Pregabalin Drug Interaction Studies: Lack of Effect on the Pharmacokinetics of Carbamazepine, Phenytoin, Lamotrigine, and Valproate in Patients with Partial Epilepsy

doi:10.1111/j.1528-1167.2005.19204.x

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Wiley InterScience

Epilepsia

Volume 46 Issue 9, Pages 1407 - 1413

Published Online: 1 Sep 2005

Published on behalf of the International League Against Epilepsy (ILAE)

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Clinical Research

Pregabalin Drug Interaction Studies: Lack of Effect on the Pharmacokinetics of Carbamazepine, Phenytoin, Lamotrigine, and Valproate in Patients with Partial Epilepsy

†Martin J. Brodie, †Elaine A. Wilson, *David L. Wesche, *Christine W. Alvey, *Edward J. Randinitis, *†Edward L. Posvar, *Neil J. Hounslow, *Nicola J. Bron, ‡G. L. Gibson, and *Howard N. Bockbrader

*Pfizer, Global Research and Development, Ann Arbor, Michigan, U.S.A. ; †Epilepsy Unit, Western Infirmary, Glasgow, Scotland ; and ‡Clinical Study Centers, LLC, Little Rock, Arkansas, U.S.A.

Address correspondence and reprint requests to Dr. H.N. Bockbrader at 2800 Plymouth Rd., Ann Arbor, MI 48105, U.S.A. E-mail: Howard.Bockbrader@Pfizer.com

Correspondence to Present address of Dr. Posvar: Amgen, Inc., Thousand Oaks, CA, U.S.A.

KEYWORDS

Pregabalin • Lyrica • Drug–drug interaction

ABSTRACT

Summary: Purpose: Pregabalin (PGB) is an α₂-δ ligand with demonstrated efficacy in epilepsy, neuropathic pain, and anxiety disorders. PGB is highly efficacious as adjunctive therapy in patients with refractory partial seizures.

Methods: Given its efficacy as adjunctive therapy, the potential for interaction of PGB with other antiepileptic drugs (AEDs) was assessed in patients with partial epilepsy in open-label, multiple-dose studies. Patients received PGB, 600 mg/day (200 mg q8h) for 7 days, in combination with their individualized maintenance monotherapy with valproate (VPA), phenytoin (PHT), lamotrigine (LTG), or carbamazepine (CBZ).

Results: Trough steady-state concentrations of CBZ (and its epoxide metabolite), PHT, LTG, and VPA were unaffected by concomitant PGB administration. Likewise, PGB steady-state pharmacokinetic parameter values were similar among patients receiving CBZ, PHT, LTG, or VPA and, in general, were similar to those observed historically in healthy subjects receiving PGB alone. The PGB–AED combinations were generally well tolerated. PGB may be added to VPA, LTG, PHT, or CBZ therapy without concern for pharmacokinetic drug–drug interactions.

Accepted February 12, 2005.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1528-1167.2005.19204.x About DOI