NSAID MUCOSAL INJURY
Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules
Version of Record online: 28 FEB 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 7, pages 819–827, April 2012
How to Cite
Hawkey, C., Burnett, I., Gold, M. S., Garsed, K., Stevenson, D., Mannath, J., Norman, A., Shepherd, V., Subramanian, V., Johnston, R. D. and Brown, M. (2012), Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules. Alimentary Pharmacology & Therapeutics, 35: 819–827. doi: 10.1111/j.1365-2036.2012.05030.x
- Issue online: 8 MAR 2012
- Version of Record online: 28 FEB 2012
- Manuscript Revised: 26 JAN 2012
- Manuscript Accepted: 26 JAN 2012
- Manuscript Revised: 25 DEC 2011
- Manuscript Received: 20 DEC 2011
Diclofenac-potassium (diclofenac--K) 25 mg liquid capsule is absorbed more quickly than the tablet formulation. It offers potential for rapid pain relief, but may alter gastro-duodenal tolerability.
To evaluate the gastro-duodenal tolerance of diclofenac-K 25 mg liquid capsules vs. diclofenac-K 12.5 mg tablets, acetylsalicylic acid (ASA) 500 mg tablets and ibuprofen 200 mg liquid capsules.
In an endoscopist-blinded, randomised, parallel-group study, volunteers received 15 doses of diclofenac-K 25 mg liquid capsules (n = 36), diclofenac-K 2 × 12.5 mg tablets (n = 36), ibuprofen 2 × 200 mg liquid capsules (n = 24) or ASA 2 × 500 mg tablets (n = 36) over 5 days. The primary outcome was the incidence of erosive gastro-duodenal lesions at Day 6. Secondary outcomes included modified Lanza score and change in gastric mucosal prostaglandin synthesis.
The lowest incidence of erosive gastro-duodenal lesions was with diclofenac-K liquid capsules (53%), compared to 61% with diclofenac-K tablets (P = 0.52), 75% with ibuprofen (P = 0.08) and 94% with ASA (P = 0.001). Results were similar for the Lanza scores, although diclofenac-K liquid capsules were significantly superior to ibuprofen liquid capsules (P = 0.04). Diclofenac-K liquid capsules inhibited prostaglandin synthesis by 52% compared to 64% for diclofenac-K tablets (P = 0.10), 50% for ibuprofen (P = 0.85) and 79% for ASA (P = 0.002). With respect to safety, adverse events were most frequent in the ASA group, predominantly gastrointestinal events.
Mucosal injury with diclofenac-K liquid 25 mg liquid capsules was similar to diclofenac-K 25 mg tablets, significantly lower than ASA 1 g tablets and showed some superiority over ibuprofen 400 mg liquid capsules (EudraCT Number 2009-011278-14).