This was a Phase 3B study to evaluate the cardiovascular safety of 2 FDA approved gout medications, Allopurinol and Uloric. All patients must have had a diagnosis of both gout and a history of cardiovascular disease. The study enrolled males 50 years or age or older and females 55 years of age or older and approximately 7500 subjects at sites in the United States, Canada and Mexico participated. Our site screened 81 subjects and enrolled 50 into this important cardiovascular endpoint study.
Gout is characterized by sudden, severe attacks of pain, redness and tenderness in joints, often the joint at the base of the big toe. Gout is a complex form of arthritis and can affect anyone. Men are more likely to get gout, but women become increasingly susceptible to gout after menopause. An attack of gout can occur suddenly, often waking you up in the middle of the night with the sensation that your big toe is on fire. The affected joint is hot, swollen and so tender that even the weight of the sheet on it may seem intolerable. The signs and symptoms of gout almost always occur suddenly, often at night and without warning. They include:
- Intense joint pain. Gout usually affects the large joint of your big toe, but it can occur in your feet, ankles, knees, hands and wrists. The pain is likely to be most severe within the first four to 12 hours after it begins.
- Lingering discomfort. After the most severe pain subsides, some joint discomfort may last from a few days to a few weeks. Later attacks are likely to last longer and affect more joints.
- Inflammation and redness. The affected joint or joints become swollen, tender, warm and red.
- Limited range of motion. Decreased joint mobility may occur as gout progresses.
Fortunately, gout is treatable, and there are ways to reduce the risk that gout will recur.