Weekly exenatide is acceptable for T2D with moderate CKD

  • Guja C & al.
  • Diabetes Ther
  • 18 Apr 2020

  • curated by Miriam Tucker
  • Clinical Essentials
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Takeaway

  • Efficacy and safety of exenatide once-weekly (EQW) in patients with type 2 diabetes (T2D) and mild/moderate chronic kidney disease (CKD2/CKD3) are consistent with the known profile and similar between CKD2 and CKD3.

Why this matters

  • The safety profile in CKD3 was not well-established.

Study design

  • Pooled data from 8 phase 3 trials of EQW vs comparator in patients with CKD2 (n=772) or CKD3 (n=182).
  • Funding: Astra Zeneca Pharmaceuticals LP.

Key results

  • From baseline to week 26/28, between the CKD2 and CKD3 groups receiving EQW, adjusted mean changes (95% CI) were similar for:
    • HbA1c, %:
      • CKD2: −1.37 (−1.45 to −1.28) vs 
      • CKD3: −1.46 (−1.75 to −1.17).  
    • Body weight, kg:
      • CKD2: −2.18 (−2.49 to −1.87) vs 
      • CKD3: −2.61 (−3.68 to −1.55).
    • Systolic BP, mmHg:
      • CKD2: −2.2 (−3.2 to −1.2) vs
      • CKD3: −2.0 (−6.1 to 2.1).
  • Adverse effects (AEs) more common with EQW vs comparators in CKD3 (81% vs 74%) than CKD2 (72% vs 68%).
  • Serious AE rates were similar:
    • CKD2: 3.4% EQW vs 4.9% comparators.
    • CKD3: 2.7% EQW vs 6.2% comparators. 
  • Gastrointestinal AEs more common with EQW in CKD3 (42.2% vs 18.6% comparators) vs CKD2 (32.8% EQW vs 18.8% comparators).
    • However, nausea/vomiting rates were similar between the CKD groups. 
  • No dehydration; acute kidney injury occurred in 1 EQW/CKD3 and 1 comparator/CKD2.

Limitations

  • Many participants were Japanese.
  • Short duration.