Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity.

OBJECTIVES: To evaluate the body mass index (BMI) and lower urinary tract symptom (LUTS) severity on treatment response to sildenafil in men with erectile dysfunction (ED) and moderate to severe LUTS associated with benign prostatic hyperplasia.

METHODS: A post hoc analysis of data from a 12-week, double-blind, placebo-controlled study of sildenafil (50 mg once daily titrated to 100 mg once daily) was conducted. The BMI categories were obese (> or = 30 kg/m(2)), overweight (> or = 25 to < 30 kg/m(2)), and normal weight (< 25 kg/m(2)). ED was defined as a score of < or = 25 on the erectile function domain of the International Index of Erectile Function, and LUTS was defined by an International Prostate Symptom Score of > or = 12. The maximal urinary flow rate was determined by uroflowmetry.

RESULTS: Patients receiving sildenafil (n = 189) had a significant improvement in the erectile function domain scores of the International Index of Erectile Function (P < .0001 vs placebo, n = 180), which did not vary across BMI groups. A greater improvement in LUTS score was observed with sildenafil compared with placebo for men with severe LUTS (-8.6 vs -2.4, P < .0001) than in men with moderate LUTS (-3.6 vs -1.7, P = .06). Also, the improvement in LUTS scores was significant (P < or = .02) for men taking sildenafil independent of BMI (obese, -8.9 vs -5.4; overweight, -7.3 vs -3.2; normal weight, -7.1 vs -0.84). No difference was found among the treatment groups in the change from baseline maximal urinary flow rate across all LUTS and BMI categories (range 4.5 to -4.2 mL/s).

CONCLUSIONS: The results of our study have shown that daily dosing with sildenafil improved ED and LUTS independent of baseline LUTS severity or BMI.