Efficacy of tadalafil on improvement of men with erectile dysfunction caused by COVID-19:A randomized placebo-controlled trial

Objective: According to the high prevalence of COVID-19 and the subsequent risk of men's sexual health, we decided to investigate the efficacy of tadalafil on improvement of men with erectile dysfunction caused by COVID-19.Methods: In this study, 70 outpatients who were recovered from COVID-19 without acute respiratory distress syndrome with negative polymerase chain reaction test and a complaint of erectile dysfunction were divided into two groups: 35 patients who received tadalafil 5 mg daily and 35 who received placebo. For each patient, basic assessment of sexual function was performed using the 5-item version of the International Index of Erectile Function (IIEF-5) questionnaire. Then, treatment was started from 2 months after complete recovery of COVID-19 with negative polymerase chain reaction test for 3 months. At the end of the treatments, the patients were re-evaluated for sexual function using the complete version of IIEF questionnaire. Finally, the results before and after treatment in the intervention group were compared with those of the control group.Results: Treatment with both tadalafil and placebo improved the patients' sexual function criteria compared to the baseline. However, this improvement was significantly higher in the intervention group with tadalafil than the control group with placebo (p<0.05).Conclusion: Daily administration of tadalafil 5 mg seems to be effective and safe for improvement of erectile dysfunction caused by COVID-19.

The mechanistic study on Wa medicine Niang-Mu-Liang medicinal liquor mitigating diabetes mellitus erectile dysfunction in rats by inhibiting ferroptosis

Background:This study aims to investigate the therapeutic effect of Wa medicine Niang-Mu-Liang medicinal liquor(NML)on rats with diabetes mellitus erectile dysfunction(DMED)and its impact on the ferroptosis signaling pathway.Methods:Thirty Sprague-Dawley rats were randomly divided into three groups:Control,DMED,and NML.After establishing the DMED model,treatments were administered for 8 weeks.After the administration,apomorphine hydrochloride tests were conducted to measure the mass and organ index of testes and epididymides,sperm concentration and viability in each group.Penile corpus cavernosum tissues were stained with hematoxylin and eosin.Nitric oxide and cyclic guanosine monophosphate levels in the penile corpus cavernosum tissues were determined using biochemical kits and enzyme-linked immunosorbent assay,while the expression of proteins related to the ferroptosis signaling pathway was measured by Western blot.Results:Compared to the DMED group,the DMED rats treated with NML showed significantly increased erection frequency,testicular and epididymal mass and index,sperm count and viability,along with noticeable improvement in the pathological morphology of penile corpus cavernosum.The content of nitric oxide and cyclic guanosine monophosphate,and the expression of ferritin heavy chain,ferritin light chain,and glutathione peroxidase 4 proteins in penile corpus cavernosum tissue were elevated,while the expression of transferrin and STEAP3 proteins was reduced.Conclusion:NML can improve erectile function in DMED rats by inhibiting the ferroptosis signaling pathway.

Pathogenesis and treatment of diabetes mellitus-related erectile dysfunction: current therapies and potential challenges

Erectile dysfunction(ED)is one of the important complications of diabetes,which is very common in diabetic patients,affecting more than half of male patients,and the incidence of the disease is about 3.5 times that of the normal population.The pathogenesis of diabetic erectile dysfunction(DMED)is complex,involving nerve,vascular,endocrine,muscular and psychological aspects.At present,the therapeutic approaches of DMED include drug therapy,surgery,physical therapy and so on.This article provides a review of current research on the pathogenesis and treatment of DMED.Further elucidation of the pathogenesis of DMED and the development of new therapeutic approaches are of great significance for the prevention and treatment of DMED.

Efficacy and safety of platelet-rich plasma intracavernous injection for patients with erectile dysfunction:A systematic review,meta-analysis,and meta-regression

ObjectiveIntracavernous injection might be offered to patients with erectile dysfunction (ED) who did not respond to the first-line oral treatment. Platelet-rich plasma (PRP) might offer improvement in erectile function since it contains numerous growth factors. This study aimed to evaluate the efficacy and safety of PRP intracavernous injection for patients with ED.MethodsWe conducted relevant literature searches on Cochrane Library, Medline, Scopus, and ClinicalTrials.gov databases using specific keywords. The results of continuous variables were pooled into the mean difference (MD) and dichotomous variables into the odds ratio along with 95% confidence interval (95% CI).ResultsA total of six studies were included. Our pooled analysis revealed that PRP intracavernous injection was associated with a significant increase in the erectile function domain of the International Index of Erectile Function at 1 month (MD 3.47 [95% CI 2.62–4.32], p<0.00001, I^(2)=7%), 3 months (MD 3.19 [95% CI 2.25–4.12], p<0.00001, I^(2)=0%), and 6 months (MD 3.21 [95% CI 2.30–4.13], p<0.00001, I^(2)=0%) after the intervention when compared with baseline values. PRP was also superior to a placebo in terms of improvement in erectile function domain of the International Index of Erectile Function score at 1 month (MD 2.83, p<0.00001), 3 months (MD 2.87, p<0.00001), and 6 months (MD 3.20, p<0.00001) post-intervention. The adverse events from PRP injection were only mild without any serious adverse events.ConclusionPRP intracavernous injection may offer benefits in improving erectile function in patients with ED with a relatively good safety profile.

An update on the use of stem cell therapy for erectile dysfunction

ObjectiveThis systematic review aimed to analyze animal and human trial data to better understand the efficacy of stem cell therapy (SCT) for erectile dysfunction (ED) and the obstacles that may hinder its application in this field.MethodsWe searched electronic databases, including PubMed and Scopus, for published studies with the Medical Subject Heading terms of “erectile dysfunction” (AND) “stem cell therapy” (OR) “erectile dysfunction” (AND) “clinical trial of stem cell therapy” (OR) “stem cell therapy” (AND) “sexual dysfunction”. The search was limited to English-language journals and full papers only. The initial search resulted in 450 articles, of which 90 relevant to our aims were included in the analysis.ResultsED is a multifactorial disease. Current treatment options rely on pharmacotherapy as well as surgical options. Patients may have side effects or unsatisfactory results following the use of these treatment options. SCT may restore pathophysiological changes leading to ED rather than treating the symptoms. It has been evaluated in animal models and shown promising results in humans. Results confirm that SCT does improve erectile function in animals with different types of SC use. In humans, evidence showed promising results, but the trials were heterogeneous and limited mainly by a lack of randomization and the small sample size. Many challenges could limit future research in this field, including ethical dilemmas, regulation, patient recruitment, the cost of therapy, and the lack of a standardized SCT regimen. Repairing and possibly replacing diseased cells, tissue, or organs and eventually retrieving normal function should always be the goals of any therapy, and this can only be guaranteed by SCT.ConclusionSCT is a potential and successful treatment for ED, particularly in patients who are resistant to the classic therapy. SCT may promote nerve regeneration and vascular cell regeneration, not only symptomatic treatment.

Mesenchymal stem cell secretome: A promising therapeutic strategy for erectile dysfunction?

Objective:The secretome,comprising bioactive chemicals released by mesenchymal stem cells(MSCs),holds therapeutic promise in regenerative medicine.This review aimed to explore the therapeutic potential of the MSC secretome in regenerative urology,particularly for treating erectile dysfunction(ED),and to provide an overview of preclinical and clinical research on MSCs in ED treatment and subsequently to highlight the rationales,mechanisms,preclinical investigations,and therapeutic potential of the MSC secretome in this context.Methods:The review incorporated an analysis of preclinical and clinical research involving MSCs in the treatment of ED.Subsequently,it delved into the existing knowledge regarding the MSC secretome,exploring its therapeutic potential.The methods included a comprehensive examination of relevant literature to discern the processes underlying the therapeutic efficacy of the MSC secretome.

Impact of the association between elevated oestradiol and low testosterone levels on erectile dysfunction severity

Our aim was to assess the impact of the association between elevated oestradiol （E2） and low testosterone （T） levels on erectile dysfunction （ED） severity. A total of 614 male patients with ED and a normal or low T level in association with normal or elevated E2 levels were enrolled. Patients underwent routine laboratory investigations in addition to measurements of total T, total E2, follicle-stimulating hormone （FSH）, luteinizing hormone （LH） and prolactin. We compared the responses to the erectile function domain, Q3 （achieving erection） and Q4 （maintaining erection） of the International Index for Erectile Function （IIEF） score in patients with the following： normal T and E2 levels; low T level; low T level and elevated E2 level; and elevated E2 level. Of the patients included, 449 （73.1%） had normal T and E2 levels, 110 （17.9%） had a low T level, 36 （5.9%） had a low T level and an elevated E2 level, and 19 （3.1%） had an elevated E2 level. Increased ED severity was significantly associated with low T levels, elevated E2 levels, and both a low T level and an elevated E2 level. Additionally, the mean values of the EF-domain, Q3 and Q4 were significantly lower in patients with both a low T level and an elevated E2 level compared to patients with any condition alone. In conclusion, a low T level had the primary effect on erectile function; however, a concomitantly elevated E2 level had an additive impairment effect.

Prevalence and risk factors of erectile dysfunction in three cities of China: a community-based study

Aim: To determine the age-adjusted prevalence of erectile dysfunction (ED) in 3 big cities of China and to explore its potential sociodemographic, medical and lifestyle correlates. Methods: A cross-sectional, population-based survey was conducted in three cities of China. Structured questionnaires were administered to 2 226 men, aged 20 - 86 years, by trained interviewers. Results: The age-adjusted prevalence of ED was 28.34 % (mild 15.99 %, moderate 7.14 %, severe 5.21 %). In the men above 40, the prevalence was 40.2%. Age was positively correlated with ED (P<0.01). Education was negatively correlated with ED (P<0.01). Spouse companionship, living condition were positively correlated with ED (P<0.01). Histories of cardiovascular disease, diabetes, and hyperlipidemia were positively correlated with ED (P<0.01). Cigarette smoking was not correlated with ED (P>0.05), while the cigarette consumption and duration were positively correlated with ED (P<0.01). Alcohol drinking is negatively correlated with ED (P<0.01). The duration of drinking was positively correlated with ED (P<0.01). Weekly alcohol consumption was not correlated with ED (P>0.05). Conclusion: The prevalence of ED increased with age. Cardiovascular disease, diabetes and hyperlipidemia were positively correlated with the increased prevalence. Sociodemographic and lifestyle factors, such as education, spouse companionship, living condition, cigarette and alcohol consumption or duration also have association with the prevalence of ED.

Improved spontaneous erectile function in men with mild-tomoderate arteriogenic erectile dysfunction treated with a nightly dose of sildenafil for one year： a randomized trial

Aim： To test the hypothesis that sildenafil （50 mg nightly for one year） can improve spontaneous erectile function （EF） in men with mild-to-moderate arteriogenic erectile dysfunction （ED） responsive to erectogenic treatment. Methods： In a prospective open-label trial, 112 men with ED were randomized to sildenafil 50 mg nightly or sildenafil 50 or 100 mg as needed for 12 months, followed by one-month and 6-month non-medicated periods. Non-randomized, non-medicated men with ED were also assessed. The EF domain of the International Index of Erectile Function （IIEF EF） and the peak systolic velocity （PSV） of penile cavernous arteries were used to measure the efficacy. Results： After sildenafil treatment and a subsequent non-medicated month, IIEF EF was normal in 29 of 48 （60.4%, 95% confidence interval [CI]： 45.3-74.2%） of the nightly group vs. 4 of 49 （8.2%, 95% CI： 2.3-19.6%） of the as-needed group. PSV improved by 11.2 cm/s （95% CI： 4.7-21.4; P = 0.012） in the nightly group but only by 3.4 cm/s （-5.1- 14.7; P = 0.435） in the as-needed group. IIEF EF normalized in 1 of 18 （5.6%, 95% CI： 0.1-27.3%） non-medicated men and the PSV declined slightly. Six months after treatment, the IIEF EF remained normal and PSV was stabilized in most （28/29, 97%） nightly group men who had initially normalized. Conclusion： Sildenafil nightly for one year resulted in ED regression that persisted well beyond the end of treatment, so that spontaneous EF was characterized as normal on the IIEF in most men. The results from this open-label, randomized trial warrant verification under double-blind, placebo-controlled conditions.

Endothelium-specific gene and stem cell-based therapy for erectile dysfunction

Erectile dysfunction （ED） commonly results from endothelial dysfunction of the systemic vasculature. Although phosphodiesterase type 5 （PDE-5） inhibitors are effective at treating most cases of ED, they must be taken routinely and are ineffectual for a meaningful number of men. In recent years gene and stem cell-based therapies targeted at the penile endothelium have been gaining momentum in preclinical studies. These early studies reveal that gene and stem cell-based therapies may be both enduring and efficacious, and may eventually lead to a cure for ED. The following review will highlight our current understanding of endothelial-specific gene and stem cell-based therapies performed to date in a number of experimental animal models.

Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction:a randomized double-blind,parallel,placebo-controlled clinical study

Aim： To assess the efficacy and safety of tadalafil in comparison to a placebo, when taken on demand for 12 weeks by East/Southeast Asian men with erectile dysfunction （ED）, Methods： This multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August 2002 and February 2003. Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive a placebo or 20 mg of tadalafil taken as needed （maximum once daily）. Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile diary and Global Assessment Questions. Results： Tadalafil significantly improved erectile function as compared to the placebo （P 〈 0.001）. At the endpoint, the patients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts （Sexual Encounter Profile question 3： 70.9% compared to 33.5% in the placebo） and a greater proportion of improved erections （Global Assessment Question： 86.2% compared to 30.1%）. Most （≥3%） treatment emergent adverse events were mild or moderate. The most common treatment emergent adverse events were headache, back pain, dizziness and dyspepsia. Conclusion： Tadalafil was an effective and well-tolerated treatment for ED in East and Southeast Asian men.

Application of pudendal evoked potentials in diagnosis of erectile dysfunction

Aim: Extensive neurophysiological investigations were carried out in 100 healthy subjects and 84 patients with penileerectile dysfunction. Methods: Following examinations were performed, spinal and scalp somatosensory evoked poten-tials (SEPs) to stimulation of the dorsal nerve of penis, motor evoked potentials (MEPs) from bulbocavernosus (BC) inresponse to scalp and spinal root stimulation, and measurement of sacral reflex latency (SRL) from anal sphincter (AS).Results: In the healthy subjects, the mean sensory total conduction time (sensory TCT), as measured at the peak of thescalp P1 (P40) wave was 39.73 ms. The mean sensory central conduction time (sensory CCT = spinal-to-scalp conductiontime) was 28.98 ms. The mean peripheral conduction time (PCP) was 9.40 ins. Transcranial brain stimulation was per-formed by using a magnetic stimulator during voluntary contraction of the examined muscle. Spinal root stimulation wasperformed at rest. Motor total conduction time (motor TCT) to BC muscles was 20.48 ms. Motor central conductiontime (motor CCT) to sacral cord segments controlling BC muscles was 14.42 ms at rest. The mean SRL was 35.13 ms.Conclusion: Combined or isolated abnormalities of SEPs, MEPs, and SRL were found in patients with erectile dysfunc-tion. (Asian J Androl 1999 Sep; 1 : 145 - 150)

Incidence rate of prostate cancer in men treated for erectile dysfunction with phosphodiesterase type 5 inhibitors： retrospective analysis

The purpose of this study was to determine the incidence rate of prostate cancer among men with erectile dysfunction （ED） treated with phosphodiesterase type 5 inhibitors （PDE-5i） over a 7-year period vs. men with ED of the same age and with similar risk factors who were not treated with PDE-5i. In a retrospective review of electronic medical records and billing databases between the years 2000 and 2006, men with ED between the ages of 50 and 69 years and no history of prostate cancer prior to 2000 were identified. These individuals were divided into two groups： 2362 men who had treatment with PDE-5i, and 2612 men who did not have treatment. Demographic data in each group were compared. During the study period, 97 （4.1%） men with ED treated with PDE-5i were diagnosed with prostate cancer compared with 258 （9.9%） men with ED in the non-treated group （P〈00001）. A higher percentage of African Americans were treated with PDE-5i vs. those who were not （10.5% vs. 7.1%; P〈O.O001）. The PDE-5i group had lower documented diagnosis of elevated prostate-specific antigen （10.0% vs. 13.1%; P=-0.0008） and higher percentage of benign prostatic hyperplasia （38.4% vs. 35.1%; P=0.0149）. Men with ED treated with PDE-5i tended to have less chance （adjusted odds ratio： 0.4; 95% confidence intervals： 0.3-0.5; P〈0.0001） of having prostate cancer. Our data suggest that men with ED treated with PDE-5i tended to have less of a chance of beine diaenosed with orostate cancer. Further research is warranted.

Help-seeking behavior for erectile dysfunction： clinic-based survey in China

The behavior of Chinese patients seeking help for erectile dysfunction （ED） has not been described in detail. This was an observational study conducted using an outpatient clinic-based questionnaire survey of ED patients. From 2008 to 2009, physicians in 10 medical centers in China enrolled 2693 men （aged 25-70years） diagnosed with ED. The diagnosis was based on the International Index of Erectile Function 5 （IIEF-5） Questionnaire. The men completed a survey that asked questions about demographics, marital status, education level and household income as well as help-seeking behavior and awareness of medical therapy. The mean age of the 2693 men was 43.4 5.3years; 73% were 〈50-years-old and 49% had a high household income. The mean time between noticing ED and taking the first treatment was 4.3 2.1months. Of the 2577 respondents, physicians （54%） and the internet （52%） were most frequently consulted sources for information about ED. Young ED patients preferred using the internet and older patients preferred consulting with physicians. Western medicine （19%） and traditional Chinese medicine （16%） were most frequently used for treatment. Young ED patients preferred to first search the internet for information, whereas older patients first asked physicians for help. Side effects of treatment were the greatest concern, especially for older patients. Physicians and the internet are frequently consulted for ED information and therapy. On the basis of these survey results, we believe that physicians in China should enhance health education about ED, especially via the internet.

Mobilisation of endothelial progenitor cells： one of the possible mechanisms involved in the chronic administration of melatonin preventing erectile dysfunction in diabetic rats

Diabetes-induced oxidative stress plays a critical role in the mobilisation of endothelial progenitor cells （EPCs） from the bone marrow to the circulation. This study was designed to explore the effects of chronic melatonin administration on the promotion of the mobilisation of EPCs and on the preservation of erectile function in type I diabetic rats. Melatonin was administered to streptozotocin-induced type I diabetic rats. EPCs levels were determined using flow cytometry. Oxidative stress in the bone marrow was indicated by the levels of superoxide dismutase and malondialdehyde. Erectile function was evaluated by measuring the intracavernous pressure during an electrostimulation of the cavernous nerve. The density of the endothelium and the proportions of smooth muscle and collagen in the corpus cavernosum were determined by immunohistochemistry. The administration of melatonin increased the superoxide dismutase level and decreased the malondialdehyde level in the bone marrow. This effect was accompanied by an increased level of circulating EPCs in the diabetic rats. The intracavernous pressure to mean arterial pressure ratio of the rats in the treatment group was significantly greater, compared with diabetic control rats. The histological analysis demonstrated an increase in the endothelial density of the corpus cavernosum after the administration of melatonin. However, melatonin treatment did not change the proportions of smooth muscle and collagen in the corpus cavernosum of diabetic rats. Chronic administration of melatonin has a beneficial effect on preventing erectile dysfunction （ED） in type I diabetic rats. Promoting the mobilisation of EPCs is one of the possible mechanisms involved in the improvement of ED.

Adipose-derived stem cells modified by BDNF gene rescue erectile dysfunction after cavernous nerve injury

Cavernous nerve injury is the main cause of erectile dysfunction following radical prostatectomy.The recovery of erectile function following radical prostatectomy remains challenging.Our previous studies found that injecting adipose-derived stem cells(ADSCs)into the cavernosa could repair the damaged cavernous nerves,but the erectile function of the treated rats could not be restored to a normal level.We evaluated the efficacy of ADSCs infected with a lentiviral vector encoding rat brain-derived neurotrophic factor(lenti-rBDNF)in a rat model of cavernous nerve injury.The rats were equally and randomly divided into four groups.In the control group,bilateral cavernous nerves were isolated but not injured.In the bilateral cavernous nerve injury group,bilateral cavernous nerves were isolated and injured with a hemostat clamp for 2 minutes.In the ADSCGFP and ADSCrBDNF groups,after injury with a hemostat clamp for 2 minutes,rats were injected with ADSCs infected with lenti-GFP(1×106 in 20μL)and lenti-rBDNF(1×106 in 20μL),respectively.Erectile function was assessed 4 weeks after injury by measuring intracavernosal pressures.Then,penile tissues were collected for histological detection and western blot assay.Results demonstrated that compared with the bilateral cavernous nerve injury group,erectile function was significantly recovered in the ADSCGFP and ADSCrBDNF groups,and to a greater degree in the ADSCrBDNF group.Neuronal nitric oxide synthase content in the dorsal nerves and the ratio of smooth muscle/collagen were significantly higher in the ADSCrBDNF and ADSCGFP groups than in the bilateral cavernous nerve injury group.Neuronal nitric oxide synthase expression was obviously higher in the ADSCrBDNF group than in the ADSCGFP group.These findings confirm that intracavernous injection with ADSCs infected with lenti-rBDNF can effectively improve erectile dysfunction caused by cavernous nerve injury.This study was approved by the Medical Animal Care and Welfare Committee of Wuhan University,China(approval No.2017-1638)on June 20,2017.

The effects of long-term administration of tadalafil on STZ-induced diabetic rats with erectile dysfunction via a local antioxidative mechanism

Type 5 phosphodiesterase inhibitors （PDE51s） are well known being effective via the nitric oxide and cyclic guanosine monophosphate （NO-cGMP） pathway and are widely used in the treatment of diabetic erectile dysfunction （ED）. However, it is unclear whether other pathways may be involved in the treatment of diabetic ED with PDE51s. The purpose of this study was to clarify the role of antioxidants in diabetic ED treatment through the long-term administration of PDE51s. Three groups of Sprague-Dawley rats were utilized： Group N, the normal control; Group D, streptozotocin （STZ）-induced diabetic rats as a control; and Group D＋T, STZ-induced diabetic rats who received oral administration of tadalafil for 8 weeks. Erectile function was assessed by intracavernous pressure （ICP） and mean arterial pressure （MAP） during electrical stimulation of the cavernous nerve before euthanasia. The levels of malondialdehyde （MDA）, superoxide dismutase （SOD） and mitochondrial membrane potential （MMP） of cavernous tissue were assessed by biochemical analysis. The morphology of mitochondria was observed by electron microscopy. The ICP/MAP ratio was higher in Group D＋T than in Group D （P〈O.05）. The levels of MDA decreased and the activities of SOD increased in Group D＋T in comparison with Group D （P〈O.05）. The mitochondrial membrane potential level of cavernous tissue in diabetic rats was partially recovered by tadalafil treatment for 8 weeks. The morphology changes of mitochondria were also remarkably ameliorated in Group D＋T. Collectively, the long-term administration of tadalafil in diabetic rats partially reduced oxidative stress lesions of the penis via a local antioxidative stress pathway. Long-term dosages of tadalafil given once daily beginning soon after the onset of diabetes may aid in preventing rats from developing diabetic ED.

Emerging neuromodulatory molecules for the treatment of neurogenic erectile dysfunction caused by cavernous nerve injury

Advances in the neurobiology of growth factors, neural development, and prevention of cell death have resulted in a heightened clinical interest for the development of protective and regenerative neuromodulatory strategies for the cavernous nerves （CNs）, as therapies for prostate cancer and other pelvic malignancies often result in neuronal damage and debilitating loss of sexual function. Nitric oxide released from the axonal end plates of these nerves within the corpora cavernosa causes relaxation of smooth muscle, initiating the haemodynamic changes of penile erection as well as contributing to maintained tumescence; the loss of CN function is primarily responsible for the development of erectile dysfunction （ED） after pelvic surgery and serves as the primary target for potential neuroprotective or regenerative strategies. Evidence from pre-clinical studies for select neuromodulatory approaches is reviewed, including neurotrophins, glial cell line-derived neurotrophic factors （GDNF）, bone morphogenic proteins, immunophilin ligands, erythropoetin （EPO）, and stem cells.

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men： results of an integrated analysis

We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population （with varying patient demographics, disease severity, and comorbid medical conditions） of Asian men with erectile dysfunction （ED）. An integrated analysis of five double-blind, placebo-controlled trials （N = 1 046） was performed. Patients were randomly assigned to receive 10 mg tadalafil （N = 185）, 20 mg tadalafil （N = 510）, or placebo （N = 351）. Efficacy assessments included the International Index of Erectile Function （IIEF）, Sexual Encounter Profile （SEP） diary and Global Assessment Question （GAQ）. Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function （IIEF-EF） domain score in all clinical sub-populations analyzed, compared with patients receiving placebo （P 〈 0.001）. The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts （SEP3, successful intercourse）, respectively, compared with 33.4% in the placebo group （P 〈 0.001）, and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group （P 〈 0.001）. Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.

Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men： a multicenter, randomized, doubleblind, placebo-controlled, fixed dose, parallel group clinical trial

Aim： To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor （PDE5I）, in Korean men with erectile dysfunction （ED）. Methods： A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 （50, 100, or 150 mg; n = 89） or placebo （n = 30） taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function （IIEF）, Sexual Encounter Profile （SEP）, and the Global Assessment Question （GAQ）. Safety was analyzed by adverse events, laboratory values and vital signs. Results： At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo （P 〈 0.05）. Of the 89 patients in the treatment arm, 36 （42.3 %） achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness （10.9%, 7.6%, 2.5% and 2.5%, respectively）, and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion： The results of our phase Ⅱ study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.