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. 2015:17:1.
doi: 10.1186/s10194-016-0591-3. Epub 2016 Jan 21.

A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience

Andrea Negro  1   2   3 , Martina Curto  4   5   6 , Luana Lionetto  7 , Paolo Martelletti  8   4
Affiliations

A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience

Andrea Negro et al. J Headache Pain. 2015.

Abstract

Background: The efficacy and safety of OnabotulinumtoxinA (BOTOX®) in adults with chronic migraine (CM) were demonstrated in the PREEMPT program. However, the dosage used in this study was flexible from 155 U to 195 U at the physician's discretion. Therefore, the objective of this prospective study was to compare the efficacy and safety of OnabotulinumtoxinA 195 U vs. 155 U for the treatment of CM and medication overuse headache (MOH) during a 2-year period.

Methods: We prospectively evaluated the mean reduction in headache days, migraine days, acute pain medication intake days and Headache Impact Test (HIT)-6 score in 172 patients injected with OnabotulinumtoxinA 195 U. Successively, we compared the efficacy measures with data of 155 patients injected with OnabotulinumtoxinA 155 U and followed up for 2 years. All patients were affected by CM and MOH, and failed one or more previous detoxification and preventative therapies.

Results: Both OnabotulinumtoxinA 195 U and 155 U reduced significantly the number of headache and migraine days, acute pain medication intake days and HIT-6 score, when compared with the baseline measures. Nevertheless, OnabotulinumtoxinA 195 U proved to be superior of 155 U in all efficacy measures since the first injection and for all the 2 years of treatment, with the exception of the reduction in pain medication intake days that resulted significantly larger with 195 U only after the 4th injection. The safety and tolerability of the two doses were similar and treatment related adverse events were transient and mild-moderate.

Conclusions: This study represents the largest and longest post-marketing studies of doses comparison with OnabotulinumtoxinA in a real-life clinical setting. Here, we demonstrate the superior efficacy of OnabotulinumtoxinA 195 U compared to 155 U in CM patients with MOH during a 2-year treatment period with similar safety and tolerability profile.

Keywords: Chronic migraine; Medication overuse headache; Migraine abuse; OnabotulinumtoxinA; Preventative therapy.

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Figures

Fig. 1
Fig. 1
Comparison of the mean change in frequency of headache days in the OnabotulinumtoxinA 155 U and 195 U treated groups. *p < 0.001
Fig. 2
Fig. 2
Comparison of the mean change in frequency of migraine days in the OnabotulinumtoxinA 155 U and 195 U treated groups. *p < 0.001
Fig. 3
Fig. 3
Comparison of the mean change in pain medication intake days in the OnabotulinumtoxinA 155 U and 195 U treated groups. *p < 0.001
Fig. 4
Fig. 4
Comparison of the mean change in HIT-6 score in the OnabotulinumtoxinA 155 U and 195 U treated groups. *p ≤ 0.002. **p < 0.05
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