Publications
Detailed Information
Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Lee, Eun Young | - |
dc.contributor.author | Lee, Eun Bong | - |
dc.contributor.author | Park, Byung Joo | - |
dc.contributor.author | Lee, Chang Keun | - |
dc.contributor.author | Yoo, Bin | - |
dc.contributor.author | Lim, Mi Kyoung | - |
dc.contributor.author | Shim, Seung-Cheol | - |
dc.contributor.author | Sheen, Dong-Hyuk | - |
dc.contributor.author | Seo, Young Il | - |
dc.contributor.author | Kim, Hyun Ah | - |
dc.contributor.author | Baek, Han Joo | - |
dc.contributor.author | Song, Yeong Wook | - |
dc.date.accessioned | 2010-01-06T07:55:41Z | - |
dc.date.available | 2010-01-06T07:55:41Z | - |
dc.date.issued | 2007-02-14 | - |
dc.identifier.citation | Clin Ther. 2006 Dec;28(12):2052-60. | en |
dc.identifier.issn | 0149-2918 (Print) | - |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17296461 | - |
dc.identifier.uri | https://hdl.handle.net/10371/26846 | - |
dc.description.abstract | OBJECTIVE: This study evaluated the efficacy and tolerability of tramadol 37.5-mg/acetaminophen 325-mg combination tablets (tramadoUAPAP) as add-on therapy in subjects with rheumatoid arthritis (RA) pain that was inadequately controlled by NSAIDs and disease-modifying antirheumatic drugs alone. METHODS: Subjects in this multicenter, double-blind trial were randomized in a 3:1 ratio to receive 1 tramadol/ APAP tablet TID or a matching placebo for 1 week. Stable doses of previous medications were continued during the study. The primary efficacy variable was the mean daily pain relief score over 1 week, measured on a 6-point scale (4 = complete; ' = a lot; 2 = some; 1 = a little; 0 = none; -1 = worse). Secondary outcomes included the mean daily pain intensity score, measured on a 100-mm visual analog scale (VAS) (from 0 mm = no pain to 100 mm = extreme pain); pain intensity and pain relief at day 7; subjects' and investigators' mean overall assessments of study drug, measured on a Likert scale (from 2 = very good to -2 = very poor); and subjects' assessments of 8 aspects of physical function (measured on the Health Assessment Questionnaire). RESULTS: Of 277 subjects randomized to treatment, 267 (201 tramadol/APAP, 66 placebo) were included in the intent-to-treat population. Mean (SD) daily pain relief scores at the end of 1 week were significantly greater in the tramadol/APAP group compared with the placebo group (1.04 [0.89] vs 0.78 [0.80], respectively; P = 0.037), and mean daily pain intensity scores at the end of 1 week were significantly lower (47.23 [19.96] vs 53.81 [16.59]; P = 0.018). Physical function at the end of 1 week did not differ significantly between tramadol/APAP and placebo. Two hundred seventy-two subjects (205 tramadol/APAP, 67 placebo) were evaluable for tolerability. One hundred thirty-three of these subjects had at least 1 adverse event. The incidence of adverse events was significantly higher in the tramadol/APAP group than in the placebo group (57.6% vs 22.4%; P < 0.001). Discontinuations due to adverse events occurred in 19.0% of the tramadol/APAP group and 3.0% of the placebo group (P = 0.001). Of 213 treatment-related adverse events in tramadol/APAP subjects, nausea (34.1%) was the most frequent, followed by dizziness (20.0%) and vomiting (15.6%). One serious adverse event--chest discomfort, nausea, and vomiting after taking study medication-occurred in a subject receiving tramadol/APAP The symptoms resolved 1 day after discontinuing tramadol/APAP. CONCLUSIONS: In this study, tramadol/APAP used as add-on therapy in subjects with symptomatic RA was associated with a significant improvement in pain relief and a significant reduction in pain intensity compared with placebo, with no improvement in physical function. Use of tramadol/APAP may be considered when analgesics are needed in addition to conventional NSAIDs and disease-modifying antirheumatic drugs in subjects with RA. | en |
dc.language.iso | en | en |
dc.publisher | Elsevier | en |
dc.subject | Acetaminophen/administration & dosage/adverse effects/*therapeutic use | en |
dc.subject | Adult | en |
dc.subject | Aged | en |
dc.subject | Analgesics/administration & dosage/adverse effects/*therapeutic use | en |
dc.subject | Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic | en |
dc.subject | use | en |
dc.subject | Arthritis, Rheumatoid/complications/*drug therapy | en |
dc.subject | Double-Blind Method | en |
dc.subject | Drug Combinations | en |
dc.subject | Drug Therapy, Combination | en |
dc.subject | Female | en |
dc.subject | Humans | en |
dc.subject | Male | en |
dc.subject | Middle Aged | en |
dc.subject | Pain/*drug therapy/etiology | en |
dc.subject | Pain Measurement | en |
dc.subject | Recovery of Function | en |
dc.subject | Tablets | en |
dc.subject | Tramadol/administration & dosage/adverse effects/*therapeutic use | en |
dc.subject | Treatment Outcome | en |
dc.title | Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial | en |
dc.type | Article | en |
dc.contributor.AlternativeAuthor | 이은영 | - |
dc.contributor.AlternativeAuthor | 이은봉 | - |
dc.contributor.AlternativeAuthor | 박병주 | - |
dc.contributor.AlternativeAuthor | 이창근 | - |
dc.contributor.AlternativeAuthor | 유빈 | - |
dc.contributor.AlternativeAuthor | 임미경 | - |
dc.contributor.AlternativeAuthor | 심승철 | - |
dc.contributor.AlternativeAuthor | 신동혁 | - |
dc.contributor.AlternativeAuthor | 서영일 | - |
dc.contributor.AlternativeAuthor | 김현아 | - |
dc.contributor.AlternativeAuthor | 백한주 | - |
dc.contributor.AlternativeAuthor | 송영욱 | - |
dc.identifier.doi | 10.1016/j.clinthera.2006.12.019 | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.