RESUMO
INTRODUCTION: Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. AIM: This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. MAIN OUTCOME MEASURES: Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. METHODS: Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. RESULTS: IIEF erectile domain scores before and after the use of medications were (mean +/- standard deviation [SD]): placebo: 11.9 +/- 3.4 and 12.6 +/- 5.5; LC 20 mg: 15.8 +/- 4.1 and 18.9 +/- 6.6; LC 40 mg: 11.9 +/- 4.4 and 15.4 +/- 8.1; LC 80 mg: 14.2 +/- 4.7 and 22.8 +/- 6.0 (ANOVA P < 0.01). The SEP-2 scores before and after the use of medications were (Mean +/- SD): placebo: 71.0 +/- 33.1 and 51.2 +/- 43.1; LC 20 mg 70.3 +/- 34.2 and 75.5 +/- 31.5; LC 40 mg: 48.4 +/- 42.1 and 60.8 +/- 42.5; LC 80 mg: 68.6 +/- 33.5 and 89.6 +/- 26.0. The SEP-3 scores were: placebo 23.3 +/- 27.6 and 33.6 +/- 42.3; LC 20 mg: 32.3 +/- 38.9 and 51.2 +/- 41.7; LC 40 mg: 39.7 +/- 44.7 and 46.7 +/- 41.1; LC 80 mg* 17.2 +/- 29.5 and 74.3 +/- 36.4 (*P < 0.05 for difference to placebo). CONCLUSIONS: The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated.
Assuntos
Carbonatos/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Inibidores de Fosfodiesterase/uso terapêutico , Piperazinas/uso terapêutico , Pirimidinas/uso terapêutico , Administração Oral , Adulto , Idoso , Carbonatos/farmacologia , Método Duplo-Cego , Esquema de Medicação , Tolerância a Medicamentos , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 5 , Inibidores de Fosfodiesterase/farmacologia , Piperazinas/farmacologia , Estudos Prospectivos , Pirimidinas/farmacologiaRESUMO
OBJECTIVE: Determine the prevalence of erectile dysfunction in patients undergoing hemodialysis MATERIALS AND METHODS: This cross-sectional study was carried out to determine the prevalence of erectile dysfunction in a population of 58 patients in hemodialysis program. Erectile dysfunction was assessed by using the International Index of Erectile Function (IIEF). Information on demographic data, renal failure, comorbidities, laboratory tests and search for medical treatment for erectile dysfunction by means of interviews and researches in medical charts was obtained. Student t test was utilized to compare the laboratory results between group of patients with and without erectile dysfunction. The chi-square test was utilized to compare the comorbidities and the characteristics of the population studied between the groups of patients with and without erectile dysfunction. The significance level considered was 5 percent RESULTS: Mean patient age was 50.2 ± 14.6 years and the time of hemodialysis was 30.4 ± 28.4 months. The prevalence of erectile dysfunction was 60.3 percent. A progressive increase respecting the age was reported. In patients younger than 50 years, this prevalence reached 31.4 percent and in patients older than 50 years, this prevalence reached 68.6 percent. With respect to the comorbidities, hypertensive patients prevailed with 94.8 percent of the total, whilst diabetic patients represented 24.9 percent. However only the association between diabetes and erectile dysfunction was significant. Patients with erectile dysfunction presented significantly lower values for serum creatinine and Kt/V. There was no variation between the groups with reference to calcium, potassium, phosphorus, hematocrit, hemoglobin, pre- and post-dialysis urea values. There was no correlation between erectile dysfunction and time of dialysis. Amongst patients with erectile dysfunction, 8.6 percent sought medical care CONCLUSIONS: The...