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Long-Term Efficacy and Safety of Rosuvastatin 40 mg in Patients With Severe Hypercholesterolemia

dc.contributor.authorStein E.A.
dc.contributor.authorAmerena J.
dc.contributor.authorBallantyne C.M.
dc.contributor.authorBrice E.
dc.contributor.authorFarnier M.
dc.contributor.authorGuthrie R.M.
dc.contributor.authorHarats D.
dc.contributor.authorMa P.T.S.
dc.contributor.authorLe Maulf F.
dc.contributor.authorMelezinkova H.
dc.contributor.authorGold A.
dc.contributor.authorSager P.
dc.date.accessioned2011-05-15T16:15:18Z
dc.date.available2011-05-15T16:15:18Z
dc.date.issued2007
dc.identifier.citationAmerican Journal of Cardiology
dc.identifier.citation100
dc.identifier.citation9
dc.identifier.issn00029149
dc.identifier.other10.1016/j.amjcard.2007.06.029
dc.identifier.urihttp://hdl.handle.net/10019.1/13278
dc.description.abstractPatients with elevated low-density lipoprotein (LDL) cholesteral levels are at high risk of cardiovascular events but are often undertreated and fail to achieve lipid goals. This open-label, noncomparative, multicenter study assessed efficacy and safety of rosuvastatin 40 mg for ≤96 weeks in 1,380 patients with severe hypercholesterolemia, including heterozygous familial hypercholesterolemia. Patients ≥18 years old with fasting LDL cholesterol ≥190 and ≤260 mg/dl and triglycerides <400 mg/dl entered a 6-week dietary lead-in, before receiving rosuvastatin 40 mg for 48 weeks. An optional additional 48-week treatment period followed. The initial period had 2 primary end points: percentage of patients achieving National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III LDL cholesterol goals at 12 weeks, and long-term safety, assessed during 48 weeks by incidence and severity of adverse events (AEs) and abnormal laboratory values. Safety was the primary end point in the extension period. At 12 weeks, 83% of patients achieved NCEP ATP III LDL cholesterol goals, which were maintained during 48 and 96 weeks (81% and 84%, respectively). At 48 weeks, rosuvastatin 40 mg reduced LDL cholesterol from baseline by 52% and increased high-density lipoprotein (HDL) cholesterol by 11% (both p <0.0001). At 96 weeks, LDL cholesterol was reduced by 54% and HDL cholesterol increased by 13%. Rosuvastatin 40 mg was well tolerated during 96 weeks. The overall pattern and incidence of AEs and abnormal laboratory values were consistent with the published safety profile of rosuvastatin and higher doses of other statins. In conclusion, long-term treatment with rosuvastatin 40 mg is safe and effective in patients with severe hypercholesterolemia. © 2007 Elsevier Inc. All rights reserved.
dc.subjectantilipemic agent
dc.subjecthigh density lipoprotein cholesterol
dc.subjectlow density lipoprotein cholesterol
dc.subjectrosuvastatin
dc.subjecttriacylglycerol
dc.subjectadult
dc.subjectaged
dc.subjectangina pectoris
dc.subjectarthralgia
dc.subjectarticle
dc.subjectbackache
dc.subjectbronchitis
dc.subjectcardiovascular risk
dc.subjectclinical trial
dc.subjectcontrolled study
dc.subjectcoronary artery disease
dc.subjectdisease severity
dc.subjectdrug dose titration
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectfemale
dc.subjectglomerulus filtration rate
dc.subjectheadache
dc.subjecthematuria
dc.subjecthuman
dc.subjecthypercholesterolemia
dc.subjecthypertension
dc.subjectinfluenza
dc.subjectkidney disease
dc.subjectlimb pain
dc.subjectlong term care
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectmyalgia
dc.subjectnausea
dc.subjectpriority journal
dc.subjectproteinuria
dc.subjectrhabdomyolysis
dc.subjectrhinopharyngitis
dc.subjectside effect
dc.subjectsinusitis
dc.subjecttreatment outcome
dc.subjecttreatment response
dc.subjectunstable angina pectoris
dc.subjectupper respiratory tract infection
dc.subjecturinary tract infection
dc.subjectvomiting
dc.subjectAdult
dc.subjectAlanine Transaminase
dc.subjectCholesterol, HDL
dc.subjectCholesterol, LDL
dc.subjectCreatinine
dc.subjectFemale
dc.subjectFluorobenzenes
dc.subjectGlomerular Filtration Rate
dc.subjectHumans
dc.subjectHydroxymethylglutaryl-CoA Reductase Inhibitors
dc.subjectHypercholesterolemia
dc.subjectHyperlipoproteinemia Type II
dc.subjectLiver Function Tests
dc.subjectMale
dc.subjectPyrimidines
dc.subjectSulfonamides
dc.subjectTreatment Outcome
dc.titleLong-Term Efficacy and Safety of Rosuvastatin 40 mg in Patients With Severe Hypercholesterolemia
dc.typeArticle
dc.description.versionArticle


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