Moderate to Severe Benign Prostatic Hyperplasia

The American Urological Association endorses the use of combination therapy for men at greatest risk for disease progression, meaning those with moderate to severe symptoms and a prostate larger than 40 mL or a PSA level above 4 ng/dL. This recommendation was prompted by the results from a trial called Medical Therapy of Prostatic Symptoms (MTOPS). The 4.5-year investigation involved more than 3,000 men who had BPH symptoms, making it the largest trial ever to compare various types of medication for BPH.

The participants were randomly assigned to one of four treatment groups:

  • Proscar
  • Cardura
  • a combination of Proscar and Cardura, or
  • a placebo (inactive substance)

The researchers concluded that combination therapy is safe and appears to be more effective than either medication alone (Proscar or Cardura). Men on combination therapy were 66 percent less likely to experience worsening of their BPH during the study than were men who took the placebo. Men who took Cardura alone were 39 percent less likely to experience worsening symptoms; for those who took Proscar alone, the risk of worsening symptoms was 34 percent lower.

Combination therapy also reduced the risk of acute urinary retention by 79 percent compared with placebo. The risk reduction was 67 percent with Proscar, but Cardura did not significantly affect urinary retention rates.

Other research that has shown good results from combination therapy is the Combination of Avodart and Tamsulosin (CombAT) study. In this study, published in BJU International, combination therapy with the 5-alpha-reductase inhibitor Avodart and the alpha-blocker Flomax was better than either agent alone for improving quality of life and patient satisfaction with treatment.

The men in this study had prostate enlargement with moderate to severe BPH symptoms. A combination drug called Jalyn (containing Avodart and Flomax) was approved recently by the U.S. Food and Drug Administration (FDA).

Combination therapy is most effective in men with larger prostates because Proscar works by reducing prostate size. Older men, those with higher PSA levels, and men with low urinary flow rates are more likely than other men to have an enlarged prostate.

Several potential BPH drugs are under investigation, and urologists are exploring the benefits of combining BPH medications with oral ED drugs. Treatment for one disorder often helps the other, and the combination of an oral medication for ED and an alpha-blocker works better than either agent alone for men who have both conditions. This research is expected to expand the medication options in the coming years.

Publication Review By: H. Ballentine Carter, M.D.

Published: 11 Apr 2011

Last Modified: 23 Oct 2014