Table 1.

Characteristics of randomized controlled studies included in the meta-analyses

Study; year of publication	No. subjects	Primary endpoint	Intervention	Treatment duration	Inclusion criteria	Incidence of prostate cancer	Notes
ARIA series (ARIA3001, ARIA3002, ARIB3003; dutasteride BPH monotherapy); 2004	4325	BPH symptomatic relief; prostate cancer evaluated for-cause as an adverse effect	Dutasteride, 0.5 mg daily (n=2167); placebo daily (n=2158)	2 years	PSA 1.5–10 IPSS ≥12 PV ≥30 cc	Cumulative incidence of prostate cancer at 24 mos for dutasteride vs. placebo: 1.1% vs. 1.9%, p=0.025 at 24 mos; 1.2% vs. 2.5%, p=0.002 at 27 mos; 51% risk reduction at 27 mos	Pooled analysis of 3 monotherapy trials; for-cause biopsies
REDUCE; 2010	8231	Prostate cancer detected on biopsy after 2 or 4 years of treatment	Dutasteride, 0.5 mg daily (n=4105); placebo daily (n=4126)	4 years	PSA 2.5–10 IPSS <25 PV ≤80 cc	Absolute risk reduction of 5.1% in dutasteride group over 4 years; Relative risk reduction: 22.8% (95% CI: 15.2–29.8, p<0.001)	Protocol-mandated biopsies
CombAT; 2011	4844	Time to first AUR or BPH-related surgery in symptomatic BPH patients; Prostate cancer evaluated for-cause as an adverse effect	Dutasteride, 0.5 mg daily (n=1623); Tamsulosin 0.4 mg daily (n=1611); combination (dutasteride 0.5 mg + tamsulosin 0.4 mg) (n=1610) daily	4 years	PSA 1.5–10 IPSS ≥12 PV ≥30 cc	PCa detection of 2.3%combination group; 2.6% in dutasteride group; and 3.9% in tamsulosin; relative risk reduction of 40% for dutasteride (alone or in combination with tamsulosin) vs. tamsulosin monotherapy (95% confidence interval, 16–57%; p=0.002)	For-cause biopsies

BPH: benign prostatic hyperplasia; IPSS: International Prostate Symptom Score; AUR: acute urinary retention; Mos: Months; PSA: prostate-specific antigen; PV: prostate volume; CombAT: Combination of Avodart And Tamsulosin trial; REDUCE: REduction by DUtasteride of prostate Cancer Events; CI: confidence interval.