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Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease.
Int J Cardiol 2005; 102(2):327-32IJ

Abstract

OBJECTIVE

To determine whether co-administering ezetimibe with on-going simvastatin treatment was more effective than placebo plus on-going simvastatin in achieving an LDL-C treatment target of < or = 2.60 mmol/l (100 mg/dl) in hypercholesterolemic patients with coronary heart disease (CHD).

METHODS

Men and women (age > or = 18 years) with documented CHD and on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks were recruited for this study. After a 4-week simvastatin 10 or 20 mg plus placebo and diet run-in period, patients were eligible for randomization if LDL-C > 2.60 and < or = 4.20 mmol/l and triglycerides (TG) < or = 4.00 mmol/l. Eligible patients were randomized to a double-blind comparative study with ezetimibe 10 mg co-administered with on-going simvastatin 10 mg or 20 mg (n=181) versus placebo to match ezetimibe co-administered with simvastatin 10 mg or 20 mg (n=191) for 6 weeks.

RESULTS

At baseline, mean LDL-C was comparable between the ezetimibe (3.14 mmol/l) and placebo (3.19 mmol/l) groups. With the addition of ezetimibe or placebo to on-going simvastatin therapy, the percentage of patients achieving the LDL-C goal of < or = 2.60 mmol/l after 6 weeks of treatment was significantly (p < or = 0.001) greater in the ezetimibe group (74.3%) than in the placebo group (16.7%). The addition of ezetimibe to on-going simvastatin treatment also resulted in a significantly (p < or = 0.001) larger mean percent reduction in LDL-C from baseline (25.2%) compared with placebo (0.9%). Ezetimibe was generally well tolerated compared to placebo when added to on-going simvastatin treatment.

CONCLUSIONS

Co-administering ezetimibe with on-going simvastatin 10 or 20 mg treatment allowed more hypercholesterolemic patients with CHD to reach the LDL-C treatment target of < or = 2.60 mmol/l.

Authors+Show Affiliations

Point Medical, Rond Point de la Nation, 21000 Dijon, France. mfarnier@ipac.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15982505

Citation

Farnier, Michel, et al. "Effect of Co-administering Ezetimibe With On-going Simvastatin Treatment On LDL-C Goal Attainment in Hypercholesterolemic Patients With Coronary Heart Disease." International Journal of Cardiology, vol. 102, no. 2, 2005, pp. 327-32.
Farnier M, Volpe M, Massaad R, et al. Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. Int J Cardiol. 2005;102(2):327-32.
Farnier, M., Volpe, M., Massaad, R., Davies, M. J., & Allen, C. (2005). Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. International Journal of Cardiology, 102(2), pp. 327-32.
Farnier M, et al. Effect of Co-administering Ezetimibe With On-going Simvastatin Treatment On LDL-C Goal Attainment in Hypercholesterolemic Patients With Coronary Heart Disease. Int J Cardiol. 2005 Jul 10;102(2):327-32. PubMed PMID: 15982505.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. AU - Farnier,Michel, AU - Volpe,Massimo, AU - Massaad,Rachid, AU - Davies,Michael J, AU - Allen,Christopher, PY - 2004/11/23/received PY - 2005/01/06/revised PY - 2005/01/07/accepted PY - 2005/6/29/pubmed PY - 2005/10/26/medline PY - 2005/6/29/entrez SP - 327 EP - 32 JF - International journal of cardiology JO - Int. J. Cardiol. VL - 102 IS - 2 N2 - OBJECTIVE: To determine whether co-administering ezetimibe with on-going simvastatin treatment was more effective than placebo plus on-going simvastatin in achieving an LDL-C treatment target of < or = 2.60 mmol/l (100 mg/dl) in hypercholesterolemic patients with coronary heart disease (CHD). METHODS: Men and women (age > or = 18 years) with documented CHD and on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks were recruited for this study. After a 4-week simvastatin 10 or 20 mg plus placebo and diet run-in period, patients were eligible for randomization if LDL-C > 2.60 and < or = 4.20 mmol/l and triglycerides (TG) < or = 4.00 mmol/l. Eligible patients were randomized to a double-blind comparative study with ezetimibe 10 mg co-administered with on-going simvastatin 10 mg or 20 mg (n=181) versus placebo to match ezetimibe co-administered with simvastatin 10 mg or 20 mg (n=191) for 6 weeks. RESULTS: At baseline, mean LDL-C was comparable between the ezetimibe (3.14 mmol/l) and placebo (3.19 mmol/l) groups. With the addition of ezetimibe or placebo to on-going simvastatin therapy, the percentage of patients achieving the LDL-C goal of < or = 2.60 mmol/l after 6 weeks of treatment was significantly (p < or = 0.001) greater in the ezetimibe group (74.3%) than in the placebo group (16.7%). The addition of ezetimibe to on-going simvastatin treatment also resulted in a significantly (p < or = 0.001) larger mean percent reduction in LDL-C from baseline (25.2%) compared with placebo (0.9%). Ezetimibe was generally well tolerated compared to placebo when added to on-going simvastatin treatment. CONCLUSIONS: Co-administering ezetimibe with on-going simvastatin 10 or 20 mg treatment allowed more hypercholesterolemic patients with CHD to reach the LDL-C treatment target of < or = 2.60 mmol/l. SN - 0167-5273 UR - https://www.unboundmedicine.com/medline/citation/15982505/Effect_of_co_administering_ezetimibe_with_on_going_simvastatin_treatment_on_LDL_C_goal_attainment_in_hypercholesterolemic_patients_with_coronary_heart_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167-5273(05)00369-4 DB - PRIME DP - Unbound Medicine ER -