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Study Letter
ARTICLE IN PRESS
doi:
10.25259/IJDVL_1280_2023

Frequent potassium monitoring is associated with hyperkalemia that is clinically insignificant in females taking spironolactone for dermatologic conditions

Weill Cornell Medical College, New York, United States
Department of Dermatology, Wake Forest School of Medicine, Wake Forest, NC, United States
Division of Biostatistics, Department of Population Health Sciences, Weill Cornell Medicine, New York, United States
Department of Dermatology, Weill Cornell Medicine, New York, United States

Corresponding author: Dr. Shari R Lipner, Department of Dermatology, Weill Cornell Medicine, New York, United States. shl9032@med.cornell.edu

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This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

How to cite this article: Hill RC, Wang Y, Shaikh B, Christos PJ, Lipner SR. Frequent potassium monitoring is associated with hyperkalemia that is clinically insignificant in females taking spironolactone for dermatologic conditions. Indian J Dermatol Venereol Leprol. doi: 10.25259/IJDVL_1280_2023

Dear Editor,

Spironolactone is used as an off-label treatment for acne, hair loss, and hirsutism. Hyperkalemia risk by patient demographics and daily dosages requires clarification. We aimed to measure hyperkalemia prevalence and risk factors in women taking spironolactone for dermatologic conditions.

After institutional review board approval, demographics and potassium measurements were collected from female patients taking spironolactone for ≥2 weeks for acne, hair loss, or hirsutism from 2006 to 2021. Hyperkalemia was defined as ≥5.2 mEq/L.1 R Version 4.2.2 was used, with Fisher’s Exact and Wilcoxon rank sum tests with significance p<0.05.

Overall, 1,489 patients taking at least one course of spironolactone were included [Table 1]; 5.6% (n = 83, 81/83 during the first course) experienced hyperkalemia, with 97.6% mild (≤6.0 mEq/L) and none severe (≥7.0 mEq/L). On average, patients with elevated versus normal potassium measurements had more frequent potassium monitoring (4.38 vs. 2.23, p<0.001, Table 1). Using logistic regression, age, and maximum daily spironolactone dose were statistically significant hyperkalemia predictors. The odds of hyperkalemia increased by 2.36%/year of age and by 0.81%/mg. Race, ethnicity, and spironolactone indication were not hyperkalemia predictors (all p>0.05) [Table 1]. Only nine (10.7%) of hyperkalemic courses caused therapy discontinuation [Table 2].

Table 1: Patient characteristics by hyperkalemia status
Hyperkalemia Status
Overall, N = 1,489 Negative, N = 1,408 Positive, N = 81 p-value1
# of courses, n (%) 0.12
1 1,432 (96%) 1,357 (96%) 75 (93%)
2 53 (3.6%) 48 (3.4%) 5 (6.2%)
3 4 (0.3%) 3 (0.2%) 1 (1.2%)
Age on course start date 0.11
Median (IQR) 30 (25,36) 29 (25,36) 32 (25,40)
Mean (SD) 32 (10) 32 (10) 35 (13)
Range 18,78 18, 78 18, 72
Age group, n (%) 0.022
<25 329 (22%) 309 (22%) 20 (25%)
25–34 728 (49%) 699 (50%) 29 (36%)
35–44 258 (17%) 244 (17%) 14 (17%)
45-54 116 (7.8%) 104 (7.4%) 12 (15%)
55 or older 58 (3.9%) 52 (3.7%) 6 (7.4%)
Race groups, n (%) 0.4
American Indian/Alaska Nation 1 (<0.1%) 1 (<0.1%) 0 (0%)
Asian 115 (7.7%) 105 (7.5%) 10 (12%)
African American 80 (5.4%) 76 (5.4%) 4 (4.9%)
Declined 263 (18%) 255 (18%) 8 (9.9%)
Nat. Hawaiian/Other Pacific Islander 2 (0.1%) 2 (0.1%) 0 (0%)
Other Combination 175 (12%) 162 (12%) 13 (16%)
White 853 (57%) 807 (57%) 46 (57%)
Self-reported race or ethnicity, n (%) 0.8
Declined/Unknown 340 (23%) 325 (23%) 15 (19%)
Hispanic/Latin/Spanish Origin 152 (10%) 144 (10%) 8 (9.9%)
Multiracial 2 (0.1%) 2 (0.1%) 0 (0%)
Not Hispanic/Non-Latin/Spanish Origin 995 (67%) 937 (67%) 58 (72%)
Indication, n (%) 0.2
Acne 938 (63%) 896 (64%) 42 (52%)
Androgenetic Alopecia 58 (3.9%) 55 (3.9%) 3 (3.7%)
Hair Loss 178 (12%) 164 (12%) 14 (17%)
Hirsutism 101 (6.8%) 95 (6.7%) 6 (7.4%)
Multiple Indications* 214 (14%) 198 (14%) 16 (20%)
Maximum daily dose (mg) group, n (%) 0.007
≤50 528 (35%) 509 (36%) 19 (23%)
75–100 800 (54%) 754 (54%) 46 (57%)
125–200 160 (11%) 144 (10%) 16 (20%)
>200 1 (<0.1%) 1 (<0.1%) 0 (0%)
Number of Monitoring Values <0.001
Median (IQR) 1.00 (1.00, 3.00) 1.00 (1.00, 3.00) 3.00 (2.00, 6.00)
Mean (SD) 2.35 (2.38) 2.23 (2.22) 4.38 (3.75)
Range 1.00, 31.00 1.00, 31.00 1.00, 20.00

1Fisher’s exact test; Wilcoxon rank sum test

Note: Patients with hypertension, renal disease, heart failure, taking medications affecting renin-angiotensin-aldosterone and/or missing data were excluded. Eighty-three patients experienced hyperkalemia while taking a course of spironolactone. However, this summary is prepared looking at the first spironolactone course only, filtered by course start date. Since most of the cases of hyperkalemia (81/83) occurred during the first course, statistical consideration of the summary and analysis based on the first course of spironolactone is recommended. Furthermore, for the purposes of computing p-values, declined responses in Race and Ethnicity were coded as missing. In Race, American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander and Other combination were all combined into one ‘Other’ category. In Ethnic groups, multiracial was combined with the Hispanic/Latin category. Maximum daily dose of >200 (one patient) was combined with the 125–200 category, while Number of courses = 3 was combined with two courses.

includes a combination of acne, androgenic alopecia, hair loss/hair thinning, and/or hirsutism, n, N: refers to a count, Bold font: below indicates statistical significance, IQR = interquartile range, SD = standard deviation.
Table 2: Outcomes of spironolactone courses after hyperkalemia
n (%)
Spironolactone therapy stopped because of hyperkalemia 9 (10.7%)
Spironolactone therapy stopped because of other symptoms* or illness 3 (3.6%)
Spironolactone therapy stopped at the patient request 2 (2.4%)
The therapeutic dose of spironolactone was lowered because of hyperkalemia, and continued medication at a lower dose 10 (11.9%)
Repeat labs were ordered and potassium level was normalised, continued spironolactone therapy 20 (23.8%)
Repeat labs ordered but not performed, continued spironolactone therapy 3 (3.6%)
No change in spironolactone therapy and no additional labs were performed 37 (44.0%)
Breast pain, menstrual irregularities

Older patients and those taking higher spironolactone doses more often developed hyperkalemia, and race, ethnicity, and indication did not increase risk. Hyperkalemia was uncommon and most often mild, consistent with retrospective studies of 974 (Plovanich et al.) and 195 (Plante et al.) women taking spironolactone for dermatologic conditions with hyperkalemia rates of 0.72% and 3.3%, respectively, and all cases mild.1,2 In our study, >70% of hyperkalemic patients took ≥100 mg/day, consistent with Plante et al.’s study, with all hyperkalemic patients taking 100 mg/day.2 Older women in our cohort more often experienced hyperkalemia, similar to a retrospective study of 124 women taking spironolactone for acne (16.7% of those aged 45–65 vs. <1% 18–45 [p = 0.0245]).3,4

More frequent potassium monitoring was associated with clinically insignificant hyperkalemic since >70% of patients with elevated potassium had no change in treatment or potassium normalisation. Similarly, in a retrospective study of 1,863 acne patients taking isotretinoin, there were rare and clinically insignificant triglycerides (grade 3 <1%), total cholesterol (no grade 3), aminotransferase (grade 3 <0.5%), complete-blood-count (none) abnormalities, infrequently changing management and with normalisation.5 Potassium measurements are subject to haemolysis. Increased hyperkalemia prevalence with more frequent monitoring may indicate high false positive rates, given that >20% of our patients with hyperkalemia were normalised. Therefore, minimising potassium monitoring in low-risk groups may reduce costs and time burden associated with false positive hyperkalemia.

Limitations include single-centre, retrospective design, majority whites, incomplete race/ethnicity data, lack of control for diet, medication adherence, other treatments, and lack of information about comorbid endocrine disorders.

In sum, hyperkalemic measurements with spironolactone were associated with more frequent monitoring, which more often occurred in older women and patients taking higher daily dosages. Therefore, potassium monitoring in healthy young women taking spironolactone for dermatologic conditions is unwarranted, given cost, time, and patient discomfort considerations that will unlikely change management. Potassium measurements are recommended in older patients and those taking high daily dosages.

Ethical approval

The research/study was approved by the Institutional Review Board at Weill Cornell Medicine Institutional Review Board, number 19-11021077, dated 5/25/2021.

Declaration of patient consent

Patient’s consent not required as there are no patients in this study.

Financial support and sponsorship

This investigation was supported by the National Center for Advancing Translational Sciences (NCATS) grant # UL1-TR-002384 of the Clinical and Translational Science Center at Weill Cornell Medical College.

Conflicts of interest

There are no conflicts of interest.

Use of artificial intelligence (AI)-assisted technology for manuscript preparation

The authors confirm that there was no use of AI-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.

References

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