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




[image error]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.




Mai n 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.