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A Comparison of Duloxetine Plasma Levels in Postbariatric Surgery Patients Versus Matched Nonsurgical Control Subjects.
MedLine Citation:
PMID:  23771193     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Bariatric surgery such as the Roux-en-Y gastric bypass (RYGBP) is currently used as a treatment for severe obesity. Alteration of the gastrointestinal tract by this procedure suggests a potential for clinically significant alterations in the bioavailability of ingested medications including antidepressants. OBJECTIVES: The purpose of this trial was to determine to what extent the RYGBP procedure alters the area under the plasma concentration/time curve (AUC0-infinity) of the antidepressant, duloxetine. METHODS: Ten subjects who were 1 year post-RYGBP where compared with healthy control subjects matched for body mass index, age, and sex. Ultrarapid or poor metabolizers for cytochrome P450 2D6 were excluded from the study. Subjects received a single dose of 60 mg of duloxetine. Nineteen plasma samples were obtained during 72 hours to characterize the plasma level profile. RESULTS: The mean AUC0-infinity was significantly smaller for the postbariatric surgery (PBS) group (646.74 ng × h/mL [SD, 79.70; range, 539.57-791.62], P = 0.017) compared to the nonsurgical control group (1119.91 ng × h/mL [SD, 593.40; range, 415.5-2426.56]). The Tmax was also significantly shorter for the PBS group (2.2 hours) compared to the nonsurgical control group (6 hours; P = 0.005). No significant difference in Cmax or half-life was identified. CONCLUSIONS: To our knowledge, this is the first reported study exploring duloxetine pharmacokinetics PBS. This trial found that the bariatric surgery group was exposed to only 57.7% of duloxetine as compared to the nonsurgery group. This finding suggests that clinicians need to monitor patients closely after bariatric surgery and that further exploration of the effects of bariatric surgery on antidepressant pharmacokinetic parameters is warranted.
Authors:
James L Roerig; Kristine J Steffen; Cheryl Zimmerman; James E Mitchell; Ross D Crosby; Li Cao
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-6-13
Journal Detail:
Title:  Journal of clinical psychopharmacology     Volume:  -     ISSN:  1533-712X     ISO Abbreviation:  J Clin Psychopharmacol     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-6-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8109496     Medline TA:  J Clin Psychopharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
From the *Department of Clinical Neuroscience, University of North Dakota School of Medicine and Health Sciences; †The Neuropsychiatric Research Institute, Fargo, ND; and ‡Department of Pharmaceutics, University of Minnesota College of Pharmacy, Minneapolis, MN.
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