Abstract: SA-OR081
Reduction in Albuminuria with Dapagliflozin Cannot Be Predicted by Baseline Clinical Characteristics or Changes in Most Other Risk Markers
Session Information
- New Considerations for Renoprotection Clinical Trials
October 27, 2018 | Location: 1B, San Diego Convention Center
Abstract Time: 05:06 PM - 05:18 PM
Category: CKD (Non-Dialysis)
- 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Lambers Heerspink, Hiddo Jan, University of Groningen, Groningen, Netherlands
- Sjostrom, David, AstraZeneca, Gothenburg, Sweden
- Inzucchi, Silvio E., Yale University School of Medicine, New Haven, Connecticut, United States
- Hallow, Melissa, University of Georgia School of Public Health, Athens, Georgia, United States
- Cain, Valerie, Bogier Clinical and IT Solutions, Inc., Raleigh, North Carolina, United States
- Rossing, Peter, Steno Diabetes Center, Copenhagen, Gentofte, Denmark
- Stefansson, Bergur V., AstraZeneca, Gothenburg, Sweden
- Sartipy, Peter, AstraZeneca, Gothenburg, Sweden
Background
The sodium glucose co-transporter 2 inhibitor dapagliflozin (DAPA) has been shown to decrease the urine albumin:creatinine ratio (UACR). This effect varies markedly among individual patients. This study assessed the baseline characteristics and concurrent changes in other cardiovascular risk markers that could be associated with UACR response to DAPA.
Methods
A pooled analysis of 11 phase 3, randomized, controlled clinical trials was performed. UACR change from baseline post 24 weeks treatment with DAPA (10 mg/day) in 531 patients with type 2 diabetes and UACR ≥30 mg/g was determined. UACR response was defined as >30% reduction from baseline at 24-weeks and UACR non-response was defined as ≤30% reduction at 24-weeks.
Results
A total of 288 (54%) patients were classified as responders and 243 (46%) as non-responders. At 24 weeks, the UACR adjusted mean change from baseline appeared to be bimodal: −71.2% (95% CI: −73.7 to −68.3) in responders and 25.9% (95% CI: 17.1 to 35.4) in non-responders (Table). Baseline UACR, HbA1c, estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP), body weight, cardiovascular disease history, and concomitant anti-diabetic medication use were similar between responders and non-responders. Changes in HbA1c, body weight, and haematocrit were also similar between the two groups. Responders showed a numerically larger reduction in SBP and eGFR compared to non-responders (Table). The incidence of hypoglycaemia and other adverse events was similar between the two groups.
Conclusion
UACR reduction to DAPA is an individual characteristic that cannot be predicted by baseline clinical features. It is associated with a modestly larger concurrent reduction in SBP and eGFR. Whether UACR responders compared to non-responders show improved long-term renal and cardiovascular outcomes remains to be determined.
Table: Adjusted mean change from baseline at week 24*
Funding
- Commercial Support –