The VIOXX in prostate cancer prevention study: Cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups

Janet Van Adelsberg, Peter Gann, Amy T. Ko, Jan Erik Damber, Christopher Logothetis, Michael Marberger, Bernd J. Schmitz-Drager, Andrea Tubaro, Celia J. Harms, Claus Roehrborn

Research output: Contribution to journalArticle

20 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)2063-2070
Number of pages8
JournalCurrent Medical Research and Opinion
Volume23
Issue number9
DOIs
StatePublished - Sep 2007

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Prostatic Neoplasms
Placebos
Therapeutics
Prostate-Specific Antigen
Aspirin
Product Recalls and Withdrawals
Safety
rofecoxib
Heart Failure
Hypertension
Incidence
Pharmaceutical Preparations

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 journalArticle

Van Adelsberg, J, Gann, P, Ko, AT, Damber, JE, Logothetis, C, Marberger, M, Schmitz-Drager, BJ, Tubaro, A, Harms, CJ & Roehrborn, C 2007, 'The VIOXX in prostate cancer prevention study: Cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups', Current Medical Research and Opinion, vol. 23, no. 9, pp. 2063-2070. https://doi.org/10.1185/030079907X219526
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. / The VIOXX in prostate cancer prevention study : Cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. In: Current Medical Research and Opinion. 2007 ; Vol. 23, No. 9. pp. 2063-2070.
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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.",
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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

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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.

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