The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials.

Abstract

BACKGROUND:

In controlled clinical trials, compared with placebo, a significantly greater proportion of participants using lasmiditan to treat a migraine attack achieved 2-h pain freedom (PF) and experienced ≥ 1 treatment-emergent adverse event (TEAE).

OBJECTIVE:

To better inform clinicians about treatment expectations by evaluating the association between TEAEs and efficacy outcomes after lasmiditan treatment.

METHODS:

Pooled data from SAMURAI, SPARTAN, MONONOFU, and CENTURION were analyzed. A common TEAE (CTEAE) was defined as occurring in ≥ 2% in the overall population. Central nervous system (CNS)-CTEAEs were based on Medical Dictionary for Regulatory Activities.

RESULTS:

At 2 h, a significantly higher percentage of lasmiditan 200 mg-treated participants who achieved PF experienced ≥ 1 CTEAE than non-responders who continued to experience moderate/severe pain (48.2% vs. 28.7%, respectively). Correspondingly, a significantly higher percentage of lasmiditan 200 mg-treated participants who experienced ≥ 1 CTEAE achieved PF at 2 h than those who did not (39.0% vs. 30.2%, respectively). Similar results were generally observed with individual CNS-CTEAEs, but for non-CNS-CTEAEs, this pattern was less evident or in the opposite direction. No consistent differences were observed for migraine-related functional disability freedom. The percentage of participants with improved patient global impression of change (PGIC) was greater with a CNS-CTEAE versus no CNS-CTEAE.

CONCLUSIONS:

Those who had PF at 2 h were more likely to experience a CNS-CTEAE, and those with CNS-CTEAEs were more likely to experience PF. The occurrence of CTEAEs did not seem to negatively affect disability freedom or PGIC.

CLINICALTRIALS:

GOV REGISTRATION:

SAMURAI (NCT02439320), SPARTAN (NCT02605174), MONONOFU (NCT03962738), CENTURION (NCT03670810), ClinicalTrials.gov: NCT02439320, NCT02605174, NCT03962738, NCT03670810.

• Authors: Erin G Doty, Paula M Hauck, John H Krege, Mika Komori, Ann M Hake, Yan Dong, Richard B Lipton
• Journal: CNS drugs (CNS Drugs) Vol. 36 Issue 7 Pg. 771-783 (07 2022) ISSN: 1179-1934 [Electronic] New Zealand
• PMID: 35779194 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2022. Eli Lilly and Company.

Chemical References

• Benzamides
• Piperidines
• Pyridines
• Serotonin Receptor Agonists
• lasmiditan

Topics

• Benzamides
• Double-Blind Method
• Humans
• Migraine Disorders (drug therapy)
• Pain (drug therapy)
• Piperidines
• Pyridines
• Randomized Controlled Trials as Topic
• Serotonin Receptor Agonists
• Treatment Outcome