{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T10:59:22Z","timestamp":1770980362835,"version":"3.50.1"},"reference-count":38,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":980,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2010,7]]},"abstract":"<jats:p>Data from 4 phase 2\/3 studies were pooled to characterize the exposure response of daily pregabalin (150\u2013600 mg) in patients with fibromyalgia using self\u2010assessed daily pain scores (PAIN) and end\u2010of\u2010treatment patient global impression of change (PGIC). The exposure responses of both endpoints were characterized by an Emax model using nonlinear mixed\u2010effects modeling (NONMEM). Drug effect on PAIN relative to placebo was significant with additional maximum effect of 1.51 points on the logit scale and EC50 of 1.54 ng\/mL (dose of 174 mg) and a rapid onset (half\u2010life of 11 hours), consistent with the half\u2010life of the drug. The decrease in PAIN with placebo occurred more slowly, reaching maximum response (1.52 points on the logit scale) after 1 month. Drug response in fibromyalgia was dependent on age and sex, with greater PAIN reduction in older patients, in addition to the effect of creatinine clearance, and in females. For PGIC, administration of pregabalin resulted in an increase in the proportion of patients reporting improvement with an ED50 of 228 mg. The analyses support the recommended dose of pregabalin in patients with fibromyalgia of 300 to 450 mg\/d.<\/jats:p>","DOI":"10.1177\/0091270009352187","type":"journal-article","created":{"date-parts":[[2010,4,1]],"date-time":"2010-04-01T02:20:55Z","timestamp":1270088455000},"page":"803-815","source":"Crossref","is-referenced-by-count":14,"title":["Exposure\u2010Response Analyses of the Effects of Pregabalin in Patients With Fibromyalgia Using Daily Pain Scores and Patient Global Impression of Change"],"prefix":"10.1002","volume":"50","author":[{"given":"Wonkyung","family":"Byon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniele","family":"Ouellet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marci","family":"Chew","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaori","family":"Ito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paula","family":"Burger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lynne","family":"Pauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhardt","family":"Zeiher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Corrigan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_7_2_2","first-page":"5.16.1","volume-title":"Rheumatology","author":"Goldenberg DL.","year":"1994"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002281-199305020-00013"},{"issue":"19","key":"e_1_2_7_4_2","first-page":"58","article-title":"Confounding features of the fibromyalgia syndrome: a current perspective of differential diagnosis","volume":"16","author":"Bennett RM.","year":"1989","journal-title":"J Rheumatol"},{"key":"e_1_2_7_5_2","doi-asserted-by":"crossref","first-page":"2782","DOI":"10.1001\/jama.1987.03390200122026","article-title":"Fibromyalgia syndrome","volume":"257","author":"Goldenberg DL.","year":"1987","journal-title":"JAMA"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eplepsyres.2006.09.008"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0028-3908(01)00172-1"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1124\/mol.106.023309"},{"key":"e_1_2_7_9_2","doi-asserted-by":"crossref","first-page":"1086","DOI":"10.1016\/S0022-3565(24)39009-3","article-title":"Stimulus\u2010dependent modulation of [3H]\u2010norepinephrine release from rat neocortical slices by gabapentin and pregabalin","volume":"295","author":"Dooley DJ","year":"2000","journal-title":"J Pharmacol Exp Ther"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0304-3940(00)00769-2"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0304-3959(03)00173-8"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.tips.2006.12.006"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2006.09.019"},{"issue":"3","key":"e_1_2_7_14_2","first-page":"1","article-title":"A randomized, double\u2010blind, placebo\u2010controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia","volume":"35","author":"Mease PJ","year":"2008","journal-title":"J Rheum"},{"key":"e_1_2_7_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2008.03.013"},{"key":"e_1_2_7_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.20983"},{"key":"e_1_2_7_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2008.02.027"},{"issue":"3","key":"e_1_2_7_18_2","first-page":"421","article-title":"Pregabalin pharmacokinetics and safety in healthy volunteers: results from two phase 1 studies","volume":"54","author":"Bockbrader HN","year":"2000","journal-title":"Neurology"},{"key":"e_1_2_7_19_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003251119"},{"key":"e_1_2_7_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.0013-9580.2004.455003.x"},{"key":"e_1_2_7_21_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.20983"},{"issue":"3","key":"e_1_2_7_22_2","first-page":"1","article-title":"A randomized, double\u2010blind, placebo\u2010controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia","volume":"35","author":"Mease PJ","year":"2008","journal-title":"J Rheum"},{"key":"e_1_2_7_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpain.2008.03.013"},{"key":"e_1_2_7_24_2","first-page":"256","article-title":"Pregabalin for management of fibromyalgia (FM): A 14\u2010week, randomized, double\u2010blind, placebo\u2010controlled, monotherapy trial (Study A0081100)","volume":"68","author":"Pauer L","year":"2008","journal-title":"Ann Rheum Dis"},{"key":"e_1_2_7_25_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780330203"},{"key":"e_1_2_7_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3959(87)91074-8"},{"key":"e_1_2_7_27_2","volume-title":"NONMEM Users Guide: Part I\u2010VIII. NONMEM Project Group C255","author":"Beal SL","year":"1988"},{"key":"e_1_2_7_28_2","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1159\/000180580","article-title":"Prediction of creatinine clearance from serum creatinine","volume":"16","author":"Cockroft DW","year":"1996","journal-title":"Nephron"},{"key":"e_1_2_7_29_2","volume-title":"FDA Guidance for Industry on \u201cPopulation Pharmacokinetics\u201d","year":"1999"},{"key":"e_1_2_7_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjopharm.2007.10.001"},{"key":"e_1_2_7_31_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199835010-00004"},{"key":"e_1_2_7_32_2","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-199701000-00004"},{"key":"e_1_2_7_33_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpain.2004.01.007"},{"key":"e_1_2_7_34_2","doi-asserted-by":"publisher","DOI":"10.1038\/nm1196-1248"},{"key":"e_1_2_7_35_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0304-3959(99)00119-0"},{"key":"e_1_2_7_36_2","doi-asserted-by":"publisher","DOI":"10.1053\/sarh.2000.8363"},{"key":"e_1_2_7_37_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780330203"},{"key":"e_1_2_7_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3959(93)90049-U"},{"key":"e_1_2_7_39_2","unstructured":"Lyrica prescribing information. Available at:http:www.lyrica.comcontentmainprescribinginfo.jsp. AccessedOctober 24 2009."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1177%2F0091270009352187","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270009352187","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,19]],"date-time":"2025-02-19T20:17:49Z","timestamp":1739996269000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270009352187"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,7]]},"references-count":38,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2010,7]]}},"alternative-id":["10.1177\/0091270009352187"],"URL":"https:\/\/doi.org\/10.1177\/0091270009352187","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,7]]}}}