APPROVe trial

2586 patients with colorectal adenomas rofecoxib 25 mg QD vs placebo Results: 1) after 3 years, thrombotic events (cardiac, cerebrovascular) higher in refecoxib group 3.6% vs 2.0% 2) increased risk apparent after 18 months of treatment

References

Journal Watch 25(6):45, 2005 Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102. Epub 2005 Feb 15. PMID: 15713943 http://content.nejm.org/cgi/reprint/NEJMoa050493.pdf