Eficacia y tolerabilidad de cinitaprida en el tratamiento de los pacientes con dispepsia funcional y vaciamiento gástrico enlentecido / Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying

Introducción/objetivosLa dispepsia funcional es un trastorno muy frecuente, cuyos mecanismos fisiopatológicos todavía no son bien conocidos y sobre la que los procinéticos parecen tener utilidad. El objetivo del presente estudio fue evaluar el efecto procinético de cinitaprida en pacientes con dispepsia funcional tipo dismotilidad y enlentecimiento del vaciamiento gástrico.MétodosDe forma aleatoria, 19 pacientes recibieron 1mg de una solución oral de cinitaprida t.i.d. o placebo durante 4 semanas en dos periodos consecutivos, según un diseño cruzado y a doble ciego. La variable principal fue la media del cambio en el tiempo de vaciamiento gástrico a la mitad respecto al valor basal tras ingesta líquida, a las 4 semanas de tratamiento, cuantificado mediante ecografía de alta resolución en tiempo real.ResultadosAl finalizar el tratamiento, la media del tiempo de vaciamiento gástrico a la mitad disminuyó para ambos tratamientos, sin diferencias estadísticamente significativas entre ellos (p=0,8720). Esta disminución resultó mayor para cinitaprida respecto a placebo (p=0,0169) cuando se analizó a los pacientes con un vaciamiento de leve a moderadamente enlentecido. Para este grupo de pacientes, cinitaprida resultó estadísticamente superior a placebo en el área bajo la curva porcentual del área antral y en el porcentaje de días libres de náuseas. La administración de cinitaprida fue bien tolerada, con un perfil de seguridad comparable a placebo.ConclusionesCinitaprida oral es segura, facilita el vaciamiento gástrico y mejora la sintomatología clínica en pacientes con dispepsia funcional tipo dismotilidad y enlentecimiento del vaciamiento gástrico leve-moderado (AU)

Introduction and objectiveFunctional dyspepsia is a highly common disorder. The physiopathological mechanisms of this entity are not yet completely known and prokinetic drugs seem to be useful. The aim of this study was to evaluate the prokinetic effect of cinitapride in patients with dysmotility-like dyspepsia and delayed gastric emptying.MethodsNineteen patients were randomized to receive 1mg of an oral solution of cinitapride t.i.d or placebo for 4 weeks in two consecutive periods, following a crossover and double-blind design. The main variable was the mean change from baseline after 4 weeks of treatment in gastric-emptying half-time after a liquid test meal, measured by real-time ultrasonography.ResultsAt the end of treatment, the mean gastric-emptying half-time decreased with both treatments, with no statistically significant differences between them (ANOVA, p=0.8720). This decrease was greater for cinitapride than for placebo (ANOVA, p=0.0169) in patients with mild-to-moderate delayed gastric emptying. In this group of patients, cinitapride was also superior to placebo in the percentage AUC of the antral area and the percentage of days free of nausea. Cinitapride was well tolerated, with a safety profile comparable to that of placebo.ConclusionsOral cinitapride is safe and effective in improving gastric emptying and symptoms in patients with dysmotility-like dyspepsia and mild-to-moderate delayed gastric emptying(AU)

[Efficacy and tolerability of cinitapride in the treatment of functional dyspepsia and delayed gastric emptying]. / Eficacia y tolerabilidad de cinitaprida en el tratamiento de los pacientes con dispepsia funcional y vaciamiento gástrico enlentecido.

INTRODUCTION AND OBJECTIVE: Functional dyspepsia is a highly common disorder. The physiopathological mechanisms of this entity are not yet completely known and prokinetic drugs seem to be useful. The aim of this study was to evaluate the prokinetic effect of cinitapride in patients with dysmotility-like dyspepsia and delayed gastric emptying. METHODS: Nineteen patients were randomized to receive 1mg of an oral solution of cinitapride t.i.d or placebo for 4 weeks in two consecutive periods, following a crossover and double-blind design. The main variable was the mean change from baseline after 4 weeks of treatment in gastric-emptying half-time after a liquid test meal, measured by real-time ultrasonography. RESULTS: At the end of treatment, the mean gastric-emptying half-time decreased with both treatments, with no statistically significant differences between them (ANOVA, p=0.8720). This decrease was greater for cinitapride than for placebo (ANOVA, p=0.0169) in patients with mild-to-moderate delayed gastric emptying. In this group of patients, cinitapride was also superior to placebo in the percentage AUC of the antral area and the percentage of days free of nausea. Cinitapride was well tolerated, with a safety profile comparable to that of placebo. CONCLUSIONS: Oral cinitapride is safe and effective in improving gastric emptying and symptoms in patients with dysmotility-like dyspepsia and mild-to-moderate delayed gastric emptying.

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.

Acceptability of lansoprazole orally disintegrating tablets in patients with gastro-oesophageal reflux disease : ACEPTO study.

OBJECTIVE: To assess the acceptability of lansoprazole orally disintegrating tablets (LODT) in patients with gastro-oesophageal reflux disease (GORD). METHODS: A multicentre, observational, cross-sectional study of patients diagnosed with GORD aged > or =18 years under the care of 272 gastroenterologists. Acceptability was determined by global patient assessment whereby the drug's organoleptic characteristics and properties were evaluated by a self-administered 11-item ad hoc questionnaire with a 5-point Likert-type scale. RESULTS: A total of 734 patients (mean age 49.6 years [SD = 15.2]) with GORD who had been prescribed LODT > or =14 days prior to inclusion in the study were evaluable for the main endpoint. Of these, 51.1% were men. Most patients (80.7%) had been treated with doses of LODT 30mg/day for an average of 52.7 days (SD = 59.3). Overall, 93.6% of patients rated LODT treatment as 'very acceptable' or ''acceptable'. The degree of acceptability was associated with the perception that the formulation helps treatment compliance (p < 0.001). The drug's properties were rated as follows: size 'neither large nor small' (70.0%); flavour 'very pleasant' or 'pleasant' (75.2%); intensity of flavour 'neither strong nor mild', 'mild' or 'very mild' (86.1%); no 'sandy sensation' (53.4%); speed of dissolving 'fast' or 'very fast' (80.2%); use of tablets 'very easy' or 'easy' (92.4%) and use of tablets 'very convenient' or 'convenient' (91.0%). Three adverse reactions, none of them serious, were reported in three patients (0.4%). CONCLUSIONS: LODT were well accepted by patients with GORD. Patients reported that this formulation improved compliance with therapy. Tolerability was excellent.

Incidence of spontaneous notifications of adverse reactions with aceclofenac, meloxicam, and rofecoxib during the first year after marketing in the United Kingdom.

The objective was to compare the incidence of adverse reactions reported with three nonsteroidal anti-inflammatory drugs with different cyclo-oxygenase (COX)-2 selectivity. All spontaneous adverse reaction notifications in the pharmacovigilance database of the World Health Organisation Collaborating Centre for International Drug Monitoring with aceclofenac, meloxicam, and rofecoxib that were recorded during the first year of marketing were included. The incidence rate (adverse reactions/10(6) defined daily dose) and 95% confidence interval for total adverse reactions was 8.7 (6.1-12.0) for aceclofenac, 24.8 (23.1-26.6) for meloxicam, and 52.6 (49.9-55.4) for rofecoxib. Aceclofenac had a lower incidence of gastrointestinal bleeding, abdominal pain, and arterial hypertension than meloxicam and a lower incidence of gastrointestinal bleeding, abdominal pain, liver toxicity, thromboembolic cardiovascular events, arterial hypertension, and edema than rofecoxib. The incidence of total and gastrointestinal adverse reactions was significantly lower with aceclofenac than with meloxicam or rofecoxib, thus raising doubts about the hypothetical advantage of COX-2 selective inhibitors.