Abstract / Summary
Abstract Background Sodium–glucose cotransporter-2 (SGLT2) inhibitors have demonstrated cardiovascular and renal benefits in cardiovascular outcome trials (CVOTs), but the extent to which these findings are represented in official regulatory prescribing information is unclear.
Objective: To characterize the cardiovascular outcome information reported in ANVISA-approved professional prescribing information for SGLT2 inhibitors and examine its correspondence with evidence from landmark CVOTs. Methods A descriptive document analysis evaluated the most recent ANVISA-approved professional prescribing information available on 25 April 2026 for empagliflozin, dapagliflozin, and canagliflozin. Cardiovascular information was assessed using a predefined framework covering three-point major adverse cardiovascular events (MACE), quantitative reporting, clarity, correspondence with relevant CVOT evidence, and therapeutic context. Results Cardiovascular outcome reporting varied across the three documents. The empagliflozin document included quantitative cardiovascular outcome information and all three components of three-point MACE. The dapagliflozin document emphasized heart-failure and renal outcomes and provided limited information on individual MACE components. The canagliflozin document did not provide quantitative cardiovascular outcome estimates. Conclusion The evaluated ANVISA-approved professional prescribing information differed in the extent and type of cardiovascular outcome evidence communicated. These findings support further evaluation of how clinically relevant evidence is translated into regulatory drug information.