Population pharmacokinetics of pregabalin in healthy subjects and patients with post‐herpetic neuralgia or diabetic peripheral neuropathy

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Pregabalin has been approved in many countries for partial‐onset seizures, generalized anxiety disorder and a wide variety of pain disorders. • Although pharmacokinetic studies have demonstrated that pregabalin apparent clearance is correlated with estimate...

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Veröffentlicht in:British journal of clinical pharmacology 2011-07, Vol.72 (1), p.63-76
Hauptverfasser: Shoji, Satoshi, Suzuki, Misaki, Tomono, Yoshiro, Bockbrader, Howard N., Matsui, Shigeyuki
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Sprache:eng
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Zusammenfassung:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Pregabalin has been approved in many countries for partial‐onset seizures, generalized anxiety disorder and a wide variety of pain disorders. • Although pharmacokinetic studies have demonstrated that pregabalin apparent clearance is correlated with estimated creatinine clearance, quantitatively accurate estimation of this relationship is warranted for establishing clinical usage of this drug. WHAT THIS STUDY ADDS • A population pharmacokinetic model was developed from 14 pregabalin clinical trials using the first‐order conditional estimation method, where a one‐compartment model with first‐order absorption and elimination adequately described pregabalin pharmacokinetics. • Based on the developed model, pregabalin systemic exposure in patients with lower renal function (30 ≤ estimated creatinine clearance [CLcr]
ISSN:0306-5251
1365-2125
DOI:10.1111/j.1365-2125.2011.03932.x