In 3 head-to-head studies of >3400 patients
ULORIC powerfully lowered serum uric acid (sUA) to target levels <6 mg/dL1,2*
Learn more: Efficacy in Mild-Moderate CKD Patients
76% of ULORIC 80 mg patients achieved a reduction in sUA levels to <6 mg/dL by Week 21
83% of these patients maintained average sUA levels ≤6 mg/dL throughout treatment
ULORIC 80 mg was proven superior to allopurinol at lowering sUA (p<0.001)1,2
The 40-mg starting dose of ULORIC effectively lowered sUA similarly to allopurinol1
Individual results may vary based on factors such as baseline serum uric acid levels.
*Based on results combined across three phase 3 studies; ULORIC 40 mg was included only in one of the studies, and ULORIC 80 mg and allopurinol were included in each of the studies.1
†In the APEX trial, allopurinol patients (n=10) with serum creatinine >1.5 mg/dL and ≤2 mg/dL were dosed at 100 mg daily. In CONFIRMS, allopurinol patients (n=145) with estimated creatinine clearance (Clcr) ≥30 mL/min and ≤59 mL/min were dosed at 200 mg daily. All other patients received 300 mg daily.1
‡p<0.001 vs allopurinol.2
In the 6-month CONFIRMS study
ULORIC was superior to allopurinol in a subgroup of gout patients with mild to moderate renal impairment1*
Patients with mild or moderate renal impairment can be treated with either dose of ULORIC.1
For patients who do not achieve the sUA target level of <6 mg/dL after 2 weeks with ULORIC 40 mg, ULORIC 80 mg is recommended1
There are insufficient data in patients with severe renal impairment and no data in patients with severe hepatic impairment. Caution should be exercised in these patients.1
sUA=serum uric acid.
*Mild to moderate renal impairment is defined as estimated creatinine clearance (Clcr) 30-89 mL/min.3
†Allopurinol patients (n=145) with estimated Clcr ≥30 mL/min and ≤59 mL/min were dosed at 200 mg daily.1
‡p<0.05 vs allopurinol.3
§p<0.05 vs allopurinol and ULORIC 40 mg.3
Patients with mild or moderate renal impairment achieving sUA <6 mg/dL3*
Learn more: Safety Profile
||This is a descriptive analysis only.
¶In the CONFIRMS study, patients with mild renal impairment were on allopurinol 200 mg (n=10) and 300 mg (n=355); patients with moderate renal impairment were on allopurinol 200 mg (n=135) and 300 mg (n=1).2
The safety of ULORIC was extensively studied1
The safety profile of ULORIC has been evaluated in more than 4000 patients, in some for more than 5 years2
Adverse reactions occurring in ≥1% of ULORIC-treated patients and at least 0.5% greater than seen in patients receiving placebo in phase 3 controlled studies1*
Incidence of adverse events1
Patients should be instructed to inform their healthcare professional if they develop a rash or have any side effect that bothers them or does not go away.
*ULORIC 80 mg and allopurinol were included in the CONFIRMS, APEX, and FACT studies. Placebo was included only in APEX, and ULORIC 40 mg was included only in CONFIRMS.3-5
†Of the patients who received allopurinol, 10 received 100 mg, 145 received 200 mg, and 1122 received 300 mg, based on level of renal impairment.1