Reference : Early clinical experience with subcutaneous naratriptan in the acute treatment of mig...
Scientific journals : Article
Human health sciences : Neurology
Social & behavioral sciences, psychology : Neurosciences & behavior
http://hdl.handle.net/2268/24464
Early clinical experience with subcutaneous naratriptan in the acute treatment of migraine: a dose-ranging study.
English
Dahlof, C. [> > > >]
Hogenhuis, L. [> > > >]
Olesen, J. [> > > >]
Petit, H. [> > > >]
Ribbat, J. [> > > >]
Schoenen, Jean mailto [Université de Liège - ULg > Département des sciences biomédicales et précliniques > Neuro-anatomie >]
Boswell, D. [> > > >]
Fuseau, E. [> > > >]
Hassani, H. [> > > >]
Winter, P. [> > > >]
1998
European Journal of Neurology
Blackwell Science
5
5
469-477
Yes (verified by ORBi)
International
1351-5101
1468-1331
Oxford
United Kingdom
[en] Naratriptan is a novel, potent agonist at the 5HT1B/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 (tmax = 10 min) and the half-life was 5 h. In conclusion, sc naratriptan was an effective and well-tolerated acute treatment for migraine. Copyright 1998 Lippincott Williams & Wilkins
http://hdl.handle.net/2268/24464

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