Pharmacokinetics of pregabalin in subjects with various degrees of renal function

Journal of Clinical Pharmacology

Volumn 43, Issue 3, 2003, Pages 277-283

  Randinitis, Edward J ^a   Posvar, Edward L ^a,b   Alvey, Christine W ^a   Sedman, Allen J ^a   Cook, Jack A ^a   Bockbrader, Howard N ^a  

^a PFIZER INC   (United States)

^b SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; CREATININE; PREGABALIN;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DOSE CALCULATION; DOSE KIDNEY FUNCTION RELATION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HEMODIALYSIS; HUMAN; KIDNEY FUNCTION; LIQUID CHROMATOGRAPHY; MALE; OPEN STUDY; SOMNOLENCE; STEADY STATE; VALIDATION PROCESS; VERTIGO;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTICONVULSANTS; AREA UNDER CURVE; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GAMMA-AMINOBUTYRIC ACID; HALF-LIFE; HUMANS; KIDNEY FAILURE; MALE; MIDDLE AGED; RENAL DIALYSIS;

EID: 0037369152     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270003251119     Document Type: Article

References (24)

1. Arroyo S, Anhut H, Messmer S, Mathe H: Pregabalin double-blind add-on study in patients with partial seizures [abstract 1.263]. Epilepsia 2001;42(Suppl. 7):83.
2. Corbin AE, Remmers AE, LaMoreaux L, Young JP, Poole RM: Pregabalin reduces pain in patients with postherpetic neuralgia (PHN) [abstract 768]. J Pain 2001;2(Suppl. 1):37.
3. Glessner C, Sharma U, Iacobellis D, Moore J, LaMoreaux L, Poole RM: Pregabalin is efficacious for relief of painful diabetic neuropathy [abstract 769]. J Pain 2001;2(Suppl. 1):37.
4. Feltner DE, Robinson P, Liu-Dumaw M, Pande AC, for the Pregabalin Anxiety Disorders Trials Groups: Pregabalin, a novel agent in the treatment of anxiety disorders [abstract NR-023]. Presented at the meeting of the Anxiety Disorders Association of America, Atlanta, GA, March 22-25, 2001.
5. 2δ subunit of a calcium channel. J Biol Chem 1996;271:5768-5776.
6. 2+ influx by gabapentin and pregabalin in the human neocortex. Neuropharmacology 2002; 42:229-236.
7. +-evoked glutamate release from rat neocortical and hippocampal slices by gabapentin. Neurosci Lett 2000;280:107-110.
8. 3H]norepinephrine release from rat neocortical slices by gabapentin and pregabalin. J Pharmacol Exp Ther 2000;295:1086-1093.
9. 3H]glutamate from rat caudal trigeminal nucleus slices. Pain 2001;93:191-196.
10. Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E: Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV). Epilepsy Res 1999;34:1-41.
11. Welty D, Wang Y, Busch JA, Taylor CP, Vartanian MG, Radulovic LL: Pharmacokinetics (PK) and pharmacodynamics (PD) of CI-1008 (pregabalin) and gabapentin in rats with maximal electroshock [abstract 1.110]. Epilepsia 1997;38(Suppl. 8):35.
12. Bockbrader HN, Burger PJ, Kugler AR, Knapp LE, Garofalo EA, Lalonde RL: Population pharmacokinetic (PK) analyses of commonly prescribed antiepileptic drugs (AEDs) coadministered with pregabalin (PGB) in adult patients with refractory partial seizures [abstract 1.264]. Epilepsia 2001;42(Suppl. 7):84.
13. Bockbrader HN, Strand JC, Wesche DL, et al: Drug interaction studies of pregabalin (CI-1008, PGB) in patients with epilepsy maintained on either valproate (VPA), lamotrigine (LTG), phenytoin (PHT), or carbamazepine (CBZ) [abstract 1.272]. Epilepsia 2001;42(Suppl. 7):86.
14. Corrigan BW, Pool WF, Posvar EL, Strand JC, Alvey CW, Radulovic LL, et al: Metabolic disposition of pregabalin in healthy volunteers [abstract PI-68]. Clin Pharmacol Ther 2001;69(2):P18.
15. Bockbrader HN, Hunt T, Strand JC, Posvar EL, Sedman A: Pregabalin pharmacokinetics and safety in healthy volunteers: results from two phase 1 studies. Neurology 2000;54(Suppl. 3):A421.
16. Busch JA, Strand JC, Posvar EL, Bockbrader HN, Radulovic LL: Pregabalin (CI-1008) single-dose pharmacokinetics and safety/tolerance in healthy subjects after oral administration of pregabalin solution or capsule doses [abstract 2.108]. Epilepsia 1998;39(Suppl. 6):58.
17. Arroyo S, Kramer G: Treating epilepsy in the elderly: safety considerations. Drug Sar 2001;24:991-1015.
18. Ziegler D, Gries FA, Spüler M, Lessmann F, for the Diabetic Cardiovascular Autonomic Neuropathy Multicenter Study Group: The epidemiology of diabetic neuropathy. J Diabetes Complications 1992;6:49-57.
19. Gershon AA: Epidemiology and management of postherpetic neuralgia. Semin Dermatol 1996;15(Suppl 1.):8-13.
20. Alper BS, Lewis PR: Does treatment of acute herpes zoster prevent or shorten postherpetic neuralgia? A systematic review of the literature. J Fam Pract 2000;49:255-264.
21. Renal Impairment Working Group, Center for Drug Evaluation and Research: Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling [Online]. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, 1998. Available: http://www.fda.gov/ cder/guidance/1449fnl.pdf
22. Windsor BL, Radulovic LL: Measurement of new anticonvulsant, (S)-3-(aminomethyl)-5-methylhexanoic acid, in plasma and milk by high-performance liquid chromatography. J Chromatogr Biomed Appl 1995;674:143-148.
23. Gibaldi M, Perrier D: Pharmacokinetics. 2nd ed. New York: Marcel Dekker, 1982.
24. Abou-Khalil BW, Vazquez BR, Beydoun AA, et al: Pregabalin inpatient monotherapy trial: study results and impact of seizure frequency on efficacy evaluations [abstract 2.100]. Epilepsia 1999;40(Suppl. 7):109.