Maria Giner-Soriano, Rosa Morros, Ramon Monfà, Dan Ouchi, Silvia Fernández-García, Cristina Vedia, Sara Bonet Monné, Eva María Calvo Martínez, Silvia Copetti Fanlo, Noemí Morollón, Robert Belvís Nieto, Claudia Erika Delgado-Espinoza, Ana García-Sangenís
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引用次数: 0
摘要
背景：偏头痛是一种影响约12%人口的神经系统疾病，多见于女性，可导致残疾。预防性治疗建议防止慢性和镇痛药的滥用和提高生活质量，但不是所有的候选人接受它。常见的预防药物包括阿米替林、氟桂利嗪、心得安和托吡酯。它们的有效性和安全性尚未在我们的环境中得到评估。本研究的目的是评估这些药物在减少每月偏头痛天数（MMD）方面的有效性，并评估其安全性。方法：在西班牙加泰罗尼亚的初级保健中，4个平行组，开放和多中心的IV期实用随机临床试验。我们将纳入有资格接受预防性治疗的偏头痛患者。他们将被随机分配到以下药物：(1)心得安，(2)阿米替林，(3)氟桂利嗪，或(4)托吡酯。主要的疗效测量将是第12周的平均烟雾浓度与基线时的平均烟雾浓度的变化。将评估其他次要疗效和安全性措施。主要的非劣效性分析将在第12周的每个方案人群中进行，比较托吡酯与心得安作为主要分析，阿米替林和氟桂利嗪与心得安作为探索性分析。讨论：偏头痛存在流行病学、临床和药理学的性别差异，这可能导致偏头痛预防药物使用的差异。然而，最常见的预防性治疗的有效性以及男女之间在有效性和安全性方面的差异尚未得到研究。此外，由于新的昂贵药物已被批准用于预防性治疗，表明当常规药物失败时，通过临床试验评估常规口服预防性药物的有效性和安全性尤为重要。我们还计划评估它们的成本效益，临床试验将依靠患者通过为此目的设计的应用程序的积极贡献，这可能有助于未来的疾病管理。试验注册：ClinicalTrials.gov ID: NCT06499116 （https://clinicaltrials.gov/study/NCT06499116）。试验注册日期：2024年7月12日。EU CT编号：2024-513597-22。协议编号：ijj - premium -2024。赞助商：Fundació d'Investigació en Atenció Primària Jordi Gol i Gurina。Gran Via de les Corts Catalanes 587， àtic。08007，西班牙巴塞罗那。
Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: study protocol for a pragmatic clinical trial (PREMI study).
Background: Migraine is a neurological disorder affecting approximately 12% of the population, more frequent in women, causing disability. Preventive treatment is recommended to prevent chronification and analgesics' abuse and to improve quality of life, but not all candidates receive it. Common preventive drugs include amitriptyline, flunarizine, propranolol, and topiramate. Their effectiveness and safety have not yet been assessed in our setting. The objective of this study is to evaluate the effectiveness of these drugs in reducing the monthly migraine days (MMD) and to evaluate their safety.
Methods: Phase IV, pragmatic randomized clinical trial of four parallel groups, open and multicentric, in Primary Care in Catalonia, Spain. We will include adults with migraine eligible for preventive treatment. They will be randomized to the following: (1) propranolol, (2) amitriptyline, (3) flunarizine, or (4) topiramate. The main efficacy measure will be the change in the mean MMD at week 12 in comparison to the mean MMD at baseline. Other secondary efficacy and safety measures will be assessed. The main non-inferiority analysis will be conducted in the per protocol population at week 12, comparing topiramate versus propranolol as the main analysis, and amitriptyline and flunarizine versus propranolol as exploratory analyses.
Discussion: There are epidemiological, clinical and pharmacological sex-differences in migraine which may result in differences in the use of migraine preventive drugs. However, the effectiveness of the most frequent preventive treatment and the differences in effectiveness and safety between women and men have not yet been studied. Moreover, as new expensive drugs have been authorized for preventive treatment, indicated when the usual drugs have failed, assessing the effectiveness and safety of the usual oral preventive drugs through a clinical trial is especially important. We also plan to evaluate their cost-effectiveness, and the clinical trial will count on an active contribution from patients through an app designed for this purpose, which may help in the management of the disease in the future.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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