Empagliflozin for Gout

(SAVE-Care Trial)

This trial tests a medication called empagliflozin to determine if it can help people with gout by lowering uric acid levels and reducing inflammation. The trial aims to assess whether empagliflozin can decrease gout attacks over three months. Participants will receive either empagliflozin or a placebo (a pill that resembles the drug but contains no active ingredients). This trial may suit individuals who have experienced at least one gout attack in the past year and have a uric acid level of 6 mg/dl or higher. As a Phase 4 trial, empagliflozin is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

The trial requires that you stop taking colchicine or NSAIDs (nonsteroidal anti-inflammatory drugs) if you are using them for gout prevention. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Research has shown that empagliflozin is generally safe for use. It can help lower uric acid levels in the blood, which is crucial for managing gout. For instance, one study found that empagliflozin reduced the risk of high uric acid levels leading to gout by about 38%. Another study observed a 19% decrease in repeated gout attacks when using empagliflozin compared to other treatments.

Empagliflozin is unique for gout treatment because it targets the sodium-glucose co-transporter 2 (SGLT2), which is a different approach compared to standard treatments like NSAIDs, colchicine, or allopurinol that primarily focus on reducing inflammation or uric acid levels. This novel mechanism may offer additional benefits by also potentially improving kidney function and cardiovascular health, which are often concerns for gout patients. Researchers are eager to see if empagliflozin can provide a more comprehensive management of gout by addressing these broader health issues.

Research has shown that empagliflozin can lower uric acid levels, which are often elevated in people with gout. Studies have found that empagliflozin can reduce high uric acid events by 38%. Evidence also suggests it can decrease the number of gout flare-ups or the need for medication to manage gout. However, some studies did not find a significant reduction in the first or total number of gout attacks. In this trial, participants will receive either empagliflozin or a placebo to evaluate its effectiveness in managing uric acid levels, which is important for treating gout.¹²³⁴⁶