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 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 CV efficacy 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 a median of 2 days following hospital discharge.1
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
Additionally, a 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 days2
HR 0.49 (95% CI: 0.27, 0.91)
Limitations of analysis: This post hoc analysis occurred after the protocol-specified final analysis.2 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 43Number Needed to Treat to prevent 1 primary composite event of CV death, hospitalization for HF, and urgent HF visit.3
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=4.4
ARR=absolute risk reduction; CI=confidence interval; HR=hazard ratio; 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 guidelines recommend SGLT inhibitors as a foundational therapy5,6
2022 AHA/ACC/HFSA Joint Guidelines5
- Recommend GDMT should be initiated before discharge for patients with HFrEF
- State GDMT optimization is a critical component of a transition of care plan for HF patients
- Recommend using SGLT inhibitors as first-line GDMT (a Class 1A recommendation) for HFrEF
2021 ESC Guidelines6
- Recommend administering OMT pre discharge in patients with acute HF
AHA=American Heart Association; ACC=American College of Cardiology; ESC=European Society of Cardiology; GDMT=guideline‑directed medical therapy; HFrEF=heart failure with reduced ejection fraction; HFSA=Heart Failure Society of America; OMT=optimal medical therapy; SGLT=sodium‑glucose cotransporter.
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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