Heart failure & cardiomyopathies
Influence of Diabetes on Sacubitril/Valsartan Titration and Clinical Outcomes in Patients Hospitalized for Heart Failure
Authors' conclusion
Despite a higher risk profile among patients with diabetes, sacubitril/valsartan initiation either before or shortly after discharge in hospitalized patients with HFrEF resulted in comparable rates of dose up-titration and tolerability as in those without diabetes.
Study context
- Population
- Patients hospitalised for acutely decompensated heart failure with reduced ejection fraction (HFrEF), stabilised after admission460 (46.4%) with diabetes
- Participants
- 991 patients
- Comparison
- Sacubitril/valsartan initiation pre-discharge vs post-discharge, by diabetes status
- Diabetesn = 460
- Primary endpoint
- Achievement of sacubitril/valsartan target dose (97/103 mg bid)
- Follow-up
- 10 weeks
Methodological detailsopen-label, post hoc subgroup analysis
- Open-label
- Post hoc subgroup analysis
Primary result
As reported in the abstract
Relative risk ratio (RRR)
0.923
P = 0.412
diabetes subgroup: 47% (n = 105/226) vs 50% (n = 115/228)
RRR
0.878
P = 0.155
non-diabetes subgroup: 45% (n = 119/267) vs 51% (n = 133/261)
Further findings
| Outcome | Diabetes | Non-diabetes | RRR | P value |
|---|---|---|---|---|
| Achieving and maintaining 49/51 mg or 97/103 mg bid, by diabetes subgroup · 10 weeks | 0.909 | P = 0.175 | ||
| Achieving and maintaining 49/51 mg or 97/103 mg bid, by diabetes subgroup · 10 weeks | 0.906 | P = 0.118 | ||
| Any dose for ≥2 weeks leading to Week 10, by diabetes subgroupDiabetes subgroup: 85% (n = 192/226) vs 88.2% (n = 201/228) | 0.966 | P = 0.356 | ||
| Any dose for ≥2 weeks leading to Week 10, by diabetes subgroup | 0.963 | P = 0.215 | ||
| Mortality · 26 weeksDiabetes vs Non-diabetes | 3.3% | 4.0% | P = 0.438 | |
| HF rehospitalisation · 26 weeksDiabetes vs Non-diabetes | 36.3% | 33.0% | P = 0.295 |
- Achieving and maintaining 49/51 mg or 97/103 mg bid, by diabetes subgroup: diabetes subgroup: 61.1% (n = 138/226) vs 67.5% (n = 154/228)
- Achieving and maintaining 49/51 mg or 97/103 mg bid, by diabetes subgroup: non-diabetes subgroup: 62.9% [n = 168/267] vs 69.3% [n = 181/261]
- Any dose for ≥2 weeks leading to Week 10, by diabetes subgroup: non-diabetes subgroup: 86.9% (n = 232/267) vs 90.8% (n = 237/261)
Uptitration and tolerability · 26 weeks
- Similar patterns of uptitration and tolerability
NT-proBNP and hs-TnT · Weeks 4 and 10
- NT-proBNP reduced significantly from baseline in both subgroups
- P < 0.005
- hs-TnT reduced significantly from baseline in both subgroups
- P < 0.005
- Greater response among patients without diabetes
Safety
| Outcome | Diabetes | Non-diabetes |
|---|---|---|
| Hyperkalaemia · 10 weeks | 15.9% | 9.5% |
Hyperkalaemia · 10 weeks
- Hypotension and renal dysfunction rates similar
Permanent discontinuation due to adverse events · 10 weeks
- Pre-discharge: diabetes vs non-diabetes
- 7.5% vs. 7.1%
- Post-discharge: diabetes vs non-diabetes
- 5.7% vs. 4.2%
Original publication
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