PMID- 26694975 OWN - NLM STAT- MEDLINE DCOM- 20160929 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 32 IP - 3 DP - 2016 TI - The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. PG - 601-9 LID - 10.1185/03007995.2015.1134463 [doi] AB - OBJECTIVE: To evaluate pregabalin's efficacy (/=18 years, had moderate (>/=4-<7) or severe (>/=7-10) mean baseline pain scores. Analyses included mixed effects repeated measures (MMRM), baseline observation carried forward (for parameters without enough data points for MMRM), or logistic regression. CLINICAL TRIAL REGISTRATION: Study number/ClinicalTrials.gov number: A0081056/NCT00645398, A0081077/NCT00230776, A0081100/NCT00333866, A0081208/NCT00830167. MAIN OUTCOMES MEASURES: Endpoints included mean change in pain and sleep quality scores (Weeks 8 and 12), patient-reported outcomes, and adverse events (AEs). RESULTS: Baseline demographic characteristics were comparable between pregabalin and placebo in both baseline pain severity groups. Mean +/- SD baseline pain severity scores were equivalent between pregabalin and placebo within moderate (5.8 +/- 0.8) or severe pain (7.9 +/- 0.7) subgroups. All subjects reported reduced pain and improved sleep quality through Weeks 8 and 12, with larger effects observed with pregabalin over placebo and with baseline severe over moderate pain (all p < 0.01). Pregabalin was generally well tolerated, AE findings were consistent with previously published trials, and AE profiles were similar between moderate and severe baseline pain subgroups. Limitations of this pooled analysis included differences in individual trial designs (e.g., dosing schedules, racial distribution, exclusion criteria that did not enroll mild severity patients). CONCLUSIONS: Pregabalin was efficacious through 12 weeks for reducing pain and improving sleep quality in FM patients with baseline moderate or severe pain, with larger effects in the baseline severe pain subgroup. AEs were consistent with pregabalin's known safety profile and did not differ between moderate and severe pain subgroups. FAU - Clair, Andrew AU - Clair A AD - a Pfizer Inc. , New York , NY , USA. FAU - Emir, Birol AU - Emir B AD - a Pfizer Inc. , New York , NY , USA. LA - eng SI - ClinicalTrials.gov/NCT00230776 SI - ClinicalTrials.gov/NCT00333866 SI - ClinicalTrials.gov/NCT00645398 SI - ClinicalTrials.gov/NCT00830167 PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20160127 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Analgesics) RN - 55JG375S6M (Pregabalin) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Analgesics/adverse effects/*therapeutic use MH - Clinical Trials, Phase III as Topic MH - Double-Blind Method MH - Female MH - Fibromyalgia/*drug therapy MH - Humans MH - Male MH - Middle Aged MH - Pain/drug therapy MH - Pregabalin/adverse effects/*therapeutic use MH - Randomized Controlled Trials as Topic MH - Sleep/drug effects MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Fibromyalgia OT - pain management OT - pain severity OT - pregabalin EDAT- 2015/12/24 06:00 MHDA- 2016/09/30 06:00 CRDT- 2015/12/24 06:00 PHST- 2015/12/24 06:00 [entrez] PHST- 2015/12/24 06:00 [pubmed] PHST- 2016/09/30 06:00 [medline] AID - 10.1185/03007995.2015.1134463 [doi] PST - ppublish SO - Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.