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INPEFA® reduced the risk of the composite of CV death, hospitalization for HF, and urgent HF visit in patients with T2DM, CKD, and additional CV risk factors1
CKD=chronic kidney disease; CV=cardiovascular; HF=heart failure; T2DM=type 2 diabetes mellitus.
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
Patients enrolled in SCORED received the standard of care regimen, including GDMT. At baseline, patients received RAAS inhibitors (88%), beta-blockers (14%), calcium channel blockers (42%), loop diuretics (35%), and additional diuretics (30%).1
GDMT=guideline-directed medical therapy; RAAS=renin-angiotensin-aldosterone system.
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.
CI=confidence interval; HR=hazard ratio.
In a cumulative events plot of the primary endpoint, the INPEFA and placebo event curves separated early and continued to diverge over the study period following randomization.1
*Relative risk reduction.
INPEFA demonstrated a
30% risk reduction* in the independent contribution of both nonfatal MI and nonfatal stroke as part of 3‑point MACE2†
*Relative risk reduction.
†3-point MACE was predefined secondary endpoint.2
‡Time-to-event analysis was performed; event rates are percentages of patients with events.2
Limitations of analysis: 3-point MACE was a secondary endpoint. Statistical analysis was not performed based on hierarchical testing.2 These data are not in the USPI and results should be interpreted with caution. No conclusions should be drawn.
MACE=Major Adverse Cardiac Events; MI=myocardial infarction; RRR=relative risk reduction; USPI=United States Prescribing Information.
| SCORED (N=10,577) | ||
|---|---|---|
| Adverse Reaction | INPEFA (n=5,291) | Placebo (n=5,286) |
| Urinary tract infection | 11.5% | 11.0% |
| Volume depletion | 5.2% | 4.0% |
| Diarrhea | 8.4% | 6.0% |
| Hypoglycemia | 7.7% | 7.9% |
| Dizziness | 3.3% | 2.8% |
| Genital mycotic infection | 2.4% | 0.9% |
Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.
INPEFA is contraindicated in patients with hypersensitivity to any component.
INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.
INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.
Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.
Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.
Reports of Fournier's Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.
INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate.
These are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.
The most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
Please see full Prescribing Information and Patient Medication Guide.
INPEFA® is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.
INPEFA is contraindicated in patients with hypersensitivity to any component.
INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.
INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.
Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.
Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.
Reports of Fournier's Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.
INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate.
These are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.
The most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.
INPEFA® is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
Please see full Prescribing Information and Patient Medication Guide.
