Efficacy and tolerability of cyclobenzaprine extended release for acute muscle
spasm: a pooled analysis.
Author(s): Weil AJ, Ruoff GE, Nalamachu S, Altman CA, Xie F, Taylor DR.
Affiliation(s): Non-Surgical Orthopaedics, PC, Atlanta, GA 30060, USA.
nonsurgicalmd@lowbackpain.com
Publication date & source: 2010, Postgrad Med. , 122(4):158-69
OBJECTIVE: To assess the efficacy and tolerability of once-daily cyclobenzaprine
extended release (CER) 15 and 30 mg in relieving acute muscle spasm.
METHODS: This is a pooled analysis of 2 randomized, double-blind,
placebo-controlled, parallel-group studies of identical design. Adults with local
muscle spasm associated with neck/low back pain were randomized to treatment with
once-daily CER 15 (n = 127) or 30 mg (n = 126), cyclobenzaprine immediate release
(CIR) 10 mg 3 times daily (n = 123), or placebo (n = 128) for 14 days. Primary
outcome measures were the patient's rating of medication helpfulness and
physician's clinical global assessment of response to therapy at day 4.
RESULTS: Of 504 patients, 330 (65.5%) completed the studies. Significantly
greater improvements in patient's rating of medication helpfulness were reported
with CER 15 and 30 mg versus placebo at day 4 (P < 0.025). No differences were
reported between groups in physician's clinical global assessment. Significantly
greater improvements (P < 0.025) were noted in patient-rated secondary measures
versus placebo: relief from local pain at days 4 (CER 30 mg) and 8 (CER 15 and 30
mg), global impression of change at days 4 and 8 (CER 30 mg), and restriction of
movement at day 4 (CER 30 mg). Improvements with CER 15 and 30 mg on most
efficacy measures were similar to CIR. There was less reported daytime drowsiness
with CER 15 and 30 mg than with CIR (P < 0.05). Most adverse events (AEs) were
mild in intensity. The most common AEs for all groups were dry mouth,
constipation, dizziness, headache, and somnolence. The rate of somnolence
reported as an AE was lower (P < 0.05) with CER 15 (0.8%) and 30 mg (1.6%) than
with CIR (7.3%).
CONCLUSION: Once-daily CER was effective in relieving acute muscle spasm based on
patient's rating of medication helpfulness at day 4 and was generally well
tolerated with a low rate of reported somnolence.
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