N. Hudson et al., FAMOTIDINE FOR HEALING AND MAINTENANCE IN NONSTEROIDAL ANTIINFLAMMATORY DRUG-ASSOCIATED GASTRODUODENAL ULCERATION, Gastroenterology, 112(6), 1997, pp. 1817-1822
Background & Aims: Nonsteroidal anti-inflammatory drugs (NSAIDs) are s
trongly associated with gastroduodenal ulceration. How to manage patie
nts with NSAID-associated ulcers is a common clinical dilemma. High-do
se famotidine in the healing and maintenance of NSAID-associated gastr
oduodenal ulceration was therefore evaluated. Methods: One hundred fou
r patients with rheumatoid or osteoarthritis who had gastroduodenal ul
ceration received famotidine, 40 mg twice daily. Sixteen patients stop
ped and 88 continued their NSAID treatment. Ulcer healing was assessed
endoscopically at 4 and 12 weeks. Seventy-eight NSAID users with heal
ed ulcers were then randomized to receive 40 mg twice daily famotidine
or placebo anal underwent endoscopy at 4, 12, and 24 weeks. Results:
Cumulative ulcer healing rates at 12 weeks were 89.0% (95% confidence
interval [CI], 82.3%-95.7%) for patients who continued NSAID treatment
and 100% (95% CI, 82.9%-100.0%) for those who stopped. The subsequent
estimated cumulative gastroduodenal ulcer relapse over 6 months for N
SAID users who took placebo was 53.5% (95% CI, 36.6%-70.3%). This was
reduced to 26.0% (12.1%-39.9%) in patients taking famotidine (P = 0.01
1). Conclusions: High-dose famotidine is effective ulcer healing thera
py in patients who stop or continue NSAID treatment and significantly
reduced the cumulative incidence of gastroduodenal ulcer recurrence co
mpared with placebo when given as maintenance therapy.