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Famotidine: postmarketing clinical experience.
K Saigenji1, H Fukutomi, S Nakazawa
1Kitasato University, School of Medicine, Kanagawa Prefecture, Japan.
Scandinavian Journal of Gastroenterology. Supplement
|January 1, 1987
Summary
Famotidine, an H2-receptor antagonist, demonstrated high efficacy and safety in a large postmarketing survey. The drug showed a 92.4% healing rate for ulcers and effectively controlled bleeding in most patients with minimal side effects.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Research
Background:
- Famotidine is an H2-receptor antagonist used for gastrointestinal conditions.
- Postmarketing surveillance is crucial for evaluating drug safety and efficacy in real-world settings.
Purpose of the Study:
- To assess the efficacy and safety of famotidine in a large patient cohort.
- To evaluate famotidine's effectiveness across various gastrointestinal diseases, including peptic ulcers and bleeding.
Main Methods:
- A Phase IV postmarketing survey involving 6346 patients across 602 locations.
- Data collection from August 1985 to April 1986, analyzing patient outcomes and side effects.
- Efficacy assessment based on disease type, overall improvement, and hemostatic control for bleeding.
Main Results:
- High overall efficacy with an 8-week healing rate of 92.4% for treated conditions.
- Effective control of upper gastrointestinal tract bleeding in 72.3% of patients within 7 days.
- Excellent safety profile with side effects in only 0.43% of patients and minimal laboratory abnormalities.
Conclusions:
- Famotidine is a safe and effective H2-receptor antagonist for managing a range of gastrointestinal disorders.
- The postmarketing survey confirms famotidine's favorable risk-benefit profile in clinical practice.
- Low incidence of mild side effects, primarily gastrointestinal (e.g., constipation), supports its tolerability.