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, m...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.展开更多
Erectile dysfunction （ED） is a major complication after radical prostatectomy （RP）; however, debatecontinues regarding the efficacy of penile rehabilitation in the recovery of the postoperative erectile function ...Erectile dysfunction （ED） is a major complication after radical prostatectomy （RP）; however, debatecontinues regarding the efficacy of penile rehabilitation in the recovery of the postoperative erectile function （EF）. This study includeda total of 103 consecutive sexually active Japanese men with localized prostate cancer undergoing nerve-sparing RP, and analyzed the postoperative EF, focusing on the significance of penile rehabilitation. In this series, 24 and 79 patients underwent bilateral and unilateral nerve-sparing RPs, respectively, and 10 or 20 mg of vardenafil was administered to 35 patients at least once weekly, who agreed to undergo penile rehabilitation. Twelve months after RP, 48 （46.6%） of the 103 patients were judged to have recovered EF sufficient for sexual intercourse without any assistance. The proportion of patients who recovered EF in those undergoing penile rehabilitation （60.0%） was significantly greater than that in those without penile rehabilitation （38.2%）. Of several parameters examined, the preoperative International Index of Erectile Function-5 （IIEF-5） score and nerve-sparing procedure were significantly associated with the postoperative EF recovery rates in patients with and without management by penile rehabilitation, respectively. Furthermore, univariate analysis identified the preoperative IIEF-5 score, nerve-sparing procedure and penile rehabilitation as significant predictors of EF recovery, among which the preoperative IIEF-5 score and nerve-sparing procedure appeared to be independently associated with EF recovery. Considering these findings, despite the lack of independent significance, penile rehabilitation with low-dose vardenafil could exert a beneficial effect on EF recovery in Japanese men following nerve-sparing RP.展开更多
A novel, sensitive, stability indicating RP-LC method has been developed for the quantitative determination of Varde- nafil and its related impurities in both bulk drugs and Pharmaceutical dosage forms. Effective chro...A novel, sensitive, stability indicating RP-LC method has been developed for the quantitative determination of Varde- nafil and its related impurities in both bulk drugs and Pharmaceutical dosage forms. Effective chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a simple gradient pro- gramme and quantitation was by ultraviolet detection at 210 nm. The mobile phase consisted of a buffer and acetonitrile delivered at a flow rate 0.25 ml?min–1. Buffer consisted of 20 mM Ammonium bi carbonate, pH adjusted to 5.0 by using ortho Phosphoric acid. In the developed UPLC method the resolution (Rs) between vardenafil and its four potential impurities was found to be grater than 2.0.Regrreation analysis showed an r value (correlation coefficient) grater than 0.999 for vardenafil and its four impurities. This method was capable to detect all four impurities of vardenafil at a level of 0.25 μg.mL–1 with respect to test concentration of 500 μg?ml–1 for a 2 μl injection volume. The inter and intra day precision values for all four impurities and for vardenafil was found to be with in 2.0% RSD. The method showed good and consistent recoveries for vardenafil in bulk drugs (98.8% - 100.9%), pharmaceutical dosage forms (100.5% - 101.5%) and its all four impurities (99.8% - 102.5%).The test solutions was found to stable in acetonitrile for 48 h. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. Considerable degradation was found to occur in peroxide hydrolysis. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.9%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.展开更多
Objective: To explore the clinical efficacy of different doses of vardenafil for the treatment of neonatal persistent pulmonary hypertension. Methods: A total of 60 neonates with persistent pulmonary hypertension were...Objective: To explore the clinical efficacy of different doses of vardenafil for the treatment of neonatal persistent pulmonary hypertension. Methods: A total of 60 neonates with persistent pulmonary hypertension were diagnosed and treated in this hospital between August 2013 and April 2017, all of them received vardenafil therapy and they were divided into low dose group (2.5 mg), medium dose group (5 mg) and high dose group (10 mg) according to the doses, 20 cases in each group. The differences in pulmonary arterial systolic pressure (PASP) levels as well as the contents of myocardial injury markers and endothelial injury indexes were compared among the three groups of children after 1 month of treatment. Results: After 1 month of treatment, the PASP level in high dose group was lower than that in medium dose group and low dose group;myocardial injury markers hs-cTnT, BNP and LDH contents in peripheral blood were lower than those of medium dose group and low dose group;endothelial injury indexes ET-1 and HIF-1 contents in peripheral blood were lower than those of medium dose group and low dose group whereas ADM and NO contents were higher than those of medium dose group and low dose group. The change trend of the above indicators in medium dose group was greater than that in low dose group. Conclusion: Vardenafil is a reliable drug for clinical treatment of neonatal persistent pulmonary hypertension, and the efficacy is dose-dependent.展开更多
文摘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.
文摘Erectile dysfunction （ED） is a major complication after radical prostatectomy （RP）; however, debatecontinues regarding the efficacy of penile rehabilitation in the recovery of the postoperative erectile function （EF）. This study includeda total of 103 consecutive sexually active Japanese men with localized prostate cancer undergoing nerve-sparing RP, and analyzed the postoperative EF, focusing on the significance of penile rehabilitation. In this series, 24 and 79 patients underwent bilateral and unilateral nerve-sparing RPs, respectively, and 10 or 20 mg of vardenafil was administered to 35 patients at least once weekly, who agreed to undergo penile rehabilitation. Twelve months after RP, 48 （46.6%） of the 103 patients were judged to have recovered EF sufficient for sexual intercourse without any assistance. The proportion of patients who recovered EF in those undergoing penile rehabilitation （60.0%） was significantly greater than that in those without penile rehabilitation （38.2%）. Of several parameters examined, the preoperative International Index of Erectile Function-5 （IIEF-5） score and nerve-sparing procedure were significantly associated with the postoperative EF recovery rates in patients with and without management by penile rehabilitation, respectively. Furthermore, univariate analysis identified the preoperative IIEF-5 score, nerve-sparing procedure and penile rehabilitation as significant predictors of EF recovery, among which the preoperative IIEF-5 score and nerve-sparing procedure appeared to be independently associated with EF recovery. Considering these findings, despite the lack of independent significance, penile rehabilitation with low-dose vardenafil could exert a beneficial effect on EF recovery in Japanese men following nerve-sparing RP.
文摘A novel, sensitive, stability indicating RP-LC method has been developed for the quantitative determination of Varde- nafil and its related impurities in both bulk drugs and Pharmaceutical dosage forms. Effective chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a simple gradient pro- gramme and quantitation was by ultraviolet detection at 210 nm. The mobile phase consisted of a buffer and acetonitrile delivered at a flow rate 0.25 ml?min–1. Buffer consisted of 20 mM Ammonium bi carbonate, pH adjusted to 5.0 by using ortho Phosphoric acid. In the developed UPLC method the resolution (Rs) between vardenafil and its four potential impurities was found to be grater than 2.0.Regrreation analysis showed an r value (correlation coefficient) grater than 0.999 for vardenafil and its four impurities. This method was capable to detect all four impurities of vardenafil at a level of 0.25 μg.mL–1 with respect to test concentration of 500 μg?ml–1 for a 2 μl injection volume. The inter and intra day precision values for all four impurities and for vardenafil was found to be with in 2.0% RSD. The method showed good and consistent recoveries for vardenafil in bulk drugs (98.8% - 100.9%), pharmaceutical dosage forms (100.5% - 101.5%) and its all four impurities (99.8% - 102.5%).The test solutions was found to stable in acetonitrile for 48 h. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. Considerable degradation was found to occur in peroxide hydrolysis. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.9%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.
文摘Objective: To explore the clinical efficacy of different doses of vardenafil for the treatment of neonatal persistent pulmonary hypertension. Methods: A total of 60 neonates with persistent pulmonary hypertension were diagnosed and treated in this hospital between August 2013 and April 2017, all of them received vardenafil therapy and they were divided into low dose group (2.5 mg), medium dose group (5 mg) and high dose group (10 mg) according to the doses, 20 cases in each group. The differences in pulmonary arterial systolic pressure (PASP) levels as well as the contents of myocardial injury markers and endothelial injury indexes were compared among the three groups of children after 1 month of treatment. Results: After 1 month of treatment, the PASP level in high dose group was lower than that in medium dose group and low dose group;myocardial injury markers hs-cTnT, BNP and LDH contents in peripheral blood were lower than those of medium dose group and low dose group;endothelial injury indexes ET-1 and HIF-1 contents in peripheral blood were lower than those of medium dose group and low dose group whereas ADM and NO contents were higher than those of medium dose group and low dose group. The change trend of the above indicators in medium dose group was greater than that in low dose group. Conclusion: Vardenafil is a reliable drug for clinical treatment of neonatal persistent pulmonary hypertension, and the efficacy is dose-dependent.
