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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 Attacks More Common at Night: Study
Source: MedicineNet Arthritis Specialty [2014.12.12]
Title: Gout Attacks More Common at Night: Study
Category: Health News
Created: 12/11/2014 12:00:00 AM
Last Editorial Review: 12/12/2014 12:00:00 AM

Nighttime gout attack risk more than two times higher than in the daytime
Source: Arthritis / Rheumatology News From Medical News Today [2014.12.11]
Novel research reveals that the risk of acute gout attacks is more than two times higher during the night or early morning hours than it is in the daytime.

Nighttime Risky for Gout
Source: MedPage Today Rheumatology [2014.12.11]
(MedPage Today) -- When the sun goes down, gout attacks.

Gout: data from Phase III studies of lesinurad in combination with allopurinol
Source: Gout News From Medical News Today [2014.11.19]
AstraZeneca has presented top-line results of two pivotal Phase III trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), when used in combination...

Pseudogout
Source: MedicineNet Amyloidosis Specialty [2014.10.14]
Title: Pseudogout
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 10/14/2014 12:00:00 AM

more news >>

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.

more studies >>

Clinical Trials Related to Uloric (Febuxostat)

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

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease [Recruiting]
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.

The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina [Not yet recruiting]
The purpose of this study is to assess the affect of febuxostat on coronary artery flow in patients with coronary artery disease.

An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. [Not yet recruiting]
The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks. Secondary end-points of this study will include analyzing the effects of uric acid-lowering therapy (specifically with the FDA approved medication Febuxostat) in a subgroup of patients, checking for the presence of inflammatory markers to see if there is any correlation with the proposed chronic inflammation, and evaluating for other characteristic findings of gout on MRI.

Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout [Recruiting]
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in subjects with elevated serum urate levels and gout.

more trials >>

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: 2014-12-12

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