PDE5 Inhibitor Treatment Persistence and Adherence in Brazilian Men: Post-hoc Analyses from a 6-Month, Prospective, Observational Study

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. .

Resposta pressórica de pacientes com miocardiopatia chagásica ante o uso do sildenafil / Pressure response in chagasic cardiomyopathy patients after using sildenafil

OBJETIVO: Verificar o efeito do sildenafil na pressão arterial (PA) e freqüência cardíaca (FC) de indivíduos portadores de miocardiopata chagásica (MCC) e de disfunção ventricular sistólica grave (FE<40 por cento) submetidos à atividade física. MÉTODOS: Foram avaliados 12 homens com fração de ejeção<40 por cento e MCC confirmada por sorologia. Foi realizado o Teste de 6 minutos (T6M) antes e após a ingestão de sildenafil 50 mg, com intervalo de 30 minutos. Antes e depois de cada T6M aferiram-se a freqüência cardíaca (FC) e a pressão arterial sistólica (PAS) e diastólica (PAD). Para análise estatística, o estudo foi dividido em 4 etapas: Antes do T6M realizado antes do Sildenafil (T1); após o T6M, antes do Sildenafil (T2); após o sildenafil, antes do T6M (T3); após o Sildenafil, após o T6M (T4). RESULTADOS: A idade dos participantes variou entre 47 e 68 anos (57,6±6,4). PAS e PAD após o T6M e uso do sildenafil (T4) mostraram-se menores do que antes do fármaco (T2): 134,2±15,1 versus 125,5±14,0 e 88,4±12,4 versus 83,0±10,8, respectivamente. Nenhum indivíduo referiu sintomas durante a realização do T6M. Não houve diferença na distância total percorrida no T6M antes e depois do uso do sildenafil (487,5±15,22 versus 505,3±18,45 metros, respectivamente) - p=0,056, e na FC (antes sildenafil 75,5±8,79 e 96,8±10,36 bpm e após 77,1±9,81 e 96,1 ± 12,97 bpm). CONCLUSÃO: Observou-se significante diminuição da PA após atividade física sob uso do sildenafil. Entretanto, durante o Teste de 6 minutos, não foram relatados sintomas pelos pacientes, sugerindo, então, que esse efeito parece não ser suficiente para causar manifestações clínicas entre os portadores de MCC e insuficiência cardíaca.

OBJECTIVE: To accurately verify the effect of Sildenafil on blood pressure (BP) and heart rate (HR) in individuals with Chagasic myocardiopathy (CMC) and severe systolic ventricular dysfunction (EF<40 percent) submitted to physical activity. METHODS: Twelve men with ejection fractions <40 percent and CMC confirmed by a serological test were assessed. The six-minute walk test (6MWT) was performed before and after administration of 50 mg of Sildenafil, with a 30 minute interval. Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure were taken and compared before and after each 6MWT. For statistical analysis purposes, the study was divided into four stages: before the 6MWT and administration of Sildenafil (S1); after the 6MWT but before the administration of Sildenafil (S2); after the administration of Sildenafil but before the 6MWT (S3); and after the administration of Sildenafil and the 6MWT (S4). RESULTS: Participant ages ranged from 47 to 68 years (57.6 ± 6.4). SBP and DBP after the 6MWT and the administration of Sildenafil (S4) were lower than before taking the drug (S2): 134.2 ± 15.1 versus 125.5 ± 14.0 and 88.4 ± 12.4 versus 83.0 ± 10.8, respectively. None of the patients reported any symptoms during the 6MWT. There were no differences in the distances walked during the 6MWT before or after taking Sildenafil (487.5±15.22 versus 505.3±18.45 meters, respectively)-p=0.056, or in HR (before Sildenafil 75.5 ± 8.79 and 96.8 ± 10.36 bpm and after 77.1 ± 9.81 and 96.1 ± 12.97 bpm). CONCLUSION: Based on these results, it can be concluded that both prediction equations significantly overestimated HRmax measured during maximal GXT in Brazilian elderly women, a finding that may have important implications when prescribing exercise intensity for this population. In addition, HRmax was inversely related to the volunteers' age, suggesting that the chronotropic reserve continues to decline after age 60.

Effect of sildenafil citrate on the cardiovascular system

Sildenafil citrate is a drug commonly used to manage erectile dysfunction. It is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H -pyrazolo[4,3-d]pyrimidin-5-yl)-4 ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate (C22H30N6O4 S). It is a highly selective inhibitor of cyclic guanine monophosphate-specific phosphodiesterase type 5. In late March through mid-November 1998, the US Food and Drug Administration (FDA) published a report on 130 confirmed deaths among men (mean age, 64 years) who received prescriptions for sildenafil citrate, a period during which >6 million outpatient prescriptions (representing about 50 million tablets) were dispensed. The US FDA recently reported that significant cardiovascular events, including sudden cardiac death, have occurred in men with erectile dysfunction who were taking sildenafil citrate. These reports have raised concerns that sildenafil citrate may increase the risk of cardiovascular events, particularly fatal arrhythmias, in patients with cardiovascular disease. In the past few years, the cardiac electrophysiological effects of sildenafil citrate have been investigated extensively in both animal and clinical studies. According to extensive data available to date, sildenafil citrate has been shown to pose minimal cardiovascular risks to healthy people taking this drug. Some precautions are needed for patients with cardiovascular diseases. However, the only absolute contraindication for sildenafil citrate is the concurrent use of nitrates. This article is intended to review sildenafil citrate's cardiovascular effects, as well as current debates about its arrhythmogenic effects.

Lipid abnormalities in chronic renal failures undergoing hemodialysis

Lipid abnormalities are common in patients with renal disease, probably contributing to the high incidence of cardiovascular diseases in this population. In this study we determined the plasma and erythrocyte lipid profile in patients with chronic renal failure (CRF) along 30 months under hemodialysis. In the same patients the influence of cuprophane and polysulphone dialysis membranes on the fatty acid pattern of plasma and erythrocytes, before and after dialysis, was also studied. Fluidity in erythrocyte membranes was also assessed by diphenylhexatriene (DPH) fluorescence polarization measurements. Triglyceride levels were increased in the plasma and in erythrocyte membranes of CRF patients compared to healthy subjects. Plasma polyunsaturared fatty acids decreased whereas palmitic and monounsaturated acids increased in CRF patients. No changes were observed in either the fatty acid profile or DPH fluorescence anisotropy of erythrocyte membranes. The lipid composition abnormalities persisted after 18 months and they became more notorious after 30 months. Neither the plasma nor the erythrocyte membrane lipid pattern changed in CRF patients during the dialysis session, regardless of the dialysis membrane used. We conclude that CRF patients under regular hemodialysis evidence a gradual deteriorarion in the fatty acid and triglyceride abnormalities, a finding that might be relevant to the risk of cardiovascular disease in this setting.

Significación clínico-epidemiológica de la hepatotoxicidad por fármacos en la consulta hepatológica / Clinic-epidemiological significance of the hepatotoxicity by pharmaceutical preparations in the liver consultation

Se analizaron los datos epidemiológicos y clínico-evolutivos de la hepatotoxicidad por fármacos en una experiencia de 10 años (1988-1998) de nuestra Unidad de Hígado, que incluye 10342 historias clínicas de registro prospectivo. La prevalencia en este material fué de 5,6 por ciento, con ligero predominio femenino (1.4:1) y en mayores de 40 años; más del 50 por ciento ingirieron 2 o más fármacos. Predominaron las formas agudas (91.4 por ciento) e ictéricas (60.4 por ciento) con manifestaciones sistémicas de hipersensibilidad en 29.3 por ciento, el 4.5 por ciento de las formas agudas se presentaron como fallo hepático agudo severo, con necesidad de transplante hepático en un caso. los 4 casos de hepatitis crónica presentaron evolución a la cirrosis en un caso, y un caso de colestasis con ductopenia (CBP-simil) evolucionó favorablemente en 19 semanas, recibiendo ácido ursode-soxicólico 10 mg/k/día. Seis fármacos representaron el 53.4 por ciento de los casos: anticonceptivos orales, isoniacida, sulfamidas, clorpropamida, carbamacepina y amiodarona.

Pacientes em quimioterapia anti-hansênica: problemas nasais / Patients with Hansen's disease during the course of drug treatement: nasal problems

Objetivando identificar os problemas nasais de pacientes hansenianos em tratamento medicamentoso específico, realizamos este trabalho junto a 50 portadores desta doença, internados no Instituto "Lauro de Sousa Lima". Levantamos as variáveis:- sexo, idade, forma clínica da hanseníase, período provável de evoluçäo da moléstia, tempo de terapêutica, droga utilizada, regularidade na ingestäo dos medicamentos e resultado da baciloscopia. Através de entrevista, obtivemos informaçöes a respeito dos problemas nasais anteriores a terapia sistêmica e os percebidos atualmente. Pelo exame do nariz com espéculo nasal, identificamos os comprometimentos da porçäo anterior das narinas. Analisando os resultados, percebemos que 98 por cento dos pacientes examinados apresentavam algum tipo de problema nasal, independente de qualquer das variáveis levantadas. A amostra estudada era predominantemente do sexo masculino, com idade média de 52,2 anos, tempo médio de doença 18,7 anos, e tempo médio de tratamento de 16,9 anos. Em relaçäo à forma clínica, 68 por cento eram virchowianos, 18 por cento tuberculóides e 14 por cento dimorfos. Estavam em tratamento monoterápico com sulfona 88 por cento e 4 por cento recebiam as medicaçöes do Esquema 1; 4 por cento do Esquema 3; também 4 por cento recebiam, além da sulfona, droga experimental. Quanto à baciloscopia, 20 por cento tinham resultados laboratoriais indicando positividade e, em 22 por cento dos prontuários clínicos näo foi encontrado resultado deste exame. A ingestäo da quimioterapia anti-hansênica foi relatada como irregular por 38 por cento dos entrevistados. Tinham conhecimento de que a hanseníase pode comprometer o nariz 68 por cento dos pacientes, enquanto que 8 por cento ignoravam e 24 por cento negavam esta possibilidade. Poucos pacientes referiram pertubaçöes nasais anteriores ao início do tratamento. Os achados na rinoscopia anterior, foram semelhantes aos mencionados durante a entrevista. Os problemas nasais mais frequentes foram: presença de crostas e secreçöes, palidez e ressecamento da mucosa nasal, atrofia do corneto inferior, perfuraçäo de septo, desabamento da pirâmide nasal, cicatrizes e fetidez. Concluimos que, mesmo na vigência da terapêutica medicamentosa, todo hanseniano deveria ter seu nariz examinado para aquilatar a necessidade da adequaçäo de cuidados locais.

Dermatosis ampollar cronica benigna del nino. Estudio clinico e inmunofluorescente de 6 casos. / Chronic benign bullous dermatosis of children Clinical and immunofluorescent study in 6 cases

La dermatosis ampollar cronica benigna del nino es una entidad caracterizada por la presencia de ampollas tensas, aisladas o agrupadas en forma de "roseta", que se localiza preferentemente en la zona pelviana pudiendo afectar otros sectores. La evolucion es benigna, con curacion en 2 o 3 anos. Fueron estudiados 6 casos en los cuales se destaca el predominio del sexo masculino (5/1) y algunas localizaciones poco frecuentes, como cuero cabelludo, orejas, manos, pies y mucosa lingual. La evolucion se efectuo por brotes, curando en el lapso de 3 a 41 meses, coincidiendo con la mayoria de los casos relatados.Desde el punto de vista histopatologico se observo una formacion ampollar dermoepidermica semejante a penfigoide ampollar en 3 casos y compatible com dermatitis herpetiformes en 2 de ellos. Los hallazgos de inmunofluorescencia directa no fueron constantes; en 2 casos se demostro deposito de IgA lineal en la zona de la union dermoepidermica, en otros 3 los resultados fueron negativos. En ninguno se pudo evidenciar anticuerpos circulantes con inmunofluorescencia