2023-08-24 17:15:36
An international phase III clinical trial demonstrates the efficacy of atogepant (or atogepant), an oral drug in preventing chronic migraine.
The trial has been led from the Vall d’Hebron Research Institute (VHIR) in Barcelona.
In the study, carried out on more than 770 people, it has been determined that the atogepant reduces the frequency of migraine attacks and the need to take medication.
Chronic migraine is characterized by the presence of 15 days a month with headache, which is very disabling and has a great impact on the quality of life of the people who suffer from it. Until now, these patients only had the option of injectable or intravenous treatments. However, the recent phase III international clinical trial, in which the Headache and Neurological Pain group of the Vall d’Hebron Research Institute (VHIR) has participated, has shown the efficacy of the 60 mg oral atomying drug for the prevention of attacks of migraine in cases of chronic migraine.
The study was led by Dr. Patricia Pozo-Rosich, Section Head of the Neurology Service and Headache Unit at Vall d’Hebron University Hospital, Head of the VHIR Headache and Neurological Pain group and director of the MABC (Migraine Adaptive Brain Center) of Vall d’Hebron and it has been possible to carry it out thanks to the collaboration of more than 140 centers from 16 countries.
Dr. Patricia Pozo-Rosich. (Photo: VHIR)
Atogepant is an inhibitor of the CGRP protein, which is released during migraine attacks. Recently, monoclonal antibodies that block CGRP have been approved, and are representing a therapeutic revolution for patients with migraine, but, until now, it was only available in a subcutaneous or intravenous injectable format. “Atogepant is the first oral drug that can be useful for patients with chronic migraine, which makes it easier to access, there is more flexibility in drug administration and it is easier to maintain, since the injectable is used to need to be kept in a fridge”, explains Dr. Patricia Pozo-Rosich.
This drug demonstrated positive results in a study with patients with episodic migraine, that is, in people who had less than 15 migraine days per month. The objective of the study presented now was to study its efficacy for the prevention of chronic migraine. To do this, the trial included 778 people between the ages of 18 and 74 with chronic migraine, who were classified into three groups according to the medication they were taking. People in one group were taking 30 mg of atogepant twice a day, those in the other group were taking 60 mg once a day, and those in the third group were taking a placebo.
The results of the study showed that people taking the drug had, on average, seven fewer migraine days each month, regardless of whether they took 30 mg twice a day or 60 mg once a day. In contrast, people in the placebo group had only five fewer migraine days per month. This difference is statistically significant. The study followed the patients for 12 months and confirmed that the improvement was maintained, especially in the group taking 30 mg twice daily.
“Chronic migraine is a very debilitating disease with a great impact on society, since it affects approximately 2% of the population and is the most serious expression of the disease,” says Dr. Pozo-Rosich, who assures that “these results are encouraging, since we have observed that this treatment reduces the days in which people have migraines. This means an improvement in their quality of life”.
On the other hand, it also stands out that the fact of taking autogepant reduces the need to take medication to stop migraine attacks once they appear. Regarding the side effects of the medication, the most common were constipation or nausea, but none were found to be serious.
“We have confirmed that atogepant is a safe, well-tolerated and effective treatment for people with severely disabling migraines. The results of this work offer new opportunities to prevent and treat these patients”, says Dr. Pozo-Rosich.
Based on the good results of atogepant, researchers have also analyzed its efficacy in patients with episodic migraine, who have less than 15 migraines per month, but do not respond to treatment (refractory migraine). The study was presented in April at the 75th Annual Meeting of the American Academy of Neurology.
In this case, the trial was carried out with 309 people who had at least four migraine days per month and who had previously tried between two and four types of migraine prevention drugs, but without improvement. Half of them took atogepant orally, while the other half took a placebo in order to compare the results obtained.
The results of the study showed that people taking the drug had, on average, four fewer migraine days each month, while those taking placebo had only two fewer migraine days per month. As in the case of chronic migraine, it also highlights that taking autogepant reduces the need to take medication without observing serious side effects.
“We think that atogepant is a very complete drug. We are seeing that, thanks to its efficacy and tolerability, it is working in all the spectrums of the disease and it will be useful for the prevention of migraine in many different types of patients”, concludes Dr. Pozo-Rosich.
The new study is titled “Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomized, double-blind, placebo-controlled, phase 3 trial.” And it has been published in the academic journal The Lancet. (Source: VHIR)
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