Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 36, Issue 6, 2009, Pages 565-584

  Frame, Bill ^a   Miller, Raymond ^b   Hutmacher, Matthew M ^c  

^a Wolverine Pharmacometrics   (United States)

^b PFIZER INC   (United States)

^c ANN ARBOR PHARMACOMETRICS GROUP   (United States)

Author keywords

Dizziness; Dropout; Drowsiness; Joint likelihood; Mixed model; NONMEM; Piecewise Weibull; Platykurtosis

Indexed keywords

PLACEBO; PREGABALIN;

ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIZZINESS; DROWSINESS; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GENERALIZED ANXIETY DISORDER; HUMAN; MAJOR CLINICAL STUDY; MALE; PARAMETER; PREDICTIVE VALIDITY; PRIORITY JOURNAL; PROBABILITY; RATING SCALE; SCORING SYSTEM; STATISTICAL ANALYSIS; STATISTICAL MODEL;

ANTI-ANXIETY AGENTS; ANXIETY DISORDERS; COMPUTER SIMULATION; CREATININE; DIZZINESS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; GAMMA-AMINOBUTYRIC ACID; HUMANS; KAPLAN-MEIERS ESTIMATE; MARKOV CHAINS; MODELS, BIOLOGICAL; MODELS, STATISTICAL; MULTICENTER STUDIES AS TOPIC; PATIENT DROPOUTS; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX; SLEEP STAGES; TIME FACTORS; TREATMENT OUTCOME;

EID: 72349097560     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-009-9137-5     Document Type: Article

References (23)

1. Lalovic B, Hutmacher MM, Frame B, Ito K, Miller R (2007) Modeling the dropout from longitudinal adverse event data: selecting optimal titration regimens. Abstract 1137. p 16 ( www.page-meeting.org/?abstract=1137 )
2. Kowalski KG, McFadyen L, Hutmacher MM, Frame B, and Miller R (2003) A two-part mixture model for longitudinal adverse event data. J Pharmacokin Pharmacodyn 30(5):315-336
3. K Ito MM Hutmacher J Liu R Qiu B Frame R Miller 2008 Exposure-response analysis of spontaneously reported dizziness in pregabalin-treated patient with generalized anxiety disorder Clin Pharmacol Ther 84 127 135 10.1038/sj.clpt. 6100491 1:CAS:528:DC%2BD1cXnt1KqsLg%3D 18253146 (Pubitemid 351861494)
4. S Arroyo H Anhut AR Kugler CM Lee LE Knapp EA Garofalo, et al. 2004 Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures Epilepsia 45 20 27 10.1111/j.0013-9580.2004.31203.x 1:CAS:528:DC%2BD2cXhtVOhs7w%3D 14692903 (Pubitemid 38063660)
5. AC Pande DE Feltner JW Jefferson JR Davidson M Pollack MB Stein, et al. 2004 Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study J Clin Psychopharmacol 24 141 149 10.1097/01.jcp.0000117423.05703.e7 1:CAS:528:DC%2BD2cXjslSitrY%3D 15206660 (Pubitemid 38380837)
6. DE Feltner JG Crockatt SJ Dubovsky CK Cohn RK Shrivastava SD Targum, et al. 2003 A randomized, double-blind, placebo-controlled, fixed-dose, multicenter study of pregabalin in patients with generalized anxiety disorder J Clin Psychopharmacol 23 240 249 10.1097/00004714-200306000-00005 1:CAS:528: DC%2BD3sXltFKjtL8%3D 12826986 (Pubitemid 36807791)
7. AC Pande JG Crockatt DE Feltner CA Janney WT Smith R Weisler, et al. 2003 Pregabalin in generalized anxiety disorder: a placebo-controlled trial Am J Psychiatry 160 533 540 10.1176/appi.ajp.160.3.533 12611835 (Pubitemid 41094262)
8. R Sabatowski R Galvez DA Cherry F Jacquot E Vincent P Maisonobe, et al. 2004 Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial Pain 109 26 35 10.1016/j.pain.2004.01.001 1:CAS:528:DC%2BD2cXjtVCgurw%3D 15082123 (Pubitemid 38479767)
9. RH Dworkin AE Corbin JP Young Jr U Sharma L LaMoreaux H Bockbrader, et al. 2003 Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial Neurology 60 1274 1283 1:STN:280:DC%2BD3s7ovVKiuw%3D%3D 12707429
10. PH Zingmark M Kagedal MO Karlsson 2005 Modelling a spontaneously reported side effect by use of a Markov mixed-effects model J Pharmacokinet Pharmacodyn 32 261 281 10.1007/s10928-005-0021-7 16283538 (Pubitemid 41712743)
11. E Henin B You E VanCutsem PM Hoff J Cassidy C Twelves, et al. 2009 A dynamic model of hand-and-foot syndrome in patients receiving capecitabine Clin Pharmacol Ther 85 418 425 10.1038/clpt.2008.220 1:CAS:528:DC%2BD1MXjtlSlsrw%3D 19078948
12. Sheiner LB, Beal SL, Dunne A (1997) Analysis of nonrandomly censored ordered categorical longitudinal data from analgesic trials. J Am Stat Assoc 92(440):1235-1255
13. AA Noura KLQ Read 1990 Proportional hazards changepoint models in survival analysis Appl Statist 39 241 253 10.2307/2347763
14. JA John NR Draper 1980 An alternative family of transformations Appl Stat 29 190 197 10.2307/2986305
15. Boeckmann AJ, Beal SL, Sheiner LB (2006) NONMEM users guide. Parts I-VIII. UCSF, San Francisco CA
16. DC Heilbron 1994 Zero-altered and other regession models for count data with added zeros Biomed J 36 531 547
17. D Lambert 1992 Poisson regression with an application to defects in manufacturing Technometrics 34 1 14 10.2307/1269547
18. Aitchison J, Brown JAC (1957) The lognormal distribution. Cambridge University Press, Cambridge
19. L Liu JZ Ma BA Johnson 2008 A multi-level two-part random effects model, with application to an alcohol dependence study Statst Med 27 3528 3539 10.1002/sim.3205
20. Olsen MK, Schafer JL (2001) A two-part random-effects model for semicontinuous longitudinal data. J Am Stat Assoc 96(454):730-745
21. Cook RJ, Kalbfleisch JD, Yi GY (2002) A generalized mover-stayer model for panel data. Biostatistics 3(3):407-420
22. Frame B, Beal SL, Miller R, Barrett J, Burger P (2007) Mixed effects modeling of weight change associated with placebo and pregabalin administration. J Pharmacokinet Pharmacodyn 34(6):753-770
23. Beal SL (2005) Conditioning on certain random events associated with statistical variability in PK/PD. J Pharmacokinet Pharmacodyn 32(2):213-243