- 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.
- 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.
- 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).
- HbA1c, %:
- 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.
- Many participants were Japanese.
- Short duration.