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DRUG INTERACTIONS

Pharmacokinetics of Aripiprazole and Concomitant Lithium and Valproate

Leslie Citrome, MD, MPH, Richard Josiassen, PhD, Nigel Bark, MD, Daniel E. Salazar, PhD and Suresh Mallikaarjun, PhD

From the Nathan S. Kline Institute for Psychiatric Research and the Rockland Psychiatric Center, Orangeburg, New York, and New York University School of Medicine, New York (Dr Citrome); Arthur P. Noyes Research Foundation, Norristown, Pennsylvania, and the University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania (Dr Josiassen); Bronx Psychiatric Center and the Albert Einstein College of Medicine, Bronx, New York (Dr Bark); Bristol-Myers Squibb, Lawrenceville, New Jersey (Dr Salazar); and Otsuka Maryland Research Institute, Rockville, Maryland (Dr Mallikaarjun).

The objective of this study was to assess the pharmacokinetics of the antipsychotic aripiprazole when coadministered with lithium or valproate. Two open-label, sequential treatment design studies were conducted in chronically institutionalized patients with schizophrenia or schizoaffective disorder requiring treatment with lithium (n = 12) or valproate (divalproex sodium) (n = 10). Patients received aripiprazole 30 mg/day on days 1 to 14 and aripiprazole with concomitant therapy on days 15 to 36. Lithium was titrated from 900 mg until serum concentrations reached 1.0 to 1.4 mEq/L for at least 5 days. Valproate was titrated to 50 to 125 mg/L. Coadministration with lithium increased mean Cmax and AUC values of aripiprazole by about 19% and 15%, respectively, whereas the apparent oral clearance decreased by 15%. There was no effect on the steady-state pharmacokinetics of the active metabolite of aripiprazole. Coadministration with valproate decreased the AUC and Cmax of aripiprazole by 24% and 26%, respectively, with minimal effects on the active metabolite. Therapeutic doses of lithium and divalproex had no clinically significant effects on the pharmacokinetics of aripiprazole in patients with schizophrenia or schizoaffective disorder.

Key Words: Aripiprazole • valproate • lithium • schizophrenia • pharmacokinetics

Address for reprints: Leslie Citrome, MD, MPH, 140 Old Orangeburg Road, Orangeburg, NY 10962.






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