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Uloric (Febuxostat) - Summary

 
 



ULORIC SUMMARY

ULORIC (febuxostat) is a xanthine oxidase inhibitor.

ULORIC® is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.


See all Uloric indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Uloric (Febuxostat)

Gout flare-ups could be managed by blood pressure diet
Source: Arthritis / Rheumatology News From Medical News Today [2016.08.15]
Gout is both painful and common, yet the mechanisms behind it are not known. A new analysis of old data shows that easy dietary changes may keep it at bay.

Gout Attack Symptoms, Causes, Treatment, and Diet
Source: MedicineNet Elbow Pain Specialty [2016.07.15]
Title: Gout Attack Symptoms, Causes, Treatment, and Diet
Category: Slideshows
Created: 6/6/2008 12:00:00 AM
Last Editorial Review: 7/15/2016 12:00:00 AM

Gout (Gouty Arthritis)
Source: MedicineNet Bunions Specialty [2016.06.06]
Title: Gout (Gouty Arthritis)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 6/6/2016 12:00:00 AM

Newspapers often publish false depictions of gout
Source: Gout News From Medical News Today [2016.05.04]
A new analysis reveals that popular newspaper articles depict gout as a self-inflicted condition that is socially embarrassing and the focus of humor.

Steroid pill safe and effective first-line treatment for acute gout
Source: Gout News From Medical News Today [2016.02.23]
An oral steroid had similar effectiveness to an oral non-steroid anti-inflammatory drug (NSAID) for improving pain in patients with acute gout, according to a trial published in Annals of Internal...

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Published Studies Related to Uloric (Febuxostat)

Febuxostat in gout: serum urate response in uric acid overproducers and underexcretors. [2011.07]
OBJECTIVE: Hyperuricemia of gout can arise due to either overproduction or underexcretion of uric acid. Not all available urate-lowering therapies are equally effective and safe for use in patients with renal disease. The objective of this post-hoc analysis was to determine the effectiveness of the xanthine oxidase inhibitor febuxostat in reducing serum urate (sUA) levels in gouty patients who were either overproducers or underexcretors... CONCLUSION: Febuxostat is a highly efficacious urate-lowering therapy in patients with gout regardless of overproduction or underexcretion status.

An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. [2011]
gout in Japan to compare its efficacy and safety with those of allopurinol... CONCLUSIONS: These results suggest that febuxostat is safe at doses of 40 and 60

An allopurinol-controlled, randomized, double-dummy, double-blind, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. [2011]
these drugs... CONCLUSIONS: Febuxostat at 40 mg/d demonstrated more potent hypouricemic effects

The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. [2010]
INTRODUCTION: The purpose of this study was to compare urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate (sUA) > or = 8.0 mg/dL in a six-month trial... CONCLUSIONS: Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol (300/200 mg), which were comparable. In subjects with mild/moderate renal impairment, both febuxostat doses were more efficacious than allopurinol and equally safe. At the doses tested, safety of febuxostat and allopurinol was comparable. CLINICAL TRIAL REGISTRATION: NCT00430248.

Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. [2009.02]
OBJECTIVES: This 5-yr study assessed urate-lowering and clinical efficacy and safety of long-term febuxostat therapy in subjects with gout. The primary efficacy end-point was reduction to and maintenance of serum urate (sUA) levels < 6.0 mg/dl... CONCLUSIONS: Long-term treatment with febuxostat resulted in durable maintenance of sUA < 6.0 mg/dl for most subjects. There was nearly complete abolition of gout flares in patients completing the study. Baseline tophi resolved in a majority of subjects.

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Clinical Trials Related to Uloric (Febuxostat)

Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. [Completed]
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study [Terminated]
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood pressure) and overall cardiovascular disease risk in several studies. The relationship has even been noted to be independent of metabolic syndrome and kidney function. It has been repeatedly noted that hyperuricemia was an independent risk factor of death in those at high cardiovascular disease risk. A recent review concluded that there is strong evidence that hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events. Although this correlation of hypertension and hyperuricemia is known, there has only been one published study that has evaluated if lowering the uric acid would reduce the blood pressure. The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased the blood pressure. Despite this, further evaluation of this therapeutic approach has not been studied. The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood pressure lowering effects superior to allopurinol in patients diagnosed with gout.

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in participants with gout.

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease [Completed]
Hyperuricemia is emerging as a risk factor for development of diabetes and metabolic syndrome. Recently, it was shown in in-vitro cell culture experiments that hyperuricemia induces redox-dependent signaling and oxidative stress in adipocytes. By targeting levels of uric acid with febuxostat we hypothesize that the levels of oxidative stress in adipose tissue (obtained by fat biopsy) will decrease. Primary aims of the study is to determine whether febuxostat therapy in overweight or obese, diabetic patients with stage 3 CKD and high serum uric acid levels 1. decreases adipose tissue concentrations of thiobarbituric acid reactive substance (TBARS), a marker of oxidative stress 2. increases adipose tissue expression and concentrations of adiponectin and 3. decreases urinary concentrations of transforming growth factor (TGF)- B1.

Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment [Completed]
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

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Reports of Suspected Uloric (Febuxostat) Side Effects

Gout (11)Renal Failure Acute (9)Rash (7)Condition Aggravated (6)Diarrhoea (5)Oedema Peripheral (4)Nausea (4)Jaundice (3)Erythema (3)Dizziness (3)more >>


Page last updated: 2016-08-15

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