OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program
| Autor: | Jessica Ailani, Patrick Gillard, Sepideh F. Varon, Ronald E. DeGryse, Noah Rosen, Richard B. Lipton |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Migraine Disorders Headache impact Placebo law.invention Migraine prophylaxis 03 medical and health sciences 0302 clinical medicine Chronic Migraine Double-Blind Method Randomized controlled trial Quality of life law Internal medicine medicine Humans 030212 general & internal medicine Botulinum Toxins Type A Chronic migraine Health related quality of life business.industry MSQ Original Articles General Medicine Middle Aged medicine.disease health-related quality of life onabotulinumtoxinA Treatment Outcome Neuromuscular Agents Migraine HIT-6 Physical therapy Female prophylaxis Neurology (clinical) business 030217 neurology & neurosurgery |
| Zdroj: | Cephalalgia |
| ISSN: | 1468-2982 0333-1024 |
| Popis: | Background Chronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL). Methods Patients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively. Results A total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p Conclusions Benefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks. |
| Databáze: | OpenAIRE |
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