@article {van Adelsberg:September 2007:0300-7995:2063,
	author = "van Adelsberg, Janet",
	author = "Gann, Peter",
	author = "Ko, Amy T.",
	author = "Damber, Jan-Erik",
	author = "Logothetis, Christopher",
	author = "Marberger, Michael",
	author = "Schmitz-Drager, Bernd J.",
	author = "Tubaro, Andrea",
	author = "Roehrborn, Celiaus",
	title = "The VIOXX in prostate cancer prevention study: cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups",
	journal = "Current Medical Research and Opinion",
	volume = "23",
	year = "September 2007",
	abstract = "<I>Background:</I> A double-blind, randomized, placebo-controlled study was designed to determine the cumulative incidence of developing prostate cancer over 6 years of treatment with rofecoxib 25 mg/day versus placebo. Before completion, this trial was terminated following the voluntary withdrawal of rofecoxib. (On September 30, 2004, Merck &#38; Co., Inc. announced the voluntary worldwide withdrawal of rofecoxib from the market.) Here we report the cardiovascular (CV) safety data collected from this study.<P></P><I>Methods:</I> A total of 4741 men (44-81 years old) exhibiting prostate-specific antigen levels (PSA) between 2.5 and 10 ng/mL were enrolled. Patients were stratified by PSA level and use of low-dose aspirin (LDA), then randomized to rofecoxib 25 mg (<I>n</I> = 2369) or placebo (<I>n</I> = 2372). Safety data were analyzed in all patients receiving &#8805;1 dose of study medication. All reported thrombotic CV events occurring on-treatment or within 14 days after study drug discontinuation were adjudicated by an independent panel of clinical experts blinded to treatment assignment. Rates per 100 patient-years and relative risk (RR) of thrombotic CV events, rofecoxib vs. placebo, were determined.<P></P><I>Results:</I> Approximately 36% of patients had &#8805;2 CV risk factors or LDA indicated. Median treatment duration was 4.14 (range: 0.03-15.90) months. Twenty-nine patients (14 rofecoxib, rate 1.27; 15 placebo, rate 1.36) experienced confirmed thrombotic CV events; RR 0.94 (95% CI: 0.45, 1.94) vs. placebo. Four patients (one rofecoxib; three placebo) died due to a confirmed thrombotic event. Significantly (<I>p</I> = 0.002) more patients receiving rofecoxib (<I>n</I> = 20; 0.8%) experienced hypertension-related adverse events versus placebo (<I>n</I> = 2; 0.1%). There were no cases of congestive heart failure.<P></P><I>Conclusions:</I> Rofecoxib 25 mg and placebo demonstrated similar risk of thrombotic CV events in this limited dataset.",
	pages = "2063-2070(8)",
	url = "http://www.ingentaconnect.com/content/apl/cmro/2007/00000023/00000009/art00004"
	doi = "doi:10.1185/030079907X219526"
}