Antisecretory activity of Esomeprazole (Emanera) in the conditions of longterm monitoring of intragastric pH in patients with acid-related diseases

Aim of the study

The research of antisecretory potential of generic medicine esomeprazole – Emanera (KRKA).

Subjects and methods

Long-term (48-hour) monitoring of intragastric pH was performed in 10 patients with acid-related diseases (ulcer disease and erosive gastroduodenitis) using ‘Gastroscan-24’ (Istok-Sistema, Fryasino).

All patients received a 40 mg dose of the medicine Emanera on the second day of the study.

In the study the following parameters were estimated: the mean and median daily pH values; the median time of maintenance of pH >4 and >6; the proportion of time with the corresponding pH values; the area under the pH distribution curve from 1 to 10.

Corresponding parameters before and after the administration of 40 mg of Emanera were compared using the Wilcoxon test. The differences were considered significant at p <0.05.

Results of the study

The study demonstrated high antisecretory potential of the medicine.

After a short latent period (1.27 hours on average), a significant increase of pH in gastric corpus was obtained in response to the first dose (40 mg) of the medicine the median of mean daily pH values was 6.25.

A comparison of the area under pH distribution curves (in 24 hours) before and after the administration of the medicine has confirmed an increased antisecretory activity of Emanera.

Cases of intrinsic resistance were not observed.

Conclusion

Emanera® in a 40 mg dose can be used in acid-related conditions, including the conditions that require suppression of increased acid levels (optimisation of eradication therapy, erosive GERD and Barrett's esophagus, extraesophageal manifestations of GERD and others).