Extended-Release Tramadol Effective for Osteoarthritis Pain

August 4, 2004

NEW YORK (Reuters Health) Aug 02 - A once-daily extended-release formulation

of tramadol hydrochloride is a " robust analgesic " for treating

osteoarthritis, results of a clinical trial suggest. " Significant

differences from placebo were evident at week 1, " the authors report.

Tramadol is a recommended treatment for osteoarthritis pain that cannot be

controlled adequately with nonopioid analgesics, Dr. Najib Babul and

associates write in their report, published in the Journal of Pain and

Symptom Management for July. However, it must be taken every 6 hours for

optimal pain relief.

Dr. Babul, a pharmacologist at TheraQuest Biosciences in Blue Bell,

Pennsylvania, and his team evaluated an extended-release formulation of

tramadol in a randomized, double-blind, placebo-controlled study in patients

with moderate to severe osteoarthritis of the knee.

The 12-week trial included 246 participants, who first underwent a wash-out

period with all pain medication discontinued. They were randomized to

extended release tramadol or placebo when pain levels reached 40 mm on a

100-mm visual analog scale.

The drug was initiated at 100 mg daily, increased to 200 mg/day between day

4 and day 8, then increased to 300 to 400 mg daily as needed.

" All efficacy outcome measures favored tramadol ER over placebo, " the

investigators write. For the primary outcome variable -- average change from

baseline in the Arthritis Pain Intensity Visual Analog Scale -- tramadol ER

was associated with a least squares mean change from baseline of 30.4 mm,

compared with 17.7 mm for placebo (p < 0.001).

Measures of joint stiffness, physical function, and sleep were also better

in the tramadol-ER group, as were scores on the Patient and Physician Global

Assessments of Therapy.

There were more adverse effects with tramadol-ER, but the authors note that

" the safety profile...is consistent with the known pharmacology of the

drug. " The authors recommend further clinical trials for treatment of other

chronic pain conditions.

J Pain Symptom Manage 2004;28:59-71.

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