STOCKHOLM — Outcomes were better when men with moderate symptoms of benign prostate hyperplasia were treated with dutasteride plus tamsulosin hydrochloride (Duodart, GlaxoSmithKline) than when they were monitored with watchful waiting, new research shows.
At each follow-up time point, "men who received lifestyle advice and alpha blocker therapy if they failed to improve had less symptom improvement than men who received combination therapy right from the start," said Claus Roehrborn, MD, professor and chair of urology at UT Southwestern Medical Center in Dallas.
First results from the CONDUCT trial, sponsored by GlaxoSmithKline, "suggest that in men with moderate symptoms but large prostates, combination therapy should be the treatment of choice," he told Medscape Medical News.
"Because 30% to 50% of elderly men will eventually develop prostatic enlargement, it's very important to see the long-term outcome of anything that's taken prophylactically," said Arnulf Stenzl, MD, from Tubingen Hospital in Germany
Dr. Stenzl is chair of the European Association of Urology (EAU) scientific abstract committee that selected the study as a late-breaking presentation here at the EAU 29th Annual Congress.
The multicenter, European, randomized, phase 4 study involved 742 men with a confirmed diagnosis of benign prostate hyperplasia and only moderate symptoms. Mean age was 66 years.
All men received lifestyle advice about caffeine and alcohol avoidance, fluid management, and bladder retraining. They were then randomized to watchful waiting (n = 373) or to daily treatment for 2 years with a single capsule containing the 5-alpha reductase inhibitor dutasteride 0.5 mg plus the alpha blocker tamsulosin 0.4 mg (n = 369)
Baseline characteristics were similar in the treatment and watchful waiting groups. Mean total serum prostate-specific antigen (PSA) levels ranged from 3.7 to 3.9 ng/mL, mean prostate volumes ranged from 51.0 to 52.6 cc, and the mean International Prostate Symptom Score (I-PSS) was "fairly modest," ranging from 12.9 to 13.2, Dr. Roehrborn reported.
When symptoms worsened, men in the watchful waiting group were stepped up to once-daily tamsulosin 0.4 mg. By the end of the trial, 61% of these men were receiving tamsulosin.
About 80% of subjects in each group completed the trial. More men in the treatment group than in the watchful waiting group discontinued therapy because of adverse events (36% vs 18%).
Mean change in IPSS from baseline — the primary end point — was significantly greater in the treatment group than in the watchful waiting group (5.4 vs 3.6; P < .001). In addition, IPSS improved by at least 25% in significantly more men in the treatment group (73% vs 60%; P < .001).
At the end of the study, the rate of clinical progression of benign prostate hyperplasia was 43.1% lower in the treatment group than in the watchful waiting group (18% vs 29%; P < .001).
Similarly, improvements in hyperplasia symptoms and related quality of life were significantly greater the treatment group (P < .001).
Drug-related adverse events were more common in the treatment group than in the watchful waiting group (24% vs 10%), as were serious adverse events (10% vs 8%). The most common adverse events in the treatment and watchful waiting groups were retrograde ejaculation (5% vs 4%) and erectile dysfunction (8% vs 0%).
This study provided us with "information about the longer-term use of this therapy, the side-effect profile, and the impact this has on clinical progression," said Christopher Chapple, MD, consultant urological surgeon at Sheffield Teaching Hospitals, honorary professor at the University of Sheffield, and visiting professor at Sheffield Hallam University in the United Kingdom.
However, he told Medscape Medical News, "2 years is probably too short a time from which to draw too many meaningful conclusions."
The study was sponsored by GlaxoSmithKline. Dr. Roehrborn reports financial relationships with GlaxoSmithKline. Dr. Chapple reports financial relationships with Allergan, Astellas, AMS, GlaxoSmithKline, Lilly, ONO, Pfizer, and Recordati.
European Association of Urology (EAU) 29th Annual Congress: Abstract LBA1. Presented April 15, 2014.