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Patients With Low Back Pain Achieve Relief With Tapentadol Therapy: Presented at ANA

By Charlene Laino

BALTIMORE, Md -- October 18, 2009 -- The dual-acting analgesic tapentadol provides greater pain relief than placebo in patients suffering from low back pain severe enough to require opioid treatment -- and they experience fewer gastrointestinal adverse events compared with similar patients on oxycodone, researchers noted at the American Neurological Association (ANA) 134th Annual Meeting.

"Compared with placebo, tapentadol extended release 100 mg to 250 mg twice a day provided effective relief of moderate to severe chronic low back pain, and significantly reduced the interference of pain with physical function," said Harvey Leslie, MD, Best Clinical Research, Inc., Decatur, Georgia, speaking here at a poster presentation on October 12.

In the 15-week study, 319 patients (58% female) received placebo for back pain. Another 318 patients (61% female) were assigned to receive tapentadol. A third group of 328 patients were assigned to receive oxycodone controlled-release therapy.

Scores on the Brief Pain Inventory scale from the tapentadol group declined 2.3 points (P < .001) and also declined 2 points from the oxycodone group (P = .023) compared with a 1.6-point decline in pain among those on placebo in the Pain Interference subscale score.

Similarly, in both the Pain Interference subscale score and in the total scores, both tapentadol and oxycodone achieved significantly better relief than did placebo.

About 61.9% of patients on oxycodone reported gastrointestinal adverse disorders, compared with 43.7% on tapentadol and 26.3% on placebo. "Tapentadol extended-release 100 mg to 250 mg twice a day was associated with better gastrointestinal tolerability than oxycodone controlled release 20 mg to 50 mg twice a day," Dr. Leslie noted.

The patients in the study were about 50 years of age; more than 80% of them were younger than 65 years of age, more than 70% were white. Approximately 90% of patients said their pain was severe, and more than half had previously been treated with opioid medications. To enrol in the study, patients were required to have experienced chronic moderate to severe low back pain of nonmalignant origin for at least 3 months.

Funding for this study was provided by Johnson and Johnson Pharmaceutical Research and Development and Grünenthal GmbH.

[Presentation title: Tapentadol Extended Release for Chronic Low Back Pain: Brief Pain Inventory Results. Abstract M-5]

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