SUMMARY OF COMBINED CLINICAL ANALYSIS OF CONTROLLED CLINICAL-TRIALS WITH TIZANIDINE

Data from three placebo-controlled and II active-controlled studies of tizanidine were combined to permit analysis of the subsets, which wer e too small to evaluate within the individual studies. Overall analysi s of placebo-controlled data confirms the effectiveness of tizanidine in reducing muscle tone in patients with spasticity of spinal cord ori gin. Subset analyses suggest that patients with more severe spasticity are more likely to respond, but age, sex, and race were not predictiv e of response. Comparisons of tizanidine with active controls showed n o differences in efficacy compared with baclofen or diazepam. However, when compared with controls, patients treated with tizanidine did not experience increased weakness. Furthermore, patients tolerated tizani dine better than the control medications. More patients experienced ad verse events during tizanidine treatment than did patients receiving p lacebo. The most common adverse events reported were dry mouth, somnol ence, asthenia, and dizziness. Mild elevations in liver function tests were noted occasionally, but improved in all patients with dose reduc tion or withdrawal. Three patients from the double-blind database repo rted formed Visual hallucinations. All three cleared; two continued ti zanidine, and one discontinued.