Effects of mirodenafil on the hemodynamics in hypertensive patients taking amlodipine

While phosphodiesterase type 5 inhibitors have been used for erectile dysfunction with acceptable safety profile, they can induce orthostatic hypotension in patients taking antihypertensive drugs with blood pressure lowering effect. This study evaluated the hemodynamic effects of 100 mg mirodenafil in hypertensive patients taking an amlodipine. Thirteen hypertensive patients who were taking 5 or 10 mg of amlodipine once daily participated in a randomized, double-blind, placebo-controlled, crossover study. A single oral dose of mirodenafil 100 mg or placebo was administered at 4.5 hour after administration of amlodipine. The maximal change in systolic and diastolic blood pressure (ΔmaxSBP and ΔmaxDBP) and pulse rate (ΔmaxPR) were compared between mirodenafil and placebo periods. Twelve patients completed this study and were included analysis. The values of ΔmaxPR in standing and supine position were significantly greater in the mirodenafil period (13.25±7.12 and 11.17±4.86 beats/minute) when compared to the placebo (8.50±4.72 and 6.58±3.90 beats/minute). The ΔmaxSBP and ΔmaxDBP in standing position appeared to be lower in the mirodenafil period, but they were not statistically different from those in the placebo period (ΔmaxSBP = -7.42±5.6 vs -4.42±5.37 mmHg and ΔmaxDBP = -7.17±5.72 vs -3.50±3.37 mmHg). Both ΔmaxSBP and ΔmaxDBP in standing and supine position were not significantly different between mirodenafil and placebo. This study demonstrated that mirodenafil exerted minimal hemodynamic effects in the patients taking amlodipine, that is unlikely associated with a clinically significant hypotensive event.

Comparison of Erectile Dysfunction Treatment Efficacy of Mirodenalfil 50mg Once Daily and 100mg On-Demand in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction: Multicenter, Randomized

PURPOSE: To Compare the improvement of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) as well as the efficacy of mirodenalfil 50mg once daily and 100mg on-demand in patients with benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). MATERIALS AND METHODS: Prospective study was done with 220 patients who had BPH and ED from June 2013 to October 2014. Out of 220 individuals, 260 met inclusion criteria and 204 finished the research. Patients were divided into two groups. Group 1 had mirodenafil 50mg once daily and Group 2 had mirodenafil 100mg on-demand. The five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), Qmax, and residual urine volume(PVR) were assessed immediately before initiation of treatment (V1) and after four (V2) and twelve weeks of treatment (V3). RESULTS: No difference of IIEF-5, IPSS, Qmax, and PVR between two groups in V1. At V3, both groups had improvements of IPSS and group 1 had better improvements (-5.1+/-4.4 vs. -3.1+/-3.9 p<0.001). And Group 1 had larger improvements than Group 2 in Qmax significantly. No difference in PVR in both groups comparing V1 vs. V2 and V1 vs V3. Group 1 had better improved IIEF-5 than Group 2 (V1 vs. V3: 4.8+/-5.8 vs. 4.4+/-5.1; p=0.032). There was no drop out patients due to cardiovascular problems. CONCLUSIONS: Once daily mirodenafil 50mg was more efficacious in treating both ED and LUTS than on-demand dosing mirodenafil 100mg without any complication of cardiovascular problems.