"We found that compared to placebo, patients receiving the tramadol product really improved in their overall scores as measured by the Chronic Pain Sleep Inventory (CPSI). There is definitely a role that tramadol plays in not only treating pain but improving sleep as well," said Anuprita Patkar, PhD, consultant, Ortho-McNeil Janssen Scientific Affairs, Raritan, New Jersey.

Dr. Patkar presented the findings on behalf of the study's authors in a poster session here on February 8^th.

The study examined the impact of tramadol on sleep, with clinicians analyzing results from 2 double-blind, placebo-controlled, randomized, parallel-group studies. Patients enrolled in the studies were diagnosed with moderate to severe osteoarthritis confirmed radiographically.

For the first study, investigators evaluated data on 101 patients who received at least 200 mg of tramadol ER and 119 patients on placebo.

The second study -- the larger of the 2 studies -- included 1,020 individuals with osteoarthritis of the knee or hip. This study also differed slightly from the first in the fact that it was a fixed-dose study. Of the 1,020 individuals enrolled in the study researchers analyzed data on 1,011 patients in the intent-to-treat population. They assigned 205 individuals to receive placebo, 202 to tramadol ER 100 mg/day, 201 patients to 200 mg/day, 201 patients to 300 mg/day, and 202 patients received 400 mg of tramadol/day.

For both studies they assessed the impact on sleep using the Chronic Pain Sleep Inventory (CPSI) based on a 100-mm visual analogue scale. In addition, researchers developed a Sleep Problems Index.

Results show that patients in the tramadol ER groups in both studies experienced significant improvement in SPI scores from baseline to endpoint (study 1, tramadol ER versus placebo, P < .05; study 2, tramadol ER 100, 200, and 300 mg versus placebo, all with a statistical significance of P < .05).

Patients in the larger study reported significant improvements as early as the first week of treatment (P < .05) with those improvements lasting throughout the 12-week study period.

Limitations of the investigations were that the 2 studies differed in patient demographics, and perhaps most significantly, the studies included data on patients receiving doses of 400 mg/day -- a dose that is not commercially available.

"The next step in our study is to examine quality-of-life issues and how treating both pain and improved sleep provides benefit to the lives of patients," Dr. Patkar added.


[Presentation title: Tramadol Improves Sleep in Osteoarthritis. Abstract 122]

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