Sex differences in response to the endothelin receptor antagonist atrasentan in individuals with type 2 diabetes and chronic kidney disease: a post hoc analysis of the SONAR trial
Authors' conclusion
Atrasentan showed greater kidney protection in female than in male participants but also induced more heart failure events in the female participants. These data suggest that sex-specific dosing regimens may be considered to optimise ERA treatment.
Study context
- Population
- Individuals with T2D and chronic kidney disease (CKD) (eGFR 25–75 ml/min per 1.73 m², UACR 300–5000 mg/g); 946 (25.8%) femalerandomised
- Participants
- 3,668 individuals
- Comparison
- Atrasentan 0.75 mg/day vs placebo, by sex
- Primary endpoint
- Time to first doubling in serum creatinine or kidney failure (eGFR <15 ml/min per 1.73 m², chronic dialysis, kidney transplantation or death from kidney failure)
Methodological detailsdouble-blind, placebo-controlled, subgroup analysis by sex
- Double-blind
- Placebo-controlled
- Subgroup analysis by sex
Primary result
As reported in the abstract
Composite kidney outcome, by sex
Atrasentan vs PlaceboHazard ratio (95% CI)P value
Female participants
0.46(0.28–0.76)
Male participants
0.83(0.65–1.05)
p value for interaction 0.032Secondary outcomes
Atrasentan plasma exposure (geometric mean AUC)
P < 0.001
| Outcome | Treatment effect difference (ml/min per 1.73 m²) | P value |
|---|---|---|
| eGFR decline, treatment effect by sexAtrasentan reduced eGFR decline more in female participants | −0.99 | P for interaction = 0.020 |
Safety
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| Hospitalisation for HF, by sexAtrasentanvs PlaceboMale participants | 1.14 (0.74–1.76) | ||
| Hospitalisation for HF, by sexAtrasentanvs PlaceboFemale participants | 1.88 (0.98–3.63) | P for interaction = 0.217 | |
| 0.20.5125Relative risk (log scale) |
Original publication
Sex differences in response to the endothelin receptor antagonist atrasentan in individuals with type 2 diabetes and chronic kidney disease: a post hoc analysis of the SONAR trial. Diabetologia. Published 11 December 2024. doi:10.
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