New gout medicine
by Nathan Wei, MD, FACP, FACR
Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.
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Gout is a type of arthritis caused by a build-up of uric acid. This triggers the formation of crystals in the joints, especially the big toe, which can lead to painful attacks that last from a few hours to several days.
Some of the more recent gout treatments include a drug called febuxostat (Uloric), which works by inhibiting xanthine oxidase, an enzyme that converts purines in food into uric acid.
In the majority of clinical trial participants, febuxostat reduced and maintained the lowered levels of uric acid - the standard goal in the treatment of chronic gout.
SAN ANTONIO, October 19, 2004 – TAP Pharmaceutical Products Inc. announced today data showing its investigational medication, febuxostat, lowered uric acid levels among patients with chronic gout in a Phase II clinical trial. The data were presented at the 68th Annual Scientific Meeting at the American College of Rheumatology.
Febuxostat is a novel non-purine, selective inhibitor of xanthine oxidase (NP-SIXO) being studied for its effects on lowering elevated levels of serum uric acid (sUA) in patients with gout. Hyperuricemia, elevated uric acid levels in the body, is associated with gout, a painful type of arthritis.
"Study findings show that treatment with febuxostat lowers uric acid levels," said H. Ralph Schumacher, M.D., professor of medicine, University of Pennsylvania School of Medicine. "Moreover, in the majority of these patients, long-term treatment with febuxostat, up to two years, resulted in significant reduction and maintenance of sUA below 6.0 mg/dL."
According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. Gout is the most common inflammatory arthritis in men older than 40 years.
Two-year data were presented from an ongoing Phase II, long-term, open-label extension of a four-week, double-blind, placebo-controlled study with febuxostat. Patients with diagnosed gout and sUA levels greater than 8.0 mg/dL at baseline who completed the original four-week study were eligible to participate in the extension study. Study participants were initially given 80 mg/day of febuxostat and the dose was then adjusted as necessary to either 40 mg/day or 120 mg/day and were to achieve a stable dose by study week 28 based on sUA levels and reported side effects. Colchicine 0.6 mg twice daily was provided to help prevent gout flares during the first four weeks of treatment.
A total of 116 patients began the open-label study and 69 patients (59 percent) continued into the open label study for at least two years. Patients exhibited rapid reduction in sUA levels and most patients (74 – 81 percent) maintained sUA levels of less than 6.0 mg/dL throughout the study period. Experts recognize that the standard goal in the treatment of chronic gout is reduction and maintenance of serum uric acid levels of less than 6 mg/dL.
The majority of adverse events were mild to moderate in severity. The most common treatment-related adverse events were diarrhea, headache, and increase in liver function test results.
Phase I Results: Hepatic-Impaired Subjects
Data also were presented evaluating the pharmacokinetics (PK), pharmacodynamics (PD) and safety of febuxostat in 27 subjects with normal, mildly impaired or moderately impaired hepatic function. No clinically significant difference was observed among the groups.
Uric Acid and Gout
Gout is a chronic condition characterized by attacks, or "flares," marked by intense pain, redness, inflammation, and warmth in the affected joint. These attacks often occur at night, waking the patient from sleep. Typically, symptoms begin in the big toe but may involve other joints. These symptoms are the result of an acute inflammation to the presence of crystallized uric acid in the joint(s). As the disease progresses, these attacks may become more frequent and patients may develop large deposits of crystallized uric acid visible under the skin, known as tophi, that can eventually lead to joint deformity.
Uric acid is a by-product created when the body breaks down naturally occurring substances called purines. Hyperuricemia occurs when this process results in elevated uric acid levels, either through overproduction or underexcretion of uric acid or a combination of the two. Hyperuricemia is a precursor to gout; the higher a person’s urate level, the greater the risk for developing gout.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint venture between Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited, of Osaka, Japan. TAP markets Prevacid® (lansoprazole) and Lupron Depot® (leuprolide acetate for depot suspension). For more information about TAP Pharmaceutical Products Inc., and its products, visit the company's Web site at www.tap.com.
Another drug that is being used for gout is the anti-hypertension drug losartan (Cozaar). Many patients with gout have hypertension already so this drug may be a logical solution.
Finally, PEG uricase (Krystexxa) is an intravenous drug that is helpful in dissolving tophi- the collection of uric acid crystals that cause lumps and bumps under the skin in patients with gout. It converts uric acid into the inert ingredient, allantoin, which is excreted in the urine.
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