PMID- 16178946
OWN - NLM
STAT- MEDLINE
DCOM- 20060228
LR  - 20161124
IS  - 0017-8748 (Print)
IS  - 0017-8748 (Linking)
VI  - 45
IP  - 9
DP  - 2005 Oct
TI  - Lumiracoxib is effective in the treatment of episodic tension-type headache.
PG  - 1163-70
AB  - OBJECTIVE: To evaluate the efficacy of single doses of lumiracoxib, the most 
      selective cyclo-oxygenase (COX)-2 inhibitor, in the treatment of episodic 
      tension-type headache (ETTH), with particular emphasis on time to onset of 
      analgesia. BACKGROUND: ETTH is the most frequently occurring type of headache 
      with an annual prevalence rate of up to 40%. Some patients with ETTH do not 
      respond to currently available therapies, thus an effective analgesic is needed 
      that provides a rapid onset of analgesia alongside significant pain relief. 
      Lumiracoxib is the most selective COX-2 inhibitor developed for the treatment of 
      acute and chronic pain. METHODS: In this single-center, randomized, double-blind, 
      double-dummy, placebo-controlled, parallel-group study, patients with ETTH were 
      randomly assigned to receive single-dose lumiracoxib (200 or 400 mg, n = 60 in 
      each group) or placebo (n = 30) within 1 hour of an ETTH. Efficacy was assessed 
      over a 3-hour period, the primary efficacy variable being the time to onset of 
      analgesia. Other efficacy variables included summed pain intensity difference 
      from 0 to 3 hours after dosing, time-specific pain intensity difference, 
      time-specific pain relief, time-specific pain relief intensity difference, total 
      pain relief over 0 to 3 hours, patient's global evaluation of treatment effect, 
      the proportion of patients who achieved onset of analgesia by 1 hour and time to 
      rescue medication intake. Safety was assessed by monitoring and recording of all 
      adverse events (AEs). RESULTS: The median time to onset of analgesia was 
      significantly faster for lumiracoxib 200 mg (47 minutes; 95% confidence interval 
      [CI]: 41, 52) and lumiracoxib 400 mg (41 minutes; 95% CI: 36, 48) than for 
      placebo (>3 hours; both P < .001). Both doses of lumiracoxib were significantly 
      superior to placebo for all secondary efficacy variables. There were no AEs 
      recorded in any treatment group. CONCLUSIONS: Single 200 or 400 mg doses of 
      lumiracoxib provided rapid and effective relief from the acute pain associated 
      with ETTH.
FAU - Packman, Elias
AU  - Packman E
AD  - Institute for Applied Pharmaceutical Research, Philadelphia, PA, USA.
FAU - Packman, Barry
AU  - Packman B
FAU - Thurston, Helen
AU  - Thurston H
FAU - Tseng, Lillian
AU  - Tseng L
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Headache
JT  - Headache
JID - 2985091R
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Organic Chemicals)
RN  - 144O8QL0L1 (Diclofenac)
RN  - V91T9204HU (lumiracoxib)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cyclooxygenase Inhibitors/therapeutic use
MH  - Diclofenac/analogs & derivatives
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Organic Chemicals/*therapeutic use
MH  - Tension-Type Headache/*drug therapy
MH  - Treatment Outcome
EDAT- 2005/09/24 09:00
MHDA- 2006/03/01 09:00
CRDT- 2005/09/24 09:00
PHST- 2005/09/24 09:00 [pubmed]
PHST- 2006/03/01 09:00 [medline]
PHST- 2005/09/24 09:00 [entrez]
AID - HED239 [pii]
AID - 10.1111/j.1526-4610.2005.00239.x [doi]
PST - ppublish
SO  - Headache. 2005 Oct;45(9):1163-70. doi: 10.1111/j.1526-4610.2005.00239.x.