This is a bright example of the added value of real-world studies over clinical trials because elderly patients were not included in the original OnabotulinumtoxinA studies on chronic migraine. So the use of botulinum toxin was not prohibited in elderly patients. So why not study the outcomes of that treatment in real life? We have patients that have been treated with that kind of treatment, so why not publish in our results?
So we generated data from a real-world cohort of almost 3,000 patients...
This is a bright example of the added value of real-world studies over clinical trials because elderly patients were not included in the original OnabotulinumtoxinA studies on chronic migraine. So the use of botulinum toxin was not prohibited in elderly patients. So why not study the outcomes of that treatment in real life? We have patients that have been treated with that kind of treatment, so why not publish in our results?
So we generated data from a real-world cohort of almost 3,000 patients. Among them, we extracted a subpopulation, a subgroup of patients, aged to 65 years or older, which are not many in our clinics because we all know that migraine is a disease of the young. Still, we found that in elderly patients who continue to have migraine and chronic migraine in particular, OnabotulinumtoxinA is feasible and effective without generating new adverse events of concern. We lacked evidence about it and maybe no clinical trials would ever focus on that population. So maybe we are generating new evidence that can be the base for new consensus statements.