1.Comparison of the Efficacy, Safety and Patient Preference of the Phosphodiesterase Type 5 Inhibitors for the Patients with Erectile Dysfunction.
Changhee YOO ; Jinsung PARK ; Wansuk KIM ; Bumsik HONG ; Junhyuk HONG ; Tai Young AHN
Korean Journal of Urology 2007;48(2):219-225
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
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Erectile Dysfunction*
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Humans
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Male
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Patient Preference*
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Phosphodiesterase 5 Inhibitors*
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Phosphodiesterase Inhibitors
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Prospective Studies
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Questionnaires
2.A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Therapeutic Confirmatory Study to Evaluate the Safety and Efficacy of Avanafil in Korean Patients with Erectile Dysfunction.
Hyun Jun PARK ; Sae Woong KIM ; Je Jong KIM ; Sung Won LEE ; Jae Seung PAICK ; Tae Young AHN ; Kwangsung PARK ; Jong Kwan PARK ; Nam Cheol PARK
Journal of Korean Medical Science 2017;32(6):1016-1023
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*
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Humans
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Male
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Penile Erection
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Phosphodiesterase 5 Inhibitors
3.Korean Society for Sexual Medicine and Andrology (KSSMA) Guideline on Erectile Dysfunction.
Ji Kan RYU ; Kang Su CHO ; Su Jin KIM ; Kyung Jin OH ; Sung Chul KAM ; Kyung Keun SEO ; Hong Seok SHIN ; Soo Woong KIM
The World Journal of Men's Health 2013;31(2):83-102
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
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Erectile Dysfunction
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Korea
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Male
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Phosphodiesterase 5 Inhibitors
4.Experience of using three phosphodiesterase type 5 inhibitors in the same period for the treatment of erectile dysfunction.
National Journal of Andrology 2007;13(3):226-228
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
5.Update of PDE5 inhibitors for the treatment of ischemia-reperfusion.
National Journal of Andrology 2011;17(9):842-846
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
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drug therapy
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Humans
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Male
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Phosphodiesterase 5 Inhibitors
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therapeutic use
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Phosphodiesterase Inhibitors
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therapeutic use
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Reperfusion Injury
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drug therapy
6.Utilization, Safety, and Related Factors of Illegal Phosphodiesterase Type 5 Inhibitors in South Korean Men.
Bong Gi KIM ; Sun Young JUNG ; Kyoung eun KWON ; Byung Joo PARK
Korean Journal of Clinical Pharmacy 2015;25(1):50-55
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
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Humans
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Interviews as Topic
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Korea
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Male
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Phosphodiesterase 5 Inhibitors*
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Prescriptions
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Public Relations
7.Usage and perceptions of phosphodiesterase type 5 inhibitors among the male partners of infertile couples.
Seung Hun SONG ; Dong Suk KIM ; Sung Han SHIM ; Jung Jin LIM ; Seung Choul YANG
Clinical and Experimental Reproductive Medicine 2016;43(1):26-30
OBJECTIVE: We aimed to investigate the prevalence of erectile dysfunction (ED) and the usage of phosphodiesterase type 5 (PDE5) inhibitors for ED treatment in infertile couples. METHODS: A total of 260 male partners in couples reporting infertility lasting at least 1 year were included in this study. In addition to an evaluation of infertility, all participants completed the International Index of Erectile Function (IIEF)-5 questionnaire to evaluate their sexual function. The participants were asked about their use of PDE5 inhibitors while trying to conceive during their partner's ovulatory period and about their concerns regarding the risks of PDE5 inhibitor use to any eventual pregnancy and/or the fetus. RESULTS: Based on the IIEF-5 questionnaire, 41.5% of the participants (108/260) were classified as having mild ED (an IIEF-5 score of 17-21), while 10.4% of the participants (27/260) had greater than mild ED (an IIEF-5 score of 16 or less). The majority (74.2%, 193/260) of male partners of infertile couples had a negative perception of the safety of using a PDE5 inhibitor while trying to conceive. Only 11.1% of men (15/135) with ED in infertile couples had used a PDE5 inhibitor when attempting conception. CONCLUSION: ED was found to be common in the male partners of infertile couples, but the use of PDE5 inhibitors among these men was found to be very low. The majority of male partners were concerned about the risks of using PDE5 inhibitors when attempting to conceive. Appropriate counseling about this topic and treatment when necessary would likely be beneficial to infertile couples in which the male partner has ED.
Counseling
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Erectile Dysfunction
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Family Characteristics*
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Fertilization
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Fetus
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Humans
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Infertility
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Male*
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Phosphodiesterase 5 Inhibitors*
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Pregnancy
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Prevalence
8.Pharmacokinetics, Efficacy, and Safety of Selective Inhibitors of Phosphodiesterase Type 5 and Sublingual Apomorphine for the Treatment of Erectile Dysfunction.
Korean Journal of Andrology 2002;20(3):113-125
Oral pharmacotherapy has become the first-line therapy for the majority of patients with erectile dysfunction (ED) of broad-spectrum etiology since the introduction of oral sildenafil, a potent, selective inhibitor of phosphodiesterase type 5 (PDE5). More than 3 years following the launch of sildenafil have made us informed fully about the mechanism of sildenafil, its clinical efficacy and safety, and appropriate use of the drug. Recently, the efficacy and tolerability of another potent, selective inhibitors of PDE5, vardenafil and tadalafil have been reported one after another and their phase 3 clinical studies worldwide have just finished. The PDE5 inhibitors are contraindicated in patients taking nitrates and may be restricted in others. The recent introduction of sublingual (SL) apomorphine, a centrally acting dopaminergic agonist with known erectogenic effects, could provide patients and clinicians with an additional option in the treatment of ED, although its efficacy and safety need to be verified further by worldwide clinical studies. We are in face of the era of multiple oral agents available for the treatment of ED. Due to the complex nature of individual patient-oriented goals and the multifactorial nature of ED, choices are needed that can be adapted to the requirements and responses of the individual patients. In this review, an overview of the pharmacokinetics, efficacy and safety of the oral PDE5 inhibitors, sildenafil, vardenafil and tadalafil, and sublingual apomorphine are provided.
Apomorphine*
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Dopamine Agonists
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Drug Therapy
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Erectile Dysfunction*
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Humans
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Male
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Nitrates
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Pharmacokinetics*
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Phosphodiesterase 5 Inhibitors
9.Patients' Satisfaction and Quality of Sex Life in Patients Undergoing Long-term Intracavernous Injections with Trimix.
Korean Journal of Andrology 2008;26(4):204-211
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
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Friends
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Helium
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Humans
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Male
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Nitrogen
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Oxygen
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Phosphodiesterase 5 Inhibitors
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Quality of Life
10.The risk factors, diagnosis and treatment guideline of erectile dysfunction.
Journal of the Korean Medical Association 2015;58(5):443-451
Erectile dysfunction (ED) can negatively impact the quality of life among men, and increasingly affects all age strata. This has led to an explosion of health information on ED both for patients and doctors, which may cause potentially harmful effects when misused or abused. Therefore, the necessity of developing a standardized, appropriate guideline for the diagnosis and management of ED is increasing. In this review, the author describes risk factors, diagnosis and treatment guidelines for ED, which can be usefully applied in clinical practice.
Diagnosis*
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Erectile Dysfunction*
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Explosions
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Humans
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Male
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Phosphodiesterase 5 Inhibitors
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Quality of Life
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Risk Factors*