Efficacy and tolerability of fixed-dose combination of simvastatin plus ezetimibe in patients with primary hypercholesterolemia

Results of a multicentric trial from India

Pinakini K. Shankar, Rama Bhat, Mukhyaprana Prabhu, Bandi Partha Saradhi Reddy, M. Srinivasa Reddy, Mohan Reddy

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. Methods: This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C] >120 mg/dL for patients on previous hypolipidemic drugs or >135 mg/dL for naïve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category. Results: At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7%) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28%, P < 0.05). Significantly greater percentage of patients (88%, P < 0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71%). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. Conclusion: Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.

Original languageEnglish
Pages (from-to)264-270
Number of pages7
JournalJournal of Clinical Lipidology
Volume1
Issue number4
DOIs
Publication statusPublished - 01-08-2007

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Simvastatin
Hypercholesterolemia
India
LDL Cholesterol
Cholesterol
Safety
HDL Cholesterol
Therapeutics
Simvastatin Drug Combination Ezetimibe
Triglycerides
Hypolipidemic Agents
Education
Double-Blind Method
Ezetimibe

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics
  • Cardiology and Cardiovascular Medicine

Cite this

@article{f15a7cfd455744eb921773a4d4c1965b,
title = "Efficacy and tolerability of fixed-dose combination of simvastatin plus ezetimibe in patients with primary hypercholesterolemia: Results of a multicentric trial from India",
abstract = "Objective: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. Methods: This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C] >120 mg/dL for patients on previous hypolipidemic drugs or >135 mg/dL for na{\"i}ve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category. Results: At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7{\%}) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28{\%}, P < 0.05). Significantly greater percentage of patients (88{\%}, P < 0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71{\%}). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. Conclusion: Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.",
author = "Shankar, {Pinakini K.} and Rama Bhat and Mukhyaprana Prabhu and Reddy, {Bandi Partha Saradhi} and Reddy, {M. Srinivasa} and Mohan Reddy",
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Efficacy and tolerability of fixed-dose combination of simvastatin plus ezetimibe in patients with primary hypercholesterolemia : Results of a multicentric trial from India. / Shankar, Pinakini K.; Bhat, Rama; Prabhu, Mukhyaprana; Reddy, Bandi Partha Saradhi; Reddy, M. Srinivasa; Reddy, Mohan.

In: Journal of Clinical Lipidology, Vol. 1, No. 4, 01.08.2007, p. 264-270.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and tolerability of fixed-dose combination of simvastatin plus ezetimibe in patients with primary hypercholesterolemia

T2 - Results of a multicentric trial from India

AU - Shankar, Pinakini K.

AU - Bhat, Rama

AU - Prabhu, Mukhyaprana

AU - Reddy, Bandi Partha Saradhi

AU - Reddy, M. Srinivasa

AU - Reddy, Mohan

PY - 2007/8/1

Y1 - 2007/8/1

N2 - Objective: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. Methods: This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C] >120 mg/dL for patients on previous hypolipidemic drugs or >135 mg/dL for naïve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category. Results: At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7%) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28%, P < 0.05). Significantly greater percentage of patients (88%, P < 0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71%). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. Conclusion: Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.

AB - Objective: To compare the efficacy and safety of fixed-dose combination (FDC) of simvastatin and ezetimibe vs simvastatin monotherapy in Indian patients with primary hypercholesterolemia. Methods: This multicentric, double-blind, comparative, study conducted in India enrolled 230 patients with hypercholesterolemia (baseline low-density lipoprotein cholesterol [LDL-C] >120 mg/dL for patients on previous hypolipidemic drugs or >135 mg/dL for naïve subjects) were randomly assigned to receive either simvastatin (10 mg/day) or simvastatin (10 mg) plus ezetimibe (10 mg) FDC for 12 weeks. The primary efficacy endpoint was the mean percentage change in LDL-C from baseline to 12 weeks of therapy for simvastatin monotherapy vs simvastatin plus ezetimibe FDC. Secondary efficacy endpoints were mean percentage of changes in total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C) from baseline to end of treatment, as well as proportion of patients achieving National Cholesterol Education Program Adult Treatment Panel III target LDL-C levels in each risk category. Results: At the end of 12 weeks, the mean percentage reduction from baseline in LDL-C (-33.7%) was significantly greater with simvastatin and ezetimibe FDC compared to simvastatin alone (-26.28%, P < 0.05). Significantly greater percentage of patients (88%, P < 0.001) attained National Cholesterol Education Program Adult Treatment Panel III LDL-C target levels following ezetimibe/simvastatin treatment compared to simvastatin monotherapy (71%). Reductions in TG were significantly greater with ezetimibe/simvastatin than simvastatin (P < 0.001). Increases in HDL-C, and reduction in TC were similar between treatment groups. Safety and tolerability profiles were comparable for both treatments. Conclusion: Fixed-dose combination of simvastatin and ezetimibe provides a more effective means for reducing LDL cholesterol levels in Indian patients with hypercholesterolemia than simvastatin monotherapy without compromising the safety and tolerability profile.

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