Time to response in patients treated with immediate- and extended-release cyclobenzaprine

Abstract

Time to response is a clinically-meaningful assessment in the treatment of acute, painful musculoskeletal conditions. Prompt interruption of the spasmpain-spasm cycle can ease discomfort and enable a more rapid return to function. This analysis examined data from patients with muscle spasm of cervical/lumbar origin, randomly assigned to 1 of 4 groups: cyclobenzaprine extendedrelease (CER) 15mg QD (n=117), CER 30mg QD (n=121), cyclobenzaprine immediate-release (CIR) 10mg TID (n=118), and placebo (n=117). Three variables were analyzed: patient's rating of medication helpfulness, relief from local pain, and restriction of movement. The Kaplan-Meier method was used to estimate time to response distributions; differences between treatment groups and placebo were tested using the log-rank test. Results showed time to response was accelerated with CER and CIR. For medication helpfulness, time to achieve a very good/excellent rating was a median 10 days with CER 15mg (95% CI: 7,11; p=0.0199), 8 with CER 30mg (7,10; p=0.0038), 7 with CIR 10mg (6,8; p<0.001), and >14 (9,.) with placebo. For relief from local pain, time to achieve a lot/complete relief was 6 days with CER 15mg (5,7; p=0.0157), 5 with CER 30mg (4,7; p=0.0022), 5 with CIR 10mg (4,6; p=0.002), and 8 (6,11) with placebo. For restriction of movement, time to achieve a lot/complete relief was 6 days with CER 15mg (5,7; p=0.0643), 5 with CER 30mg (4,6; p=0.0041), 5 with CIR 10mg (4,6; p=0.009), and 7 (6,9) with placebo. Adverse events were generally mild. Somnolence rates were lower with CER 15mg (0.8%) and 30mg (1.6%) than with CIR 10mg (7.3%). Overall, patients taking cyclobenzaprine responded more rapidly than those taking placebo, CER being associated with less somnolence than CIR. Given muscle spasm may affect the ability to work, these findings may have economic consequences, with accelerated response allowing patients to resume normal activities sooner. (Sponsored by Cephalon, Inc.) Time to response is a clinically-meaningful assessment in the treatment of acute, painful musculoskeletal conditions. Prompt interruption of the spasmpain-spasm cycle can ease discomfort and enable a more rapid return to function. This analysis examined data from patients with muscle spasm of cervical/lumbar origin, randomly assigned to 1 of 4 groups: cyclobenzaprine extendedrelease (CER) 15mg QD (n=117), CER 30mg QD (n=121), cyclobenzaprine immediate-release (CIR) 10mg TID (n=118), and placebo (n=117). Three variables were analyzed: patient's rating of medication helpfulness, relief from local pain, and restriction of movement. The Kaplan-Meier method was used to estimate time to response distributions; differences between treatment groups and placebo were tested using the log-rank test. Results showed time to response was accelerated with CER and CIR. For medication helpfulness, time to achieve a very good/excellent rating was a median 10 days with CER 15mg (95% CI: 7,11; p=0.0199), 8 with CER 30mg (7,10; p=0.0038), 7 with CIR 10mg (6,8; p<0.001), and >14 (9,.) with placebo. For relief from local pain, time to achieve a lot/complete relief was 6 days with CER 15mg (5,7; p=0.0157), 5 with CER 30mg (4,7; p=0.0022), 5 with CIR 10mg (4,6; p=0.002), and 8 (6,11) with placebo. For restriction of movement, time to achieve a lot/complete relief was 6 days with CER 15mg (5,7; p=0.0643), 5 with CER 30mg (4,6; p=0.0041), 5 with CIR 10mg (4,6; p=0.009), and 7 (6,9) with placebo. Adverse events were generally mild. Somnolence rates were lower with CER 15mg (0.8%) and 30mg (1.6%) than with CIR 10mg (7.3%). Overall, patients taking cyclobenzaprine responded more rapidly than those taking placebo, CER being associated with less somnolence than CIR. Given muscle spasm may affect the ability to work, these findings may have economic consequences, with accelerated response allowing patients to resume normal activities sooner. (Sponsored by Cephalon, Inc.)