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1.
Medicine (Baltimore) ; 98(51): e18361, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31860994

RESUMO

BACKGROUND: Diabetic mellitus erectile dysfunction (DMED) refers to erectile dysfunction (ED) secondary to diabetes. As people's lifestyle changes and the population ages, the incidence of DMED continues to increase. Many clinical trials have proven that PDE5-inhibitors-vardenafil has a significant effect in the treatment of Diabetic mellitus erectile dysfunction. In this systematic review, we aim to evaluate the effectiveness and safety of PDE5-inhibitors-vardenafil for Diabetic mellitus erectile dysfunction. METHODS: We will search PubMed, Cochrane Library, AMED, EMbase, WorldSciNet; Nature, Science online and China Journal Full-text Database (CNKI), China Biomedical Literature CD-ROM Database (CBM), and related randomized controlled trials included in the China Resources Database. The time is limited from the construction of the library to February 2019.We will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the Revman 5.3 and Stata13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of Diabetic mellitus erectile dysfunction. ETHICS AND DISSEMINATION: This systematic review will evaluate the efficacy and safety of PDE5-inhibitors-vardenafil for treating Diabetic mellitus erectile dysfunction. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process Trial. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018095185.


Assuntos
Complicações do Diabetes , Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Dicloridrato de Vardenafila/uso terapêutico , Humanos , Masculino , Metanálise como Assunto , Revisão Sistemática como Assunto
2.
World J Gastroenterol ; 24(3): 438-444, 2018 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-29391766

RESUMO

Non-selective beta-blockers are the mainstay of medical therapy for portal hypertension in liver cirrhosis. Inhibitors of phosphodiesterase-5 (PDE-5-inhibitors) reduce portal pressure in the acute setting by > 10% which may suggest a long-term beneficial effect. Currently, there is no available data on long-term treatment of portal hypertension with PDE-5-inhibitors. This case of a patient with liver cirrhosis secondary to autoimmune liver disease with episodes of bleeding from esophageal varices is the first documented case in which a treatment with a PDE-5-inhibitor for eight years was monitored. In the acute setting, the PDE-5-inhibitor Vardenafil lowered portal pressure by 13%. The portal blood flow increased by 28% based on Doppler sonography and by 16% using MRI technique. As maintenance medication the PDE-5-inhibitor Tadalafil was used for eight consecutive years with comparable effects on portal pressure and portal blood flow. There were no recurrence of bleeding and no formation of new varices. Influencing the NO-pathway by the use of PDE-5 inhibitors may have long-term beneficial effects in compensated cirrhosis.


Assuntos
Colangite Esclerosante/complicações , Hepatite Autoimune/complicações , Hipertensão Portal/tratamento farmacológico , Cirrose Hepática/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Administração Oral , Colangite Esclerosante/diagnóstico por imagem , Colangite Esclerosante/patologia , Angiografia por Tomografia Computadorizada , Endoscopia do Sistema Digestório , Varizes Esofágicas e Gástricas/diagnóstico por imagem , Varizes Esofágicas e Gástricas/etiologia , Varizes Esofágicas e Gástricas/cirurgia , Feminino , Seguimentos , Hemorragia Gastrointestinal/diagnóstico por imagem , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/cirurgia , Hemodinâmica/efeitos dos fármacos , Hepatite Autoimune/diagnóstico por imagem , Hepatite Autoimune/patologia , Humanos , Hipertensão Portal/diagnóstico por imagem , Hipertensão Portal/etiologia , Hipertensão Portal/patologia , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/etiologia , Cirrose Hepática/patologia , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 5/farmacologia , Síndrome , Tadalafila/farmacologia , Tadalafila/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Dicloridrato de Vardenafila/farmacologia , Dicloridrato de Vardenafila/uso terapêutico
3.
J Clin Endocrinol Metab ; 103(4): 1601-1611, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29409064

RESUMO

Context: Erectile function is important for life satisfaction and often impaired in men with obstructive sleep apnea (OSA). Uncontrolled studies show that treating OSA with continuous positive airway pressure (CPAP) improves erectile function. Phosphodiesterase type 5 inhibitors (e.g., vardenafil) are the first-line therapy for erectile dysfunction (ED), but may worsen OSA. Objective: To assess the effects of CPAP and vardenafil on ED. Design: Sixty-one men with moderate-to-severe OSA and ED were randomized to 12 weeks of CPAP or sham CPAP, and 10 mg daily vardenafil or placebo in a two-by-two factorial design. Main Outcome Measures: International Index of Erectile Function (primary end point), treatment and relationship satisfaction, sleep-related erections, sexual function, endothelial function, arterial stiffness, quality of life, and sleep-disordered breathing. Results: CPAP increased the frequency of sleep-related erections, overall sexual satisfaction, and arterial stiffness but did not change erectile function or treatment or relationship satisfaction. Vardenafil did not alter erectile function, endothelial function, arterial stiffness, or sleep-disordered breathing, but did improve overall self-esteem and relationship satisfaction, other aspects of sexual function, and treatment satisfaction. Adherent CPAP improved erectile function, sexual desire, overall sexual, self-esteem, relationship, and treatment satisfaction, as well as sleepiness, and quality of life. Adherent vardenafil use did not consistently change nocturnal erection quality. Conclusion: CPAP improves overall sexual satisfaction, sleep-related erections, and arterial stiffness. Low-dose daily vardenafil improves certain aspects of sexual function and did not worsen OSA. Adherent CPAP or vardenafil use further improves ED and quality of life.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/métodos , Disfunção Erétil/terapia , Inibidores da Fosfodiesterase 5/uso terapêutico , Apneia Obstrutiva do Sono/terapia , Dicloridrato de Vardenafila/uso terapêutico , Adulto , Idoso , Terapia Combinada , Disfunção Erétil/complicações , Disfunção Erétil/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Inibidores da Fosfodiesterase 5/administração & dosagem , Qualidade de Vida , Comportamento Sexual/efeitos dos fármacos , Apneia Obstrutiva do Sono/complicações , Apneia Obstrutiva do Sono/tratamento farmacológico , Resultado do Tratamento , Dicloridrato de Vardenafila/administração & dosagem
4.
Urologiia ; (1): 103-107, 2017 Apr.
Artigo em Russo | MEDLINE | ID: mdl-28394532

RESUMO

This review article describes the differences in efficacy and side effects between available phosphodiesterase type 5 (PDE-5) inhibitors used for treating erectile dysfunction. The most studied PDE-5 inhibitor is sildenafil.


Assuntos
Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Humanos , Masculino , Citrato de Sildenafila/uso terapêutico , Tadalafila/uso terapêutico , Dicloridrato de Vardenafila/uso terapêutico
5.
Expert Rev Clin Pharmacol ; 10(3): 339-344, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28129714

RESUMO

BACKGROUND: A rapid onset of action for phosphodiesterase type 5 inhibitors (PDE5is) emerged to be of clinical importance in men treated for erectile dysfunction (ED). Data from randomized clinical trials (RCTs) showed a rapid onset of action for vardenafil 10 mg orodispersible tablet (ODT). However, the effectiveness of vardenafil ODT has never been tested in a real-life setting. We assessed the efficacy and time to onset of action of vardenafil ODT in men seeking medical help for ED in the everyday real-life clinical practice. RESEARCH DESIGN AND METHODS: Patients completed a baseline and follow-up International Index of Erectile Function (IIEF), along with a 8-item self-administered questionnaire about onset of action and overall treatment outcomes. Descriptive statistics tested efficacy rates, patient timing of drug intake and time to post-dosing onset of action. RESULTS: Overall, 118(59.9%) patients used vardenafil ODT. Satisfactory erections for vaginal penetration were reported in 39(34.5%) and 26(21.8%), patients in =15 and =30, minutes post-dosing, respectively. Minimal Clinically Important Differences (MCIDs) criteria and Yang's criteria for responders were obtained in 80(67.8%) and 72(60.8%) patients. CONCLUSIONS: This study showed that one in three patients had satisfactory erection for vaginal penetration in less than 15 min post-dosing in the real-life setting.


Assuntos
Disfunção Erétil/tratamento farmacológico , Ereção Peniana/efeitos dos fármacos , Inibidores da Fosfodiesterase 5/uso terapêutico , Dicloridrato de Vardenafila/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Comprimidos , Fatores de Tempo , Resultado do Tratamento , Dicloridrato de Vardenafila/administração & dosagem , Adulto Jovem
6.
Urol Int ; 98(2): 198-204, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27509143

RESUMO

OBJECTIVE: To determine the effectiveness of the Phosphodiesterase 5 (PDE5) Inhibitors for the treatment of erectile dysfunction in patients with spinal trauma. METHODS: A systematic review and meta-analysis comparing PDE5 inhibitors versus placebo were carried out for clinical trials conducted between 1980 and 2014 that evaluated male patients older than 18 years, diagnosed with spinal cord trauma and erectile dysfunction. We designed a search strategy for Medline, CENTRAL, EMBASE and other electronic sources. Two investigators independently and blindly screened the studies for inclusion. A random effect meta-analysis was performed. RESULTS: Six studies involving 963 patients were included. Male patients over 18 years with ED attributable or subsequent to traumatic spinal cord injury (SCI) were included from these studies. In 4 of these studies, patients were randomized to the treatment group receiving sildenafil and the comparison group was placebo. Out of the remaining 2 trials, one compared tadalafil against the placebo and the other vardenafil versus placebo. The improvement on SCIs with PDE5 inhibitors was found to be large (standardized mean difference 0.71; 95% CI 0.39-1.03), with a high heterogeneity (I2 = 74.4%). CONCLUSIONS: PDE5 inhibitors are effective for the treatment of erectile dysfunction secondary to SCI.


Assuntos
Carbolinas/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Citrato de Sildenafila/uso terapêutico , Traumatismos da Medula Espinal/complicações , Adulto , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Tadalafila/uso terapêutico , Resultado do Tratamento , Dicloridrato de Vardenafila/uso terapêutico , Adulto Jovem
7.
Sex Med Rev ; 4(3): 270-284, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27871960

RESUMO

INTRODUCTION: Phosphodiesterase type 5 (PDE-5) hydrolyzes cyclic guanylate monophosphate (cGMP) specifically to 5' GMP, promoting successful corporeal vascular relaxation and penile erection during sexual stimulation. Oral PDE-5 inhibitors such as sildenafil, vardenafil, tadalafil, and avanafil have provided noninvasive, effective, well-tolerated treatment for erectile dysfunction (ED) patients and, at the same time, stimulated both academic and clinical interests. Lately, some oral PDE-5 inhibitors were released as low-dose preparations with the concept of potential daily administration and long-term use. AIM: To highlight the possible potential implications of low-dose long-term use of PDE-5 inhibitors. METHOD: A systematic review was carried out until December 2015 based on a search of all concerned articles in MEDLINE, medical subjects heading (MeSH) databases, Scopus, The Cochrane Library, EMBASE, and CINAHL databases without language restriction. Key words used to assess the outcome and estimates for concerned associations were: PDE-5 inhibitors; erectile dysfunction; low-dose; long-term; sildenafil; tadalafil; vardenafil; avanafil. MAIN OUTCOME MEASURES: Demonstrating different implications for low-dose long-term use of PDE-5 inhibitors. RESULTS: Low-dose and/or long-term use of PDE-5 inhibitors was shown to put forth beneficial sound effects in different medical implications with potentials that could be extended for different utilities. These implications included sexual, urogenital, cardiovascular, pulmonary, cutaneous, gastrointestinal, and reproductive, as well as neurological disorders. However, it is evident that most potential appliances were carried out experimentally on preclinical studies with off-label indications. CONCLUSION: Making use of and exploring low-dose and/or long-term use of several PDE-5 inhibitors for their possible implications seem to be valuable in different medical disorders. Increased knowledge of the drug characteristics, comparative treatment regimens, optimal prescribing patterns, and well-designed clinical trials are needed before these agents can be recommended for use.


Assuntos
Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Relação Dose-Resposta a Droga , Humanos , Masculino , Inibidores da Fosfodiesterase 5/efeitos adversos , Citrato de Sildenafila/uso terapêutico , Tadalafila/uso terapêutico , Resultado do Tratamento , Dicloridrato de Vardenafila/uso terapêutico
8.
Cutis ; 98(2): E15-9, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27622263

RESUMO

Levamisole is an immunomodulatory drug that was previously used to treat various medical conditions, including parasitic infections, nephrotic syndrome, and colorectal cancer. Over the last few years, increasing amounts of levamisole have been used as an adulterant in cocaine. Levamisole-cut cocaine has become a concern because it is known to cause a necrotizing purpuric rash, autoantibody production, and life-threatening leukopenia. Mixed histologic findings of vasculitis and thrombosis are characteristic of levamisole-induced purpura. The recommended management of levamisole-induced vasculitis currently involves withdrawal of the culprit along with supportive treatment. We describe a patient with levamisole-induced vasculitis who continued to develop skin lesions despite self-reported cocaine cessation. Complete resolution of cutaneous disease occurred with the addition of oral prednisone and vardenafil hydrochloride, suggesting the possibility of a new treatment option in patients with refractory disease. In addition, we review the clinical presentation, disease course, diagnostic approach, laboratory findings, histology, and management of levamisole-induced vasculitis. The harmful effects of levamisole-cut cocaine are serious enough that public alerts have been issued to increase awareness. Clinicians should consider the possibility of levamisole exposure in cocaine users presenting with any combination of fever, neutropenia, and necrotic skin lesions, especially in acral areas including the ears.


Assuntos
Antinematódeos/efeitos adversos , Glucocorticoides/uso terapêutico , Levamisol/efeitos adversos , Prednisona/uso terapêutico , Dermatopatias/tratamento farmacológico , Dicloridrato de Vardenafila/uso terapêutico , Vasculite/tratamento farmacológico , Vasodilatadores/uso terapêutico , Cocaína , Transtornos Relacionados ao Uso de Cocaína , Contaminação de Medicamentos , Humanos , Masculino , Pessoa de Meia-Idade , Necrose , Púrpura/induzido quimicamente , Púrpura/tratamento farmacológico , Púrpura/patologia , Pele/patologia , Dermatopatias/induzido quimicamente , Dermatopatias/patologia , Vasculite/induzido quimicamente , Vasculite/patologia
9.
Undersea Hyperb Med ; 43(4): 463-465, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28763176

RESUMO

Erectile dysfunction (ED), defined as the inability to achieve or sustain an erection firm enough for sexual intercourse, is common in men older than 50 years of age whose medical history includes diabetes mellitus. This case report describes a male patient treated with hyperbaric oxygen (HBO2) therapy as part of a comprehensive wound treatment plan for an open right foot wound. The patient's medical history included Type 1 diabetes mellitus and chronic ED refractory to previous trials of phosphodiesterase type 5 inhibitors. The patient completed a total of 60 HBO2 treatments over a 15-week period. He reported an improvement in his ED symptoms after the first 20 hyperbaric treatments, with morning tumescence being the first sign of a change. Patient continued to report morning tumescence 24 weeks after final HBO2 treatment.


Assuntos
Disfunção Erétil/terapia , Oxigenação Hiperbárica , Inibidores da Fosfodiesterase 5/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Citrato de Sildenafila/uso terapêutico , Tadalafila/uso terapêutico , Resultado do Tratamento , Dicloridrato de Vardenafila/uso terapêutico
10.
Andrologia ; 48(1): 20-8, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25684196

RESUMO

We carried out a systematic review and meta-analysis to assess the efficacy and safety of phosphodiesterase type 5 (PDE5) inhibitors for treating erectile dysfunction (ED) after bilateral nerve-sparing radical prostatectomy (BNSRP). A literature review was performed to identify all published randomised double-blind, placebo-controlled trials of PDE5 inhibitors for the treatment of ED after BNSRP. The search included the following databases: MEDLINE, EMBASE and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Six publications involving a total of 1678 patients were used in the analysis, including six RCTs that compared PDE5 inhibitors (tadalafil, sildenafil, avanafil and vardenafil) with placebo. Co-primary efficacy end points: International Index of Erectile Function-Erectile Function (IIEF-EF) domain score [the standardised mean difference (SMD) = 4.04, 95% confidence interval (CI) = 2.87-5.22, P < 0.00001]; successful vaginal penetration (SEP2) [the odds ratio (OR) = 14.87, 95%CI = 4.57-48.37, P < 0.00001]; and successful intercourse (SEP3) (OR = 47, 95%CI = 3-13.98, P < 0.00001) indicated that PDE5 inhibitors was more effective than the placebo. Specific adverse events with PDE5 inhibitors included headache (12.08%), dyspepsia (6.76%) and flushing (6.52%), which were significantly less likely to occur with placebo. This meta-analysis indicates that PDE5 inhibitors to be an effective and well-tolerated treatment for ED after BNSRP.


Assuntos
Disfunção Erétil/tratamento farmacológico , Tratamentos com Preservação do Órgão , Inibidores da Fosfodiesterase 5/uso terapêutico , Complicações Pós-Operatórias/tratamento farmacológico , Prostatectomia/métodos , Humanos , Masculino , Nervos Periféricos , Pirimidinas/uso terapêutico , Citrato de Sildenafila/uso terapêutico , Tadalafila/uso terapêutico , Resultado do Tratamento , Dicloridrato de Vardenafila/uso terapêutico
11.
Drug Des Devel Ther ; 9: 6129-37, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26604700

RESUMO

Vesicular drug delivery systems have recently gained attention as a way of improving dosing accuracy for drugs with poor transdermal permeation. The current study focuses on utilization of the natural biocompatible vesicles to formulate vardenafil nanoethosomes (VRD-NE), for the enhancement of their transdermal permeation and bioavailability. Fifteen formulations were prepared by thin-layer evaporation technique according to Box-Behnken design to optimize formulation variables. The effects of lipid composition, sonication time, and ethanol concentration on particle size and encapsulation efficiency were studied. The diffusion of vardenafil (VRD) from the prepared nanoethosomes specified by the design was carried out using automated Franz diffusion cell apparatus. The optimized formula was investigated for in vivo pharmacokinetic parameters compared with oral VRD suspension. Confocal laser scanning microscopy images were used to confirm enhanced diffusion release of VRD in rat skin. The results showed that the optimized formula produced nanoethosomes with an average size of 128 nm and an entrapment efficiency of 76.23%. VRD-NE provided a significant improvement in permeation with an enhancement ratio of 3.05-fold for a film made with optimally formulated VRD-NE compared with a film made with VRD powder. The transdermal bioavailability of VRD from the nanoethosome film was approximately twofold higher than the oral bioavailability from an aqueous suspension. VRD-NE thus provide a promising transdermal drug delivery system. As a result, management of impotence for a longer duration could be achieved with a reduced dosage rate that improves patient tolerability and compliance for the treatment of erectile dysfunction.


Assuntos
Sistemas de Liberação de Medicamentos , Disfunção Erétil/tratamento farmacológico , Dicloridrato de Vardenafila/administração & dosagem , Dicloridrato de Vardenafila/uso terapêutico , Administração Cutânea , Animais , Disponibilidade Biológica , Difusão , Portadores de Fármacos/química , Masculino , Tamanho da Partícula , Ratos , Absorção Cutânea/efeitos dos fármacos , Propriedades de Superfície , Dicloridrato de Vardenafila/farmacocinética
12.
Andrology ; 3(5): 909-18, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26311340

RESUMO

Erectile Dysfunction is considered a multifactorial disease, where organic and psychological aspects are often interconnected. In a randomized controlled pilot study, we compared the efficacy of combined vardenafil orodispersible tablet (VARD) and cognitive-behavioral sex therapy (CBST) vs. VARD alone in improving sexual symptoms in both male and female partners. Thirty male patients with erectile dysfunction, and their partners were randomly assigned with a 2 : 1 ratio, to two different arms and treated for 10 weeks with VARD (Group A; n = 19) or VARD+CBST (Group B; n = 11). International Index of Erectile Dysfunction (IIEF-15), Female Sexual Function Index (FSFI) and Index of Sexual Satisfaction (ISS) were, respectively, administered to male, female, and both partners at times (T) 0, 1 (+5 weeks of therapy) and 2 (+10 weeks of therapy). Groups A and B were similar in their sociodemographic and clinical characteristics. Pre-treatment (T0) test scores did not significantly differ among the groups. In both group A and B, the IIEF-Erectile Function domain showed a significant improvement from T0 to T1 (p = 0.005 and p < 0.0001 vs. T0, respectively) and from T0 to T2 only in group B (p = 0.013). In group A, FSFI and both male and female ISS did not show any significant change at T1 and T2 vs. T0. In group B, a significant improvement at final time-point in FSFI and male and female ISS scores was reported (p < 0.05, T2 vs. T0 in all scores). The results of our study suggest that both VARD alone and VARD+CBST improved erectile function, however, only VARD+CBST improved couple sexual satisfaction and female sexual function.


Assuntos
Terapia Cognitivo-Comportamental/métodos , Coito/fisiologia , Disfunção Erétil/terapia , Satisfação do Paciente , Dicloridrato de Vardenafila/uso terapêutico , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ereção Peniana/efeitos dos fármacos , Ereção Peniana/psicologia , Projetos Piloto , Autorrelato , Comportamento Sexual/psicologia , Inquéritos e Questionários , Resultado do Tratamento
13.
Curr Drug Targets ; 16(5): 420-6, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25392015

RESUMO

Erectile dysfunction is usually of vascular origin and is frequently encountered in men with cardiovascular disease. The introduction of phosphodiesterase-5 inhibitors has revolutionized the management of patients with erectile dysfunction. Currently available phosphodiesterase-5 inhibitors have distinct pharmacokinetic and pharmacodynamic properties, thus permitting for tailoring sexual therapy according to patient characteristics and needs. Phosphodiesterase-5 inhibitors possess vasorelaxing properties and exert systemic hemodynamic effects, which need to be taken into account when other cardiovascular drugs are co-administered. Special caution is needed with alpha-blockers, while the co-administration with nitrates is contra-indicated due to the risk of life-threatening hypotension. This review presents the advent of sexual therapy, describes the mechanism of action and the specific characteristics of commercially available phosphodiesterase-5 inhibitors, summarizes the efficacy and safety of these drugs with special emphasis on the cardiovascular system, and discusses the clinical criteria used for the selection of each drug for the individual patient.


Assuntos
Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Vasodilatadores/uso terapêutico , Doenças Cardiovasculares/complicações , Doenças Cardiovasculares/tratamento farmacológico , Incompatibilidade de Medicamentos , Disfunção Erétil/etiologia , Humanos , Masculino , Inibidores da Fosfodiesterase 5/efeitos adversos , Citrato de Sildenafila/efeitos adversos , Citrato de Sildenafila/uso terapêutico , Tadalafila/efeitos adversos , Tadalafila/uso terapêutico , Dicloridrato de Vardenafila/efeitos adversos , Dicloridrato de Vardenafila/uso terapêutico , Vasodilatadores/efeitos adversos
14.
Int J Impot Res ; 27(3): 95-102, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25471318

RESUMO

To investigate the change of erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction (ED). Effect of levitra on sustenance of erection was an open-label, prospective, multicenter and single-arm study designed to measure the duration of erection in men with ED receiving a flexible dose of vardenafil over an 8-week treatment period. Patients were instructed to take vardenafil 10 mg 60 min before attempting the intercourse. Vardenfil could be increased to 20 mg or decreased to 5 mg concerning patients' efficacy and safety. Following the initial screening, patients entered a 4-week treatment-free run-in phase and 8-week treatment period, during which they were instructed to attempt intercourse at least four times on four separate days. A total of 95 men were enrolled in 10 centers. After the 8 weeks treatment, the mean duration of erection leading to successful intercourse was statistically superior when patients were treated with vardenafil. After an 8-week treatment, the duration of erection leading to successful intercourse was 9.39 min. There were significant benefits with vardenafil in all domains of International Index of Erectile Function. Secondary efficacy end points included success rate of penetration, maintaining erection, ejaculation and satisfaction were superior when patients were treated with vardenafil. There was a significant correlation between duration of erection with other sexual factors. Also partner's sexual satisfaction was increased with vardenafil. Most adverse events were mild or moderate in severity. Vardenafil was safe and well tolerated. Vardenafil therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED with female partner.


Assuntos
Disfunção Erétil/tratamento farmacológico , Ereção Peniana/efeitos dos fármacos , Inibidores da Fosfodiesterase 5/uso terapêutico , Dicloridrato de Vardenafila/uso terapêutico , Adolescente , Adulto , Idoso , Consumo de Bebidas Alcoólicas , Grupo com Ancestrais do Continente Asiático , Coito/psicologia , Relação Dose-Resposta a Droga , Ejaculação , Determinação de Ponto Final , Disfunção Erétil/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ereção Peniana/psicologia , Inibidores da Fosfodiesterase 5/efeitos adversos , Estudos Prospectivos , Fumar , Dicloridrato de Vardenafila/efeitos adversos , Adulto Jovem
15.
Int J Clin Pract ; 69(4): 436-43, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25311239

RESUMO

BACKGROUND: Erectile dysfunction (ED) is a common male sexual disorder worldwide. Three oral phosphodiesterase type 5 inhibitors (PDE5Is) - sildenafil, tadalafil and vardenafil - are available for treatment of ED. This study quantitatively evaluated the therapeutic efficacy and safety of these medications to assist treatment decision making. METHODS: We used multiple criteria decision analysis (MCDA) to assess the totality of risk-benefit of PDE5Is. We created two models: (i) the overall model included 'overall improvement in erections' and 'any adverse events' and (ii) the detailed model included 'erectile function domain', 'ability for sexual intercourse', 'duration of erection last', 'serious adverse events', 'headache', 'flushing' and 'dyspepsia'. We calculated a synthetic utility for each drug accounting for all of its benefits and risks. RESULTS: Considering the overall risk-benefit, vardenafil had the highest synthetic utility among three medications; in the order of synthetic utilities: vardenafil (0.568), tadalafil (0.478) and sildenafil (0.437). However, when specific risk and benefit criteria were assessed, tadalafil had the highest synthetic utility (0.602) according to the conjoint evaluation (synthetic utility for vardenafil is 0.491 and sildenafil is 0.442, respectively). The sensitivity analysis based on the uncertainties of weight on risks of any adverse events (including serious adverse events and headache) suggested our results were robust. CONCLUSIONS: This study provides a useful approach that comprehensively and systematically assesses and compares the risk-benefit of several treatment alternatives. Our study not only rank treatment alternatives by synthetic utilities based on the risk-benefit balance but also compare specific risk and benefit criteria between these medicines. Our results provide valuable evidence that can guide clinicians and patients in making treatment decisions.


Assuntos
Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Citrato de Sildenafila/uso terapêutico , Tadalafila/uso terapêutico , Dicloridrato de Vardenafila/uso terapêutico , Adulto , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Ereção Peniana/efeitos dos fármacos , Inibidores da Fosfodiesterase 5/efeitos adversos , Medição de Risco/métodos , Citrato de Sildenafila/efeitos adversos , Tadalafila/efeitos adversos , Dicloridrato de Vardenafila/efeitos adversos
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