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

de Argila CM, Ponce J, Márquez E, Plazas MJ, Galván J, Heras J, Porcel J

Clinical drug investigation, 2007

734 participants · 9 citations

Abstract

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…

How strong is the evidence?

Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 734 participants or records.

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