GlaxoSmithKline ( GSK ) has announced that Duodart, a fixed dose combination of Dutasteride ( 0.5mg ), and Tamsulosin ( 0.4mg ) has received approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State.
Duodart is indicated for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia ( BPH ) and reduction in the risk of acute urinary retention ( AUR ) and surgery in patients with moderate-to-severe symptoms of BPH.

The regulatory submission for Duodart was based on data from the CombAT ( Combination therapy with Avodart and Tamsulosin ) trial was a multinational randomised study of 4,844 men, at increased risk of BPH progression, which investigated whether combination treatment with the 5-alpha reductase inhibitor ( 5ARI ), Dutasteride ( 0.5mg ), and an alpha blocker, Tamsulosin ( 0.4mg ), was more effective than either monotherapy in improving symptoms and clinical outcomes in men with moderate-to-severe symptomatic benign prostatic hyperplasia.

CombAT showed that the combination of Dutasteride and Tamsulosin offers patients with moderate-to-severe symptoms of benign prostatic hyperplasia:

a) significantly superior and sustained symptom improvement compared with the most frequently prescribed medication, the alpha blocker Tamsulosin;

b) symptom improvement that starts as rapidly as Tamsulosin monotherapy and is sustained over 4 years;

c) a reduction in the risk of BPH complications ( AUR and BPH related surgery ) versus Tamsulosin by 66% ( p<0.001 ) and by 20% versus Dutasteride ( p=ns ) monotherapy at 4 years.

The combination therapy was generally well-tolerated and most reported drug-related adverse events were as anticipated from the known safety profiles of the two drugs, with erectile dysfunction and ejaculatory disorders as the most commonly reported drug-related adverse events.
There was no difference in overall cardiovascular events across treatment groups, although the incidence of cardiac failure observed was higher in the combination arm ( 0.9% ) than in the Tamsulosin arm (0.6%) and the Dutasteride arm ( 0.2% ).
No causal relationship between Dutasteride ( alone or in combination with an alpha-blocker ) and cardiac failure has been established.

Benign prostatic hyperplasia is a very common condition. The histological prevalence in the general male population is estimated to be over 50% of men aged 51-60 years, and increases to 90% in those aged 81-903.The prevalence in Europe of moderate-to-severe symptoms of BPH in men ranges from 14% to 30%.
For men who have moderate benign prostatic hyperplasia, many experience the bothersome symptoms which impact their quality of life, including interrupted sleep due to nocturia, limitations on daily activities due to a frequent and urgent need to urinate, adverse impact on close relationships, anxiety, and fear of surgery.

Source: GSK, 2010

XagenaMedicine2010