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Spain, April 2010.-Duodart ® by GlaxoSmithKline, a combination to fixed-dose (CDF) of dutasterida (0.5 mg) and tamsulosin (0,4 mg), has received approval in Europe through a registration procedure decentralized starring Germany as reference Member State. Duodart is indicated for the treatment of symptoms of benign hyperplasia of prostate (BPH) of moderate to severe and for reducing the risk of acute retention of urine (RAO) and surgery in patients with symptoms of BPH in moderate to graves.1

“Given the proven benefits of these two medications and the demonstrated significant benefit from their combined use, GSK developed this new fixed-dose combination medication to provide patients and physicians a convenient treatment that is administered once a day and reduces the impact of the bothersome symptoms and the risk of potential complications and surgery related to this common disease”said Eddie Gray, President of GSK Pharmaceuticals Europe. “These are the factors that create uncertainty and anxiety to many men, and which can also give rise to additional costs not planned for health care providers.”

The documentation submitted for the approval of dutasterida and tamsulosin CDF was based on the results of the study CombAT ** 2.

CombAT proved that the combination of dutasterida and tamsulosin provides patients with moderate to severe BPH symptoms:

-Significantly higher and maintained symptomatic improvement compared with medication prescribed more often, the alpha-blocker tamsulosin after nine months.

-Improvement of symptoms as quick as with monotherapy with tamsulosin which stays for 4 years.

-A reduction in the risk of complications of BPH – RAO and surgery related to BPH compared monotherapy with tamsulosin 66% ** (p < 0.001) and 20% compared to dutasterida (p = ns) 4 years.

** The bioequivalence between the fixed dose combination and the free combination has been shown.

** Tamsulosin is not indicated to reduce the risk of RAO or BPH-related surgery.

As a general rule, the combination therapy was well tolerated and most collected drug-related adverse effects were the same as those already described in the safety profiles of the two drugs, erectile dysfunction and ejaculation disorders being the most common drug-related adverse events. There was no difference in cardiovascular events in general between treatment groups, although the incidence of heart failure observed was superior in the therapy of combination (0.9%) than monotherapy with tamsulosin (0.6%) and in the monotherapy dutasterida (0.2%).

Causal relationship between dutasterida (alone or in combination with an alpha-blocker) and cardiaca.1 insufficiency has not been established

European decentralised registration procedure

It is hoped the granting of national authorisations in the States members of the EU during 2010, with the start of the marketing of the drug in different countries from the next few months.

CombAT

Study of four-year therapy in combination with Avidart and Tamsulosin (CombAT), randomized, international, involving 4.844 men with high risk of progression of BPH, investigating if the treatment in combination with an inhibitor of 5-alpha reductase (5ARI), dutasterida (0.5 mg) and an alpha-blocker, tamsulosin (0,4 mg), was more effective than both monotherapies separately to improve symptoms and the clinical progression in men with symptoms of BPH moderates to severe.

Benign prostatic hyperplasia

BPH is very common. It is estimated that its historical prevalence in the general male population is more than 50% in men aged 51 to 60 years of age and increases to 90% which are between 81 and 90 years of edad3. The prevalence of symptoms of BPH in moderate to severe in men in Europe varies from 14% to 30% 4.

Many of the men who have BPH moderate experience bothersome symptoms affecting their quality of life, including interruptions in the dream because of nocturia, limitations in daily activities due to a frequent and urgent need to urinate, adverse effects in intimate relationships, anxiety and fear of surgery 5,6,7.

BPH is a progresiva8 disease and can lead to serious complications such as the RAO and 5.9 BPH-related surgery. BPH has an important social burden and economic 10,11,12.

Duodart ® is a registered trademark of the Group of companies GlaxoSmithKline for use in European markets with local approval pending selected.
Avidart ® is a registered trademark of the Group of companies GlaxoSmithKline.

Combodart ® is a registered trademark of the Group of companies GlaxoSmithKline for use in European markets with local approval pending selected.

References

1. Summary of product of Duodart.
2 Roehrborn CG, P Siami, Barkin J., et to the. The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study. EUR. Ural. 2010; 5 7: 123-131.
3 Roehrborn CG et to the. The Benign Prostatic Hyperplasia Registry and Patient Survey: study design, methods and patient baseline characteristics BJU Int 2007; 100: 813-9.
4 Madersbacher S et to the. EAU 2004 Guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). EUR. Ural. (2004); 46: 547-554.
5 Emberton M et to the. Benign prostatic hyperplasia as a progressive disease: to guide to the risk factors and options for medical management. Int. J Clin microbiol. Pract. 2008; 62: 18-26.
6 Garraway W et to the. Impact of previously unrecognized benign prostatic hyperplasia on the daily activities of middle – aged and elderly men. British Journal of General Practice 1003, 318-321.
7 Mitropoulos D et to the. Symptomatic Benign Prostate Hyperplasia: Impact on Partners’ Quality of Life Eur. Ural. 41 (2002) 240-245.
8 Crawford ED et to the. Baseline Factors as Predictors of Clinical Progression of Benign Prostatic Hyperplasia in Men Treated with Placebo. Journal of medicine 2006; 175, 1422-14.
9. Roehrborn CG. Acute Urinary Retention: Risks and Management. Med Reviews 2005; 7: 31-41.
10 Fenter CT, Naslund MJ, Shah MB, et to the. The Cost of Treating the 10 Most Prevalent Diseases in Men 50 Years of Age or Older Am J Manag Care 2006.
11 Black L, Naslund MJ, Gilbert TD, et to the. An Examination of Treatment Patterns and Costs of Care Among Patients With Benign Prostatic Hyperplasia Am J Manag Care 2006; 12:S99 – S110.
12 McVary KT. BPH: Epidemiology and Co-morbidities. Am J of Managed Care 2006; 12 (5): 122-128.