Estudio sobre el cumplimiento subjetivo y la aceptabilidad de lansoprazol comprimidos bucodispersables en traumatología. Estudio ECOF-TR / A study on the subjective compliance and acceptance of oral lanzoprazole in traumatology. The ECOFT-TR Study

Objetivo: Valorar el cumplimiento terapéutico con lansoprazol comprimidos bucodispersables en pacientes tratados por especialistas en traumatología. Material y método: Estudio observacional, transversal. Participaron 370 especialistas en traumatología que incluyeron a pacientes con un mínimo de 18 años. Los aspectos logísticos del estudio fueron financiados por Laboratorios Almirall, S.A., los investigadores y pacientes no percibieron compensación alguna por su participación en el estudio. La valoración subjetiva del cumplimiento con lansoprazol comprimidos bucodispersables se realizó mediante el test de Haynes Sackett. La aceptabilidad del tratamiento, considerada como la valoración general del paciente tras evaluar las características organolépticas y propiedades de uso, y su preferencia con respecto a tratamientos previos, se evaluó mediante un cuestionario ad hoc, autoaplicado, de 15 ítems con una escala tipo Likert con 2-5 posibles respuestas, que los pacientes cumplimentaron en una única ocasión. Resultados: Fueron valorables 1.085 pacientes, con una media±desviación estándar de edad de 56,09±13,8 años; un 56,77% eran mujeres. La media de tiempo en tratamiento fue 51,24±38,8 días. El 94,74% de los pacientes cumplieron con el tratamiento. El grado medio de cumplimiento fue 94,5±12,12. El 91,09% de los pacientes calificó el tratamiento como «muy aceptable/aceptable». No hubo diferencias significativas en el porcentaje de pacientes cumplidores según las variables demográficas y clínicas. El grado o porcentaje de cumplimiento fue significativamente mejor entre los pacientes sin enfermedades y tratamientos concomitantes y sin dificultad en la toma de comprimidos. Para 1 (0,09%) paciente se notificó una reacción adversa no grave. Conclusiones: El cumplimiento con lansoprazol comprimidos bucodispersables fue muy elevado. Los pacientes valoraron que la formulación bucodispersable de lansoprazol les ayudaba a cumplir mejor con el tratamiento y lo prefirieron al que recibían previamente. La tolerabilidad fue excelente (AU)

Objective: To assess compliance with oral lansoprazole disintegrating tablets (LODT) in patients treated by traumatology specialists. Material and method: A multicenter, observational, cross-sectional study involving 370 traumatology specialists and patients aged 18 or more. Study logistics were sponsored by Almirall Laboratories, S.A.; neither investigators nor patients received any economic compensation for their participation. Patient subjective compliance with LODT was assessed with the Haynes Sackett test. Acceptability was based on patients’ global assessments of the drug's organoleptic characteristics and properties of use, and preferences regarding previous treatments, recorded by means of a self-administered 15-item ad hoc questionnaire with a 2-5-point Likert-type scale, that patients fulfilled once. Results: One thousand and eighty five patients were evaluable for the main endpoint. Mean age was 56.09±13.8 years; 56.77% were women. Mean treatment duration was 51.24±38.8 days. 94.74% of the patients complied with the treatment. Mean percentage of compliance was 94.5±12.12; 91.09% of patients rated the treatment as «acceptable or highly acceptable». No significant differences were observed between compliant and non-compliant patients in terms of demographic or clinical variables. Mean percentage of compliance was significantly higher among patients without concomitant illness or treatment and without difficulties in taking tablets. One non-serious adverse reaction was reported in one (0.09%) patient. Conclusions: Compliance with lansoprazole orally disintegrating tablets was high. Patients reported that this formulation improved their compliance and that they preferred LODT to previous medication. Tolerability was excellent (AU)

[A study on the subjective compliance and acceptance of oral lanzoprazole in traumatology. The ECOFT-TR Study]. / Estudio sobre el cumplimiento subjetivo y la aceptabilidad de lansoprazol comprimidos bucodispersables en traumatología. Estudio ECOF-TR.

OBJECTIVE: To assess compliance with oral lansoprazole disintegrating tablets (LODT) in patients treated by traumatology specialists. MATERIAL AND METHOD: A multicenter, observational, cross-sectional study involving 370 traumatology specialists and patients aged 18 or more. Study logistics were sponsored by Almirall Laboratories, S.A.; neither investigators nor patients received any economic compensation for their participation. Patient subjective compliance with LODT was assessed with the Haynes Sackett test. Acceptability was based on patients' global assessments of the drug's organoleptic characteristics and properties of use, and preferences regarding previous treatments, recorded by means of a self-administered 15-item ad hoc questionnaire with a 2-5-point Likert-type scale, that patients fulfilled once. RESULTS: One thousand and eighty five patients were evaluable for the main endpoint. Mean age was 56.09±13.8 years; 56.77% were women. Mean treatment duration was 51.24±38.8 days. 94.74% of the patients complied with the treatment. Mean percentage of compliance was 94.5±12.12; 91.09% of patients rated the treatment as «acceptable or highly acceptable¼. No significant differences were observed between compliant and non-compliant patients in terms of demographic or clinical variables. Mean percentage of compliance was significantly higher among patients without concomitant illness or treatment and without difficulties in taking tablets. One non-serious adverse reaction was reported in one (0.09%) patient. CONCLUSIONS: Compliance with lansoprazole orally disintegrating tablets was high. Patients reported that this formulation improved their compliance and that they preferred LODT to previous medication. Tolerability was excellent.

Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. Satisfaction and expectancies.

BACKGROUND: One of the factors affecting compliance is the pharmaceutical formulation used. Many patients find it difficult to swallow tablets or capsules. The fast dissolving tablet (FDT) formulation could help to enhance patient compliance, because of its ease of administration and because no liquid is required to help intake. MATERIAL AND METHODS: A survey was conducted in patients diagnosed with allergic rhinitis or dermatitis (positive skin tests and/or specific IgE) and urticaria to asses the degree of acceptance of and preference for an FDT formulation. RESULTS: Of the 7,686 patients who participated in the survey, 90 % considered the initial flavor and 83 % considered the aftertaste to be very or quite satisfactory, 95 % were very satisfied with the disintegration time, 79 % were very satisfied with the form, 82 % with the size, 72 % with the packaging and 78 % with the instructions for use. Ninety-three percent considered that being able to take the drug at any time or place was very important or fairly important. Ninety-four percent considered the ease of use to be much better or better. If given the choice, 93 % would choose an FDT formulation. Eighty-eight percent of the patients would like to change their current antihistaminic drug for a new allergy drug in an FDT formulation. CONCLUSIONS: Most of the patients were highly satisfied with the characteristics of the FDT formulation and would choose it for the treatment of their allergies.

Acceptance survey of a fast dissolving tablet pharmaceutical formulation in allergic patients. Satisfaction and expectancies

Background: One of the factors affecting compliance is the pharmaceutical formulation used. Many patients find it difficult to swallow tablets or capsules. The fast dissolving tablet (FDT) formulation could help to enhance patient compliance, because of its ease of administration and because no liquid is required to help intake. Material and methods: A survey was conducted in patients diagnosed with allergic rhinitis or dermatitis (positive skin tests and/or specific IgE) and urticaria to asses the degree of acceptance of and preference for an FDT formulation. Results: Of the 7,686 patients who participated in the survey, 90 % considered the initial flavor and 83 % considered the aftertaste to be very or quite satisfactory, 95 % were very satisfied with the disintegration time, 79 % were very satisfied with the form, 82 % with the size, 72 % with the packaging and 78 % with the instructions for use. Ninety-three percent considered that being able to take the drug at any time or place was very important or fairly important. Ninety-four percent considered the ease of use to be much better or better. If given the choice, 93 % would choose an FDT formulation. Eighty-eight percent of the patients would like to change their current antihistaminic drug for a new allergy drug in an FDT formulation. Conclusions: Most of the patients were highly satisfied with the characteristics of the FDT formulation and would choose it for the treatment of their allergies

Introducción: Uno de los factores que afecta al cumplimiento es la forma farmacéutica oral utilizada. Muchos pacientes encuentran difícil poder tragar comprimidos o cápsulas. La forma farmacéutica en liofilizado oral (Flas) podría contribuir a un mayor cumplimiento del tratamiento por parte del paciente, dada su facilidad de administración y por no precisar la ayuda de ningún líquido para su ingesta. Material y Método: Se realizó una encuesta a pacientes diagnosticados de rinitis o dermatitis alérgica (pruebas cutáneas y/o IgE específica positiva) y urticaria, para evaluar el grado de aceptación y la preferencia por una formulación en liofilizado oral (Flas). Resultados: De los 7686 pacientes que respondieron a la encuesta, el 90% consideraron que el sabor inicial y el 83% que el sabor final era muy o bastante satisfactorio, el 95% estaban muy o bastante satisfechos con el tiempo de disgregación; el 79% estaban muy satisfechos con la forma, el 82% con el tamaño, el 72% con el envasado y el 78% con las instrucciones de uso. El 93% opinaron que era muy o bastante importante que el medicamento pueda tomarse en cualquier momento y lugar. El 94% opinaron que su comodidad de uso era mucho mejor o mejor. Si pudieran elegir el 93% elegirían una formulación Flas. Un 88% de los pacientes desea cambiar su antihistamínico actual por un nuevo medicamento para la alergia en forma de liofilizado oral (Flas). Conclusiones: La mayoría de los pacientes se muestran muy satisfechos con las características de la formulación liofilizada oral Flas y elegirían ésta para el tratamiento de su alergia