Regular paperEfficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia☆
Section snippets
Study population:
Prospective patients with primary hypercholesterolemia were provided information about the trial, had questions answered, and signed an informed consent. The patient population consisted of adults ≥18 years of age, currently taking a stable daily dose of a statin for ≥6 weeks. Patients must have been previously instructed on a cholesterol-lowering diet. Each patient’s mean LDL cholesterol level, calculated from 2 separate determinations during screening (visits 1 and 2), had to be at or above
Demographic and baseline characteristics and patient disposition:
Between December 2000 and April 2001, 769 patients taking statin monotherapy were randomized to treatment with either the addition of ezetimibe 10 mg/day (n = 379) or matching placebo (n = 390) at 80 study centers (51 United States centers, 29 international). Patient demographics and baseline characteristics are listed in Table 1. Treatment groups were generally balanced with respect to age, gender, race, diet, weight, and body mass index. Approximately 68% of patients had coronary heart
Discussion
The objective of the present study was to evaluate the efficacy and safety of ezetimibe when added to ongoing statin therapy in a population of patients at high cardiovascular risk who had not achieved their recommended LDL cholesterol goal. The results indicate that a clinically meaningful reduction in LDL cholesterol occurs when ezetimibe is added to ongoing statin therapy. Moreover, this reduction is associated with achievement of the treatment goal in a substantial number of patients not
Acknowledgements
We wish to thank Arlene Reiss, BS, and Ken Youngren, PhD, for assisting in the preparation of this manuscript.
References (26)
- et al.
In vivo metabolism-based discovery of a potent cholesterol absorption inhibitor, SCH58235, in the rat and rhesus monkey through the identification of the active metabolites of SCH48461
J Pharmacol Exp Ther
(1997) - et al.
Comparison of the activity and disposition of the novel cholesterol absorption inhibitor, SCH58235, and its glucuronide, SCH60663
Br J Pharmacol
(2000) - et al.
Ezetimibe selectively inhibits intestinal cholesterol absorption in rodents in the presence and absence of exocrine pancreatic function
Br J Pharmacol
(2001) - et al.
Effect of ezetimibe on serum concentrations of lipid-soluble vitamins
Atherosclerosis
(2001) - et al.
The effect of gender on the pharmacokinetics of SCH 58235, a cholesterol absorption inhibitor (abstr)
- et al.
Effect of SCH 58235 on the activity of drug metabolizing enzymes in vivo
Clin Pharmacol Ther
(2000) - et al.
Pharmacodynamic interaction between fenofibrate and the cholesterol absorption inhibitor ezetimibe
Atherosclerosis
(2001) - et al.
Ezetimibe does not affect the pharmacokinetics or pharmacodynamics of warfarin
Clin Pharmacol Ther
(2001) - et al.
Pharmacodynamic interaction between fluvastatin and ezetimibe has favorable clinical implications
Atherosclerosis
(2001) - et al.
Ezetimibe does not affect the pharmacokinetics and pharmacodynamics of glipizide
Clin Pharmacol Ther
(2001)
Ezetimibe does not affect the pharmacokinetics of oral contraceptives
Clin Pharmacol Ther
zetimibe does not alter the pharmacokinetics and pharmacodynamics of digoxin (abstr)
Cited by (0)
- ☆
This trial was funded by MSP Singapore Company, LLC, a joint venture between Schering Corporation and Merck & Co., North Wales, Pennsylvania.
- *
A complete list of participants appears in the Appendix.