Combination therapy improves symptomatic BPH

August 12, 2010

The FDA has approved Jalyn, a single-capsule combination of dutasteride, 0.5 mg, and tamsulosin, 0.4 mg, to treat symptomatic BPH.

The FDA has approved Jalyn, a single-capsule combination of dutasteride, 0.5 mg, and tamsulosin, 0.4 mg, to treat symptomatic BPH.

In a clinical study of nearly 5,000 men, co-administration of these two medicines significantly improved symptoms of BPH compared with either medicine taken alone.

Approval of the combination was based on 2-year results from the CombAT (Combination of Avodart and Tamsulosin) study. The study compared changes in urinary symptoms seen with dutasteride co-administered with tamsulosin as opposed to either medicine alone. Changes were measured via a validated symptom index.

Reported adverse events were consistent with the known safety profiles of dutasteride and tamsulosin. The most common adverse reactions reported in subjects receiving combination therapy were erectile dysfunction, decreased libido, breast disorders, ejaculation disorders, and dizziness.