Linked Life Data

12034651

Source:http://linkedlifedata.com/resource/pubmed/id/12034651

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
21
pubmed:dateCreated
2002-5-29
pubmed:abstractText
BACKGROUND: Patients with homozygous familial hypercholesterolemia (HoFH) have a high incidence of cardiovascular morbidity and mortality from premature atherosclerosis, and the efficacy of pharmacological therapy has been limited. We evaluated the efficacy, safety, and tolerability of ezetimibe, a novel cholesterol absorption inhibitor, in a multicenter, double-blind, randomized trial of HoFH patients receiving atorvastatin or simvastatin. Methods and Results- Fifty patients with a diagnosis of HoFH on the National Cholesterol Education Program Step 1 or stricter diet and taking open-label atorvastatin 40 mg/d or simvastatin 40 mg/d (statin-40) with (n=25) or without (n=25) concomitant LDL apheresis were randomized to 1 of 3 double-blind treatments: atorvastatin or simvastatin 80 mg/d (statin-80, n=17); ezetimibe 10 mg/d plus atorvastatin or simvastatin 40 mg/d (n=16); or ezetimibe 10 mg/d plus atorvastatin or simvastatin 80 mg/d (n=17) for 12 weeks. The primary end point was mean percentage change in LDL cholesterol (LDL-C) from statin-40 baseline to the end point for patients receiving statins alone (statin-80) versus patients receiving ezetimibe plus atorvastatin or simvastatin at either dose (ezetimibe plus statin-40/80). Ezetimibe plus statin-40/80 significantly reduced LDL-C levels compared with statin-80 (-20.7% versus -6.7%, P=0.007). In the high-dose statin cohorts, ezetimibe plus statin-80 reduced LDL-C by an additional 20.5% (P=0.0001) versus statin-80. Similar significant reductions in LDL-C concentrations were observed for patients with genotype-confirmed HoFH (n=35). Ezetimibe was safe and well tolerated. CONCLUSIONS: Ezetimibe coadministered with atorvastatin or simvastatin in patients with HoFH produced clinically important LDL-C reductions compared with best current therapy. Ezetimibe provides a new, complementary pharmacological approach for this high-risk population.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
1524-4539
pubmed:author
pubmed:issnType
Electronic
pubmed:day
28
pubmed:volume
105
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
2469-75
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:12034651-Adolescent, pubmed-meshheading:12034651-Adult, pubmed-meshheading:12034651-Anticholesteremic Agents, pubmed-meshheading:12034651-Arteriosclerosis, pubmed-meshheading:12034651-Azetidines, pubmed-meshheading:12034651-Blood Component Removal, pubmed-meshheading:12034651-Child, pubmed-meshheading:12034651-Cholesterol, LDL, pubmed-meshheading:12034651-Creatine Kinase, pubmed-meshheading:12034651-Diet Therapy, pubmed-meshheading:12034651-Dose-Response Relationship, Drug, pubmed-meshheading:12034651-Double-Blind Method, pubmed-meshheading:12034651-Drug Synergism, pubmed-meshheading:12034651-Drug Therapy, Combination, pubmed-meshheading:12034651-Female, pubmed-meshheading:12034651-Heptanoic Acids, pubmed-meshheading:12034651-Homozygote, pubmed-meshheading:12034651-Humans, pubmed-meshheading:12034651-Hyperlipoproteinemia Type II, pubmed-meshheading:12034651-Liver Function Tests, pubmed-meshheading:12034651-Male, pubmed-meshheading:12034651-Pyrroles, pubmed-meshheading:12034651-Simvastatin, pubmed-meshheading:12034651-Treatment Outcome
pubmed:year
2002
pubmed:articleTitle
Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia.
pubmed:affiliation
Chul du Chuq, Ste-Foy, Québec, Canada.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study