TY - JOUR
T1 - The VIOXX in prostate cancer prevention study
T2 - Cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups
AU - Van Adelsberg, Janet
AU - Gann, Peter
AU - Ko, Amy T.
AU - Damber, Jan Erik
AU - Logothetis, Christopher
AU - Marberger, Michael
AU - Schmitz-Drager, Bernd J.
AU - Tubaro, Andrea
AU - Harms, Celia J.
AU - Roehrborn, Claus
N1 - Funding Information:
report having received consultant and/or lecture fees from Merck. AT, BS-D, and CL have received grant support from Merck. AL, JVA, ATK, CJH, and MEJ are employees of Merck and own stock and/or hold stock options in the company. Dr Antonio Lombardi and Mary E. Jones (Merck Research Laboratories) were also contributing authors of this manuscript. The authors thank Dr Paul Cavanaugh (formerly of Merck Research Laboratories) for assistance with preparation of this manuscript.
PY - 2007/9
Y1 - 2007/9
N2 - Background: 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 & Co., Inc. announced the voluntary worldwide withdrawal of rofecoxib from the market.) Here we report the cardiovascular (CV) safety data collected from this study. Methods. 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 (n = 2369) or placebo (n = 2372). Safety data were analyzed in all patients receiving ≥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. Results: Approximately 36% of patients had ≥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 (p = 0.002) more patients receiving rofecoxib (n = 20; 0.8%) experienced hypertension-related adverse events versus placebo (n = 2; 0.1%). There were no cases of congestive heart failure. Conclusions: Rofecoxib 25 mg and placebo demonstrated similar risk of thrombotic CV events in this limited dataset.
AB - Background: 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 & Co., Inc. announced the voluntary worldwide withdrawal of rofecoxib from the market.) Here we report the cardiovascular (CV) safety data collected from this study. Methods. 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 (n = 2369) or placebo (n = 2372). Safety data were analyzed in all patients receiving ≥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. Results: Approximately 36% of patients had ≥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 (p = 0.002) more patients receiving rofecoxib (n = 20; 0.8%) experienced hypertension-related adverse events versus placebo (n = 2; 0.1%). There were no cases of congestive heart failure. Conclusions: Rofecoxib 25 mg and placebo demonstrated similar risk of thrombotic CV events in this limited dataset.
KW - Cardiovascular
KW - Prostate cancer
KW - Rofecoxib
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=36048954173&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36048954173&partnerID=8YFLogxK
U2 - 10.1185/030079907X219526
DO - 10.1185/030079907X219526
M3 - Article
C2 - 17651539
AN - SCOPUS:36048954173
SN - 0300-7995
VL - 23
SP - 2063
EP - 2070
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 9
ER -