What are the latest breakthroughs and challenges in migraine treatment?
It is a great moment for migraine treatment because we have new drugs for the prevention of acute attacks. The first of those new drugs, erenumab, is already available in the USA and hopefully it will soon become available in other countries. Other drugs such as fremanezumab, galcanezumab and eptinezumab are on the way.
The new drugs are monoclonal antibodies which act on the calcitonin gene-related peptide pathway. Available studies indicated that those drugs are effective for migraine prevention. Additionally, they have a good tolerability profile and ease of use because they can be administered via subcutaneous injections once a month or even quarterly.
They will offer a substantial improvement to the treatment of the disease as currently available drugs are associated with poor adherence to treatment because of side-effects, lack of the expected benefits from patients, and poor compliance with the daily intake. The shortcoming of the new drugs is represented by the costs which will be high limiting the number of patients who will benefit from them.
What is the aim of the consensus article and what are you hoping to achieve for patients and physicians?
Migraine mostly affects women in their reproductive age and the issue of hormonal contraception in women with migraine is very common in the daily clinical practice. A joint group of experts in headache, hormonal contraception, and stroke developed two consensus documents on the use of hormonal contraception in women with migraine. The documents were supported by the European Headache Federation (EHF) and the European Society of Hormonal Contraception and Reproductive Health.
The aim of the documents was to provide suggestions useful for the everyday clinical practice. On one side, there are the headache specialists who treat migraine patients but who do not have in some instances sufficient knowledge of the benefits and harms of all the possible contraceptive options. On the other side, we have the gynecologists who know hormonal contraceptives but may pay not enough attention to the presence of migraine.
In the two consensus papers, we pooled together the knowledge in the two areas in order to improve the use of hormonal contraceptives in women with migraine.
Would you like to pick out relevant examples to illustrate the importance of the findings from the consensus article?
I can give you two examples each referring to one of the two consensus documents.
The first consensus article was about safety as the use of hormonal contraceptive containing estrogens increases the risk of ischemic stroke in women with migraine and especially in those with migraine with aura. I’ve recently admitted to my hospital a woman aged 37 years who developed a left hemispheric ischemic stroke. After extensive investigations, the only evident factors which could have triggered the stroke were a history of migraine with aura and the recent initiation of an oral combined hormonal contraceptive containing 30 mcg of ethinylestradiol.
This young woman was left with a serious disability. By applying our guidelines this stroke would probably have been prevented as the use of the combined hormonal contraceptive was contraindicated because the woman had migraine with aura.
The second consensus article was about the impact of exogenous sexual hormones on the course of migraine. I can provide the example of a 24 years old woman with polycystic ovary syndrome and dysmenorrhea who started treatment with a 24/7 combined hormonal pill following the suggestion of her gynecologist. The woman experienced worsening of her previous migraine without aura attacks soon after the first cycle of treatment. The pain was particularly severe and occurred during the pill-free week. In this case the replacement of the 24/7 pill with an oral extended combined hormonal contraceptive regimen led to improvement of the attacks.
The two examples point out the two main points of our documents: safe use of hormonal contraception in women with migraine and impact of hormones on the course of migraine. Applying the guidelines, we can prevent ischemic stroke, improve migraine, and avoid worsening related to the use of hormonal contraception.
Tell us more about the process and efforts of getting this document together, how long did it take and what challenges did you encounter?
It took about a year each to develop the documents. Both were developed according to a standardized methodology which implied systematic review to get evidence-based recommendations. The major challenge was that in this field the quality of scientific evidence is low and recommendations were mostly based on experts’ opinions.
As you can imagine, it is not easy to agree about something when evidence is limited. The discussion on some recommendations was very animated and several rounds of revisions were needed to agree on a shared recommendation. We cannot guarantee that some of our recommendations won’t change in the next years as new evidence becomes available.
In your view what are the most important goals?
I think that there are two important goals of our documents. The first is to provide guidelines which can be easily applied in the everyday clinical practice by those who are involved in the care of women with migraine and in the prescription of hormonal contraceptives. Hopefully, the consensus documents will be valuable also for the general practitioners who are the main care providers for many women.
Secondly, we hope that the documents may foster further research on this topic to provide evidences to further improve current knowledge.