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Saturday, March 16, 2013

Most Men on Androgel and Testim Stop Using Them





Medication Adherence and Treatment Patterns for Hypogonadal
Patients Treated with Topical Testosterone Therapy: A Retrospective Medical Claims Analysis


Michael Jay Schoenfeld, MA, Emily Shortridge, PhD, Zhanglin Cui, PhD, and David Muram, MD

Eli Lilly and Company, Indianapolis, IN, USA DOI: 10.1111/jsm.12114

A B S T R A C T

Introduction.  There is limited information  on adherence to topical testosterone replacement  therapy (TRT) among hypogonadal  men.
Aim.  To determine  adherence  rates among men treated  with topical testosterone gels and to examine factors that may influence adherence,  including age, presence of a specific diagnosis, and index dose.

Methods.  Included were 15,435 hypogonadal men, from the Thomson Reuters MarketScan® Database, who had an initial topical testosterone prescription  in 2009 and who were followed for 12 months.

Main Outcome Measures.  Adherence to testosterone was measured by medication possession ratio (MPR), with high adherence  defined as >0.8. Persistence  was defined as the duration  of therapy from the index date to the earliest of the following events: end date of the last prescription, date of the first gap of >30 days between prescriptions,  or end of the study period (12 months).

Results.  Adherence to topical TRT was low. By 6 months,  only 34.7% of patients had continued  on medication; at 12 months, only 15.4%. Adherence rates were numerically similar among men who received AndroGel® or Testim® topical gels and did not differ among men of different age groups. Approximately 80% of patients  initiated  at the recommended dose of 50 mg/day. Over time, an increased proportion of men used a higher dose. This change was the result of dose escalation, rather  than of greater  adherence  among men initiating  therapy  at a high dose. Dose escalation  was seen as early as 1 month  into  therapy.  Approximately  50%  of men  who  discontinued  treatment resumed therapy; most men used the same medication  and dose.

Conclusions. Discontinuation rates are high among hypogonadal men treated with testosterone gels, irrespective of their age, diagnosis, and index dose. Further study, evaluating other  measurable factors associated with low adherence among patients receiving topical TRT, may lead to interventions designed to improve adherence with therapy

COMMENTS:

About 50% of patients who were followed over time resumed TRT. It is possible that some patients  experienced  alleviation of symptoms and were not sure they needed to remain on therapy. Once therapy was discontinued and symptoms recurred  in some patients, the benefits of replacement  therapy may have become clearer;   thus,   prompting  these   men   to  restart therapy  at the same effective dose. 

An important limitation  of the study is that  claims data do not  include important patient level data, such as symptoms, reasons for discontinuation (e.g., application method), side effects (e.g., skin reaction), testosterone  levels,  responses  to  therapy,  and  so  forth. While  perception  of efficacy has significant effect on  patient  adherence,   this  study  was unable  to assess severity of symptoms or of symptomatic relief, once patients initiated  therapy.

The study was unable to identify characteristics that were associated with the time patients would be on therapy  before treatment was interrupted or who would resume therapy after a brief interruption. Most  patients  who  resumed  therapy  did  so  by using the  same topical TRT agent  and the  same dose they used prior to the interruption. It is possible that these patients perceived efficacy, were proficient  in the application method,  and possibly had a prescription  that  they  were able to use or refill without  the  need for an office visit. Only  a small percentage  of patients  using topical therapy resumed therapy by using a different method  or a change in the dosing regimen.


Lesson:

Patients on testosterone should have their blood levels and symptoms evaluated after a few weeks on therapy.  Depending on these follow up results, dose adjustment or change of delivery method should be explored as well as other issues that may potentially affect efficacy and adherence (life style, other medications, body mass index, etc).  Expectations should also be clearly described at the start of therapy (for more on what to expect, read this ) so that patients have realistic views.  Stamina and sexual function are multifactorial and testosterone blood levels are only part of the puzzle.

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