Lucas Hendrik Overeem (Berlin/ DE), Raffaele Ornello (L'Aquila/ IT), Maria Magdalena Pocora (Pavia/ IT), Aud Nome Dueland (Sandvika/ NO; Oslo/ NO), Simona Sacco (L'Aquila/ IT), Cristina Tassorelli (Pavia/ IT), Uwe Reuter (Berlin/ DE; Greifswald/ DE), Bianca Raffaelli (Berlin/ DE), Daniele Martinelli (Pavia/ IT)
Abstract text (incl. figure legends and references)
Objective
Onabotulinumtoxin A (BoNTA) is a safe and effective treatment for chronic migraine (CM). The local action of BoNTA favors the combination with oral treatments with systemic action. However, little is known about the possible interactions with other preventives. We aimed to describe pharmacological patterns in patients with CM treated with BoNTA in routine clinical care and discuss safety and efficacy according to the presence or absence of concomitant oral treatments.
Methods
In this multi-center, observational, retrospective, cohort study, we collected data from patients with CM receiving prophylactic treatment with BoNTA. We documented concomitant migraine prophylactic treatments (CcMP) and their side effects during four BoNTA treatment cycles. Additionally, we collected monthly headache days (MHDs) and monthly acute medication days (AMDs) from the patients' headache diaries. Patients with a CcMP treatment were compared with those without using a nonparametric approach.
Results
We analyzed data from 181 patients, of whom 77 (43%) received a CcMP treatment. The most prescribed concomitant treatments were antidepressants and antihypertensive drugs. Side effects caused by the CcMP treatments occurred in 18% (n=14) of the patients. Only in 4% (n=3), these adverse events (all caused by topiramate) had a significant interference with the patients" functioning. Both patients with and without CcMP treatment had a significant reduction of MHDs and AMDs (p<0.001). The reduction of MHDs, however, was significantly lower in patients with CcMP treatment (p=0.018) during the fourth treatment cycle compared to patients without any concomitant treatment.
Conclusion
In our cohort, we did not identify any unexpected safety issues in patients treated with BoNTA and a CcMP treatment. Patients with a CcMP treatment might have a smaller reduction in MHDs than those without CcMP treatments, possibly due to the high resistance to treatments in that subgroup of patients.