vardenafil, Levitra
[Efficacy and safety of vardenafil in men with erectile dysfunction and depression]

[Article in Chinese]

Hu L.

Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China. huliquan0202 sina.com

Erectile dysfunction (ED) usually exists in combination with depression in men. The comorbidity of the two diseases may bring more troubles to patients, so it is important to find an effective treatment. Recently, DRIVER (Depression Related Improvement with Vardenafil for Erectile Response) trials showed that, phosphodiesterase 5 (PDE 5) inhibitor vardenafil could improve not only erectile function but also depressive symptoms and quality of life in men with ED and depression. Vardenafil was generally safe and well tolerated.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15595695&dopt=Abstract vardenafil Levitra



vardenafil, Levitra
Vardenafil provides reliable efficacy over time in men with erectile dysfunction.

Montorsi F, Hellstrom WJ, Valiquette L, Bastuba M, Collins O, Taylor T, Thibonnier M, Homering M, Eardley I; North American and European Vardenafil Groups.

Instituto San Raffaele, Milan, Italy.

OBJECTIVES: To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED). METHODS: In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group. RESULTS: At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis. CONCLUSIONS: Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15596195&dopt=Abstract vardenafil Levitra



vardenafil, Levitra
[Influence of gender on clinical research.]

[Article in Spanish]

Arenere Mendoza M, Cilveti Sanchez U, Idoipe Tomas A, Izuel Rami M, Navarro Aznarez H, Palomo Palomo P.

Servicio de Farmacia. Hospital Universitario Miguel Servet. Zaragoza, Spain.

Objective: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. Material and methods: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. Data sources: protocols and summary reports by the pharmacy department, Gecos(R) software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. Results: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. Conclusions: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15628948&dopt=Abstract vardenafil Levitra



vardenafil, Levitra
Gateways to clinical trials.

Bayes M, Rabasseda X, Prous JR.

Prous Science, S.A., P.O. Box 540, 08080 Barcelona, Spain. mbayes prous.com

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (PE)HRG214, 1E10, 21-Aminoepothilone B; Ad.Egr.TNF.11D, Ad100-B7.1/HLA, adalimumab, adefovir dipivoxil, alefacept, alemtuzumab, AMD-070, anhydrovinblastine, aripiprazole, asimadoline, atrasentan, AVE-5883; Bimatoprost, BNP-7787, bosentan, botulinum toxin type B, BR-1; Canfosfamide hydrochloride, ciclesonide, curcumin, cypher; D0401, darbepoetin alfa, darifenacin hydrobromide, D-D4FC, dendritic cell-based vaccine, desloratadine, dextrin sulfate, dolastatin 10, drospirenone drospirenone/estradiol, DS-992, duloxetine hydrochloride, dutasteride; E-7010, efalizumab, eletriptan, EM-1421, enfuvirtide, entecavir, etoricoxib, everolimus, exenatide, ezetimibe; Favid, fidarestat, fingolimod hydrochloride, FK-352; Gefitinib, gemifloxacin mesilate, gepirone hydrochloride, gimatecan; HE-2000; Imatinib mesylate, indisulam, insulin detemir, irofulven, ISIS-5132; Lapatinib, levocetirizine, liraglutide, lumiracoxib; Metformin/Glyburide, methionine enkephalin, MK-0431, morphine hydrochloride, motexafin gadolinium, mycobacterium cell wall complex; Naturasone, neridronic acid, nesiritide; Oblimersen sodium, olanzapine/fluoxetine hydrochloride, omalizumab, oral insulin; Paclitaxel poliglumex, PC-515, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pegvisomant, pexelizumab, picoplatin, pramlintide acetate, prasterone, pregabalin; Quercetin; Ramelteon, ranirestat, RG228, rhGAD65, roflumilast, rubitecan; Sitaxsentan sodium, solifenacin succinate; Tadalafil, taxus, tipifarnib, tolevamer sodium, topixantrone hydrochloride; Valganciclovir hydrochloride, vardenafil hydrochloride hydrate, vildagliptin, voriconazole; XTL-001; Zoledronic acid monohydrate. Copyright 2004 Prous Science. All rights reserved.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15632957&dopt=Abstract vardenafil Levitra



vardenafil, Levitra
[Efficacy and safety of oral vardenafil in the treatment of erectile dysfunction]

[Article in Chinese]

Pan T, Zhuang S, Ma H, Hong K, Tang W.

Department of Urology, the Third Hospital of Peking University, Beijing 100083, China.

OBJECTIVE: To evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies. METHODS: A total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. RESULTS: This study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo. CONCLUSION: Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15638033&dopt=Abstract vardenafil Levitra