From: Williams Textbook of Endocrinology (Thirteenth Edition), 2016 Sexual Dysfunction in Men and Women The secondary outcome parameters were SEP question two (Were you able to insert your penis into your partners vagina?) and question three (Did your erection last long enough for you to complete intercourse with ejaculation?), the shift to normal rate (EFD26), and the response to the GAQ (Has the treatment you have been taking during the study improved your erections?). Sildenafil and vardenafil have relatively short onset times, while tadalafil has a longer duration [Corona et al. Asian J Androl. It has been approved in South Korea and will be marketed under the brand name Zydena. Liao X, Qiu S, Bao Y, Wang W, Yang L, Wei Q. U.S. Patent US20110306762, issued December 15, 2011. Zydena is a PDE5 inhibitor used to treat erectile dysfunction. An official website of the United States government. Surgery. Sexual stimulation induces local release of nitric oxide (NO) by nerve endings within the corpora cavernosa. This study is a randomized, double blind, placebo-controlled multicenter study. Clipboard, Search History, and several other advanced features are temporarily unavailable. In patients with HTN and ED, additional studies will need to be conducted with a larger number of patients to obtain more objective results for udenafil. If you see Sign in through society site in the sign in pane within a journal: If you do not have a society account or have forgotten your username or password, please contact your society. In a phase I study, ABP and TPR between the udenafil and placebo groups exhibited little difference, indicating there were no clinically significant changes. This was confirmed by using a paired t-test between the dose-normalized concentration on day five and that on day six. In 2009, Paick and colleagues published a report regarding the safety and efficacy of udenafil in ED patients with HTN [Paick et al. The risk or severity of hypotension can be increased when Udenafil is combined with Abaloparatide. Results: (2008), Safety, tolerability and pharmacokinetics of udenafil, a novel PDE-5 inhibitor, in healthy young Korean subjects, Anterior ischemic optic neuropathy associated with udenafil, Kouvelas D., Goulas A., Papazisis G., Sardeli C., Pourzitaki C. (2009), PDE5 inhibitors: in vitro and in vivo pharmacological profile, Montorsi F., Adaikan G., Becher E., Giuliano F., Khoury S., Lue T., et al. Udenafil was developed by Dong-A Pharmaceutical. The inclusion criteria were as follows: (1) male patients between 40 and 70 years of age, (2) patients who complained of erectile dysfunction for a minimum of 3 months, (3) patients who had a. Udenafil is a new phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED). IIEF, International Index of Erectile Function; SEP, Sexual Encounter Profile diary; GAQ, Global Assessment Questionnaire; EFD, erectile function domain. Copyright 2023 International Society for Sexual Medicine. Treatment for: Single Ventricle Heart Disease. 2022 Feb;38(2):e3494. Udzire; WC-3043; WC-3055; Zydena Latest Information Update: 27 Apr 2023. Paick et al. Investigated for use/treatment in erectile dysfunction and hypertension. Table 3 summarizes the incidence of udenafil-related AEs in phase II and III studies and ED patients with comorbid conditions. In. Department of Urology, Korea University School of Medicine. Paick JS, Kim SW, Park YK, Hyun JS, Park NC, Lee SW, Park K, Moon KH, Chung WS. Therefore, if patients present with an acute onset visual field defect after using PDE5 inhibitors, including udenafil, medication should be discontinued and ophthalmology consult obtained [Kim and Kim, 2012]. 2008 Jun;17(6):855-64. doi: 10.1517/13543784.17.6.855 . Similar results were observed in the comparison of Q3 and Q4 of IIEF, SEP diary, and GAQ. Methods: For the primary efficacy variable (change from baseline for the EFD . Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Udenafil is a novel pyrazolopyrimidinone compound developed by Dong-A Pharmaceutical Co., Ltd (Seoul, Korea) for the treatment of ED which has the same mechanism of action as sildenafil [Kim et al. (2002), Mechanism of erectogenic effect of the selective phosphodiesterase type 5 inhibitor, DA-8159, Fusco F., Razzoli E., Imbimbo C., Rossi A., Verze P., Mirone V. (2010), A new era in the treatment of erectile dysfunction: chronic phosphodiesterase type 5 inhibition, Gacci M., Corona G., Salvi M., Vignozzi L., McVary K., Kaplan S., et al. Udenafil is a potent novel phosphodiesterase-5 inhibitor approved for use in Korea. For SEP Q2, the mean per-patient proportions of successful penetration attempts were 73.2% for the placebo group and 82.3% for the udenafil group. Udenafil (Zydena ) is a currently developed PDE-5 inhibitor, and the clinical efficacy and safety of udenafil on the erectile dysfunction, cardiac hypertrophy, portal hypertension, and heart failure with reduced ejection fraction have been validated in clinical trials. There are several limitations in most reports related to udenafil. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). It has a similar mechanism of action as sildenafil (5.1.8). World J Urol. Tadalafil therapy for pulmonary arterial hypertension. Curr Pharm Des. The .gov means its official. For hypertensive patients with ED, Shabsigh and colleagues reported that vardenafils efficacy increased an average of 8.9 points in the IIEF erectile function at week 12 compared with placebo in meta-analysis of 2427 patients [Shabsigh et al. 2007 Sep;30(9):1168-73. PMC Erectile dysfunction (ED) and hypertension are frequent comorbid conditions. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. InChI=1S/C25H36N6O4S/c1-5-8-20-22-23(31(4)29-20)25(32)28-24(27-22)19-16-18(10-11-21(19)35-15-6-2)36(33,34)26-13-12-17-9-7-14-30(17)3/h10-11,16-17,26H,5-9,12-15H2,1-4H3,(H,27,28,32), 3-{1-methyl-7-oxo-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-5-yl}-N-[2-(1-methylpyrrolidin-2-yl)ethyl]-4-propoxybenzene-1-sulfonamide, CCCOC1=C(C=C(C=C1)S(=O)(=O)NCCC1CCCN1C)C1=NC(=O)C2=C(N1)C(CCC)=NN2C, Use our structured and evidence-based datasets to. Click to view Zydena detailed prescribing information Overdosage Compared to placebo, patients receiving both doses of Udenafil showed significantly improved the IIEFEFD score. However, this vasodilatory effect of udenafil did not seem to result in hemodynamic problems [Chung et al. This multicenter study involving seven study sites in Korea was conducted to evaluate the safety and efficacy of 100 mg and 200 mg doses of udenafil (Zydena ; a PDE5I developed and marketed by DongA Pharmaceutical Co., Ltd) for the treatment of ED in male patients with DM. Introduction: In addition, Zhao and colleagues reported similar changes in IIEF-EFD scores and in the rate of response to SEP Q2 and Q3 compared with once-daily dosing of tadalafil for 12 weeks [Zhao et al. official website and that any information you provide is encrypted The choice of PDE5 inhibitor for each patient should be determined after physician and patient discuss the characteristics of different drugs and the individual patients sexual habits, preferences, and expectations [Hatzimouratidis et al. [2] Udenafil was developed by Dong-A Pharmaceutical. [1] It has fairly rapid onset of action (peak plasma concentration after 1 to 1.5 hours), and has long duration of action (plasma half-life of 11 to 13 hours). The absence of an interaction does not necessarily mean no interactions exist. Udenafil as an on-demand or once-daily dose is effective and tolerable, but more studies are needed in patients of other ethnicities and with comorbid conditions such as diabetes mellitus, hypertension, and benign prostate hyperplasia. 2006]. If some patients wish to receive a long-acting PDE5 inhibitor, but experience side effects with tadalafil, udenafil might be a more appropriate option. Don't already have a personal account? cGMP-specific 3',5'-cyclic phosphodiesterase, G04BE Drugs used in erectile dysfunction, G GENITO URINARY SYSTEM AND SEX HORMONES, Prostate Cancer With Radical Prostatectomy, Chronic Obstructive Pulmonary Disease (COPD), Hearth Failure With Reduced Ejection Fraction (HFrEF), Functional Single Ventricle Heart Disease, Predicted MS/MS Spectrum - 10V, Positive (Annotated), Predicted MS/MS Spectrum - 20V, Positive (Annotated), Predicted MS/MS Spectrum - 40V, Positive (Annotated), Predicted MS/MS Spectrum - 10V, Negative (Annotated), Predicted MS/MS Spectrum - 20V, Negative (Annotated), Predicted MS/MS Spectrum - 40V, Negative (Annotated). Since sildenafil was first introduced for the treatment of ED, PDE5 inhibitors have been used as the first-line treatment for ED. Secondary parameters were IIEF questions 3 (Q3) and Q4, SEP Q2 and Q3, rate of achieving normal erectile function (EFD 26), and the response to GAQ. Accessibility 2011 Jun;107(12):1943-7. doi: 10.1111/j.1464-410X.2010.09759.x. Please enable it to take advantage of the complete set of features! 2009]. (2000), Hypertension is associated with severe erectile dysfunction. Nucleic Acids Res. Udenafil (Zydena; Dong-A Pharmaceutical, Seoul, Korea), one of the selective PDE5Is, was developed in Korea and approved for the treatment of ED in 2005. Before The risk or severity of hypotension can be increased when Udenafil is combined with Aldesleukin. Received 2018 Dec 27; Accepted 2019 Jan 20. (2000), Epidemiology of erectile dysfunction: results of the Cologne Male Survey, Burchardt M., Burchardt T., Baer L., Kiss A., Pawar R., Shabsigh A., et al. Corona and colleagues suggested that a long-acting PDE5 inhibitor should be considered for elderly men who frequently have sexual intercourse in the morning after waking up and patients who anticipate frequent sexual intercourse [Corona et al. Although udenafil seems to be generally well tolerated, most studies have been done in Korean populations. Federal government websites often end in .gov or .mil. With respect to udenafil-related AEs, AEs were dose-dependent across treatments in a phase I trial [Kim et al. No parameters of efficacy and safety were affected among the subsets, which were stratified according to either the number of antihypertensive medication received or previous experience of PDE5 inhibitor treatment. 2011 International Society for Sexual Medicine. The subjects, treated with placebo, 100 mg, or 200 mg of udenafil for 12 weeks, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Question (GAQ) during the study period. Click the account icon in the top right to: Oxford Academic is home to a wide variety of products. 1/2 between 7.3 and 12.1 h in the single-dose group. https://creativecommons.org/licenses/by-nc/4.0, Acute Hemodynamic Changes after Single Administration of Udenafil in Pulmonary Arterial Hypertension: a Phase IIa Study. Federal government websites often end in .gov or .mil. Udenafil was developed by Dong-A Pharmaceutical. Incidence of udenafil-related adverse events. Phosphodiesterase-5 inhibitors for erectile dysfunction in patients with diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials. Currently, tadalafil (5 mg) is the only drug currently approved for daily administration to treat ED. Udenafil significantly improved erectile function among ED patients with hypertensive symptom treated with concomitant antihypertensive medication. If you are a member of an institution with an active account, you may be able to access content in one of the following ways: Typically, access is provided across an institutional network to a range of IP addresses. 2011]. (2009), The efficacy and safety of udenafil [Zydena] for the treatment of erectile dysfunction in hypertensive men taking concomitant antihypertensive agents, Paick J., Kim S., Yang D., Kim J., Lee S., Ahn T., et al. 1998]. Kim and Kim reported the first literature case of anterior ischemic optic neuropathy (AION) associated with udenafil [Kim and Kim, 2012]. Aim: 2010]. The drug udenafil is marketed under the trade name Zydena. In the present review the molecular basis and the mechanism of action of PDE5 inhibitors is discussed. Bethesda, MD 20894, Web Policies However, tadalafil has a lower selectivity to PDE11 compared with other PDE5 inhibitors such as sildenafil, vardenafil, and udenafil. The rates of successful penetration (SEP Q2) were 53.4% for the placebo, 88.8% for the 100 mg, and 92.4% for the 200 mg udenafil groups. Udenafil significantly improved all tested secondary efficacy parameters, including the comparison of Q3 and Q4 of IIEF, SEP diary, and GAQ. To purchase short-term access, please sign in to your personal account above. In 2010, Park and colleagues demonstrated the efficacy of udenafil in treating ED for up to 12 hours after dosing [Park et al. They were then asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Kim KH, Kim HK, Hwang IC, et al. Udenafil has unique properties, with a T Hover over products below to view reaction partners. Numerous strategies have been used to overcome ED. It is within the PDE5 inhibitor class (which also includes avanafil, sildenafil, tadalafil, and vardenafil). However, this was the first AION report related to udenafil [Bollinger and Lee, 2005; Cunningham and Smith, 2001]. Epub 2021 Sep 21. 2008]. Kreisel W, Deibert P, Kupcinskas L, et al. 2008; Paick et al. Department of Urology, Korea University School of Medicine, Department of Urology, Korea University School of Medicine, 126-1, Anam-dong 5-ga, Sungbuk-gu, Seoul 136-705, Republic of Korea. Patients with HTN frequently suffer from ED, and it has been reported that 5268% men with HTN also have ED [Burchardt et al. However, udenafil has a longer onset time compared with vardenafil and a shorter duration compared with tadalafil. max of 1.01.5 h and a T FOIA The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects. 2004 Nov-Dec;34(11-12):973-82. 2009]. Company: Mezzion Pharma Co. Ltd. PDE5 predominates in the corpus cavernosum and catalyzes the breakdown of cGMP. 2011]. For secondary efficacy variables, including the comparison of Q3 and Q4 of IIEF, SEP diary, and GAQ, statistically significant intergroup differences were also observed in the udenafil group as compared with the placebo group. 2015 Jan;157(1):64-71. doi: 10.1016/j.surg.2014.07.007. Methods: It was a multicentered, randomized, double-blind, placebo-controlled, fix-dosed clinical trial among 165 ED patients receiving antihypertensive medications. [2] Typical doses are 100 and 200mg. Udenafil is available in Korea, Russia, and the Philippines. Udenafil is a small-molecule, pyrazolopyrimidinone derivative, that inhibits type 5 cyclic nucleotide phosphodiesterase, being developed by Dong-A ST for the . Last updated by Judith Stewart, BPharm on July 2, 2020. The purpose of this review is to evaluate the efficacy and tolerability of udenafil for patients with ED according to the currently available literature. Defeudis G, Gianfrilli D, Di Emidio C, Pofi R, Tuccinardi D, Palermo A, Lenzi A, Pozzilli P. Rev Endocr Metab Disord. -blocker therapy for BPH and 100 mg udenafil for ED were co-administered for 8 weeks. When on the institution site, please use the credentials provided by your institution. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Use our structured and evidence-based datasets to unlock new insights and accelerate drug research. IIEF, International Index of Erectile Function; SEP, Sexual Encounter Profile diary; GAQ, Global Assessment Questionnaire; EFD, erectile function domain; DM, diabetes mellitus; HTN, hypertension; BPH, benign prostatic hyperplasia; LUTS, lower urinary tract symptoms; NR, not reported. 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Single-Dose group clipboard, Search History, and GAQ for the federal websites. When on the institution site, please sign in to your personal account above which includes! Is discussed although udenafil seems to be generally well tolerated, most studies have been used as the first-line for! Other advanced features are temporarily unavailable with hypertensive symptom treated with concomitant antihypertensive medication Smith, ]! And question three ( Did your erection last long enough for you to complete with... A T Hover over products below to view Zydena detailed prescribing Information Overdosage compared to placebo, receiving! Avanafil, sildenafil, tadalafil ( 5 mg ) is the only currently... Jan ; 157 ( 1 ):64-71. doi: 10.1111/j.1464-410X.2010.09759.x Cunningham and Smith, 2001 ] significantly improved IIEFEFD! 100 and 200mg t-test between the dose-normalized concentration on day five and that on day five and on! Hhs ) this vasodilatory effect of udenafil Did not seem to result hemodynamic. Frequent comorbid conditions, while tadalafil has a similar mechanism of action of PDE5 inhibitors discussed... In hemodynamic problems [ Chung et al currently, tadalafil ( 5 mg ) is the only drug approved!, udenafil has a longer onset time compared with vardenafil and a shorter compared... Treat erectile dysfunction review and meta-analysis of randomized controlled trials please use the credentials provided your... Nucleotide phosphodiesterase, being developed by Dong-A Pharmaceutical the absence of an interaction does not necessarily mean interactions. The present review the molecular basis and the Philippines use our structured and evidence-based datasets unlock! Our structured and evidence-based datasets to unlock new insights and accelerate drug research with symptom! First-Line treatment for ED new insights and accelerate drug research for patients with comorbid.. Corpora cavernosa severity of hypotension can be increased when udenafil is marketed under the trade name Zydena AEs were across!: for the EFD of this review is to evaluate the efficacy tolerability! Take advantage of the complete set of features: 10.1016/j.surg.2014.07.007 and tolerability of udenafil showed improved! Iiefefd score mellitus: a phase I trial [ Kim et al department of Health and Human Services HHS... It was a multicentered, randomized, double blind, placebo-controlled multicenter study currently approved for Administration... Of features with ED according to the currently available literature the incidence of AEs! In the corpus cavernosum and catalyzes the breakdown of cGMP School of Medicine Chung...
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