AstraZeneca has reported positive results from the DECLARE-TIMI 58 trial that evaluated the efficacy of farxiga against placebo in adults with type-2 diabetes (T2D) who are at risk of cardiovascular (CV) events.
Results showed that farxiga significantly lowered the risk of hospitalisation for heart failure (hHF) or CV death by 17% compared to placebo, fulfilling one of the two primary efficacy endpoints of the trial.
However, farxiga failed to fulfil the other primary efficacy endpoint of the trial of demonstrating a statistically significant outcome in preventing major adverse cardiovascular events (MACE).
The double-blinded, placebo-controlled trial confirmed the safety profile of farxiga, demonstrating no increase in the composite of MACE, defined as CV death, heart attack or stroke.
In addition, the trial did not demonstrate any imbalance in terms of safety with farxiga against placebo in the areas of amputations, fractures, bladder cancer or Fournier’s gangrene.
Incidences of diabetic ketoacidosis and genital infections were reported to be rare.
AstraZeneca vice-president and cardiovascular head Elisabeth Björk said: “These positive results are clinically relevant to the 425 million people worldwide living with diabetes, of whom those with type-2 diabetes have a two to five times greater risk of heart failure along with an increased risk of a heart attack or stroke.
“Heart failure survival rates are only 50% after five years from diagnosis, which is why these new findings are so important in broadening our understanding of how to go beyond blood glucose so we may better address this serious and often overlooked cardiovascular complication.”
The DECLARE-TIMI 58 trial enrolled more than 17,000 patients with CV risk factors and disease across 882 sites in 33 countries.
Academic investigators from US-based TIMI study group and Israel’s Hadassah Hebrew University medical centre were involved in the trial.