Resumen
Introducción: Se elaboró una forma farmacéutica masticable de diclofenac sódico microencapsulado gastrorresistente utilizando una nueva tecnología. Objetivo: Evaluar la tolerabilidad digestiva y la eficacia del diclofenac en comprimidos masticables gastrorresistentes en pacientes gastrolábiles, con antecedentes de intolerancia digestiva leve o moderada a antiinflamatorios no esteroideos (AINE), con enfermedad musculoarticular aguda, susceptible de ser tratada con diclofenac. Métodos: Ensayo prospectivo, abierto, multicéntrico; pacientes ambulatorios con enfermedad músculoarticular aguda y antecedentes de intolerancia digestiva a AINE; tratamiento: diclofenac masticable 50 mg, 1-3 veces por día, 7 a 14 días. Se evaluó la tolerabilidad con respecto a AINE usados anteriormente y la eficacia mediante el cuestionario de Impresión General del Paciente (PGI) y el dolor por medio de una escala visual analógica (EVA). Resultados: 54 pacientes evaluados; mediana de edad: 53 años; dosis diaria: 78% de los pacientes recibieron 150 mg/día, y 22%, 100 mg/día; tiempo promedio de tratamiento: 10.35 ± 2.84 días; 83.33% presentaron buena tolerabilidad; 14 pacientes tuvieron eventos adversos (25.92%); 10 de los cuales fueron digestivos (18.51%); PGI: 92.45% mejoraron con el tratamiento; EVA basal: 6.34 ± 1.49, postratamiento: 2.01 ± 1.40, p < 0.01, según la prueba de la T de Student. Conclusiones: El diclofenac masticable 50 mg demostró ser eficaz y bien tolerado en los pacientes gastrolábiles evaluados, con intolerancia previa a AINE y enfermedad musculoarticular aguda.

Palabras clave
diclofenac, masticable, gastrolábil, tolerabilidad

Artículo completo
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Abstract
Background: A pharmaceutical form of chewable, microencapsulated, gastro-resistant diclofenac sodium tablets was developed using new technology. Objective: To evaluate the efficacy and gastrointestinal tolerability of chewable, gastro-resistant diclofenac tablets in gastro-labile patients with a history of mild to moderate gastrointestinal intolerance to NSAIDs, undergoing acute musculoarticular conditions susceptible of being treated with diclofenac. Methods: Prospective, open-label and multicentric study. Outpatients with acute musculoarticular conditions and history of gastrointestinal intolerance to NSAIDs were included. Patients treated with chewable diclofenac 50 mg, 1-3 times daily for 7 to 14 days were evaluated. The tolerability assessment included a comparison with other previously non-tolerated NSAIDs and the efficacy was evaluated by means of Patient Global Impression (PGI) scale and a Visual Analogue Scale (VAS) for pain. Results: 54 patients (35 female and 19 male) were evaluated. Median age: 53.5 years. Daily dose: 78% received 150 mg and 22% received 100 mg. Mean duration of treatment: 10.35 ± 2.84 days. 83.33% of patients showed good global tolerability. 14 patients presented adverse events (25.92%), 10 of them were digestive (18.51%). According to the PGI scale, 92.45% improved with the treatment. VAS: Baseline: 6.34 ± 1.49, Post-treatment: 2.01 ± 1.40, p < 0.01 (Student's t-test). Conclusions: Chewable diclofenac 50 mg showed to be effective and well tolerated in most gastro-labile evaluated patients, with musculoarticular conditions and history of intolerance to other NSAIDs.

Key words
diclofenac, chewable, gastro-labile, tolerability