Treatment with dutasteride in men with only mild symptoms of benign prostatic hyperplasia may prevent future complications associated with the condition, suggest researchers.
The study looked at 1,617 men with a prostate size greater than 40 mL and a baseline International Prostate Symptom Score (IPSS) of less than eight, 792 of whom were randomised to dutasteride 0.5 mg daily and 825 randomised to placebo. The primary endpoint was clinical progression as defined by urinary retention, surgery, urinary tract infection, or symptom deterioration of four or more IPSS points during the four-year follow-up.
Clinical progression occurred in 167 (21%) patients receiving dutasteride compared with 297 (36%) patients taking placebo. This equated to statistically significant 15% absolute and 41% relative risk reductions associated with dutasteride treatment, giving a number needed to treat of 6.7. Multivariable analysis adjusting for covariates indicated that dutasteride treatment was independently associated with a significant 53% reduction in the odds of clinical progression. The most common drug-related adverse events was erectile dysfunction, occurring in 9.0% of patients receiving dutasteride compared with 5.1% of those receiving placebo.
What this means for GPs
The authors say their findings suggest dutasteride or other 5α-reductase inhibitors could potentially be used for the prevention of future complications in men with an enlarged prostate. They comment: ‘For men found to have a large prostate gland during routine rectal examination or imaging, this information may be used to select those for whom preventive medication may improve their quality of life and also yield economic benefits.’