From the Institute for Applied Pharmaceutical Research, Philadelphia, PA (Drs. Packman and Packman); Novartis Pharma AG, Basel, Switzerland (Ms. Thurston); and Novartis Pharmaceuticals Corporation, East Hanover, NJ (Dr. Tseng).
Lumiracoxib Is Effective in the Treatment of Episodic Tension-Type Headache
Article first published online: 15 SEP 2005
Headache: The Journal of Head and Face Pain
Volume 45, Issue 9, pages 1163–1170, October 2005
How to Cite
Packman, E., Packman, B., Thurston, H. and Tseng, L. (2005), Lumiracoxib Is Effective in the Treatment of Episodic Tension-Type Headache. Headache: The Journal of Head and Face Pain, 45: 1163–1170. doi: 10.1111/j.1526-4610.2005.00239.x
- Issue published online: 15 SEP 2005
- Article first published online: 15 SEP 2005
- Accepted for publication March 22, 2005.
- episodic tension-type headache;
- cyclo-oxygenase-2 inhibitor;
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.