[Evaluation of preferences in patients with gastroesophageal reflux disease and dysphagia concerning treatment with lansoprazole orally disintegrating tablets].
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.


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).


CONCLUSIONS
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.
Blanco
María Angeles
MA
Servicio de Gastroenterología, Hospital Virgen de la Torre, Madrid, España.
Prieto
Miguel
M
Mearin
Fermín
F
Plazas
María José
MJ
Armengol
Silvia
S
Heras
Joan
J
Mas
Marta
M
Piqué
Josep M
JM
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D018592:Cross-Over Studies; D003680:Deglutition Disorders / Q000188:drug therapy*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D054328:Proton Pump Inhibitors; D013607:Tablets
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D013607:Tablets; D064747:Lansoprazole