title: Efficacy and tolerability of sumatriptan injection for the treatment of morning migraine: two multicenter, prospective, randomized, double-blind, controlled studies in adults.
abstract: OBJECTIVE
  The aim of this study was to assess the efficacy and tolerability of sumatriptan injection in the treatment of morning migraine.
  
  
  METHODS
  In 2 multicenter (20 sites for study 1 and 25 sites for study 2), randomized, double-blind, controlled, parallel-group studies, male and female patients aged 18 to 65 years with migraine meeting International Headache Society criteria received SC sumatriptan succinate injection 6 mg or inactive vehicle (control) for the outpatient treatment of a single morning migraine, defined as migraine with moderate or severe pain on awakening. The primary end point was the percentage of patients who achieved pain-free relief (moderate or severe pain reduced to no pain) at 2 hours after treatment. Tolerability was assessed using spontaneous reporting or noted by a clinician during the studies, assessed at the return visit.
  
  
  RESULTS
  The efficacy analysis included, in the succinate group, 145 patients in study 1, 148 in study 2; control, 152 in study 1, 139 in study 2. The mean (SD) ages in the sumatriptan group were 40.2 (9.7) and 38.8 (10.1) years in studies 1 and 2, respectively; control, 41.4 (10.4) and 39.3 (9.7) years. The majority of patients in the 2 studies were female (sumatriptan, 84% and 93% in studies 1 and 2, respectively; control, 82% and 81%) and white (sumatriptan, 83% and 81%; control, 78% and 89%). Two hours after treatment, 48% and 57% of patients treated with sumatriptan injection compared with 18% and 19% of control patients reported pain-free relief in studies 1 and 2, respectively (both, P < 0.001). Two hours after treatment, 72% and 77% of patients treated with sumatriptan injection reported headache relief (moderate or severe pain reduced to mild or no pain) compared with 32% and 41% of control patients (both, P < 0.001). Onset of efficacy versus control (the first time point with statistical significance of pain relief) was observed beginning 10 minutes postdose (P < 0.05 sumatriptan injection vs placebo across pooled studies). Mean time to efficacy in the sumatriptan group was 10 minutes (P < 0.05 vs controls). The most commonly reported adverse events were nausea (sumatriptan, 6% and 4%; control, 2% and 2%) and injection-site reaction (ie, burning or stinging at the injection site) (sumatriptan, 5 % and 5%; control, 2% and 1%). Injection-site reaction was also the only adverse event considered treatment related and reported in > or =5 % of all patients.
  
  
  CONCLUSIONS
  The results of these 2 randomized, double-blind, controlled studies suggest that sumatriptan injection was effective and well tolerated in the acute treatment of morning migraine in these adults.
authors.affiliation: Palm Beach Headache Center, West Palm Beach, Florida 33407, USA. eneuro@aol.com
authors.forename: Paul
authors.initials: P
authors.lastname: Winner
authors.forename: James
authors.initials: J
authors.lastname: Adelman
authors.forename: Sheena
authors.initials: S
authors.lastname: Aurora
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Lener
authors.forename: Michael
authors.initials: M
authors.lastname: Ames
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D017366:Serotonin Receptor Agonists; D018170:Sumatriptan