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Meta-Analysis
. 2008 Dec;106(2-3):300-7.
doi: 10.1016/j.schres.2008.09.002. Epub 2008 Oct 29.

Changes in non-high-density lipoprotein cholesterol levels and triglyceride/high-density lipoprotein cholesterol ratios among patients randomized to aripiprazole versus olanzapine

John W Newcomer  1 , Jonathan M Meyer, Ross A Baker, James M Eudicone, Andrei Pikalov, Estelle Vester-Blokland, Robert D McQuade, David T Crandall, William H Carson, Ronald N Marcus, Gilbert L'italien
Affiliations
Meta-Analysis

Changes in non-high-density lipoprotein cholesterol levels and triglyceride/high-density lipoprotein cholesterol ratios among patients randomized to aripiprazole versus olanzapine

John W Newcomer et al. Schizophr Res. 2008 Dec.

Abstract

Objective: Non-high-density lipoprotein cholesterol (non-HDL-C) and the triglyceride to high-density lipoprotein cholesterol ratio (TG:HDL-C) are predictors of cardiovascular risk. This post-hoc analysis assessed changes in these parameters during treatment with the atypical antipsychotics olanzapine or aripiprazole using pooled data from three randomized, long-term clinical studies in patients with schizophrenia.

Methods: Data were pooled from one open-label and two double-blind (26- or 52-week) studies in patients randomized to olanzapine (5-20 mg/day) or aripiprazole (15-30 mg/day). Change from baseline in non-HDL-C levels between groups was analyzed in the Observed Case (OC) dataset at each time point and Last Observation Carried Forward (LOCF) dataset at endpoint using analysis of covariance, with treatment as main effect and baseline non-HDL-C as covariate. Differences between groups in median changes from baseline in TG:HDL-C were assessed with Kruskal-Wallis tests.

Results: This analysis included 546 patients (olanzapine, n=274; aripiprazole, n=272). Mean changes from baseline in non-HDL-C levels were significantly different (p<0.0001) with olanzapine versus aripiprazole at Weeks 26 (+13.0 versus -7.5 mg/dL) and 52 (+12.2 versus -8.1 mg/dL). Baseline TG:HDL-C was high in the olanzapine (3.73) and aripiprazole (3.79) groups. Differences in median changes from baseline in TG:HDL-C were significant with olanzapine versus aripiprazole at Weeks 26 (+0.22 versus -0.54; p<0.0001) and 52 (+0.24 versus -0.62; p=0.004).

Conclusions: Long-term aripiprazole treatment is associated with improvements in lipid profiles of schizophrenia patients versus no improvement or worsening during olanzapine treatment. Consideration of cardiovascular risk is needed when prescribing antipsychotics, as is close monitoring for metabolic changes during treatment.

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Conflict of interest statement

Conflict of Interest: John W Newcomer has no significant financial conflict of interest in compliance with the Washington University School of Medicine Conflict of Interest Policy. Dr Newcomer has received research grant support from the National Institute of Mental Health, the National Alliance for Research on Schizophrenia and Depression, the Sidney R. Baer Jr. Foundation, Janssen Pharmaceuticals, Bristol-Myers Squibb, Wyeth Pharmaceuticals Inc., and Pfizer Inc.; he has served as a consultant to AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer Inc., Solvay, Wyeth Pharmaceuticals Inc., Forest, Sanofi, Tikvah, and Vanda; he has served as a member of Data and Safety Monitoring Boards for Organon, Schering-Plough, Dainippon Sumitomo, and Vivus; he has been a consultant to litigation; and he has received royalties from Compact Clinicals for a metabolic screening form.

Jonathan M. Meyer, MD, has received research support from Bristol-Myers Squibb and Pfizer, Inc. Dr Meyer has also received speaking or advising fees from AstraZeneca Pharmaceuticals, Bristol-Myers Squibb, Janssen Pharmaceutica, Pfizer, Inc., Schering-Plough, Vanda Pharmaceuticals, and Wyeth.

Ross A. Baker, James M. Eudicone, Estelle Vester-Blokland, David T. Crandall, Ronald N. Marcus and Gilbert L'Italien are employees of Bristol-Myers Squibb Company.

William H. Carson and Robert D. McQuade are employees of Otsuka Pharmaceutical Development & Commercialization, Inc.

Andrei Pikalov is an employee of Otsuka America Pharmaceutical, Inc

Figures

Figure 1
Figure 1
(A) Mean ± standard error change from baseline in non-HDL-C levels and (B) median change from baseline in TG:HDL-C ratios among observed cases in aripiprazole and olanzapine groups at 6, 12, 26 and 52 weeks (Observed Cases at each week). Evaluations at Week 6 and 12 include pooled studies CN138-002 and CN138-003, evaluations at Week 26 include pooled studies CN138-003 and CN138-047ext, and evaluations at Week 52 include CN138-002, CN138-003 and CN138-047ext. Non-HDL-C=non-high-density lipoprotein cholesterol; ANCOVA=analysis of covariance; TG:HDL-C=triglyceride:high-density lipoprotein cholesterol ratio
Figure 1
Figure 1
(A) Mean ± standard error change from baseline in non-HDL-C levels and (B) median change from baseline in TG:HDL-C ratios among observed cases in aripiprazole and olanzapine groups at 6, 12, 26 and 52 weeks (Observed Cases at each week). Evaluations at Week 6 and 12 include pooled studies CN138-002 and CN138-003, evaluations at Week 26 include pooled studies CN138-003 and CN138-047ext, and evaluations at Week 52 include CN138-002, CN138-003 and CN138-047ext. Non-HDL-C=non-high-density lipoprotein cholesterol; ANCOVA=analysis of covariance; TG:HDL-C=triglyceride:high-density lipoprotein cholesterol ratio
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