TY - JOUR
T1 - Characterization of Dizziness After Lasmiditan Usage
T2 - Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials
AU - Tepper, Stewart J.
AU - Krege, John H.
AU - Lombard, Louise
AU - Asafu-Adjei, Josephine K.
AU - Dowsett, Sherie A.
AU - Raskin, Joel
AU - Buchanan, Andrew S.
AU - Friedman, Deborah I.
N1 - Funding Information:
Conflict of Interest: Tepper has received grants for research (no personal compensation) from Alder, Allergan, Amgen, ATI, Dr. Reddy’s, ElectroCore, eNeura, Neurolief, Scion Neurostim, Teva, and Zosano; serves as consultant and/or on Advisory Boards for Acorda, Alder, Alexsa, Allergan, Alphasights, Amgen, ATI, Axsome Therapeutics, BioDelivery Sciences International, Biohaven, Cefaly, Charleston Labs, DeepBench, Dr. Reddy’s, ElectroCore, Eli Lilly and Company, eNeura, ExpertConnect, GLG, GSK, Guidepoint Global, Impel, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pfizer, Reckner Healthcare, Relevale, Satsuma, Scion Neurostim, Slingshot Insights, Sorrento, Sudler and Hennessey, Supernus, Teva, Theranica, Trinity Partners, XOC, Zosano; has stock options for ATI; has royalties from Springer; and receives salary from Dartmouth-Hitchcock Medical Center and American Headache Society. Krege, Lombard, Asafu-Adjei, Dowsett, Raskin, and Buchanan are full-time employees and minor stockholders at Eli Lilly and Company. Friedman serves on advisory boards for Alder, Allergan, Amgen, Biohaven, electroCore, Promius, Supernus, Teva, and Zosano. She is on the speakers’ bureau for Allergan, Amgen, electroCore, Supernus, and Teva and has received grant support from Autonomic Technologies, Inc., electroCore, Eli Lilly and Company, and Merck. Financial Support: The SPARTAN and SAMURAI studies were sponsored by CoLucid Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company. Trial registration at clinicaltrials.gov: SAMURAI (NCT02439320) and SPARTAN (NCT02605174).
Publisher Copyright:
© 2019 American Headache Society
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2019/7/1
Y1 - 2019/7/1
N2 - Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.
AB - Trial Design: SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies conducted in the United States, as well as the United Kingdom and Germany (SPARTAN only). Individuals with migraine were randomized to receive oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo within 4 hours of onset of a migraine attack. The aim of this analysis was to characterize dizziness reported with lasmiditan treatment. Methods: Data from SAMURAI and SPARTAN were pooled for the current post hoc analyses. Onset time and duration of dizziness were analyzed using descriptive statistics. Subgroup analyses based on presence/absence of dizziness were performed for the endpoints of interference with daily activity, patient global impression of change (PGIC), pain at 2 hours, and most bothersome symptom (MBS) at 2 hours based on adverse events occurring within 2 hours of taking study drug. Results: Dizziness incidence was as follows: Placebo (N = 1262), 2.9% (0.1% severe); lasmiditan 50 mg (N = 654), 8.6% (0.3% severe); lasmiditan 100 mg (N = 1265), 14.9% (0.7% severe); and lasmiditan 200 mg (N = 1258), 16.8% (1.4% severe). Among participants who received lasmiditan as their first dose, risk factors for dizziness were higher lasmiditan dosage, being non-Hispanic/Latino, mild or moderate severity of migraine attack, and lower body mass index. The median time to onset of dizziness was generally 30-40 minutes, and the median duration was 1.5-2 hours. The presence of dizziness did not appear to have a negative influence on lasmiditan's effect on daily activity, PGIC, freedom from pain, or MBS. Overall, 21 participants experienced vertigo: Lasmiditan 50 mg, n = 2 (0.3%); 100 mg, n = 11 (0.9%); 200 mg, n = 7 (0.6%); and placebo, n = 1 (<0.1%). Conclusion: The incidence of dizziness with lasmiditan increased with dose. Dizziness was generally mild or moderate in severity and of quick onset and short duration. The presence of dizziness did not influence drug efficacy.
KW - clinical trial
KW - dizziness
KW - lasmiditan
KW - vertigo
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U2 - 10.1111/head.13544
DO - 10.1111/head.13544
M3 - Article
C2 - 31152441
AN - SCOPUS:85068969619
SN - 0017-8748
VL - 59
SP - 1052
EP - 1062
JO - Headache
JF - Headache
IS - 7
ER -