EAN 2025 | A pilot prospective observational study exploring GLP-1R agonists in the treatment of migraine

This was basically an open-label study in which we enrolled patients with obesity and migraine, because the drug is currently labeled as you know for obesity and diabetes. And we assessed before and after three months the monthly headache frequency following liraglutide administration. Liraglutide was administered 1.2 mg per day, daily, and the findings are pretty straightforward in the sense that monthly headache days basically halved, and patients experienced approximately 10 days less per month with headache, which is a huge result. Of course, since this was an open-label study, we did not have a comparator placebo arm, which is something that we want to do in the near future, like in a randomized clinical trial. This was just a pilot prospective study, and we are very happy with that, but this has to be the foundation of larger multicenter randomized control studies. We do believe that GLP-1 agonists might have exerted in this study their beneficial effect in headache by lowering ICP pressure, which means intracranial pressure, basically. We think that this mechanism of action could be the one underlying their therapeutic benefit. Of course, this is just our speculation, but it comes from many years of thinking that derangement in intracranial pressure control, although milder, although intermittent, and not sufficient to cause the development of papilledema or overt intracranial hypertension, could be nonetheless one of the pathophysiological mechanisms of migraine. For this idea, our group led by Professor Roberto De Simone has been in the forefront, I would say, over the last 10 or 15 years. And right now, this is one of the first major evidences supporting this concept, although I want to be clear that this is just preliminary evidence, we have to confirm it. Right now, we can only say that obese patients can benefit from this because this is the only evidence that we have so far. However, our study demonstrated also that the beneficial effect was not to be attributed to weight loss. So weight loss did not have anything to do with the beneficial effect in monthly headache frequency. Therefore, right now we only have data on obese patients, but since the mechanisms of action probably does not really relate with weight loss, we hope that in the future we can extend the administration of the drug also to other kinds of patients, and not only obese ones, but right now only obese ones. If this study is worth to be confirmed by subsequent larger randomized controlled studies, probably GLP-1 agonists could indeed become one of the options for treating migraine. Right now we cannot really say that, this is just a very promising, I would say, avenue, but it needs to be confirmed.

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