2009-10-09 New data presented at World Congress on Men's Health

Largest international study of treatment outcomes from long-acting injectable testosterone therapy confirms tolerability and effectiveness

Vienna, October 9, 2009 – Bayer Schering Pharma presents preliminary data confirming the tolerability and good safety profile of injectable long-acting testosterone undecanoate (Nebido®) in a large, International, multi-centre, Post-Authorisation Surveillance Study (IPASS). This data was shown at the World Congress on Men's Health (WCMH), Vienna, Austria 9th to 11th October 2009. This ongoing observational study aims to provide further and more detailed data of long-acting testosterone replacement therapy in hypogonadal men in real life.

“We are most encouraged by the compelling results. It confirmes that testosterone therapy can reverse or arrest much of the decline in hypogonadal men’s general health that we often associate with ageing”, said Professor Michael Zitzmann, IPASS Principal Investigator. “This is the first ever trial with long-acting testosterone undecanoate including a very large number of patients from various Asian and Latin American countries and will therefore significantly increase our knowledge of the treatment with Nebido in different groups regarding ethnic background, co-morbidities and age.”

The IPASS study aims to include up to 1500 hypogonadal men from over 25 countries, spanning five continents. The interim analysis includes data from 763 men who received at least one injection of TU. Patient data were acquired by interviews during an observation period of up to 12 months and recorded in case report forms. Improvements in routinely-monitored treatment outcomes and symptoms associated with hypogonadism including sexual desire/libido, vigour and vitality, mood, ability to concentrate, erectile dysfunction (ED), sleep disturbances and hot flushes were observed. Data also confirm positive effects on the components of the metabolic syndrome, especially including fast reduction of waist circumference. A majority of patients received Nebido without experiencing any adverse drug reaction. No serious drug related events have been recorded and also no cases of prostate cancer. Preliminary findings from IPASS confirm and extend previous findings that testosterone replacement therapy is well tolerated in long-term use and the data have also shown that Nebido has a good safety profile irrespective of the ethnic background.

Testosterone Deficiency Syndrome (TDS) is considered by experts to be at the origin of a number of serious men’s health problems and has a significant negative impact on quality of life and increased morbidity. There is a close association between testosterone deficiency, underlying medical conditions and erectile dysfunction. IPASS has demonstrated a high acceptance in men treated with injectable testosterone undecanoate. 88 percent of men are “satisfied” or “very satisfied” with the therapy. The majority of hypogonadal men treated with Nebido in the study reported real improvements in their symptoms especially in erectile function and libido, vitality and concentration. IPASS is scheduled for completion in 2010.

Hypogonadism and the spiral of decline in men’s overall health.

Hypogonadism, or symptomatic testosterone deficiency, affects around 5.6 percent of men aged between 30 and 79 years and increases markedly with age, 18.4 percent of men between 70 and 79 may be testosterone deficient (1).  Signs and symptoms include decreased libido, erectile dysfunction including reduction in morning erections, increased body fat, and loss of vitality, energy and work performance, loss of concentration, loss of body and facial hair, decreased bone density. However symptoms are frequently ignored by the man or attributed to other causes (such as normal ageing). Other serious medical conditions occur alongside hypogonadism these include cardiovascular disease, dyslipidaemia and diabetes, the risk factors for which also increase with age. If left untreated, a spiral of decline continues leading to chronic ill health because testosterone can be key in many metabolic processes.

At the first signs, treat to break the vicious circle and restore the man.

Older men with subnormal testosterone levels have an unfavourable metabolic profile and fat distribution. There is evidence of a vicious circle between TDS and underlying medical conditions. Men with metabolic syndrome have been shown to have a threefold increased risk of developing hypogonadism whereas men with testosterone levels in the lower quartile were twofold more likely to develop the metabolic syndrome. Testosterone replacement therapy has a positive influence on the metabolic syndrome and is an effective and safe medication that may have a positive impact on this vicious circle (2,3).  Testosterone replacement therapy is a valuable tool in improving the overall health of hypogonadal men. Bayer Schering Pharma is committed to improving men’s healthcare with its range of products (Nebido, Testogel® and Levitra® (vardenafil HCI)), offering solutions for low testosterone and erectile dysfunction (ED). Treatment with testosterone replacement therapy can restore vitality and libido, alongside Levitra to improve sexual performance. Levitra is the only PDE5i proven to extend the duration of erection in men with ED (4,5). Find more information about ED at www.in-bed.info.

About hypogonadism and the metabolic syndrome

Studies suggest that hypogonadism in men is often under-diagnosed and under-treated; because the symptoms can be easily attributed to aging or other medical causes. The effects of hypogonadism can have a very serious impact on quality of life and cause men to experience diminished sexual desire and erection quality/frequency, changes in mood and decreased cognitive function, decreased lean body mass and muscle volume/strength, increased visceral fat, and decreased bone and mineral density (10). It is likely that low testosterone is a fundamental component of the metabolic syndrome (6), a condition involving a cluster of interrelated factors, including erectile dysfunction, high cholesterol, high blood pressure, diabetes and obesity. Around 20-25 percent of the world’s adult populations present a metabolic syndrome and they are twice as likely to die from – and three times as likely to have – a heart attack or stroke than people without a metabolic syndrome (7). A report has identified a clear relationship between low testosterone levels in men and the metabolic syndrome (8). Researchers found that men with the metabolic syndrome were 2.8 to 3.2 times more likely to develop hypogonadism, as defined by total testosterone levels less than 11 nmol/L (9). 

About Nebido®

Nebido is the first long-acting injectable testosterone preparation for the testosterone replacement therapy of male hypogonadism. Hypogonadism is a condition in which men have low levels of testosterone (serum total testosterone levels below 12 nmol/L) (10) and typical symptoms of the testosterone deficiency syndrome. Nebido restores low testosterone levels to the normal range (12–30 nmol/L) (11). Nebido is injected every 10 to 14 weeks in long-term treatment, which avoids unphysiological peaks and troughs of serum testosterone levels in the blood stream. Nebido is indicated for the testosterone replacement therapy of adult male hypogonadism. Low testosterone levels are also associated with erectile dysfunction (ED) and other serious health conditions (12).

References
(1) Araujo AB et al. Journal Clin. Endocrinol Metab 92(11): 4241-4247 (2007)
(2) Svartberg J et al. Int Journal Impot. Res., 2008;20, 378–387
(3) Heufelder, A. E., et al., 52-week treatment with diet and exercise plus transdermal testosterone reverses the metabolic syndrome and improves glycaemic control in men with newly diagnosed Type 2 Diabetes and subnormal plasma testosterone. J Androl, 2009;published online ahead of print July 3.
(4) Miner M et al. Journal Sex. Med. 2008;5(6):1455-67
(5) Rosenberg MT et al. Int. Journal Clin. Practice, 2009;63:1
(6) Makhsida N, Shah J, Yan G, Fisch H, Shabsigh R. Hypogonadism and metabolic syndrome: implications for testosterone therapy. J Urol. 2005;174(3):827-34
(7) IDF Worldwide Definition of the Metabolic Syndrome: Frequently asked questions. http://www.idf.org/home/index.cfm?node=1429; accessed September 2007
(8) Miner MM, Sadovsky R.  Evolving issues in male hypogonadism: evaluation, management, and related comorbidities. Cleve Clin J Med. 2007;74(3):S38-46
(9) Laaksonen DE, Niskanen L, Punnonen K, Nyyssönen K, Tuomainen TP, Valkonen VP, Salonen JT. The metabolic syndrome and smoking in relation to hypogonadism in middle-aged men: a prospective cohort study. Journal Clin. Endocrinol Metab. 2005;90(2):712-9.
(10) Wang C, Nieschlag E, Swerdloff R, Behre HM et all, Investigation, Treatment, and Monitoring of Late-Onset Hypogonadism in Males: ISA, ISSAM, EAU, EAA, and ASA Recommendations. Journal Androl. 2008 August;30(7):121-130
(11) AA Yassin, F Saad. Plasma levels of dihydrotestosterone remain in the normal range in men treated with long- acting parenteral testosterone undecanoate. Andrologia. 2007;39(5):181-4
(12) MM Miner, R Sadovsky. Evolving issues in male hypogonadism: evaluation, management, and related  comorbidities. Cleve Clin. Journal Med. 2007;74(3):S38-46

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