Valoración de la satisfacción del tratamiento con levotiroxina sódica trirranurada en pacientes hipotiroideos

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RESUMEN

Antecedentes: la levotiroxina sódica trirranurada tiene presentación en comprimidos que garantizan el corte exacto, precisión de la dosis y homogeneidad en cada fracción, lo que permite individualizar la dosis administrada. Es importante la satisfacción del paciente porque podría influir en el apego al tratamiento y, por tanto, en su efectividad. Objetivo: identificar, en pacientes con hipotiroidismo primario, la dosis correcta inicial y de mantenimiento y valorar la satisfacción del tratamiento, eficacia y seguridad de la levotiroxina sódica trirranurada. Material y metodo: estudio multicéntrico, prospectivo, abierto, no comparativo y longitudinal al que se incluyeron pacientes de uno y otro sexo con límites de edad de 18 y 75 años. Se administró levotiroxina trirranurada a dosis de 1.6 mcg por kg de peso, independientemente de la dosis y el medicamento previamente administrado. Para la valoración clìnica se utilizó la escala de Zulewski y se aplicó un cuestionario para la valoración de satisfacción con el tratamiento (TSQM por sus siglas en inglés). Resultados: se incluyeron 85 pacientes de seis centros nacionales. De acuerdo con la valoración clínica inicial y el perfil tiroideo se demostró que 62 pacientes (61%) no se encontraban en adecuado control clínico o químico: 54 por hipofunción y 8 por sobredosis, se cambió a levotiroxina trirranurada y se ajustó la dosis. En la escala de Zulewski se observaron diferencias significativas al comparar los valores obtenidos en la medición basal (3.94 ± 3.94) vs la visita final (1.69 ± 1.56) p

Palabras clave: hipotiroidismo, levotiroxina trirranurada

ABSTRACT

Background: Levothyroxine sodium tablets trirranurada has presentation to ensure accurate cutting, precision and homogeneity of dose in each fraction, allowing tailoring the dose administered. It is important to patient satisfaction because it may affect compliance with treatment and therefore their effectiveness. Objective: This study was to identify in primary hypothyroid patients, the correct dose, both initial and maintenance and assess satisfaction to the treatment, efficacy and safety of levothyroxine sodium trigroove. Methods: It was a multicenter, prospective, open, non-comparative and longitudinal study. Patients of both sexes, between 18 and 75 years of age, were included. It was administered levotiroxina at 1.6 mcg/kg of weight, regardless of the dose and drug previously administered. Was applied to evaluate the clinical using the Zulewski’s scale. In addition, it was applied a questionnaire for the evaluation of satisfaction with the treatment. Results: 85 patients from six participating centers at national level were included. According to the initial clinical assessment, the clinical diagnosis index of hypothyroidism proposed by Zulewski and the thyroid profile demonstrated that 62 (61%) were not in appropriate clinical and/or chemical control: 54 by hypofunction and 8 due to a overdosage were changed to levotiroxine trigroove and the dose was adjusted. Significant differences were observed in the inferential analysis related to the scale of Zulewski when comparing the values obtained in the basal measurement (3.94 ± 3.94) vs the final visit (1.69 ± 1.56) p < 0.05. With regard to the levels of TSH, it was observed a significant difference by comparing basal values (2.68 ± 5.76) with respect to the values of the final visit (1.65 ± 2.5) p < 0.05. Of the total number of patients, 65.5% at the end of the study ended with a dose of levothyroxine which is usually not prescribed. In the three parameters assessed by the doctor (efficacy, safety and accuracy of dosage) an “excellent” evaluation prevailed. Conclusions: According to our results, identifying the correct dose per kilogram of weight, both initial and maintenance in hypothyroid patients and assess the satisfaction to the treatment, efficacy and safety and that the individualization of the therapeutic, allowed to obtain an excellent result of effectiveness of 98.8%. Key words: Hypothyroidism, Levothyroxine, Trigroove.

Keywords: hypothyroidism, Levothyroxine, Trigroove

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