AstraZeneca reported that its Phase 3 Cardio‑TTransform trial of dapagliflozin plus baxdrostat did not meet its primary endpoint of reducing major adverse cardiovascular events (MACE) compared with dapagliflozin alone in high‑risk patients with cardiovascular disease.
The event‑driven, randomized study evaluated whether adding baxdrostat, an aldosterone synthase inhibitor, to dapagliflozin could further lower the risk of cardiovascular death, non‑fatal myocardial infarction, or non‑fatal stroke in a broad population with established cardiovascular disease. While the combination did not achieve a statistically significant benefit on the composite MACE endpoint, AstraZeneca noted that it remains committed to exploring baxdrostat’s potential in other indications.
Cardio‑TTransform is part of a wider clinical program assessing baxdrostat across cardiovascular and metabolic conditions, including hypertension and heart failure. Earlier Phase 3 data with baxdrostat in resistant hypertension showed blood pressure reductions, but the current results underscore the challenges of improving outcomes beyond those achieved with existing therapies such as SGLT2 inhibitors.
Dapagliflozin is already approved for multiple indications, including heart failure and chronic kidney disease, based on prior trials demonstrating reductions in cardiovascular death and heart failure hospitalizations. AstraZeneca said it will analyze the full Cardio‑TTransform dataset to understand subgroup responses and potential signals that could inform future development.
Regulatory filings based on Cardio‑TTransform are not planned at this time, and ongoing baxdrostat studies in other settings will continue as scheduled.
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