When is Spironolactone (Aldactone) used in the treatment of heart failure?

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Last updated: January 26, 2025 • View editorial policy

From the Guidelines

Spironolactone (Aldactone) is used in the treatment of heart failure when patients remain symptomatic despite optimal treatment with ACE inhibitors and beta blockers, particularly in those with severe heart failure (NYHA III-IV).

Key Indications

  • Severe heart failure (NYHA III-IV): Spironolactone is recommended in addition to ACE inhibition and diuretics to improve survival and morbidity 1.
  • Advanced heart failure: The RALES mortality trial showed that low-dose spironolactone (12.5–50 mg) on top of an ACE inhibitor and a loop diuretic markedly and progressively improved survival of patients in advanced (NYHA class III or IV) heart failure 1.

Administration and Dosing

  • Initial dose: 12.5–25 mg daily 2.
  • Monitoring: Check serum potassium and creatinine after 4–6 days, and adjust dose accordingly 2.
  • Contraindications: Avoid using spironolactone in patients with severe renal impairment (creatinine >250 mmol/L) or hyperkalemia (potassium >5.0 mmol/L) 2.

Benefits

  • Mortality reduction: Spironolactone has been shown to reduce mortality by 30-35% in patients with severe heart failure 1, 3.
  • Hospitalization reduction: Spironolactone has also been shown to reduce hospitalization rates for worsening heart failure 1, 3.

Important Considerations

  • Hyperkalemia risk: Spironolactone can cause hyperkalemia, particularly when used with ACE inhibitors or ARBs, and requires careful monitoring of serum potassium levels 3, 4.

From the FDA Drug Label

Heart Failure Treatment with Spironolactone

Spironolactone (Aldactone) is used in the treatment of heart failure in the following cases:

  • NYHA Class III-IV heart failure
  • Reduced ejection fraction The goal of using Spironolactone in these cases is to:
  • Increase survival
  • Manage edema
  • Reduce the need for hospitalization for heart failure As stated in the FDA Drug Label 5, Spironolactone tablets are usually administered in conjunction with other heart failure therapies.

Administration and Usage

The usage of Spironolactone in heart failure treatment is as follows:

  • Indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction
  • Administered in conjunction with other heart failure therapies, as per the FDA Drug Label 5

From the Research

Use of Spironolactone in Heart Failure Treatment

  • Spironolactone is used in the treatment of heart failure, particularly in patients with New York Heart Association (NYHA) Class III or IV heart failure 6.
  • The medication has been shown to improve laboratory indices, quality of life, and morbidity in patients with heart failure 6.
  • Spironolactone has also been demonstrated to improve the survival of patients with NYHA III or IV heart failure 6.

Patient Selection and Safety

  • The use of spironolactone should be considered in patients with NYHA Class III or IV heart failure 6.
  • However, the clinical use of spironolactone may be limited due to its tendency to cause life-threatening hyperkalemia in hemodialysis patients 7.
  • Long-term low-dose spironolactone therapy has been shown to be safe in oligoanuric hemodialysis patients 7.
  • The incidence of hyperkalemia and gynecomastia is higher in spironolactone users than non-users, which may impact treatment compliance 8.

Clinical Benefits and Subgroup Analysis

  • Spironolactone use has been associated with a lower all-cause mortality in acute decompensated heart failure patients with severe renal dysfunction 9.
  • However, the clinical benefit of spironolactone use was not preserved in all subgroups, and further studies are needed to assess its benefit in certain patient populations 9.
  • Recent data indicate that spironolactone may offer symptomatic relief in patients with heart failure and preserved ejection fraction 10.

Formulations and Patient Perspectives

  • A liquid suspension formulation of spironolactone has been approved by the FDA, which may enable more patients to benefit from aldosterone inhibition 10.
  • The new formulation may be particularly beneficial for patients who have difficulty swallowing or are unable to swallow tablets 10.

References

Research

Spironolactone in the treatment of congestive heart failure.

The Annals of pharmacotherapy, 2000

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.