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Uric acid and Gout

2. Goals of Meeting. Address an important, and often ignored, public health issueGather input regarding issues to consider for clinical trials intended to support the development and approval for drugs that treat gout and/or uric acidAcute situationsChronic situations. 3. Gout: The Problem. Impo

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Uric acid and Gout

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    1. 1 Uric acid and Gout James Witter MD, PhD Arthritis Advisory Meeting June 2, 2004

    2. 2 Goals of Meeting Address an important, and often ignored, public health issue Gather input regarding issues to consider for clinical trials intended to support the development and approval for drugs that treat gout and/or uric acid Acute situations Chronic situations

    3. 3 Gout: The Problem Important unmet medical need acute and chronic pain joint and renal damage Increasing incidence and severity estimates of 8.4 per 1,000 in U.S. female: male = 1:6 increase not related to diuretics Earlier age especially males Increases may be related to obesity insulin resistance syndrome

    4. 4 Gout: Approved Treatments Limited options NSAIDs prostaglandins colchicine microtubules oral, IV allopurinol xanthine oxidase inhibitor probenecid renal tubule inhibitor

    5. 5 Claims and Labels Although label claims have legal and regulatory uses, their central purpose is to inform health care providers and patients about the documented benefits and risks associated with a product Claims describe clinical benefit Promotion allowed on approved claims Accurate product labels allow for effective risk management

    6. 6 Labeling Options? For chronic use: For treatment of hyperuricemia associated with: Gouty flares Gouty arthritis Tophi Renal calculi For acute or prophylactic use: For the short-term treatment of uric acid-induced gout

    7. 7 Approved INDICATIONS: Indocin® (indomethacin) effective in active stages of acute gouty arthritis Benemid® (probenecid) for treatment of the hyperuricemia associated with gout and gouty arthritis Zyloprim® (allopurinol) the management of patients with signs and symptoms of primary and secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) not innocuous drug…not for asymptomatic hyperuricemia Colchicine for the treatment of gout…relieving pain of acute attacks as interval therapy to prevent acute attacks of gout

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