Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.

@article{Bresalier2005CardiovascularEA,
  title={Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.},
  author={Robert S. Bresalier and Robert S. Sandler and Hui Quan and James A. Bolognese and Bettina Oxenius and Kevin J. Horgan and Christopher R. Lines and Robert H Riddell and Dion G. Morton and {\'A}ngel Lanas and Marvin A. Konstam and John A. Baron},
  journal={The New England journal of medicine},
  year={2005},
  volume={352 11},
  pages={
          1092-102
        }
}
BACKGROUND Selective inhibition of cyclooxygenase-2 (COX-2) may be associated with an increased risk of thrombotic events, but only limited long-term data have been available for analysis. We report on the cardiovascular outcomes associated with the use of the selective COX-2 inhibitor rofecoxib in a long-term, multicenter, randomized, placebo-controlled, double-blind trial designed to determine the effect of three years of treatment with rofecoxib on the risk of recurrent neoplastic polyps of… 

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    The Annals of pharmacotherapy
  • 2005
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...

References

SHOWING 1-10 OF 33 REFERENCES

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

TLDR
Celecoxib use was associated with a dose-related increase in the composite end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure, providing further evidence that the use of COX-2 inhibitors may increase the risk of serious cardiovascular events.

Patients Exposed to Rofecoxib and Celecoxib Have Different Odds of Nonfatal Myocardial Infarction

TLDR
A casecontrol study from 36 hospitals in a 5-county area found that reported recent use of a COX-2 selective inhibitor was similar among adults with a first, nonfatal myocardial infarction (MI) and randomly selected community controls with no history of MI, however, reported use of rofecoxib was associated with a higher odds of MI than was use of celecoxib.

The risk of cardiovascular thrombotic events with selective cyclooxygenase-2 inhibitors.

TLDR
Two large outcome trials were designed to demonstrate GI safety superior to that of traditional NSAIDs, as used in regular clinical practice, assessed by “clinically meaningful” upper GI events, at twice recommended clinical doses for long-term use.

Relationship Between Selective Cyclooxygenase-2 Inhibitors and Acute Myocardial Infarction in Older Adults

TLDR
Current rofecoxib use was associated with an elevated relative risk of AMI compared with celecoxib use and no NSAID use, and Dosages of rofECoxib >25 mg were associated with a higher risk than dosages ≤25 mg, which was elevated in the first 90 days of use but not thereafter.

Cyclooxygenase-2–Specific Inhibitors and Cardiorenal Function: A Randomized, Controlled Trial of Celecoxib and Rofecoxib in Older Hypertensive Osteoarthritis Patients

TLDR
Patients taking antihypertensive therapy and receiving cyclooxygenase-2–specific inhibitors should be monitored for the development of cardiorenal events.

Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis

TLDR
In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.

Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly.

TLDR
The findings of this observational study suggest no increase in the short-term risk of AMI among users of selective cyclooxygenase 2 inhibitors as commonly used in clinical practice and do not support a short- term reduced risk ofAMI with naproxen.