INTRODUCTION AND OBJECTIVES: Statins are cholesterol lowering agents that are commonly used for cardiovascular health. Recent studies have suggested a benefit of statins in BPH. Prior studies have shown statin use to be associated with decreased lower urinary tract symptoms (LUTS), prostate volumes, and International Prostate Symptom Scores (IPSS). However, a 6-month trial of atorvastatin vs. placebo showed no effect of statins on IPSS or prostate volume. Because the role of statins in BPH remains unclear, we evaluated the association between statin use and development of LUTS among asymptomatic men in REDUCE.METHODS: REDUCE was a 4-year, multicenter, randomized, double-blind, placebo-controlled study that followed biopsy-negative men testing dutasteride for prostate cancer risk reduction. Eligible men were aged 50-75 years, had serum PSA between 2.5-10 ng/mL, a prior negative prostate biopsy, and baseline prostate volume<80 cc. Men completed the IPSS questionnaire at time of enrollment and every 6 months thereafter. Exclusion criteria included men on BPH medical therapy or baseline IPSS!8. Incident LUTS was defined as the first report of medical treatment, surgery, or sustained clinically significant BPH symptoms (two IPSS>14). Men who progressed within 30 days of study enrollment were excluded. Cox proportional hazards were used to test whether statin use independently predicted time to incident LUTS.RESULTS: Of the 3,057 men who met study enrollment criteria, 553 (18%) reported statin use. They were older (62.7 vs. 61.8 years, p¼0.003) and had higher BMI (27.3 vs 26.8, p<0.001) but had similar baseline prostate volume and IPSS vs. non-statin users. Overall, 329 men progressed to symptomatic BPH. On crude analysis, statin use was not associated with decreased risk of incident LUTS (HR 1.03, p¼0.849). When adjusting for treatment group, race, diabetes, BMI, coronary artery disease, smoking status, region, PSA, IPSS, prostate volume, and age, the result was similar (HR 1.02, p¼0.900).CONCLUSIONS: Among men with mild to no LUTS, statin use was not associated with decreased risk of developing incident LUTS. If confirmed, these findings do not support the use of statins in BPH progression.