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Predictive Value of Early Changes in Triglycerides and Weight for Longer-Term Changes in Metabolic Measures During Olanzapine, Ziprasidone or Aripiprazole Treatment for Schizophrenia and Schizoaffective Disorder: Post Hoc Analyses of 3 Randomized, Controlled Clinical Trials

Hoffmann, Vicki P. PharmD*; Case, Michael MS; Stauffer, Virginia L. PharmD; Jacobson, Jennie G. PhD; Conley, Robert R. MD

Journal of Clinical Psychopharmacology: December 2010 - Volume 30 - Issue 6 - p 656-660
doi: 10.1097/JCP.0b013e3181faf670
Original Contributions
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The objective of this study was to determine if early changes in triglycerides and weight may be useful in predicting longer-term changes in weight and other metabolic parameters. Data were from three 24- to 28-week randomized, controlled studies comparing olanzapine to ziprasidone or aripiprazole for treatment of schizophrenia. Analyses were restricted to completers with fasting laboratory data at all protocol-specified time points. Analyses were primarily descriptive and included mean changes and categorical outcomes. In all treatment groups, participants who did not experience a 20 mg/dL or greater increase in triglycerides at early time points were unlikely to experience a change of 50 mg/dL or more in triglycerides after 6 months. Negative predictive values were 83% to 95%. However, early change in triglycerides was not useful for predicting later change in glucose, cholesterol, or weight. Similarly, early weight change gave robust negative predictive values for longer-term weight change (≥10 kg), but not for change in glucose or cholesterol. Lack of early elevation in triglyceride concentrations was predictive of later lack of substantial increase in triglycerides in olanzapine-, ziprasidone-, and aripiprazole-treated participants. Lack of early elevation in weight was predictive of later lack of substantial increase in weight in all 3 treatment groups. Early monitoring of triglyceride concentrations and weight may help clinicians assess risk that individuals will experience significant increase in triglycerides or weight gain, allowing assessments of potential risks and benefits earlier in treatment. Clinical monitoring is advised throughout treatment for all patients.

From *Neuroscience, Eli Lilly and Company, and †Neuroscience, Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN.

Received November 3, 2009; accepted after revision September 3, 2010.

Reprints: Vicki Poole Hoffmann, PharmD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 (e-mail: vph@lilly.com).

Some of the data in this manuscript were previously presented at The European College of Neuropsychopharmacology, August 30 to September 3, 2008, Barcelona, Spain; The Institute on Psychiatric Services, October 2 to 5, 2008, Chicago, Illinois; and the International Congress on Schizophrenia Research, March 28 to April 1 2009, San Diego, California.

This study was funded by Lilly USA, LLC.

Manuscript hypothesis was conceived by V.P.H., M.C. and V.L.S. All authors contributed to design of the analyses and interpretation of results. The manuscript was drafted by J.G.J. All authors read and approved the final manuscript.

© 2010 by Lippincott Williams & Wilkins.