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).

In 76% of ULORIC 80 mg patients, reduction in serum uric acid levels to less than 6 mg per dL was noted by the Week 2 visit. Average serum uric acid levels were maintained at 6 mg per dL or below throughout treatment in 83% of these patients.

In all treatment groups, fewer subjects with higher baseline serum urate levels (≥ 10 mg per dL) and/or tophi achieved the goal of lowering serum uric acid to less than 6 mg per dL at the final visit; however, a higher proportion achieved a serum uric acid less than 6 mg per dL with ULORIC 80 mg than with ULORIC 40 mg or allopurinol.

Study 1 eva luated efficacy in patients with mild to moderate renal impairment (i.e., baseline estimated Clless than 90 mL per minute). The results in this sub-group of patients are shown in Table 4.

Table 3: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL at Final Visit 
     Difference in Proportion
(95% CI)
StudyRandomization 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.  ULORIC
40 mg daily ULORIC
80 mg daily allopurinol Placebo ULORIC 40 mg
vs
allopurinol ULORIC 80 mg
vs
allopurinol
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%)
Table 4: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL in Patients with Mild or Moderate Renal Impairment at Final Visit 
   Difference in Proportion
(95% CI)
ULORIC
40 mg daily
(N=479) ULORIC
80 mg daily
(N=503) allopurinolAllopurinol patients (n=145) with estimated Clcr ≥ 30 mL per min and Clcr ≤ 59 mL per min were dosed at 200 mg daily.
300 mg daily