Use and side‐effect profile of spironolactone in a private cardiologist's practice

Abstract

SummaryBackground: The beneficial effects of spironolactone on the treatment of cardiovascular diseases are well known, but translating these benefits into private practice can be difficult because of the drug's side-effect profile.Hypothesis: When patients are monitored over the long term, spironolactone can be used safely with an acceptable side-effect profile.Methods: We retrospectively studied 762 patients taking spironolactone over a 7-year period in a cardiologist's referralbased practice and monitored them for side effects from the medication.Results: Data were available on 762 patients. The average age of our patients when started on the medication was 67.2 ± 0.5 years. Of these, 585 (76.8%) patients were treated for heart failure and 155 (20.3%) for hypertension. An average dose of 38.4 ± 1.4 mg of spironolactone was used for treatment of all conditions. Of the 762 patients, 81 (10.6%) experienced side effects while using the medication; 40 had hyperkalemia (5.3%), 14 had gynecomastia (1.8%), and 15 had gastritis (2%). Of the patients with hyperkalemia, average creatinine clearance decreased from 64.6 ± 5.8 ml/min at therapy start to 50.3 ± 5.5 ml/min at the time of onset of side effects.

Mineralocorticoid receptor antagonist pattern of use in heart failure with reduced ejection fraction: findings from BIOSTAT‐CHF

“…Despite guideline indication, other factors may be responsible for the persistently low prescription rate, and these include the excessive concern raised by the publication of population‐based studies associating MRA therapy with the increase in hyperkalaemia‐associated morbidity and mortality . As subsequently recognized, patients enrolled in these studies commonly received inappropriate dosing, or had formal contraindications to MRA therapy, and had below trial‐ and guideline‐recommended serum potassium and renal function monitoring . It is also noticeable that there is a poor understanding of the mechanisms of action of MRAs beyond their ‘diuretic with potassium‐sparing properties’ heading, lack of pharmaceutical company‐sponsored drug marketing and education for clinicians, and lack of guidance on how to initiate MRAs on a background of ACEi/ARBs and beta‐blocker up‐titration .…”

Spironolactone Use and Higher Hospital Readmission for Medicare Beneficiaries With Heart Failure, Left Ventricular Ejection Fraction <45%, and Estimated Glomerular Filtration Rate <45 ml/min/1.73 m2

“…However, incident life-threatening hyperkalemia is unlikely to fully explain an isolated higher hospital readmission without an associated higher mortality among patients in the spironolactone group in our study as deaths associated with hyperkalemia would be expected to be due to cardiac arrhythmias that would also preclude hospital readmission. Spironolactone has also been shown to worsen kidney function, 9 although it has been suggested to be temporary. 10,11 Further, patients in the spironolactone group in our study had lower baseline serum creatinine levels.…”

Use of Aldosterone Antagonists in Heart Failure

“…Other factors that may have slowed adoption are (1) published hyperkalemia rates that may have been an overestimation of harm 4 as well as other published reports of safety concerns [14][15][16][17][18][19] and adequacy in laboratory monitoring, 20,21 (2) poor understanding of using spironolactone as an aldosterone antagonist rather than as a potassium-sparing diuretic, (3) minimal pharmaceutical company-sponsored drug marketing and drug education to clinicians, (4) the adverse-effect profile of spironolactone, (5) evidence for use based primarily on a single randomized, multicenter trial initiated before ␤-blocker therapy was routinely used, (6) selection of other HF add-on drug therapies when patients remain symptomatic, and (7) clinicians' plans for initiating therapy after hospital discharge once ACE inhibitor or ARB and ␤-blocker therapies are optimized.…”