Dutasteride (Avodart) in combination with tamsulosin for the treatment of patients with moderate to severe benign prostatic hyperplasia (BPH) has been given approval in Sweden.

Approval for the dual-acting 5-alpha reductase inhibitor was given through the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State, DGNews reports.

It is believed that further approvals will be granted in the coming months across the remaining 26 European countries.

Approval for the treatment followed positive two-year results from the ongoing Combination of Avodart and Tamsulosin (CombAT) study.

The four-year, randomised, double-blind, parallel-group study is investigating the efficacy and safety of dutasteride 0.5 mg and tamsulosin 0.4 mg in 4,844 men with moderate to severe BPH symptoms both separately and in combination.

Findings from the research thus far show that the combination therapy improves peak urinary flow and quality of life more markedly than either agent used alone.

The dutasteride and tamsulosin combination has also been shown to provide significantly superior and sustained improvements in BPH symptoms versus dutasteride alone from month three, and versus tamsulosin alone from month nine.

At four years, the study will evaluate the efficacy of dutasteride and tamsulosin combination therapy versus each agent alone in reducing the risk of acute urinary retention and BPH-related surgery.

Researchers also noted that although drug-related adverse events (mainly sexually related) were more common with combination therapy, rates of withdrawal from the study due to adverse events were low across treatment groups.

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