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

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...

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Main Authors: David Muram MD, Anna Kaltenboeck MA, Natalie Boytsov PhD, Eleanor Hayes-Larson MPH, Jasmina Ivanova MA, Howard G. Birnbaum PhD, Ralph Swindle PhD
Format: Article
Language:English
Published: SAGE Publishing 2015-11-01
Series:American Journal of Men's Health
Online Access:https://doi.org/10.1177/1557988314551569
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spelling doaj-9132fe2ffacf4115bab04562933581df2020-11-25T03:46:03ZengSAGE PublishingAmerican Journal of Men's Health1557-98831557-98912015-11-01910.1177/1557988314551569Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical TestosteroneDavid Muram MD0Anna Kaltenboeck MA1Natalie Boytsov PhD2Eleanor Hayes-Larson MPH3Jasmina Ivanova MA4Howard G. Birnbaum PhD5Ralph Swindle PhD6Lilly USA, LLC, Indianapolis, IN, USAAnalysis Group, Inc., New York, NY, USAEli Lilly and Company, Indianapolis, IN, USAAnalysis Group, Inc., New York, NY, USAAnalysis Group, Inc., New York, NY, USAAnalysis Group Inc., Boston, MA, USAEli Lilly and Company, Indianapolis, IN, USAPatterns 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.https://doi.org/10.1177/1557988314551569
collection DOAJ
language English
format Article
sources DOAJ
author David Muram MD
Anna Kaltenboeck MA
Natalie Boytsov PhD
Eleanor Hayes-Larson MPH
Jasmina Ivanova MA
Howard G. Birnbaum PhD
Ralph Swindle PhD
spellingShingle David Muram MD
Anna Kaltenboeck MA
Natalie Boytsov PhD
Eleanor Hayes-Larson MPH
Jasmina Ivanova MA
Howard G. Birnbaum PhD
Ralph Swindle PhD
Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
American Journal of Men's Health
author_facet David Muram MD
Anna Kaltenboeck MA
Natalie Boytsov PhD
Eleanor Hayes-Larson MPH
Jasmina Ivanova MA
Howard G. Birnbaum PhD
Ralph Swindle PhD
author_sort David Muram MD
title Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
title_short Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
title_full Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
title_fullStr Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
title_full_unstemmed Retrospective Analysis of Dose Titration and Serum Testosterone Level Assessments in Patients Treated With Topical Testosterone
title_sort retrospective analysis of dose titration and serum testosterone level assessments in patients treated with topical testosterone
publisher SAGE Publishing
series American Journal of Men's Health
issn 1557-9883
1557-9891
publishDate 2015-11-01
description 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.
url https://doi.org/10.1177/1557988314551569
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