BACKGROUND:Carisoprodol, a centrally active skeletal muscle relaxant, is widely used for the treatment of acute, painful musculoskeletal disorders. When administered at a dose of 350 mg four times daily, carisoprodol demonstrated significant clinical benefit in its early clinical development trials; however, some unfavorable side effects, such as drowsiness and dizziness, were reported. Recently, research was conducted to determine if a lower dose of carisoprodol would retain efficacy but improve tolerability compared to the higher 350-mg dose. OBJECTIVE: The purpose of this multicenter study was to compare the efficacy and safety of carisoprodol 250-mg tablets four times daily to 350-mg tablets four times daily and to placebo in patients with acute, painful musculoskeletal spasm of the lower back. RESEARCH DESIGN AND METHODS: In this 1-week double-blind, placebo-controlled, parallel-group multicenter trial, patients 18 to 65 years of age with moderate to severe back spasm were randomly assigned to treatment with carisoprodol 250-mg tablets (n = 264), 350-mg tablets (n = 273), or matching placebo tablets (n = 269) three times daily and at bedtime. MAIN OUTCOME MEASURES: The coprimary efficacy variables were patient-rated relief from starting backache and patient-rated global impression of change assessed on treatment day 3. RESULTS: The carisoprodol 250-mg regimen was significantly more effective than placebo as assessed by both patient-rated relief from starting backache (p = 0.0001) and patient-rated global impression of change (p = 0.0046). There were no significant differences between the 250-mg and 350-mg dosages for the coprimary efficacy endpoints, and patients improved with or without sedation. Fewer than 1% of patients in the carisoprodol 250-mg group discontinued prematurely because of treatment-emergent adverse events, and no patient discontinued because of drowsiness. CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.
RCT Entities:
BACKGROUND:Carisoprodol, a centrally active skeletal muscle relaxant, is widely used for the treatment of acute, painful musculoskeletal disorders. When administered at a dose of 350 mg four times daily, carisoprodol demonstrated significant clinical benefit in its early clinical development trials; however, some unfavorable side effects, such asdrowsiness and dizziness, were reported. Recently, research was conducted to determine if a lower dose of carisoprodol would retain efficacy but improve tolerability compared to the higher 350-mg dose. OBJECTIVE: The purpose of this multicenter study was to compare the efficacy and safety of carisoprodol 250-mg tablets four times daily to 350-mg tablets four times daily and to placebo in patients with acute, painful musculoskeletal spasm of the lower back. RESEARCH DESIGN AND METHODS: In this 1-week double-blind, placebo-controlled, parallel-group multicenter trial, patients 18 to 65 years of age with moderate to severe back spasm were randomly assigned to treatment with carisoprodol 250-mg tablets (n = 264), 350-mg tablets (n = 273), or matching placebo tablets (n = 269) three times daily and at bedtime. MAIN OUTCOME MEASURES: The coprimary efficacy variables were patient-rated relief from starting backache and patient-rated global impression of change assessed on treatment day 3. RESULTS: The carisoprodol 250-mg regimen was significantly more effective than placebo as assessed by both patient-rated relief from starting backache (p = 0.0001) and patient-rated global impression of change (p = 0.0046). There were no significant differences between the 250-mg and 350-mg dosages for the coprimary efficacy endpoints, and patients improved with or without sedation. Fewer than 1% of patients in the carisoprodol 250-mg group discontinued prematurely because of treatment-emergent adverse events, and no patient discontinued because of drowsiness. CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.
Authors: Aidan G Cashin; Thiago Folly; Matthew K Bagg; Michael A Wewege; Matthew D Jones; Michael C Ferraro; Hayley B Leake; Rodrigo R N Rizzo; Siobhan M Schabrun; Sylvia M Gustin; Richard Day; Christopher M Williams; James H McAuley Journal: BMJ Date: 2021-07-07