GlaxoSmithKline’s Combodart - the first treatment to offer two individual therapies for benign prostatic hyperplasia in a single pill - has been approved for use in the UK to tackle disease progression and provide symptom relief.

The new once-daily combination pill, a fixed-dose combination of the 5-alpha reductase inhibitor dutasteride and the alpha blocker tamsulosin hydrochloride, has been cleared by regulators to treat moderate-to-severe BPH and reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

BPH is basically a non-cancerous enlargement of the prostate gland driven by a natural increase in the male hormone dihydrotestosterone (DHT) with age, which causes the urethra to narrow and an obstruction to the bladder, leading to a range of symptoms such as a more frequent urge to urinate and hesitancy when passing urine.

The condition currently affects around 3.2 million men (one in three over 50) in the UK but is on the rise as the population ages. If it is not treated, BPH can lead to serious long-term complications such as not being able to pass urine or surgery, which both involve costly hospital stays.

The arrival of Combodart on the market is being hailed as a new era of treatment for BPH, as it offers patients a two-pronged attack against the disease through dutasteride’s action of delaying disease progression by inhibiting DHT, and tamsulosin’s ability to provides rapid symptom relief by reducing smooth muscle tone in the prostate and bladder neck.

Better compliance?
According to Jon Rees, a GP with a special interest in urology from Bristol, the UK approval of GSK’s new drug is “an important development” as patients taking 5-alpha reductase inhibitors such as dutasteride often stop taking their medication because they don’t experience rapid symptom relief.

“By combining the medication that targets the underlying cause of the disease with one that relieves symptoms fairly quickly, patients will be more likely to keep taking their medication, which in turn will decrease the risk of disease progression or patients requiring emergency surgery”, he explained.

UK approval of the drug was based on clinical trial data showing that the combination of
Combodart slashed the risk of AUR or BPH-related surgery by 66% compared with tamsulosin alone, and that the combo also cut the risk of disease progression by 44% versus tamsulosin and 31% compared with dutasteride alone, clearly demonstrating its advantages over the individual therapies and leaving it in good stead to snap up a significant share of the BPH market.