Conference Roundup treatment-emergent adverse events, according to research presented at AAN 2019. Data were taken from the double-blind, phase 3 SPARTAN and SAMURAI studies. A total of 4439 participants with migraine were assigned to lasmiditan 50 mg (n=654), 100 mg (n=1265), 200 mg (n=1258), and placebo (n=1262). Participants were instructed to take the dose within 4 hours of the start of a migraine attack. A total of 7 participants distributed equally across all groups reported serious adverse events; no deaths were reported. At least 1 treatment-emergent adverse event occurred in 13.5% of placebo, 25.4% of lasmiditan 50-mg, 36.2% of lasmiditan 100-mg, and 40.3% of lasmiditan 200-mg groups. Most treatment-emergent adverse events in the lasmiditan groups were of mild or moderate severity, with the most significant being dizziness, paresthesia, drowsiness, fatigue, nausea, weak muscles, and hypoesthesia. The events had a median onset time of 0.50 to 0.85 hours and a median duration of 1.00 to 4.75 hours. Reference Krege JH, Liffick E, Doty EG, Dowsett SA, Wang JN, Buchanan AS. Safety findings from the phase 3 studies (SAMURAI, SPARTAN) of lasmiditan for acute treatment of migraine. Presented at: 2019 American Academy of Neurology Annual Meeting;
© OLIVER HELBIG / EYEEM / GETTY IMAGES
May 4-10, 2019; Philadelphia, PA. Abstract P1.10-009.
SMOKING INCREASES MS SEVERITY Cigarette smoking increased disease severity in patients with multiple sclerosis (MS) with severity scores remaining unchanged when considering smoking load and smoking cessation, according to research presented at AAN 2019. In this cross-sectional study, investigators sought to evaluate the impact of cigarette smoking and smoking cessation on disease severity in individuals with MS. Patients with MS completed a lifestyle
on multiple sclerosis severity: a cross-sectional study. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. Abstract P4.6-008.
Investigators concluded that smoking was associated with greater MS severity.
questionnaire from which their lifetime cigarette smoking load was estimated and then categorized into 2 groups: low smoke load and high smoke load. Disease severity was assessed using the MS Severity Score (MSSS). Of 351 patients included in the study, 190 were ever-smokers (92 current and 98 former) and 161 were never-smokers. Ever-smokers had a higher median MSSS than never-smokers (3.21 vs 2.33; P =.02) and were more likely to fall into the upper tertile of MSSS distribution when adjusted for age and gender. There was no statistically significant difference in median MSSS between current and former smokers (3.14 vs 3.25) nor between ever-smokers with low smoke loads vs high smoke loads (3.44 vs 3.10; P =.98). The investigators concluded that these results confirm the association of cigarette smoking with greater disease severity in MS. Among ever-smokers, low smoke loads and smoking cessation were not significant factors affecting MS severity.
DIAZEPAM NASAL SPRAY FOR BREAKTHROUGH SEIZURES IN EPILEPSY Diazepam nasal spray was found to be safe and well tolerated in patients with epilepsy who experience frequent breakthrough or acute repetitive seizures, according to research presented at AAN 2019. In this interim analysis, investigators assessed the long-term safety of diazepam after repeat doses were administered to patients with epilepsy who experienced frequent breakthrough seizures or acute repetitive seizures over 12 months. Doses (5 mg, 10 mg, 15 mg, or 20 mg) were based on age and body weight and were modified as needed; participants documented time and duration of seizures in patient diaries, along with any outcome events. The safety population included 109 patients who received at least 1 dose of diazepam. A total of 1585 seizure episodes were treated with diazepam over the study period. In 1457 (92%) episodes, a single dose of diazepam was adequate to stop the seizure. Overall, 67 patients reported at least 1 adverse event, and 19 experienced adverse events that were considered related to treatment.The most frequent treatment-related adverse events were nasal discomfort, epistaxis, and headache. Adverse events that were considered serious were reported by 18 patients; none were considered treatment related. ■ Reference Sperling M, Hogan R, Biton V,Tarquinio D, Carrazana E. A 12-month, open-label, repeat-dose safety study of Valtoco™ (NRL-1 diazepam nasal spray) in patients
with epilepsy: interim report. Presented at: 2019
Ivashynka A, D’Alfonso S, Copetti M, et al. Effects
American Academy of Neurology Annual Meeting;
of cigarette smoking and smoking cessation
May 4-10, 2019; Philadelphia, PA. Abstract P1.5-028.
18 THE CLINICAL ADVISOR • JUNE 2019 • www.ClinicalAdvisor.com