Nebido® publications portal (NPP)

Welcome to the Nebido® publications portal (NPP)

The purpose of the Nebido® publications portal (NPP) is to present testosterone related research, in an easily searchable and navigable interface, to health professionals who search for scientific information on hypogonadism, testosterone replacement therapy and testosterone related health issues.

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2017
Wolf J
Keipert D
Motazedi H
Ernst M
Nettleship J
Gooren L
This post-marketing surveillance study of parenteral testosterone undecanoate confirms the long-term safety and efficacy of treatment of hypogonadism with testosterone undecanoate.
For a clinical practice aspect it is notable that testosterone undecanoate has an exceptionally high adherence rate among patients. This is likely thanks to that treatment with testosterone undecanoate only requires 4-5 injections per year (as opposed to short-acting testosterone cypionate or enanthate, which requires injections every second week).
CASE REPORT
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2017
Sharma R
Oni OA
Gupta K
Sharma M
Singh V
Parashara D
Kamalakar S
Dawn B
Chen G
Ambrose JA
Barua RS
This study highlights that normalization of testosterone levels by testosterone treatment is associated with a significantly lower incidence of AF in men with initially low testosterone levels and without prior history of AF, compared with a matched group of participants who did not receive testosterone therapy.
In addition, the incidence of AF was higher in participants who failed to achieve normal testosterone levels after TRT (likely due to inadequate replacement dose or noncompliance) compared to those with normalization of testosterone levels following testosterone treatment.
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2017
Yassin A
Salman M
Talib RA
Yassin DJ
Aging Male. 2017 Jun;20(2):125-133.
* Testosterone deficient men who receive testosterone therapy have a lower incidence of prostate cancer. * Testosterone therapy may protect against high-grade prostate cancer. * Both the development and progression of prostate cancer is lower in men who receive testosterone therapy, compared to untreated men.
OBSERVATIONAL STUDY PROSPECTIVE (EPIDEMIOLOGY)
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2017
Traish AM
Haider A
Haider KS
Doros G
Saad F
J Cardiovasc Pharmacol Ther. 2017 Sep;22(5):414-433.
This study shows that long-term testosterone therapy is an effective approach to achieve sustained improvements in anthropometric parameters, cardiometabolic function, and risk of CVD events. The low number of CV events observed in the T-group compared with the untreated (control) group strongly suggest that testosterone therapy is protective. The demonstrated protective effect of testosterone on the cardiovascular system provides clinicians the opportunity to use testosterone therapy for secondary prevention in men with hypogonadism and a history of CV events.
In the absence of long-term prospective, placebo-controlled trials to investigate the risks and benefits of testosterone therapy in men with hypogonadism, observational registry studies that include a control group, such as this study, provide critical information on the long-term safety and effectiveness in routine clinical practice.
META-ANALYSIS
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2017
Nian Y
Ding M
Hu S
He H
Cheng S
Yi L
Li Y
Wang Y
This meta-analysis of randomized controlled trials shows that TRT significantly decreases the AMS total score compared with placebo. This result suggests that TRT is an effective treatment to improve quality of life in men with testosterone deficiency. The duration of TRT in all included trials was 6-12 months and the AMS total score was still above 27 (indicating mild symptom severity) at the end of the treatment period.
A further decrease of the AMS total score is possible with longer duration of testosterone treatment. This was shown in a long-term registry study with a duration for up to 10 years (Yassin, A., Nettleship, J. E., Talib, R. A., Almehmadi, Y., & Doros, G. (2016). Effects of testosterone replacement therapy withdrawal and re-treatment in hypogonadal elderly men upon obesity, voiding function and prostate safety parameters. The Aging Male, 19, 64–69). In this long-term study, cessation from TRT for 14.5 months significantly increased the AMS total score compare with before interruption, whereas the AMS total score continued to drop in the group of patients who received TRT without interruption. This evidence supports that a prolonged testosterone therapy duration – likely lifelong for most suffering men – may be needed to achieve and maintain maximal benefits of TRT.
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2017
Debruyne FM
Behre HM
Roehrborn CG
Maggi M
Wu FC
Schröder FH
Jones TH
Porst H
Hackett G
Wheaton OA
Martin-Morales A
Meuleman E
Cunningham GR
Divan HA
Rosen RC
RHYME Investigators
BJU Int. 2017 Feb;119(2):216-224
In the present longitudinal disease registry of 999 men with hypogonadism in six European countries, no evidence was seen of increased prostate cancer rates or LUTS/BPH progression in men receiving testosterone treatment compared with those who were untreated.
Prostate cancer incidence rates in RHYME were similar to rates reported in large population studies and with findings from other single country or single product registries. The PSA level was minimally affected and slight improvements in voiding symptoms were seen in our present study in men on TRT.
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2017
Traish AM.
Considerable advances in basic and clinical research have been made in understanding the role of testosterone in human physiology over the past several decades. Testosterone therapy in men with testosterone deficiency has become popular due to the recognition of the wide ranging benefits.
However, testosterone therapy remains a hotly debated issue with some academicians and media outlets purporting that testosterone therapy benefits are unproven. The publication of several studies with equivocal data that testosterone therapy increased CVD risk further increased the controversy. On the contrary, substantial evidence exists suggesting that testosterone deficiency is associated with CVD and mortality, and that testosterone therapy reduces incidence of CVD and mortality.
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2017
Alexander GC
Iyer G
Lucas E
Lin D
Singh S
This meta-analysis of randomized controlled trials shows a lack of a significant association between testosterone and myocardial infarction, stroke or mortality.
It is notable that this meta-analysis focused on specific disaggregated cardiovascular endpoints of clinical interest (myocardial infarction, stroke or mortality, also known as “hard” clinical endpoints). In contrast, most other meta-analyses pooled disparate events ranging from arrhythmias to congestive heart failure into aggregate outcomes such as “cardiovascular events” or “cardiac complaints”, which can erroneously inflate the apparent number of events and cause imprecision in risk estimation.
CONTROLLED CLINICAL TRIAL
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2017
Storer TW
Basaria S
Traustadottir T
Harman SM
Pencina K
Li Z
Travison TG
Miciek R
Tsitouras P
Hally K
Huang G
Bhasin S
Testosterone replacement for 3 years resulted improved chest-press strength, muscle power, unloaded and loaded stairclimbing power, and lean body mass. Men in the testosterone treated group significantly increased both lower and upper extremity power more than men receiving placebo. In addition, the changes in leg-press and chest-press power were significantly associated with changes in stair-climbing power, reinforcing the role of muscle power in performance of functional activities.
Unique to this 3-year study of testosterone administration in older men is the assessment of muscle power. Aging is associated with a preferential loss of type II motor units and consequently loss in the rate of force development (i.e., power). Because muscle power is more strongly associated with functional performance in daily life activities such as stair climbing, walking, and rising from a chair. assessing the effectiveness of anabolic therapies on muscle power is important.
MULTICENTER STUDY
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2017
Debruyne FM
Behre HM
Roehrborn CG
Maggi M
Wu FC
Schröder FH
Jones TH
Porst H
Hackett G
Wheaton OA
Martin-Morales A
Meuleman E
Cunningham GR
Divan HA
Rosen RC; RHYME Investigators
BJU Int. 2017 Feb;119(2):216-224
In this longitudinal disease registry of 999 men with HG in six European countries, no evidence was seen of increased prostate cancer rates or LUTS/BPH progression in men receiving TRT compared with those who were untreated.
Prostate cancer incidence rates in RHYME were similar to rates reported in large population studies and with findings from other single country or single product registries. The PSA level was minimally affected and slight improvements in voiding symptoms were seen in our present study in men on TRT.
  • PP-NEB-ALL-0347-1

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Page last modified Mon, 16/09/2019

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