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Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia.
Int J Clin Pract 2006; 60(8):914-21IJ

Abstract

It is increasingly accepted that more intensive lipid-lowering treatment is associated with greater cardiovascular risk reductions in patients with coronary heart disease (CHD), thus providing a rationale for more aggressive LDL-cholesterol (LDL-C) targets. Ezetimibe in combination with statin therapy provides an additional approach to lipid management by utilising the additive action of two different mechanisms of LDL-C reduction. In this multicentre, randomised, double-blind, placebo-controlled study, a total of 98 men and 55 women with CHD and primary hypercholesterolaemia, naïve to statin therapy, were randomised to receive treatment for 6 weeks with either ezetimibe 10 mg-simvastatin 20 mg (n = 77) or placebo-simvastatin 20 mg (n = 75). At 6 weeks, ezetimibe 10 mg-simvastatin 20 mg provided a mean additional LDL-C reduction of 14.6% (95% CI 10.1-19.1) compared with simvastatin monotherapy (p < 0.0001). Moreover, a higher proportion of patients on ezetimibe/simvastatin achieved the National Standard Framework LDL-C standard (<3.0 mmol/l; 93% vs. 75%, p < 0.001) or the new Joint British Societies (JBS 2) goal of LDL-C < 2.0 mmol/l (49.3% vs. 11.1%, p < 0.001). On logistic regression analysis, the odds ratio of achieving target LDL-C with ezetimibe 10 mg-simvastatin 20 mg was 5.1 (95% CI 1.8-15.0) times higher than with simvastatin monotherapy (p = 0.003). Clinical chemistry profiles and proportions of adverse events were similar in both groups at baseline and follow-up. In conclusion, ezetimibe 10 mg-simvastatin 20 mg is a practical, effective and safe option for the treatment of primary hypercholesterolaemia in CHD patients, and brings more patients to new aggressive cholesterol targets compared with simvastatin 20 mg monotherapy.

Authors+Show Affiliations

Sandwell Medical Research Unit, Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK. jeetesh.patel@swbh.nhs.ukNo 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

16893434

Citation

Patel, J V., and E A. Hughes. "Efficacy, Safety and LDL-C Goal Attainment of Ezetimibe 10 Mg-simvastatin 20 Mg Vs. Placebo-simvastatin 20 Mg in UK-based Adults With Coronary Heart Disease and Hypercholesterolaemia." International Journal of Clinical Practice, vol. 60, no. 8, 2006, pp. 914-21.
Patel JV, Hughes EA. Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. Int J Clin Pract. 2006;60(8):914-21.
Patel, J. V., & Hughes, E. A. (2006). Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. International Journal of Clinical Practice, 60(8), pp. 914-21.
Patel JV, Hughes EA. Efficacy, Safety and LDL-C Goal Attainment of Ezetimibe 10 Mg-simvastatin 20 Mg Vs. Placebo-simvastatin 20 Mg in UK-based Adults With Coronary Heart Disease and Hypercholesterolaemia. Int J Clin Pract. 2006;60(8):914-21. PubMed PMID: 16893434.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. AU - Patel,J V, AU - Hughes,E A, PY - 2006/8/9/pubmed PY - 2007/4/7/medline PY - 2006/8/9/entrez SP - 914 EP - 21 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 60 IS - 8 N2 - It is increasingly accepted that more intensive lipid-lowering treatment is associated with greater cardiovascular risk reductions in patients with coronary heart disease (CHD), thus providing a rationale for more aggressive LDL-cholesterol (LDL-C) targets. Ezetimibe in combination with statin therapy provides an additional approach to lipid management by utilising the additive action of two different mechanisms of LDL-C reduction. In this multicentre, randomised, double-blind, placebo-controlled study, a total of 98 men and 55 women with CHD and primary hypercholesterolaemia, naïve to statin therapy, were randomised to receive treatment for 6 weeks with either ezetimibe 10 mg-simvastatin 20 mg (n = 77) or placebo-simvastatin 20 mg (n = 75). At 6 weeks, ezetimibe 10 mg-simvastatin 20 mg provided a mean additional LDL-C reduction of 14.6% (95% CI 10.1-19.1) compared with simvastatin monotherapy (p < 0.0001). Moreover, a higher proportion of patients on ezetimibe/simvastatin achieved the National Standard Framework LDL-C standard (<3.0 mmol/l; 93% vs. 75%, p < 0.001) or the new Joint British Societies (JBS 2) goal of LDL-C < 2.0 mmol/l (49.3% vs. 11.1%, p < 0.001). On logistic regression analysis, the odds ratio of achieving target LDL-C with ezetimibe 10 mg-simvastatin 20 mg was 5.1 (95% CI 1.8-15.0) times higher than with simvastatin monotherapy (p = 0.003). Clinical chemistry profiles and proportions of adverse events were similar in both groups at baseline and follow-up. In conclusion, ezetimibe 10 mg-simvastatin 20 mg is a practical, effective and safe option for the treatment of primary hypercholesterolaemia in CHD patients, and brings more patients to new aggressive cholesterol targets compared with simvastatin 20 mg monotherapy. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/16893434/Efficacy_safety_and_LDL_C_goal_attainment_of_ezetimibe_10_mg_simvastatin_20_mg_vs__placebo_simvastatin_20_mg_in_UK_based_adults_with_coronary_heart_disease_and_hypercholesterolaemia_ L2 - https://doi.org/10.1111/j.1742-1241.2006.01023.x DB - PRIME DP - Unbound Medicine ER -