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Spironolactone Use Requires Monitoring for Potassium Levels in Ambulatory Heart Failure Patients: Presented at ESC-HF

By Chris Berrie

HAMBURG, GERMANY -- June 14, 2007 -- There is the potential for hyperkalaemia and renal failure with spironolactone treatment in patients with moderate to severe left ventricular systolic dysfunction (LVSD). Thus, it is recommended that patients on spironolactone be monitored closely for potassium and creatinine levels, researchers reported here at the Heart Failure Association of the European Society of Cardiology Heart Failure (ESC-HF) congress.

With the use of spironolactone in patients with New York Heart Association (NYHA) class 3 or 4 heart failure, there have been some reports of serious adverse effects, including hyperkalaemia and renal failure, principal investigator Ricardo Lopes, MD, resident in cardiology, internal medicine/ cardiology, Hospital de Sao Joao, Oporto, Portugal.

The aim of this study, which was presented here on June 11th, was to determine the frequency and evaluate the adverse effects related to spironolactone use in patients with moderate to severe LVSD on optimised medical therapy.

The study enrolled 134 patients with a mean age of 66 years (male, 69%). In this cohort, 68.4% had severe LVSD, 31.6% had NYHA class 3-4, 51.5% had ischaemic heart failure aetiology, and 27.2% had diabetes. Mean serum potassium level was 4.60 meq/L, and mean serum creatinine was 1.26 mg/dL.

Medications being used at baseline included diuretics (95.6%), beta blockers (91.9%), angiotensin-converting enzyme inhibitors (91.2%), and angiotensin II receptor blockers (11.8%).

Criteria for spironolactone use were initially set as moderate to severe LVSD with potassium levels no greater than 5 meq/L and creatinine no greater than 2.5 mg/dL.

Spironolactone was started at the dose of 12.5 mg/day, which was increased to 25 mg/day after 4 weeks if potassium remained <5.5 meq/L with stable creatinine levels. Potassium and creatinine levels were monitored at 1 week, 1 month, and at least every 3 to 6 months thereafter. Spironolactone was withdrawn if potassium levels were greater than 5.5 meq/L or if creatinine increased by 30% to 50% or greater of its basal value, or in the case of gynaecomastia.

The only significant differences seen at baseline between no-spironolactone (n = 58) and spironolactone (n = 76) treatment groups were the percent of patients who had once been assessed as having NYHA class 3 or 4 (19% vs 40.8%; P =.012) and serum potassium levels (4.74 vs. 4.51 meq/L; P =.039).

Their rate of spironolactone withdrawals was 25.0%, with the reasons being given as hyperkalaemia plus renal failure (10.5%); hyperkalaemia alone (6.6%); renal function alone (2.6%), gynaecomastia plus renal failure (1.3%); gynaecomastia alone (3.5%); and other reasons (1.4%).

The pooling of adverse effects arising from the spironolactone treatment indicates that 17.1% of patients had hyperkalaemia, with 9.2% showing potassium levels at 6 meq/L or greater, although none of these cases were fatal. Similarly, while 14.5% of patients showed renal failure, none of these needed dialysis.

Dr. Lopes stressed that there were indeed reasonable levels of hyperkalaemia and renal failure seen, and noted the need to monitor these two main associated side effects during spironolactone treatment in patients with moderate to severe LVSD.


[Presentation title: Safety of Spironolactone Use in Ambulatory Heart Failure Patients. Abstract P453]

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