Safety and Effcacy of Lansoprazole Injection in Upper Gastrointestinal Bleeding: a Postmarketing Surveillance Conducted in Indonesia
ABSTRACT: to assess the safety
and effectiveness of lansoprazole injection (Prosogan®) in patients with upper gastrointestinal
bleeding due to peptic ulcers or erosive gastritis. Methods: this study was a
multicenter observational postmarketing study of lansoprazole (Prosogan®)
injection. Patients with upper gastrointestinal bleeding due to peptic ulcers
or erosive gastritis were given intravenous lansoprazole for a maximum of 7
days or until the bleeding stopped and the patients were able to take oral
doses of lansoprazole. Primary outcome of the study was cessation of bleeding.
Some laboratory parameters were also measured. Results: among a total of 204
patients evaluable for safety, there was no adverse event reported during the
study. A total of 200 patients were eligible for effcacy evaluation, 125
patients (62.5%) were males. Among these patients, upper GI bleeding stopped in
20 patients (10.0%) on day 1, in 71 patients (35.5%) on day 2, 75 patients
(37.5%) on day 3, 24 patients (12.0%) on day 4, and 7 patients (3.5%) on day 5,
making a cumulative of 197 patients (98.5%) on day 5. The hemostatic effect was
rated as “excellent” if the bleeding stopped within 3 days, and “good” if the
bleeding stopped within 5 days. Thus, the results were “excellent” in 166
patients (83.0%) and “good” in 31 patients (15.5%). These results were not
different between males and females, between age below 60 years and 60 years
and above, and between baseline Hb below 10 g/dL and 10 g/dL and above.
Conclusion: the results of this observational postmarketing study in 200
patients with upper gastrointestinal bleeding due to peptic ulcers or erosive
gastritis demonstrated that intravenous lansoprazole twice a day was well
tolerated and highly effective.
Author: Ari F. Syam, Arini
Setiawati
Kode Jurnal: jpkedokterangg130260
