Source: DGNews  |  Posted 3 years ago

By Ed Susman

KISSIMMEE, FL -- February 18, 2008 -- Patients with acute, painful musculoskeletal spasms of the lower back appear to get better and faster relief from the muscle relaxant carisoprodol than from placebo.

In a clinical trial involving more than 800 patients, researchers said the 250-mg dose of carisoprodol taken 4 times daily was superior to placebo and similar to the 350-mg tablets of carisoprodol. However, the larger dose of carisoprodol increased adverse events more than either of the comparator preparations.

"This study demonstrated that patients with acute muscle spasms of the lower back had significantly greater relief of the acute discomfort associated with lower back spasm, and had improved functional status during treatment with carisoprodol 250-mg tablets compared with placebo," said Gregory Serfer, DO, Head, South Florida Clinical Research Center, Hollywood, Florida, United States.

Dr. Serfer presented the findings in a poster session on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

In the trial, 264 patients were randomly assigned to receive carisoprodol 250 mg, 273 patients were assigned to carisoprodol 350 mg, and 269 patients were assigned to the placebo arm.

Carisoprodol 250 mg was significantly superior to placebo in patients' global impression of change -- increasing about 2.2 points on the 4-point scale compared with an increase of 1.9 for placebo patients (P < .01).

Carisoprodol was also significantly more effective than placebo in patient-rated relief of backache, measured from baseline to day 3. Patients taking carisoprodol 250 mg showed about a 1.7-point improvement compared with a 1.5-point improvement for placebo, also statistically significant (P < .01).

Discontinuation due to treatment-emergent adverse events occurred more frequently in the carisoprodol 350-mg group of patients compared with the carisoprodol 250-mg group and placebo (3.9% vs 0.7% vs 1.8%, respectively), Dr. Serfer said.

Funding for this study was provided by Meda Pharmaceuticals.

[Presentation title: Randomized, Double-Blind Trial of Carisoprodol 250-mg Tablets Compared to Placebo and Carisoprodol 350-mg Tablets in Patients With Acute, Painful Musculoskeletal Spasm of the Lower Back. Abstract 114]