ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • Register
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: L08

Long Term Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Chronic Gout: The Febuxostat versus Allopurinol Streamlined Trial (on Behalf of the FAST Investigators)

Thomas MacDonald1, Isla Mackenzie1, George Nuki2 and Ian Ford3, 1University of Dundee, Dundee, Scotland, United Kingdom, 2University of Edinburgh, Edinburgh, Scotland, United Kingdom, 3University of Glasgow, Glasgow, Scotland, United Kingdom

Meeting: ACR Convergence 2020

Date of first publication: October 23, 2020

Keywords: Cardiovascular, Drug toxicity, gout, Late-Breaking 2020, Randomized Trial

  • Tweet
  • Email
  • Print
Save to PDF
Session Information

Date: Monday, November 9, 2020

Session Title: Late-Breaking Abstracts (L06–L11)

Session Type: Late-Breaking Abstract Session

Session Time: 11:30AM-1:00PM

Background/Purpose: Febuxostat and allopurinol are uric acid lowering agents. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency (EMA) recommended a post-authorization study comparing the cardiovascular (CV) safety of febuxostat versus allopurinol.

Methods: We did a prospective, randomized, open-label, blinded endpoint (PROBE) trial of febuxostat versus allopurinol in patients with chronic symptomatic hyperuricaemia (gout) in the UK, Denmark, and Sweden. Eligible patients were 60 years or older, were currently treated with allopurinol, and had at least one additional cardiovascular risk factor. After increasing allopurinol dose if necessary to achieve serum uric acid (SUA) levels < 0·357 mmol/L (< 6 mg/dL), patients were randomly assigned to continue allopurinol (at optimised dose) or start febuxostat at a dose of 80mg daily, increasing to 120mg, if necessary, to achieve serum uric acid level < 0·357 mmol/L. A short washout period (7-21 days) was included before randomized therapy was started. The primary outcome was the composite of hospitalisation for non-fatal myocardial infarction/biomarker positive acute coronary syndrome, non-fatal stroke or cardiovascular death. The hazard ratio (febuxostat versus allopurinol) in a Cox proportional hazards model was assessed for non-inferiority (limit of 1·3) in an on-treatment (OT) analysis and then by intention to treat (ITT). This study is registered with the EU Clinical Trials Register (EudraCT 2011-001883-23) and ISRCTN (ISRCTN72443728).

Results: 6128 patients (mean age 71, 85·3% male, 33·4% prior established CV disease) were randomised to receive allopurinol (n=3065) or febuxostat (n=3063) and were followed up for a median of 4 years during which 5·5% and 6·2% respectively withdrew from all follow up. In both the on-treatment and intention-to-treat analyses, febuxostat was non-inferior to allopurinol for incidence of the primary endpoint (OT analysis: febuxostat 172 patients [1·72 events per 100 patient years]; allopurinol 241 patients [2·05 events per 100 patient years]; hazard ratio 0·85 [95% CI 0·70-1·03], p< 0·001; ITT analysis: febuxostat 256 patients [2·05 events per 100 patient years], allopurinol 285 patients [2·29 events per 100 patient years]; hazard ratio 0·89 [95% CI 0·75-1·06], p< 0·001). 222 (7·2%) patients died in the febuxostat group compared to 263 deaths (8·6%) in the allopurinol group.

Conclusion: Febuxostat was non-inferior to allopurinol therapy for the primary cardiovascular outcome. Long-term use of febuxostat was not associated with an increased risk of death compared with allopurinol.

Funding: Menarini provided funding. The University of Dundee was the sponsor and Menarini had no involvement in the running of the study.


Disclosure: T. MacDonald, Pfizer, 2, GSK, 2, Amgen, 2, Menarini, 2, 8, Takeda, 8, Astellus, 8, Servier, 8, Shire, 8, AstraZeneca, 8; I. Mackenzie, Sanofi, 2, Menarini, 2, AstraZeneca, 5; G. Nuki, Research funding from Menarini to the University of Edinburgh for conducting this study, 2; I. Ford, Servier, 2, 5, GSK, 2, 5, Adaptimmune, 2, 5, Pharmacosmos, 2.

To cite this abstract in AMA style:

MacDonald T, Mackenzie I, Nuki G, Ford I. Long Term Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Chronic Gout: The Febuxostat versus Allopurinol Streamlined Trial (on Behalf of the FAST Investigators) [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/long-term-cardiovascular-safety-of-febuxostat-and-allopurinol-in-patients-with-chronic-gout-the-febuxostat-versus-allopurinol-streamlined-trial-on-behalf-of-the-fast-investigators/. Accessed February 27, 2021.
  • Tweet
  • Email
  • Print
Save to PDF

« Back to ACR Convergence 2020

ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-cardiovascular-safety-of-febuxostat-and-allopurinol-in-patients-with-chronic-gout-the-febuxostat-versus-allopurinol-streamlined-trial-on-behalf-of-the-fast-investigators/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Convergence: Where Rheumatology Meets. All Virtual. November 5-9.

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2021 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.