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

Clin Drug Investig. 2007;27(11):765-70. doi: 10.2165/00044011-200727110-00003.

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 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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage*
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cross-Sectional Studies
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Lansoprazole
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care*
  • Patient Compliance
  • Proton Pump Inhibitors / administration & dosage*
  • Tablets

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Tablets
  • Lansoprazole