Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules

Alimentary Pharmacology and Therapeutics

Volumn 35, Issue 7, 2012, Pages 819-827

  Hawkey, C ^a   Burnett, I ^b   Gold, M S ^c   Garsed, K ^a   Stevenson, D ^a   Mannath, J ^a   Norman, A ^a   Shepherd, V ^a   Subramanian, V ^a   Johnston, R D ^a   Brown, M ^a  

^a NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^b Department of Toxicology   (Switzerland)

^c Novartis Consumer Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; DICLOFENAC; IBUPROFEN; PROSTAGLANDIN; UNCLASSIFIED DRUG; VOLTAREN DOLO FORTE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL EVALUATION; CONTROLLED STUDY; DRUG CAPSULE; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG LIQUID CAPSULE; DRUG SAFETY; DRUG TOLERANCE; DRUG WITHDRAWAL; EPIGASTRIC PAIN; FEMALE; GASTRODUODENUM DISEASE; GASTROINTESTINAL DISEASE; GASTROINTESTINAL ENDOSCOPY; GASTROINTESTINAL TRACT; HUMAN; HUMAN EXPERIMENT; LIP DISEASE; LIP SWELLING; MALE; NORMAL HUMAN; PRIORITY JOURNAL; PROSTAGLANDIN SYNTHESIS; SIDE EFFECT; STOMACH MUCOSA; STOMACH ULCER; TABLET FORMULATION; TINNITUS;

ADOLESCENT; ADULT; ANALGESICS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ASPIRIN; CAPSULES; DICLOFENAC; DRUG TOLERANCE; DUODENUM; ENDOSCOPY, GASTROINTESTINAL; FEMALE; GASTRIC MUCOSA; HUMANS; IBUPROFEN; MALE; PAIN MEASUREMENT; TABLETS; TIME FACTORS; YOUNG ADULT;

EID: 84863393555     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2012.05030.x     Document Type: Article

References (21)

1. Wegman A, van der Windt D, van Tulder M, Stalman W, de Vries T,. Nonsteroidal anti-inflammatory drugs or acetaminophen for osteoarthritis of the hip or knee? A systematic review of evidence and guidelines. J Rheumatol 2004; 31: 344-54. (Pubitemid 38160758)
2. Doherty M, Hawkey C, Goulder M, et al,. A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain. Ann Rheum Dis 2011; 70: 1534-41.
3. Malfertheiner P, Chan F, McColl K,. Peptic ulcer disease. Lancet 2009; 374: 1449-61.
4. Hawkey C, Langman M,. Non-steroidal anti-inflammatory drugs: overall risks and management. Complementary roles for COX-2 inhibitors and proton pump inhibitors. Gut 2003; 52: 600-8. (Pubitemid 36363420)
5. Lanas A,. A review of the gastrointestinal safety data-a gastroenterologist's perspective. Rheumatology 2010; 49: 3-10.
6. Henry D, Lim L, Garcia Rodriguez L, et al,. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis. BMJ 1996; 312: 1563-6. (Pubitemid 26188573)
7. Hawkey C, Weinstein W, Smalley W, et al,. Effect of risk factors on complicated and uncomplicated ulcers in the TARGET lumiracoxib outcomes study. Gastroenterol 2007; 133: 57-64. (Pubitemid 47031133)
8. Moore N,. Ibuprofen: a journey from prescription to over-the-counter use. JRSM 2007; 100: 2-6. (Pubitemid 351204439)
9. Hawkey C, Weinstein W, Stricker K, et al,. Clinical trial: comparison of the gastrointestinal safety of lumiracoxib with traditional nonselective nonsteroidal anti-inflammatory drugs early after the initiation of treatment-findings from the Therapeutic Arthritis Research and Gastrointestinal Event Trial. Aliment Pharmacol Ther 2008; 27: 838-45. (Pubitemid 351490064)
10. Moore N,. Diclofenac potassium 12.5 mg tablets for mild to moderate pain and fever. A review of its pharmacology, clinical efficacy and safety. Clin Drug Invest 2007; 27: 163-95. (Pubitemid 46440303)
11. Hinz B, Hug AM, Fotopoulos G, Gold M,. Bioequivalence study of low-dose diclofenac potassium tablet formulations. Int J Clin Pharmacol Therapeut 2009; 47: 643-8.
12. Armogida M, Gold M,. Diclofenac potassium 25 mg liquid capsules: earlier and higher exposure to diclofenac. A fasted, single-dose, comparative bioavailability study versus diclofenac potassium 2 × 12.5 mg tablets. Int J Clin Pharmacol Therapeut 2012; in press.
13. Lanza F,. Endoscopic studies of gastric and duodenal injury after the use of ibuprofen, aspirin, and other nonsteroidal anti-inflammatory agents. Am J Med 1984; 77: 19-24. (Pubitemid 14057067)
14. Hawkey C, Hawthorne A, Hudson N, Cole A, Mahida Y, Daneshmend T,. Separation of aspirin's impairment of haemostasis from mucosal injury in the human stomach. Clin Sci 1991; 81: 565-73.
15. Wight N, Gottesdiener N, Garlick N, et al,. Rofecoxib, a COX-2 inhibitor, does not inhibit human gastric mucosal prostaglandin production. Gastroenterol 2001; 120: 867-73. (Pubitemid 32193184)
16. Atherton C, Jones J, McKaig B,. Pharmacology and gastrointestinal safety of lumiracoxib, a novel cyclooxygenase-2 selective inhibitor: an integrated study. Clin Gastroenterol Hepatol 2004; 2: 113-20. (Pubitemid 38180464)
17. Hull M, Knifton A, Filipowicz B, Brough J, Vautier G, Hawkey C,. Healing with basic fibroblast growth factor is associated with reduced indomethacin induced relapse in a human model of gastric ulceration. Gut 1997; 40: 204-10. (Pubitemid 27093094)
18. Hawkey C, Jones J, Atherton C, et al,. Gastrointestinal safety of AZD3582, a cyclooxygenase inhibiting nitric oxide donator: proof of concept study in humans. Gut 2003; 52: 1537-42. (Pubitemid 37363434)
19. Yeomans N, Naesdal J,. Systematic review: ulcer definition in NSAID ulcer prevention trials. Aliment Pharmacol Ther 2008; 27: 465-72. (Pubitemid 351300861)
20. Simbec Research. Validated assay methods for diclofenac, salicylate and ibuprofen. Data on file, Simbec Research, 2010.
21. Lanza F,. An endoscopic comparison of GD injury with over-the-counter doses of ketoprofen and acetaminophen. Am J Gastroenterol 1998; 93: 1051-4. (Pubitemid 29080948)