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New Therapeutic Options for Gout Here and On the Horizon

New Therapeutic Options for Gout Here and On the Horizon

Gout is the most common inflammatory arthritis in the United States (Figure), with a prevalence of about 3%,1 and the number of persons with gout has increased over the past few decades. Until recently, however, gout management had not kept up with the rising tide. Between 1965 and early 2009, not a single new drug was approved for gout. Now, treatment is poised for a transformation. New drugs are on the market, and others are in clinical development (Table). In this article, we review newly FDA-approved treatments for patients with gout and the potential utility of several agents in the pipeline.

Figure – The prevalence of gout has increased over the past few decades. Gouty arthropathy usually presents as an acute monarticular arthritis, with initial attacks occurring primarily in the feet in men. Symptoms include joint pain, swelling, redness, and warmth.

Established treatments for patients who have acute gout—high-dose NSAIDs, high-dose oral colchicine, and oral or injectable (intra-articular, depot intramuscular) corticosteroids—are valid and often effective approaches to managing acute gouty arthropathy. However, each has limitations, including adverse effects that can potentiate, or be potentiated by, comorbidities in a patient with gout.

For example, any NSAID (including but not limited to indomethacin) may abrogate a gout attack, but many patients with gout carry 1 or multiple relative contraindications to this class of drugs, such as hypertension and renal insufficiency (Pillinger MH, Keenan R, unpublished data). Similarly, the use of oral corticosteroids is relatively contraindicated in patients with diabetes mellitus, and high-dose colchicine or NSAIDs should not be prescribed for patients with moderate to severe renal insufficiency. Thus, there is a need for alternative therapies that have novel mechanisms or different safety profiles or both.

This drug, known to Hippocrates, has been in modern use for gout since 1810. However, colchicine had never received FDA approval as gout therapy until recently.

With this deficiency in mind, the FDA countenanced a reexamination of colchicine in acute gout. This led to FDA approval of a nongeneric colchicine (Colcrys) in 2009, after a clinical trial demonstrated that 1.2 mg of oral colchicine, followed by 0.6 mg 1 hour later, is at least as successful in resolving acute gouty attacks as the previously used high-dose hourly regimen, with a dramatically improved adverse-effect and safety profile.2

The new regimen may be used in patients with renal or hepatic failure, although in these situations treatment should not be repeated for about 2 weeks. Although obviously useful, both this new treatment regimen and the older one are successful in just under half of patients by 24 hours, leaving more than 50% of patients in need of other treatment. Of note, the Colcrys study did not include persons with severe, polyarticular, well-established gouty attacks, which clinicians have long recognized to respond poorly to even the more traditional, higher-dose therapy.


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