What are the contraindications of Jardiance (Empagliflozin) in patients with heart failure?

From the Guidelines

Jardiance (empagliflozin) is not contraindicated in heart failure patients, but its use is contraindicated in patients with severe renal impairment (eGFR less than 45 mL/min/1.73m²), end-stage renal disease, or dialysis, as stated in the 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes 1.

Key Considerations

• The medication should be used with caution in patients with hypotension or volume depletion, as it can cause intravascular volume contraction 1.
• Patients with a history of serious hypersensitivity reactions to empagliflozin should avoid the medication 1.
• The standard dose for heart failure is 10 mg once daily, regardless of whether the patient has diabetes, though dose adjustments may be needed based on individual patient factors.

Recent Evidence

• A recent meta-analysis of data from EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, DELIVER, and the Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial demonstrated reduced risk for the composite of cardiovascular death or hospitalization for heart failure, cardiovascular death 2.
• The EMPEROR-Reduced trial assessed the effects of empagliflozin 10 mg once daily versus placebo on a primary composite outcome of cardiovascular death or hospitalization for worsening heart failure in a population of 3,730 individuals with NYHA class II, III, or IV heart failure and an ejection fraction of 40% or less, and found a 21% reduction in the primary outcome 2.

Patient Monitoring

• Patients with genital mycotic infections or history of recurrent urinary tract infections require careful monitoring 1.
• The medication should be temporarily discontinued before scheduled surgery or during acute illness that may lead to volume depletion.

Outcome

• Jardiance works by inhibiting sodium-glucose cotransporter-2 (SGLT2) in the kidneys, which increases glucose excretion and reduces cardiac preload and afterload, improving heart failure outcomes 2.

From the FDA Drug Label

1)]. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including JARDIANCE; some reports involved patients younger than 65 years of age Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs)

• Contraindications in heart failure: The FDA drug label does not explicitly state that Jardiance is contraindicated in heart failure. However, it does mention that congestive heart failure is a factor that may predispose patients to acute kidney injury, and that renal function should be evaluated prior to initiation of JARDIANCE and monitored periodically thereafter 3.
• Key considerations:
  • Use of JARDIANCE is not recommended when eGFR is persistently less than 45 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2.
  • Patients with heart failure may be at increased risk of acute kidney injury due to hypovolemia, chronic renal insufficiency, or concomitant medications.
  • Monitor patients for signs and symptoms of acute kidney injury and discontinue JARDIANCE promptly if acute kidney injury occurs.

From the Research

Jardiance Contraindications in Heart Failure

• The studies 4, 5, 6, 7, 8 do not explicitly state contraindications for Jardiance (empagliflozin) in heart failure, but rather highlight its benefits in reducing cardiovascular death, hospitalization for heart failure, and slowing the decline in kidney function.
• However, the studies do mention potential adverse effects of empagliflozin, including: + Genital infections 4, 7 + Kidney failure 4, 7 + Diabetic ketoacidosis 4 + Hepatotoxicity 4 + Risk of cancer (especially bladder cancer) 4 + Volume depletion and a fall in blood pressure, especially during co-administration with other diuretics or antihypertensive drugs 4
• The studies also note that empagliflozin interacts with nephrotoxic drugs, which can aggravate its adverse effects and decrease its hypoglycemic potency 4.
• It is essential to consider these potential adverse effects and interactions when prescribing Jardiance to patients with heart failure.
• The studies 5, 6, 7, 8 demonstrate the efficacy and safety of empagliflozin in patients with heart failure, including those with reduced ejection fraction and preserved ejection fraction, as well as those with and without diabetes.
• Overall, the evidence suggests that Jardiance can be a valuable treatment option for patients with heart failure, but its use should be carefully considered and monitored to minimize potential adverse effects.