A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
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).
The drug tested in this study was called Febuxostat (TMX-67). Febuxostat compared with allopurinol was evaluated for the cardiovascular (CV) safety in people with gout and significant CV comorbidities.
The study enrolled 6198 patients. Participants with a diagnosis of gout were enrolled in a 1:1 ratio to receive either:
Participants received febuxostat 40 mg or 80 mg for the study depending on their serum uric acid levels were either <6.0 mg/dL or ≥6.0 mg/dL during specified visits. Allopurinol 200 mg to 400 mg (for moderate renal impairment),or 300 mg to 600 mg (for normal and mild renal impairment), increased in 100 mg increments each month until serum uric acid was <6.0 mg/dL was received.
This multi-center trial was conducted in Canada, Mexico and United States. The overall time to participate in this study was approximately 7 years (84 months). Participants made multiple visits to the clinic and were also contacted through the telephone.
Inclusion Criteria:
The participant or the participant's legally acceptable representative signs and dates a written, informed consent form/Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to the initiation of any study procedures.
The participant is male ≥50 years of age or female ≥55 years of age and at least 2-years post-menopausal.
The participant has a history of major CV or cerebrovascular disease including at least one of the following:
The participant has a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout:
A tophus proven to contain urate crystals by chemical or polarized light microscopic means, and/or
Characteristic urate crystals in the joint fluid, and/or
History of at least 6 of the following clinical, laboratory, and X-ray phenomena:
The participants must have either:
The participant is capable of understanding and complying with protocol requirements
Exclusion Criteria:
Participants who meet any of the following criteria will not qualify for entry into this study:
Jalisco, Mexico City, Mexico