Document Detail

Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis.
MedLine Citation:
PMID:  12501222     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Current guidelines recommend that patients at risk for ulcer disease who require treatment for arthritis receive nonsteroidal antiinflammatory drugs (NSAIDs) that are selective for cyclooxygenase-2 or the combination of a nonselective NSAID with a proton-pump inhibitor. We assessed whether celecoxib would be similar to diclofenac plus omeprazole in reducing the risk of recurrent ulcer bleeding in patients at high risk for bleeding. METHODS: We studied patients who used NSAIDs for arthritis and who presented with ulcer bleeding. After their ulcers had healed, we randomly assigned patients who were negative for Helicobacter pylori to receive either 200 mg of celecoxib twice daily plus daily placebo or 75 mg of diclofenac twice daily plus 20 mg of omeprazole daily for six months. The end point was recurrent ulcer bleeding. RESULTS: In the intention-to-treat analysis, which included 287 patients (144 receiving celecoxib and 143 receiving diclofenac plus omeprazole), recurrent ulcer bleeding occurred in 7 patients receiving celecoxib and 9 receiving diclofenac plus omeprazole. The probability of recurrent bleeding during the six-month period was 4.9 percent (95 percent confidence interval, 3.1 to 6.7) for patients who received celecoxib and 6.4 percent (95 percent confidence interval, 4.3 to 8.4) for patients who received diclofenac plus omeprazole (difference, -1.5 percentage points; 95 percent confidence interval for the difference, -6.8 to 3.8). Renal adverse events, including hypertension, peripheral edema, and renal failure, occurred in 24.3 percent of the patients receiving celecoxib and 30.8 percent of those receiving diclofenac plus omeprazole. CONCLUSIONS: Among patients with a recent history of ulcer bleeding, treatment with celecoxib was as effective as treatment with diclofenac plus omeprazole, with respect to the prevention of recurrent bleeding. Renal toxic effects are common in high-risk patients receiving celecoxib or diclofenac plus omeprazole.
Francis K L Chan; Lawrence C T Hung; Bing Y Suen; Justin C Y Wu; Kenneth C Lee; Vincent K S Leung; Aric J Hui; Ka F To; Wai K Leung; Vincent W S Wong; S C Sydney Chung; Joseph J Y Sung
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  347     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2002 Dec 
Date Detail:
Created Date:  2002-12-26     Completed Date:  2003-01-02     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2104-10     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2002 Massachusetts Medical Society
Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects,  therapeutic use*
Anti-Ulcer Agents / therapeutic use
Arthritis / drug therapy*
Cyclooxygenase 2
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors / adverse effects,  therapeutic use*
Diclofenac / adverse effects,  therapeutic use
Double-Blind Method
Drug Therapy, Combination
Duodenal Ulcer / chemically induced,  prevention & control
Helicobacter pylori / isolation & purification
Isoenzymes / antagonists & inhibitors
Membrane Proteins
Omeprazole / therapeutic use
Peptic Ulcer Hemorrhage / chemically induced,  prevention & control*
Prospective Studies
Prostaglandin-Endoperoxide Synthases
Recurrence / prevention & control
Risk Factors
Stomach Ulcer / chemically induced,  prevention & control
Sulfonamides / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Anti-Ulcer Agents; 0/Cyclooxygenase 2 Inhibitors; 0/Cyclooxygenase Inhibitors; 0/Isoenzymes; 0/Membrane Proteins; 0/Pyrazoles; 0/Sulfonamides; 15307-86-5/Diclofenac; 169590-42-5/celecoxib; 73590-58-6/Omeprazole; EC 2; EC protein, human; EC Synthases
Comment In:
J Fam Pract. 2003 May;52(5):363-4   [PMID:  12737768 ]
N Engl J Med. 2003 Jun 12;348(24):2464-6; author reply 2464-6   [PMID:  12803213 ]
ACP J Club. 2003 Jul-Aug;139(1):12   [PMID:  12841716 ]
Z Gastroenterol. 2003 Aug;41(8):883-4   [PMID:  12910429 ]
N Engl J Med. 2002 Dec 26;347(26):2162-4   [PMID:  12501230 ]
N Engl J Med. 2003 Jun 12;348(24):2464-6; author reply 2464-6   [PMID:  12802035 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Influenza-related hospitalizations among children in Hong Kong.
Next Document:  Natural history of alkaptonuria.