Presentazione%20di%20PowerPoint

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Cardiovascular Events Associated with Rofecoxib
in a Colorectal Adenoma Chemoprevention Trial
Robert S. Bresalier, M.D., Robert S. Sandler,
M.D., Hui Quan, Ph.D., James A. Bolognese,
M.Stat., Bettina Oxenius, M.D., Kevin Horgan,
M.D., Christopher Lines, Ph.D., Robert Riddell,
M.D., Dion Morton, M.D., Angel Lanas, M.D.,
Marvin A. Konstam, M.D., John A. Baron, M.D. and
the Adenomatous Polyp Prevention on Vioxx
(APPROVe) Trial Investigators
N Engl J Med Volume 352111092-1102 March 17,
2005
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Study Overview

• In a clinical trial of chemoprevention for
  colorectal adenomas, the use of rofecoxib was
  found to be associated with a significantly
  increased risk of cardiovascular events,
  primarily myocardial infarctions and ischemic
  cerebrovascular events
• Although rofecoxib has been removed from the
  market by the manufacturer, these data need to be
  carefully considered in making decisions about
  any future use of rofecoxib

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Enrollment, Randomization, and Outcomes
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Baseline Characteristics of the Patients
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Incidence of Adjudicated Thrombotic Adverse Events
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Kaplan-Meier Estimates of the Cumulative
Incidence of Confirmed Serious Thrombotic Events
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Summary of Rates and Relative Risks of Confirmed
Serious Thrombotic Events and the APTC End Point
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Kaplan-Meier Estimates of the Cumulative
Incidence of Investigator-Reported Congestive
Heart Failure (CHF), Pulmonary Edema (PE), or
Cardiac Failure (CF)
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Incidence of Nonadjudicated Cardiovascular
Adverse Events
Bresalier, R. et al. N Engl J Med
20053521092-1102
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Conclusions

• Among patients with a history of colorectal
  adenomas, the use of rofecoxib was associated
  with an increased cardiovascular risk