Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study.

AIM: To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. METHODS: This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. RESULTS: Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001). CONCLUSION: TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.

Evaluación de la preferencia de los pacientes con enfermedad por reflujo gastroesofágico y disfagia por el tratamiento con comprimidos bucodispersables de lansoprazol / Evaluation of preferences in patients with gastroesophageal reflux disease and dysphagia concerning treatment with lansoprazole orally disintegrating tablets

Introducción y objetivoRecientemente se dispone de una nueva formulación de lansoprazol en forma de comprimidos bucodispersables (CBD) que puede contribuir a mejorar la aceptabilidad y el cumplimiento con este tipo de medicación. El objetivo del presente estudio fue evaluar la preferencia del paciente con enfermedad por reflujo gastroesofágico (ERGE) y disfagia por los CBD en comparación con las cápsulas de lansoprazol.Material y métodosSe diseñó un estudio clínico fase IV, multicéntrico, cruzado, abierto y aleatorizado en pacientes con síntomas de ERGE y disfagia asociada. Los pacientes se trataron durante 3 días con cápsulas de lansoprazol (30mg) y otros 3 días con CBD de lansoprazol (30mg). El orden del tratamiento (primero cápsulas y después CBD o al revés) fue determinado mediante aleatorización en bloques de forma centralizada. La variable principal del estudio fue la puntuación en una escala visual analógica (EVA), en la que se solicitaba al paciente que valorara su grado de preferencia por los CBD o las cápsulas.ResultadosSe incluyó a 145 pacientes y se evaluó finalmente a 126 por protocolo. Un 47% (59 de 126) de los pacientes prefirió los CBD, un 33% (42 de 126) prefirió las cápsulas y al resto (25 de 126) le fue indiferente. El valor medio de preferencia en la EVA fue de 5,31 (4,72±5,90), favorable a los CBD aunque sin significación estadística. En general, las diferencias a favor de los CBD se acentuaron en los pacientes de mayor edad. El porcentaje de pacientes libres de pirosis al final de ambas secuencias de tratamiento estuvo alrededor del 75% y no fue distinto entre los que habían empezado con cápsulas o los que habían empezado con CBD. Finalmente, la valoración de preferencia mediante las técnicas de disponibilidad para pagar obtuvo resultados similares, que de nuevo fueron más favorables a los CBD (4,18±6,86 euros frente a 3,47±5,78 euros)(AU)

ConclusiónLas formulaciones farmacéuticas en cápsulas y CBD de lansoprazol tienen una aceptación comparable entre los pacientes con ERGE que presentan disfagia. Sin embargo, y aunque sin potencia suficiente para demostrar significación estadística, se ha observado una clara tendencia hacia la preferencia por los CBD entre los pacientes de mayor edad(AU)

Introduction and objectiveRecently, a new lansoprazole formulation consisting of orally disintegrating tablets has become available, which could improve acceptability and compliance with this type of medication. The aim of the present study was to evaluate preferences in patients with gastroesophageal reflux disease concerning lansoprazole orally disintegrating tablets compared with lansoprazole capsules.Material and methodsA phase IV, multicenter, crossed, open and randomized clinical trial was performed in patients with symptoms of gastroesophageal reflux disease and associated dysphagia. The patients were treated with 30mg lansoprazole capsules for 3 days and with 30mg lansoprazole orally disintegrating tablets for another 3 days. The order of treatment (first capsules followed by orally disintegrating tablets or vice versa) was determined by centralized block randomization. The main measure was the visual analog scale (VAS) score in which patients was asked to rate their degree of preference for the orally disintegrating tablets or the capsules.ResultsOf the 145 patients included, 126 could be evaluated by the protocol. A total of 47% (59/126) of the patients preferred the orally disintegrating tablets, 33% (42/126) preferred the capsules and the remainder (25/126) had no preference. The mean preference value in the VAS was 5.31 (4.72 ± 5.90) in favor of the orally disintegrating tablets, although this difference was not statistically significant. In general, differences in favor of the orally disintegrating tables were more marked in older patients. The percentage of patients free of pyrosis at the end of both treatment sequences was approximately 75% with no differences according to which treatment was administered first. Finally, preference evaluation through willingness to pay techniques showed similar results, again in favor of the orally disintegrating tablets (4.18 € ± 6.86 € vs 3.47 € ± 5.78 €)(AU)

ConclusionThe acceptability of pharmaceutical formulations of lansoprazole in capsules and orally disintegrating tables is similar among patients with gastroesophageal reflux disease and associated dysphagia. However, a clear, but nonsignificant, trend was observed in favor of orally disintegrating tablets among older patients(AU)

[Evaluation of preferences in patients with gastroesophageal reflux disease and dysphagia concerning treatment with lansoprazole orally disintegrating tablets]. / Evaluación de la preferencia de los pacientes con enfermedad por reflujo gastroesofágico y disfagia por el tratamiento con comprimidos bucodispersables de lansoprazol.

INTRODUCTION AND OBJECTIVE: Recently, a new lansoprazole formulation consisting of orally disintegrating tablets has become available, which could improve acceptability and compliance with this type of medication. The aim of the present study was to evaluate preferences in patients with gastroesophageal reflux disease concerning lansoprazole orally disintegrating tablets compared with lansoprazole capsules. MATERIAL AND METHODS: A phase IV, multicenter, crossed, open and randomized clinical trial was performed in patients with symptoms of gastroesophageal reflux disease and associated dysphagia. The patients were treated with 30mg lansoprazole capsules for 3 days and with 30mg lansoprazole orally disintegrating tablets for another 3 days. The order of treatment (first capsules followed by orally disintegrating tablets or vice versa) was determined by centralized block randomization. The main measure was the visual analog scale (VAS) score in which patients was asked to rate their degree of preference for the orally disintegrating tablets or the capsules. RESULTS: Of the 145 patients included, 126 could be evaluated by the protocol. A total of 47% (59/126) of the patients preferred the orally disintegrating tablets, 33% (42/126) preferred the capsules and the remainder (25/126) had no preference. The mean preference value in the VAS was 5.31 (4.72 +/- 5.90) in favor of the orally disintegrating tablets, although this difference was not statistically significant. In general, differences in favor of the orally disintegrating tables were more marked in older patients. The percentage of patients free of pyrosis at the end of both treatment sequences was approximately 75% with no differences according to which treatment was administered first. Finally, preference evaluation through willingness to pay techniques showed similar results, again in favor of the orally disintegrating tablets (4.18 euro +/- 6.86 euro vs 3.47 euro +/- 5.78 euro). CONCLUSION: The acceptability of pharmaceutical formulations of lansoprazole in capsules and orally disintegrating tables is similar among patients with gastroesophageal reflux disease and associated dysphagia. However, a clear, but nonsignificant, trend was observed in favor of orally disintegrating tablets among older patients.

Desarrollo y producción de cefazolina 500 mg y 1 g, polvo estéril para inyección / Development and production of 500 mg and 1 mg cefalozin, sterile powder for injection

Se describe el desarrollo de la formulación para la obtención de cefazolina 500 mg y 1 g, polvo estéril para inyección, con la calidad requerida, así como el estudio de estabilidad para determinar su vida útil, tanto en forma de polvo como después de reconstituida. Se desarrolló este medicamento con calidad similar a las firmas internacionales al contar con la infraestructura necesaria, el personal técnico calificado y la posibilidad de adquirir la materia prima, además de reducir los costos, los que garantiza un gran beneficio social y económico

Desarrollo y producción de cefazolina 500 mg y 1 g, polvo estéril para inyección / Development and production of 500 mg and 1 mg cefalozin, sterile powder for injection

Se describe el desarrollo de la formulación para la obtención de cefazolina 500 mg y 1 g, polvo estéril para inyección, con la calidad requerida, así como el estudio de estabilidad para determinar su vida útil, tanto en forma de polvo como después de reconstituida. Se desarrolló este medicamento con calidad similar a las firmas internacionales al contar con la infraestructura necesaria, el personal técnico calificado y la posibilidad de adquirir la materia prima, además de reducir los costos, los que garantiza un gran beneficio social y económico (AU)