Original ArticleEfficacy and Safety of Ezetimibe Coadministered With Simvastatin in Patients With Primary Hypercholesterolemia: A Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Selection Criteria
Each patient gave written informed consent to participate in this study. Eligible patients were men and women aged 18 years or older with primary hypercholesterolemia (LDL-C, 145-250 mg/dL; TG, ≤350 mg/dL), liver transaminase levels (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) no more than 2 times the upper limit of normal with no active liver disease, and creatine kinase (CK) level no more than 1.5 times the upper limit of normal.
Exclusionary concomitant conditions and
Demographics, Baseline Characteristics, and Patient Accounting
The treatment groups were well balanced with respect to demographics and baseline characteristics (Table 1). The ITT population consisted of 887 patients: 473 women and 414 men, aged 22 to 81 years, with mean baseline LDL-C plasma concentrations ranging from 174 to 176 mg/dL across treatment groups. Of the 887 randomized patients, 813 patients completed the study (Figure 1). Seventy-four patients discontinued treatment because of consent withdrawn (n=31), adverse events (n=28), lost to
DISCUSSION
Because blood cholesterol levels are maintained through both endogenous synthesis and intestinal absorption, our hypothesis was that a treatment strategy that affects these 2 sources would be more effective than a strategy that affects only 1. The results of our study confirm those of an earlier study14 and support the hypothesis that coadministration of ezetimibe/simvastatin, working through dual inhibition of cholesterol synthesis and absorption, is more efficacious than simvastatin
CONCLUSION
This study showed that coadministration of ezetimibe/simvastatin, a treatment strategy that targets both synthesis and intestinal absorption of cholesterol, had greater lipidlowering efficacy than simvastatin monotherapy, as well as a similar overall safety profile. Thus, coadministration of ezetimibe/simvastatin is a highly efficacious and well-tolerated treatment for improving lipid profiles in patients with hypercholesterolemia.
Ezetimibe Study Group.—Harold Bays, MD, L-MARC Research Center,
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Lipoprotein(a) and Atherosclerotic Cardiovascular Disease, the Impact of Available Lipid-Lowering Medications on Lipoprotein(a): An Update on New Therapies
2023, Endocrine PracticeCitation Excerpt :Ezetimibe is a LDL-lowering agent which binds and inhibits the intestinal cholesterol transporter, Niemann-Pick C1 Like 1 (NPC1L1).(21) The largest meta-analysis evaluating the effect of ezetimibe on Lp(a) concentrations included seven RCTs published between 2002 and 2004 with a total of 2337 patients.(21–28) Participants had a history of primary hypercholesterolemia and were randomized to ezetimibe monotherapy (n = 1597) or placebo (n=740).(21–28)
The effect of Ezetimibe and Simvastatin Combination Therapy on percutaneous coronary intervention patients
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This study was sponsored by Merck/Schering-Plough Pharmaceuticals, North Wales, Pa. Drs Sapre and Mitchel and Ms Liu and Ms Capece are employees of Merck & Co, Inc, and own stock in Merck & Co, Inc.