Effects of a fast disintegrating/ rapid release oral formulation of sumatriptan on functional ability in patients with migraine
- 21 October 2004
- journal article
- clinical trial
- Published by Informa Healthcare in Current Medical Research and Opinion
- Vol. 20 (12) , 2021-2029
- https://doi.org/10.1185/030079904x15200
Abstract
Background: A new oral form of sumatriptan has been developed to facilitate tablet disintegration and drug dispersion and to mitigate the effects of gastric stasis that can accompany migraine. Objective: To evaluate the effects on functional ability of the new fast disintegrating/rapid release formulation of sumatriptan. Methods: Sumatriptan 50 mg (n = 137), 100 mg (n = 142), or placebo (n = 153) was administered early when pain was mild for the acute treatment of a single migraine attack in a randomized, double-blind, parallel-group, placebo-controlled clinical trial. For this report, main health-outcomes endpoints (which were secondary endpoints for this clinical trial that was primarily designed to assess pain-free efficacy) included functional ability measured through 2 h postdose on a 5-point scale and lost time equivalents, a composite measure of migraine-associated time missed from activities, and reduced effectiveness at activities through 24 h postdose. Results: Normal functional ability was restored in a significantly ( p < 0.05) greater percentage of patients treated with sumatriptan than placebo beginning 45 min postdose for sumatriptan 100 mg and 1 h postdose for sumatriptan 50 mg. During the 24 h after initial dosing, the median (range) lost time equivalents for the combination of paid work activities and activities outside of paid work were significantly lower in the groups treated with sumatriptan (1.1 [0–10] sumatriptan 100 mg; 0.8 [0–36] sumatriptan 50 mg) compared with placebo (2.9 [0–24]) ( p ≤ 0.01 each sumatriptan group versus placebo). The corresponding mean ± SD values for lost time equivalents were 1.9 ± 2.3 and 2.5 ± 4.7 for sumatriptan 100 mg and 50 mg, respectively, compared with 3.5 ± 4.3 for placebo. Conclusion: A new oral sumatriptan formulation confers rapid, sustained restoration of functional ability in the acute treatment of migraine so that patients can return rapidly to normal functioning at work and outside of work.Keywords
This publication has 18 references indexed in Scilit:
- The Economic Impact of Migraine: An Analysis of Direct and Indirect CostsHeadache: The Journal of Head and Face Pain, 2002
- Mixing Sumatriptan: A Prospective Study of Stratified Care Using Multiple FormulationsHeadache: The Journal of Head and Face Pain, 2001
- Workplace ProductivityPharmacoEconomics, 2001
- Effect of early intervention with sumatriptan on migraine pain: Retrospective analyses of data from three clinical trialsClinical Therapeutics, 2000
- Burden of Migraine in the United StatesArchives of internal medicine (1960), 1999
- Oral Sumatriptan Pharmacokinetics in the Migraine StateClinical Drug Investigation, 1999
- Measuring the Functional Status and Well‐Being of Patients with Migraine HeadacheHeadache: The Journal of Head and Face Pain, 1994
- Assessment of Health-Related Quality of Life in MigraineCephalalgia, 1993
- Impact of Migraine in the United States: Data from the National Health Interview SurveyHeadache: The Journal of Head and Face Pain, 1993
- Migraine and Drug AbsorptionClinical Pharmacokinetics, 1978