Cardiovascular Risk Associated With Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention

Solomon, Scott D.; McMurray, JJ; Pfeffer, Marc A.

doi:10.1016/j.accreview.2005.05.024

Cited by 92 publications

(119 citation statements)

References 34 publications

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“…More recent information links long‐term use of celecoxib and short‐term use of parecoxib and valdecoxib (though non‐significantly for the latter two) with adverse cardiovascular events. 5 , 6 This is consistent with a class effect.…”

supporting

confidence: 82%

COX‐2 inhibitors: exemplars of the drug‐safety conundrum

Nelson

Tonkin

Cicuttini

et al. 2005

Medical Journal of Australia

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supporting

confidence: 82%

COX‐2 inhibitors: exemplars of the drug‐safety conundrum

Nelson

Tonkin

Cicuttini

et al. 2005

Medical Journal of Australia

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“…Subjects with only one prescription for the study NSAID were classified as non-exposed. This reference group was based on randomized studies [7][8][9] which provided evidence that the receipt of only one prescription does not increase the risk of AMI. A major difference between our observational studies and those previously published is that, predicated on the results of the clinical trials, we elected to evaluate duration of use for each NSAID as the primary exposure variable rather than currency of use which was used in other studies.…”

Section: Discussionmentioning

confidence: 99%

Diclofenac and acute myocardial infarction in patients with no major risk factors

Jick

Kaye

Jick

2007

Brit J Clinical Pharma

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What is already known about this subject • We recently published the results of a study on the risk of acute myocardial infarction (AMI) AimsTo explore further a recent finding that long-term users of diclofenac are at increased risk of acute myocardial infarction (AMI) similar to users of rofecoxib and celecoxib. MethodsUsing the General Practice Research Database, we conducted three separate nested case-control studies of three nonsteroidal anti-inflammatory drugs (NSAIDs) where use started after 1 January 1993 -diclofenac, ibuprofen and naproxen. Cases of AMI were identified between 1 January 1993 and 31 December 2000. Relative risk (RR) estimates for AMI in patients with no major clinical risk factors were determined for each NSAID according to number of prescriptions received compared with one prescription. Results were adjusted for variables possibly related to risk of AMI. ResultsThere was no material elevation of AMI risk according to the number of prescriptions for ibuprofen [RRs and 95% confidence intervals (CIs) 1.0 (0.6, 1.6) and 1.7 (0.9, 3.1) for use of 10-19 and 20+ prescriptions, respectively, compared with one prescription] or naproxen [RRs 1.0 (0.5, 2.2) and 2.0 (0.9, 4.5) for use of 10-19 and 20+ prescriptions, respectively]. However, a substantial increased risk similar to that obtained in our prior study was found in patients who received Ն10 prescriptions for diclofenac [RRs 1.9 (1.3, 2.7) and 2.0 (1.3, 3.0) for use of 10-19 and 20+ prescriptions, respectively]. ConclusionsExtensive use of diclofenac substantially increases the risk of AMI. There is little suggestion of such an effect in users of ibuprofen and naproxen.

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“…There has been intense interest in the relationship between use of relatively selective inhibitors of cyclooxygenase-2 (COX-2) and vascular ischaemic events [1,2]. The increased risks seen in randomized placebo-controlled trials were associated mainly with high daily doses (25-50 mg of rofecoxib or 400-800 mg of celecoxib) [2][3][4]. Published pharmaco-epidemiological studies have documented the use of lower average doses in clinical practice [1,[5][6][7][8][9][10].…”

Section: Introductionmentioning

confidence: 99%

Cyclooxygenase‐2 inhibitors and coronary occlusion – exploring dose–response relationships

McGettigan

Han

Henry

2006

Brit J Clinical Pharma

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Aims To investigate the relationship between acute coronary syndrome (ACS) and ingested doses of selective cyclooxygenase‐2 (COX‐2) inhibitors and other nonsteroidal anti‐inflammatory drugs (NSAIDs). Methods Case–control study, commenced August 2003. Cases were patients admitted to hospital with ACS (myocardial infarction/unstable angina). Controls were hospital patients admitted for reasons other than acute vascular ischaemia or conditions that are believed to be complications of treatment with COX‐2 inhibitors or NSAIDs. Structured interviews were undertaken within 7 days of admission, collecting information on cardiovascular events and risk factors and all ingested drugs, including the doses of COX‐2 inhibitors and NSAID consumed in the previous week and month. Results An interim analysis of the data was conducted in late 2004 to inform a review of the COX‐2 inhibitors by the Australian drug regulatory agency. Between August 2003 and October 2004, we recruited 328 ACS cases and 478 controls. With non‐use of COX‐2 inhibitors or NSAIDs as the reference the adjusted odds ratios (OR) for ACS were: celecoxib 1.11 (95% confidence interval 0.59, 2.11), rofecoxib 0.63 (0.31, 1.28) and other NSAIDs 0.67 (0.41, 1.09). Among control subjects, median daily ingested doses of celecoxib and rofecoxib were 200 mg and 13.4 mg, respectively. Using these to stratify risk, adjusted ORs for ACS were: ‘low’ dose (< median) 0.44 (0.19, 1.03); ‘high’ dose (≥ median) 1.22 (0.67, 2.21). A test for interaction across doses was statistically significant, OR 2.8 (1.0, 7.7), suggesting that at low doses, COX‐2 inhibitors may be protective, becoming risk‐inducing only at higher doses. Conclusion The possibility that the gradient of cardiovascular risk with COX‐2 inhibitors runs from protective to risk‐inducing has biological plausibility and merits further investigation.

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Cardiovascular Risk Associated With Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention

Cited by 92 publications

References 34 publications

COX‐2 inhibitors: exemplars of the drug‐safety conundrum

COX‐2 inhibitors: exemplars of the drug‐safety conundrum

Diclofenac and acute myocardial infarction in patients with no major risk factors

Cyclooxygenase‐2 inhibitors and coronary occlusion – exploring dose–response relationships

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