scholarly journals Lasmiditan is an effective acute treatment for migraine

Neurology ◽  
2018 ◽  
Vol 91 (24) ◽  
pp. e2222-e2232 ◽  
Author(s):  
Bernice Kuca ◽  
Stephen D. Silberstein ◽  
Linda Wietecha ◽  
Paul H. Berg ◽  
Gregory Dozier ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Migraine Attack ◽  
Acute Treatment ◽  
Adult Patients ◽  
Electronic Diary ◽  
Double Blind ◽  
Bothersome Symptom ◽  
Headache Pain

ObjectiveTo assess the efficacy and safety of lasmiditan in the acute treatment of migraine.MethodsAdult patients with migraine were randomized (1:1:1) to a double-blind dose of oral lasmiditan 200 mg, lasmiditan 100 mg, or placebo and were asked to treat their next migraine attack within 4 hours of onset. Over 48 hours after dosing, patients used an electronic diary to record headache pain and the presence of nausea, phonophobia, and photophobia, one of which was designated their most bothersome symptom (MBS).ResultsOf the 1,856 patients who treated an attack, 77.9% had ≥1 cardiovascular risk factors in addition to migraine. Compared with placebo, more patients dosed with lasmiditan 200 mg were free of headache pain at 2 hours after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 2.0–3.6, p< 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6–3.0, p< 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% CI 1.3–2.1, p< 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3–2.2, p< 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity.ConclusionsLasmiditan dosed at 200 and 100 mg was efficacious and well tolerated in the treatment of acute migraine among patients with a high level of cardiovascular risk factors.ClinicalTrials.gov identifierNCT02439320.Classification of evidenceThis study provides Class I evidence that for adult patients with migraine, lasmiditan increases the proportion of subjects who are headache pain free at 2 hours after treating a migraine attack.

scholarly journals A.07 Efficacy, safety, and tolerability of ubrogepant for the acute treatment of migraine: a single-attack phase 3 study, ACHIEVE I

2019 ◽  
Vol 46 (s1) ◽  
pp. S9-S10 ◽  
Author(s):  
DW Dodick ◽  
RB Lipton ◽  
J Ailani ◽  
K Lu ◽  
H Lakkis ◽  
...  
Keyword(s):  
Migraine Attack ◽  
Initial Dose ◽  
Acute Treatment ◽  
Phase 3 ◽  
Double Blind ◽  
Safety Population ◽  
Parallel Group ◽  
Attack Phase ◽  
Headache Pain ◽  
Cgrp Receptor Antagonist

Background: To evaluate efficacy, safety, and tolerability of ubrogepant, an oral CGRP receptor antagonist, for acute treatment of a single migraine attack. Methods: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, single-attack, phase 3 study (NCT02828020). Patients randomized 1:1:1 to placebo, ubrogepant 50mg, or ubrogepant 100mg had 60 days to treat one migraine attack (moderate/severe pain intensity). Co-primary efficacy endpoints: pain freedom 2 hours post initial dose and absence of most bothersome migraine-associated symptom (MBS). Results: 1672 patients were randomized (safety population: n=1436; mITT population: n=1327). Mean age: 40.7 years; white (82.4%); female (87.5%). A significantly greater percentage of ubrogepant- than placebo-treated patients achieved pain freedom 2 hours post initial dose (50mg: 19.2%, adjusted P=0.0023; 100mg: 21.2%, adjusted P=0.0003; placebo: 11.8%). A significantly greater percentage of ubrogepant patients achieved absence of MBS (50mg: 38.6%, adjusted P=0.0023, 100mg: 37.7%, adjusted P=0.0023; placebo: 27.8%). The adverse event (AE) profile of ubrogepant was similar to placebo. The most common AEs (incidence ≥2% in any treatment group) within 48 hours of initial or optional second dose were nausea, somnolence, and dry mouth (all with incidence &lt;5%). Conclusions: Both co-primary endpoints were met, with clinically meaningful effects on migraine headache pain and MBS. Ubrogepant was well tolerated, with no identified safety concerns.

scholarly journals P.027 Efficacy and Safety of Eptinezumab Initiated During a Migraine Attack: Results from the RELIEF Study

2021 ◽  
Vol 48 (s3) ◽  
pp. S27-S28
Author(s):  
PK Winner ◽  
P McAllister ◽  
G Chakhava ◽  
J Ailani ◽  
L Mehta ◽  
...  
Keyword(s):  
Adverse Events ◽  
Migraine Attack ◽  
Rapid Onset ◽  
Migraine Treatment ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Bothersome Symptom ◽  
Post Infusion ◽  
Headache Pain

Background: Eptinezumab is approved for migraine prevention, with demonstrated rapid onset of preventive benefit. RELIEF evaluated the efficacy and safety of eptinezumab initiated during a migraine attack. Methods: RELIEF (NCT04152083; parallel-group, double-blind, placebo-controlled) randomized adults with migraine (4-15d/mo in 3mo prior to screening) to eptinezumab 100mg or placebo, administered IV within 1-6h of qualifying migraine onset. Co-primary efficacy endpoints were time to headache pain freedom and time to absence of most bothersome symptom (MBS). Results: Eptinezumab (n=238) compared with placebo (n=242) achieved significantly faster headache pain freedom (median 4h vs 9h; hazard ratio=1.54, P=0.0006) and absence of MBS (2h vs 3h; 1.75, P<0.0001). At 2h, 23.5% and 12.0% (P=0.0009) of eptinezumab-treated and placebo patients, respectively, reported headache pain freedom, and 55.5% and 35.8% (P<0.0001) reported absence of MBS. Significantly fewer eptinezumab-treated patients used rescue medication within 24h (31.5% vs 59.9%; P<0.0001). Treatment-emergent adverse events occurred in 10.9% eptinezumab-treated and 10.3% placebo patients; no serious adverse events occurred. Conclusions: Infusion of the preventive migraine treatment, eptinezumab, during a migraine resulted in rapid and sustained freedom from headache pain and MBS vs placebo, starting 2h post-infusion, decreasing need for acute medication within 24h post-infusion. No notable safety findings were identified.

scholarly journals Regular consumption of n-3 fatty acid-enriched pork modifies cardiovascular risk factors

2008 ◽  
Vol 101 (4) ◽  
pp. 592-597 ◽  
Author(s):  
Alison M. Coates ◽  
Stelios Sioutis ◽  
Jonathan D. Buckley ◽  
Peter R. C. Howe
Keyword(s):  
Risk Factors ◽  
Cardiovascular Risk ◽  
Fatty Acid ◽  
Cardiovascular Risk Factors ◽  
Cardiovascular Health ◽  
Control Group ◽  
Double Blind ◽  
Regular Control ◽  
Regular Consumption ◽  
Thromboxane Production

The long-chain (LC) n-3 PUFA content of pork, particularly DHA, can be increased by including 15 % PorcOmega® (a fortified tuna fishmeal product) in pig finisher diets. The aim of the present study was to see whether this enriched pork could deliver cardiovascular health benefits to consumers. In a double-blind intervention trial, thirty-three healthy adult volunteers (sixteen female and seventeen male) were randomised to consume either n-3-enriched or regular (control) pork (a selection of five fresh cuts totalling 1000 g/week) for 12 weeks. Fasting blood samples were collected every 4 weeks and analysed for serum lipids, maximally stimulated thromboxane production and erythrocyte fatty acid composition. The n-3-enriched pork provided subjects with 1·3 g LC n-3 PUFA per week. Erythrocyte DHA levels rose 15 % in the n-3 group and fell 5 % in the control group over 12 weeks (P = 0·001). Compared with the control group, serum TAG decreased to a greater extent in the n-3 group (P = 0·02) and serum thromboxane production increased to a lesser extent (P = 0·004). Changes in the latter were inversely associated with changes in incorporation of DHA into erythrocytes (r − 0·54; P < 0·05). Thus the modest increases in LC n-3 PUFA intake resulting from regular consumption of enriched pork can improve cardiovascular risk factors.

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