SPH-260-4

To evaluate the use of concomitant medication in combination with a mouthwash of delmopinol HCl 0.2% based on data from 8 phase III efficacy studies on the mouthwash.

Clinical data obtained from 8 previously performed phase III studies, carried out to document the clinical efficacy of a mouthwash of delmopinol HCl 0.2% with respect plaque and gingivitis, were used to analyse the use of concomitant medication. In these 8 randomised double-blind clinical phase III studies the patients were - in addition to their normal oral hygiene measures - treated for 2-6 months with mouthwashes containing delmopinol HCl 0.2%, delmopinol HCl 0.1%, chlorhexidine digluconate 0.2% or placebo. The number of visits in each study was three. Each time the patients visited the dentist for efficacy determinations, other data were also recorded. One of these was whether the patient had used any other medication during the study. In this paper, the number of treatments of different types of concomitant medication (antibiotics, nasal decongestants and others) was used as a basis for statistical comparisons between the different test groups.

For antibiotics (all indications), a 27% lower number of treatments was obtained in the delmopinol 0.2% group in comparison with the placebo group, and a 41% decrease was observed for treatments with antibiotics for respiratory infections. For nasal decongestants, the number of treatments was 53% lower in the delmopinol 0.2% group.

The delmopinol HCl 0.2% solution in patients with gingivitis provided a statistically significant reduction of concomitant use of antibiotics and nasal decongestants.