RESUMO
BACKGROUND: Phosphodiesterase type 5 (PDE5) inhibitors have discontinuation rates as high as 60% in men with erectile dysfunction. Treatment satisfaction has been significantly associated with treatment continuation. Understanding key characteristics in terms of treatment preference, relationship, and lifestyle issues could provide direction on how to improve compliance with PDE5 inhibitor treatment globally. OBJECTIVE: The objective was to identify subgroups of interest in the pooled database of two observational studies conducted in Latin America (LA) and Middle East/North Africa (MENA) exploring patient characteristics and prescription of either a long- or short-acting PDE5 inhibitor at baseline. METHODS: Two identical prospective, non-interventional, observational, studies in MENA (N = 493) and LA (N = 511) treated men with an 'on demand' (pro re nata, PRN) PDE5 inhibitor (sildenafil, tadalafil, vardenafil, or lodenafil) during 6 months. In this post-hoc meta-analysis of two observational studies with equal design, pooled data were analyzed to determine patient characteristics and PDE5 inhibitor prescribed/used most likely to be associated with patient expectations, satisfaction, self-esteem, and patient-partner relationships. Decision tree analyses, with and without weighting, were used to identify and describe key features. RESULTS: In each analysis of patient expectations, patient-partner relationship, and self-esteem, we describe the two major subgroups at baseline for each decision tree. Analyses of patient expectations and sexual self-esteem revealed that patients prescribed long-acting PDE5 inhibitors (59%) highlighted the importance of treatment effect duration, second to partner satisfaction with treatment, while patients prescribed short-acting PDE5 inhibitors (32%) placed less importance on treatment effect duration but considerable importance on treatment effect lasting until intercourse completion. Further insights regarding patients, partner relationship characteristics, and treatment expectations were identified. CONCLUSION: Our analyses have described key characteristics, such as self- and partner perceptions, sexual attitudes, and treatment expectations in relation to the patients' country and prescribed treatment, which might guide treatment decisions in MENA and LA men with ED.
Assuntos
Disfunção Erétil , Relações Interpessoais , Inibidores da Fosfodiesterase 5 , Autoimagem , Adulto , África do Norte/epidemiologia , Árvores de Decisões , Preparações de Ação Retardada/classificação , Preparações de Ação Retardada/farmacologia , Preparações de Ação Retardada/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/epidemiologia , Disfunção Erétil/psicologia , Humanos , América Latina/epidemiologia , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Oriente Médio/epidemiologia , Cooperação do Paciente , Preferência do Paciente , Inibidores da Fosfodiesterase 5/classificação , Inibidores da Fosfodiesterase 5/farmacocinética , Inibidores da Fosfodiesterase 5/uso terapêutico , Padrões de Prática Médica , Estudos Prospectivos , Inquéritos e Questionários , Resultado do TratamentoRESUMO
OBJECTIVES: To assess persistence/adherence rates of phosphodiesterase type-5 inhibitor (PDE5I) on-demand dosing in Latin American men with erectile dysfunction (ED), and explore patient characteristics and treatment factors that may be predictive for PDE5I persistence and adherence. METHODS: Men from Brazil, Mexico, and Venezuela with ED who were naïve to PDE5Is were prescribed sildenafil, tadalafil, vardenafil, or lodenafil on-demand dosing and asked to provide information about PDE5I use at baseline and at 1, 3, and 6 months. Patients were persistent if they used ≥1 dose during the 4 week period prior to each evaluation. Patients were adherent if they complied with dosing instructions during most recent dose. Main outcome measures included Persistence and Adherence Questionnaire (PAQ), Partner Relationship Questionnaire (PRQ), Self-Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence and adherence. RESULTS: A total of 511 men were enrolled; most had mild to moderate ED (77.1%); 317 patients (62.0%) were prescribed tadalafil, 116 (22.7%) sildenafil, 75 (14.7%) vardenafil, and 3 (0.6%) lodenafil (not further analyzed). A total of 340 patients (66.5%) were 'persistent' at 6 months; 345 (67.5%) were 'adherent'. Persistence and adherence were associated with age, education level, and ED duration. Reasons for non-persistence included medication cost and lack of efficacy. Study limitations included its design, brief observation period, its bias observed toward tadalafil selection; its dependence on patient self-reporting, limited number of factors that were analyzed for persistence/adherence association, its small number of participating patients and Latin American countries, and inherent differences in PDE5I preference and medical practices. CONCLUSION: Approximately two-thirds of PDE5I-naïve, Latin American men with ED were persistent and adherent after 6 months of therapy. Factors like education level, ED severity, and ED duration were associated with persistence and adherence; additional study is warranted to investigate the predictive value of these factors.
Assuntos
Disfunção Erétil/tratamento farmacológico , Adesão à Medicação , Inibidores da Fosfodiesterase 5/uso terapêutico , Carbolinas/uso terapêutico , Carbonatos/uso terapêutico , Humanos , Imidazóis/uso terapêutico , América Latina , Masculino , Pessoa de Meia-Idade , Piperazinas/uso terapêutico , Estudos Prospectivos , Purinas/uso terapêutico , Pirimidinas/uso terapêutico , Autoimagem , Citrato de Sildenafila , Sulfonas/uso terapêutico , Inquéritos e Questionários , Tadalafila , Resultado do Tratamento , Triazinas/uso terapêutico , Dicloridrato de VardenafilaRESUMO
INTRODUCTION: Low sexual desire in men is a condition that has received little attention; nevertheless it occurs with high frequency. Clinicians are in need of clear guidelines to address this problem. AIM: To develop standardized operational procedures to be implemented with men presenting low sexual desire/interest (LSD/I). METHODS: Review of relevant evidence-based literature and published guidelines, integrated with expert opinion. MAIN OUTCOME: Operational procedures for LSD/I that are recommended for clinical practice with various degrees of support from published evidence. RESULTS: A new classification scheme is proposed; LSD/I is proposed as an umbrella term for which hypoactive sexual desire disorder (HSDD) is only a subtype. The following standard operational procedures are described: (i) Detection of LSD/I: screening for LSD/I, screening for LSD/I in patients with other sexual dysfunctions; (ii) Diagnosis and assessment of etiology: diagnostic criteria for LSD/I, assessment of depression status, assessment of relationship status, assessment of endocrinologic status, diagnostic criteria for HSDD in men; (iii) TREATMENT: treatment of LSD/I secondary to low testosterone, treatment of LSD/I secondary to elevated prolactin, treatment of LSD/I secondary to other endocrinologic disorders, treatment of LSD/I secondary to depressive illness and or anxiety disorders, treatment of LSD/I secondary to relationship conflict and treatment of HSDD. A diagnostic and treatment algorithm is presented. CONCLUSIONS: LSD/I is a common condition that should be identified in patients; it is recommended that this condition be actively investigated by the clinician. Once the diagnosis of LSD/I in men is confirmed, a thorough search for possible causes needs to include both biological and psychological causes. TREATMENT should be etiologically oriented.
Assuntos
Disfunções Sexuais Psicogênicas/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Protocolos Clínicos/normas , Humanos , Libido/fisiologia , Masculino , Guias de Prática Clínica como Assunto/normas , Disfunções Sexuais Psicogênicas/classificação , Disfunções Sexuais Psicogênicas/etiologia , Disfunções Sexuais Psicogênicas/fisiopatologia , Disfunções Sexuais Psicogênicas/terapiaRESUMO
AIM: To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). METHODS: A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. MAIN OUTCOME MEASURES: The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. SECONDARY OUTCOMES INCLUDED: Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. RESULTS: Men naive to tadalafil OaD were enrolled (N = 378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P < 0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50 ± 0.78 following tadalafil OaD, 0.5 ± 0.72 for tadalafil PRN, and 0.39 ± 0.67 for sildenafil PRN. The difference in least-squares mean was 0.12 ± 0.04 (confidence interval [CI] = 0.04, 0.19; P = 0.001) between tadalafil OaD and sildenafil PRN and 0.01 ± 0.04 (CI = -0.06, 0.08; P = 0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P < 0.001). There were no differences in SEAR scores between treatments. CONCLUSIONS: Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.
Assuntos
Carbolinas/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Inibidores da Fosfodiesterase 5/uso terapêutico , Piperazinas/uso terapêutico , Sulfonas/uso terapêutico , Administração Oral , Carbolinas/administração & dosagem , Estudos Cross-Over , Esquema de Medicação , Disfunção Erétil/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 5/administração & dosagem , Piperazinas/administração & dosagem , Purinas/administração & dosagem , Purinas/uso terapêutico , Citrato de Sildenafila , Sulfonas/administração & dosagem , Tadalafila , Resultado do TratamentoRESUMO
INTRODUCTION: Previous research has demonstrated that sildenafil citrate users alter dosing-sexual attempt behavior when switched to tadalafil. The impact of geography and culture on sexual behavior with phosphodiesterase type 5 (PDE5) inhibitor treatment has not been fully investigated. AIM: To describe and compare the changes in dosing-sexual attempt behavior with sildenafil citrate vs. tadalafil treatment across four distinct geographies: Asia, Australia/New Zealand (ANZ), Central Eastern Europe/Middle East (CEE/ME), and Latin America (LA). METHODS: Data from a single-arm, open-label clinical trial conducted in 21 countries from November 2002 to May 2004 were used in this analysis. Men with erectile dysfunction and a history of > or =6-week prior sildenafil citrate use continued sildenafil citrate treatment for 4 weeks then switched to tadalafil for 8 weeks. Dosing instructions were provided. MAIN OUTCOMES MEASURES: Timing of dose and sexual intercourse was assessed through patient diaries for the final 4 weeks of each treatment period. RESULTS: A total of 2,760 men were enrolled: Asia 15.8%; ANZ 29.4%; CEE/ME 19.7%; LA 35.1%. The median time from dosing to intercourse was significantly increased during tadalafil treatment across all geographical regions; however, the magnitude of increase differed significantly by geography (P < 0.0001). The Asian cohort demonstrated the shortest duration between dosing and sexual intercourse attempts (irrespective of drug), and altered sexual behavior the least upon switching to tadalafil. The ANZ cohort demonstrated the longest duration between dosing and sexual intercourse attempts (irrespective of drug), and altered sexual behavior the most upon switching to tadalafil. CONCLUSION: Men with a history of established sildenafil citrate use alter their dose-attempt behavior when treated with tadalafil irrespective of geography. However, the extent to which sexual behavior alters is not uniform across geographical regions, suggesting that dosing instructions and duration of drug effectiveness, in combination with personal and cultural preferences, may determine sexual behavior with PDE5 inhibitor use.
Assuntos
Carbolinas/uso terapêutico , Coito , Impotência Vasculogênica/tratamento farmacológico , Inibidores de Fosfodiesterase/uso terapêutico , Piperazinas/uso terapêutico , Sulfonas/uso terapêutico , Análise de Variância , Ásia , Austrália , Intervalos de Confiança , Europa (Continente) , Geografia , Indicadores Básicos de Saúde , Humanos , América Latina , Masculino , Pessoa de Meia-Idade , Oriente Médio , Nova Zelândia , Satisfação do Paciente , Purinas/uso terapêutico , Citrato de Sildenafila , Tadalafila , Fatores de TempoRESUMO
INTRODUCTION: Although erectile dysfunction (ED) affects both members of the couple, no tools exist for the detection of ED by the female partner. AIM: The aim of this study was to develop a scale for the detection of ED, as assessed by the female partner. METHODS: Development and validation of the Female Assessment of Male Erectile dysfunction detection scale (FAME) consisted of five stages: (i) two focus group discussions conducted among female partners of ED sufferers; (ii) item construction; (iii) initial content validation to document face validity and reduce number of items; (iv) final selection of items and investigation of concurrent validity and reliability, sensitivity and specificity of the scale in 83 Spanish-speaking couples; and (v) multicenter study conducted in a group of 106 English-speaking couples. Concurrent validity was assessed using Spearman's rho correlation coefficients between FAME and clinical diagnosis, the Sexual Health Inventory for Men (SHIM), and the erectile function domain of the International Index of Erectile Function (IIEF-EF). Reliability was tested using Cronbach's alpha, and sensitivity and specificity was investigated using clinical diagnosis as the gold standard criterion. MAIN OUTCOME MEASURES: Validity, reliability, specificity, and sensitivity of the FAME scale when correlated with SHIM, IIEF-EF, and clinical diagnosis. RESULTS: Qualitative analysis yielded 44 clues; 21 items demonstrated statistical significance as the best discriminating items using a t-test for independent samples. A final scale of six items was tested for validity, reliability, specificity, and sensitivity. FAME correlated significantly with clinical diagnosis (0.791, P < 0.001), the SHIM (0.788, P < 0.001), and the IIEF-EF (0.777, P < 0.001). Additional support for discriminant validity was obtained with receiver operating characteristics analysis. Cronbach's alpha was 0.941. Sensitivity was 96.1% and specificity 86.0%. CONCLUSIONS: Accurate detection of ED in men by the female partner is possible. In this study, FAME demonstrated concurrent validity and very good reliability, as well as excellent sensitivity and specificity.
Assuntos
Impotência Vasculogênica/diagnóstico , Disfunção Erétil/diagnóstico , Feminino , Grupos Focais , Indicadores Básicos de Saúde , Humanos , Relações Interpessoais , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Fatores Sexuais , Comportamento Sexual , Estatística como Assunto , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Clinical research on erectile dysfunction (ED) has focused primarily on the male and the impact of treatment on their erectile function (EF) and sexual quality of life. However, ED affects the quality of life of both the male and the female partner. The literature examining the impact on the female partner resulting from treating the male's ED is somewhat limited. AIMS: To determine the efficacy of tadalafil 5 mg taken once daily compared with placebo on men's EF and sexual quality of life, and to determine the impact of this treatment on the female partner's sexual quality of life. MAIN OUTCOME MEASURES: The co-primary outcome measures for this study were changes from baseline to end point in the EF domain of the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) question 2 (SEP-2) and question 3 (SEP-3), and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ) (subject and partner). Methods. Following a 4-week treatment-free run-in phase, 342 subjects and their partners were randomly assigned to either placebo (N = 78) or tadalafil 5 mg (N = 264) for 12 weeks. The subjects' and partners' responses to study measures were collected throughout the study. RESULTS: Compared with placebo, tadalafil-treated subjects showed a significant improvement on efficacy measures (P < 0.001) including changes in the IIEF-EF, SEP-2 and SEP-3. In addition, the sexual quality of life of men and their female partners, as measured by the SQoL domain, was significantly improved with tadalafil 5 mg taken once daily (P < 0.001) compared with placebo. CONCLUSIONS: Tadalafil 5 mg once daily significantly improved EF and sexual quality of life for men with ED. In addition, the sexual quality of life of the female partners of the men treated with tadalafil was significantly improved.
Assuntos
Carbolinas/administração & dosagem , Disfunção Erétil/tratamento farmacológico , Inibidores de Fosfodiesterase/administração & dosagem , Qualidade de Vida , Comportamento Sexual/efeitos dos fármacos , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Parceiros Sexuais , Tadalafila , Resultado do TratamentoRESUMO
INTRODUCTION: Homosexuality is a topic that needs to be integrated into the knowledge base of the practitioner of sexual medicine. AIM: To present to the reader a summary of the current literature on homosexuality and sexual orientation and address specifically issues that pertain to the relationship sexual orientation and sexual medicine practice. MAIN OUTCOME MEASURES: The information is presented in a continued medical education format, with a series of evaluation questions at the end of the activity. Methods. A review of the literature is presented and organized according to the authors' judgment of the value of the information as to provide the reader with an inclusive panorama of the issues covered. RESULTS: Current concepts, debates, and need for further research are presented. CONCLUSIONS: The professional of sexual medicine needs to be aware of the various topics reviewed in this article as his or her involvement in the area of sexuality can create the expectation on the part of the patients of knowingness of all aspects of human sexuality. Sexual orientation is a complex area but considerable understanding has fortunately been achieved in many issues in reference to homosexuality and heterosexuality.