Enteric coating of aspirin significantly decreases gastroduodenal mucosal lesions

• Published in: Alimentary pharmacology & therapeutics Vol. 13; no. 8; pp. 1109 - 1114
• Main Authors: DAMMANN, H. G, BURKHARDT, F, WOLF, N
• Format: Journal Article
• Language: English
• Published: Oxford UK Blackwell Science Ltd 01.08.1999; Blackwell
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Aspirin - administration & dosage; Aspirin - adverse effects; Biological and medical sciences; Cross-Over Studies; Double-Blind Method; Drug toxicity and drugs side effects treatment; Duodenal Diseases - chemically induced; Duodenal Diseases - pathology; Female; Gastric Mucosa - pathology; Humans; Intestinal Mucosa - pathology; Male; Medical sciences; Pharmacology. Drug treatments; Stomach Diseases - chemically induced; Stomach Diseases - pathology; Tablets, Enteric-Coated; Toxicity: digestive system; Human; Duodenal disease; Healthy subject; Toxicity; Dosage form; Digestive diseases; Acetylsalicylic acid; Salicylates; Enteric coating; Gastric disease
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1046/j.1365-2036.1999.00588.x

Background : Low‐dose aspirin (acetylsalicylic acid, ASA) increases the risk of developing peptic ulceration. Aim : 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.