Results of the largest and longest study of the medical management of benign prostatic hyperplasia (BPH) published recently in the New England Journal of Medicine show that combination therapy with finasteride (Merck Sharp & Dohme) and doxazosin (Pfizer) compared to either drugs as monotherapy, or placebo (sugar pill), was the most effective medical therapy of the four treatment arms in the study for patients with lower urinary tract symptoms and BPH.
The Medical Therapy of Prostatic Symptoms Study (MTOPS) was independently conducted and funded by the US National Institutes of Health.
"The results of the study clearly demonstrated that men who have benign enlargement of the prostate were able to significantly reduce their risk of clinical progression of BPH by using a combination of finasteride and doxazosin," said Kevin T. McVary, M.D., study investigator and associate professor, Department of Urology, Feinberg School of Medicine, Northwestern University.
"The study evaluated the effectiveness of three treatment strategies – each drug alone and then in combination – on clinical progression of BPH. The results indicated that combination therapy is an important alternative for the treatment of BPH."
BPH may adversely affect a man’s quality of life and interfere with daily living, and can block the flow of urine through the urethra. BPH may cause symptoms such as feeling an urgency to urinate, frequent urination and nighttime urination.
The results showed that long-term combination therapy with finasteride and doxazosin reduced the risk of clinical progression of BPH by 66 percent compared to 34 percent with finasteride alone and 39 percent with doxazosin. In the study, the risk of developing acute urinary retention was reduced by 81 percent with combination therapy and by 68 percent with finasteride.
Doxazosin alone was not significant versus placebo in reducing the risk of AUR in the study. The risk of needing invasive therapy was reduced by 67 percent with combination therapy and by 64 percent with finasteride. The effect of doxazosin alone was not significant versus placebo in reducing the risk of invasive therapy in this study.
"The MTOPS trial provides important new information in pursuit of the optimal treatment for BPH patients," added McVary. "MTOPs also reaffirms what we’ve seen with finasteride in previous trials demonstrating reduced risk of developing acute urinary retention and the need for invasive therapy."
Patients seeking additional information about benign prostatic hyperplasia (BPH) should consult a doctor.
