Cost regulators in Scotland have given the green light for GlaxoSmithKline’s new combination treatment for benign prostatic hyperplasia.

The Scottish Medicines Consortium has accepted Combodart (dutasteride/ tamsulosin) for use on the NationalHealth Service. It is the first fixed dose combination of a 5-alpha reductase inhibitor (dutasteride) and an alpha blocker and is indicated for the treatment of moderate-to-severe BPH and reduction in the risk of acute urinary retention and BPH-related surgery.

GSK noted that dutasteride which it sells as Avodart, delays progression of the disease by inhibiting the production of the male hormone dihydrotestosterone (DHT) that stimulates prostate growth. Tamsulosin, which is sold for BPH by Boehringer Ingelheim and Astellas Pharma under a variety of brand names (eg Flomax, Alna, Harnal) and is now available generically, provides rapid symptom relief by reducing smooth muscle tone in the prostate and bladder neck.

Combodart received marketing authorisation in the UK in May based on the 4-year CombAT trial results, which demonstrated that the combo significantly reduced the risk of AUR or BPH-related surgery by 66% compared with tamsulosin alone. It was also shown that combination therapy significantly reduced the risk of BPH disease progression by 44% compared with tamsulosin and 31% compared with dutasteride alone.

BPH affects an estimated 3.2 million men in the UK (one in three men over the age of 50 years) and this number is expected to increase with the growing elderly population.