scholarly journals Consensus of the Hellenic Headache Society on the diagnosis and treatment of migraine

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Evangelos Kouremenos ◽  
◽  
Chrysa Arvaniti ◽  
Theodoros S. Constantinidis ◽  
Ermioni Giannouli ◽  
...  
Keyword(s):  
Chronic Migraine ◽  
Botulinum Toxin Type A ◽  
Good Clinical Practice ◽  
Symptomatic Treatment ◽  
Episodic Migraine ◽  
Diagnosis And Treatment ◽  
High Dose ◽  
Migraine Prevention ◽  
Regulatory Affairs ◽  
First Choice

AbstractMore than 0.6 million people suffer from disabling migraines in Greece causing a dramatic work loss, but only a small proportion of migraineurs attend headache centres, most of them being treated by non-experts. On behalf of the Hellenic Headache Society, we report here a consensus on the diagnosis and treatment of adult migraine that is based on the recent guidelines of the European Headache Federation, on the principles of Good Clinical Practice and on the Greek regulatory affairs. The purposes are three-fold: (1) to increase awareness for migraine in Greece; (2) to support Greek practitioners who are treating migraineurs; and (3) to help Greek migraineurs to get the most appropriate treatment. For mild migraine, symptomatic treatment with high dose simple analgesics is suggested, while for moderate to severe migraines triptans or non-steroidal anti-inflammatory drugs, or both, should be administered following an individually tailored therapeutic strategy. A rescue acute treatment option should always be advised. For episodic migraine prevention, metoprolol (50–200 mg/d), propranolol (40–240 mg/d), flunarizine (5–10 mg/d), valproate (500–1800 mg/d), topiramate (25–100 mg/d) and candesartan (16–32 mg/d) are the drugs of first choice. For chronic migraine prevention topiramate (100-200 mg/d), valproate (500–1800 mg/d), flunarizine (5–10 mg/d) and venlafaxine (150 mg/d) may be used, but the evidence is very limited. Botulinum toxin type A and monoclonal antibodies targeting the CGRP pathway (anti-CGRP mAbs) are recommended for patients suffering from chronic migraine (with or without medication overuse) who failed or did not tolerate two previous treatments. Anti-CGRP mAbs are also suggested for patients suffering from high frequency episodic migraine (≥8 migraine days per month and less than 14) who failed or did not tolerate two previous treatments.

Anti-CGRP monoclonal antibodies for migraine prevention: A systematic review and likelihood to help or harm analysis

Cephalalgia ◽  
2021 ◽  
pp. 033310242198960
Author(s):  
Konstantina Drellia ◽  
Lili Kokoti ◽  
Christina I Deligianni ◽  
Dimitrios Papadopoulos ◽  
Dimos D Mitsikostas
Keyword(s):  
Clinical Trials ◽  
Monoclonal Antibodies ◽  
Chronic Migraine ◽  
Episodic Migraine ◽  
Randomised Clinical Trials ◽  
Migraine Prevention ◽  
Number Of Patients ◽  
Calcitonin Gene ◽  
Using Data ◽  
Risk Ratios

Introduction and objective Monoclonal antibodies targeting the calcitonin gene-related peptide pathway (anti-CGRP mAbs) have shown promising efficacy in randomised clinical trials for the prevention of episodic and chronic migraine, but no head-to-head comparisons with established treatments are available. We aimed to examine absolute differences in benefit-risk ratios between anti-CGRP mAbs, topiramate and propranolol for the prevention of episodic migraine and between anti-CGRP mAbs, topiramate and onabotulinumtoxinA for the prevention of chronic migraine using a likelihood to help versus harm analysis. Methods The number of patients needed to be treated for a patient to achieve ≥ 50% reduction in migraine days (NNTB50%) was used as an effect size metric of efficacy. The number of patients needed to be treated for a patient to experience an adverse event that led to treatment discontinuation (NNTHD-AE) was used as a measure of risk. Likelihood to help versus harm values – which are the ratios of NNTH:NNTB – were calculated using data from phase 3 randomised clinical trials. Results All agents tested were more likely to be beneficial than harmful (likelihood to help versus harm > 1) with the exception of topiramate at 200 mg per day for the prevention of episodic migraine. Anti-CGRP mAbs in all tested doses had higher LHH values than propranolol or topiramate for episodic migraine and onabotulinumtoxinA or topiramate for chronic migraine prevention. Fremanezumab had the highest LHH ratio in episodic migraine and galcanezumab in chronic migraine. Conclusion This analysis showed that anti-CGRP mAbs exhibit a more favourable benefit-risk ratio than established treatments for episodic and chronic migraine. Head-to-head studies are needed to confirm these results.

What´s left and new in the management of migraine?

2021 ◽  
pp. 1-23
Author(s):  
Oihane Goñi ◽  
◽  
Leire Leache ◽  
Esther Lacalle ◽  
Maria Teresa Acin ◽  
...  
Keyword(s):  
Health Service ◽  
Botulinum Toxin A ◽  
Preventive Treatment ◽  
Poor Response ◽  
Symptomatic Treatment ◽  
Episodic Migraine ◽  
Prescription Database ◽  
First Line ◽  
First Choice ◽  
Service Data

INTRODUCTION Migraine is a neurological disorder that generally manifests in the form of headache. The treatment of migraine is based on changes in lifestyle, symptomatic treatment and preventive therapies. The pharmacotherapeutic approach to migraine is based on widely-used drugs and novel drugs, which include monoclonal antibodies (mAbs), which emerge as an alternative for patients with poor response to standard preventive treatments. PURPOSE The objective of this study is to assess the efficacy and safety of the medications employed for the symptomatic and preventive treatment of migraine. Another objective is to determine its place in therapeutics and identify the best treatment based on the type of migraine and characteristics of the patient. METHODS A A search was performed of clinical practice guidelines, documents from regulatory agencies, systematic reviews and primary studies assessing symptomatic and preventive treatments of migraine. Data related to the use of triptans in Navarra, Spain, was extracted from the prescription database of the Navarre Health Service. Data about patients receiving mAb therapy in our community and their progress was extracted from electronic medical records and the Navarre Health Service pharmacotherapy management system. CONCLUSIONS The symptomatic treatment of choice for mild-moderate migraine includes non-steroidal anti-inflammatory drugs (NSAIDs), whereas triptans are frequently reserved for moderate-severe migraine. Oral drugs are the first-line preventive treatment, with ß-blockers and topiramate as the first choice. Botulinum toxin A is used in patients with chronic migraine who are unresponsive to oral preventive therapies. mAbs emerge as an alternative to prevent chronic or episodic migraine in patients unresponsive to previous treatments. These treatments, however, have a modest efficacy as compared to placebo. In addition, no comparative studies have been published to date about other first-line preventive therapies. The long-term safety and efficacy of mAbs have not yet been established, and their cost is high. MAbs are funded by the public health system only as fourth-line prophylactic therapy for chronic or high-frequency episodic migraine.

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.

Clinical and Morphological Features of Myocardial Damage and the Course of Fulminant Myocarditis on the Background of СOVID-19, Diagnosis and Treatment Tactics

2020 ◽  
Vol 75 (5S) ◽  
pp. 414-425
Author(s):  
Olga S. Oynotkinova ◽  
Evgenii L. Nikonov ◽  
Oleg V. Zayratyants ◽  
Elena V. Rzhevskaya ◽  
Evgenii V. Krukov ◽  
...  
Keyword(s):  
Myocardial Dysfunction ◽  
Myocardial Damage ◽  
Heart Rhythm ◽  
Microvascular Dysfunction ◽  
Symptomatic Treatment ◽  
Clinical Situation ◽  
Diagnosis And Treatment ◽  
Screening Tests ◽  
Fulminant Myocarditis ◽  
Heart Rhythm Disorders

In a review article based on my own clinical experience of managing patients with acute myocardial injury and fulminant myocarditis, taking into account expert recommendations on the clinical treatment of myocardial damage associated with novel coronavirus infection a National clinical geriatric medical research center, division of cardiovascular diseases, the Chinese geriatrics society, Department of cardiology, Beijing Medical Association and European clinics discusses the pathogenesis, diagnosis and treatment of myocardial damage and FM patients, infected with SARS-CoV-2 in the context of the COVID-19 pandemic. Clinical features and diagnostic criteria are presented, including screening tests of markers of myocardial damage in the form of a highly sensitive troponin test, a natriuretic peptide. The article discusses in detail the pathogenesis and mechanisms of myocardial damage, including immune mechanisms, cytokine storm, systemic inflammation with macro- and microvascular dysfunction and the development of myocardial dysfunction with acute heart failure, hypotension, cardiogenic shock and/or life-threatening heart rhythm disorders caused by hypoxia and metabolic disorders at the cellular level. Features of the clinical course of fulminant myocarditis in infected patients (SARS-CoV-2) in the conditions of the COVID-19 pandemic are presented. For the first time, a detailed histo-morphological analysis of pathological myocardial injuries and complications is presented on the basis of unique autopsy material on post-mortem diagnostics of various pathoanatomic autopsies of those who died from COVID-19 in Moscow. Based on the clinical, functional and morphological material, the Protocol of etiopathogenetic treatment is presented. The basis of standard therapy is considered antiviral drugs, immunoglobulin G, the use of monoclonal antibodies to interleukin-6, anticoagulants, glucocorticoids, depending on the clinical situation, cardioprotectors and symptomatic treatment are recommended to maintain the heart, which in combination can achieve a certain clinical effectiveness. As adjuvant cardioprotective targeted therapy, the sodium salt of phosphocreatine is considered in order to preserve the myocardium, maintain its contractility and vital activity.

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).

Anthropometric and Pharmacotherapeutic Variables on Acute Emesis Induced by Cisplatin-Containing Chemotherapy

2000 ◽  
Vol 34 (5) ◽  
pp. 573-579 ◽  
Author(s):  
José Luis Catalán Arlandis ◽  
N Víctor Jiménez Torres
Keyword(s):  
Prognostic Factors ◽  
Odds Ratio ◽  
Logistic Model ◽  
Therapeutic Failure ◽  
High Dose ◽  
Anthropometric Parameters ◽  
Cycle Number ◽  
Chemotherapeutic Regimen ◽  
Acute Emesis ◽  
First Choice

OBJECTIVE: To characterize the effects of anthropometric and pharmacotherapeutic variables on acute emesis induced by cisplatin-containing regimens with dosages ·50 mg·m−2. METHODS: A prospective, cross-sectional, noncontrolled study was performed to analyze acute vomiting during the first 24 hours in patients treated in a Spanish hospital. The patients received an intravenous combination of drugs (2 doses of metoclopramide 3 mg/kg, dexamethasone 20 mg) as first-choice antiemetic therapy. Intravenous ondansetron 8 mg and dexamethasone 20 mg served as an alternative regimen in patients <30 years old with a history of extrapyramidal manifestations or emesis in previous cycles. Therapeutic failure was used as a dependent variable, defined as three or more vomiting episodes documented by the patients. Other variables were the chemotherapeutic regimen; antiemetic regimen; patient gender, age, weight, and height; and cycle number. The reference logistic model and two reduced-models derived from the latter were designed. The logistic models were subsequently validated by means of receiving operating characteristic curves. RESULTS: A total of 319 cycles involving 106 patients were studied. The metoclopramide regimen was administered in 66% of the cycles. The therapeutic failure rate was 21% for the metoclopramide regimen and 32% for the ondansetron treatment. The logistic model developed identified the type of chemotherapeutic regimen provided as the most significant prognostic variable (p < 0.0001). Patient weight (odds ratio 1.64) and height (odds ratio 1.28) were identified as prognostic factors related with therapeutic failure. CONCLUSIONS: The type of chemotherapeutic regimen administered and the anthropometric characteristics of the patients exert a clear conditioning effect on risks associated with therapeutic failure against acute emesis following high-dose cisplatin therapy. Such anthropometric parameters have not been previously identified as prognostic factors.

The efficacy of botulinum toxin type-A for intractable chronic migraine patients with no pain-free time

2021 ◽  
pp. 204946372110145
Author(s):  
Dominic Atraszkiewicz ◽  
Rieko Ito ◽  
Anish Bahra
Keyword(s):  
Botulinum Toxin ◽  
Chronic Migraine ◽  
Botulinum Toxin A ◽  
Botulinum Toxin Type A ◽  
Botulinum Toxin Type ◽  
Free Time ◽  
Phase Iii ◽  
Pharmacological Management ◽  
Sustained Reduction ◽  
New Onset

Aim: This is a retrospective report of the efficacy of botulinum toxin-A, Botox® (Allergan), in intractable chronic migraine patients non-responsive to previous pharmacological management and with largely no pain-free time, including those with new onset daily persistent headache. Methods: Thirty-three patients, all with severe Headache Impact Test (HIT)-6 scores at baseline, received 3-monthly injections of Botox® as per Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PRE-EMPT) protocol over a maximum 33-month period. Response criteria were a sustained reduction of HIT-6 scores below 60. Results: Four patients had headache on at least 20 days a month; the remaining patients had daily headache with no pain-free time, including nine patients with new onset persistent migraine. There was a significant reduction in HIT-6 scores following Botox® therapy ( x̅ = −5.45, p = 0.000920). Twenty-one percent of the cohort exhibited a sustained reduction in HIT-6 scores below 60. The number of headache days and pain-free time did not change in five of the six responders, but disability improved. There was no difference between patients with episodic migraine evolving to chronic as opposed to those with chronic migraine from onset. Conclusion: This report suggests that Botox® treatment is efficacious in intractable chronic migraine without pain-free time. The HIT-6 is a reliable and practical parameter to assess disability in this patient group. Use of such validated parameters should be considered with greater weight in future International Classification of Headache Disorders (ICHD) guidelines for controlled clinical trials.

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