title: Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone.
abstract: 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.
authors.affiliation: Lilly USA, LLC, Indianapolis, IN, USA.
authors.forename: David
authors.initials: D
authors.lastname: Muram
authors.affiliation: Analysis Group, Inc., New York, NY, USA anna.kaltenboeck@analysisgroup.com.
authors.forename: Anna
authors.initials: A
authors.lastname: Kaltenboeck
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Natalie
authors.initials: N
authors.lastname: Boytsov
authors.affiliation: Analysis Group, Inc., New York, NY, USA.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Hayes-Larson
authors.affiliation: Analysis Group, Inc., New York, NY, USA.
authors.forename: Jasmina
authors.initials: J
authors.lastname: Ivanova
authors.affiliation: Analysis Group Inc., Boston, MA, USA.
authors.forename: Howard G
authors.initials: HG
authors.lastname: Birnbaum
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Ralph
authors.initials: R
authors.lastname: Swindle
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000367:Age Factors; D000368:Aged; D015331:Cohort Studies; D016208:Databases, Factual; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment; D013739:Testosterone / Q000097:blood* / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013739:Testosterone
keywords: dose titration; hypogonadism; physiological and endocrine disorders; testosterone replacement therapy; topical testosterone