Novel therapeutic agents: Lumiracoxib, a novel COX-2 selective inhibitor, is effective in the treatment of episodic tension-type headache

Abstract

A majority of the general population will experience an episodic tension-type headache (ETTH) during their lifetime. The objective of this double-blind, randomized, single-center, in-patient, placebo-controlled, parallel-group trial was to evaluate the analgesic efficacy of a single dose of lumiracoxib 200mg or 400mg, or placebo, in the treatment of ETTH, with emphasis on the time to onset of analgesia. A total of 150 patients with moderately severe to severe pain were randomized to receive lumiracoxib 200mg (n=60), lumiracoxib 400mg (n=60) or placebo (n=30) within 1 hour of onset of an ETTH. Pain assessments were performed at scheduled timepoints for 3 hours after dosing; the two-stopwatch technique was used to determine time to onset of analgesia, the primary efficacy parameter. For time to onset of analgesia, both doses of lumiracoxib were statistically superior to placebo (p<0.001) and comparable to each other. Median (95% CI) time to onset of analgesia was 47 (41, 52) and 41 (36, 48) minutes for lumiracoxib 200mg and 400mg, respectively (placebo >3 hours). A significantly greater proportion of subjects receiving lumiracoxib 200mg (70%) or 400mg (75%) experienced onset within 1 hour compared with those receiving placebo (30%; both p<0.001). For pain intensity difference and pain relief scores at individual timepoints (1, 2 and 3 hours), and for summed measures combining scores over 3 hours, both doses of lumiracoxib were superior to placebo (p<0.05) and generally comparable to each other. Similar results were obtained for patient global evaluation of treatment effect. No adverse events were reported. In summary, single 200mg or 400mg doses of lumiracoxib provided rapid and effective relief of pain associated with ETTH. Both lumiracoxib doses were well tolerated.