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Dapagliflozin offers new hope for HFrEF patients



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Heart failure (HF) is one of the most common cardiovascular diseases worldwide. The prevalence of heart failure in India is estimated to be about 8-10 million (1). Around 1.8 million hospitalizations occur in India annually due to HF (2). Approximately 50% of these cases can be attributed to HF with reduced ejection fraction (HFrEF), referring to a left ventricular ejection fraction (LVEF) of 40% or less (3). Despite significant advances in treatment, there remains a significant unmet need.


Sodium-glucose cotransporter 2 (SGLT2) inhibitors initially developed for the management of type 2 diabetes mellitus are known to reduce the risk of death and other adverse outcomes among patients with chronic heart failure and a reduced ejection fraction and in those with chronic kidney disease, regardless of the presence or absence of type 2 diabetes mellitus. Current clinical guidelines strongly recommend the use of SGLT2 inhibitors in patients with chronic heart failure and a reduced ejection fraction (4). In recent years, Dapagliflozin, has emerged as a promising therapy for patients with HFrEF. Recent clinical trials, DAPA-HF and DELIVER established the potential benefits of Dapagliflozin in the management of heart failure.


DAPA-HF: Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure


The DAPA-HF trial evaluated the effects of Dapagliflozin in patients with heart failure and reduced ejection fraction (HFrEF), both with and without type 2 diabetes. This was a multinational, randomized, double-blind, placebo-controlled study. The trial enrolled over 4,700 patients and demonstrated significant benefits with Dapagliflozin compared to the placebo (4).


Cardiovascular death, hospitalization for heart failure, or urgent heart failure visit occurred in 16.3% of the Dapagliflozin group compared with 21.2% of the placebo group (p < 0.001) (4).


DELIVER: Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure


The objective of this trial is to investigate the effects of Dapagliflozin in patients with heart failure and preserved ejection fraction (HFpEF). This was a randomized, double-blind, placebo-controlled trial that enrolled over 4,800 patients (5).


Key study findings


  • Cardiovascular death or worsening HF – Dapagliflozin 16.4% vs. placebo 19.5%

  • Cardiovascular death - Dapagliflozin 7.4% vs. placebo 8.3%

  • HF hospitalization or urgent visit for HF: Dapagliflozin 11.8% vs.  placebo 14.5%


Dapagliflozin showed meaningful enhancements in heart failure symptoms, functional status, quality of life, and natriuretic peptides compared to the placebo group and no significant impact on mean NT-proBNP levels. Safety events were rare and evenly distributed between the groups (6).


Conclusion


Dapagliflozin, an SGLT2 inhibitor, has demonstrated significant clinical benefits in patients with HFrEF. Its ability to improve heart failure outcomes beyond glycemic control has established Dapagliflozin as a promising therapeutic approach. With its favourable efficacy and safety profile, Dapagliflozin offers new hope for patients living with HFrEF and represents a valuable addition to the existing heart failure treatments.

About the Author


Leena Patil is an M. Pharmacy post-graduate from research background. She is enthusiastic about learning new things and loves reading, painting, and traveling.


References


  1. Chaturvedi V, Parakh N, Seth S, et al. Heart failure in India: The INDUS (INDia Ukieri Study) study. J Pract Cardiovasc Sci 2016;2:28-35.

  2. Singh, A., Chauhan, S., Devasia, T. et al. Financial burden of heart failure in a developing country: cost analysis from Manipal Heart Failure Registry, India. J Public Health (Berl.) 29, 585–594 (2021).

  3. Gupta M, Rao S, Manek G, et al. The Role of Dapagliflozin in the Management of Heart Failure: An Update on the Emerging Evidence. Ther Clin Risk Manag. 2021 Aug 12;17:823-830.

  4. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008.

  5. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098.

  6. Nassif ME, Windsor SL, Tang F, et al. Dapagliflozin Effects on Biomarkers, Symptoms, and Functional Status in Patients With Heart Failure With Reduced Ejection Fraction: The DEFINE-HF Trial. Circulation. 2019 Oct 29;140(18):1463-1476.

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