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Consistency of Return to Normal Function, Productivity, and Satisfaction Following Migraine Attacks Treated With Sumatriptan/Naproxen Sodium Combination.
- Source :
-
Headache: The Journal of Head & Face Pain . Apr2014, Vol. 54 Issue 4, p640-654. 15p. - Publication Year :
- 2014
-
Abstract
- Objectives To assess the consistency of improved functioning, productivity, and medication satisfaction in migraines treated with a single tablet of sumatriptan 85 mg/naproxen sodium 500 mg ( S/ NS) using an early intervention approach. Methods Two randomized, double-blind, placebo-controlled, 4-period crossover, multi-attack, multi-center, outpatient studies of moderate to severe adult migraineurs were conducted to compare S/ NS with placebo. Participants recorded outcome assessments in a diary during the 24 hours following study medication. Analyses were conducted on the intent-to-treat population who treated at least 1 attack. Statistical significance between treatment groups used analysis of variance repeated measures models and the intent-to-treat population. There were no corrections for multiplicity. Results Almost half (48.5%) of migraineurs treated with S/ NS returned to normal functioning at 2 hours and 73.3% at 4 hours postdose, compared with 28.7% (2 hours) and 43.3% (4 hours) of placebo-treated attacks. Total productivity loss over the 24 hours postdose was significantly reduced following S/ NS treatment (2.5 hours on average) compared with placebo (4.0 hours). Sumatriptan/naproxen treatment resulted in significantly higher medication satisfaction scores on the efficacy, functionality, and total efficacy subscales compared with placebo in all attacks in both studies. Sumatriptan/naproxen treatment also provided significantly greater ease of use in 7 of the 8 attacks. Although tolerability was high in both treatment groups (over 90%), the placebo group was significantly less bothered by side effects in 6 of 8 attacks. Conclusion Results from these 2 randomized, double-blind, placebo-controlled, multi-attack, crossover studies demonstrated the rapid and consistent restoration of patients' functioning, the consistent reduction in productivity loss, and high satisfaction ratings from patients treating multiple migraine attacks with S/ NS using an early intervention approach. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ANALYSIS of variance
*COMBINATION drug therapy
*CROSSOVER trials
*LABOR productivity
*MIGRAINE
*NAPROXEN
*HEALTH outcome assessment
*PATIENT satisfaction
*QUESTIONNAIRES
*RESEARCH funding
*SUMATRIPTAN
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*REPEATED measures design
*BLIND experiment
*DESCRIPTIVE statistics
Subjects
Details
- Language :
- English
- ISSN :
- 00178748
- Volume :
- 54
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Headache: The Journal of Head & Face Pain
- Publication Type :
- Academic Journal
- Accession number :
- 95344921
- Full Text :
- https://doi.org/10.1111/head.12214