Year 2020 / Volume 27 / Number 3

Original

Characteristics of patients suffering mild to severe pain treated with orodispersible tablets of paracetamol 325 mg/tramadol HCL 37,5mg (Paxiflas®) in comparison with other oral formulations containing the same combination. PROPAX study

Rev. Soc. Esp. Dolor. 2020; 27(3): 168-177 / DOI: 10.20986/resed.2020.3771/2019

Marc Aguilar, Cristina Aranda, Grupo PROPAX


ABSTRACT

Objective: To compare profiles of patients suffering mild to severe pain treated with orodispersible formulation of paracetamol 325 mg/tramadol HCL 37,5 mg (Paxiflas®) in comparison with other oral formulations of paracetamol 325 mg/tramadol HCL 37,5mg. In addition, to compare adherence, satisfaction and preference between groups.
Materials and methods: Propax is a postautorization, observational, cross-sectional retrospective and multicentre study. The primary variable was the clinic and sociodemographic profile of the patient. Patient satisfaction was measured by STAMED generic questionnaire; adherence was measured by Morisky-Green questionnaire and preference was measured using a battery of questions with Likert-like answer.
Results: A number 835 patients were evaluated. Clinical and sociodemographic statistically significant differences were not observed between both groups of patients. However, there were statistically significant differences among Paxiflas® group of patients in satisfaction assessment, in both total score (p = 0,002) and dimensions: side effects interferences in everyday life (p = 0,006), convenience and ease of use (p < 0,001) and overall opinion of medication and health condition (p = 0,010). In addition, patient preference of Paxiflas® over other oral combinations of tramadol HCI (37.5 mg) and paracetamol (325 mg) was statistically significant (p < 0,001), including perception of pain relief speed, medication convenience, taste and likeable sensation, tablet size convenience and final election of treatment.
Conclusions: Statistically significant differences were not observed in neither patient profile nor adherence. Paxiflas® orodispersible tablets demonstrated to provide greater satisfaction and preference among patients suffering acute and mild chronic musculoskeletal pain than other oral formulations.



RESUMEN

Objetivo: Comparar el perfil del paciente con dolor musculoesquelético moderado a intenso en tratamiento con los comprimidos bucodispersables, Paxiflas® [tramadol HCl (37,5 mg) y paracetamol (325 mg)] respecto a otras combinaciones de tramadol HCl (37,5 mg) y paracetamol (325 mg). Secundariamente, se comparó la adherencia, satisfacción y preferencia entre grupos.
Materiales y métodos: El estudio Propax es un estudio postautorización, observacional, transversal, retrospectivo y multicéntrico. La variable principal fue el perfil sociodemográfico y clínico del paciente. La satisfacción de los pacientes en tratamiento se midió mediante el cuestionario genérico SATMED-Q; la adherencia, con el cuestionario Morisky-Green; y la preferencia, mediante una batería de preguntas con respuesta tipo Likert.
Resultados: Se evaluaron 835 pacientes. No se observaron diferencias estadísticamente significativas en el perfil clínico y sociodemográfico de los pacientes entre ambos grupos de tratamiento, pero sí entre los pacientes en tratamiento con Paxiflas®, en relación con la evaluación de la satisfacción, tanto en la puntuación total (p = 0,002) como en las dimensiones: la interferencia de los efectos secundarios de la medicación en las actividades cotidianas (p = 0,006), la comodidad de uso (p < 0,001) y la opinión general respecto a la medicación y su estado de salud (p = 0,010). Además, la preferencia de los pacientes por el tratamiento con Paxiflas® fue estadísticamente significativas (p < 0,001) en comparación con otras combinaciones orales de tramadol HCI (37,5 mg) y paracetamol (325 mg), incluyendo la percepción de rapidez en el alivio del dolor, comodidad de la medicación, sabor y sensación agradable, conveniencia del tamaño del comprimido, y elección final del tratamiento.
Conclusiones: Entre los distintos grupos de tratamiento no se encontraron diferencias estadísticamente significativas en el perfil de los pacientes, ni en el grado de adherencia a la medicación. Los comprimidos bucodispersables Paxiflas® han demostrado un mayor grado de satisfacción y preferencia por parte de los pacientes con dolor musculoesquelético agudo y crónico moderado e intenso frente a otras formas orales.





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Instrucciones para citar

Aguilar M, Aranda C, PROPAX G. Characteristics of patients suffering mild to severe pain treated with orodispersible tablets of paracetamol 325 mg/tramadol HCL 37,5mg (Paxiflas®) in comparison with other oral formulations containing the same combination. PROPAX study. Rev Soc Esp Dolor 2020; 27(3): 168-177 / DOI: 1020986/resed20203771/2019


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Recibido: 16/10/2019

Aceptado: 23/03/2020

Prepublicado: 22/04/2020

Publicado: 16/06/2020

Tiempo de revisión del artículo: 148 días

Tiempo de prepublicación: 189 días

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