Rafael Hijano-Esqué , Jesús Ignacio González Orodea , Javier Imaz Fandos , Natividad Pacheco Rubio , Gonzalo Daniel Alzuarte , Manuel Ruiz Cuetos , Amelia Rodríguez Mariblanca , Eva García Aguilar , En representación del grupo de investigación VERTINEL
{"title":"在西班牙的临床实践中,不同来源的眩晕患者使用固定剂量的低剂量菊酯20mg和维地那酸40mg联合治疗的有效性和安全性。VERTINEL研究结果","authors":"Rafael Hijano-Esqué , Jesús Ignacio González Orodea , Javier Imaz Fandos , Natividad Pacheco Rubio , Gonzalo Daniel Alzuarte , Manuel Ruiz Cuetos , Amelia Rodríguez Mariblanca , Eva García Aguilar , En representación del grupo de investigación VERTINEL","doi":"10.1016/j.mcpsp.2024.100489","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Vertigo is a condition affecting millions of people and significantly impacting their quality of life. Traditionally, vertigo management includes the use of antiemetics, vestibular sedatives, and betahistine, though these treatments have limitations and side effects. The aim of this study was to evaluate the efficacy and safety of a low-dose fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in routine clinical practice.</div></div><div><h3>Methods</h3><div>An observational, multicenter study was conducted, comprising a primary retrospective cohort and a cross-sectional cohort as a control group, across 28 Primary Care centers and Otolaryngology specialist clinics nationwide in Spain. Adult patients with vertigo of various origins treated with the fixed low-dose combination of cinnarizine 20 mg and dimenhydrinate 40 mg were included, and compared with a control group without treatment. Efficacy was assessed using the Vertigo and Dizziness Symptom Questionnaire (VDI-SS), and quality of life was evaluated through the VDI-HRQoL. Additional outcomes such as speed of action, tolerability, and treatment satisfaction were also measured.</div></div><div><h3>Results</h3><div>A total of 181 patients were analyzed, showing significant improvement in vertigo symptoms and quality of life in those treated with the drug combination compared to both pre-treatment and control groups. The pre-post treatment difference was 28.41 points on the VDI-SS questionnaire, <em>p</em> < 0.0001. Additionally, the difference between the post-treatment group and the control group was 24.07 points in favor of the treated group; 20.26 (95% CI 18.8–21.7) vs. 44.33 (95% CI 42.6–46), <em>p</em> < 0.0001. In quality-of-life assessments, the mean difference was 14.56 points between pretreatment and post-treatment, <em>p</em> < 0.0001, with a similar result observed in comparison with the control group, <em>p</em> < 0.0001. Improvement was reported by 78.3% (65) of treated subjects within the first week, with 55.4% reporting benefits in the first few days of treatment, and reaching 89.1% by the second week. Tolerability was rated as very good or good in most cases, with no serious adverse events reported, and no extrapyramidal effects, drowsiness, or inhibition of vestibular compensation mechanisms were noted. Overall treatment satisfaction was high.</div></div><div><h3>Discussion</h3><div>The results confirm the efficacy and safety of the low-dose fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in vertigo treatment. This therapeutic approach not only addresses specific vertigo symptoms but also improves patients' quality of life. Its rapid onset of action, along with high tolerability and satisfaction, supports the viability of this intervention in routine clinical practice, offering an effective and safe alternative for managing vertigo.</div></div>","PeriodicalId":36921,"journal":{"name":"Medicina Clinica Practica","volume":"8 2","pages":"Article 100489"},"PeriodicalIF":0.0000,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Eficacia y seguridad del tratamiento con la combinación fija a dosis bajas de cinarizina 20 mg y dimenhidrinato 40 mg en el vértigo de origen diverso en la práctica clínica en España. 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The aim of this study was to evaluate the efficacy and safety of a low-dose fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in routine clinical practice.</div></div><div><h3>Methods</h3><div>An observational, multicenter study was conducted, comprising a primary retrospective cohort and a cross-sectional cohort as a control group, across 28 Primary Care centers and Otolaryngology specialist clinics nationwide in Spain. Adult patients with vertigo of various origins treated with the fixed low-dose combination of cinnarizine 20 mg and dimenhydrinate 40 mg were included, and compared with a control group without treatment. Efficacy was assessed using the Vertigo and Dizziness Symptom Questionnaire (VDI-SS), and quality of life was evaluated through the VDI-HRQoL. Additional outcomes such as speed of action, tolerability, and treatment satisfaction were also measured.</div></div><div><h3>Results</h3><div>A total of 181 patients were analyzed, showing significant improvement in vertigo symptoms and quality of life in those treated with the drug combination compared to both pre-treatment and control groups. The pre-post treatment difference was 28.41 points on the VDI-SS questionnaire, <em>p</em> < 0.0001. Additionally, the difference between the post-treatment group and the control group was 24.07 points in favor of the treated group; 20.26 (95% CI 18.8–21.7) vs. 44.33 (95% CI 42.6–46), <em>p</em> < 0.0001. In quality-of-life assessments, the mean difference was 14.56 points between pretreatment and post-treatment, <em>p</em> < 0.0001, with a similar result observed in comparison with the control group, <em>p</em> < 0.0001. 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引用次数: 0
摘要
眩晕是一种影响数百万人的疾病,严重影响了他们的生活质量。传统上,眩晕治疗包括使用止吐药、前庭镇静剂和倍他司汀,尽管这些治疗有局限性和副作用。本研究的目的是评价低剂量固定联合肉桂利嗪20mg和苯海明40mg在常规临床实践中的疗效和安全性。方法进行了一项多中心观察性研究,包括主要回顾性队列和横断面队列作为对照组,涉及西班牙全国28个初级保健中心和耳鼻喉科 专科诊所。本研究纳入了采用肉桂利嗪20 mg和苯海明40 mg固定低剂量联合治疗的各种来源的眩晕的成年患者,并与未治疗的对照组进行比较。采用眩晕和头晕症状问卷(VDI-SS)评估疗效,通过VDI-HRQoL评估生活质量。其他结果如作用速度、耐受性和治疗满意度也被测量。结果共分析181例患者,与治疗前和对照组相比,联合用药组眩晕症状和生活质量均有显著改善。治疗前后VDI-SS量表差异为28.41分,p <;0.0001. 此外,治疗后组与对照组的差异为24.07分;20.26 (95% CI 18.8-21.7) vs. 44.33 (95% CI 42.6-46), p <;0.0001. 在生活质量评估中,治疗前后的平均差异为14.56分,p <;0.0001,与对照组比较的结果相似,p <;0.0001. 78.3%(65)的治疗对象在第一周内报告了改善,55.4%的人在治疗的前几天报告了改善,到第二周达到89.1%。在大多数情况下,耐受性被评为非常好或良好,没有严重的不良事件报告,没有锥体外系效应,嗜睡或前庭代偿机制的抑制。整体治疗满意度高。探讨小剂量固定联合肉桂利嗪20 mg与苯海明40 mg治疗眩晕的有效性和安全性。这种治疗方法不仅解决了特定的眩晕症状,而且提高了患者的生活质量。它的快速起效,以及高耐受性和满意度,支持了这种干预在常规临床实践中的可行性,为治疗眩晕提供了一种有效和安全的选择。
Eficacia y seguridad del tratamiento con la combinación fija a dosis bajas de cinarizina 20 mg y dimenhidrinato 40 mg en el vértigo de origen diverso en la práctica clínica en España. Resultados del estudio VERTINEL
Introduction
Vertigo is a condition affecting millions of people and significantly impacting their quality of life. Traditionally, vertigo management includes the use of antiemetics, vestibular sedatives, and betahistine, though these treatments have limitations and side effects. The aim of this study was to evaluate the efficacy and safety of a low-dose fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in routine clinical practice.
Methods
An observational, multicenter study was conducted, comprising a primary retrospective cohort and a cross-sectional cohort as a control group, across 28 Primary Care centers and Otolaryngology specialist clinics nationwide in Spain. Adult patients with vertigo of various origins treated with the fixed low-dose combination of cinnarizine 20 mg and dimenhydrinate 40 mg were included, and compared with a control group without treatment. Efficacy was assessed using the Vertigo and Dizziness Symptom Questionnaire (VDI-SS), and quality of life was evaluated through the VDI-HRQoL. Additional outcomes such as speed of action, tolerability, and treatment satisfaction were also measured.
Results
A total of 181 patients were analyzed, showing significant improvement in vertigo symptoms and quality of life in those treated with the drug combination compared to both pre-treatment and control groups. The pre-post treatment difference was 28.41 points on the VDI-SS questionnaire, p < 0.0001. Additionally, the difference between the post-treatment group and the control group was 24.07 points in favor of the treated group; 20.26 (95% CI 18.8–21.7) vs. 44.33 (95% CI 42.6–46), p < 0.0001. In quality-of-life assessments, the mean difference was 14.56 points between pretreatment and post-treatment, p < 0.0001, with a similar result observed in comparison with the control group, p < 0.0001. Improvement was reported by 78.3% (65) of treated subjects within the first week, with 55.4% reporting benefits in the first few days of treatment, and reaching 89.1% by the second week. Tolerability was rated as very good or good in most cases, with no serious adverse events reported, and no extrapyramidal effects, drowsiness, or inhibition of vestibular compensation mechanisms were noted. Overall treatment satisfaction was high.
Discussion
The results confirm the efficacy and safety of the low-dose fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in vertigo treatment. This therapeutic approach not only addresses specific vertigo symptoms but also improves patients' quality of life. Its rapid onset of action, along with high tolerability and satisfaction, supports the viability of this intervention in routine clinical practice, offering an effective and safe alternative for managing vertigo.