Abstract:
OBJECTIVE:Presentation of pooled analysis of safety data for fremanezumab in patients with chronic (CM) or episodic migraine (EM) from 4 placebo-controlled phase 2b and phase 3 studies. BACKGROUND:There is a need for an effective, safe, and well-tolerated preventive therapy that specifically targets the pathophysiology of migraine to reduce the frequency and severity of migraine attacks in patients with CM or EM who experience 4 or more migraine days per month. Fremanezumab is a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, a neuropeptide involved in the pathophysiology of migraine. DESIGN/METHODS:The 4 placebo-controlled phases 2b and 3 studies included in this analysis were 16-week, multicenter, randomized, double-blind, placebo-controlled, and parallel-group studies consisting of a screening visit, a 28-day pretreatment baseline period, and a 12-week treatment period with a final evaluation 4 weeks after the final dose of the study drug. Safety endpoints included adverse events (AEs) and immunogenicity. RESULTS:A total of 2566 patients were randomized across all studies (fremanezumab, n = 1704; placebo, n = 862), and 2563 patients were treated. Common reasons for study discontinuation were withdrawal by patient (n = 78), patient lost to follow-up (n = 60), and AE (n = 50). The mean (standard deviation) duration of exposure was 83.8 (13.6) days for the patients who received fremanezumab, with a total exposure of 390.4 patient years and maximum exposure of 181 days. AEs were mostly mild to moderate in severity and were reported among 48-69% of patients in all treatment groups, and most were injection site reactions (pain, induration, and erythema). Two deaths occurred (chronic obstructive pulmonary disease and intentional overdose of diphenhydramine), both of which were deemed unrelated to study drug by the investigators and sponsor. Cardiovascular adverse events, abnormal liver function tests, and hypersensitivity were uncommon and occurred at similar rates between the placebo and fremanezumab groups. CONCLUSIONS:Fremanezumab is a generally safe and well-tolerated preventive therapy for migraine in adults.
journal_name
Headachejournal_title
Headacheauthors
Silberstein SD,McAllister P,Ning X,Faulhaber N,Lang N,Yeung P,Schiemann J,Aycardi E,Cohen JM,Janka L,Yang Rdoi
10.1111/head.13534subject
Has Abstractpub_date
2019-06-01 00:00:00pages
880-890issue
6eissn
0017-8748issn
1526-4610journal_volume
59pub_type
杂志文章,meta分析相关文献
HEADACHE文献大全abstract:OBJECTIVE:To evaluate the efficacy and safety of AVP-825, a drug-device combination of low-dose sumatriptan powder (22 mg loaded dose) delivered intranasally through a targeted Breath Powered device vs an identical device containing lactose powder (placebo device) in the treatment of migraine headache. BACKGROUND:Earl...
journal_title:Headache
pub_type: 杂志文章,随机对照试验
doi:10.1111/head.12472
更新日期:2015-01-01 00:00:00
abstract:OBJECTIVES:To estimate the 1-year prevalence of headache, its repercussion and its association with the academic performance of university students. METHODS:Cross-sectional study. Three hundred eighty students were randomly selected out of the 1718, 90.5% of them were interviewed. A semi-structured interview, the Head...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2011.02012.x
更新日期:2011-11-01 00:00:00
abstract::Seventy-six patients with vascular (migraine or mixed migraine and tension) headache (HA) participated in a controlled evaluation of a minimal-therapist-contact, largely home-based, treatment program which combined relaxation (R) training with thermal biofeedback (TBF). One group received TBF + R administered in 3 off...
journal_title:Headache
pub_type: 临床试验,杂志文章
doi:10.1111/j.1526-4610.1990.hed3006371.x
更新日期:1990-05-01 00:00:00
abstract:OBJECTIVE:To explore the effects of olmesartan on frequency and severity of migraine attacks in patients with comorbid hypertension and prehypertension. BACKGROUND:A randomized, double-blind, placebo-controlled, crossover study with a total of 60 patients has demonstrated the efficacy and safety of the angiotensin II ...
journal_title:Headache
pub_type: 杂志文章,随机对照试验
doi:10.1111/j.1526-4610.2006.00382.x
更新日期:2006-03-01 00:00:00
abstract:OBJECTIVES:To determine the 1-year prevalence of headache and clinical characteristics of primary headaches among school children in South Korea. BACKGROUND:Many population-based studies have estimated the 1-year prevalence of headache, migraine, and tension-type headache (TTH). The results of those studies vary in te...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2011.02001.x
更新日期:2012-04-01 00:00:00
abstract::Significant progress in molecular genetics has advanced our understanding of the genetic basis of migraine. The fundamentals of molecular genetics, and the recent advances in the field, are important for clinicians to understand, as they provide a foundation for critical appraisal of the literature, unprecedented insi...
journal_title:Headache
pub_type: 杂志文章,评审
doi:10.1111/head.12156
更新日期:2013-09-01 00:00:00
abstract:OBJECTIVE:To test whether chronic headache (>3 days/week) is more prevalent than episodic headache (<3 days/week) in patients with a previous history of significant head trauma. METHOD:We included 903 consecutive patients referred to a specialist center for headache during a period of 2 years. As the main parameter, w...
journal_title:Headache
pub_type: 杂志文章
doi:10.1046/j.1526-4610.2003.03010.x
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Medication-overuse headache (MOH) refers to headache attributed to excessive use of acute medications. The role of personality needs studies to explain the shifting from drug use to drug abuse. The main aim of this study is to study personality, according to Minnesota Multiphasic Personality Inventory, compa...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2011.01978.x
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:Neuromodulators such as topiramate (TPM) and divalproex sodium (DVS) are effective in the preventive treatment of migraine. Nonetheless, patients often discontinue their use due to side effects. OBJECTIVES:The study aims to determine whether the combination of lower doses of TPM and DVS may be useful for pa...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2011.02035.x
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVE:To investigate whether intravenously infused provokes migraine aura and migraine headache in migraine patients with aura. BACKGROUND:Migraine with aura has been associated with endothelial dysfunction and increased stroke risk. The initiating mechanism of migraine aura symptoms is not known. Experimental pro...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/head.13753
更新日期:2020-04-01 00:00:00
abstract::Two cases of baroreflex failure presented with tension-type/exertional headache. The usefulness of noninvasive physiological tests in diagnosing baroreflex failure and the role of baroreceptors in trigeminal nociception are discussed. ...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2006.00514_3.x
更新日期:2006-07-01 00:00:00
abstract:OBJECTIVE:To examine the efficacy of L-kynurenine and a novel kynurenic acid derivative on the nitroglycerin-induced calmodulin-dependent protein kinase II alpha (CamKIIalpha) and calcitonin gene-related peptide (CGRP) expression changes in the rat caudal trigeminal nucleus. BACKGROUND:Systemic administration of the n...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2009.01574.x
更新日期:2010-05-01 00:00:00
abstract:OBJECTIVE:We conducted the present study to determine whether there are headache precipitating and aggravating factors that differentiate migraine from tension-type headache and headache precipitating and aggravating factors that differentiate tension-type headache from migraine. METHODS:We interviewed 38 patients wit...
journal_title:Headache
pub_type: 杂志文章
doi:10.1046/j.1526-4610.2001.041006554.x
更新日期:2001-06-01 00:00:00
abstract:OBJECTIVE:To characterize adult patients with episodic migraine who achieved 100% response to galcanezumab treatment. BACKGROUND:Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide (CGRP) and has demonstrated efficacy in reducing migraine headache days (MHD) in...
journal_title:Headache
pub_type: 杂志文章,随机对照试验
doi:10.1111/head.13427
更新日期:2018-10-01 00:00:00
abstract:BACKGROUND:Short-lasting unilateral neuralgiform headache with conjunctival injection and tearing (SUNCT) and trigeminal neuralgia (TN) are unilateral painful conditions that can share the same triggering factors, autonomic features and the main location, as well as the cyclically recurrent crises. Both these syndromes...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/head.12007
更新日期:2013-10-01 00:00:00
abstract::A case is reported in which a patient with sexual and orgasmic headaches was treated successfully with a calcium channel blocker, diltiazem. To the best of our knowledge, this is the first case of successful treatment of sexual headaches with calcium channel blockers reported in the English medical literature. The lit...
journal_title:Headache
pub_type: 杂志文章,评审
doi:10.1111/j.1526-4610.1991.hed3103141.x
更新日期:1991-03-01 00:00:00
abstract::Previously called "childhood periodic syndromes that are commonly precursors of migraine" in International Headache Classification of Headache Disorders (ICHD)-II, these disorders were renamed "episodic syndromes that may be associated with migraine" in ICHD-III beta. The specific disorders reviewed in this article in...
journal_title:Headache
pub_type: 杂志文章,评审
doi:10.1111/head.12624
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Migraine is a common neurological disorder, ranked among the world's leading causes of years lived with disability by the World Health Organization. The burden of migraine is highest in women of reproductive age. METHODS:We characterized the prevalence, symptoms, and correlates of migraine and other headach...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/head.12206
更新日期:2014-04-01 00:00:00
abstract::Patients with cluster headaches have been reported to have low serum ionized magnesium levels. We examined the possibility that patients with cluster headaches and low ionized magnesium levels may respond to an intravenous infusion of magnesium sulfate. Thirty-eight infusions of magnesium sulfate were given to 22 pati...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.1995.hed3510597.x
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:It has been suggested that homocysteine (Hcy) and the 5'-10'-methylenetetrahydrofolate reductase (MTHFR) C677T variant are implicated in the pathogenesis of migraine. Homocysteine has the potential to damage endothelium and accelerate atherosclerosis. Genetic factors such as the MTHFR C677T polymorphism, and...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2009.01484.x
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Though triptans are considered the standard of acute therapy for migraine attacks with headache-related disability, they are used by the minority of potentially eligible persons. Understanding the socio-demographic and headache features that predict triptan use may help to clarify barriers to optimal treatme...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.2011.02032.x
更新日期:2012-02-01 00:00:00
abstract::In a data base of 1013 patients with chronic headache, 44.1% reported the onset of headaches before the age of 20 (preadult-onset headache) and 55.9% at or after that age (adult-onset headache). Circumstances of headache onset were mentioned significantly more frequently in the latter than in the former group (8.5% ve...
journal_title:Headache
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1526-4610.1999.3905317.x
更新日期:1999-05-01 00:00:00
abstract::The study compared the psychological symptoms of 26 young men and 65 young women referred to a neurology clinic in northern Israel by their family physicians for medical advice regarding headache. The main findings indicated that the women had more severe psychological symptoms than the men in six subscales, although ...
journal_title:Headache
pub_type: 杂志文章
doi:10.1046/j.1526-4610.1998.3801031.x
更新日期:1998-01-01 00:00:00
abstract::Paroxysmal headaches often occur in benign headache disorders such as episodic cluster headache, chronic paroxysmal hemicrania (CPH) and episodic paroxysmal hemicrania. We report 2 patients with paroxysmal headaches occurring in association with cerebrovascular disease. The first patient had paroxysmal headaches from ...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.1992.hed3202075.x
更新日期:1992-02-01 00:00:00
abstract:OBJECTIVE:To review and analyze published reports on the acute treatment of migraine headache with triptans, dihydroergotamine (DHE), and magnesium in emergency department, urgent care, and headache clinic settings. METHODS:MEDLINE was searched using the terms "migraine" and "emergency," and "therapy" or "treatment." ...
journal_title:Headache
pub_type: 杂志文章,评审
doi:10.1111/j.1526-4610.2011.02062.x
更新日期:2012-01-01 00:00:00
abstract::The present study evaluated the effects of relaxation treatment in 36 adolescents aged 13 to 18 years (mean +/- SD, 15.4 +/- 1.55 years) suffering from migraine or migraine and tension-type headache as compared with a waiting-list condition group. The subjects rated various characteristics of migraine and tension-type...
journal_title:Headache
pub_type: 杂志文章
doi:10.1046/j.1526-4610.2001.111006290.x
更新日期:2001-03-01 00:00:00
abstract::Consumption of monosodium glutamate has long been considered to precipitate headaches in susceptible patients. In this study the direct effects of glutamate and its metabolite, glutamine, on arterial contractility were examined using rings of rabbit aorta. In a high concentration glutamate caused significant concentra...
journal_title:Headache
pub_type: 杂志文章
doi:10.1111/j.1526-4610.1990.hed3009575.x
更新日期:1990-09-01 00:00:00
abstract::In a period of one year (1990) we selected 40 patients suffering from migraine. For an open randomized study there were 2 groups of patients: the first were treated with 10mg of flunarizine per day and the second with 3 mg per day. The patients were treated for 4 months consecutively. There were 11 drop outs (27.5%): ...
journal_title:Headache
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1526-4610.1992.hed3208390.x
更新日期:1992-09-01 00:00:00
abstract::The ergot alkaloids are a family of chemical entities that have many pharmacologic effects. Their diversity results from their interaction with multiple receptors, their variable receptor affinity and intrinsic activity, and their variable organ-specific receptor access. Ergotamine tartrate (ET) was one of the first e...
journal_title:Headache
pub_type: 杂志文章,评审
doi:
更新日期:1997-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the effectiveness of rizatriptan for acute migraine treatment and patient satisfaction with the drug in usual clinical practice settings. BACKGROUND:Although rizatriptan has been shown to effectively relieve migraine symptoms in clinical trials, we wished to assess its utility in typical patient ...
journal_title:Headache
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1046/j.1526-4610.2003.03045.x
更新日期:2003-03-01 00:00:00