PMID- 20675978
OWN - NLM
STAT- MEDLINE
DCOM- 20100914
LR  - 20131121
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 122
IP  - 4
DP  - 2010 Jul
TI  - Efficacy and tolerability of cyclobenzaprine extended release for acute muscle 
      spasm: a pooled analysis.
PG  - 158-69
LID - 10.3810/pgm.2010.07.2182 [doi]
AB  - 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.
FAU - Weil, Arnold J
AU  - Weil AJ
AD  - Non-Surgical Orthopaedics, PC, Atlanta, GA 30060, USA. 
      nonsurgicalmd@lowbackpain.com
FAU - Ruoff, Gary E
AU  - Ruoff GE
FAU - Nalamachu, Srinivas
AU  - Nalamachu S
FAU - Altman, Charles A
AU  - Altman CA
FAU - Xie, Fang
AU  - Xie F
FAU - Taylor, Donald R
AU  - Taylor DR
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Muscle Relaxants, Central)
RN  - 0 (Placebos)
RN  - 1806D8D52K (Amitriptyline)
RN  - 69O5WQQ5TI (cyclobenzaprine)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Amitriptyline/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Chi-Square Distribution
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Humans
MH  - Middle Aged
MH  - Muscle Relaxants, Central/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Pain Measurement
MH  - Placebos
MH  - Spasm/*drug therapy
MH  - Statistics, Nonparametric
MH  - Treatment Outcome
MH  - United States
EDAT- 2010/08/03 06:00
MHDA- 2010/09/16 06:00
CRDT- 2010/08/03 06:00
PHST- 2010/08/03 06:00 [entrez]
PHST- 2010/08/03 06:00 [pubmed]
PHST- 2010/09/16 06:00 [medline]
AID - 10.3810/pgm.2010.07.2182 [doi]
PST - ppublish
SO  - Postgrad Med. 2010 Jul;122(4):158-69. doi: 10.3810/pgm.2010.07.2182.