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Dapagliflozin reduces HF in diabetes

Dapagliflozin reduces HF in diabetes

Publication date: Thursday, 07 February 2019

Results from the DECLARE study show that the sodium–glucose cotransporter 2 (SGLT-2) inhibitor dapagliflozin reduces hospitalisation for heart failure or cardiovascular (CV) death with no increase in major CV events compared with placebo in a broad population of over 17,000 patients with type 2 diabetes. DECLARE-TIMI 58 is the first CV outcomes trial in its class to include a majority of people without established CV disease and to include hospitalisation for heart failure as part of a primary outcome. These are important findings, and more or less consistent with findings noted with other SGLT-2 inhibitors. These drugs reduce hyperglycaemia in patients with diabetes by reducing renal glucose reabsorption and thus increasing urinary glucose excretion.

Results from DECLARE-TIMI 58 show dapagliflozin significantly reduced the risk of hospitalisation for heart failure or CV death vs placebo by 17% (4.9% vs 5.8%; HR 0.83 [95% CI 0.73-0.95], p=0.005) in one of two primary efficacy endpoints. The reduction in heart failure or CV death was consistent across the entire patient population studied in DECLARE- TIMI 58, which included those with multiple CV risk factors and those with established CV disease.

The study also confirmed the safety profile for dapagliflozin by meeting the primary safety endpoint of non-inferiority vs placebo, demonstrating no increase in the composite of major adverse cardiovascular events (MACE), defined as CV death, heart attack (myocardial infarction), or stroke (upper boundary of the 95% CI, 1.3; p0.001for non-inferiority). While there were fewer MACE events observed with dapagliflozin, this did not reach statistical significance for superiority versus placebo as the second primary effcacy endpoint (8.8% for dapagliflozin vs 9.4% for placebo; HR 0.93 [95% CI 0.84-1.03]; p=0.17).

Dapagliflozin reduced the rate of new or worsening kidney disease by 24% vs placebo (4.3% vs 5.6%; HR 0.76 [95% CI 0.67-0.87]), which is important because T2D is one of the biggest risk factors for developing chronic kidney disease. In addition, there were fewer all-cause mortality events with dapagliflozin vs placebo (6.2% vs 6.6%; HR 0.93 [95% CI 0.82-1.04]). 

DAPAGLIFLOZIN SUMMARY

  • As a monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
  • Dapagliflozin is not indicated for prevention of CV events.
  • In Europe, dapagliflozin is indicated for adults aged 18 years and older with type 2 diabetes to improve glycaemic control:
  • In combination with other glucose-lowering medical products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

 

ACTION

Heart failure is often overlooked as a complication of type 2 diabetes although these patients are 33% more likely to develop heart failure compared to the general population. The results of this study show that dapagliflozin reduces the risk of hospitalisation and CV death in patients with established CV disease and in those at high risk who have not already had an event.

Wiviott S, Raz I, Bonaca M, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. NEJM 2019; 380:347-57.  https://www.nejm.org/doi/full/10.1056/NEJMoa1812389?query=featured_home

 

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Topics covered:
Category: Evidence in Practice
Edition: Volume 4 Number 2 PCCJ Online 2019

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