title: Frovatriptan versus other triptans in the acute treatment of migraine: pooled analysis of three double-blind, randomized, cross-over, multicenter, Italian studies.
abstract: The objective of the study is to systematically review the efficacy and safety of frovatriptan (F) versus rizatriptan (R), zolmitriptan (Z) and almotriptan (A), through a pooled analysis of three individual studies. 414 subjects with a history of migraine with or without aura (IHS criteria) were randomized to F 2.5 mg or R 10 mg (study 1), F 2.5 mg or Z 2.5 mg (study 2), and F 2.5 mg or A 12.5 mg (study 3). The studies had an identical multicenter, randomized, double blind, cross-over design, with each of the two treatment periods lasting not more than 3 months. The number of pain free (PF) and pain relief (PR) episodes at 2 h, and the number of sustained pain free (SPF) and recurrent episodes within the 48 h were the efficacy endpoints. 346 patients were included in the intention-to-treat analysis. Rate of PF episodes at 2 h was 30% with F and 34% with comparators (p = NS). PR episodes at 2 h were 55% for F and 59% for comparators (p = NS). SPF episodes at 48 h were also similar between the two groups (22% F vs. 21% comparators). Rate of recurrence was significantly (p < 0.001) lower under F (27 vs. 40% comparators). Drug-related adverse events were significantly (p < 0.05) less under F, particularly cardiovascular symptoms. Our systematic analysis of individual studies suggests that F has a similar immediate efficacy, but a more sustained effect and a better tolerability than R, Z and A.
authors.affiliation: Clinica Neurologica, Dipartimento di Scienze Neurologiche, Università di Bologna, Via Ugo Foscolo, 7, 40123 Bologna, Italy. pietro.cortelli@unibo.it
authors.forename: Pietro
authors.initials: P
authors.lastname: Cortelli
authors.forename: Gianni
authors.initials: G
authors.lastname: Allais
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tullo
authors.forename: Chiara
authors.initials: C
authors.lastname: Benedetto
authors.forename: Dario
authors.initials: D
authors.lastname: Zava
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Gennaro
authors.initials: G
authors.lastname: Bussone
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D002227:Carbazoles / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D014363:Tryptamines / Q000627:therapeutic use*
chemical_list: D000700:Analgesics; D002227:Carbazoles; D014363:Tryptamines; C108128:frovatriptan