INPEFA® is an inhibitor of SGLT2 and SGLT1.
INPEFA® is indicated to reduce the risk of CV death, hospitalization for heart failure, and urgent HF visit in adults with:
heart failure1, or
type 2 diabetes mellitus, chronic kidney disease, and other CV risk factors1
INPEFA® is a once‑daily,
200 mg, oral treatment1
CV=cardiovascular; HF=heart failure; SGLT1=sodium‑glucose cotransporter 1; SGLT2=sodium‑glucose cotransporter 2.
SOLOIST‑WHF: Demonstrated significant efficacy of INPEFA® in reducing the composite risk of CV death, hospitalization for HF, and urgent HF visit1
SOLOIST‑WHF—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
Assigned treatment was initiated in the hospital or within 3 days following hospital discharge.2
33%risk reduction*
in the primary composite endpoint of CV death, hospitalization for HF, and urgent HF visit1
HR 0.67 (95% CI: 0.53, 0.85), p=0.001
Post hoc analysis in patients initiated on or before discharge showed:
>50% risk reduction* in readmission for HF‑related event or CV death within 30 days3
HR 0.49 (95% CI: 0.27, 0.91)
Limitations of analysis: This post hoc analysis occurred after the protocol-specified final analysis.3 No formal statistical testing was planned for this analysis therefore no conclusions can be drawn. This data is not in the USPI and results should be interpreted with caution.
An incredibly low NNT of 44Number Needed to Treat to prevent 1 primary composite event of CV death, hospitalization for HF, and urgent HF visit.4
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 patients for a year.2
ARR=absolute risk reduction; CI=confidence interval; HR=hazard ratio; NNT=number needed to treat; T2DM=type 2 diabetes mellitus; USPI=United States Prescribing Information.
*Relative risk reduction.
INPEFA® adverse events
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
HF treatment guideline recommends SGLT inhibitors as a foundational therapy5
2022 AHA/ACC/HFSA Joint Guideline5
- Recommends using SGLT inhibitors as first-line GDMT (a Class 1A recommendation) for HFrEF
- Recommends GDMT should be initiated before discharge for patients with HFrEF
- States GDMT optimization is a critical component of a transition of care plan for HF patients
- References SOLOIST‑WHF study
2023 ACC expert consensus6
- Establishes SGLT inhibitors as the foundational therapy for HFpEF
ACC=American College of Cardiology; AHA=American Heart Association; GDMT=guideline‑directed medical therapy; HFpEF=heart failure with preserved ejection fraction; HFrEF=heart failure with reduced ejection fraction; HFSA=Heart Failure Society of America; SGLT=sodium‑glucose cotransporter.
Review SCORED
study data
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.
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