacy than doubling the dose of ATV from 10 to 20 mg and were well tolerated in patients with T2D. SN - 1462-8902 UR - https://www.unboundmedicine.com/medline/citation/17451425/Efficacy_of_ezetimibe/simvastatin_10/20_and_10/40_mg_compared_with_atorvastatin_20_mg_in_patients_with_type_2_diabetes_mellitus_ L2 - https://doi.org/10.1111/j.1463-1326.2007.00725.x DB - PRIME DP - Unbound Medicine ER -