Efficacy and safety of Dapagliflozin in chronic kidney disease stages 4 and 5.

<h2 id="background">Background</h2><p>Patients with stage 4 and 5 CKD have a notably high risk of cardiorenal syndrome, with potential complications of AKI and HF.</p><h2 id="aim">Aim</h2><p>Study aims to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with CKD.</p><h2 id="method">Method</h2><ul><li>This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study.</li><li>Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease (DAPA advKD) trial enrolled patients with eGFR levels 10-30 mL/min/1.73 m2 and who had a steady eGFR decline of:2:: 2.5 mL/min/1.73 m2 per year.</li><li>"This is the first SGLT2 inhibitor renal outcome trial to include patients with an eGFR less than 20 mL/min/1.73 m2" quoted the author as the findings were presented at the American Society of Nephrology (ASN) Kidney Week 2024.</li><li>Patients 2:: 20 years were randomly assigned 2:1 to treatment with dapagliflozin 5 to 10 mg per day (n = 120), in addition to integrated CKD care, or integrated CKD care alone (n = 60).</li><li>Both groups had mean age of 67.5 vs 71.4 years; female population 34.2% vs 45%, respectively.</li><li>Mean eGFR at baseline was about 19 mL/min/1.73 m2 and 56 patients had stage 5 CKD.</li></ul><h2 id="study-outcomes">Study Outcomes</h2><ul><li><strong>Primary outcome:</strong><ul><li>Time to the First Occurrence of Any of the Components of the Composite: 2::50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.</li></ul></li><li><strong>Secondary outcome:</strong><ul><li><strong>First:</strong> Time to the First Occurrence of Any of the Components of the Composite: 2::50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.</li><li><strong>Second:</strong> Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.</li><li><strong>Third:</strong> Time to Death From Any Cause.</li></ul></li></ul><h2 id="results">Results</h2><ul><li>In patients with CKD stage 4-5, Dapagliflozin plus integrated CKD care compared to CKD care alone showed,<ul><li>Improved total eGFR slope composite renal outcomes</li><li>Improved composite renal and HF outcomes</li><li>Improved renal and CV outcomes.</li></ul></li><li>The primary and secondary outcomes of Dapagliflozin plus integrated CKD care compared to CKD care alone in patients with CKD stage 4-5 are shown in the table.</li></ul><h2 id="table">Table</h2><ul><li>Comparison of primary and secondary outcomes in Dapagliflozin plus integrated therapy vs integrated therapy alone.</li></ul><figure class="image"><img style="aspect-ratio:726/196;" src="https://cdn.megawecare.com/GHBY/Internal-Images/diabetes%20update.webp" width="726" height="196"></figure><ul><li>A subgroup analysis of the renal composite outcome favored the use of dapagliflozin plus integrated care regardless of CKD stage, UACR level, or use of RAS inhibitors.</li><li>SAEs occurred in 31.2% of patients in the dapagliflozin group vs 40% with integrated care.</li><li>No significant differences in terms of MACE, electrolyte imbalances, other nonfatal SAEs including HHF, CKD fluid overload hospitalization, and 5-point MACE were observed between the groups.</li></ul><h2 id="conclusion">Conclusion</h2><ul><li>Dapagliflozin was found to be safe in patients with CKD stages 4-5.</li><li>Dapagliflozin provides significant benefits in the treatment of CKD even when initiated in patients with the most severe stages of the disease who are typically excluded from clinical trials.</li></ul>

Diabetes Update   Issue 6   Nov 2024

<ul><li><a href="#background">Background</a></li><li><a href="#aim">Aim</a></li><li><a href="#method">Method</a></li><li><a href="#study-outcomes">Study Outcomes</a></li><li><a href="#results">Results</a></li><li><a href="#table">Table</a></li><li><a href="#conclusion">Conclusion</a></li></ul><p>&nbsp;</p>

Efficacy and safety of Dapagliflozin in chronic kidney disease stages 4 and 5.

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