NDLI: Mixed effects modeling of weight change associated with placebo and pregabalin administration

Content Provider	Springer Nature Link
Author	Frame, Bill Beal, Stuart L. Miller, Raymond Barrett, Jeannette Burger, Paula
Copyright Year	2007
Abstract	Objective: To characterize change from baseline weight over time for pregabalin and placebo administration. Methods: Asymptotic fraction of baseline weight was modeled with a nonmixture model and a mixture model as a function of baseline weight, exposure, time, covariate effects, and subject-specific random effects. Model fit was assessed using standard diagnostic plots. Predictive performance was assessed using both data similar to the original data, and open-label data. Results: The nonmixture model indicated that a typical patient (baseline weight 82 kg) receiving placebo or 300 mg/day pregabalin approached an asymptotic fractional change from baseline weight of [mean (95% prediction interval for typical individual)] 0.7% (−5.5% to 7.4%) or 2.5% (−3.8% to 9.1%), respectively, with a half-life of 17 days. Substantial between-subject variability is observed, with some drug-treated subjects remaining weight neutral or losing weight, at all levels of exposure. Structural fixed effects parameters for the two submodels (mixture model) were in close agreement with each other and with those for the nonmixture model. The mixture model described two subpopulations differing in interindividual variability. No significant interindividual-varying covariates influencing the mixture probabilities were identified other than exposure. Both models had adequate fit; both models performed well during external validation. Predictive performance (nonmixture model) was adequate to ~900 days. Conclusions: The weight of a typical 82-kg patient receiving placebo or pregabalin (300 mg/day) approaches an asymptotic fractional change from baseline weight of 0.7%, or 2.5%, respectively, with a half-life of 17 days. Substantial between-subject variability remains unexplained.
Starting Page	753
Ending Page	770
Page Count	18
File Format	PDF
ISSN	1567567X
Journal	Journal of Pharmacokinetics and Pharmacodynamics
Volume Number	34
Issue Number	6
e-ISSN	15738744
Language	English
Publisher	Springer US
Publisher Date	2007-08-10
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Weight change Pregabalin Mixed effects Unbounded likelihood NONMEM Biochemistry Biomedical Engineering Veterinary Medicine Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Pharmacology

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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