Discover INPEFA®: Powerful risk reduction in HF events1
SOLOIST‑WHF Study:
HR=0.67 [95% CI: 0.53, 0.85], p=0.001
SCORED Study:
HR=0.75 [95% CI: 0.63, 0.88], p<0.001
INPEFA is an inhibitor of SGLT2 and SGLT1 that reduces the risk of CV death, hospitalization for HF, and urgent HF visit in adults with:
Heart Failure,1 or
Type 2 diabetes mellitus, chronic kidney disease, and other CV risk factors1
CI=confidence interval; CV=cardiovascular; HF=heart failure; HR=hazard ratio; SGLT1=sodium-glucose cotransporter 1; SGLT2=sodium-glucose cotransporter 2; WHF=worsening heart failure.
INPEFA, as featured in the HF management guidelines, is considered a first-line therapy for patients with HF regardless of EF1‑3
EF=ejection fraction.
Learn about the efficacy and safety of INPEFA
Soloist‑WHF Study: Patients with worsening HF
A multi‑center, randomized, double‑blind, placebo‑controlled, Phase 3 study in patients with T2DM who had been admitted to the hospital, HF unit, infusion center, or emergency department for worsening HF (N=1,222), evaluating the HF outcomes and safety of INPEFA (n=608) versus placebo (n=614) when added to standard of care.1
T2DM=type 2 diabetes mellitus.
Assigned treatment was initiated in the hospital or within 3 days following hospital discharge.1,4
33% risk reduction*
in the primary composite endpoint of CV death, hospitalization for HF, and urgent HF visit.1
HR=0.67 (95% CI: 0.53, 0.85), p=0.001
*Relative risk reduction.
A low NNT of 45
Number Needed to Treat to prevent 1 primary composite event of CV death, hospitalization for HF, and urgent HF visit.5
Calculation: The rate of primary endpoint events was 51.3 events per 100 patient years in the INPEFA group and 76.4 events per 100 patient years in the placebo group. Absolute difference=76.4‑51.3=25.1, NNT=1/ARR=1/0.25=4 patient years.4
Post hoc analysis in patients initiated on INPEFA or before discharge showed:
>50% risk reduction*
in readmission for HF‑related event or CV death at 30 days, with consistent efficacy extending over 90 days.6
30 days: HR=0.49 (95% CI: 0.27, 0.91)
90 days: HR=0.54 (95% CI: 0.35, 0.82)
*Relative risk reduction.
Limitations of analysis: This post hoc analysis occurred after the protocol‑specified final analysis.6 No formal statistical testing was planned for this analysis; therefore, no conclusions can be drawn. These data are not in the USPI and results should be interpreted with caution.
ARR=absolute risk reduction; NNT=number needed to treat; USPI=United States Prescribing Information.
Adverse events in SOLOIST‑WHF Study
Adverse reactions reported in ≥2% of patients treated with INPEFA and at greater frequency than placebo were urinary tract infection (8.6% vs 7.2%), volume depletion (9.3% vs 8.8%), diarrhea (6.9% vs 4.1%), hypoglycemia (4.3% vs 2.8%), and dizziness (2.6% vs 2.5%).1
Scored Study: Patients at risk of HF events
A multi-center, randomized, double-blind, placebo‑controlled, Phase 3 study in 10,584 patients with T2DM, CKD, and additional CV risk factors, evaluating the HF outcomes of INPEFA versus placebo when added to standard of care.1
INPEFA demonstrated a
25% risk reduction*
in the primary composite endpoint of CV death, hospitalization for HF, and urgent HF visit.1
HR=0.75 (95% CI: 0.63, 0.88), p<0.001
*Relative risk reduction.
21% risk reduction* in 3‑point MACE,†
a composite of total occurrence of CV death, nonfatal MI, and nonfatal stroke.7
30% risk reduction* in the independent contribution of both nonfatal MI and nonfatal stroke as part of 3‑point MACE7†
- Nonfatal MI: 30% RRR, HR=0.70
(95% CI: 0.53, 0.94) - Nonfatal stroke: 30% RRR, HR=0.70
(95% CI: 0.50, 0.99) - CV death‡: 10% RRR, HR=0.90
(95% CI: 0.73, 1.12)
*Relative risk reduction.
†3‑point MACE was a predefined secondary endpoint.7
‡Time‑to‑event analysis was performed; event rates are percentages of patients with events.7
Limitations of analysis: 3‑point MACE was a secondary endpoint. Statistical analysis was not performed based on hierarchical testing.7 These data are not in the USPI and results should be interpreted with caution. No conclusions should be drawn.
CKD=chronic kidney disease; MACE=major adverse cardiac events; MI=myocardial infarction; RRR=relative risk reduction.
Adverse events in SCORED Study
Adverse reactions reported in ≥2% of patients treated with INPEFA and at greater frequency than placebo were urinary tract infection (11.5% vs 11%), volume depletion (5.2% vs 4%), diarrhea (8.4% vs 6%), hypoglycemia (7.7% vs 7.9%), dizziness (3.3% vs 2.8%), and genital mycotic infection (2.4% vs 0.9%).1
INPEFA is considered a first‑line therapy for patients with HF regardless of EF1‑3
INPEFA is featured in clinical practice HF guidelines2,3,8
The clinical benefits of INPEFA for patients with HF, as demonstrated in the SOLOIST‑WHF study, were featured in the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure and were carried through in the 2023 ACC Expert Consensus Decision Pathway on Management of HFpEF and 2024 ACC Expert Consensus Decision Pathway for Treatment of HF with HFrEF2,3,8
2022 AHA/ACC/HFSA HFGuideline Summary
HFrEF2,3
2024 ACC Expert Consensus Decision Pathway for Treatment of HFrEF
- Recognizes SGLT inhibitors (including SGLT1/2 or SGLT2 inhibitors) as a core therapy in the 4 pillars of medical care for HFrEF
- Reports that in SOLOIST-WHF, INPEFA reduced HF events among individuals with T2DM hospitalized for HF who were treated during or soon after hospitalization
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
- Recommends SGLT inhibitors as class 1A GDMT for HFrEF
- Reports that SOLOIST‑WHF, which evaluated INPEFA in patients with worsening HF, demonstrated the benefits of in‑hospital initiation of GDMT in patients with worsening HF
HFmrEF2
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
- Recommends SGLT inhibitors as class 2A GDMT that can be beneficial in decreasing HF hospitalizations and CV mortality
HFpEF2,8
2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure with Preserved Ejection Fraction
- Establishes SGLT inhibitors as the foundational therapy for HFpEF
- Asserts that INPEFA significantly reduced the risk of CV death, hospitalization for HF, and urgent HF visit when compared to placebo as evaluated in SOLOIST‑WHF
2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
- Recommends SGLT inhibitors as class 2A GDMT for HFpEF
ACC=American College of Cardiology; AHA=American Heart Association; GDMT=guideline‑directed medical therapy; HFmrEF=heart failure with mid‑range ejection fraction; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; HFSA=Heart Failure Society of America; SGLT=sodium‑glucose cotransporter.