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Enteric coating of aspirin significantly decreases gastroduodenal mucosal lesions
Author(s) -
Dammann Hg,
F. Burkhardt,
Nicole De Wolf
Publication year - 1999
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1999.00588.x
Subject(s) - medicine , placebo , aspirin , tolerability , duodenal bulb , gastroenterology , morning , dosing , adverse effect , lesion , antacid , stomach , surgery , pathology , alternative medicine
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.