In women prescribed spironolactone for acne, the rate of incident hyperkalemia at follow-up was significantly higher for those aged 46 to 65 years compared with those aged 18 to 45 years, warranting further serum potassium monitoring guidance and protocols, according to findings from International Journal of Women’s Dermatology.
“These data suggest that women over 45 years of age with no known hypertension, renal failure or diabetes who are exposed to spironolactone for the treatment of acne have a significantly greater risk of incident hyperkalemia compared with younger women,” Rebecca M. Thiede, MD, resident and fellow of the division of dermatology at University of Arizona College of Medicine-Tucson, and colleagues wrote.
The researchers utilized data on all women aged 18 to 65 years with a diagnosis of acne from the Northwestern Medicine Enterprise Data Warehouse, which compiles information from more than 5 million patients in the Chicago metropolitan area. For inclusion in the analysis, women had serum potassium monitoring at baseline, defined as within 12 months before or concurrent with the initiation of spironolactone, and at follow-up, defined as 1 to 12 months after treatment initiation.
A total of 618 women were diagnosed with acne and prescribed spironolactone by a dermatologist between January 2006 and October 2016. After excluding those with comorbidities and those who did not meet potassium monitoring requirements, 124 women were included in the analysis; all had baseline serum potassium values within normal limits. One hundred twelve women were in the group aged 18 to 45 years, and 12 were in the group aged 46 to 65 years.
At follow-up, three patients had incident hyperkalemia: one woman aged 42 years and two women aged 47 years. The rate of incident hyperkalemia was significantly higher for those aged 46 to 65 years at 16.7% compared with those aged 18 to 45 years at less than 1% (P = .0245).
Sixty-seven percent of the original 618 women prescribed spironolactone for acne had no serum potassium monitoring within 12 months of treatment initiation. Moreover, researchers reported no serum potassium monitoring in 40.1% of 618 women or monitoring that took place more than 12 months before or after spironolactone initiation.
“This physiologic age-related decline in renal function and corresponding increased risk of medication-related adverse events underscore the need for age-specific guidelines in the full prescribing information for spironolactone,” Thiede and colleagues wrote.
Currently, the prescribing information advises serum potassium monitoring within 1 week of initiation or titration of spironolactone and regularly thereafter for its FDA-approved indications, according to the report.
The researchers said that serum potassium monitoring inconsistencies reinforce the need for guidelines to establish optimal monitoring in women prescribed spironolactone for acne. – by Abigail Sutton
Disclosures: The authors report no relevant financial disclosures.