PMID- 17379050 OWN - NLM STAT- MEDLINE DCOM- 20070807 LR - 20131121 IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 29 IP - 1 DP - 2007 Jan TI - Efficacy of sumatriptan tablets in migraineurs self-described or physician-diagnosed as having sinus headache: a randomized, double-blind, placebo-controlled study. PG - 99-109 AB - 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 > or =2 of the following: unilateral location, pulsating quality, moderate or severe intensity, aggravation by moderate physical activity; and > or =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 (intent-to-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 placebo groups, respectively, were dizziness (5% vs < 1%), nausea (3% vs 2%), other pressure/tightness (defined as sense of heaviness; heaviness of upper body, upper extremities; jaw tension; neck tension) (4% vs 0%), and temperature sensations (defined as warm feeling of back of neck, or flushing) (2% vs 0%). No patients experienced any serious AEs. CONCLUSIONS: Sumatriptan 50-mg tablets were effective and generally well tolerated in the treatment of these patients presenting with migraine headaches that were self-described or physician-diagnosed as sinus headaches. FAU - Ishkanian, Gary AU - Ishkanian G AD - Elkind Headache Center, Mount Vernon, New York 10550, USA. gishkanian@optonline.net FAU - Blumenthal, Harvey AU - Blumenthal H FAU - Webster, Christopher J AU - Webster CJ FAU - Richardson, Mary S AU - Richardson MS FAU - Ames, Michael AU - Ames M LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Serotonin Receptor Agonists) RN - 0 (Vasoconstrictor Agents) RN - 8R78F6L9VO (Sumatriptan) SB - IM MH - Administration, Oral MH - Adolescent MH - Adult MH - Aged MH - Dizziness/chemically induced MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Migraine with Aura/classification/diagnosis/*drug therapy MH - Migraine without Aura/classification/diagnosis/*drug therapy MH - Nausea/chemically induced MH - Paranasal Sinuses/drug effects MH - Serotonin Receptor Agonists/adverse effects/*therapeutic use MH - Sumatriptan/adverse effects/*therapeutic use MH - Vasoconstrictor Agents/adverse effects/*therapeutic use EDAT- 2007/03/24 09:00 MHDA- 2007/08/08 09:00 CRDT- 2007/03/24 09:00 PHST- 2006/10/23 00:00 [accepted] PHST- 2007/03/24 09:00 [pubmed] PHST- 2007/08/08 09:00 [medline] PHST- 2007/03/24 09:00 [entrez] AID - S0149-2918(07)00026-4 [pii] AID - 10.1016/j.clinthera.2007.01.012 [doi] PST - ppublish SO - Clin Ther. 2007 Jan;29(1):99-109. doi: 10.1016/j.clinthera.2007.01.012.