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1.
Arq Neuropsiquiatr ; 81(3): 248-252, 2023 03.
Article in English | MEDLINE | ID: covidwho-2300743

ABSTRACT

BACKGROUND: Due to coronavirus disease 2019 (COVID-19) pandemic response measures, the administration of botulinum toxin (BTX) was delayed for many patients during the first lockdown period in Portugal. OBJECTIVES: To review the impact of postponing BTX treatment on migraine control. METHODS: This was a retrospective, single-center study. Patients with chronic migraine who had done at least three previous BTX cycles and were considered responders were included. The patients were divided into two groups, one that has had their treatment delayed (group P), and one that has not (controls). The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) protocol was used. Migraine-related data were obtained at baseline and at three subsequent visits. RESULTS: The present study included two groups, group P (n = 30; 47.0 ± 14.5 years; 27 females, interval baseline -1st visit: 5.5 [4.1-5.8] months) and the control group (n = 6; 57.7 ± 13.2 years; 6 females; interval baseline-1st visit 3.0 [3.0-3.2] months). No difference between the groups was present at baseline. When compared to baseline, the number of days/month with migraine (5 [3-6.2] vs. 8 [6-15] p < 0.001), days using triptans/month (2.5 [0-6] vs. 3 [0-8], p = 0.027) and intensity of pain (7 [5.8-10] vs. 9 [7-10], p = 0.012) were greater in the first visit for group P, while controls did not present a significant variation. The worsening of migraine-related indicators decreased in the following visits; however, even in the third visit, it had not returned to baseline. Correlations were significant between the delayed time to treatment and the increase in days/month with migraines at the first visit after lockdown (r = 0.507; p = 0.004). CONCLUSIONS: There was a deterioration of migraine control after postponed treatments, with a direct correlation between the worsening of symptoms and the number of months that the treatment was delayed.


ANTECEDENTES: Devido às medidas de resposta à pandemia de coronavirus disease 2019 (covid-19), a administração de toxina botulínica (TXB) foi adiada para muitos pacientes durante o primeiro confinamento em Portugal. OBJETIVOS: Avaliar o impacto do adiamento do tratamento com TXB no controle da enxaqueca. MéTODOS: Estudo retrospectivo unicêntrico. Foram incluídos pacientes com enxaqueca crônica com pelo menos três ciclos prévios de TXB e que tenham sido considerados respondedores. Os pacientes foram divididos em dois grupos, sendo um com atraso do tratamento (grupo P) e outro sem atraso (controles). O protocolo Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) foi utilizado. Dados clínicos relacionados com a enxaqueca foram obtidos na consulta inicial (T0) e nas três consultas subsequentes (T1­3). RESULTADOS: O presente estudo incluiu dois grupos, o grupo P (n = 30; 47,0 ± 14,5 anos; 27 mulheres, intervalo T0-1ª visita: 5,5 [4,1­5,8] meses) e o grupo controle (n = 6; 57,7 ± 13,2 anos; 6 mulheres; intervalo T0­1ª visita 3,0 [3,0­3,2] meses). Os grupos não apresentavam nenhuma diferença no início do estudo. Quando comparado à T0, o número de dias/mês com enxaqueca (5 [3­6,2] vs. 8 [6­15], p < 0,001), dias usando triptanos/mês (2,5 [0­6] vs. 3 [0­8], p = 0,027) e intensidade da dor (7 [5,8­10] vs. 9 [7­10], p = 0,012) foram maiores na primeira visita no grupo P, não apresentando os controles variação significativa. A piora dos indicadores relacionados com a enxaqueca diminuiu nas visitas seguintes; porém, mesmo na terceira visita, ainda não haviam retornado ao basal. As correlações foram significativas entre o atraso do tratamento e o aumento de dias/mês com enxaqueca na primeira consulta após o confinamento (r = 0,507; p = 0,004). CONCLUSãO: Houve piora clínica da enxaqueca após o adiamento do tratamento em correlação direta com a duração do atraso.


Subject(s)
Botulinum Toxins, Type A , COVID-19 , Migraine Disorders , Female , Humans , Botulinum Toxins, Type A/therapeutic use , Pandemics , Retrospective Studies , Treatment Outcome , Communicable Disease Control , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control
2.
Cephalalgia ; 43(1): 3331024221128250, 2023 01.
Article in English | MEDLINE | ID: covidwho-2266706

ABSTRACT

BACKGROUND: Atogepant is a United States Food and Drug Administration-approved oral calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine. The study objective was to evaluate the long-term safety and tolerability of atogepant in participants who completed the phase 3 ADVANCE trial (NCT03777059). METHODS: This 40-week, open-label extension trial (NCT03939312) monitored safety in participants receiving oral atogepant 60 mg once daily, followed by a four-week safety follow-up period. RESULTS: Of the 685 participants taking at least one dose of atogepant, the treatment period was completed by 74.6% of participants with a mean (standard deviation) treatment duration of 233.6 (89.3) days. Treatment-emergent adverse events occurred in 62.5% of participants, with upper respiratory tract infection (5.5%), urinary tract infection (5.3%), nasopharyngitis (4.8%), sinusitis (3.6%), constipation (3.4%), and nausea (3.4%) occurring at ≥3%. Serious adverse events were observed in 3.4% of participants (none were treatment-related), and there were no deaths. Adverse events leading to discontinuation occurring at >0.1% were nausea (0.4%) and abdominal pain, vomiting, weight decrease, dizziness, and migraine (0.3% each). CONCLUSION: These results are consistent with atogepant's known safety profile and support long-term use of atogepant 60 mg once daily dosing as safe and well tolerated.ClinicalTrials.gov Registration Number: NCT03939312.


Subject(s)
Migraine Disorders , Humans , Treatment Outcome , Double-Blind Method , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Nausea
3.
Medicina (Kaunas) ; 59(1)2022 Dec 23.
Article in English | MEDLINE | ID: covidwho-2229438

ABSTRACT

Background and Objectives: The Greek Society of Migraine and Headache Patients conducted, in 2020, its second online survey, titled "Migraine in Greece-2020", after publication of the first similar online survey conducted in 2018. To compare the current findings with the corresponding data obtained in 2018, we herein release the second part of results obtained from the 2020 survey on the efficacy of preventive and symptomatic anti-migraine medications and the patients' reported satisfaction with these treatments. Materials and Methods: We surveyed 2105 migraine patients from all over Greece with the use of a 151-questions specific migraine-focused questionnaire in Greek language, which was distributed through the online research software "SurveyMonkey". Results: Triptans were mostly used with efficacy for the symptomatic relief of migraine attacks. About 2 of 3 surveyed patients had received various prophylactic oral medications and the majority of them discontinued these prophylactic medications as a result of inefficacy/safety issues. BoNTA was reported to be effective only when administration was commenced by a trained neurologist/headache specialist, while our current findings are generally comparable to those obtained in our 2018 pre-COVID-19 survey and the pandemic has not imposed any significant attitudes on migraine therapies and corresponding patients' satisfaction. Conclusion: Although a market change is anticipated with the evolving widespread use of anti-CGRPs monoclonal antibodies or gepants in the symptomatic and prophylactic treatment of migraine, it is of great interest to review published results of larger longitudinal population-based studies to further ascertain the satisfaction of patients to migraine therapies.


Subject(s)
COVID-19 , Migraine Disorders , Humans , Patient Satisfaction , Greece , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Surveys and Questionnaires , Headache , Personal Satisfaction , Internet
4.
J Headache Pain ; 23(1): 142, 2022 Nov 18.
Article in English | MEDLINE | ID: covidwho-2153502

ABSTRACT

BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).


Subject(s)
Migraine Disorders , Quality of Life , Humans , Adult , Adolescent , Child , Switzerland , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Receptors, Calcitonin Gene-Related Peptide , Headache , Delivery of Health Care
5.
Nutrients ; 14(14)2022 Jul 17.
Article in English | MEDLINE | ID: covidwho-2066291

ABSTRACT

Migraine is a headache disorder associated with a high socioeconomic burden. The digital therapeutic sinCephalea provides an individualized low-glycemic diet based on continuous glucose measurement and is intended to provide a non-pharmacological migraine prophylaxis. We performed two prospective studies with migraine patients who used sinCephalea over a period of 16 weeks. The patients used a headache diary and recorded their migraine-related daily life impairments using the assessment tools HIT-6 and MIDAS for a pre versus post comparison. In addition, continuous glucose data of patients were compared to healthy controls. In both studies, patients reported a reduction of headache and migraine days as well as reductions in HIT-6 and MIDAS scores. More specifically, migraine days decreased by 2.40 days (95% CI [-3.37; -1.42]), HIT-6 improved by 3.17 points (95% CI [-4.63; -1.70]) and MIDAS by 13.45 points (95% CI [-22.01; -4.89]). Glucose data suggest that migraine patients have slightly increased mean glucose values compared to healthy controls, but drop into a glucose range that is below one's individual standard range before a migraine attack. In conclusion, sinCephalea is a non-pharmacological, digital migraine prophylaxis that induces a therapeutic effect within the range of pharmacological interventions.


Subject(s)
Migraine Disorders , Glucose , Headache/therapy , Humans , Migraine Disorders/prevention & control , Prospective Studies
6.
Lancet Neurol ; 21(7): 597-607, 2022 07.
Article in English | MEDLINE | ID: covidwho-1895523

ABSTRACT

BACKGROUND: The monoclonal antibody eptinezumab, which targets calcitonin gene-related peptide, has shown migraine preventive effects starting the day following infusion and acceptable safety and tolerability in phase 3 trials, but benefits in the subpopulations of patients with previous preventive treatment failures were not examined. We aimed to investigate the safety and efficacy of eptinezumab for migraine prevention in adults with migraine and two-to-four previous preventive treatment failures. METHODS: DELIVER was a multicentre, multi-arm, phase 3b trial comprising a 24-week double-blind, placebo-controlled period and a 48-week dose-blinded extension. We recruited adults with episodic or chronic migraine with at least 4 monthly migraine days (as per International Headache Society guidelines) and documented evidence of two-to-four previous preventive treatment failures within the past 10 years, from 96 study locations across Europe (n=93) and the USA (n=3). Patients were randomly assigned (1:1:1) via a centralised randomisation system, stratified by baseline monthly headache days and country, to eptinezumab 100 mg, eptinezumab 300 mg, or placebo. The primary efficacy endpoint was the change from baseline in mean monthly migraine days (captured using a daily electronic diary) in weeks 1-12, assessed in the full analysis set. All participants and study personnel were masked to study drug assignments. The dose-blinded extension period is ongoing. The trial is registered with ClinicalTrials.gov, NCT04418765, and EudraCT, 2019-004497-25. FINDINGS: Between June 1, 2020, and Oct 7, 2021, 891 individuals were randomly assigned and received at least one dose of study drug (safety population; eptinezumab 100 mg n=299 [34%], eptinezumab 300 mg n=294 [33%], placebo n=298 [33%]). 865 patients completed the placebo-controlled period. The change from baseline to weeks 1-12 in mean monthly migraine days was -4·8 (SE 0·37) with eptinezumab 100 mg, -5·3 (0·37) with eptinezumab 300 mg, and -2·1 (0·38) with placebo. The difference from placebo in change in mean monthly migraine days from baseline was significant with eptinezumab 100 mg (-2·7 [95% CI -3·4 to -2·0]; p<0·0001) and eptinezumab 300 mg (-3·2 [-3·9 to -2·5]; p<0·0001). Treatment-emergent adverse events occurred in 127 (42%) of 299 patients in the eptinezumab 100 mg group, in 120 (41%) of 294 in the eptinezumab 300 mg group, and in 119 (40%) of 298 in the placebo group. The most common treatment-emergent adverse event was COVID-19 (20 [7%] of 299 patients in the eptinezumab 100 mg group, 17 [6%] of 294 in the eptinezumab 300 mg group, and 16 [5%] of 298 in the placebo group). Serious adverse events were uncommon (five [2%] of 299 in the eptinezumab 100 mg group, seven [2%] of 294 in the eptinezumab 300 mg group, four [1%] of 298 in the placebo group) and included anaphylactic reaction (eptinezumab 300 mg n=2) and COVID-19 (eptinezumab 100 mg n=1 and eptinezumab 300 mg n=1). INTERPRETATION: In adults with migraine and two-to-four previous preventive treatment failures, eptinezumab provided significant migraine preventive effects compared with placebo, with acceptable safety and tolerability, indicating that eptinezumab might be an effective treatment option for this patient population. The dose-blinded extension period will provide additional long-term safety data in patients with migraine and previous preventive treatment failures. FUNDING: H Lundbeck.


Subject(s)
Antibodies, Monoclonal, Humanized , Migraine Disorders , Adult , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19 , Double-Blind Method , Headache , Humans , Migraine Disorders/prevention & control , Treatment Failure , Treatment Outcome
7.
BioDrugs ; 36(3): 337-339, 2022 May.
Article in English | MEDLINE | ID: covidwho-1872796

ABSTRACT

The introduction of new drug classes for migraine, such as monoclonal antibodies that target the calcitonin gene-related peptide (CGRP) or its receptor and small-molecule antagonists of CGRP, have opened a new scenario in a large population of individuals suffering from migraines. The provision of an effective and safe therapy can help overcome the high social and personal costs together with the burden of this disease by offering social, work and economic recovery to the people affected by migraine. Whether the satisfaction of personal and collective unmet needs will be achieved in the vast majority of migraine sufferers now depends only on the efficiency of the organizational care structures dedicated to this socially impactful disease. This path will offer personal benefits and significant psychosocial relief that will help to reduce the enormous current healthcare expenditure necessary for the management of the huge number of individuals suffering from migraines. The new pharmacological classes for prevention must be applied as an interdiction to the chronic phase to express their full rehabilitation potential.


Subject(s)
Calcitonin Gene-Related Peptide Receptor Antagonists , Migraine Disorders , Antibodies, Monoclonal/pharmacology , Antibodies, Monoclonal/therapeutic use , Calcitonin Gene-Related Peptide , Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use , Humans , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Receptors, Calcitonin Gene-Related Peptide
8.
Neurol India ; 69(Supplement): S51-S58, 2021.
Article in English | MEDLINE | ID: covidwho-1771349

ABSTRACT

BACKGROUND: Migraine is a common primary headache disorder and Episodic migraine is characterized by the occurrence of up to 14 headache days in a month. The preventive treatment of migraine is useful in patients with frequent migraine attacks, impaired activities of daily living, failure of acute pain management, disabling aura and limitations in the use of acute treatment. It is aimed at reducing headache frequency and intensity, improve response to acute treatment of migraine and improve the quality of life. AIM: To analyze the evidence for the efficacy and tolerability of preventive oral drugs used in the management of episodic migraine. METHODS: A narrative review of the references were reviewed by searching the literature for the articles published in PubMed in English language using all the following MeSH keywords "preventive treatment", "preventive oral treatment", AND "episodic migraine", "migraine". RESULTS: Out of articles identified in the search, 38 articles were reviewed for evidence and summarized. The various oral drugs used in the prevention of episodic migraine are antihypertensives (beta-blockers, calcium channel blockers and Angiotensin-converting enzyme inhibitors/Angiotensin receptor blockers), antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors), antiepileptic drugs (valproic acid, topiramate, lamotrigine) and other miscellaneous agents. HURT questionnaire and HALT 30 index are useful in assessing response to treatment in the follow up of migraine patients. CONCLUSION: An appropriately chosen oral drug is useful in the preventive treatment of episodic migraine. In patients, who fail to respond to the preventive treatment, it is essential to review the diagnosis of migraine, titrate the dosage and duration of preventive treatment and ensure patient compliance. In those patients who fail to respond to monotherapy, polytherapy is a useful option to be considered.


Subject(s)
Migraine Disorders , Quality of Life , Activities of Daily Living , Anticonvulsants/therapeutic use , Humans , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Topiramate/therapeutic use
9.
J Clin Neurosci ; 97: 87-92, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1712826

ABSTRACT

Since the onset of the COVID-19 pandemic, the use of personal protective equipment (PPE) and disinfectants has become necessary to prevent transmission of the virus. However, the effects of such pandemic obligations on chronic diseases such as migraine have not been fully elucidated. We aimed to investigate the effects of the COVID-19 pandemic, as well as the use of masks and disinfectants, on migraine patients. A total of 310 migraine patients were included. Demographic data, migraine characteristics, and mask and disinfectant use were obtained through a face-to-face survey. Patients were grouped as worsening, stable, or improving according to pre-pandemic and pandemic migraine characteristics. Migraine worsening was found in 177 (57.1%) patients, stable course in 96 (31%) patients, and improvement in 37 (11.9%) patients. The use of scalp contact masks and double masks and daily mask duration were higher in the worsening group (p:0.005, p:0.005 and p:0.001). In addition, the frequency of personal disinfectant use was higher in this group (p:0.011). In regression analysis, mask type, daily mask duration, presence of allodynia, being a health worker, depression score, and odor were determined as independent risk factors for migraine worsening. We found a worsening of migraines in more than half of patients during the COVID-19 pandemic. We also demonstrated a relationship between migraine worsening and mask type, number of masks, and intensive disinfectant use. Migraine patients should be advised of optimal prevention methods based on individual social and working conditions rather than exaggerated preventative measures.


Subject(s)
COVID-19 , Disinfectants , Migraine Disorders , COVID-19/prevention & control , Humans , Masks/adverse effects , Migraine Disorders/epidemiology , Migraine Disorders/etiology , Migraine Disorders/prevention & control , Pandemics/prevention & control , SARS-CoV-2
10.
Cephalalgia ; 42(7): 608-617, 2022 06.
Article in English | MEDLINE | ID: covidwho-1685876

ABSTRACT

INTRODUCTION: Headaches associated with personal protective equipment were reported in health-care workers in previous epidemiological studies. METHODS: National web-based survey advertised by the Portuguese Headache Society and National Headache and Migraine patient´s organization between September-December 2020 screening for personal protective equipment usage pattern, pre-existing and de novo headaches after the onset of the COVID-19 pandemic, and its relation to personal protective equipment use. RESULTS: Of 5064 participants, 90.6% (4562/5034) were women, mean age was 37.2 ± 11 years. Most questions had a completion rate above 87% (non-completion rate ranging from 0-12.7%). Twenty percent were health-care professionals (993/5046). Surgical and cloth masks were the most common personal protective equipment type, whereas protective eyewear and FFP2/FFP3 masks were mostly used by health-care professionals. About 97% (1814/1870) of migraine and headache participants reported aggravation of pre-existing headaches with personal protective equipment use, and 56% (2476/4420) had de novo headaches. Participants with de novo headaches had a higher frequency of pre-existing migraine (1118/1226, 91.2% vs 1408/1600, 88%, P = .042), and wore personal protective equipment for longer periods of time (7 ± 2 h 42 vs 6 ± 2 h 54 min per day, P < .001). In multivariate analysis longer mean duration of personal protective equipment use (OR of 1.1, 95% CI 1-1.2) and previous migraine (OR of 1.2, 95% CI 1-1.4) were predictors of developing de novo headaches. CONCLUSIONS: Almost all participants with pre-existing headache reported worsening of their headaches, and more than half of the study population developed de novo headaches following personal protective equipment use. Duration of personal protective equipment usage and pre-existing migraine were the strongest predictors of de novo headaches.


Subject(s)
COVID-19 , Migraine Disorders , Adult , Female , Headache/epidemiology , Humans , Male , Middle Aged , Migraine Disorders/epidemiology , Migraine Disorders/prevention & control , Pandemics/prevention & control , Personal Protective Equipment
11.
Pain Med ; 23(1): 164-188, 2022 Jan 03.
Article in English | MEDLINE | ID: covidwho-1455341

ABSTRACT

OBJECTIVE: To systematically evaluate the efficacy and effectiveness of percutaneous interventional treatments for prevention of migraine through a qualitative and (when possible) quantitative analysis. METHODS: An expert panel was asked to develop recommendations for the multidisciplinary preventive treatment of migraine, including interventional strategies. The committee conducted a systematic review and (when evidence was sufficient) a meta-analytic review by using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria and the modified Cochrane Risk of Bias analysis available in the Covidence data management program. Clinical questions addressed adults with migraine who should be offered prevention. Examined outcomes included headache days, acute medication use, and functional impairment. Acute management of migraine was outside the scope of this guideline. RESULTS: The committee screened 1,195 studies and assessed 352 by full text, yielding 16 randomized controlled trials that met the inclusion criteria. RECOMMENDATIONS AND CONCLUSIONS: As informed by evidence related to the preselected outcomes, adverse event profile, cost, and values and preferences of patients, onabotulinumtoxinA received a strong recommendation for its use for chronic migraine prevention and a weak recommendation against its use for episodic migraine prevention. Greater occipital nerve blocks received a weak recommendation for their use for chronic migraine prevention. For greater occipital nerve block, steroid received a weak recommendation against its use vs the use of local anesthetic alone. Occipital nerve with supraorbital nerve blocks, sphenopalatine ganglion blocks, cervical spine percutaneous interventions, and implantable stimulation all received weak recommendations for their use for chronic migraine prevention. The committee found insufficient evidence to assess trigger point injections in migraine prevention and highly discouraged the use of intrathecal medication.


Subject(s)
Migraine Disorders , Adult , Anesthetics, Local , Cervical Vertebrae , Headache/therapy , Humans , Injections , Migraine Disorders/prevention & control
12.
N Engl J Med ; 385(8): 695-706, 2021 08 19.
Article in English | MEDLINE | ID: covidwho-1364626

ABSTRACT

BACKGROUND: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist that is being investigated for the preventive treatment of migraine. METHODS: In a phase 3, double-blind trial, we randomly assigned adults with 4 to 14 migraine days per month in a 1:1:1:1 ratio to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks. The primary end point was the change from baseline in the mean number of migraine days per month across the 12 weeks. Secondary end points included headache days per month, a reduction from baseline of at least 50% in the 3-month average of migraine days per month, quality of life, and scores on the Activity Impairment in Migraine-Diary (AIM-D). RESULTS: A total of 2270 participants were screened, 910 were enrolled, and 873 were included in the efficacy analysis; 214 were assigned to the 10-mg atogepant group, 223 to the 30-mg atogepant group, 222 to the 60-mg atogepant group, and 214 to the placebo group. The mean number of migraine days per month at baseline ranged from 7.5 to 7.9 in the four groups. The changes from baseline across 12 weeks were -3.7 days with 10-mg atogepant, -3.9 days with 30-mg atogepant, -4.2 days with 60-mg atogepant, and -2.5 days with placebo. The mean differences from placebo in the change from baseline were -1.2 days with 10-mg atogepant (95% confidence interval [CI], -1.8 to -0.6), -1.4 days with 30-mg atogepant (95% CI, -1.9 to -0.8), and -1.7 days with 60-mg atogepant (95% CI, -2.3 to -1.2) (P<0.001 for all comparisons with placebo). Results for the secondary end points favored atogepant over placebo with the exceptions of the AIM-D Performance of Daily Activities score and the AIM-D Physical Impairment score for the 10-mg dose. The most common adverse events were constipation (6.9 to 7.7% across atogepant doses) and nausea (4.4 to 6.1% across atogepant doses). Serious adverse events included one case each of asthma and optic neuritis in the 10-mg atogepant group. CONCLUSIONS: Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks. Adverse events included constipation and nausea. Longer and larger trials are needed to determine the effect and safety of atogepant for migraine prevention. (Funded by Allergan; ADVANCE ClinicalTrials.gov number, NCT03777059.).


Subject(s)
Calcitonin Gene-Related Peptide Receptor Antagonists/administration & dosage , Migraine Disorders/prevention & control , Piperidines/administration & dosage , Pyridines/administration & dosage , Pyrroles/administration & dosage , Spiro Compounds/administration & dosage , Adolescent , Adult , Aged , Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects , Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use , Constipation/chemically induced , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Intention to Treat Analysis , Male , Middle Aged , Nausea/chemically induced , Piperidines/adverse effects , Piperidines/therapeutic use , Pyridines/adverse effects , Pyridines/therapeutic use , Pyrroles/adverse effects , Pyrroles/therapeutic use , Spiro Compounds/adverse effects , Spiro Compounds/therapeutic use , Young Adult
13.
Pain Med ; 22(11): 2728-2738, 2021 11 26.
Article in English | MEDLINE | ID: covidwho-1284891

ABSTRACT

OBJECTIVE: Aim of the present observational study was to assess the impact of coronavirus disease 2019 (COVID-19) quarantine on migraine and evaluate potential influencing factors. Previous studies reported mixed results regarding clinical outcome during quarantine in patients with migraine. In particular, data from areas strongly affected by COVID-19 pandemic are missing. METHODS: One hundred and seventy patients, previously assessed at the Headache Centre-ASST Spedali Civili Brescia, underwent a telephonic interview regarding migraine features and clinical, occupational, and lifestyle variables. RESULTS: Compared to baseline, during quarantine, we found a significant overall reduction in migraine days (14.7 ± 0.6 vs 12.3 ± 0.7, P < .001), with 47.1% patients reporting a clinical improvement. Outdoor living spaces (odds ratio [OR] 2.3, 95% confidence interval [CI] 1.7-3.07, P = .009), a positive attitude throughout quarantine (OR 4.12, 95% CI 2.3-7.1, P = 0.03), working full-time (OR 1.03, 95% CI 0.5-1.9, P < .001) and a baseline diagnosis of chronic migraine (OR 1.4, 95% CI 1.1-2.02, P = 0.002) were associated with an increased chance of migraine improvement. Being single (OR 1.5, 95% CI 1.1-2.01, P = .05) and physical inactivity (OR 1.3, 95% CI 1.1-1.6, P = .02) were associated with an increased risk of worsening. CONCLUSIONS: Quarantine had an overall positive impact on migraine. Based on our results, we hypothesize the reduction of daily hassles and challenges might be the main reason for such improvement.


Subject(s)
COVID-19 , Migraine Disorders , Humans , Migraine Disorders/diagnosis , Migraine Disorders/epidemiology , Migraine Disorders/prevention & control , Pandemics , Quarantine , SARS-CoV-2
14.
J Headache Pain ; 21(1): 115, 2020 Sep 24.
Article in English | MEDLINE | ID: covidwho-791318

ABSTRACT

BACKGROUND: Since the declaration COVID-19 as a pandemic, healthcare systems around the world have faced a huge challenge in managing patients with chronic diseases. Patients with migraine were specifically vulnerable to inadequate medical care. We aimed to investigate the "real-world" impact of COVID-19 pandemic on migraine patients, and to identify risk factors for poor outcome. METHODS: We administered an online, self-reported survey that included demographic, migraine-related, COVID-19-specific and overall psychosocial variables between July 15 and July 30, 2020. We recruited a sample of patients with migraine from headache clinic registry and via social media to complete an anonymous survey. Outcomes included demographic variables, change in migraine frequency and severity during the lockdown period, communication with treating physician, compliance to migraine treatment, difficulty in getting medications, medication overuse, symptoms of anxiety and/or depression, sleep and eating habits disturbance, screen time exposure, work during pandemic, use of traditional medicine, effect of Botox injection cancellation, and overall worries and concerns during pandemic. RESULTS: A total of 1018 patients completed the survey. Of the respondents, 859 (84.3%) were females; 733 (71.9%) were aged 20 to 40 years, 630 (61.8%) were married, and 466 (45.7%) reported working during the pandemic. In comparison to pre-pandemic period, 607 respondents (59.6%) reported increase in migraine frequency, 163 (16%) reported decrease in frequency, and 105 (10.3%) transformed to chronic migraine. Severity was reported to increase by 653 (64.1%) respondents. The majority of respondents; 626 (61.5%) did not communicate with their neurologists, 477 (46.9%) reported compliance to treatment, and 597 (58.7%) reported overuse of analgesics. Botox injections cancellation had a negative impact on 150 respondents (66.1%) from those receiving it. Forty-one respondents (4%) were infected with COVID-19; 26 (63.4%) reported worsening of their headaches amid infection period. Sleep disturbance was reported by 794 (78.1%) of respondents, and 809 (79.5%) reported having symptoms of anxiety and/or depression. CONCLUSIONS AND RELEVANCE: COVID-19 pandemic had an overall negative impact on patients with migraine. Several risk factors for poor outcome were identified. Long-term strategies should be validated and implemented to deliver quality care for patients with migraine, with emphasis on psychosocial well-being.


Subject(s)
Coronavirus Infections/epidemiology , Migraine Disorders/physiopathology , Pneumonia, Viral/epidemiology , Prescription Drug Overuse/statistics & numerical data , Adult , Analgesics/therapeutic use , Anxiety/psychology , Betacoronavirus , Botulinum Toxins, Type A/therapeutic use , COVID-19 , Communication , Depression/psychology , Female , Health Services Accessibility , Humans , Internet , Kuwait/epidemiology , Male , Middle Aged , Migraine Disorders/drug therapy , Migraine Disorders/prevention & control , Migraine Disorders/psychology , Neuromuscular Agents/therapeutic use , Pandemics , Physician-Patient Relations , Risk Factors , SARS-CoV-2 , Sleep , Sleep Initiation and Maintenance Disorders/physiopathology , Sleep Initiation and Maintenance Disorders/psychology , Surveys and Questionnaires , Young Adult
15.
Headache ; 60(8): 1806-1811, 2020 09.
Article in English | MEDLINE | ID: covidwho-642109

ABSTRACT

OBJECTIVE: To summarize for the trainee audience the possible mechanisms of headache in patients with COVID-19 as well as to outline the impact of the pandemic on patients with headache disorders and headache medicine in clinical practice. BACKGROUND: COVID-19 is a global pandemic caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2, of which a large subset of patients features neurological symptoms, commonly headache. The virus is highly contagious and is, therefore, changing clinical practice by forcing limitations on in-person visits and procedural treatments, more quickly shifting toward the widespread adaptation of telemedicine services. DESIGN/RESULTS: We review what is currently known about the pathophysiology of COVID-19 and how it relates to possible mechanisms of headache, including indirect, potential direct, and secondary causes. Alternative options for the treatment of patients with headache disorders and the use of telemedicine are also explored. CONCLUSIONS: Limited information exists regarding the mechanisms and timing of headache in patients with COVID-19, though causes relate to plausible direct viral invasion of the nervous system as well as the cytokine release syndrome. Though headache care in the COVID-19 era requires alterations, the improved preventive treatment options now available and evidence for feasibility and safety of telemedicine well positions clinicians to take care of such patients, especially in the COVID-19 epicenter of New York City.


Subject(s)
COVID-19/complications , Education, Medical, Continuing , Headache Disorders, Secondary/etiology , Neurology/education , Pandemics , SARS-CoV-2/pathogenicity , Aged, 80 and over , Anosmia/etiology , Anosmia/virology , COVID-19/epidemiology , COVID-19/physiopathology , COVID-19/prevention & control , Comorbidity , Cytokine Release Syndrome/complications , Cytokine Release Syndrome/physiopathology , Headache/epidemiology , Headache Disorders, Secondary/physiopathology , Humans , Inflammation Mediators/metabolism , Leukoencephalitis, Acute Hemorrhagic/etiology , Migraine Disorders/complications , Migraine Disorders/prevention & control , Migraine Disorders/therapy , New York City/epidemiology , Physical Distancing , SARS-CoV-2/isolation & purification , SARS-CoV-2/physiology , Telemedicine
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