PURPOSE: To compare the clinical efficacy and safety of three phosphodiesterase type 5 (PDE5) inhibitors in the treatment of mele erectile dysfunction according to patient preference. MATERIALS AND METHODS: Between January 2004 and August 2005, 113 male erectile dysfunctional patients were enrolled to this randomized, prospective, comparative, open-label, triple-crossover study of three PDE5 inhibitors. Patients were assigned to one of six medication schedules, and were prescribed a full dose of the drugs for 8 weeks, with a week of washout period prior to the next drug cycle. The International Index of Erectile Function (IIEF) scores and side effects related with each medication were obtained at the end of study. 48 patients finished all the medications, and completed the study with a global assessment questionnaire on their drug preference and reasons for that preference. RESULTS: The mean age of the patients was 54.6 (33-73) years. The mean pre-treatment IIEF and EF domain scores (+/-S.D.) were 28.2+/-14.7 and 10.6+/-6.6, respectively. The scores were significantly improved, to 47.9+/-14.6 and 19.9+/-6.6 with sildenafil, to 49.7+/-12.3 and 21.3+/-5.8 with vardenafil, and to 47.9+/-14.9 and 19.8+/-7.2 with tadalafil (p < 0.01). There were no significant differences in the scores or frequencies of side effects between the drugs. The preference percentages were 29.2, 29.2 and 35.4% for sildenafil, vardenafil and tadalafil, respectively. Patient preference was mainly due to improvement in erectile function (70.9%), such as rigid erection, prolonged erection and fast erection, and not to the infrequent rate of side effects (20.8%). CONCLISIONS: There were no significant differences of the efficacy and safety among the three PDE5 inhibitors. The preference for a drug for the treatment of erectile dysfunction was mainly related to the efficacy on the improvement of erectile function rather than the less frequent side effects.
Appointments and Schedules ; Erectile Dysfunction* ; Humans ; Male ; Patient Preference* ; Phosphodiesterase 5 Inhibitors* ; Phosphodiesterase Inhibitors ; Prospective Studies ; Questionnaires

In February 2011, the Korean Society for Sexual Medicine and Andrology (KSSMA) realized the necessity of developing a guideline on erectile dysfunction (ED) appropriate for the local context, and established a committee for the development of a guideline on ED. As many international guidelines based on objective evidence are available, the committee decided to adapt these guidelines for local needs instead of developing a new guideline. Considering the extensive research activities on ED in Korea, data with a high level of evidence among those reported by Korean researchers have been collected and included in the guideline development process. The latest KSSMA guideline on ED has been developed for urologists. The KSSMA hopes that this guideline will help urologists in clinical practice.
Andrology ; Erectile Dysfunction ; Korea ; Male ; Phosphodiesterase 5 Inhibitors

A multi-center, randomized, double-blind, placebo-controlled study was conducted with 158 subjects who were randomized to placebo or avanafil 50, 100, and 200 mg on demand for 8 weeks to evaluate the safety, tolerability, and efficacy of avanafil in the treatment of erectile dysfunction (ED) in Korean men. The primary outcome was the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcomes included changes in the scores of IIEF questions 3 and 4 (IIEF Q3, Q4) from baseline, changes in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2–5 (SEP2–5), the Global Efficacy Assessment Question (GEAQ), and the number of subjects whose EF domain score at the 8th week visit was ≥ 26. After 8 weeks of treatment, the dose groups except avanafil 50 mg scored significantly higher on the IIEF-EF domain from baseline than the placebo group. The changes from baseline in the avanafil group in IIEF Q3 (all doses) and Q4 (200 mg alone) were higher than the placebo group. The differences between avanafil and placebo groups were significant in SEP2 (100 and 200 mg) and SEP3–5 (200 mg). The differences in the GEAQ “Yes” response were also significant in the avanafil 100 and 200 mg groups. Regarding the ratio of normal EF at the end of the study, avanafil 200 mg differed significantly from the placebo. Most treatment-associated adverse events were mild and resolved spontaneously. This is a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT02477436).
Erectile Dysfunction* ; Humans ; Male ; Penile Erection ; Phosphodiesterase 5 Inhibitors

Phosphodiesterase type 5 (PDE5) inhibitors are used most commonly in the treatment of penile erectile dysfunction (ED). Recent studies show that PDE5 inhibitors are ideal drugs for treating ischemia-reperfusion injury. This review focuses on the results of basic and clinical researches on PDE5 inhibitors for the treatment of ischemia-reperfusion injury and provides some theoretical evidence for clinical options of the drugs.
Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase 5 Inhibitors ; therapeutic use ; Phosphodiesterase Inhibitors ; therapeutic use ; Reperfusion Injury ; drug therapy

OBJECTIVETo observe and compare the effects and adverse events of the three phosphodiesterase type 5 (PDE-5) inhibitors sildenafil, vardenafil and tadalafil used in the same period for the treatment of erectile dysfunction (ED).

METHODSA total of 311 ED patients were treated with the three PDE-5 inhibitors in the same period, 134 with sildenafil, 109 with vardenafil and 88 with tadalafil, and followed up for 2-11 months. Their effects were compared.

RESULTSSildenafil produced satisfactory effect in 72 patients (79.12%), vardenafil in 63 (81.81%) and tadalafil in 52 (78.78%), respectively. And the efficacy rates of sildenafil, vardenafil and tadalafil in the treatment of ED with premature ejaculation were 55.56%, 44.44% and 42.3%, respectively. Our study also showed that the young and the newly married preferred vardenafil, the middle-aged chose tadalafil and the older and long-term users tend to take sildenafil. The main reasons for discontinuing the use of the three inhibitors were their high price, incomplete effect and the patients' worry about their adverse action.

CONCLUSIONThe three PDE-5 inhibitors can produce basically similar effects on ED, all with safety and few mild adverse events.

Adult ; Erectile Dysfunction ; drug therapy ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Phosphodiesterase 5 Inhibitors ; Phosphodiesterase Inhibitors ; administration & dosage

PURPOSE: Intracaverous injections (ICI) are the standard treatment for erectile dysfunction (ED) when oral phosphodiesterase 5 inhibitors (PDE5I) fail or are contraindicated. However, many patients are wary of ICI because of aversion to the injection. We assessed patients' satisfaction and the quality of the sex life in patients undergoing long-term ICI with trimix. MATERIALS AND METHODS: One hundred five patients with ED who had used ICI with trimix for at least 6 months were enrolled in the study. We investigated the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire (EDITS), quality of sex life, and pain on injection and erection. The EDITS questions were scored on a 0 to 4-point scale and the mean scores were multiplied by 25 to normalize the scores to a 100-point scale and to create the EDITS index. A total score > 50 was defined as "satisfied with treatment" and a score of < 50 was defined as "not satisfied with treatment." RESULTS: The mean age of the patients was 70+/-8.2 years, the mean duration of ED was 6.4+/-3.3 years, and the mean duration of ICI treatment was 50.3+/-32.6 months. Of the 105 patients, 48.5% had received PDE5I treatment prior to ICI treatment. Among the 51 patients who had received PDE5I, 72.5% (37/51) and 19.6% (10/51) discontinued PDE5I due to inefficacy and side effects, respectively. Four patients used PDE5I in combination with ICI. The mean number of injections was 2.99+/-1.26 per month and the mean dose of trimix was 0.33+/-0.14 ml per injection. The mean EDITS index was 73.7+/-14.5, and 93% of the patients were classified in the satisfaction group according to the EDITS index criteria. Patients noted an improvement in their sex life (78.1%), their relationship with their partner (68.6%), and their quality of life (65.7%) after using ICI with trimix; 92.3% of patients responded that they were ready to recommend ICI with trimix to their friends. The mean scores for pain on injection and erection were 1.04/10 and 0.98/10, respectively. CONCLUSIONS: In spite of long-term treatment, ICI with trimix met the expectations of patients. ICI with trimix is revealed as easy, effective, and tolerable treatment. ICI with trimix should be positively recommended when PDE5I fails or is contraindicated.
Erectile Dysfunction ; Friends ; Helium ; Humans ; Male ; Nitrogen ; Oxygen ; Phosphodiesterase 5 Inhibitors ; Quality of Life

BACKGROUND: Phosphodiesterase Type 5 Inhibitors (PDE5Is), which are prescription drug in South Korea, have been concerned about misuse, overuse and illegal provision of the drugs. This study was performed to investigate utilization and safety of illegal Phosphodiesterase Type 5 Inhibitors (PDE5Is), and related factors among South Korean men. METHODS: A questionnaire survey was conducted from May to July in 2013 among 1,500 nationally representative general males using computer-assisted telephone interview (CATI). The questionnaire included the characteristics of population, the characteristics of PDE5Is use, the experience with the use of illegally obtained PDE5Is, and adverse events after PDE5Is use. RESULTS: Among study population, the 1,015 (67.7%) men answered that they have used the illegally obtained PDE5Is. Younger age, single, lower frequency of PDE5Is use in a lifetime was associated with an increased use of illegally obtained PDE5Is. The men experienced adverse events after PDE5Is use is 528 (35.2%). The most common adverse event was mild to moderate hot flashes. CONCLUSION: We need to enhance awareness about the risk of illegally obtained PDE5Is use, especially in younger men and single. Proactive educations and public relations on safe use of PDE5Is for proper patients are needed.
Hot Flashes ; Humans ; Interviews as Topic ; Korea ; Male ; Phosphodiesterase 5 Inhibitors* ; Prescriptions ; Public Relations

OBJECTIVETo evaluate the clinical efficacy and safety of phosphodiesterase 5 (PDE-5) inhibitors for erectile dysfunction (ED) in patients with diabetes mellitus and provide some evidence for the clinical treatment of the disease.

METHODSWe searched MedMed, EMbase, Cochrane Library, CNKI, Wan Fang Data, VIP and ZADL for randomized controlled trials on PDE-5 inhibitors for ED in diabetic men and evaluated the methodology of the included trials with the Jadad scale. We used the erectile function domain in the IIEF (IIEF-EF), IIEF questions (IIEF-Q) 3 and 4, SEP-2 and -3, and Global Assessment Questions (GAQ) as the main evaluation indexes and employed the Review Manager 5. 1. 0 software for meta analysis.

RESULTSA total of 13 studies were included, which were all high quality trials with Jadad score > 3. The IIEF-EF scores in 10 of the included studies were subjected to meta analysis using the random-effect model (REM), with a weighted mean difference (WMD) of 5.64 (95% CI 4.41 - 6.83, P < 0.001). The fixed-effect model (FEM) analysis of the IIEF-Q scores in 6 of the studies showed the WMD to be 0.96 (95% CI 0.83 -1.08, P < 0.001) for IIEF-Q3 and 1.11 (95% CI 0.98 - 1.25, P < 0.001) for IIEF-Q4. FEM analysis of the SEP-2 scores showed WMD = 17.67 (95% CI 12. 38 - 22. 97, P < 0.001) in 2 of the studies, and that of the SEP-3 scores WMD = 23.64 (95% CI 17. 49 - 29.79, P < 0.001) in 5 of the studies. The GAQ scores in 11 of the studies were subjected to REM analysis, with OR = 6. 20 and 95% CI 3.65 - 10.52 (P < 0.001). REM analysis was performed on the adverse reactions in 11 of the studies, with OR = 7.43 and 95% CI 4.11 - 13.44 (P < 0.001).

CONCLUSIONPDE-5 inhibitors can effectively and safely improve erectile function in patients with diabetes mellitus.

Diabetes Mellitus ; Erectile Dysfunction ; drug therapy ; Gangliosides ; Humans ; Male ; Penile Erection ; Phosphodiesterase 5 Inhibitors ; therapeutic use

Erectile dysfunction (ED) is a common problem, for which PDE5 inhibitors (PDE5I) represent the first line therapy at present and have a success rate of approximately 80%. Refractory ED, which refers to ED in some patients with chronic diseases such as diabetes mellitus and cardiovascular diseases or in those treated by radical prostatectomy, receives little benefit from PDE5I alone. Apart from the NO-cGMP pathway, the processes of erection and ED involve several signaling pathways, such as RhoA/Rho kinase, H2S, CO, etc. The complicated signaling network contributes to the pathogenesis of refractory ED. PDE5I-based alternative therapy and combined therapy may increase the success rate of its treatment. This article outlines the advances in the studies of refractory ED that fails to respond to PDE5I.
Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase 5 Inhibitors ; therapeutic use

Phosphodiesterase-5 inhibitors (PDE5i) have been used as the first-line treatment for erectile dysfunction (ED) in recent years. However, with the increased clinical application of PDE5i, the incidence rate of PDE5i-induced adverse reactions is on the rise, which may involve the cardiovascular, digestive, nervous, respiratory, and reproductive systems. Most of the adverse reactions are mild to moderate, occasionally with serious or rare complications. The probability and severity of the adverse reactions are associated with the dosage and frequency of medication as well as with individual differences. Therefore individualized medication is necessitated and, for the patients with cardiovascular disease, epilepsy, psychosis, or anaphylactic conditions, PDE5i should be cautiously given or avoided. This review provides an overview of PDE5i-induced adverse reactions and countermeasures in the treatment of ED.
Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase 5 Inhibitors ; administration & dosage ; adverse effects