Effects of onabotulinumtoxinA treatment in chronic migraine patients with and without daily headache at baseline: results from the COMPEL Study

Autor: William B. Young, J. Ivan Lopez, John F. Rothrock, Amelia Orejudos, Aubrey Manack Adams, Richard B. Lipton, Andrew M. Blumenfeld
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: The Journal of Headache and Pain, Vol 20, Iss 1, Pp 1-10 (2019)
Druh dokumentu: article
ISSN: 1129-2369
1129-2377
DOI: 10.1186/s10194-018-0953-0
Popis: Abstract Background OnabotulinumtoxinA is effective in preventing chronic migraine (CM); however, the benefit of onabotulinumtoxinA in patients with CM with daily headache is unknown because these patients are typically excluded from clinical trials. This subanalysis of the COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without daily headache. Methods In total, 715 patients received onabotulinumtoxinA 155 U with or without concomitant oral preventive treatment. Patients who had complete daily diary records for the 28 days of the baseline period were stratified based on daily headache status. The primary outcome variable was reduction in headache-day frequency per 28-day period at 108 weeks (after 9 treatment cycles) relative to baseline. Exploratory outcomes included moderate to severe headache days, migraine disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire v2 [MSQ]). Adverse events and their relatedness were recorded. Results Overall, 641 patients had complete daily diary records at baseline. In patients with daily headache (n = 138) versus without (n = 503), treatment with onabotulinumtoxinA was associated with a significant mean (SD) reduction in 28-day headache-day frequency relative to baseline at week 108 (− 10.5 [9.2] vs − 12.2 [6.7], respectively; both P
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