Steroidal Mineralocorticoid Receptor Antagonist Side Effects and Reasons for Discontinuation: A Patient Survey (RELICS-PS)

Emma L Richard,1 Judith J Stephenson,1 Nihar R Desai,2 Vincent J Willey,1 Alain Gay,3 Charlie Scott,4 Kerstin Folkerts,5 Elena Pessina,6 Rakesh Singh,7 Chia-Chen Teng,1 Nikolaus G Oberprieler8 1Health Economics and Outcomes Research, Carelon Research, Wilmington, DE, USA; 2Department of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA; 3Clario, Philadelphia, PA, USA; 4Clinical Statistics and Analytics, Bayer US LLC, Whippany, NJ, UK; 5Bayer AG, Wuppertal, Germany; 6Bayer S.p.A., Milan, Italy; 7Value, Evidence,and Outcomes, Eli Lilly and Co, Indianapolis, IN, USA; 8Bayer AS, Oslo, NorwayCorrespondence: Emma L Richard, Senior Researcher, Health Economics and Outcomes Research, Carelon Research, 123 Justison Street, Wilmington, DE, 19801, USA, Email [email protected]: To understand steroidal mineralocorticoid receptor antagonists (sMRAs) treatment patterns and side effects from patients’ perspectives.Methods: The RELICS-PS study, a complement to the claims-based RELICS study, used a cross-sectional patient survey targeting adults with commercial or Medicare Advantage health insurance who had at least one pharmacy claim for sMRAs (spironolactone or eplerenone) between July 2021 and June 2022. It used the Healthcare Integrated Research Database (HIRD®) as the sampling frame to identify eligible patients. A total of 600 completed surveys were targeted from current and past sMRA users between November and December 2022. The survey collected data on demographics, chronic conditions, prespecified side effects, and reasons for discontinuation among past sMRA users, describing the data without inferential testing.Results: Of 600 respondents, 49.2% reported at least one side effect. Side effects varied from 5.5% (weak pulse and chest pains) to 40.0% (sluggishness or fatigue). Reports of symptoms of male gynecomastia were noticeably higher than in medical claims in RELICS (17.4% vs 2.9%). Past users, consisting of 24.3% of respondents, were more likely to report experiencing side effects, experiencing them more frequently, and being more affected by them. Approximately a third of these respondents reported side effects as a deciding factor for discontinuation. Healthcare providers’ recommendations, often informed by medication effectiveness and patient tolerance, were the most cited reason for discontinuation.Conclusion: Although half of the respondents reported experiencing side effects, 39.0% of past users identified side effects as a reason for discontinuation. This suggests a gap between patient experience and perceived reasons for discontinuation. A notable finding from the study is the significant role of healthcare providers in influencing the decisions to start or stop sMRA treatment. Therefore, future research should focus on exploring the factors that shape healthcare providers’ decision-making processes when initiating and discontinuing treatment options.Keywords: steroidal mineralocorticoid receptor antagonists, patient reported side effects