Lasmiditan, a 5-HT1F receptor agonist, when dosed at 200 mg and 100 mg, is more effective than placebo for the treatment of migraine in patients with cardiovascular risk factors, according to findings from a phase 3 study published in Neurology.
Patients with disabling migraine for at least 1 year with or without aura were enrolled. Study investigators randomly assigned patients 1:1:1 to either 200 mg lasmiditan (n=609), 100 mg lasmiditan (n=630), or placebo (n=617). During an outpatient treatment period, patients were asked to treat their migraine attacks within 4 hours of migraine occurrence. Headache pain was subsequently assessed with an electronic headache diary over a 48-hour period. The International Headache Society 4-point headache severity rating scale was used to rate headache pain as either none (0), mild (1), moderate (2), or severe (3). In addition, patients self-assessed for the presence of associated symptoms, including nausea, phonophobia, and photophobia.
The majority of migraineurs included in the final cohort presented with 1 or more cardiovascular risk factors (77.9%), including an increased total cholesterol, a history of diabetes, and smoking. A significantly greater proportion of patients who received lasmiditan, 200 mg achieved headache freedom at 2 hours after treatment compared with patients treated with placebo (32.2% vs 15.3%, respectively; odds ratio [OR] 2.6; 95% CI, 2.0-3.6; P <.001). In addition, more patients dosed with lasmiditan, 100 mg achieved headache freedom at 2 hours posttreatment vs patients receiving placebo (28.2% vs 15.3%, respectively; OR 2.2; 95% CI, 1.6-3.0; P <.001).
Significantly more patients who received lasmiditan, 200 mg were also free of their most bothersome symptom at 2 hours compared with patients treated with placebo (40.7% vs 29.5%; OR 1.6; 95% CI, 1.3-2.1; P <.001). Patients treated with lasmiditan, 100 mg were also free of their most bothersome symptom at 2-hour follow-up compared with placebo recipients (40.9% vs 29.5%, respectively; OR 1.7; 95% CI, 1.3-2.2; P <.001).
A limitation of the analysis included the reliance on self-reports for the occurrence of migraine and migraine-associated symptoms after treatment.
“Although no clinical trial is fully generalizable to clinical practice,” the researchers explained, “the inclusion of patients with cardiovascular risk factors increases the generalizability of this study to real-world populations.”
Kuca B, Silberstein SD, Wietecha L, et al; COL MIG-301 Study Group. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91(24):e2222-e2232.