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Testosterone therapy
(TTh)

Normalisation of testosterone levels

Normalisation of testosterone with TTh can have other secondary clinical benefits in addition to symptomatic control of testosterone deficiency (TD).1,2

All-cause mortality and cardiovascular (CV) risk have been reduced in men with TD through testosterone normalisation (vs. men with untreated TD).1,2

Kaplan-Meier all-cause mortality in a retrospective analysis of propensity-matched US veterans with untreated TD vs. normalised-treated TD1

Kaplan-Meier all-cause mortality in a retrospective analysis of propensity-matched US veterans with untreated TD vs. normalised-treated TD graph

Sharma et al. investigated 83,010 men (76,762 propensity-matched) with recorded low testosterone levels. The primary outcomes were incidence of myocardial infarction (MI), ischaemic stroke and all-cause mortality.1

Low testosterone was defined by less than the lower limit of normal laboratory reference range (NLRR) reported for individual test results to allow for different assays implemented over the 14+ year follow-up period.1

In this large observational cohort with extended follow-up, normalisation of testosterone after TTh was associated with a significant reduction in all-cause mortality, MI and stroke.1

Adjusted hazard ratios (HR) for all-cause mortality, MI and stroke

HRNormalised treated
(n, per 100,000 PY)
Untreated
(n, per 100,000 PY)
p-value
Overall Mortality0.44 (CI 95% 0.42–0.46)1,6543,635<0.0001
MI0.76 (CI 95% 0.63–0.93)1892630.005
Stroke0.64 (CI 95% 0.43–0.96)43590.031

Kaplan-Meier of MI-free survival in propensity-matched men with normal T levels, untreated TD, and normalised, treated TD3

Kaplan-Meier of MI-free survival in propensity-matched men with normal T levels, untreated TD, and normalised, treated TD graph

MI, myocardial infarction; TD, testosterone deficiency; T2DM, type 2 diabetes mellitus; TT, total testosterone; TTh, testosterone therapy.
*The number of patients alive at the start of the study and at the end of the study.

Muraleedharan et al. (2013)3 investigated mortality rates and TD in a prospective, longitudinal cohort study of 581 men with T2DM and measured testosterone levels with a 6-year follow-up.

Mortality rates were compared among men with T2DM with a mean age of 59.5 years in two study groups:3

  • Total testosterone >10.4 nmol/L (300 ng/dL; n = 343)
  • Total testosterone ≤10.4 nmol/L (n = 238)

The effect of TTh was assessed using a retrospective analysis of the low testosterone group.

TD predicted increased mortality in men with T2DM (vs. men with normal testosterone levels).3

Mortality, independent of comorbidities and therapies, decreased by over 50% in men with T2DM and TD that received TTh (vs. men with T2DM and untreated TD)4

References

  1. Sharma R, Oni OA, Gupta K, et al. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J. 2015;36(40):2706–2715.
  2. Corona G, Rastrelli G, Di Pasquale G, et al. Testosterone and Cardiovascular Risk: Meta-Analysis of Interventional Studies. J Sex Med. 2018;15(6):820–838.
  3. Muraleedharan V, Marsh H, Kapoor D, et al. Testosterone deficiency is associated with increased risk of mortality and testosterone replacement improves survival in men with type 2 diabetes. Eur J Endocrinol. 2013;169(6):725–733.
  4. Khera M, Adaikan G, Buvat J, et al. Diagnosis and Treatment of Testosterone Deficiency: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015). J Sex Med. 2016;13(12):1787–1804.

TES/2020/009. April 2021.

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: pharmacovigilance@besins-healthcare.com