Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4B
pubmed:dateCreated
1998-9-28
pubmed:abstractText
Cerivastatin is a new, third-generation 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor ("statin"), which is administered to hypercholesterolemic patients at doses equivalent to 1-3% of the doses of other statins. This report reviews the pivotal Phase IIb/III clinical trials in which the efficacy and safety of cerivastatin was compared with placebo and active comparator statins (lovastatin, simvastatin, and pravastatin) after both short- and long-term administration. Overall, the studies showed that at doses of 0.025-0.4 mg/day, cerivastatin produced dose-dependent reductions in low-density lipoprotein (LDL) cholesterol and total cholesterol, which were significantly greater than placebo. The greatest reductions were achieved with 0.4 mg/day cerivastatin. On this dose, >40% of patients achieved reductions in LDL cholesterol >40% and in a further 9% of patients, LDL cholesterol was decreased by >50%. At higher doses, cerivastatin also demonstrated potent triglyceride-lowering effects in a subgroup of patients with raised plasma triglycerides. Reductions in atherogenic lipids and lipoproteins were accompanied by significant increases in high-density lipoprotein (HDL) cholesterol, apolipoprotein A-I, and antiatherogenic lipoprotein A-I. Long-term administration of cerivastatin for periods of up to 2 years was associated with persistent reductions in LDL cholesterol, total cholesterol, triglycerides, and apolipoprotein B as well as increases in HDL cholesterol similar to those observed after initial administration. Long-term cerivastatin treatment was also well tolerated. There was no significant difference between the incidence of adverse effects with cerivastatin and comparator statins or between cerivastatin and other statins with respect to clinically significant increases in either hepatic enzymes or creatine phosphokinase. In conclusion, these studies indicate that cerivastatin is a safe and effective long-term treatment for patients with primary hypercholesterolemia and also suggest that higher doses should be investigated.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
0002-9149
pubmed:author
pubmed:issnType
Print
pubmed:day
27
pubmed:volume
82
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
32J-39J
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:9737644-Adolescent, pubmed-meshheading:9737644-Adult, pubmed-meshheading:9737644-Aged, pubmed-meshheading:9737644-Apolipoprotein A-I, pubmed-meshheading:9737644-Cholesterol, HDL, pubmed-meshheading:9737644-Cholesterol, LDL, pubmed-meshheading:9737644-Dose-Response Relationship, Drug, pubmed-meshheading:9737644-Double-Blind Method, pubmed-meshheading:9737644-Drug Evaluation, pubmed-meshheading:9737644-Female, pubmed-meshheading:9737644-Follow-Up Studies, pubmed-meshheading:9737644-Humans, pubmed-meshheading:9737644-Hydroxymethylglutaryl-CoA Reductase Inhibitors, pubmed-meshheading:9737644-Hypercholesterolemia, pubmed-meshheading:9737644-Lovastatin, pubmed-meshheading:9737644-Male, pubmed-meshheading:9737644-Middle Aged, pubmed-meshheading:9737644-Pravastatin, pubmed-meshheading:9737644-Pyridines, pubmed-meshheading:9737644-Safety, pubmed-meshheading:9737644-Simvastatin, pubmed-meshheading:9737644-Treatment Outcome
pubmed:year
1998
pubmed:articleTitle
Clinical efficacy and safety of cerivastatin: summary of pivotal phase IIb/III studies.
pubmed:affiliation
Clinical Research Institute of Montreal, Quebec, Canada.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase II, Clinical Trial, Phase III