Frequency of Treatment Switching for Spironolactone Compared to Oral Tetracycline-Class Antibiotics for Women With Acne: A Retrospective Cohort Study 2010-2016
June 2018 | Volume 17 | Issue 6 | Original Article | 632 | Copyright © June 2018
John S. Barbieri MD MBA,a Juliana K. Choi MD PhD,a,b Nandita Mitra PhD,c David J. Margolis MD PhDa,c
aUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA bDepartment of Veteran Affairs, Philadelphia, PA cDepartment of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA
BACKGROUND: Long-term oral antibiotic use in acne may be associated with a variety of adverse effects including antibiotic resistance, pharyngitis, inflammatory bowel disease, and breast and colon cancer. Spironolactone may represent an effective and safe alternative to oral antibiotics for women with moderate to severe acne, however comparative studies are lacking. METHODS: Using the OptumInsight™ Clinformatics™ DataMart, we conducted a retrospective analysis of the frequency of switching to a different systemic agent within the first year of therapy among women with acne who were started on either spironolactone or an oral tetracycline-class antibiotic between 2010-2016, after controlling for age, topical retinoid, and oral contraceptive use. RESULTS: Among women with acne who were started on spironolactone, 14.4% were prescribed a different systemic agent within one year, compared with 13.4% started on an oral tetracycline-class antibiotic. After adjusting for age, topical retinoid, and oral contraceptive use, the odds ratio for being prescribed a different systemic agent within one year was 1.07 (95% CI 0.99-1.16) for those prescribed spironolactone when compared with oral tetracycline-class antibiotics and the risk difference was 0.007 (95% CI -0.002-0.017). CONCLUSIONS: Based on the observation of similar switching between the two groups, spironolactone may have similar clinical effectiveness to that of oral tetracycline-class antibiotics. While ultimately large clinical trials are needed to determine the optimal management strategy for women with moderate to severe acne, these results provide additional support that spironolactone represents an effective treatment for women with acne. J Drugs Dermatol. 2018;17(6):632-638.
Acne is one of the most common diseases worldwide, affecting 85% of adolescents. In addition, acne often persists into adulthood, with over 50% of women reporting acne between 20-29 years of age and over 35% between 30-39 years of age.1,2 While topical agents are typically sufficient for mild acne, moderate to severe acne often requires treatment with systemic agents, such as oral antibiotics, spironolactone, and isotretinoin.3Oral antibiotics are the most common systemic agent used in the treatment of acne and dermatologists prescribe more antibiotics per capita than any other specialty.4,5 However, antibiotic use may be associated with a variety of adverse outcomes including antibiotic resistance, pharyngitis, inflammatory bowel disease, and colon and breast cancer.6–15 As a result, there have been calls to reduce overuse of antibiotics throughout medicine and multiple guidelines regarding the treatment of acne recommend limiting the duration of therapy with oral antibiotics.16–20,3,21For women with moderate to severe acne, spironolactone may represent an effective, safe, and well-tolerated alternative to oral antibiotics and its use is becoming more common over time.5,22–27 However, despite expert opinion supporting the use of spironolactone in the treatment of acne, spironolactone is not approved by the Food and Drug Administration for this indication and clinical evidence demonstrating the effectiveness of spironolactone is limited to small studies.24–27 The objective of this study was to compare the outcomes with spironolactone and oral tetracycline-class antibiotics among a large, broadly representative population of women with acne. Specifically, this study sought to characterize the frequency with which women who are started on either spironolactone or an oral tetracycline-class antibiotic subsequently switch to a different systemic agent within the first year of therapy, since this switching may reflect treatment failure, whether due to lack of efficacy, side-effects, cost, or other reasons.28
This study was a retrospective analysis using the OptumInsight™ Clinformatics™ DataMart (OptumInsight, Eden Prairie, MN) between 2010 and 2016. The OptumInsight Clinformatics DataMart includes de-identified commercial claims data for approximately