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Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Comorbidities

2014-08-27 03:14:40 | BioPortfolio

Summary

The purpose of this study is to see if subjects with gout who receive febuxostat or allopurinol, once daily (QD), have a higher rate of serious heart and blood vessel complications.

Description

Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and additional risk factors like obesity and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form from supersaturated body fluids and settle in joints and other organs.

People with gout may also have a higher incidence of other conditions that may be associated with hyperuricemia, gout or both. This is supported by a growing body of research demonstrating that serum urate levels are an independent predictive factor for cardiovascular disease when the effects of other risk factors have been controlled.

This study will explore the cardiovascular safety of febuxostat to determine whether the use of febuxostat is associated with a moderate increase in the risk of serious adverse cardiovascular outcomes as compared to allopurinol.

Participation will last a maximum of 5 years and will include 15 to 20 visits to the study center.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Acute Coronary Syndrome

Intervention

Febuxostat, Allopurinol

Location

Birmingham
Alabama
United States

Status

Recruiting

Source

Takeda Global Research & Development Center, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:40-0400

Clinical Trials [2721 Associated Clinical Trials listed on BioPortfolio]

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

The purpose of this study is to determine the long-term safety of febuxostat compared to allopurinol in reducing serum urate levels in subjects with gout.

Zurig (Febuxostat) 40mg Efficacy and Safety Trial

Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits antihyperuricemic activity by reducing the formation of uric acid. The investigators conducted an i...

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This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attaches. These therapies have never been compared ...

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

The purpose of this study is to evaluate the safety and efficacy of febuxostat versus allopurinol in subjects with gout.

PubMed Articles [11585 Associated PubMed Articles listed on BioPortfolio]

Design and rationale for the veterans affairs "cooperative study program 594 comparative effectiveness in gout: Allopurinol vs. febuxostat" trial.

Gout patients do not routinely achieve optimal outcomes related in part to suboptimal administration of urate lowering therapy (ULT) including first-line xanthine oxidase inhibitors allopurinol or feb...

The APEX Trial: Effects of Allopurinol on Exercise Capacity, Coronary and Peripheral Endothelial Function and Natriuretic Peptides in Patients with Cardiac Syndrome X.

The role of endothelial dysfunction and oxidative stress in the pathogenesis of cardiac syndrome X has recently been recognised. Allopurinol has previously been shown to improve endothelial dysfunctio...

All-Cause Mortality Following an Acute Coronary Syndrome: 12-Year Follow-Up of the Comprehensive 2002 New Zealand Acute Coronary Syndrome Audit.

To describe the long-term mortality of a complete national cohort of acute coronary syndrome (ACS) patients enrolled in 2002, to compare this with a national age, sex and Māori ethnicity matched popu...

The features of a functional state of the coronary circulation in women-smokers with non st elevation acute coronary syndrome.

Acute coronary syndrome is one of the most adverse prognostic clinical forms of ischemic heart disease. In recent years, attention of researchers and cardiologists practical attract female patients du...

Colchicine Therapy and Plaque Stabilization in Patients With Acute Coronary Syndrome: A CT Coronary Angiography Study.

The authors sought to evaluate the plaque-modifying effects of low-dose colchicine therapy plus optimal medical therapy (OMT) in patients post-acute coronary syndrome (ACS), as assessed by coronary co...

Medical and Biotech [MESH] Definitions

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

Abnormal balloon- or sac-like dilatation in the wall of CORONARY VESSELS. Most coronary aneurysms are due to CORONARY ATHEROSCLEROSIS, and the rest are due to inflammatory diseases, such as KAWASAKI DISEASE.

An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Malformations of CORONARY VESSELS, either arteries or veins. Included are anomalous origins of coronary arteries; ARTERIOVENOUS FISTULA; CORONARY ANEURYSM; MYOCARDIAL BRIDGING; and others.

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