RESUMO
PURPOSE: To date, few studies have validated the Prostate Imaging Reporting and Data System Version 2 (PI-RADS v. 2) for the diagnosis of prostate cancer. Our aim was to validate PI-RADS v.2 using 3 Tesla (T) MRI. MATERIALS AND METHODS: This is a retrospective study of 54 consecutive patients who underwent 3T MRI with a body-array coil for diagnostic confirmation of prostate cancer or cancer staging between June 2013 and June 2015. Sensitivity, specificity, and agreement were calculated based on a criterion of PI-RADS score = 3. Inter-examiner agreement was determined by the weighted kappa statistic. RESULTS: Histological findings were positive for cancer in 33 patients and negative in 21 patients. Considering a PI-RADS score of 3 as positive for cancer, the accuracy of each reader was 85.20% and 70.40%, respectively, and agreement coefficients were κ = 0.69 and κ = 0.35. Considering PI-RADS 3 as absence of cancer, the accuracy of each reader was 77.80% and 77.80%, respectively, and agreement was κ = 0.55 and κ = 0.54. Inter-reader agreement was moderate/good (weighted κ = 0.53; 95% confidence interval: 0.39-0.66; P = 0.038). CONCLUSION: High accuracy was obtained for the diagnosis of prostate cancer using 3T MRI with a body coil and the PI-RADS v.2 score. J. Magn. Reson. Imaging 2016;44:1354-1359.
Assuntos
Interpretação de Imagem Assistida por Computador/normas , Imageamento por Ressonância Magnética/instrumentação , Imageamento por Ressonância Magnética/normas , Guias de Prática Clínica como Assunto , Neoplasias da Próstata/diagnóstico por imagem , Sistemas de Informação em Radiologia/normas , Transdutores/normas , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Humanos , Interpretação de Imagem Assistida por Computador/instrumentação , Internacionalidade , Masculino , Pessoa de Meia-Idade , Neoplasias da Próstata/patologia , Doses de Radiação , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
PURPOSE: Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). MATERIALS AND METHODS: Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. RESULTS: 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. CONCLUSION: Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.
Assuntos
Disfunção Erétil/tratamento farmacológico , Adesão à Medicação , Inibidores da Fosfodiesterase 5/uso terapêutico , Adulto , Idoso , Brasil , Carbolinas/uso terapêutico , Escolaridade , Humanos , Imidazóis/uso terapêutico , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Piperazinas/uso terapêutico , Estudos Prospectivos , Purinas/uso terapêutico , Citrato de Sildenafila , Estatísticas não Paramétricas , Sulfonas/uso terapêutico , Inquéritos e Questionários , Tadalafila , Fatores de Tempo , Resultado do Tratamento , Triazinas/uso terapêutico , Dicloridrato de VardenafilaRESUMO
Purpose Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). Materials and Methods Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. Results 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Conclusion Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment. .
Assuntos
Adulto , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Disfunção Erétil/tratamento farmacológico , Adesão à Medicação , /uso terapêutico , Brasil , Carbolinas/uso terapêutico , Escolaridade , Imidazóis/uso terapêutico , Satisfação do Paciente , Estudos Prospectivos , Piperazinas/uso terapêutico , Purinas/uso terapêutico , Estatísticas não Paramétricas , Inquéritos e Questionários , Sulfonas/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Triazinas/uso terapêuticoRESUMO
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
PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95 percent confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95 percent CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.
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Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Anti-Inflamatórios não Esteroides/uso terapêutico , /uso terapêutico , Isoxazóis/uso terapêutico , Cetoprofeno/uso terapêutico , Cólica Renal/tratamento farmacológico , Doença Aguda , Analgesia/métodos , Método Duplo-Cego , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: Although non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , Isoxazóis/uso terapêutico , Cetoprofeno/uso terapêutico , Cólica Renal/tratamento farmacológico , Doença Aguda , Adolescente , Adulto , Idoso , Analgesia/métodos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
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% (ANOVA P < 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% (ANOVA P < 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.
Assuntos
Inibidores da Fosfodiesterase 5 , Inibidores de Fosfodiesterase/uso terapêutico , Idoso , Carbonatos/efeitos adversos , Carbonatos/uso terapêutico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Ereção Peniana/efeitos dos fármacos , Inibidores de Fosfodiesterase/efeitos adversos , Piperazinas/efeitos adversos , Piperazinas/uso terapêutico , Estudos Prospectivos , Pirimidinas/efeitos adversos , Pirimidinas/uso terapêutico , Resultado do TratamentoRESUMO
Objetivo: Avaliar o efeito do sildenafil em pacientes brasileiros com disfunção erétil secundária à lesão de medula espinhal. Métodos: Os participantes foram examinados por ocasião da adesão ao estudo, e duas e seis semanas depois. Dados iniciaise de seguimento sobre a função sexual foram obtidos. Depois da segunda semana, a dose inicial de sildenafil (50 mg) podia ser ajustada, de acordo com a eficácia e tolerabilidade. A eficácia foi avaliada principalmente pelos escores nas questões 3 e 4 do questionário do Índice Internacional para Disfunção Erétil. Análises secundárias incluíram questões e domínios do índice, a avaliação da eficácia global, percentual de sucesso na relação sexual, respostas ao questionário de Qualidade de Vida e Função Erétil, além da satisfação da parceira. Resultados: Noventa e um pacientes foram avaliados quanto à eficácia e 94 quanto à segurança. A mediana da idade dos pacientes foi de 33 anos e a mediana do tempo entre a lesão medular e a adesão ao estudo de três anos. O sildenafil levou a um aumento significativo nos escores médios nas questões 3 e 4(p < 0,001 nas duas comparações), bem como em outras questõese em todos os domínios do Índice Internacional para Disfunção Erétil. A melhora na ereção foi relatada por 89% dos pacientes e a proporção de relações sexuais bem sucedidas aumentou de 6 para 74%(p < 0,001). Os escores médios do questionário de Qualidade de Vida e Função Erétil aumentaram de 60 para 74% (p < 0,001). Noventa por cento de 42 mulheres estavam moderadamente ou bastante satisfeitas com o tratamento do parceiro. Os efeitos adversos maiscomuns foram cefaléia (16%), rubor (11%) e congestão nasal (10%). Conclusões: Sildenafil se mostrou seguro e efetivo no tratamentode homens brasileiros portadores de disfunção erétil secundária à lesão traumática da medula espinhal.