Heart failure & cardiomyopathiesSecondary analysis
Sex Differences in Diabetic Cardiomyopathy and Treatment Response to AT-001
- Secondary analysis of the ARISE-HF randomised trial
- Phase 3
- international
- placebo-controlled
- sex-based subgroup analysis
Authors' conclusion
Despite baseline differences between women and men with DbCM, the efficacy and safety of high-dose AT-001 are comparable across sexes.
Study context
- Population
- Patients with diabetic cardiomyopathy (DbCM) and T2DM at high risk for progression to overt heart failure (HF)
- Participants
- 691 patients
- Comparison
- High-dose AT-001 vs placebo, by sex
- Womenn = 348
- Primary endpoint
- Sex differences in baseline characteristics and in treatment response to high-dose AT-001 (aldose reductase inhibitor)
Primary result
As reported in the abstract
Placebo-corrected peak oxygen uptake change with high-dose AT-001, by sex
Women
0.26
Men
0.27
P = 0.58
Further findings
| Outcome | Women | Men |
|---|---|---|
| Baseline characteristics, women vs men | ||
| NT-proBNP | 92 ng/L | 60 ng/L |
| Peak oxygen uptake | 13.87 mL/kg/min | 17.59 mL/kg/min |
| CPET duration | 8.47 minutes | 11.05 minutes |
| KCCQ overall summary score | 87.79 | 92.55 |
| PASE score | 137.87 | 171.09 |
- Baseline characteristics, women vs men: all P < 0.001
Change in KCCQ and PASE scores, by sex · baseline to month 15
- No significant sex differences
- all P > 0.05
Original publication
Sex Differences in Diabetic Cardiomyopathy and Treatment Response to AT-001. JACC Heart Fail. Published 8 May 2025. doi:10.1016/j.jchf.2025.02.015
Summarised from the published abstract; every number is checked against it