2. Heart failure (HF) with kidney issues is a serious concern,
increasing hospitalizations and mortality rates.
Sacubitril/valsartan is a medication that benefits both the
heart and kidneys, reducing hospitalizations and deaths in
patients with reduced heart pumping ability (HFrEF).
The TRANSITION study compared the use of
sacubitril/valsartan in HFrEF patients, particularly those
with kidney problems, to those without.
The study assessed kidney function, heart markers, and re-
hospitalizations over a 26-week period
INTRODUCTION
Banerjee D etal national guidance. Heart. 2019;105(12):904-10
3. Methodology
Comparing heart medication-
sacubitril/valsartan, either in the
hospital or within 1-14 days after
leaving the hospital in stable
HFrEF patients with ADHF.
Adults (≥18 years) with reduced
heart pumping ability (HFrEF).
Hospitalized for sudden worsening
or new-onset heart failure (ADHF),
Ethical guidelines (ICH GCP, Helsinki)
were strictly adhered to in the study.
Study Design
Ethical
Compliance:
Randomizatio
n and
Treatment:
Comparison and
Assessment:
Patient
Population
Summary:
Patients were randomized 1:1 for
in-hospital or post-discharge
initiation of sacubitril/valsartan.
Treatment lasted for 10 weeks
from randomization, followed by a
16-week follow-up period.
The study compared how well and
safely sacubitril/valsartan was
increased between patients with
kidney problems (RD) and those
without.
RD was defined as eGFR of ≥30–
<60 mL/min/1.73 m2 at enrollment,
assessed using a formula.
General Assembly of the World Medical J Am Coll Dent. 2014;81(3):14-8.
4. Primary Endpoint -
Sacubitril/Valsartan
Dose Achievement:
Target dose (97/103 mg bid)
achievement at Week 10: 41.9% in
RD vs. 54.3% in non-RD.
No significant impact of in-hospital vs.
post-discharge initiation on target
dose achievement.
Secondary Endpoint -
Treatment Maintenance:
Patients with RD had lower
maintenance of target dose for ≥2
weeks by Week 10 (58.3% in RD vs.
72.7% in non-RD).
Higher discontinuation due to adverse
events in RD group (9.1% in RD vs.
2.5% in non-RD).
Result
01
02
Yan Y etal Esc Heart Fail. 2021;8(3):2210-9.
5. Discussion points
Renal Dysfunction (RD) in
HF Patients:
•RD is common in HF and
worsens patient outlook.
•It leads to less use of vital
HF treatments.
PARADIGM-HF Trial and RD:
•In a major trial, over 30% with RD
benefitted from
sacubitril/valsartan.
TRANSITION Study Findings:
•Starting sacubitril/valsartan in
the hospital after HF is doable,
with half reaching the right dose
early.
•Other health issues often limit
proper HF treatment.
Impact of Sacubitril/Valsartan
on Biomarkers and Renal
Function:
•This treatment notably betters
biomarkers and kidney function in
HF, particularly for those with RD.
Treatment Individualization
and TITRATION Study:
•Tailoring treatment and
gradually increasing doses
work well, especially for those
with RD.
Damman K .etal JACC Heart Fail. 2018;6(6):489-98
6. Tolerability of Sacubitril/Valsartan:
Most HFrEF patients with RD tolerated early
initiation of sacubitril/valsartan after ADHF,
showing good tolerance.
Renal Function Improvement:
Starting sacubitril/valsartan led to significant and
sustained improvements in eGFR, a marker of
kidney function.
Encouraging ARNI Use:
The proven benefits of ARNI in HFrEF should
encourage physicians to start sacubitril/valsartan
early, even in patients with RD.
Quiroga B Nefrologia (Engl Ed). 2019;39(6):646- 52.