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Early clinical experience with subcutaneous naratriptan in the acute treatment of migraine: a dose‐ranging study
Author(s) -
Dahlöf Carl,
Hogenhuis Leon,
Olesen Jes,
Petit Henri,
Ribbat Jacques,
Schoenen Jean,
Boswell Diane,
Fuseau Eliane,
Hassani Habib,
Winter Paul
Publication year - 1998
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1046/j.1468-1331.1998.550469.x
Subject(s) - sumatriptan , medicine , placebo , dose ranging study , tolerability , migraine , anesthesia , adverse effect , phonophobia , pharmacokinetics , agonist , double blind , aura , alternative medicine , receptor , pathology
Naratriptan is a novel, potent agonist at the 5HT 1B/1D receptor. A total of 335 migraine patients were treated in this randomized, double‐blind, placebo‐controlled, dose‐ranging, in‐clinic study, to evaluate the efficacy, safety and tolerability of five doses of subcutaneous (sc) naratriptan (0.5, 1, 2.5, 5 or 10 mg) in comparison with sc sumatriptan (6 mg) and placebo in the acute treatment of a moderate/severe migraine attack. Headache relief [reduction of headache severity from moderate or severe (grade 2/3) to mild or none (grade 1/0)] at 1 and 2 h after each dose, was reported by a statistically significantly higher proportion of patients for all doses of sc naratriptan and sc sumatriptan (6 mg) than for placebo. The percentages of patients with headache relief at 2 h post‐dose were: naratriptan (0.5 mg) 65%, (1 mg) 75%, (2.5 mg) 83%, (5 mg) 94% and (10 mg) 91%; sumatriptan (6 mg) 89%; placebo 41%, ( P < 0.005). The earliest report of a statistically significant difference compared with placebo for the times assessed was with sc naratriptan (10 mg) at 10 min post‐dose ( P = 0.023). The percentages of patients reporting adverse events were dose‐related; sc naratriptan (0.5 mg) 33%, (1 mg) 29%, (2.5 mg) 43%, (5 mg) 59% and (10 mg) 71%; sc sumatriptan 53%; placebo 22%. There were no clinically significant changes in electrocardiogram (ECG), vital signs or laboratory parameters. Systemic exposure increased proportionally to the dose, the absorption of sc naratriptan was rapid (t max = 10 min) and the half‐life was 5 h. In conclusion, sc naratriptan was an effective and well‐tolerated acute treatment for migraine.