A key opinion leader considers the importance of the pain freedom end point, and discusses the American Headache Society (AHS) and American Academy of Neurology (AAN) guidelines for the treatment of acute setting.
Amaal J. Starling, MD: It’s important to consider the practical importance of pain freedom versus pain relief. I may have a bit of a biased opinion regarding this because my practice is in a tertiary headache center. The majority of my patients have chronic migraine. Pain freedom is a wonderful goal, and I hope that the majority of my patients with acute migraine treatment options can achieve pain freedom. That is always the ultimate goal. Pain relief from a medication is also a good goal. I understand why, from a clinical trial perspective, it is important for the FDA to have very clear guidelines for pain freedom. It’s a very black-or-white way to compare trials without having head-to-head trials to be able to compare medications and approve medications.
If I also have data from trials that provide medications with pain relief, that’s very important because I can combine medications. If I know that a medication like a triptan provides some pain relief, I can combine that with an NSAID [nonsteroidal anti-inflammatory drug] as well as a neuroleptic medication, like a promethazine, naproxen, and a triptan for a very complicated chronic migraine patient having an acute exacerbation. Together with that combination of medications, if I can get them back to their baseline and out of that migraine attack, it may be helpful. Although pain freedom is a very important clinical end point in trials and does have practical importance in the clinic, pain relief also provides good clinical information for my patient and me when we’re sitting together brainstorming about options for migraine attack treatment.
From a migraine treatment perspective, based on the American Headache Society and American Academy of Neurology guidelines, the most important thing is to remember that we do have migraine-specific therapies that can be used for the treatment of migraine. Although simple analgesics do have some evidence, the majority of patients who have come to a neurologist for the treatment of migraine have already tried those treatment options. We need to use more migraine-specific treatment options such as triptans, or medications like lasmiditan, gepants like ubrogepant and rimegepant, or even device options that have been specifically designed based on what is happening in the brain in migraine. Then we can also use a combination of these treatment options, in combination with neuroleptic medications, to appropriately treat that patient with migraine.
Based on those guidelines, we should personalize the treatment for that patient’s migraine attack. If a patient is having a lot of nausea and vomiting, we want to be able to optimize their formulation. If a person is having a lot of vomiting, we want to be able to use nasal spray formulations, orally disintegrating tablets, injections if we need to, or even devices. We want to personalize the treatment options and use migraine-specific treatment options.
In the guidelines, it also mentions that when you need to use acute migraine therapies too frequently, you need to start talking about medication-overuse headache, and you need to start thinking about initiating preventive treatment options. These are guidelines that you should talk to patients about whenever you are prescribing your acute medications. Whenever you are prescribing acute medications, have the discussion with patients right away that these are medications that patients should be using 1 to 2 times per week. If patients need acute migraine therapies more than 1 to 2 times per week, then we need to initiate a conversation about prevention to prevent medication overuse headache, which is a complication of frequent migraine attacks in chronic migraine.