Efficacy and safety of vardenafil in renal transplant recipients with erectile dysfunction
ABSTRACT Erectile dysfunction (ED) profoundly affects the quality of life. The prevalence of ED in renal transplant recipients is reported by high as 50% to 60%. We evaluated the efficacy and safety of vardenafil in these patients with ED as well as its effects on graft function and on cylosporine or tacrolimus concentrations. Thirty-nine recipients with ED and serum creatinine values<2 mg/dL were treated with vardenafil. ED was assessed using the self-administered International Index of Erectile Function (IIEF). ED was diagnosed by using penile color-Doppler ultrasonography and intracavernosal injection. Vardenafil efficacy was assessed by readministering the IIEF questionnaire after 4 weeks of therapy. Serum creatinine levels, creatinine clearances, and cyclosporine/tacrolimus concentrations were measured before and after vardenafil therapy. Twenty-one recipients with ED served as placebo controls and 15 without ED as another control group. The IIEF scores improved from 12.80+/-3.5 to 26.46+/-2.4 in vardenafil-treated patients with ED (P<.001). Renal function and cyclosporine/tacrolimus concentrations did not change with vardenafil therapy. Side effects were observed in 7 (18%) patients: headache in three, palpitations in one, flushing in two, and dyspepsia in one. This study demonstrated that ED improved with vardenafil in renal transplant recipients with ED. For 4 weeks vardenafil therapy was free of side effects. Renal function tests did not change. Also, no dose change in immunosuppressive drugs was required during 4 weeks of verdanafil therapy.
SourceAvailable from: acponline.org[Show abstract] [Hide abstract]
ABSTRACT: Descripción: El American College of Physicians desarrolló estas guías clínicas para presentar la evidencia disponible sobre la evaluación hormonal y el tratamiento farmacológico de la disfunción eréctil. Las terapéutica farmacológica actual incluye a los inhibidores de la 5-fosfodiesterasa (PDE-5) como el sildenafil, vardenafil, tadalafil, mirodenafil y udenafil, así como el tratamiento hormonal. Métodos: La literatura publicada sobre este tema fue identificada usando MEDLINE (1966 a mayo del 2007), EMBASE (1980 a la semana 22 del 2007), el Registro Central de Estudios Controlados Cochrane (segunda trimestre del 2007), PsycINFO (1985 a junio del 2007), AMED (1985 a junio del 2007), y SCOPUS (2006). La búsqueda bibligráfica fue actualizada buscando artículos en MEDLINE y EMBASE publicados entre mayo 2007 y abril 2009. Las búsquedas se limitaron a publicaciones en idioma inglés. Esta guía clínica establece el nivel de evidencia y el grado de recomendación utilizando el sistema de graduación de las guías clínicas del American College of Physicians.
[Show abstract] [Hide abstract]
ABSTRACT: Introduction. This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil.Aim. Expanding information on LC efficacy and safety.Main Outcome Measures. International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs).Methods. A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC.Results. IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] ± standard deviation [SD]): placebo = 13.9 ± 5.2 and 14.8 ± 7.8; LC 40 mg = 13.6 ± 5.3 and 18.6 ± 8.0; LC 80 mg = 13.4 ± 4.9 and 20.6 ± 7.7 (analysis of variance [anova]P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M ± SD): placebo = 55.3 ± 43.2% and 52.1 ± 41.4%; LC 40 mg = 46.4 ± 44.3% and 63.5 ± 42.0%; LC 80 mg = 50.2 ± 40.9% and 80.8 ± 32.3% (anovaP < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 ± 32.3% and 29.7 ± 38.1%; LC 40 mg = 19.6 ± 34.3% and 50.8 ± 44.4%; LC 80 mg = 20.8 ± 33.2% and 66.0 ± 39.3% (anovaP < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness.Conclusions. LC showed a satisfactory efficacy–safety profile for oral therapy of ED. Glina S, Fonseca GN, Bertero EB, Damião R, Rocha LCA, Jardim CRF, Cairoli CE, Teloken C, Torres LO, Faria GE, da Silva MB, and Pagani E. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: A phase III clinical trial. J Sex Med 2010;7:1928–1936.Journal of Sexual Medicine 02/2010; 7(5):1928 - 1936. DOI:10.1111/j.1743-6109.2010.01711.x · 3.15 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: INTRODUCTION.: The phosphodiesterase type 5 (PDE5) inhibitors are generally well tolerated and effective for treating erectile dysfunction (ED), including in patients with significant comorbidity. Because of this benign safety profile, investigators have used PDE5 inhibitors to treat patients with ED and severe renal disease or those who have received renal transplants. AIM.: To assess safety and efficacy of PDE5 inhibitors in patients receiving dialysis or renal transplants. MAIN OUTCOME MEASURES.: Erectile function as assessed by the International Index of Erectile Function (IIEF) and Global Assessment Questions; adverse events (AEs). METHODS.: We reviewed published studies of PDE5 inhibitors in patients receiving dialysis or renal transplants. RESULTS.: In double-blind, placebo-controlled studies in patients receiving dialysis or renal transplants, sildenafil significantly improved erectile function as assessed by the IIEF, and 75-85% of patients reported improved erectile function on Global Assessment Questions; efficacy was more variable in less well-controlled studies. In >260 patients undergoing dialysis who received sildenafil in clinical studies, there were only six reported discontinuations because of AEs (headache [N = 3], headache and nausea [N = 1], gastrointestinal [N = 1], and symptomatic blood pressure decrease [N = 1]). In approximately 400 patients with renal transplants who received sildenafil, only three patients discontinued because of AEs. Vardenafil improved IIEF scores of up to 82% of renal transplant recipients in randomized, controlled studies (N = 59, total), with no reported discontinuations because of AEs. Limited data also suggest benefit with tadalafil. CONCLUSIONS.: ED is common in patients undergoing renal dialysis or postrenal transplant and substantially affects patient quality of life. Sildenafil and vardenafil appear to be efficacious and well tolerated in patients receiving renal dialysis or transplant.Journal of Sexual Medicine 01/2013; DOI:10.1111/jsm.12038 · 3.15 Impact Factor