TY - JOUR
T1 - Lasmiditan for Patients with Migraine and Contraindications to Triptans
T2 - A Post Hoc Analysis
AU - Krege, John H.
AU - Lipton, Richard B.
AU - Baygani, Simin K.
AU - Komori, Mika
AU - Ryan, Sinéad M.
AU - Vincent, Maurice
N1 - Funding Information:
John H. Krege, Simin K. Baygani, Mika Komori and Maurice Vincent are full-time employees and minor shareholders of Eli Lilly and Company. Sinéad M. Ryan is a full-time employee of Eli Lilly and Company. Maurice Vincent has received funds from Eli Lilly and Company for attending meetings and or/travel as part of his work in the company. Richard B. Lipton has received research funding from NIH/NIA 2PO1 AG003949 (Einstein Aging Study), the S&L Marx Foundation, Czap Foundation, the NIH, the FDA, the Migraine Research Foundation and the National Headache Foundation. Richard B. Lipton has served/serves as consultant, advisory board member, and received honoraria from or research support from: AbbVie (Allergan), American Academy of Neurology, American Headache Society, Amgen, Biohaven, Biovision, Boston, Dr. Reddy’s (Promius), Electrocore, Eli Lilly and Company, eNeura, Equinox, GlaxoSmithKline, Grifols, Lundbeck (Alder), Merck, Pernix, Pfizer, Teva, Vector and Vedanta. Richard B. Lipton has stock or stock options in Biohaven and CtrlM Health.
Funding Information:
This study was funded by Eli Lilly and Company. All publication costs including the journal’s Rapid Service Fee were also funded by Eli Lilly and Company.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/6
Y1 - 2022/6
N2 - Introduction: As 5-HT1B receptor agonists, triptans produce vasoconstriction and have cardiovascular contraindications and precautions. Lasmiditan, a selective 5-HT1F receptor agonist, has a low affinity for 5-HT1B receptors, does not cause vasoconstriction, and is free of cardiovascular contraindications and precautions. The objective of this post hoc analysis was to evaluate the efficacy and safety of lasmiditan in patients with and without at least one triptan contraindication. Methods: Patient subgroups, with and without triptan contraindications, were analyzed from pooled patient data from four randomized, double-blind, placebo-controlled clinical trials (SAMURAI, SPARTAN, CENTURION, and MONONOFU). Patients experiencing a single migraine attack of moderate or severe intensity were treated with lasmiditan 50 mg (SPARTAN and MONONOFU only), 100 mg, 200 mg, or placebo, and efficacy data were recorded in an electronic diary. Results: Of 5704 patients, 207 (3.6%) patients had at least one contraindication to triptans. Overall subgroup analysis revealed that the effects of lasmiditan on pain freedom, pain relief, freedom from most bothersome symptom, disability freedom, and Patient Global Impression of Change at 2 h post-dose did not differ in patient groups with and without triptan contraindications. These outcomes generally showed a similar benefit pattern for lasmiditan in both subgroups, with all results being statistically significant in patients without contraindications, and pain relief being statistically significant in patients with contraindications. The safety and tolerability profiles of patients with triptan versus without triptan contraindications were similar, including dizziness in 18.3 to 22.8% and somnolence in 7.9 to 9.9% of patients at the highest dose of lasmiditan. Conclusions: In pooled analyses from four trials, patients with and without triptan contraindications did not differ in their patterns of lasmiditan efficacy. Lasmiditan may be a treatment option in patients with contraindications to triptans. Trial Registration Numbers: SAMURAI, NCT:02439320; SPARTAN, NCT:02605174; CENTURION, NCT:03670810; and MONONOFU, NCT:03962738.
AB - Introduction: As 5-HT1B receptor agonists, triptans produce vasoconstriction and have cardiovascular contraindications and precautions. Lasmiditan, a selective 5-HT1F receptor agonist, has a low affinity for 5-HT1B receptors, does not cause vasoconstriction, and is free of cardiovascular contraindications and precautions. The objective of this post hoc analysis was to evaluate the efficacy and safety of lasmiditan in patients with and without at least one triptan contraindication. Methods: Patient subgroups, with and without triptan contraindications, were analyzed from pooled patient data from four randomized, double-blind, placebo-controlled clinical trials (SAMURAI, SPARTAN, CENTURION, and MONONOFU). Patients experiencing a single migraine attack of moderate or severe intensity were treated with lasmiditan 50 mg (SPARTAN and MONONOFU only), 100 mg, 200 mg, or placebo, and efficacy data were recorded in an electronic diary. Results: Of 5704 patients, 207 (3.6%) patients had at least one contraindication to triptans. Overall subgroup analysis revealed that the effects of lasmiditan on pain freedom, pain relief, freedom from most bothersome symptom, disability freedom, and Patient Global Impression of Change at 2 h post-dose did not differ in patient groups with and without triptan contraindications. These outcomes generally showed a similar benefit pattern for lasmiditan in both subgroups, with all results being statistically significant in patients without contraindications, and pain relief being statistically significant in patients with contraindications. The safety and tolerability profiles of patients with triptan versus without triptan contraindications were similar, including dizziness in 18.3 to 22.8% and somnolence in 7.9 to 9.9% of patients at the highest dose of lasmiditan. Conclusions: In pooled analyses from four trials, patients with and without triptan contraindications did not differ in their patterns of lasmiditan efficacy. Lasmiditan may be a treatment option in patients with contraindications to triptans. Trial Registration Numbers: SAMURAI, NCT:02439320; SPARTAN, NCT:02605174; CENTURION, NCT:03670810; and MONONOFU, NCT:03962738.
KW - Cardiovascular
KW - Contraindication
KW - Headache
KW - Lasmiditan
KW - Migraine
KW - Serotonin
KW - Triptan
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U2 - 10.1007/s40122-022-00388-8
DO - 10.1007/s40122-022-00388-8
M3 - Article
AN - SCOPUS:85128951441
VL - 11
SP - 701
EP - 712
JO - Pain and Therapy
JF - Pain and Therapy
SN - 2193-8237
IS - 2
ER -