FDA gives nod to combination treatment for BPH

June 26, 2008

FDA has approved the 5-alpha-reductase inhibitor dutasteride (Avodart) in combination with the alpha-blocker tamsulosin (Flomax) for treatment of symptomatic enlarged prostate. Both drugs had previously been approved individually for treatment of enlarged prostate.

FDA has approved the 5-alpha-reductase inhibitor dutasteride (Avodart) in combination with the alpha-blocker tamsulosin (Flomax) for treatment of symptomatic enlarged prostate. Both drugs had previously been approved individually for treatment of enlarged prostate.

“The combination of Avodart and tamsulosin at diagnosis allows doctors to simultaneously treat the patient’s prostate on two fronts by reducing prostate size and rapidly improving symptoms,” said Steven A. Kaplan, MD, of Weill Cornell Medical College of Cornell University, New York.

FDA approval was based on 2-year results of the multicenter, randomized, double-blind, parallel-group CombAT (Combination of Avodart and Tamsulosin) study of men age 50 years and older. Results showed that combination therapy was superior to both monotherapies at month 12 extending to month 24 (J Urol 2008; 179:616-21).

Data from the remaining 2 years of the CombAT study will provide further information on the pattern of symptoms and long-term outcomes associated with combination therapy versus dutasteride and tamsulosin monotherapies.