Long-term open-label and real-world studies of lasmiditan, ubrogepant, and rimegepant for the acute treatment of migraine attacks

Abstract

Background Long-term data helps assess the consistency of efficacy, tolerability, and safety of acute treatment over repeated use for different attacks. Real-world studies help assess tolerability, safety, and efficacy in patients with possibly refractory chronic migraine, more comorbidities, other diseases such as cardiovascular diseases, and polypharmacy. Methods This is a narrative review of the long-term open-label and real-world studies of lasmiditan, ubrogepant, and rimegepant for the acute treatment of migraine. Both manuscripts and abstracts were reviewed. Results The efficacy and tolerability of lasmiditan, ubrogepant, and rimegepant are maintained over time. No significant cardiovascular adverse events were thought to be related to any of these medications. The rare instances of palpitations and/or tachycardia occurred within 48 hours of lasmiditan. One participant with a history of supraventricular tachycardia had sinus tachycardia thought to be related to ubrogepant which did not recur despite continued use. One case of thrombocytopenia and two cases of increased aspartate aminotransferase and alanine transaminase were thought to be possibly related, but the alanine transaminase and aspartate aminotransferase levels normalized despite continued use of ubrogepant. A case of first-degree atrioventricular block was considered possibly related to rimegepant. Acute use of rimegepant was associated with a decrease in monthly migraine days over time. The three medications were associated with improvement in function and/or productivity. Conclusion Long-term and real-world data of tolerability, safety and efficacy of lasmiditan, ubrogepant, and rimegepant is thus far consistent with prior studies, but more longitudinal data that clarifies long-term safety as well as consistency and predictors of response is needed.

Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature

“…Further, study populations tended to be very homogeneous, as most studies excluded either non-responders, patients with medication overuse or patients with chronic migraine, limiting their generalizability. Some of these aspects are investigated with more detail in other papers within this Special Collection (37,38). Moreover, placebo response rate variations for two-hour pain free outcomes vary by nearly two-fold, which offers caution in terms of consistency of effect as a key assumption in network meta-analysis (39).…”

New migraine drugs

“…The International Headache Society deems, therefore, that the composition of the author groups will provide a presentation of the efficacy and potential side effects or safety aspects of the new drugs for the treatment of acute migraine attacks and for the prevention of migraine that is as objective as possible and can be used for clinical practice. In addition to meta-analyses of efficacy and tolerability or safety for both acute and preventive medications (1–3), some of the publications address practical aspects of use, such as migraine prevention in patients with medication overuse or medication overuse headache (4), the results of open-label long-term studies for both drugs for acute therapy (5) and for migraine prophylaxis (6), and other aspects such as nonresponders to previous therapies, combination therapy switching, and termination of therapy (7,8).…”

Neues bei Kopfschmerzen 2022–2023

“…Post-hoc-Analysen ergaben keine Unterschiede in der Wirksamkeit von Gepanten und Lasmiditan bei Personen, bei denen Triptane nicht oder nicht ausreichend wirksam waren [20], d. h. die neuen Substanzen könnten für Patienten eine Therapieoption darstellen, die bisher nur unzureichend behandelt werden konnten. Die Interpretation der Ergebnisse ist schwierig, da es keinen Konsens über die Definition von Non-Respondern gibt [21].…”