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Soloist‑WHF
INPEFA® demonstrated significant efficacy in reducing the composite risk of CV death, hospitalization for HF, and urgent HF visit, regardless of EF1
SOLOIST‑WHF—a multi-center, randomized, double‑blind, placebo‑controlled, Phase 3 study in patients with type 2 diabetes mellitus who had been admitted to the hospital, heart failure 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 post hoc analysis: This 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 US Prescribing Information 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 visit4,†
Limitations of post hoc analysis: This 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 US Prescribing Information and results should be interpreted with caution.
*Relative risk reduction.
†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; CV=cardiovascular; EF=ejection fraction; HF=heart failure; NNT=number needed to treat.
33% risk reduction* in the primary composite endpoint of CV death, hospitalization for HF, and urgent HF visit1
In a cumulative events plot of the primary composite endpoint, INPEFA® and placebo event curves diverged early and remained separated over the study period.1
Primary Endpoint1
Primary composite endpoint (total occurrence of CV death, hospitalization for HF, and urgent HF visit) was based on investigator-reported events in all randomized patients, analyzed according to the treatment group allocated by randomization.1
CI=confidence interval; HR=hazard ratio.
An incredibly low
NNT of 44
Number Needed to Treat to prevent 1 primary composite event of CV death, hospitalization for HF, and urgent HF visit4,§
§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
Post Hoc Analysis3
>50% risk reduction in readmission for HF‑related event or CV death within 30 days3
Readmission for HF‑related event or CV death within 30 and 90 days from hospital discharge‡
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.
USPI=United States Prescribing Information.
‡Patients included in this analysis received INPEFA® prior to discharge in either the hospital or urgent care setting.3
The INPEFA® safety profile in the 30‑ and 90‑day post-randomization windows was generally consistent with that observed for the overall study duration.3
INPEFA® SOLOIST‑WHF study adverse events
Adverse reactions reported in ≥2% of patients treated with INPEFA® and at greater frequency than placebo.1
SOLOIST‑WHF(N=1,216) | ||
---|---|---|
Adverse Reaction | INPEFA®(n=605) | Placebo(n=611) |
Urinary tract infection | 8.6% | 7.2% |
Volume depletion | 9.3% | 8.8% |
Diarrhea | 6.9% | 4.1% |
Hypoglycemia | 4.3% | 2.8% |
Dizziness | 2.6% | 2.5% |
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