Enteric coating of aspirin significantly decreases gastroduodenal mucosal lesions.
BACKGROUND
Low-dose aspirin (acetylsalicylic acid, ASA) increases the risk of developing peptic ulceration.


OBJECTIVE
To investigate the gastroduodenal mucosal tolerability of enteric-coated ASA (EC-ASA) 100 mg/day compared to either placebo (study 1) or plain ASA 100 mg/day (study 2) in healthy volunteers.


METHODS
Study 1: In this double-blind study 18 volunteers received randomized dosing with either EC-ASA 100 mg or placebo for 15 days. Study 2: 41 volunteers underwent randomized 7-day dosing of either EC-ASA 100 mg or plain ASA 100 mg in this double-blind, parallel-group, comparison study. In both studies acute gastroduodenal mucosal lesions were assessed endoscopically before treatment, on the morning of day 1 after the first dose (only in study 2), and on the morning after the last dose of the test medication.


RESULTS
Study 1 did not reveal any significant differences between the lesion scores of EC-ASA and placebo. In contrast, in study 2 significantly higher total gastroduodenal mucosal lesion scores were observed on day 1 after the first dose and after 7 days of dosing with plain ASA (mean sum of the lesion scores in the gastric fundus, body, antrum and in the duodenal bulb: day 1: plain ASA 3.95+/-3.38 vs. EC-ASA 1.43+/-1.91, P = 0.03; day 7: plain ASA 6.35+/-4.10 vs. EC-ASA 2.00+/-2.02, P = 0.0004). Tolerance of the test drugs was good, and no other adverse events were observed.


CONCLUSIONS
Enteric-coated aspirin 100 mg/day causes significantly less gastroduodenal damage over 7 days than the same dose of plain aspirin, when given to healthy subjects. There was little gastric injury and no significant differences between EC-ASA and placebo in this respect.
Dammann
H G
HG
Klinische Forschung Hamburg, Wissenschaftliches Institut, Hamburg, Germany. HGDammann@compuserve.com
Burkhardt
F
F
Wolf
N
N
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects*; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004378:Duodenal Diseases / Q000139:chemically induced* / Q000473:pathology; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D013272:Stomach Diseases / Q000139:chemically induced* / Q000473:pathology; D013608:Tablets, Enteric-Coated
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013608:Tablets, Enteric-Coated; D001241:Aspirin