Lasmiditan is an effective acute treatment for migraine A phase 3 randomized study

被引：191

作者：

Kuca, Bernice ^{[1
]}

Silberstein, Stephen D. ^{[2
]}

Wietecha, Linda ^{[3
]}

Berg, Paul H. ^{[3
]}

Dozier, Gregory ^{[4
]}

Lipton, Richard B. ^{[5
]}

Adams, Michael ^{[6
]}

Alftine, Christopher ^{[7
]}

Allaw, Mohammed ^{[8
]}

Allen, Lawrence ^{[9
]}

Ampajwala, Madhavi ^{[10
]}

Bakhtari, Ladan ^{[11
]}

Bhasker, Kala ^{[12
]}

Bird, David ^{[13
]}

Bolshoun, David ^{[14
]}

Brown, Judith ^{[15
]}

Brownstone, Paul ^{[16
]}

Bruce, Tami ^{[17
]}

Burke, Dina ^{[9
]}

Chuang, Rita ^{[18
]}

Conrady, Rickie ^{[19
]}

Davis, Bethany ^{[20
]}

Davis, Cedrice ^{[21
]}

Dawson, Mark ^{[22
]}

Desantis, Donna ^{[23
]}

Dushkin, Holly ^{[24
]}

Ellison, William ^{[25
]}

Ervin, John ^{[26
]}

Essink, Beal ^{[27
]}

Fakhouri, Ibrahim ^{[28
]}

Fiel, Thomas ^{[29
]}

Fitzgibbons, William ^{[30
]}

Francyk, David ^{[31
]}

Geisberg, Harry ^{[32
]}

Geohas, Jeff ^{[33
]}

Giep, Son ^{[34
]}

Glover, Richard ^{[35
]}

Godbole, Narendra ^{[36
]}

Grainger, William ^{[37
]}

Griffin, Carl ^{[38
]}

Halpern, Steven ^{[39
]}

Han, Michael ^{[40
]}

Hiotis, Louis ^{[41
]}

Huffman, Cynthia ^{[42
]}

Hummel, Matthew ^{[43
]}

Hurley, Donald ^{[44
]}

Inzerello, Anthony ^{[45
]}

Jagielo, Ted ^{[46
]}

Jennings, William ^{[47
]}

Kaiser, Scott ^{[48
]}

机构：

[1] CoLucid Pharmaceut Inc, Cambridge, MA USA

[2] Thomas Jefferson Univ, Philadelphia, PA 19107 USA

[3] Eli Lilly & Co, Indianapolis, IN 46285 USA

[4] IQVIA, Durham, NC USA

[5] Montefiore Headache Ctr, Bronx, NY USA

[6] Radiant Res, Murray, UT USA

[7] Sunstone Med Res LLC, Medford, OR USA

[8] Radiant Res, Evansville, IN USA

[9] Diagnost Ctr Med, Las Vegas, NV USA

[10] Acrc Trials, Plano, TX USA

[11] Doctors Internal Med, Plano, TX USA

[12] Radiant Res, Vista, CA USA

[13] Colorado Springs Family Practice, Colorado Springs, CO USA

[14] Radiant Res, Denver, CO USA

[15] Orange Grove Family Practice, Tucson, AZ USA

[16] Alpine Clin Res Ctr, Boulder, CO USA

[17] Cent Arizona Med Associates, Mesa, AZ USA

[18] Rita B Chuang MD LLC, Henderson, NV USA

[19] Oklahoma City Clin, Edmond, OK USA

[20] Radiant Res, Atlanta, GA USA

[21] Urban Family Practice Associates, Marietta, GA USA

[22] Acrc Trials, Austin, TX USA

[23] East Valley Family Phys, Chandler, AZ USA

[24] Rapid Med Res Inc, Cleveland, OH USA

[25] Radiant Res, Greer, SC USA

[26] Ctr Pharmaceut Res, Kansas City, MO USA

[27] Oregon Ctr Clin Invest Inc, Portland, OR USA

[28] Nevada Family Care, Henderson, NV USA

[29] Fiel Family & Sports Med, Tempe, AZ USA

[30] Skyline Med Ctr, Elkhorn, NE USA

[31] Family Practice Specialists Ltd, Phoenix, AZ USA

[32] Primary Care Associates, Anderson, SC USA

[33] Evanston Premier Healthcare Res LLC, Evanston, IL USA

[34] Plano Internal Med Associates, Plano, TX USA

[35] Heartland Res Associates, Newton, KS USA

[36] Thunderbird Internal Med, Glendale, AZ USA

[37] Neurol Phys Arizona Inc, Gilbert, AZ USA

[38] Lynn Health Sci Inst, Oklahoma City, OK USA

[39] Radiant Res, Santa Rosa, CA USA

[40] Southview Med Grp, Birmingham, AL USA

[41] Michigan Ave Internists, Chicago, IL USA

[42] Meridien Res, Tampa, FL USA

[43] Fountain Hills Family Practice PC, Fountain Hills, AZ USA

[44] Med Res South, Charleston, SC USA

[45] Clin Res Advantage Inc, Evansville, IN USA

[46] Med & Procedural Specialists Illinois, Chicago, IL USA

[47] Radiant Res, San Antonio, TX USA

[48] Clinix Healing Ctr, Centennial, CO USA

[49] Radiant Res Inc, Council Bluffs, IA USA

[50] Continuum Health Care, Overland Pk, KS USA

来源：

NEUROLOGY | 2018年 / 91卷 / 24期

关键词：

EPISODIC MIGRAINE; TRIPTANS; RELIABILITY; PREVALENCE; PROFILE; PEOPLE;

D O I：

10.1212/WNL.0000000000006641

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Objective To assess the efficacy and safety of lasmiditan in the acute treatment of migraine. Methods Adult 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). Results Of 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. Conclusions Lasmiditan 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 identifier NCT02439320. Classification of evidence This 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.

引用

页码：E2222 / E2232

页数：11

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