Frovatriptan versus zolmitriptan for the acute treatment of migraine: a double-blind, randomized, multicenter, Italian study.
The objective of this study is to assess patients' satisfaction with migraine treatment with frovatriptan (F) or zolmitriptan (Z), by preference questionnaire. 133 subjects with a history of migraine with or without aura (IHS criteria) were randomized to F 2.5 mg or Z 2.5 mg. The study had a multicenter, randomized, double-blind, cross-over design, with each of the two treatment periods lasting no more than 3 months. At the end of the study, patients were asked to assign preference to one of the treatments (primary endpoint). The number of pain-free (PF) and pain-relief (PR) episodes at 2 h, and number of recurrent and sustained pain-free (SPF) episodes within 48 h were the secondary study endpoints. Seventy-seven percent of patients expressed a preference. Average score of preference was 2.9 +/- 1.3 (F) versus 3.0 +/- 1.3 (Z; p = NS). Rate of PF episodes at 2 h was 26% with F and 31% with Z (p = NS). PR episodes at 2 h were 57% for F and 58% for Z (p = NS). Rate of recurrence was 21 (F) and 24% (Z; p = NS). Time to recurrence within 48 h was better for F especially between 4 and 16 h (p < 0.05). SPF episodes were 18 (F) versus 22% (Z; p = NS). Drug-related adverse events were significantly (p < 0.05) less under F (3 vs. 10). In conclusion, our study suggests that F has a similar efficacy of Z, with some advantage as regards tolerability and recurrence.
Tullo
Vincenzo
V
Department of Clinical Neurosciences, National Neurological Institute Carlo Besta, Via Celoria 11, 20133, Milan, Italy.
Allais
Gianni
G
Ferrari
Michel D
MD
Curone
Marcella
M
Mea
Eliana
E
Omboni
Stefano
S
Benedetto
Chiara
C
Zava
Dario
D
Bussone
Gennaro
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D002227:Carbazoles / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D023303:Oxazolidinones / Q000627:therapeutic use*; D010147:Pain Measurement; D017060:Patient Satisfaction; D018579:Patient Selection; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014363:Tryptamines / Q000627:therapeutic use*
D002227:Carbazoles; D023303:Oxazolidinones; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C089750:zolmitriptan; C108128:frovatriptan
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