★ Available in Spain, the first and only Ditan approved for the symptomatic treatment of migraine with or without aura in adults.

Migraine is a neurological disease that affects 5 million people in Spain.³underdiagnosed and undertreated² and it is the number one cause of disability in those under 50 years of age.³. Although triptans may work well in some patients with acute migraine episodes, others may not respond well or be unsuitable for available symptomatic treatment options.^4.5. For these patients, Lilly’s lasmiditan, the first and only ditan approved for the symptomatic treatment of migraine with and without aura in adults, is now available in Spain.⁶.

Migraine is characterized by recurrent episodes of moderate to severe headaches lasting 4 to 72 hours without treatment; and in patients suffering from migraine with aura, the pain is accompanied by symptoms that are usually visual or sensory and last less than an hour.¹.

According to Dr. Pablo Irimia, Consultant, Department of Neurology, University Hospital of Navarra, “A person with migraine needs to find a drug that controls the pain, and lasmiditan is a therapeutic alternative to triptans and anti-inflammatory drugs. However, with frequent migraine attacks, it is necessary to supplement treatment with preventive therapy. The goal of preventive treatment is to reduce the frequency and intensity of pain crises and improve the patient’s quality of life. Unfortunately, only 37% of patients requiring preventive treatment currently receive it.”

Lasmidistan was studied in phase III randomized, double-blind, placebo-controlled studies evaluating it as an acute treatment for migraine: two studies that assessed a single attack of migraine (the SAMURAI and SPARTAN studies);^7.8 and a study assessing efficacy during the first attack and uniformity of response across 4 attacks (the CENTURION study).⁹

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Combined analysis of SAMURAI and SAPARTAN studies¹⁰ showed that patients taking lasmiditan experienced faster pain relief and relief compared to those receiving placebo. Some indicators showed improvement within 30 minutes after treatment with 100 or 200 mg of this drug: relief of pain and most bothersome symptoms (MMS) such as photophobia, phonophobia, etc., as well as functional disability associated with migraine. Additionally, it has been shown to rapidly and completely eliminate SMM within 2 hours with a single dose.^7.8 and its effectiveness is independent of previous response to triptans.^eleven. In the CENTURION study, it showed consistency of response across multiple migraine episodes.⁹.

Dr. Irimiya further adds that “A holistic approach to migraine is key. Drugs such as lasmiditan are needed to control attacks of pain, and preventative treatment should also be given to patients who experience frequent migraines. Lasmiditan acts on serotonin receptors called 5-HT1 and does not have the vasoconstrictor effect of traditional treatments such as triptans. This is advantageous because it can be used in patients with vascular risk factors and certain cardiovascular diseases in which the use of triptans is contraindicated.”

As for the safety and tolerability of treatment, this drug has no cardiovascular contraindications.¹² and presents the profile of adverse events expected due to its central action, with dizziness being the most commonly reported adverse event.¹³. The open-label GLADIATOR study, which evaluated long-term treatment, provides information on intermittent and repeated dosing (up to 1 year), confirming good overall tolerability of the drug.¹⁴. In the CENTURION study, the incidence of adverse events, including dizziness, tended to decrease with repeated use.^9.15.

For him Dr. Jesús Porta Etessam, neurologist at the San Carlos Clinical Hospital, “Patients strive to lead a normal life and improve its quality. “This treatment is a particularly interesting option for those patients who do not respond to current treatments, have side effects, or suffer from vascular risk factors.”.

80% of migraine patients in Spain are women, the pathology affects women three times more often than men³. In fact, the most common migraine patient profile in Spain is a middle-aged woman with episodic migraine in a family situation.³. In addition, it has a strong impact and burden on the patient’s quality of life at work, family and social levels, both during crises and in periods between crises.¹

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The importance of prevention and individualization of treatment.

Treatment of migraine patients is based on three aspects: general management measures and information about the disease; preventive treatment aimed at reducing the frequency, intensity and duration of headache attacks; and symptomatic treatment aimed at controlling headache attacks and reducing symptoms.³.

Experts agree that treatment should be tailored to the patient’s needs and individualize crises. As Dr. Porta explains, “All migraine patients should find treatment that controls their pain attacks, as people with migraine experience severe disability during attacks that force them to abandon their daily activities.” For his part, Dr. Irimiya concludes that “A crisis that begins with severe pain is not the same as a crisis that progressively worsens, a crisis that awakens the patient, or a crisis that is accompanied by nausea or vomiting. Therefore, we must tailor treatment to the patient’s profile.” attacks to lead to the correct approach to the disease.”

Recommendations

1. Ashina M, Reiter Y, Smith T, et al. A randomized controlled trial of lasmiditan for four migraine attacks: results from the CENTURION trial. Cephalgia. 2021;41(3):294-304. https://doi.org/10.1177/0333102421989232

2. Pascual J, Nunez M, Panni T, et al. Burden and unmet needs of patients with migraine: results from the OVERCOME study (Spain). Pain Ther 12, 1209–1220 (2023). https://doi.org/10.1007/s40122-023-00538-6

3. Lilly’s Official Migraine Book: https://www.neurologia.lilly.es/assets/pdf/libro_blanco_de_la_migrana.pdf

4. Ailani J., and others. American Headache Society Consensus Statement: Update on the Integration of New Migraine Treatments into Clinical Practice. Headache. 2021;00:1-19

5. Bigal M, and others. Satisfaction with current migraine therapy: experience from three centers in the United States and Sweden. Headache. 2007;47:475-479

6. Vila-Pueyo M. Targeted 5-HT1F therapy for migraine. Neurotherapy. 2018;15(2):291-303

7. Godsby P.J., and others. A phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for the treatment of acute migraine. Brain. 2019;142(7):1894-1904

8. Cuba B, and others; Colonel MIG-301 study group. Lasmiditan is an effective acute treatment for migraine: a randomized phase 3 trial. Neurology. 2018;91(24):e2222-e2232

9. Ashina M, Reiter Y, Smith T, et al. Randomized controlled trial of lasmiditan for four migraine attacks; Results of the CENTURION study. Cephalgia. 2021;41(3):294-304

10. Ashina M., and others. Onset of efficacy following oral lasmiditan for the treatment of acute migraine: pooled results from two randomized, double-blind, placebo-controlled, phase 3 clinical trials. Headache. 2019;59(10):1788-1801

11. Knievel K., and others. Lasmiditan for the treatment of acute migraine: subgroup analysis by prior response to triptans. Cephalgia. Jan 2020;40(1):19-27

12. Krege J. H., and others. Safety results from phase 3 studies of lasmiditan for the treatment of acute migraine: results from SAMURAI and SPARTAN. Cephalgia. 2019;39(8):957-966

13. Brandes J.L., and others. Interim results from a prospective, randomized, open-label, phase 3 study of the long-term safety and efficacy of lasmiditan in the acute treatment of migraine (GLADIATOR study). Cephalgia. 2019;39(11):1343-1357

14. Brandes J.L., and others. Long-term safety and efficacy of lasmiditan in the acute treatment of migraine: final results of the GLADIATOR trial. Reports of cephalalgia. 2020;3

15. Tassorelli S, and others. Safety results from the CENTURION Phase 3 consensus study of lasmiditan for the treatment of acute migraine. J Headache. 2021;22(1):132

Fountain: Lilly