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1.
J Headache Pain ; 22(1): 6, 2021 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-33549036

RESUMO

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.


Assuntos
Anticorpos Monoclonais Humanizados , Transtornos de Enxaqueca , Peptídeo Relacionado com Gene de Calcitonina , Método Duplo-Cego , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Resultado do Tratamento
2.
J Headache Pain ; 22(1): 2, 2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33413075

RESUMO

BACKGROUND: Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, including the fully humanized monoclonal antibody (IgG2Δa) fremanezumab, have demonstrated safety and efficacy for migraine prevention. Clinical trials include responders and nonresponders; efficacy outcomes describe mean values across both groups and thus provide little insight into the clinical benefit in responders. Clinicians and their patients want to understand the extent of clinical improvement in patients who respond. This post hoc analysis of fremanezumab treatment attempts to answer this question: what is the benefit in subjects who responded to treatment during the two, phase 3 HALO clinical trials? METHODS: We included subjects with episodic migraine (EM) or chronic migraine (CM) who received fremanezumab quarterly (675 mg/placebo/placebo) or monthly (EM: 225 mg/225 mg/225 mg; CM: 675 mg/225 mg/225 mg) during the 12-week randomized, double-blind, placebo-controlled HALO EM and HALO CM clinical trials. EM and CM responders were defined as participants with a reduction of ≥ 2 or ≥ 4 monthly migraine days, respectively. Treatment benefits evaluated included reductions in monthly migraine days, acute headache medication use, and headache-related disability, and changes in health-related quality of life (HRQoL). RESULTS: Overall, 857 participants from the HALO trials were identified as responders (EM: 429 [73.8%]; CM: 428 [56.7%]). Reductions in the monthly average number of migraine days were greater among EM (quarterly: 5.4 days; monthly: 5.5 days) and CM (quarterly: 8.7 days; monthly: 9.1 days) responders compared with the overall population. The proportion of participants achieving ≥ 50% reduction in the average monthly number of migraine days was also greater in responders (EM: quarterly, 59.8%; monthly, 63.7%; CM: quarterly, 52.8%; monthly, 59.0%) than in the overall population. Greater reductions in the average number of days of acute headache medication use, greater reductions in headache-related disability scores, and larger improvements in HRQoL were observed among EM and CM responders compared with the overall populations. CONCLUSIONS: Fremanezumab responders achieved clinically meaningful improvements in all outcomes. The magnitude of improvements with fremanezumab across efficacy outcomes was far greater in responders than in the overall trial population, providing insight into expected treatment benefits in participants who respond to fremanezumab in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT02629861 (HALO EM) and NCT02621931 (HALO CM).


Assuntos
Transtornos de Enxaqueca , Qualidade de Vida , Anticorpos Monoclonais , Método Duplo-Cego , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Resultado do Tratamento
3.
J Headache Pain ; 22(1): 1, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407070

RESUMO

BACKGROUND: Triptans and erenumab are both migraine-specific agents acting on the calcitonin gene-related peptide pathway. Therefore, response to triptans might be associated with response to erenumab. MAIN BODY: In our study, consecutive patients referring to the Headache Centers of the Abruzzo region from January 2019 to March 2020 and treated with erenumab were interviewed about past use and efficacy of triptans. Triptan users were classified as 'triptan responders' if they were headache-free 2 h after treating ≥3 migraine attacks with ≥1 triptan. We considered patients as 'erenumab responders', if they had a ≥ 50% mean reduction in monthly migraine days between the 4th and the 6th month from treatment start compared with baseline. Of 91 triptan users, 73 (80.2%) were triptan responders and 58 (63.7%) were erenumab responders. The odds ratio of being erenumab responder was 3.64 (95% CI, 1.25-10.64) for triptan users as compared to non-users. (P = 0.014). Besides, starting erenumab improved triptan response in both erenumab responders and non-responders. CONCLUSIONS: Our data of an association between response to triptans and response to erenumab can be useful for patient advice and to improve the understanding of migraine pathophysiology and treatment.


Assuntos
Transtornos de Enxaqueca , Triptaminas , Anticorpos Monoclonais Humanizados , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina , Humanos , Transtornos de Enxaqueca/tratamento farmacológico
4.
Medicine (Baltimore) ; 100(2): e24179, 2021 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-33466192

RESUMO

BACKGROUND: Migraine is a clinically high incidence rate of neurovascular disease. It is a recurrent headache. It is characterized by nausea, vomiting, fear of voice, and photophobia. Nowadays, a large number of randomized controlled clinical studies have shown that Chinese patent medicine has the advantages of good curative effect and high safety in the treatment of migraine. However, due to the variety of proprietary Chinese medicines, their relative effectiveness and safety have not yet been verified. Therefore, this study will use the network meta-analysis method to verify the effectiveness and safety of different kinds of Chinese patent medicines in the treatment of migraine. METHODS: All randomized controlled trials of Toutongning capsule, Yangxue Qingnao granule, naoxintong capsules, Tianmagouteng granules in the treatment of migraine were searched from PubMed, Cochrane Library, web of science, EMBASE, sinomed, CNKI, Wanfang database, VIP. The retrieval time is from the establishment of the database to November 18, 2020. In order to avoid omission, we will manually retrieve relevant references and conference papers. According to the inclusion and exclusion criteria, we evaluated the quality and risk of all the retrieved literatures. Methodological quality assessment and bias risk will be assessed using the Cochrane bias risk tool. Revman 5.3, WinBUGS 1.4.3, and stata14.2 software will be used for all data analysis. RESULTS: This study will directly or indirectly compare the effectiveness of different interventions on migraine outcome indicators, and rank the effectiveness. The main outcome measures included total effective rate (total effective rate = rocovery + obvious effective + effective/total number of cases × 100%), visual analogue scale (VAS) score, and secondary outcome indicators included analgesic effect evaluation index and quality of life scale. CONCLUSION: To provide evidence for evidence-based medicine and clinical researchers to choose more effective Chinese patent medicines to treat migraine.


Assuntos
Protocolos Clínicos , Medicina Tradicional Chinesa/métodos , Medicina Tradicional Chinesa/normas , Transtornos de Enxaqueca/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Medicamentos sem Prescrição/uso terapêutico , Manejo da Dor/métodos , Manejo da Dor/normas , Revisões Sistemáticas como Assunto
5.
J Headache Pain ; 22(1): 5, 2021 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-33421995

RESUMO

BACKGROUND: The CGRP antagonists offer a novel therapeutic approach in migraine. Their utility in patients with severe forms of chronic migraine is a subject of particular interest. We present outcomes of 9 months of erenumab treatment in a cohort of patients with difficult-to-control chronic migraine, all of whom had prior unsatisfactory response to onabotulinumtoxinA. METHODS: We offered erenumab to 98 patients with a prior unsatisfactory response to onabotulinumtoxinA. Eighty of 98 had trialled greater occipital nerve injections (82%), 32/98 peripheral neurostimulation (33%) and 18/98 intravenous dihydroergotamine (18%). Thirty eight of 98 (39%) met the definition of triptan overuse and 43/98 (44%) analgesic overuse. All patients met the EHF criteria for 'resistant migraine'. Outcome measures (recorded monthly) included days with headache limiting activities of daily living ("red"), not limiting ("amber"), headache free ("green"), and requiring triptans or other analgesics. Quality of life scores - headache impact test 6 (HIT-6), patient health questionnaire 9 (PHQ-9) and pain disability index (PDI) - were also measured. RESULTS: Mean number of red days improved by - 6.4 days (SE 0.67, 95%CI - 7.7 to - 5.1, p=0.001) at 3 months; - 6.8 days (SE 0.96, 95%CI - 8.80 to - 4.9, p=0.001) at 6 months and - 6.5 days (SE 0.86, 95%CI - 8.3 to - 4.8, p=0.001) at 9 months. Repeated measures ANOVA confirmed improvements in the number of red (p=0.001), green (p=0.001), triptan (p=0.001) and painkiller days (p=0.001) as well as scores of the HIT-6 (p=0.001), PHQ-9 (p=0.001), and PDI (p=0.001) across the duration of study. CONCLUSION: We observed improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment.


Assuntos
Toxinas Botulínicas Tipo A , Transtornos de Enxaqueca , Atividades Cotidianas , Anticorpos Monoclonais Humanizados , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina , Doença Crônica , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Dor , Qualidade de Vida , Resultado do Tratamento
7.
Drugs Today (Barc) ; 56(12): 769-780, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33332483

RESUMO

Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist developed with a novel quick-dissolve oral tablet formulation for the acute treatment of migraine by Biohaven Pharmaceuticals, under license from Bristol Myers Squibb. The completed phase II and III trials showed its efficacy in terms of pain freedom, pain relief, release of migraine symptoms and lifestyle recovery, with an effect sustained up to 48 h. Significant clinical efficacy has been reported with a rimegepant single dose. Rimegepant was well tolerated and the few adverse events were mild or moderate and did not cause trial discontinuation. It received Food and Drug Administration (FDA) approval on February 27, 2020, for the acute treatment of migraine headache. Three clinical trials are currently ongoing to evaluate: i) the long-term safety as migraine acute treatment; ii) the efficacy and safety as a preventive treatment for migraine; and iii) the efficacy and safety for refractory trigeminal neuralgia. Future studies should be designed also to evaluate potential drug-drug interactions.


Assuntos
Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina , Transtornos de Enxaqueca , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Piperidinas , Piridinas
8.
Zhongguo Zhong Yao Za Zhi ; 45(21): 5057-5067, 2020 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-33350221

RESUMO

The present clinical practice guideline was written by experts organized by the special group of key projects in the 13 th five-year plan period of the China Academy of Chinese Medical Sciences based on the standards and procedures of World Health Orga-nization Handbook for Guideline Development, with "evidence-based, consensus-based, and experience-based principle" as a guide. On the basis of practice in traditional Chinese medicine(TCM) and clinical research for migraine, following the idea and method of evidence-based medicine, as well as the expert experience, the current best evidence and patients' values, the internationally recognized evidence quality evaluation methods and recommendation grading system were combined with the prescription record of classical TCM, TCM expert experience, and modern clinical research evidences. The acupuncture therapy, classic prescriptions and Chinese patent medicines used in the treatment of migraine in acute stage and preventive treatment were summarized to obtain five classic prescriptions(Chuanxiong Chatiao Powder, Chuanxiong Dingtong Yin, Sanpian Decoction, Xuefu Zhuyu Decoction, and Tongqiao Huoxue Decoction), and four Chinese patent medicines(Zhengtian Pills, Toutongning Capsules, Tongtian Oral Liquid, and Yangxue Qingnao Granules/Pills), and the common problems in their clinical application were analyzed. The purpose of this guideline is to standardize the treatment of migraine with TCM, reduce the frequency and severity of migraine attacks, and improve the patients' quality of life. It provides the clinical basis for the TCM treatment of migraine, and ensures the safety, effectiveness, practicability and scientificity of the treatment, so as to promote the TCM treatment of migraine. Due to the influence of region, nationality, race and other factors of the users, the detailed implementation of the guideline should be determined according to the actual situation.


Assuntos
Terapia por Acupuntura , Medicamentos de Ervas Chinesas , Transtornos de Enxaqueca , China , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Medicina Tradicional Chinesa , Transtornos de Enxaqueca/tratamento farmacológico , Qualidade de Vida
9.
Zhongguo Zhong Yao Za Zhi ; 45(21): 5068-5082, 2020 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-33350222

RESUMO

To systemically assess the clinical efficacy of oral Chinese patent medicine for migraine by using network Meta-analysis. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Medline, EMbase, Cochrane Library) and ClinicalTrials.gov were systematically and comprehensively retrieved from the establishment of each database to April 24, 2020. Rando-mized controlled trial(RCT) on oral Chinese patent medicine combined with Flunarizine for migraine were screened out according to inclusion criteria and exclusion criteria. Literature screening and data extraction were conducted independently by 2 researchers. The included studies were evaluated with the Cochrane bias risk assessment tool. Data analysis was conducted by using Stata 16.0 software. Finally, a total of 52 RCTs were included, involving 11 kinds of oral Chinese patent medicines. The results of the network Meta-analysis showed that in terms of headache frequency, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Zhengtian Pills>combined with Toutongning Capsules>combined with Yangxue Qingnao Granules>combined with Tianshu Capsules>combined with Xuefu Zhuyu Capsules>combined with Danzhen Toutong Capsules>combined with Chuanxiong Qingnao Granules>combined with Songling Xuemaikang Capsules. In terms of headache intensity, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Zhengtian Pills>combined with Danzhen Toutong Capsules>combined with Tianshu Capsules>combined with Toutongning Capsules>combined with Chuanxiong Qingnao Granules>combined with Yuntongding Capsules>combined with Yang-xue Qingnao Granules>combined with Danqi Soft Capsules. In terms of headache lasting time, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Yangxue Qingnao Granules>combined with Toutongning Capsules>combined with Zhengtian Pills>combined with Danzhen Toutong Capsules>combined with Tianshu Capsules>combined with Xuefu Zhuyu Capsules>combined with Yuntongding Capsules>combined with Chuanxiong Qingnao Granules>combined with Songling Xuemaikang Capsules. The results showed that oral Chinese patent medicines combined with Flunarizine were effective in improving the clinical efficacy for migraine. Due to the differences in the number and quality of studies included in studies of different Chinese patent medicines, and the lack of direct comparison of Chinese patent medicines, the results of the above order of Chinese patent medicines need to be demonstrated in future multi-center, large-sample, and double-blind randomized trial.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional do Leste Asiático , Transtornos de Enxaqueca , Grupo com Ancestrais do Continente Asiático , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Metanálise em Rede , Medicamentos sem Prescrição
10.
Zhongguo Zhong Yao Za Zhi ; 45(21): 5093-5102, 2020 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-33350224

RESUMO

To evaluate the efficacy and safety of Yangxue Qingnao Granules alone or combined with calcium channel blocker in treatment of migraine. In this study, four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and clinical trials registration center(ClinicalTrials.gov) were retrieved. The retrieval time was from the establishment of each database to January 8, 2020. According to the set inclusion criteria and exclusion criteria,the randomized controlled trial(RCT) of Yangxue Qingnao Granules alone or combined with calcium channel blocker was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.3 was used to conduct Meta-analysis of the included studies and grade system was used to evaluate the evidence quality of the outcome indicators. A total of 583 documents were retrieved and finally included in 23 studies, with a total sample size of 2 308 cases, 1 171 cases in the treatment group and 1 137 cases in the control group. The overall quality of the research included was not high. Meta-analysis showed that,(1)in terms of effective rate, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(RR=1.24, 95%CI[1.17, 1.32], P<0.000 01), and there was no significant difference between Yangxue Qingnao Granules and calcium channel blocker(RR=1.36, 95%CI[0.91, 2.03], P=0.14).(2)In terms of reducing headache frequency, when the unit of headache frequency was times per month, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.39, 95%CI[-1.83,-0.95], P<0.000 01), when the unit of headache frequency was times daily, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-2.08, 95%CI[-2.34,-1.82], P<0.000 01).(3)In terms of headache intensity, when headache intensity was scored by pain intensity, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-0.70, 95%CI[-0.81,-0.59], P<0.000 01), when headache intensity was scored by VAS score, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.59, 95%CI[-2.13,-1.06], P<0.000 01).(4)In terms of reducing headache duration, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(SMD=-3.13, 95%CI[-4.12,-2.15], P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. Twelve cases of adverse reactions were reported, all of which were mild. The results showed that the combination of Yang-xue Qingnao Granules can improve the effective rate, reduce the headache frequency, the headache intensity and the headache duration, and had good safety and low incidence of adverse reactions compared with the single calcium channel blocker. However, there was no difference in the effective rate between Yangxue Qingnao Granules alone and calcium channel blocker. In view of the low quality of this study, which affects the reliability of the conclusion, it is necessary to use the conclusion of this study carefully, and more high-quality randomized controlled trials are needed to further verify in the future.


Assuntos
Medicamentos de Ervas Chinesas , Transtornos de Enxaqueca , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Reprodutibilidade dos Testes
11.
Zhongguo Zhong Yao Za Zhi ; 45(21): 5103-5109, 2020 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-33350225

RESUMO

In this study, common prescriptions were retrieved from existing data in multiple ways to determine the selection principle of common formulas in traditional Chinese medicine(TCM) clinical practice guidelines. Taking the selection of common prescriptions in the clinical practice guidelines of TCM for migraine as an example, we searched common prescriptions for migraines from National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, three teaching materials and two clinical practice guidelines, and we also electronically searched CNKI, VIP, WanFang about famous clinical experience for migraine published from 1990 to 2019. At the same time, 32 prescriptions commonly used by experts in the clinical questionnaire survey were collected to summarize and analyze the TCM clinically applicable syndrome types and medication rules of the included prescriptions and medicines. From the National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, we got 12 Chinese patent medicines. From the teaching materials, we got 9 prescriptions. From the clinical practice guidelines, we got 8 prescriptions. We got 3 prescriptions from the experience of famous experts and got 4 prescriptions from experts in the clinical questionnaire survey. A total of 24 prescriptions were included from the above results. External wind syndrome, syndrome of blood stasis and brain blocking, and syndrome of liver Yang transforming into wind were the common syndrome types in the treatment of migraine. Chuanxiong Rhizoma and Angelicae Dahuricae Radix were the most common Chinese herbs in the prescriptions. Chuanxiong Rhizoma-Angelicae Dahuricae Radix was the most common drug pair for the treatment of migraine. By retrieving the data such as the famous clinical experience and teaching materials, we systematically summarized the prescriptions in the treatment of migraine in this study, which can provide a basis for the selection of traditional Chinese medicines in clinical practice guidelines.


Assuntos
Medicamentos de Ervas Chinesas , Transtornos de Enxaqueca , Feminino , Humanos , Medicina Tradicional Chinesa , Transtornos de Enxaqueca/tratamento farmacológico , Medicamentos sem Prescrição , Gravidez , Prescrições
12.
Medicine (Baltimore) ; 99(42): e22253, 2020 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-33080672

RESUMO

BACKGROUND: Omega-3 fatty acids (FAs) can produce several beneficial effects and are commonly used for the treatment of migraine symptoms. Although current therapeutic measures for migraine included pharmacological therapies, dietary supplements, and herbal ingredients, dietary patterns, acupuncture, relaxation techniques, biofeedback, and psychotherapy, omega-3 FAs therapeutic role seems to be obtained through the inhibition or reduction of the release of inflammatory cytokines. The present review aims to provide updated information about the effects of omega-3 FAs in migraine treatment, investigating their clinical effects alone or in combination with other substances. METHODS: Bibliographic research was conducted by examining scientific literature from January 2000 until January 31, 2020. Ten clinical studies were included in the review. Quality assessment of randomized controlled trials was performed by using the JADAD scale. RESULTS: Clinical studies methodology is not always of good quality and results show moderate evidence concerning the therapeutic role of omega-3 FAs in migraine. CONCLUSION: Further clinical trials are necessary to implement the knowledge concerning the use of omega-3 fatty acids in the treatment of migraine.


Assuntos
Suplementos Nutricionais , Ácidos Graxos Ômega-3/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Humanos
13.
Neurol Sci ; 41(12): 3385-3389, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33001407

RESUMO

OBJECTIVES: The COVID-19 pandemic and the consequent lockdown came as a storm disrupting people's everyday life. This study aimed at observing whether the COVID-19 related lockdown influenced migraine frequency and disability in migraine patients on therapy with monoclonal antibodies inhibiting the CGRP pathway. METHODS: In this longitudinal observational cohort study, 147 consecutive patients receiving monthly administration of erenumab or galcanezumab were enrolled in four Italian headache centers. All patients filled a questionnaire concerning working and household settings, recent flu symptoms or COVID-19 diagnosis, and family loss due to COVID-19 infection. Monthly migraine days (MMDs), monthly painkiller intake (MPI), and HIT-6 disability relative to the first month of lockdown imposition (T-lock) and the month before (T-free) were also collected. RESULTS: From T-free to T-lock, the cohort displayed a reduction in MMDs (from 10.5 ± 7.6 to 9.8 ± 7.6, p = .024) and HIT-6 scores (from 59.3 ± 8.3 men reduced MPI more frequently than women (p = .005). CONCLUSIONS: Our study observed that the lockdown impact to 57.8 ± 8.8, p = .009), while MPI resulted unchanged (from 11.6 ± 11.5 to 11.1 ± 11.7; p = .114). MMDs, MPI, and HIT-6 variations from T-free to T-lock did not differ according to work settings or household. Patients beyond the first 3 months of therapy presented less often a reduction in MMDs (p = .006) and on everyday life did not affect the migraine load in patients receiving monoclonal antibodies inhibiting the CGRP pathway. Patients in the first months of therapy experienced a greater improvement according to drug pharmacokinetics, while women more frequently needed rescue medications, possibly indicating presenteeism or cephalalgophobia.


Assuntos
Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/uso terapêutico , Infecções por Coronavirus/prevenção & controle , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/epidemiologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Quarentena/psicologia , Adulto , Anticorpos Monoclonais Humanizados/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Itália/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
14.
Farm. hosp ; 44(5): 212-217, sept.-oct. 2020. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-195148

RESUMO

OBJETIVO: Recientemente se han desarrollado anticuerpos monoclonales contra la vía del péptido relacionado con el gen de la calcitonina para la prevención de la migraña. El objetivo de este estudio es comparar la eficacia de los fármacos anticuerpos monoclonales contra la vía del péptido relacionado con el gen de la calcitonina en migraña crónica a través de una comparación indirecta ajustada, y establecer si pueden considerarse alternativas terapéuticas equivalentes en esta patología. MÉTODO: Se realizó una búsqueda bibliográfica de ensayos clínicos aleatorizados en la base de datos PubMed el 26 de diciembre de 2019. Los criterios de inclusión fueron: ensayos clínicos aleatorizados fase II/III de anticuerpos monoclonales contra la vía del péptido relacionado con el gen de la calcitonina con similar población, duración de seguimiento y comparador. Se seleccionó la reducción de al menos un 50% de días de migraña/mes como variable de eficacia. Se definió migraña crónica como ≥ 15 días de dolor de cabeza/mes, de los cuales ≥ 8 fueron días de migraña (duración del evento ≥ 4 horas). Se excluyeron los ensayos clínicos aleatorizados con diferentes contextos clínicos de migraña crónica y definición de enfermedad. Se desarrolló una compa-ración indirecta ajustada utilizando el método de Bucher. Para la evaluación de la posible equivalencia terapéutica se siguieron las directrices de la guía de alternativas terapéuticas equivalentes de posicionamiento. El valor delta (Δ, máxima diferencia como criterio clínico de equivalencia) se calculó como la mitad de la reducción absoluta del riesgo obtenida en un metaanálisis de los ensayos clínicos aleatorizados incluidos en la comparación indirecta ajustada. RESULTADOS: Se encontraron 30 ensayos clínicos aleatorizados: erenumab (n = 12), fremanezumab (n = 7), galcanezumab (n = 10) y eptinezumab (n = 1). Se seleccionaron tres estudios: uno de erenumab, uno de fremanezumab y otro de eptinezumab. El resto no se incluyó en la comparación indi-recta ajustada por incumplimiento de los criterios de inclusión. Los resultados de la comparación indirecta ajustada entre las diferentes posologías de los fármacos estudiados no mostraron diferencias estadísticamente signifi-cativas, y la mayor parte del intervalo de confianza del 95% se encontró dentro de los márgenes delta calculados (Δ = 9,5%). No se encontraron diferencias de seguridad relevantes entre los tres medicamentos. CONCLUSIONES: La comparación indirecta ajustada no mostró diferencias estadísticamente significativas en la reducción de ≥ 50% de días de migraña/mes entre erenumab, fremanezumab y eptinezumab. Se encontró una probable equivalencia clínica entre estos fármacos en términos de eficacia y seguridad, por lo que podrían considerarse alternativas terapéuticas equivalentes en migraña crónica


OBJECTIVE: New monoclonal antibodies against the calcitonin gene-related peptide pathway have recently been developed for the prevention of migraine. The aim of this study is to compare the efficacy of monoclonal antibodies against the calcitonin generelated peptide pathway drugs in chronic migraine through an adjusted indirect treatment comparison, and to establish whether they can be considered equivalent therapeutic alter-natives in this pathology. METHOD: A bibliographic search of randomized clinical trials was performed in PubMed database on December 26, 2019. The inclusion criteria were phase II/III randomized clinical trials of monoclonal anti-bodies against the calcitonin generelated peptide pathway with similar population, length of follow-up and treatment comparator. The reduction of at least 50% migraine-days/month was selected as efficacy endpoint. Chronic migraine was defined as ≥ 15 headache days/month, of which ≥ 8 were migraine-days (event duration ≥ 4 hours). Randomized clinical trials with different clinical chronic migraine context and definition of disease were excluded. An indirect treatment comparison was developed using Bucher's method. The equivalent therapeutic alternatives positioning guide was used for the evaluation of potentially equivalent alternatives. Delta value (Δ, maximum difference as clinical criterion of equivalence) was calculated as half of absolute risk reduction obtained in a meta-analysis of randomized clinical trials included in indirect treatment comparison. RESULTS: Thirty randomized clinical trials were found: erenumab (n = 12), fremanezumab (n = 7), galcanezumab (n = 10) and eptinezumab (n = 1). Three studies were selected: one of erenumab, one of fremanezumab and another of eptinezumab. The rest were not included in indirect treatment comparison for non-compliance of inclusion criteria. Results of indirect treatment comparison among different regimens of studied drugs showed no statistically significant differences, and the most part of 95% confidence interval was within calculated delta margins (Δ = 9.5%). No relevant safety differences among the three drugs were found. CONCLUSIONS: Indirect treatment comparison showed no statistically sig-nificant differences in reduction of ≥ 50% migraine days/month between erenumab, fremanezumab and eptinezumab. Probable clinical equiva-lence was found between these drugs in terms of efficacy and safety, therefore they could be considered equivalent therapeutic alternatives in chronic migraine


Assuntos
Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Anticorpos Monoclonais/administração & dosagem , Peptídeo Relacionado com Gene de Calcitonina/administração & dosagem , Anticorpos Monoclonais/metabolismo , Peptídeo Relacionado com Gene de Calcitonina/metabolismo , Medicina Baseada em Evidências , Análise de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
J Headache Pain ; 21(1): 109, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32887548

RESUMO

BACKGROUND: The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire. METHODS: In the extension study (N = 1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients answered a survey evaluating patient satisfaction, treatment and dosing preferences, and changes in patient-reported outcomes. RESULTS: Of the 557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey. The mean (standard deviation) satisfaction rating for fremanezumab was 6.1 (1.4; 1 = "extremely dissatisfied" to 7 = "extremely satisfied"). Most patients (175 [69.2%]) preferred quarterly over monthly fremanezumab dosing. Among patients taking antiepileptics (most common class of prior preventive medication; n = 130), 91.5% preferred fremanezumab. Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab. CONCLUSION: In this study, treatment satisfaction with fremanezumab was high, most patients preferred quarterly fremanezumab dosing, and fremanezumab was generally preferred to prior preventive medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT02638103 (HALO LTS), registered December 22, 2015.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Inquéritos e Questionários , Adulto , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente
17.
Rinsho Shinkeigaku ; 60(10): 668-676, 2020 Oct 24.
Artigo em Japonês | MEDLINE | ID: mdl-32893246

RESUMO

Migraine is a common and debilitating neurological disorder characterized by recurrent attacks of moderate to severe throbbing headache accompanied by nausea, vomiting and photophobia/phonophobia. Because of its high prevalence, migraine causes a considerable financial burden on the society as well as impaired quality of life in individual patients. Scientific evidence shows that migraine is a quite complex neurological disorder that involves not only the trigeminovascular and autonomic systems but also the hypothalamus and cerebral cortex. Calcitonin gene-related peptide (CGRP) was originally discovered as a 37-amino acid neuropeptide derived from a calcitonin gene splicing variant. CGRP is found to be expressed in trigeminal ganglion neurons. Much attention has been attracted to this molecule since CGRP was found to be released from trigeminal terminals in animal migraine models. Subsequent studies demonstrated that CGRP administration induced migraine-like headache attacks specifically in migraineurs, thus highlighting a pivotal role of CGRP in the development of migraine attacks. Several CGRP receptor antagonists were shown to be efficacious for the treatment of acute migraine. Among them, telcagepant, was shown to exert a significant migraine prophylactic action as well. Nevertheless, the development of most of these agents were discontinued due to hepatotoxicity. Currently, newer CGRP receptor antagonists are being developed. On the other hand, monoclonal antibodies targeting CGRP and its receptor showed consistent efficacy for migraine prophylaxis with excellent safety profiles in Phase III clinical trials. Furthermore, emerging data support the long-term safety and efficacy of these antibodies. In this review article, the development and perspective of anti-migraine therapeutic strategies using CGRP-related antibodies are discussed.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Antagonistas do Receptor do Peptídeo Relacionado ao Gene de Calcitonina/administração & dosagem , Peptídeo Relacionado com Gene de Calcitonina/imunologia , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/genética , Terapia de Alvo Molecular , Animais , Anticorpos Monoclonais Humanizados/administração & dosagem , Desenvolvimento de Medicamentos , Humanos , Camundongos , Transtornos de Enxaqueca/prevenção & controle , Receptores de Peptídeo Relacionado com o Gene de Calcitonina/imunologia
18.
Mol Pharmacol ; 98(4): 433-444, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32958571

RESUMO

For decades the broad role of opioids in addiction, neuropsychiatric disorders, and pain states has been somewhat well established. However, in recent years, with the rise of technological advances, not only is the existing dogma being challenged, but we are identifying new disease areas in which opioids play a critical role. This review highlights four new areas of exploration in the opioid field. The most recent addition to the opioid family, the nociceptin receptor system, shows promise as the missing link in understanding the neurocircuitry of motivation. It is well known that activation of the kappa opioid receptor system modulates negative affect and dysphoria, but recent studies now implicate the kappa opioid system in the modulation of negative affect associated with pain. Opioids are critical in pain management; however, the often-forgotten delta opioid receptor system has been identified as a novel therapeutic target for headache disorders and migraine. Lastly, changes to the gut microbiome have been shown to directly contribute to many of the symptoms of chronic opioid use and opioid related behaviors. This review summarizes the findings from each of these areas with an emphasis on identifying new therapeutic targets. SIGNIFICANCE STATEMENT: The focus of this minireview is to highlight new disease areas or new aspects of disease in which opioids have been implicated; this includes pain, motivation, migraine, and the microbiome. In some cases, this has resulted in the pursuit of a novel therapeutic target and resultant clinical trial. We believe this is very timely and will be a refreshing take on reading about opioids and disease.


Assuntos
Analgésicos Opioides/farmacologia , Transtornos de Enxaqueca/metabolismo , Transtornos Relacionados ao Uso de Opioides/microbiologia , Dor/metabolismo , Receptores Opioides/metabolismo , Analgésicos Opioides/uso terapêutico , Animais , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Motivação , Transtornos Relacionados ao Uso de Opioides/metabolismo , Dor/tratamento farmacológico , Receptores Opioides delta/metabolismo , Receptores Opioides kappa/metabolismo , Transdução de Sinais/efeitos dos fármacos
19.
Lancet Neurol ; 19(10): 814-825, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32949542

RESUMO

BACKGROUND: Many patients who require migraine preventive treatment have not been able to tolerate or have not responded to multiple previous preventive medications. We aimed to assess the safety and efficacy of galcanezumab, an antibody to calcitonin gene-related peptide, in patients with migraine who had not benefited from preventive medications from two to four categories. METHODS: CONQUER was a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial done at 64 sites (hospitals, clinics, or research centres) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, the Netherlands, South Korea, Spain, the UK, and the USA). Patients were 18-75 years of age, with episodic or chronic migraine, with migraine onset before the age of 50 years, who had a documented failure of preventive medications from two to four drug categories in the past 10 years owing to lack of efficacy or tolerability, or both. Patients were randomised 1:1 to receive subcutaneous placebo or galcanezumab 120 mg per month (with a 240 mg loading dose administered as two 120 mg injections) for 3 months. For masking purposes, patients receiving placebo also received two injections during the first dosing visit. Randomisation was done by a computer-generated random sequence by means of an interactive web-response system stratified by country and migraine frequency (low frequency episodic migraine, four to fewer than eight migraine headache days per month; high frequency episodic migraine, eight to 14 migraine headache days per month and fewer than 15 headache days per month; chronic migraine, at least eight migraine headache days per month and at least 15 headache days per month). The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days during the 3-month treatment period in all patients who were randomly assigned and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03559257, and is now completed. FINDINGS: Between Sept 10, 2018, and March 21, 2019, 462 participants with episodic (269 [58%]) or chronic (193 [42%]) migraine were randomly assigned and received at least one injection with placebo (n=230) or galcanezumab (n=232). Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3. The galcanezumab group had on average 4·1 fewer monthly migraine headache days compared with baseline (13·4), while the placebo group had on average 1·0 fewer than at baseline (13·0; between-group difference -3·1 [95% CI -3·9 to -2·3]; p<0·0001; effect size=0·72). Types and number of treatment-emergent adverse events were similar between galcanezumab and placebo. Treatment-emergent adverse events were reported in 122 (53%) of 230 patients in the placebo group and 119 (51%) of 232 patients in the galcanezumab group. There were four serious adverse events during the study, two (1%) reported in the placebo group and two (1%) reported in the galcanezumab group. INTERPRETATION: Galcanezumab was superior to placebo in the preventive treatment of migraine and was safe and well tolerated in patients for whom multiple previous standard-of-care preventive treatments had failed. Galcanezumab might represent an important treatment option for patients who have not benefited from or tolerated previous standard-of-care treatments. FUNDING: Eli Lilly.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/tratamento farmacológico , Falha de Tratamento , Adolescente , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
20.
J Headache Pain ; 21(1): 115, 2020 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-32972360

RESUMO

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.


Assuntos
Infecções por Coronavirus/epidemiologia , Transtornos de Enxaqueca/fisiopatologia , Pneumonia Viral/epidemiologia , Uso Excessivo de Medicamentos Prescritos/estatística & dados numéricos , Adulto , Analgésicos/uso terapêutico , Ansiedade/psicologia , Betacoronavirus , Toxinas Botulínicas Tipo A/uso terapêutico , Comunicação , Depressão/psicologia , Feminino , Acesso aos Serviços de Saúde , Humanos , Internet , Kuweit/epidemiologia , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/tratamento farmacológico , Transtornos de Enxaqueca/prevenção & controle , Transtornos de Enxaqueca/psicologia , Fármacos Neuromusculares/uso terapêutico , Pandemias , Relações Médico-Paciente , Fatores de Risco , Sono , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Distúrbios do Início e da Manutenção do Sono/psicologia , Inquéritos e Questionários , Adulto Jovem
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