Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting
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Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6 ± 10.8 years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7 ± 45.8MU onabotulinumtoxinA (Botox®) according to the PREEMPT scheme. During the study period altogether 6.5 ± 2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1 ± 36.9 weeks). 96 % of the patients reported benefit. Monthly headache days were reduced from 18.9 ± 3.9 to 8.7 ± 4.5 (p < 0.001, −53.7 %), migraine days from 16.8 ± 4.9 to 7.4 ± 4.6 (p < 0.001, −55.1 %), autonomic days from 8.6 ± 7.5 to 2.7 ± 4.2 (p < 0.001, −71.9 %) and medication days from 14.2 ± 4.6 to 8.3 ± 4.2 (p < 0.001, −71.1 %). Health-related quality of life improved by 0.6–1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4–2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6 ± 0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.
KeywordsBotulinum toxin Botox® OnabotulinumtoxinA Chronic migraine Long-term treatment Real-life setting
Compliance with ethical standards
Conflict of interest
KK and BM received travel grants and honoraria for lectures from Allergan, Ipsen and Merz. LP received travel grants from Ipsen and Merz. MK received honoraria for lectures from Allergan. DD received honoraria for consultations from Allergan, Bayer, Eisai, IAB- Interdisciplinary Working Group for Movement Disorders, Ipsen, Merz, Syntaxin and UCB. He is shareholder of Allergan and holds several patents on Botulinum Toxins. CE, DUW and DF state that they have no conflict of interest.
- Aurora SK, Dodick DW, Diener HC, DeGryse RE, Turkel CC, Lipton RB, Silberstein SD (2014) OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 129:61–70. doi: 10.1111/ane.12171 CrossRefPubMedPubMedCentralGoogle Scholar
- Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of OnabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program: October 2010. Headache J Head Face Pain 50:1406–1418. doi: 10.1111/j.1526-4610.2010.01766.x CrossRefGoogle Scholar
- Diener HC, Weimar C (2012) Therapie der Migräne. In: Leitlinien für Diagnostik und Therapie in der Neurologie. Thieme Verlag, StuttgartGoogle Scholar
- Dodick D, Mauskop A, Elkind A, DeGryse R, Brin M, Silberstein S (2005) Botulinum toxin type a for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study. Headache 45:315–324CrossRefPubMedGoogle Scholar
- Sandrini G, Perrotta A, Tassorelli C, Torelli P, Brighina F, Sances G, Nappi G (2011) Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study. J Headache Pain 12:427–433. doi: 10.1007/s10194-011-0339-z CrossRefPubMedPubMedCentralGoogle Scholar