scholarly journals Progress in the Treatment of Migraine Attacks: From Traditional Approaches to Eptinezumab

2021 ◽  
Vol 14 (9) ◽  
pp. 924
Author(s):  
Damiana Scuteri ◽  
Giacinto Bagetta
Keyword(s):  
Chronic Migraine ◽  
Specific Treatment ◽  
Episodic Migraine ◽  
Migraine Treatment ◽  
Acute Migraine ◽  
Bothersome Symptom ◽  
Post Marketing ◽  
Marketing Data ◽  
Artery Disease ◽  
Traditional Approaches

Migraine is the second cause of disability and of lost years of healthy life worldwide. Migraine is characterized by recurrent headache attacks and accompanying disabling symptoms lasting 4–48 h. In episodic migraine, attacks occur in less than 15 days per month and in chronic migraine, in more than 15 monthly days. Whilst successful translation of pharmacological discoveries into efficacious therapeutics has been achieved in the preventative therapy of chronic migraine, treatment of acute migraine suffers the lack of effective advancements. An effective treatment affords complete freedom from pain two hours after therapy and provides the absence of the most bothersome symptom (MBS) associated with migraine after 2 h. However, available anti-migraine abortive treatments for acute attacks do not represent an effective and safe treatment for all the populations treated. In particular, the most used specific treatment is represented by triptans that offer 2-h sustained freedom from pain achieved in 18–50% of patients but they are contraindicated in coronary artery disease, stroke and peripheral vascular disease due to the vasoconstriction at the basis of their pharmacologic action. The most novel therapies, i.e., gepants and ditans, are without sufficient post-marketing data for secure use. Here, an attempt is proposed to analyse the rational basis and evidence in favour of investigating the efficacy and safety in acute migraine attacks of eptinezumab, i.e., monoclonal antibody (mAb) directed towards calcitonin gene-related peptide (CGRP) unique for intravenous infusion administration.

The Acute Treatment of Episodic and Chronic Migraine in the USA

Cephalalgia ◽  
2009 ◽  
Vol 29 (8) ◽  
pp. 891-897 ◽  
Author(s):  
ME Bigal ◽  
S Borucho ◽  
D Serrano ◽  
RB Lipton
Keyword(s):  
Chronic Migraine ◽  
Odds Ratio ◽  
Acute Treatment ◽  
Specific Treatment ◽  
Episodic Migraine ◽  
Validated Questionnaires ◽  
The Us ◽  
Specific Medication ◽  
The Usa ◽  
Sizable Proportion

Understanding the patterns of acute treatment of migraine in the population is a necessary step in evaluating treatment in relation to guidelines, and in improving care. Herein we assess the specific medication used for the acute treatment of migraine and chronic migraine (CM) in the population. We identified 24 000 headache sufferers, drawn from over 165 000 individuals representative of the US population. This sample has been followed with annual surveys using validated questionnaires. As part of the survey, subjects were asked to report the specific medications currently used for their most severe headaches, dose, and number of days per month using medication. Complete responses were obtained from 14 540 individuals, including 9128 with episodic migraine and 503 with CM. For episodic migraine, specific treatment was used by 19.2% of subjects (triptans 18.7%; compounds with ergotamine 0.5%). A total of 11.1% routinely used opiates, whereas 6% used compounds with barbiturates. For CM, 22% used migraine-specific treatment, whereas 34.3% used opiates and barbiturates. Non-prescribed medications were frequently used in both groups. Opiates were more commonly used by those with CM [odds ratio (OR) 2.12, 95% confidence interval (CI) 1.69, 2.65], as were butalbital-containing compounds (OR 2.46, 95% CI 1.88, 3.22). The minority of migraineurs in the USA use specific medication, and one-fifth use opiates or barbiturates. For CM, > 34% use opiates or barbiturates. Accordingly, a sizable proportion use medications that are not firstline according to the US Headache Consortium Guidelines.

scholarly journals Opioids and Migraine: Opioid Awareness and Frequency of Use among Turkish Migraineurs

2019 ◽  
Vol 7 (3) ◽  
pp. 139-145
Author(s):  
D. H. Ertem ◽  
C. I. Basarir ◽  
G. Baran ◽  
N. Gonderten ◽  
F. Ilik
Keyword(s):  
Chronic Migraine ◽  
Episodic Migraine ◽  
Opioid Therapy ◽  
Cross Sectional Study ◽  
Migraine Treatment ◽  
Opioid Use ◽  
Cross Sectional ◽  
Opioid Prescription ◽  
Cardiovascular Comorbidities ◽  
Frequency Of Use

Despite the inadequate evidence of effi cacy and safety of opioid use for the treatment of migraine, it has been reported that patients with moderate to severe migraine headaches are prescribed opioids. Migraineurs may experience serious health impacts from opioids such as headache-related disability, psychiatric and cardiovascular comorbidities. The reduction of the risk of opioid abuse and prevention of an opioid epidemic are important public health challenges. The aim of this study was to assess the awareness of opioid therapy for migraine and the frequency of use among Turkish patients with episodic and chronic migraine. Materials and methods: consecutive migraine patients were enrolled in this cross-sectional study. A semi-structured questionnaire was developed and used by the researchers to assess the patients’ awareness of an opiod treatment option and the frequency of use of opioids for migraine treatment. Results. One hundred two patients were enrolled, of which 72 had episodic migraine and 30 had chronic migraine. All subjects reported that they had not been offered or prescribed any kind of opioids by general practitioners and neurologists for their headache. Besides, only 7 % of patients declared that they had heard of opioid treatment for migraine but they had never consulted their doctors about its effects. Conclusions. Our fi ndings demonstrated that opioids were not preferred as an option for acute or preventive migraine treatment by Turkish migraineurs and their physicians. The reduction of opioid prescription will help to prevent the development of medication overuse and opiate-induced headaches and drug addiction.

scholarly journals Effectiveness and safety of erenumab and galcanezumab in the prevention of chronic and episodic migraine: a retrospective cohort study

2021 ◽  
Author(s):  
Adrián Viudez-Martinez ◽  
Angela Pascual-Carrasco ◽  
Isabel Beltrán Blasco ◽  
Raquel Hernandez-Lorido ◽  
Rosa Fuster-Ruiz-de-Apodaca
Keyword(s):  
Chronic Migraine ◽  
Real World ◽  
Test Score ◽  
Daily Practice ◽  
Episodic Migraine ◽  
Migraine Prevention ◽  
Acute Migraine ◽  
Inclusion Criteria ◽  
Patient Reported ◽  
Specific Medication

Aim and Methods: Erenumab and galcanezumab have shown great results for migraine prevention in several clinical trials. However, strict inclusion criteria, absence of concomitant medication and selective outcome report may sometimes be barely representative of the real-world daily practice. Therefore, this observational, retrospective, non-comparative study was aimed to evaluate the effectiveness and safety of erenumab 140 mg and galcanezumab 120 mg in real-world patients with difficult-to-treat episodic or chronic migraine, who previously did not respond to up to three well-stablished pharmacological alternatives for migraine prevention. A combination of objective well-defined tools and vastly used patient reported outcome measurements were evaluated at baseline and after the administration of 3 and 6 doses. Results: from 180 patients, 142 matched inclusion criteria for the present study. Data here reported shows that erenumab and galcanezumab reduced mean headache days, acute migraine specific medication days, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses in real-world patients diagnosed with difficult to treat chronic or episodic migraine (p<0.01). Moreover, acute migraine specific medication days were reduced by a half in, at least, a 50% of the patients enrolled in each of the groups of the study. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. Conclusions: Erenumab and galcanezumab seem effective and well tolerated for migraine prevention in real-world patients with episodic or chronic migraine who previously failed to oral preventive therapies.

Patient-specific treatment allocation for carotid artery disease

2009 ◽  
Vol 1 (1) ◽  
pp. 41-49
Author(s):  
Marc Bosiers ◽  
Koen Deloose ◽  
Jurgen Verbist ◽  
Patrick Peeters
Keyword(s):  
Carotid Artery ◽  
Carotid Artery Disease ◽  
Specific Treatment ◽  
Patient Specific ◽  
Treatment Allocation ◽  
Artery Disease

scholarly journals Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study

Cephalalgia ◽  
2021 ◽  
pp. 033310242110241
Author(s):  
Shuu-Jiun Wang ◽  
Artemio A Roxas ◽  
Bibiana Saravia ◽  
Byung-Kun Kim ◽  
Debashish Chowdhury ◽  
...  
Keyword(s):  
Latin America ◽  
Middle East ◽  
Primary Endpoint ◽  
Episodic Migraine ◽  
Acute Migraine ◽  
Efficacy And Safety ◽  
Medication Treatment ◽  
Significant Difference ◽  
Specific Medication ◽  
Secondary Endpoints

Objective EMPOwER, a double-blind, randomised, phase 3 study, evaluated the efficacy and safety of erenumab in adults with episodic migraine from Asia, the Middle East, and Latin America. Methods Randomised patients (N = 900) received monthly subcutaneous injections of placebo, erenumab 70 mg, or 140 mg (3:3:2) for 3 months. Primary endpoint was change from baseline in monthly migraine days at Month 3. Other endpoints included achievement of ≥50%, ≥75%, and 100% reduction in monthly migraine days, change in monthly acute migraine-specific medication treatment days, patient-reported outcomes, and safety assessment. Results At baseline, mean (standard deviation) age was 37.5 (9.9) years, 81.9% were women, and monthly migraine days was 8.2 (2.8). At Month 3, change from baseline in monthly migraine days (primary endpoint) was −3.1, −4.2, and −4.8 days for placebo, erenumab 70 mg, and erenumab 140 mg, respectively, with a statistically significant difference for erenumab versus placebo (P = 0.002 [70 mg], P < 0.001 [140 mg]). Both erenumab doses were also significantly superior to placebo on all secondary endpoints, including the proportion of patients achieving ≥50% reduction from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication treatment days and change from baseline in the Headache Impact Test-6™ scores. The safety profile of erenumab was comparable with placebo; no new safety signals were observed. Conclusions This study of erenumab in patients with episodic migraine from Asia, the Middle East, and Latin America met all primary and secondary endpoints. A consistent numerical benefit was observed with erenumab 140 mg versus erenumab 70 mg across all efficacy endpoints. These findings extend evidence of erenumab’s efficacy and safety to patients under-represented in previous trials. ClinicalTrials.gov identifier: NCT03333109

scholarly journals Differences in Frontal Lobe Dysfunction in Patients with Episodic and Chronic Migraine

2021 ◽  
Vol 10 (13) ◽  
pp. 2779
Author(s):  
Sang-Hwa Lee ◽  
Yeonkyeong Lee ◽  
Minji Song ◽  
Jae Jun Lee ◽  
Jong-Hee Sohn
Keyword(s):  
Chronic Migraine ◽  
Frontal Lobe ◽  
Iowa Gambling Task ◽  
Medication Overuse Headache ◽  
Wisconsin Card Sorting Test ◽  
Episodic Migraine ◽  
Frontal Lobe Dysfunction ◽  
Card Sorting ◽  
Cross Sectional ◽  
Frontal Lobe Function

Neuroimaging and neuropsychological investigations have indicated that migraineurs exhibit frontal lobe-related cognitive impairment. We investigated whether orbitofrontal and dorsolateral functioning differed between individuals with episodic migraine (EM) and chronic migraine (CM), focusing on orbitofrontal dysfunction because it is implicated in migraine chronification and medication overuse headache (MOH) in migraineurs. This cross-sectional study recruited women with CM with/without MOH (CM + MOH, CM − MOH), EM, and control participants who were matched in terms of age and education. We conducted neuropsychological assessments of frontal lobe function via the Trail Making Test (TMT) A and B, the Wisconsin Card Sorting Test (WCST), and the Iowa Gambling Task (IGT). We enrolled 36 CM (19 CM + MOH, 17 CM–MOH), 30 EM, and 30 control participants. The CM patients performed significantly (p < 0.01) worse on the TMT A and B than the EM patients and the control participants. The WCST also revealed significant differences, with poorer performance in the CM patients versus the EM patients and the control participants. However, the net scores on the IGT did not significantly differ among the three groups. Our findings suggest that the CM patients exhibited frontal lobe dysfunction, and, particularly, dorsolateral dysfunction. However, we found no differences in frontal lobe function according to the presence or absence of MOH.

scholarly journals Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Michael Ament ◽  
Kathleen Day ◽  
Virginia L Stauffer ◽  
Vladimir Skljarevski ◽  
Mallikarjuna Rettiganti ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Migraine Headache ◽  
Randomized Clinical Trials ◽  
Episodic Migraine ◽  
Double Blind Study ◽  
Double Blind ◽  
Prodromal Symptoms ◽  
Link Type ◽  
Associated Symptoms ◽  
Severe Migraine

Abstract Background Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo. Here, we analyze data from 3 randomized clinical trials (2 episodic trials [EVOLVE-1, EVOLVE-2] and 1 chronic trial [REGAIN]), to examine if galcanezumab also alleviates the severity and symptoms of migraine. Methods The episodic migraine trials were 6-month, double-blind studies in patients with episodic migraine (4–14 monthly migraine headache days). The chronic migraine trial was a 3-month, double-blind study in patients with chronic migraine (≥ 15 headache days per month, where ≥ 8 met criteria for migraine). Patients (18–65 years) were randomized to placebo or galcanezumab 120 mg with a 240-mg loading dose or 240 mg. Patients recorded headache characteristics, duration, severity, and presence of associated symptoms with each headache. The outcomes analyzed were changes from baseline in number of monthly migraine headache days with nausea and/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms other than aura. Additional outcomes analyzed included the number of moderate-to-severe monthly migraine headache days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Change from baseline in the proportion of days with nausea and/or vomiting and the proportion of days with photophobia and phonophobia among the remaining monthly migraine headache days were also analyzed. Results Galcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine such as nausea and/or vomiting, photophobia and phonophobia, and prodromal symptoms. Galcanezumab reduced the frequency of migraine headache days with aura in the episodic migraine studies. There was a significant reduction in the proportion of remaining migraine headache days with nausea and/or vomiting for the episodic and chronic migraine studies, and with photophobia and phonophobia for the episodic migraine studies. Galcanezumab was superior to placebo in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days. Conclusions Galcanezumab reduces the frequency of migraine headache days and can alleviate potentially disabling non-pain symptoms on days when migraine is present in patients with episodic or chronic migraine. Trial registration NCT, NCT02614183 (EVOLVE-1), registered 25 November 2015; NCT, NCT02614196, (EVOLVE-2), registered 25 November 2015; NCT, NCT02614261 (REGAIN), registered 25 November 2015.

scholarly journals Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Messoud Ashina ◽  
Joshua M. Cohen ◽  
Maja Galic ◽  
Verena Ramirez Campos ◽  
Steve Barash ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Medication Use ◽  
Episodic Migraine ◽  
Inadequate Response ◽  
Open Label ◽  
Double Blind ◽  
Moderate Severity ◽  
Preventive Medication ◽  
Open Label Extension ◽  
Acute Headache

Abstract Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. In this study, we evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab. Methods Episodic migraine and chronic migraine patients completing the 12-week double-blind period of the FOCUS trial entered the 12-week open-label extension and received 3 monthly doses of fremanezumab (225 mg). Changes from baseline in monthly migraine days, monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia/phonophobia, days with nausea or vomiting, disability scores, and proportion of patients achieving a ≥50% or  ≥75% reduction in monthly migraine days were evaluated. Results Of the 807 patients who completed the 12-week double-blind treatment period and entered the open-label extension, 772 patients completed the study. In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing regimens, respectively, patients had fewer average monthly migraine days (mean [standard deviation] change from baseline: − 4.7 [5.4]; − 5.1 [4.7]; − 5.5 [5.0]), monthly headache days of at least moderate severity (− 4.5 [5.0]; − 4.8 [4.5]; − 5.2 [4.9]), days per month of acute headache medication use (− 4.3 [5.2]; − 4.9 [4.6]; − 4.8 [4.9]), days with photophobia/phonophobia (− 3.1 [5.3]; − 3.4 [5.3]; − 4.0 [5.2]), and days with nausea or vomiting (− 2.3 [4.6]; − 3.1 [4.5]; − 3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of patients, respectively, achieved a ≥50% reduction and 16%, 15%, and 20%, respectively, achieved a ≥75% reduction in monthly migraine days. Disability scores were substantially improved in all 3 treatment groups. There were low rates of adverse events leading to discontinuation (<1%). Conclusion Fremanezumab demonstrated sustained efficacy up to 6 months and was well tolerated in patients with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes. Trial registration ClinicalTrials.gov NCT03308968 (FOCUS).

scholarly journals Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan

Breast Cancer ◽  
2021 ◽  
Author(s):  
Yucherng Chen ◽  
Satoshi Noma ◽  
Yoshio Taguchi ◽  
Masashi Takahashi ◽  
Junji Tsurutani ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Age Distribution ◽  
Metastatic Breast ◽  
Advanced Age ◽  
Spontaneous Reports ◽  
Post Marketing ◽  
Marketing Data

Abstract Background This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan. Methods Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data. Results Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had ≥ 1 symptom at diagnosis, commonly dyspnea/shortness of breath (59%), cough (44%), and/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status. Conclusion Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit–risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.

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