RESEARCH - Tramadol/acetaminophen tablets added to regular therapy for RA pain

[Guest guest]

Clin Ther. 2006 Dec;28(12):2052-60.

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.

Lee EY, Lee EB, Park BJ, Lee CK, Yoo B, Lim MK, Shim SC, Sheen DH, Seo

YI, Kim HA, Baek HJ, Song YW.

Division of Rheumatology, Department of Internal Medicine, Seoul

National University College of Medicine, Chongno-Gu, Seoul, Republic

of Korea.

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.

PMID: 17296461

http://www.ncbi.nlm.nih.gov/pubmed/17296461

Not an MD