The Scottish Medicines Consortium (SMC) Approves Nebido(R) For Testosterone Deficiency Syndrome
April 02, 2017
The SMC has accepted Nebido® (testosterone undecanoate) for use in Scotland for the treatment of hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests1. Hypogonadism, also known as Testosterone Deficiency Syndrome (TDS), describes men with low testosterone levels (below 12nmol/l) who experience one or more typical features which include erectile dysfunction (ED), loss of libido and feelings of depression2-5 (for full advice and list of symptoms see 'Notes to Editors').
TDS affects approximately one in every 200 men6 and one in ten men over the age of 50 years7. Approximately 37% of men with ED8 and around 50% of men with Type 2 diabetes have low testosterone levels9. Studies have also shown that men with low testosterone levels may have an increased risk of more serious diseases such as cardiovascular illness and Type 2 diabetes10,11.
TDS can be treated effectively with testosterone therapy3,10. By restoring testosterone levels to the normal range, improvements can be seen in sexual desire (libido), energy and drive, erectile function, mood, lean body mass and reductions in waist circumference 3,10.
Nebido is the first long-acting testosterone injection available in the UK, requiring 3-5 injections per year as maintenance therapy12, compared with current preparations which can require up to 24 injections per year13,14, minimising the disruption to patients' lives. Due to Nebido's slow release mode of action, testosterone levels are maintained within the physiological range, minimising peaks and troughs12.
Professor Richard Anderson, Consultant in Reproductive Medicine, Edinburgh Royal Infirmary commented; "Treatment options for men needing testosterone replacement have previously been very limited. The positive review of Nebido in Scotland by the SMC provides a convenient and effective choice for men and their doctors. It offers a longer-acting preparation with more stable testosterone levels resulting in improved treatment of symptoms and other consequences of deficiency."
New recommendations on the identification, monitoring and treatment of hypogonadism have been formulated by major international scientific organisations, including the European Association of Urology, the European Society of Endocrinology and the European Academy of Andrology3. These state that all patients presenting with ED, especially those with ED and Type 2 diabetes, should have their serum testosterone levels measured on a blood sample taken in the morning between 07.00 and 11.003.
1) Full advice from the SMC: following a full submission testosterone undecanoate (Nebido) is accepted for use within NHS Scotland as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests1.
Compared with alternative intramuscular preparations it offers the advantage of reduced frequency of dosing with less inter-dose fluctuation of testosterone levels1.
2) Under real life conditions, Nebido appears to be a well tolerated and effective treatment for TDS15. In a study published at the Annual Congress of The European Association of Urology, March 2007, 92.5% of patients expressed satisfaction with the treatment15.
3) Common features of TDS include: rarely being in the mood for sex, a feeling of constant tiredness or lack of energy and impotence. Men with TDS may also experience one or more of the following features2-5:
- Increased abdominal waist size (more than 102cm or 40" when measured just above the naval)
- Regular feelings of depression or irritability
- Memory loss or inability to concentrate
- Hot flushes or sweating
- Marked weight loss and muscle strength
- Loss of body hair and skin alterations
- Sleep disturbances
- Bone fractures or low bone density
4) Contraindications include androgen-dependent prostate cancer or breast cancer.12 Although, clinical studies have demonstrated that Nebido does not increase prostate specific antigen levels above the normal range16,17.
References
1. Scottish Medicines Consortium, scottishmedicines
2. AACE. Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hypogonadism in Adult Male Patients. Endocr Pract. 2002;8(6):439-456
3. Wang C et al. ISA, ISSAM, EAU, EAA and ASA Recommendations: Investigation, Treatment and Monitoring of Late-Onset Hypogonadism in Males: The Aging Male. 2008; 1-8.
4. Svartberg J et al. Waist Circumference and Testosterone Levels in Community Dwelling Men. The Tromsø Study. European Journal of Epidemiology 2004;19:657-663
5. Carruthers M. Male Menopause or Andropause. The Testosterone Revolution. 2001 p49
6. Handelsman DJ. Androgens. Endocrinology of Male Reproduction. 2004
7. Wylie K. Dealing with Male Sexual Dysfunction. Testosterone Replacement. NHS Sheffield Care Trust. 2006
8. Guay AT et al. Efficacy and Safety of Sildenafil Citrate for Treatment of Erectile Dysfunction in a Population with Associated Organic Risk Factors. J Androl 2001;22:793-797
9. Kapoor D et al. Clinical and Biochemical Assessment of Hypogonadism in Men with Type 2 Diabetes. Diabetes Care 2007;30:911-917
10. Miner MM, Sadovsky R. Evolving Issues in Male Hypogonadism: Evaluation, Management, and Related Comorbidities. Cleve Clin J Med. 2007;74(3):S38-46
11. Kalyani RR et al. Male Hypogonadism in Systemic Disease. Endocrinol Metab Clin N Am. 2007;36(2):333-348
12. Bayer Schering Pharma Nebido SmPC, June 2007
13. Cambridge Labatories Testosterone Enanthate SmPC, February 2007
14. Organon Labatories Ltd Sustanon SmPC, February 2008
15. Behre H. Testosterone Therapy: Nebido Proves Safe and Effective Treatment with High Satisfaction. Abstract Presented at the Annual Congress of the European Association of Urology (EAU), March 2007
16. Saad F et al. More than Eight Years' Hands-On Experience with the Novel Long-Acting Parenteral Testosterone Undecanoate. Asian J Androl. 2007;9(3):291-7
17. Smith R et al. Clinical Experience of Nebido: Monitoring the Efficacy and Safety of Intramuscular Testosterone Undecanoate in Hypogonadal Men. Endocrine Abstracts 2008; 15: 297
Source
European Association of Urology