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Cardiovascular Safe...
Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer : The Primary Results of the PRONOUNCE Randomized Trial
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- Lopes, Renato D. (author)
- Duke Clinical Research Institute (DCRI)
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- Higano, Celestia S. (author)
- Fred Hutchinson Cancer Research Center
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- Slovin, Susan F. (author)
- Memorial Sloan-Kettering Cancer Center
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- Nelson, Adam J. (author)
- Duke Clinical Research Institute (DCRI)
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Bigelow, Robert (author)
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- Sørensen, Per S. (author)
- Ferring Pharmaceuticals AS
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- Melloni, Chiara (author)
- Duke Clinical Research Institute (DCRI)
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- Goodman, Shaun G. (author)
- Saint Michael's Hospital
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- Evans, Christopher P. (author)
- University of California, Davis
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- Nilsson, Jan (author)
- Lund University,Lunds universitet,Kirurgi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lever-, pankreas- och gallvägskirurgi,Forskargrupper vid Lunds universitet,Surgery (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Hepato-Pancreato-Biliary Surgery,Lund University Research Groups
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- Bhatt, Deepak L. (author)
- Harvard Medical School
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- Clarke, Noel W. (author)
- Salford Royal NHS FoundationTrust
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- Olesen, Tine K. (author)
- Ferring Pharmaceuticals AS
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- Doyle-Olsen, Belinda T. (author)
- Ferring Pharmaceuticals AS
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- Kristensen, Henriette (author)
- Ferring Pharmaceuticals AS
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- Arney, Lauren (author)
- Duke Clinical Research Institute (DCRI)
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- Roe, Matthew T. (author)
- Duke Clinical Research Institute (DCRI)
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- Alexander, John H. (author)
- Duke Clinical Research Institute (DCRI)
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(creator_code:org_t)
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- 2021
- 2021
- English 13 s.
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In: Circulation. - 1524-4539. ; 144:16, s. 1295-1307
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http://dx.doi.org/10... (free)
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Abstract
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- BACKGROUND: The relative cardiovascular safety of gonadotropin-releasing hormone (GnRH) antagonists compared with GnRH agonists in men with prostate cancer and known atherosclerotic cardiovascular disease remains controversial. METHODS: In this international, multicenter, prospective, randomized, open-label trial, men with prostate cancer and concomitant atherosclerotic cardiovascular disease were randomly assigned 1:1 to receive the GnRH antagonist degarelix or the GnRH agonist leuprolide for 12 months. The primary outcome was the time to first adjudicated major adverse cardiovascular event (composite of death, myocardial infarction, or stroke) through 12 months. RESULTS: Because of slower-than-projected enrollment and fewer-than-projected primary outcome events, enrollment was stopped before the 900 planned participants were accrued. From May 3, 2016, to April 16, 2020, a total of 545 patients from 113 sites across 12 countries were randomly selected. Baseline characteristics were balanced between study groups. The median age was 73 years, 49.8% had localized prostate cancer; 26.3% had locally advanced disease, and 20.4% had metastatic disease. A major adverse cardiovascular event occurred in 15 (5.5%) patients assigned to degarelix and 11 (4.1%) patients assigned to leuprolide (hazard ratio, 1.28 [95% CI, 0.59-2.79]; P=0.53). CONCLUSIONS: PRONOUNCE (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease) is the first, international, randomized clinical trial to prospectively compare the cardiovascular safety of a GnRH antagonist and a GnRH agonist in patients with prostate cancer. The study was terminated prematurely because of the smaller than planned number of participants and events, and no difference in major adverse cardiovascular events at 1 year between patients assigned to degarelix or leuprolide was observed. The relative cardiovascular safety of GnRH antagonists and agonists remains unresolved. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02663908.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- agonists
- atherosclerosis
- cardiotoxicity
- drug therapy
- gonadotropin-releasing hormone
- prostatic neoplasms
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Lopes, Renato D.
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Higano, Celestia ...
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Slovin, Susan F.
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Nelson, Adam J.
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Bigelow, Robert
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Sørensen, Per S.
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show more...
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Melloni, Chiara
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Goodman, Shaun G ...
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Evans, Christoph ...
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Nilsson, Jan
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Bhatt, Deepak L.
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Clarke, Noel W.
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Olesen, Tine K.
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Doyle-Olsen, Bel ...
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Kristensen, Henr ...
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Arney, Lauren
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Roe, Matthew T.
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Alexander, John ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Circulation
- By the university
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Lund University