Does concomitant use of paracetamol potentiate the gastroduodenal mucosal injury associated with aspirin? A prospective, randomised, pilot study.

Abstract

BACKGROUND:

Paracetamol is commonly prescribed for first-line symptomatic treatment in patients with osteoarthritis and aspirin is often co-administered for cardiovascular prophylaxis. It is not known if an interaction exists between aspirin and paracetamol in regards to gastroduodenal mucosal injury.

AIM:

To investigate whether or not co-administered aspirin with paracetamol results in an increased rate of endoscopic gastroduodenal mucosal injury as compared to either agent alone.

METHODS:

In this prospective, double-blind, randomised, three-arm, placebo- and active-controlled, parallel-group pilot study healthy adult subjects (18-75 years old) with a normal baseline trans-nasal oesophagogastroduodenoscopy (TN-EGD), received oral paracetamol 4000 mg q.d.s. (n = 21), aspirin 325 mg q.d.s. (n = 19) or paracetamol 4000 mg q.d.s. and aspirin 325 mg q.d.s. (n = 20). Upper gastrointestinal mucosal injury was evaluated after 7 days of treatment with TN-EGD.

RESULTS:

The rate of gastric ulcers in subjects receiving paracetamol (0/21, 0%) alone or aspirin (3/19, 16%) or both (2/20, 10%) was not different. There were, however, significantly more subjects with one or more lesions (erosion or ulcer) per subject in the paracetamol and aspirin (16/20, 80%) treated subjects as compared to the aspirin (8/19, 42%, P < 0.001) or the paracetamol (3/21, 14%, P < 0.01) exposed subjects. The mean number of lesions per subject was also greater (7.9 vs. 0.7, P < 0.01) in those treated with aspirin and paracetamol compared to paracetamol alone.

CONCLUSIONS:

Co-administration of paracetamol and aspirin was not associated with a significant difference in endoscopic ulcer rates compared to either drug alone. There was a strong signal for increased endoscopic erosions and ulcers in the combined group compared to either aspirin or paracetamol alone.

• Authors: J R Boike, R Kao, D Meyer, B Markle, J Rosenberg, J Niebruegge, A C Stein, J Berkes, J L Goldstein
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 36 Issue 4 Pg. 391-7 (Aug 2012) ISSN: 1365-2036 [Electronic] England
• PMID: 22742578 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 Blackwell Publishing Ltd.

Chemical References

• Analgesics, Non-Narcotic
• Anti-Inflammatory Agents, Non-Steroidal
• Drug Combinations
• Acetaminophen
• Aspirin

Topics

• Acetaminophen (adverse effects)
• Adolescent
• Adult
• Aged
• Analgesics, Non-Narcotic (adverse effects)
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects)
• Aspirin (adverse effects)
• Double-Blind Method
• Drug Combinations
• Drug Interactions
• Duodenal Ulcer (chemically induced)
• Female
• Humans
• Male
• Middle Aged
• Pilot Projects
• Prospective Studies
• Statistics as Topic
• Stomach Ulcer (chemically induced)
• Young Adult