Allopurinol Outcome Study

Inclusion criteria

• Meets the diagnosis of gout according to the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
• Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.
• If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.
• Must have had at least 2 gout flares in the past year.

Exclusion criteria

• Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
• History or suspicion of drug abuse.
• History of autoimmune disease requiring systemic treatment.
• Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or hepatitis B antibody (HBsAg) infection.
• History of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer).
• Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure, or stroke within the last 12 months.
• Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure above 95 mm Hg).
• Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.
• Kidney or other organ transplant.
• Active peptic ulcer disease requiring treatment.
• History of xanthinuria, active liver disease, or hepatic dysfunction.
• If unable to take gout flare prophylaxis of either colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal function, use of contraindicated medications).
• Known hypersensitivity or allergy to allopurinol.