IngentaConnect Acceptability of Lansoprazole Orally Disintegrating Tablets in Pa...

Authors: de Argila, Carlos Martín¹; Ponce, Julio²; Márquez, Emilio³; Plazas, M José⁴; Galván, Jordi⁴; Heras, Joan⁴; Porcel, Joana⁵

Source: Clinical Drug Investigation, Volume 27, Number 11, 2007 , pp. 765-770(6)

Publisher: Adis International

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 ≥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 ≥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.

Keywords: Gastro oesophageal reflux; Lansoprazole

Document Type: Research article

Affiliations: 1: 1 Digestive Medicine Department, Hospital Ramón y Cajal, Madrid, Spain 2: 2 Digestive Medicine Department, Hospital Universitari La Fe, Valencia, Spain 3: 3 Health Center La Orden, Huelva, Spain 4: 4 Laboratorios Almirall SA, Barcelona, Spain 5: 5 Biométrica SL, Barcelona, Spain

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Acceptability of Lansoprazole Orally Disintegrating Tablets in Patients with Gastro-Oesophageal Reflux Disease: ACEPTO Study