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VA RESEARCH QUARTERLY UPDATE
This Issue: The Aging Veteran | Table of Contents: Summer 2016 |

New Initiatives

Clinical trial of two gout medications to begin


Joint inflammation is the hallmark of gout, an arthritic disease that affects some 8 million Americans. <em>(Photo: ©iStock.wildpixel)</em>
Joint inflammation is the hallmark of gout, an arthritic disease that affects some 8 million Americans. (Photo: ©iStock.wildpixel)

Joint inflammation is the hallmark of gout, an arthritic disease that affects some 8 million Americans. (Photo: ©iStock.wildpixel)

Two widely used therapies for gout will be compared head to head in a soon-to-begin VA multisite study (Cooperative Studies Program No.594).

The four-year study, managed by researchers at the VA Nebraska-Western Iowa Health Care System in Omaha, will enroll 950 patients with a diagnosis of gout, including patients with stage 3 (moderate) chronic kidney disease (CKD). Study participants will be recruited from 18 VA facilities and five Rheumatology and Arthritis Investigational Network (RAIN) sites.

Gout, which is caused by excess uric acid in the bloodstream, is the most common form of inflammatory arthritis affecting adults. The disease causes severe pain and swelling in the joints. It most commonly affects the big toe, but may also affect the heel, ankle, hand, wrist, or elbow.

In older men, gout is a significant cause of illness and death. It can lead to a condition called hyperuricemia, which is associated with CKD and kidney failure.

Although a number of good treatments are available for gout, the disease is "extremely poorly managed" in older people, especially those with CKD, according to the study investigators. The two most widely used treatments for gout are the drugs allopurinol and febuxostat, both of which "appear to be efficacious and generally well-tolerated."

However, the two treatments have significantly different costs and have never been compared to each other at appropriate doses. According to the research team, trials comparing the two medications to date have used fixed, and in many cases insufficient, doses of allopurinol. This is contrary to current guideline recommendations, which recommend that dosages be adjusted depending on the severity of the disease.

The research team also states that these previous studies have included only very small proportions of gout patients with CKD, although CKD is present in about half of all gout sufferers.

The team hypothesizes that allopurinol will be "non-inferior" to febuxostat in the treatment of gout, and will conduct a randomized open-label non-inferiority trial to see if they are correct.

In open-label trials, both researchers and participants know which treatment is being administered. Non-inferiority trials are attempts to determine whether a new treatment is at least as good as an existing one.

The trial is not yet recruiting patients. Recruitment will occur over two years, after which each study participant will be followed for 72 weeks.


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