Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2063-2070 |
| Number of pages | 8 |
| Journal | Current Medical Research and Opinion |
| Volume | 23 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 2007 |
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Keywords
- Cardiovascular
- Prostate cancer
- Rofecoxib
- Safety
ASJC Scopus subject areas
- Medicine(all)
Cite this
The VIOXX in prostate cancer prevention study : Cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. / Van Adelsberg, Janet; Gann, Peter; Ko, Amy T.; Damber, Jan Erik; Logothetis, Christopher; Marberger, Michael; Schmitz-Drager, Bernd J.; Tubaro, Andrea; Harms, Celia J.; Roehrborn, Claus.
In: Current Medical Research and Opinion, Vol. 23, No. 9, 09.2007, p. 2063-2070.Research output: Contribution to journal › Article
}
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
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
VL - 23
SP - 2063
EP - 2070
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
SN - 0300-7995
IS - 9
ER -