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.
Key words: postmarketing surveillance (PMS), lansoprazole, upper gastrointestinal bleeding (UGIB)
Author: Ari F. Syam, Arini Setiawati
Kode Jurnal: jpkedokterangg130260

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