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Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis.
BMJ. 2005 Dec 03; 331(7528):1310-6.BMJ

Abstract

OBJECTIVE

To determine the risk of an adverse upper gastrointestinal event in patients taking different cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs.

DESIGN

Nested case-control study.

SETTING

367 general practices contributing to the UK QRESEARCH database, spread throughout every strategic health authority and each health board in England, Wales, and Scotland.

PARTICIPANTS

Patients aged 25 or more with a first ever diagnosis of an adverse upper gastrointestinal event (peptic ulcer or haematemesis) between 1 August 2000 and 31 July 2004 and up to 10 controls per case matched for age, sex, calendar time, and practice.

MAIN OUTCOME MEASURES

Unadjusted and adjusted odds ratios for adverse upper gastrointestinal events associated with celecoxib, rofecoxib, ibuprofen, diclofenac, naproxen, other selective and non-selective non-steroidal anti-inflammatory drugs, and aspirin.

RESULTS

The incidence of adverse upper gastrointestinal events was 1.36 per 1000 person years (95% confidence interval 1.34 to 1.39). We identified 9407 incident cases and 88 867 matched controls. Increased risks of adverse gastrointestinal events were associated with current use of cyclo-oxygenase-2 inhibitors and with conventional non-steroidal anti-inflammatory drugs. Risks were reduced after adjustment for confounders but remained significantly increased for naproxen (adjusted odds ratio 2.12, 95% confidence interval 1.73 to 2.58), diclofenac (1.96, 1.78 to 2.15), and rofecoxib (1.56, 1.30 to 1.87) but not for current use of celecoxib (1.11, 0.87 to 1.41). We found clinically important interactions with current use of ulcer healing drugs that removed the increased risks for adverse gastrointestinal events for all groups of non-steroidal anti-inflammatory drugs except diclofenac, which still had an increased odds ratio (1.49, 1.26 to 1.76).

CONCLUSION

No consistent evidence was found of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs. The use of ulcer healing drugs reduced the increased risk of adverse gastrointestinal outcomes with all groups of non-steroidal anti-inflammatory drugs, but for diclofenac the increased risk remained significant.

Authors+Show Affiliations

Division of Primary Care, University of Nottingham, Nottingham NG2 7RD. julia.hippisley-cox@nottingham.ac.ukNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

16322018

Citation

Hippisley-Cox, Julia, et al. "Risk of Adverse Gastrointestinal Outcomes in Patients Taking Cyclo-oxygenase-2 Inhibitors or Conventional Non-steroidal Anti-inflammatory Drugs: Population Based Nested Case-control Analysis." BMJ (Clinical Research Ed.), vol. 331, no. 7528, 2005, pp. 1310-6.
Hippisley-Cox J, Coupland C, Logan R. Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ. 2005;331(7528):1310-6.
Hippisley-Cox, J., Coupland, C., & Logan, R. (2005). Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ (Clinical Research Ed.), 331(7528), 1310-6.
Hippisley-Cox J, Coupland C, Logan R. Risk of Adverse Gastrointestinal Outcomes in Patients Taking Cyclo-oxygenase-2 Inhibitors or Conventional Non-steroidal Anti-inflammatory Drugs: Population Based Nested Case-control Analysis. BMJ. 2005 Dec 3;331(7528):1310-6. PubMed PMID: 16322018.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of adverse gastrointestinal outcomes in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. AU - Hippisley-Cox,Julia, AU - Coupland,Carol, AU - Logan,Richard, PY - 2005/12/3/pubmed PY - 2005/12/20/medline PY - 2005/12/3/entrez SP - 1310 EP - 6 JF - BMJ (Clinical research ed.) JO - BMJ VL - 331 IS - 7528 N2 - OBJECTIVE: To determine the risk of an adverse upper gastrointestinal event in patients taking different cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs. DESIGN: Nested case-control study. SETTING: 367 general practices contributing to the UK QRESEARCH database, spread throughout every strategic health authority and each health board in England, Wales, and Scotland. PARTICIPANTS: Patients aged 25 or more with a first ever diagnosis of an adverse upper gastrointestinal event (peptic ulcer or haematemesis) between 1 August 2000 and 31 July 2004 and up to 10 controls per case matched for age, sex, calendar time, and practice. MAIN OUTCOME MEASURES: Unadjusted and adjusted odds ratios for adverse upper gastrointestinal events associated with celecoxib, rofecoxib, ibuprofen, diclofenac, naproxen, other selective and non-selective non-steroidal anti-inflammatory drugs, and aspirin. RESULTS: The incidence of adverse upper gastrointestinal events was 1.36 per 1000 person years (95% confidence interval 1.34 to 1.39). We identified 9407 incident cases and 88 867 matched controls. Increased risks of adverse gastrointestinal events were associated with current use of cyclo-oxygenase-2 inhibitors and with conventional non-steroidal anti-inflammatory drugs. Risks were reduced after adjustment for confounders but remained significantly increased for naproxen (adjusted odds ratio 2.12, 95% confidence interval 1.73 to 2.58), diclofenac (1.96, 1.78 to 2.15), and rofecoxib (1.56, 1.30 to 1.87) but not for current use of celecoxib (1.11, 0.87 to 1.41). We found clinically important interactions with current use of ulcer healing drugs that removed the increased risks for adverse gastrointestinal events for all groups of non-steroidal anti-inflammatory drugs except diclofenac, which still had an increased odds ratio (1.49, 1.26 to 1.76). CONCLUSION: No consistent evidence was found of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 inhibitors compared with non-selective non-steroidal anti-inflammatory drugs. The use of ulcer healing drugs reduced the increased risk of adverse gastrointestinal outcomes with all groups of non-steroidal anti-inflammatory drugs, but for diclofenac the increased risk remained significant. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/16322018/Risk_of_adverse_gastrointestinal_outcomes_in_patients_taking_cyclo_oxygenase_2_inhibitors_or_conventional_non_steroidal_anti_inflammatory_drugs:_population_based_nested_case_control_analysis_ L2 - https://www.bmj.com/lookup/pmidlookup?view=long&pmid=16322018 DB - PRIME DP - Unbound Medicine ER -