A recent post-hoc analysis of the VERTIS CV trial reveals that ertugliflozin, a medication used to manage type 2 diabetes (T2D) and cardiovascular disease, significantly lowers uric acid (UA) levels and improves gout-related outcomes compared to a placebo. This analysis assessed data from the VERTIS CV trial (NCT01986881), focusing on patients with both T2D and atherosclerotic cardiovascular disease (ASCVD).
Dr. Vikas S. Sridhar from the Toronto General Hospital Research Institute, University Health Network, along with his team, highlighted that hyperuricemia and gout often coexist with several other conditions such as T2D, hypertension, and obesity. These conditions are components of a broader cardiovascular-kidney-metabolic syndrome, which can lead to an increased risk of ASCVD and chronic kidney disease (CKD). Dr. Sridhar noted that while elevated UA levels are linked to these conditions, it remains unclear if UA directly contributes to their development.
In the VERTIS CV trial, participants were randomly assigned to receive either placebo, ertugliflozin 5 mg, or ertugliflozin 15 mg. The study tracked UA levels over a period of 260 weeks, comparing the effects of ertugliflozin to those of the placebo. Analysis revealed that ertugliflozin reduced UA levels more effectively than the placebo, with a mean change from baseline at Week 260 of −0.19 mg/dL in the ertugliflozin group compared to a 0.07 mg/dL increase in the placebo group. This resulted in a placebo-adjusted mean reduction of −0.26 mg/dL.
The study also assessed the incidence of gout-related outcomes, including the onset of gout or the initiation of anti-gout medications. The results showed that 3.3% of patients in the placebo group experienced these outcomes, compared to 2.6% in the ertugliflozin group. Although the reduction in gout-related outcomes was not statistically significant (hazard ratio 0.76 [95% CI, 0.580-1.002]; P = .052), ertugliflozin demonstrated a numerical benefit.
Importantly, no significant differences were observed in the treatment effects across various subgroups, including those based on baseline UA levels, blood pressure, HbA1c, estimated glomerular filtration rate (eGFR), or albuminuria status.
Dr. Sridhar and his colleagues concluded that ertugliflozin not only lowers UA levels but also shows potential in reducing the incidence of gout-related outcomes in patients without a prior history of gout or current use of anti-gout medications. They suggest that the presence of risk factors for gout could be an additional consideration for clinicians when prescribing SGLT2 inhibitors like ertugliflozin. Future research, including large-scale meta-analyses and real-world studies, is necessary to validate these findings and determine the clinical significance of these outcomes for high-risk populations.
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