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Abstract: SA-PO272

Effect of Spironolactone Wash-Out on Albuminuria After Long-Term Treatment: The AFTER-PRIORITY Study

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Wasehuus, Victor, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Rotbain Curovic, Viktor, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Tofte, Nete, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Lindhardt, Morten, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Delles, Christian, University of Glasgow Institute of Cardiovascular and Medical Sciences, Glasgow, United Kingdom
  • Frimodt-Moller, Marie, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Mischak, Harald, Mosaiques Diagnostics, Hannover, Germany
  • Persson, Frederik, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • von der Leyen, Heiko, Hannover Clinical Trial Center Hannover Medical School, Hannover, Germany
  • Hansen, Tine, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Capital Region, Denmark

Group or Team Name

  • PRIORITY Study Group
Background

The PRIORITY study showed that treatment with spironolactone did not prevent progression to microalbuminuria in high kidney risk individuals as classified by the urinary proteomic risk classifier – CKD273. As spironolactone has previously shown to significantly lower albuminuria levels in chronic kidney disease, we have investigated the difference in albuminuria and kidney risk markers 6 weeks after spironolactone discontinuation.

Methods

Observational study following the nested randomized clinical trial in the PRIORITY study. A total of 115 individuals with type 2 diabetes and normoalbuminuria but high-risk for progression based on urinary proteomics, previously randomized to daily spironolactone or placebo were seen 6±2 weeks after the final visit in PRIORITY. The primary endpoint was change in urinary albumin-creatinine ratio (UACR) between the final visit in PRIORITY (baseline) and follow-up. Secondary endpoints were change in estimated glomerular filtration rate (eGFR), systolic and diastolic blood pressure (BP), and serum potassium. Statistical analysis was done using paired t-test to assess the change between baseline and follow-up and unpaired t-test for between-group analysis of end-to-end results.

Results

The mean age of the study subjects was 66±6 years and 90 (78.3%) were male. Baseline HbA1c was 56±17 mmol/mol, and eGFR was 78±19 ml/min/1.73m2. No change in UACR was observed in neither the spironolactone group (Median change: 33%, IQR -37;104, p=0.28) nor the placebo group (9%, -27;81, p=0.63) at follow-up. No difference between the groups was observed at end of study (Log difference: 0.05 mg/g, -0.22;0.13, p=0.60). Assessing the secondary endpoints, eGFR and systolic BP are seen increasing after discontinuation of spironolactone, and for systolic BP after placebo discontinuation as well. Potassium levels were lower after discontinuation of spironolactone, but higher after placebo discontinuation (all p<0.05).

Conclusion

This study supports the findings of the PRIORITY trial, that spironolactone exerted no effect on UACR in a high-risk kidney population, as classified by CKD273 score. Our findings do not support the use of spironolactone for preventing progression to microalbuminuria in high kidney risk individuals.

Funding

  • Government Support – Non-U.S.