The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study.

INTRODUCTION: Dapoxetine is a short-acting selective serotonin reuptake inhibitor for treatment of premature ejaculation (PE). AIM: To evaluate the efficacy and safety of dapoxetine 30 and 60 mg as needed in Asia-Pacific men with PE. METHODS: The study was a prospective, 12-week, open-label study to evaluate the efficacy and safety of flexible-dose dapoxetine in men with PE diagnosed by a Premature Ejaculation Diagnostic Tool score of at least 11, a self-estimated intravaginal ejaculation latency time (IELT) no longer than 2 minutes, and an International Index of Erectile Function erectile function domain score of at least 21. MAIN OUTCOME MEASURES: Percentage of subjects reporting their PE as at least "slightly better" using the Clinical Global Impression of Change (CGIC) question. RESULTS: Two hundred eighteen of 285 randomized subjects completed the study. The mean subject age was 45.9 years and 57.7% were Korean. Dosages 1 (30 mg), 2 (30 → 60 mg), and 3 (30 → 60 → 30 mg) were used in 141, 124, and 13 subjects, respectively. At study end, a PE CGIC rating of at least "slightly better" was reported by 77.3%, 92.8%, and 100% of subjects for dosages 1, 2, and 3, respectively (P = .49). At study end, a CGIC rating of "slightly better" was reported by 85.2% and 85.3% of subjects with lifelong PE and acquired PE, respectively (P = .50). At study end, a CGIC rating of "slightly better" was reported by 84.1% and 86.4% of subjects with an estimated baseline IELT no longer than and at least ≤1 minute, respectively (P = .16). The incidence of a CGIC rating of at least "slightly better" was lower in subjects reporting an adverse event of moderate or severe severity and in subjects who increased to and maintained a dapoxetine dose of 60 mg and higher in subjects older than 50 years and in subjects with a baseline estimated IELT of at least 1 minute. CONCLUSION: In this study, flexible dosing of dapoxetine (30 and 60 mg) appeared effective in the treatment of PE.

Thai men's health and sexual attitude.

Men's health awareness, including the research and study of quality of life, sexual desires and risk factors, has increased worldwide. In Thailand, this advancement is made possible by cooperation, research and sponsorship from the local Thai community. This article aims to illustrate the sexual attitudes of Thai people, to determine the degree of erectile dysfunction (ED) and to investigate how to manage and cope with ED in a Thai community. We reviewed the relevant literature from Thai-based articles and surveys in regard to men's health, sexual attitudes, the prevalence of ED and common risk factors in the Thai community. The primary risk factor for ED in Thai men was age-related health decline and the presence of vascular disease. Most Thai men will seek consultation from their partner in regard to ED. The main presentation of metabolic disease in Thai patients was dyslipidemia. New selective serotonin reuptake inhibitors are not available for premature ejaculation in Thai communities. The debate in regard to malpractice compensation is an issue that should be closely monitored. There is currently a shortage of home care for the elderly in Thailand. The insights provided by the articles helped recruit the study patients and in turn, helped us gain knowledge that can be translated into improved men's health care in Thailand.

Safety and efficacy of a prolonged-release formulation of alfuzosin 10 mg once daily in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

OBJECTIVE: Assess safety and efficacy of 10-mg prolonged-release alfuzosin (Xatral XL) in benign prostatic hyperplasia (BPH) patients with lower urinary tract symptoms (LUTS). MATERIAL AND METHOD: A multicenter observational study looking at safety by adverse events (AEs) incidence, efficacy by changes in International Prostate Symptom Score (I-PSS), quality of life index (QOL), sexual function using Danish Prostate Symptom Score (DAN-PSS sex), and flow rates. Patients were allocated to receive alfuzosin (Xatral XL) 10 mg once daily tablet along with a meal for 6 months. Patients were assessed at 3 months and 6 months. RESULTS: In 118 males, 22% had AEs (most common was dizziness). Ten patients discontinued the treatment. Of those patients, five had serious AEs, which only one was related to the study. At month 6, there were improvements from baseline in mean I-PSS (-9.3, p < 0.001), in QOL index (-2.96, p < 0.001), in symptom (-0.72, p < 0.05) and bothersome (-1.13, p < 0.01) subscores on DAN-PSS sex, and in mean flow rate (0.92, p < 0.01). Approximately 74% patients improved within two weeks. There was one case of Acute urinary retention (AUR), which none required surgery. CONCLUSION: A 10-mg prolonged-release alfuzosin safely and rapidly relieves LUTS and maintains improvement. It also improves BPH-associated sexual dysfunction.

Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction.

AIM: To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 (PDE-5) inhibitor, in men of Asian ethnicity with erectile dysfunction (ED). METHODS: In this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil (10 mg) or placebo (4:1 ratio) for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question (GAQ) on erection improvement. RESULTS: Least-squares mean baseline IIEF-EF domain scores (vardenafil 14.6, placebo 13.4) were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo (22.4 vs. 14.3; P<0.001). Vardenafil was associated with significant improvements from baseline in least squares (LS) mean success rates for SEP-2 (vardenafil 82.2 vs. placebo 43.6; P<0.001) and SEP-3 (vardenafil 66.1 vs. placebo 24.0; P<0.001). Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient. CONCLUSION: Vardenafil (10 mg) is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.

The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study.

OBJECTIVE: To evaluate the efficacy and safety of sildenafil citrate (Viagra) in a randomized, double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months' duration. MATERIAL AND METHOD: 125 patients aged 26 to 77 years were randomized at 4 centers in Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and/or tolerability) (n = 63) or a matching placebo (n = 62) taken on an 'as needed' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks. Efficacy was assessed by the patients' responses to the 15-question International Index of Erectile Function (IIEF), to questions on the event log of sexual activity, and to the global efficacy assessment question concerning improvement in erections. RESULTS: At the conclusion of the study, both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables, which included the 5 separate domains of sexual functioning of the IIEF, the percentage of successful attempts at sexual intercourse, and the global efficacy assessment question concerning improvement in erections, were all significantly improved statistically by sildenafil in comparison with placebo except in the sexual desire domain which showed no difference. The percentage of successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the placebo group it was 33.05 per cent. The percentage of global efficacy assessment was improved in the sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group. Adverse events considered treatment-related occurred in 19 patients (30.2%) receiving sildenafil and 7 (11.3%) receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache, and dizziness, which occurred in 14.3 per cent, 6.3 per cent, and 6.3 per cent of patients respectively. All events were mild in nature. CONCLUSIONS: Sildenafil is a safe and effective treatment for erectile dysfunction of broad-spectrum etiology in Thai men. Its efficacy appears similar to that reported in other studies in Western populations.

Evaluation of transurethal alprostadil for safety and efficacy in men with erectile dysfunction.

A multicenter study conducted in 5 trial centers, for the safety and efficacy of transurethral alprostadil (Pellet) in 90 subjects. The end results show quite good and the product was satisfactory and safe for all ages. Although there are multiple side effects that seemed to discourage the participants and caused them to dropout, MUSE does work but needs good understanding of the use of the device. MUSE is another alternatives for those who unable to use oral medication or those who require immediate action but need some dexterity.

Anticarcinogenic effect of FTY720 in human prostate carcinoma DU145 cells: modulation of mitogenic signaling, FAK, cell-cycle entry and apoptosis.

Despite the high frequency of prostate cancer, therapeutic options for advanced disease are limited to chemotherapy, radiation or hormonal therapy and eventually fail in all patients. Therefore, alternative approaches need to be developed. We previously reported that FTY720, a metabolite from Isaria sinclarii, is a unique antitumor agent for an androgen-independent prostate cancer cell line and requires caspase-3 activation in apoptosis. In our study, we have evaluated the effect of FTY720 on a family of mitogen-activated protein kinases (MAPKs), focal adhesion kinase (FAK), mitochondrial transmembrane potential, caspase-9 and caspase-8 and analyzed the expression of some cell-cycle regulator proteins in DU145 cells in order to understand the various antitumor effects of FTY720. Apoptosis was quantified by phosphatidylserine exposure. Activation of MAPKs, cleavage of caspase-9 and caspase-8, status of cyclin-dependent kinases (CDKs) and Cip1/p21, a cyclin-dependent kinase inhibitor, were evaluated by Western blot analysis, in addition to FAK and phospho-FAK immunoprecipitation and cell-cycle analysis by FACScan. We found that in DU145 cells, 40 microM FTY720 caused activation of p38 MAPK and the upstream kinase MKK3/MKK6 but not SAPK/JNK. Mitochondrial transmembrane potential, FAK and ERK1/2 were reduced while caspase-9 and caspase-8 were cleaved. The p38-specific inhibitor had no effect on apoptosis induced by FTY720, whereas z-VAD.FMK, a broad-spectrum caspase inhibitor, did not inhibit the p38 MAPK activation. An amount of 20 microM FTY720 resulted in G(1) arrest and a decrease of CDK2 as well as CDK4, whereas it induced Cip1/p21. FTY720 may exert anticarcinogenic effects against prostate cancer cells possibly involving modulation of mitogenic signaling, cell-cycle regulators, induction of G(1) arrest and apoptotic death in DU145 cells.