drugset / Trial / NCT01101035
Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
Timeline
- Start
- 2010-04-23
- Primary completion
- 2017-05-15
- Completion
- 2017-07-18
Outcome
Met primary endpoint
paper hazard ratio, 1.03; upper limit of the one-sided 98.5% confidence interval [CI], 1.23; P=0.002 for noninferiority). PMID 29527974 ↗
paper febuxostat was noninferior to allopurinol with respect to rates of adverse cardiovascular events. PMID 29527974 ↗
Publications
- Results White WB, Chohan S, Dabholkar A, Hunt B, Jackson R. Cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities. Am Heart J. 2012 Jul;164(1):14-20. doi: 10.1016/j.ahj.2012.04.011. Epub 2012 Jun 13.
- Results White WB, Saag KG, Becker MA, Borer JS, Gorelick PB, Whelton A, Hunt B, Castillo M, Gunawardhana L; CARES Investigators. Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout. N Engl J Med. 2018 Mar 29;378(13):1200-1210. doi: 10.1056/NEJMoa1710895. Epub 2018 Mar 12.
- Saag KG, Becker MA, White WB, Whelton A, Borer JS, Gorelick PB, Hunt B, Castillo M, Gunawardhana L; CARES Investigators. Evaluation of the Relationship Between Serum Urate Levels, Clinical Manifestations of Gout, and Death From Cardiovascular Causes in Patients Receiving Febuxostat or Allopurinol in an Outcomes Trial. Arthritis Rheumatol. 2022 Sep;74(9):1593-1601. doi: 10.1002/art.42160. Epub 2022 Aug 5.
- Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Allopurinol | Small molecule | 200 mg | Oral |
| Comparator | Allopurinol | Small molecule | 300 mg | Oral |
| Comparator | Allopurinol | Small molecule | 400 mg | Oral |
| Comparator | Allopurinol | Small molecule | 500 mg | Oral |
| Comparator | Allopurinol | Small molecule | 600 mg | Oral |
| Subject | Febuxostat | Small molecule | 40 mg | Oral |
| Subject | Febuxostat | Small molecule | 80 mg | Oral |