A 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone

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dc.contributor.authorNewcomer J.W.
dc.contributor.authorRatner R.E.
dc.contributor.authorEriksson J.W.
dc.contributor.authorEmsley R.
dc.contributor.authorMeulien D.
dc.contributor.authorMiller F.
dc.contributor.authorLeonova-Edlund J.
dc.contributor.authorLeong R.W.
dc.contributor.authorBrecher M.
dc.date.accessioned2011-05-15T16:01:56Z
dc.date.available2011-05-15T16:01:56Z
dc.date.issued2009
dc.description.abstractObjective: This randomized, 24-week, flexible-dose study compared changes in glucose metabolism in patients with DSM-IV schizophrenia receiving initial exposure to olanzapine, quetiapine, or risperidone. Method: The hypothesized primary endpoint was change (baseline to week 24) in area under the curve (AUC) 0- to 2-hour plasma glucose values during an oral glucose tolerance test (OGTT); primary analysis: olanzapine versus quetiapine. Secondary endpoints included mean change in AUC 0- to 2-hour plasma insulin values, insulin sensitivity index, and fasting lipids. The first patient enrolled on April 29, 2004, and the last patient completed the study on October 24, 2005. Results: Mean weight change (kg) over 24 weeks was +3.7 (quetiapine), +4.6 (olanzapine), and +3.6 (risperidone). Based on data from 395 patients (quetiapine, N = 115 [mean dose = 607.0 mg/day], olanzapine, N = 146 [mean dose = 15.2 mg/day], and risperidone, N = 134 [mean dose = 5.2 mg/day]), mean change in AUC 0- to 2-hour glucose value (mg/dL x h) at week 24 was significantly lower for quetiapine versus olanzapine (t = 1.98, df = 377, p = .048). Increases in AUC 0- to 2-hour glucose values were statistically significant with olanzapine (+21.9 mg/dL x h, 95% CI = 11.5 to 32.4 mg/dL x h) and risperidone (+18.8 mg/dL x h, 95% CI = 8.1 to 29.4 mg/dL x h), but not quetiapine (+9.1 mg/dL x h, 95% CI = -2.3 to 20.5 mg/dL x h). AUC 0- to 2-hour insulin values increased statistically significantly with olanzapine (+24.5%, 95% CI = 11.5% to 39.0%), but not with quetiapine or risperidone. Reductions in insulin sensitivity index were statistically significant with olanzapine (-19.1%, 95% CI = -27.9% to -9.3%) and risperidone (-15.8%, 95% CI = -25.1% to -5.4%), but not quetiapine. Total cholesterol and low-density lipoprotein levels increased statistically significantly with olanzapine (+21.1 mg/dL, 95% CI = 13.0 to 29.2 mg/dL, and +20.5 mg/dL, 95% CI = 13.8 to 27.1 mg/dL, respectively) and quetiapine (+13.1 mg/dL, 95% CI = 4.3 to 21.9 mg/dL, and +13.3 mg/dL, 95% CI = 6.1 to 20.5 mg/dL, respectively), but not risperidone. Statistically significant increases in triglycerides (+30.9 mg/dL, 95% CI = 10.9 to 51.0 mg/dL), total cholesterol/high-density lipoprotein (HDL) ratio (0.5, 95% CI = 0.2 to 0.8), and triglyceride/HDL ratio (0.3, 95% CI = 0.0 to 0.6) were observed with olanzapine only. Conclusion: The results indicate a significant difference in the change in glucose tolerance during 6 months' treatment with olanzapine versus quetiapine, with significant reductions on olanzapine and risperidone, but not quetiapine; these differential changes were largely explained by changes in insulin sensitivity. Trial Registration: clinicaltrials.gov Identifier: NCT00214578. © Copyright 2009 Physicians Postgraduate Press, Inc.
dc.description.versionArticle
dc.identifier.citationJournal of Clinical Psychiatry
dc.identifier.citation70
dc.identifier.citation4
dc.identifier.issn1606689
dc.identifier.other10.4088/JCP.08m04132
dc.identifier.urihttp://hdl.handle.net/10019.1/12224
dc.subjectlipid
dc.subjectolanzapine
dc.subjectquetiapine
dc.subjectrisperidone
dc.subjectadult
dc.subjectakathisia
dc.subjectarticle
dc.subjectcholesterol blood level
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdelusion
dc.subjectdizziness
dc.subjectdrug withdrawal
dc.subjectdyspnea
dc.subjectdystonia
dc.subjectextrapyramidal syndrome
dc.subjectfemale
dc.subjectglucose blood level
dc.subjectglucose metabolism
dc.subjectglucose tolerance
dc.subjecthallucination
dc.subjectheadache
dc.subjecthuman
dc.subjecthypertension
dc.subjectinsomnia
dc.subjectinsulin blood level
dc.subjectinsulin sensitivity
dc.subjectlipid blood level
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmulticenter study
dc.subjectneutrophil count
dc.subjectopen study
dc.subjectoral glucose tolerance test
dc.subjectpanic
dc.subjectpriority journal
dc.subjectpsychosis
dc.subjectrandomized controlled trial
dc.subjectrestlessness
dc.subjectschizophrenia
dc.subjectsedation
dc.subjectside effect
dc.subjectsomnolence
dc.subjectthorax pain
dc.subjecttreatment duration
dc.subjecttriacylglycerol blood level
dc.subjectupper abdominal pain
dc.subjectweight gain
dc.subjectAdolescent
dc.subjectAdult
dc.subjectAged
dc.subjectAntipsychotic Agents
dc.subjectBenzodiazepines
dc.subjectCholesterol, HDL
dc.subjectCholesterol, LDL
dc.subjectDibenzothiazepines
dc.subjectFemale
dc.subjectGlucose
dc.subjectHumans
dc.subjectInsulin
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectRisperidone
dc.subjectSchizophrenia
dc.subjectTriglycerides
dc.subjectYoung Adult
dc.titleA 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone
dc.typeArticle
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