Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone

• Published in: American journal of men's health 2015-11, Vol.9 (6), p.496-505
• Main Authors: Muram, David, Kaltenboeck, Anna, Boytsov, Natalie, Hayes-Larson, Eleanor, Ivanova, Jasmina, Birnbaum, Howard G., Swindle, Ralph
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adult; Age Factors; Aged; Cohort Studies; Databases, Factual; Dose-Response Relationship, Drug; Drug Administration Schedule; Follow-Up Studies; Hormone replacement therapy; Hormone Replacement Therapy - methods; Humans; Hypogonadism - blood; Hypogonadism - diagnosis; Hypogonadism - drug therapy; Male; Middle Aged; Retrospective Studies; Risk Assessment; Testosterone; Testosterone - blood; Testosterone - therapeutic use; Treatment Outcome
• ISSN: 1557-9883; 1557-9891
• DOI: 10.1177/1557988314551569

Patterns of care following topical testosterone agent (TTA) initiation are poorly understood. This study aimed to characterize care following TTA initiation and compare results between patients with and without a serum testosterone (T) assay within 30 days before and including TTA initiation. Adult men (N = 4,146) initiating TTAs from January 1, 2011, to March 31, 2012, were identified from a commercially insured database. Patients were included if they initiated at recommended starting dose (RSD) and had ≥12 and ≥6 months of continuous eligibility preinitiation (baseline) and postinitiation (study period), respectively. Patients were stratified by preinitiation T assay. Maintenance dose attainment month was determined using unadjusted generalized estimating equations regression to compare dose relative to RSD month by month. Outcomes included maintenance dose attainment month, time to stopping of index TTA refills or a claim for nonindex testosterone replacement therapy (TRT), and proportion of patients with study period T assay or diagnosis of hypogonadism (HG) or another low testosterone condition, and were compared using chi-square and Wilcoxon rank-sum tests for categorical and continuous variables, respectively. Maintenance dose was attained in Month 4 postinitiation, at 115.2% of RSD. Approximately 46% of patients had a preinitiation T assay; these men were more likely to receive a diagnosis of HG or another low testosterone condition, to have a follow-up T assay, to continue treatment by filling a nonindex TRT, and less likely to stop refilling treatment with their index TTA. Differences in care following TTA initiation suggest that preinitiation T assays (i.e., guideline-based care) may be helpful in ensuring treatment benefits.