Do I need regular check-ups or tests while taking spironolactone?

According to 2017 hypertension guidelines from the American College of Cardiology and American Heart Association (ACC/AHA), patients started on blood pressure-lowering medication should return for a follow-up appointment monthly until blood pressure goals are met [Strong Recommendation (Level B-R)].¹ At the follow-up visit, the doctor will measure blood pressure and assess for adverse effects and the need for medication adjustment, and may perform laboratory testing of renal function and electrolyte status, and make other assessments of target organ damage. Patients with severe hypertension (≥ 160 mm Hg systolic blood pressure or ≥ 100 mm Hg diastolic blood pressure) or complicating comorbid conditions, such as heart failure, diabetes, or chronic kidney disease need more frequent visits.^1,2 Once the blood pressure goal is met, visits can be at three- to six-month intervals.

The manufacturer’s prescribing information for spironolactone recommends that periodic testing be done to evaluate serum electrolytes, particularly in the elderly and individuals with kidney and liver impairment. More specifically, they recommend that patients with heart failure be monitored for potassium and creatinine one week after initiation of treatment, then monthly for three months, quarterly for a year, and then every six months.³

A number of studies have confirmed the increased risk of hyperkalemia among patients taking spironolactone.^4–11 Reported rates of hyperkalemia among patients taking spironolactone range from 1.1%,⁷ 1.6%,⁸ 2.6%,⁹ 4%,¹⁰ and 12%.¹¹ A 2014 Cochrane review (11 studies, 632 patients) determined that adding spironolactone to a regimen of angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in patients with chronic kidney disease doubled the risk of hyperkalemia (relative risk 2.00, 95% confidence interval [1.25 to 3.20]).⁸

Weir and Rolfe conducted a systematic literature review of studies of patients taking several drugs that increase the risk of hyperkalemia (ACEIs, ARBs, aldosterone receptor blockers, and direct renin inhibitors).⁶ In all, 39 studies were included. They found that the risk of hyperkalemia was increased among patients with heart failure, chronic kidney disease, or who were taking more than one drug affecting the renin-angiotensin-aldosterone system. They recommended patients with heart failure or chronic kidney disease be monitored every one to two weeks after initiation of therapy and dosage changes.

The 2017 hypertension guidelines also found strong evidence to support the recommendation of promoting other strategies to improve control of blood pressure in patients on antihypertensive therapy to include the use of home blood pressure monitoring, team-based care, and telehealth strategies [Strong Recommendation (Level A)].¹ The evidence in these studies demonstrated the benefits of a combination of home blood pressure monitoring, telehealth, and team-based (e.g., nurse case manager, pharmacist, doctor) care over just office-based follow-up.^12–14   

^References

1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task F. J Am Coll Cardiol 2018; 71 (19): e127-e248.
2. Chobanian A V., Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003; 42 (6): 1206-1252.
3. Aldactone (spironolactone) [package insert]. New York, NY: Pfizer Labs; 2018.
4. Chrysostomou A, Pedagogos E, Macgregor L, Becker GJ. Double-blind, placebo-controlled study on the effect of the aldosterone receptor antagonist spironolactone in patients who have persistent proteinuria and are on long-term angiotensin-converting enzyme inhibitor therapy, with or without an angiotensin II . Clin J Am Soc Nephrol 2006; 1 (2): 256-262.
5. Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999; 341 (10): 709-717.
6. Weir MR, Rolfe M. Potassium homeostasis and renin-angiotensin-aldosterone system inhibitors. Clin J Am Soc Nephrol 2010; 5 (3): 531-548.
7. De Souza F, Muxfeldt E, Fiszman R, Salles G. Efficacy of spironolactone therapy in patients with true resistant hypertension. Hypertension 2010; 55 (1): 147-152.
8. Bolignano D, Palmer SC, Navaneethan SD, Strippoli GFM. Aldosterone antagonists for preventing the progression of chronic kidney disease. Cochrane database Syst Rev 2014;(4): CD007004.
9. Nishizaka MK, Zaman MA, Calhoun DA. Efficacy of low-dose spironolactone in subjects with resistant hypertension. Am J Hypertens 2003; 16 (11 I): 925-930.
10. Chapman N, Dobson J, Wilson S, et al. Effect of spironolactone on blood pressure in subjects with resistant hypertension. Hypertension 2007; 49 (4): 839-845.
11. Ouzan J, Pérault C, Lincoff AM, Carré E, Mertes M. The role of spironolactone in the treatment of patients with refractory hypertension. Am J Hypertens 2002; 15 (4 I): 333-339.
12. Bosworth HB, Powers BJ, Olsen MK, et al. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med 2011; 171 (13): 1173-1180.
13. Bosworth HB, Olsen MK, Grubber JM, et al. Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med 2009; 151 (10): 687-695.
14. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA 2013; 310 (1): 46-56.