Clinical experience with spironolactone in pediatrics

Area of Science:

• Pediatric pharmacology
• Cardiovascular drug therapy
• Renal and electrolyte balance

Background:

• Spironolactone was identified by the Food and Drug Administration in 2003 as a drug requiring pediatric studies.
• This study addresses the need for more data on spironolactone use in pediatric populations.

Purpose of the Study:

• To characterize the utilization of spironolactone in a large pediatric cohort.
• To assess the safety profile of spironolactone in children, with a specific focus on its impact on serum potassium levels.

Main Methods:

• A prospective observational study design was employed.
• Data collected included patient demographics, spironolactone dosing, concurrent medications, and serum potassium concentrations.
• Patients were stratified by diagnosis, and unpaired t-tests were used for statistical comparisons.

Main Results:

• One hundred pediatric patients were analyzed, with a mean age of 20.8 months and weight of 9.5 kg.
• Sixty-two patients had heart disease (HD), 29 had chronic lung disease (CLD), and 9 had other conditions.
• Patients with CLD received higher spironolactone doses and exhibited higher initial potassium levels compared to those with HD. Twenty-six patients required potassium supplementation, and no other adverse effects were reported.

Conclusions:

• Spironolactone is a common diuretic in pediatric care, primarily associated with potassium alterations.
• Hyperkalemia was more prevalent initially, whereas hypokalemia emerged with prolonged use.
• Close potassium monitoring is crucial for pediatric patients on spironolactone, particularly those on multiple diuretics.