Mirodenafil side effects, safety, ED medication
February 1 2017

Benefit for erectile dysfunction
World J Mens Health. 2014. Mirodenafil for the treatment of erectile dysfunction: a systematic review of the literature. Phosphodiesterase type 5 (PDE5) inhibitors are the most commonly used treatment for erectile dysfunction (ED). Since the launch of sildenafil, several drugs-including mirodenafil, sildenafil citrate (sildenafil), tadalafil, vardenafil HCL (vardenafil), udenafil, and avanafil-have become available. Mirodenafil is a newly developed pyrrolopyrimidinone compound, which is a potent, reversible, and selective oral PDE5 inhibitor. Mirodenafil was launched in Korea in 2007, and an orally disintegrating film of mirodenafil was developed in 2011 for benefitting patients having difficulty in swallowing tablets. This study aimed to review the pharmacokinetic characteristic profile of mirodenafil and report evidence on its efficacy in the case of ED. In addition, we reviewed randomized controlled studies of mirodenafil's daily administration and efficacy for lower urinary tract symptoms.

Urol Int. 2014.  Impact of the Change in Urinary and Sexual Function on Health-Related Quality of Life after Once Daily Low-Dose Mirodenafil Treatment in Patients with Organic Erectile Dysfunction. We aimed to evaluate whether changes in urinary and sexual function can influence health-related quality of life. Out of 54 recruited patients, 36 were enrolled, and data for 30 participants with erectile dysfunction were available. At baseline and after 1 and 2 months, each participant completed the International Index of Erectile Function (IIEF-15), the International Prostate Symptom Score (IPSS) and the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36). Uroflowmetry, post-voiding residual volume and the nocturnal penile tumescence (NPT) test were performed at baseline and at the study's conclusion. Compared with baseline, the IPSS, IIEF-15, peak urinary flow rate, NPT parameters and mental component of the SF-36 exhibited significant improvement at the study's conclusion. Among the symptomatic parameters, the changes in the storage and erectile function parameters contributed significantly to the change in the mental component score on the SF-36. The daily administration of low-dose mirodenafil (50 mg) produced improvements in urinary and erectile function with or without sexual stimulation.

Safety and side effects
J Urol. 2013. Safety and efficacy of once daily administration of 50 mg mirodenafil in patients with erectile dysfunction: a multicenter, double-blind, placebo controlled trial. Department of Urology, Hanyang University College of Medicine, Seoul, Korea. We evaluated the improvement in erectile dysfunction and lower urinary tract symptoms as well as the safety of once daily administration of 50 mg mirodenafil phosphodiesterase ihibitor in men with erectile dysfunction. A total of 226 patients visited for treatment of erectile dysfunction and were recruited for the study. Of these men 180 met the study inclusion criteria after completing a 2-week screening period (visit [V]1). The patients were randomly allocated into 2 groups. Group 1 (90 patients) received 50 mg mirodenafil once daily and group 2 (90 patients) received a placebo daily. Blood pressure, heart rate, IIEF-5 (5-item version of the International Index of Erectile Function), and SEP (Sexual Encounter Profile) questions 2 and 3 were assessed at 4 (V2), 8 (V3) and 12 weeks after the start of treatment (V4). I-PSS (International Prostate Symptom Score), maximal flow rate and post-void residual volume were also assessed for the evaluation of lower urinary tract symptoms. Of the 180 patients 71 in group 1 and 63 in group 2 completed the 12-week clinical trial. IIEF-5 and I-PSS significantly improved in group 1 (p <0.001 for both). Facial flushing was the most common adverse effect, followed by headaches. Notably there were no statistically significant differences in either of the variables related to the cardiovascular system. Once daily administration of 50 mg mirodenafil was efficacious and safe for the treatment of erectile dysfunction and lower urinary tract symptoms.

Expert Opin Pharmacother. 2013. An update on pharmacological treatment of erectile dysfunction with phosphodiesterase type 5 inhibitors. Phosphodiesterase type 5 inhibitors (PDE5-i) are used for the oral treatment of erectile dysfunction (ED). Since the launch of sildenafil more than 15 years ago, new molecules have become available. At present, in addition to tadalafil and vardenafil, there are three other drugs, udenafil, avanafil and mirodenafil, marketed in some countries which appear to be promising. The clinical pharmacological differences in dosage and side effects of all PDE5-i are evaluated. All PDE5-i are equally effective and safe for the treatment of ED. On-demand use of any PDE5-i is also safe for patients with comorbid conditions. Tadalafil seems to be the preferred drug by patients and physicians, probably due to its peculiar pharmacological profile that makes sexual intercourse more spontaneous for the patients. Preliminary data suggest that the use of vardenafil may also be beneficial in cases of ED associated with premature ejaculation. Daily treatment is another option in men with ED and documented vascular or prostate disease. In geriatric or in difficult-to-treat populations, the evaluation of testosterone plasma levels will help to predict the efficacy of any PDE5-i. Remarkably, when such drugs are withdrawn for any reason, ED most often continues to occur because of the presence of an underlying disease.