title: Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders.
abstract: OBJECTIVE
  The study was carried out to assess the efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treating acute migraine in patients who are non-responders to sumatriptan.
  
  
  BACKGROUND
  Many migraineurs report dissatisfaction with sumatriptan efficacy. It is unclear whether sumatriptan 100 mg non-responders will respond to other triptans.
  
  
  METHODS
  This was a randomized, placebo-controlled, double-blind study in adults with >1-year history of ICHD-II (International Classification of Headache Disorders, second edition) migraine who reported that they generally do not respond to sumatriptan (≥50% unsatisfactory response). In the baseline phase, participants treated a single moderate/severe migraine attack with open-label generic sumatriptan 100 mg. Those who continued to experience moderate/severe pain at two hours post-dose were eligible to enter the double-blind treatment phase, during which participants treated three migraine attacks in crossover fashion (two with rizatriptan 10-mg ODT, one with placebo) after being randomly assigned to one of three treatment sequences (1 : 1 : 1 ratio). The primary endpoint was two-hour pain relief.
  
  
  RESULTS
  A total of 102 (94%) participants treated at least one study migraine. Pain relief at two hours was significantly greater with rizatriptan compared with placebo (51% vs. 20%, p < .001). Response rates also favored rizatriptan on two-hour pain freedom (22% vs. 12%, p = .013) as well as 24-hour sustained pain relief (38% vs. 14%, p < .001) and sustained pain freedom (20% vs. 11%, p = .036). Treatment was generally well tolerated.
  
  
  CONCLUSIONS
  Rizatriptan 10-mg ODT was superior to placebo at providing two-hour pain relief and two-hour pain freedom in the treatment of acute migraine in those who do not respond to sumatriptan 100 mg. Rizatriptan was generally well tolerated in this population.
authors.affiliation: Merck & Co., Upper Gwynedd, PA 19454, USA. jeffrey_seeburger@merck.com
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Seeburger
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Taylor
authors.forename: Deborah
authors.initials: D
authors.lastname: Friedman
authors.forename: Lawrence
authors.initials: L
authors.lastname: Newman
authors.forename: Yang
authors.initials: Y
authors.lastname: Ge
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Hustad
authors.forename: Jeanne
authors.initials: J
authors.lastname: Lasorda
authors.forename: Xiaoyin
authors.initials: X
authors.lastname: Fan
authors.forename: David
authors.initials: D
authors.lastname: Hewitt
authors.forename: Tony
authors.initials: T
authors.lastname: Ho
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Connor
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D018170:Sumatriptan / Q000627:therapeutic use; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014363:Tryptamines / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan; D018170:Sumatriptan