RESUMEN
BACKGROUND: Ibuprofen is known to be efficacious in the treatment of tension-type headache, the most common form of primary headache. A novel tablet formulation of ibuprofen sodium is more rapidly absorbed than standard ibuprofen. This study evaluated onset of analgesia and overall efficacy of ibuprofen sodium in episodic-type tension headache (ETTH) compared with standard ibuprofen and placebo. METHODS: This randomized, double-blind, single-center, parallel-group study included adults aged 18-65 years with ≥4 moderately severe ETTHs per month for 6 months. Within 45 minutes of onset of at least moderately severe ETTH, subjects were randomized 2:2:1 to receive a single oral dose of ibuprofen sodium tablets (Advil® Film Coated; 2 × 256 mg [equivalent to 400 mg standard ibuprofen]), standard ibuprofen tablets (Motrin®; 2 × 200 mg), or placebo. The coprimary end points were time-weighted sum of pain relief rating and pain intensity difference scores over 3 hours (SPRID 0-3) and time to meaningful pain relief (MPR) assessed by double-stopwatch method. RESULTS: A total of 226 subjects were randomized to ibuprofen sodium (n = 91), standard ibuprofen (n = 89), and placebo (n = 46). Demographics and baseline characteristics were comparable between treatment groups. Mean SPRID 0-3 scores were significantly superior (P < .001) for ibuprofen sodium (9.6) and standard ibuprofen (9.8) versus placebo (3.5), but were not significantly different from each other (P = .812). Time to MPR was significantly (P < .001) shorter for ibuprofen sodium and standard ibuprofen compared with placebo (median 40.6, 48.5, and >180 minutes, respectively). Time to MPR was numerically faster for ibuprofen sodium than standard ibuprofen. This difference was not statistically significant (P = .253) using the protocol-specified analysis but was (P = .022) in a post hoc analysis using the Gehan-Wilcoxon test, which assigns higher weights to earlier events. (The post hoc analysis was performed because Kaplan-Meier graphs and results for time to first perceptible relief favored ibuprofen sodium over standard ibuprofen at earlier time points.) There were no adverse events. CONCLUSIONS: This novel ibuprofen sodium tablet provided rapid, efficacious relief of ETTH and was well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov NCT01362491.
RESUMEN
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.