Study 3, a 1-year study, randomized patients to: ULORIC 80 mg daily, ULORIC 120 mg daily, or allopurinol 300 mg daily. Subjects who completed Study 2 and Study 3 were eligible to enroll in a phase 3 long-term extension study in which subjects received treatment with ULORIC for over three years.

In all three studies, subjects received naproxen 250 mg twice daily or colchicine 0.6 mg once or twice daily for gout flare prophylaxis. In Study 1 the duration of prophylaxis was 6 months; in Study 2 and Study 3 the duration of prophylaxis was 8 weeks.

The efficacy of ULORIC was also eva luated in a 4 week dose ranging study which randomized patients to: placebo, ULORIC 40 mg daily, ULORIC 80 mg daily, or ULORIC 120 mg daily. Subjects who completed this study were eligible to enroll in a long-term extension study in which subjects received treatment with ULORIC for up to five years.

Patients in these studies were representative of the patient population for which ULORIC use is intended. Table 2 summarizes the demographics and baseline characteristics for the subjects enrolled in the studies.

Table 2: Patient Demographics and Baseline Characteristics in Study 1, Study 2 and Study 3
Male 95%
Race:  Caucasian 80%
 African American 10%
Ethnicity:  Hispanic or Latino 7%
Alcohol User 67%
Mild to Moderate Renal Insufficiency
[percent with estimated Clcr less than 90 mL per min] 59%
History of Hypertension 49%
History of Hyperlipidemia 38%
BMI ≥ 30 kg per m2 63%
Mean BMI 33 kg per m2
Baseline sUA ≥ 10 mg per dL 36%
Mean baseline sUA 9.7 mg per dL
Experienced a gout flare in previous year 85% 

Serum Uric Acid Level less than 6 mg per dL at Final Visit: ULORIC 80 mg was superior to allopurinol in lowering serum uric acid to less than 6 mg per dL at the final visit. ULORIC 40 mg daily, although not superior to allopurinol, was effective in lowering serum uric acid to less than 6 mg per dL at the final visit (Table 3).

Table 3: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL at Final Visit 
     Difference in Proportion
(95% CI)
Study* ULORIC
40 mg daily ULORIC
80 mg daily allopurinol Placebo ULORIC 40 mg
vs
allopurinol ULORIC 80 mg
vs
allopurinol
*
Randomization was balanced between treatment groups, except in Study 2 in which twice as many patients were randomized to each of the active treatment groups compared to placebo.
Study 1
(6 months)
(N=2268) 45% 67% 42%  3%
(-2%, 8%) 25%
(20%, 30%)
Study 2
(6 months)
(N=643)  72% 39% 1%  33%
(26%, 42%)
Study 3
(12 months)
(N=491)  74% 36%   38%
(30%, 46%)

Randomization was balanced between treatment groups, except in Study 2 in which twice as many patients were randomized to each of the active treatment groups compared to placebo.
Study 1
(6 months)
(N=2268) 45% 67% 42%  3%
(-2%, 8%) 25%
(20%, 30%)
Study 2
(6 months)
(N=643)  72% 39% 1%  33%
(26%, 42%)
Study 3
(12 months)
(N=491)  74% 36%   38%
(30%, 46%)

In 76% of ULORIC 80 mg patients, reduction in serum uric acid levels to less than 6 mg per dL was n