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

Abstract

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.