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.
de Argila
Carlos Martín
CM
Digestive Medicine Department, Hospital Ramón y Cajal, Madrid, Spain.
Ponce
Julio
J
Márquez
Emilio
E
Plazas
M José
MJ
Galván
Jordi
J
Heras
Joan
J
Porcel
Joana
J
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D013607:Tablets
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D013607:Tablets; D064747:Lansoprazole