Efficacy of sumatriptan tablets in migraineurs self-described or physician-diagnosed as having sinus headache: A randomized, double-blind, placebo-controlled study

Abstract Background: Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as “sinus’ headache, while ignoring the possible diagnosis of migraine. Objective: The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients with migraine presenting with “sinus” headache. Methods: A randomized, double-blind, placebo-controlled, multicenter study was conducted in adult (aged 18–65 years) migraine patients presenting with self-described or physician-diagnosed “sinus” headache. From November 2001 to March 2002, patients meeting International Headache Society criteria for migraine (with ≥2 of the following: unilateral location, pulsating quality, moderate or severe intensity, aggravation by moderate physical activity; and ≥1 of: phonophobia and phonophobia, nausea and/or vomiting) and with no evidence of bacterial rhinosinusitis were enrolled and randomized in a 1:1 ratio via computer-generated randomization schedule to receive either 1 sumatriptan 50-mg tablet or matching placebo tablet. The primary efficacy end point was headache response (moderate or severe headache pain reduced to mild or no headache pain) at 2 hours after administration. The presence or absence of migraine-associated symptoms and sinus and nasal symptoms was also measured. Tolerability was assessed through patient-reported adverse events (AEs). Results: Two hundred sixteen patients with self-described or physician-diagnosed “sinus” headache received a migraine diagnosis and treated 1 migraine attack with sumatriptan 50 mg. The efficacy (intentto-treat) analysis included 215 patients treated with sumatriptan 50 mg (n = 108; mean [SD] age, 39.6 [12.3] years; mean [SD] weight, 77.7 [17.7] kg; sex, 71% female; race, 69% white) or placebo (n = 107; mean [SD] age, 41.0 [11.3] years; mean [SD] weight 80.7 [20.9] kg; sex, 69% female; race, 64% white). Significantly more patients treated with sumatriptan 50 mg achieved a positive headache response at 2 and 4 hours after administration compared with those treated with placebo (69% vs 43% at 2 hours and 76% vs 49% at 4 hours, respectively; both, P < 0.001). Significantly more sumatriptan-treated patients were free from sinus pain compared with placebo recipients at 2 hours (63% vs 49% placebo, P = 0.049) and 4 hours (77% vs 55%, P = 0.001). All treatments were generally well tolerated. The most common drug-related AEs reported in the sumatriptan and