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Arquivos Brasileiros De Cardiologia | 2009

Cardiovascular health of the brazilian male: the view of the Brazilian Society of Cardiology

Antonio Carlos Palandri Chagas; Emilio César Zilli; Joäo Fernando Monteiro Ferreira; Miguel Antonio Moretti; Rui Fernando Ramos

Correspondencia: Antonio Carlos Palandri Chagas• Avenida Marechal Câmara, 160/330, Centro 20020-907, Rio de Janeiro, RJ Brasil E-mail: [email protected] Articulo recibido el 08/12/09; revisado recibido el 08/12/09; aceptado el 08/12/09. La comprension de los mecanismos de la enfermedad ha llevado la medicina a desarrollar intensamente nuevas estrategias terapeuticas en las ultimas decadas, estrategias basadas principalmente en intervencion. Sin embargo, estas indiscutibles conquistas en mortalidad y calidad de vida no llegan a promover la curacion o remision completa de los sintomas de la enfermedad, y se acompanan de significativo aumento de los costes de la salud, lo que convierte en universal el problema del financiamiento de la salud, que alcanza incluso a los paises mas ricos. Estas cuestiones mueven de forma intensa la medicina del siglo XXI hacia la busqueda de una nueva estrategia de encarar el padecimiento del varon, y volver a tener como enfoque principal la prevencion de las enfermedades, en lugar de aguardarlas y tratarlas tras su instalacion. Este camino esta volviendose irreversible, como puede se ejemplifica por conferencia impartida por el profesor Eugene Braunwald, en el ultimo congreso europeo de cardiologia, en la ciudad de Barcelona. Dr. Braunwald participo en el simposio “Futuro de la cardiologia como especialidad” y impartio la conferencia “Cardiologia como profesion en 2020 y ademas”, en la que enfoco su presentacion en los aspectos de la prevencion como el mejor camino para el abordaje de enfermedad cardiovascular, y actitud prioritaria de los cardiologos en el proximo siglo.The comprehension of the mechanisms of disease has led Medicine to intensely develop new therapeutic strategies in the last decades, strategies based mainly on intervention. However, these indisputable achievements in mortality and quality of life have not promoted the cure or complete remission of the disease symptoms and have been accompanied by a significant increase in healthcare costs that affect even the wealthier countries. These questions are setting the Medicine of the XXI century in motion toward the search for a new strategy to face Man’s sickness and again have as the main focus the prevention of diseases, instead of waiting for the diseases to appear and treat them after they have set in. This path is becoming irreversible, as demonstrated by a lecture given by Professor Eugene Braunwald, at the last European Congress of Cardiology in the city of Barcelona, Spain. Dr. Braunwald participated in the symposium “Future of Cardiology as a Medical Specialty” and presented the lecture “Cardiology as a Profession in 2020 and beyond” and focused his presentation on the aspects of prevention as the best way to approach cardiovascular disease and the cardiologists’ high priority in the next century. The concept of prevention is not new and it is currently being used in our country. The Ministry and State Secretaries of Health have already developed several programs of health promotion that currently reach children and adolescents, women and the elderly. However, some questions have arisen: for which diseases should prevention be prioritized and which population should be the focus?Brazil is rapidly going through a demographic transition, in which the mean age of the population is older. In 2000, approximately 15% of the population (27 million people) was 50 years or older. This percentage should increase to 42% (96 million people) in 2050. The mean age of the Brazilian individual, which in 2000 was 26 years, will be 44 years in 2050. As the population ages, the non-transmissible diseases will result in a burden to the Public Health System, considering that the cost of these diseases already represents half the costs of all hospital admissions in Brazil. These diseases are already responsible for a large and increasing part of the disease burden in Brazil, reaching a percentage of 66%, compared to 24% of transmissible diseases and 10% of wounds. The change in this profile, with a higher burden of non-transmissible diseases is due to the urbanization, improvement in healthcare quality, changes in life style, specific policies and globalization itself, expanding and disseminating technical-scientific knowledge. This burden of non-transmissible diseases is not necessarily an inevitable result of a modern society, but of a harm that can be prevented. For most of these diseases (coronary diseases, strokes, diabetes and several types of cancer), the main cause is not found in genetics, but in modifiable environmental and behavioral risk factors. Among the non-transmissible diseases, the main focus is on the cardiovascular diseases, due to their current morbimortality rate as well as the somber perspectives for the following years. The World Health Organization, in a study that projects a worldwide increase in the morbimortality of cardiovascular diseases, having as basis for this analysis the year 2040, elevates us to the tragic condition of world champions, by estimating that Brazil will reach an incremental rate of 250% when compared to China (200%) and India (180%)


Arquivos Brasileiros De Cardiologia | 2009

Saúde cardiovascular do homem brasileiro: visão da Sociedade Brasileira de Cardiologia

Antonio Carlos Palandri Chagas; Emilio César Zilli; Joäo Fernando Monteiro Ferreira; Miguel Antonio Moretti; Rui Fernando Ramos

Correspondencia: Antonio Carlos Palandri Chagas• Avenida Marechal Câmara, 160/330, Centro 20020-907, Rio de Janeiro, RJ Brasil E-mail: [email protected] Articulo recibido el 08/12/09; revisado recibido el 08/12/09; aceptado el 08/12/09. La comprension de los mecanismos de la enfermedad ha llevado la medicina a desarrollar intensamente nuevas estrategias terapeuticas en las ultimas decadas, estrategias basadas principalmente en intervencion. Sin embargo, estas indiscutibles conquistas en mortalidad y calidad de vida no llegan a promover la curacion o remision completa de los sintomas de la enfermedad, y se acompanan de significativo aumento de los costes de la salud, lo que convierte en universal el problema del financiamiento de la salud, que alcanza incluso a los paises mas ricos. Estas cuestiones mueven de forma intensa la medicina del siglo XXI hacia la busqueda de una nueva estrategia de encarar el padecimiento del varon, y volver a tener como enfoque principal la prevencion de las enfermedades, en lugar de aguardarlas y tratarlas tras su instalacion. Este camino esta volviendose irreversible, como puede se ejemplifica por conferencia impartida por el profesor Eugene Braunwald, en el ultimo congreso europeo de cardiologia, en la ciudad de Barcelona. Dr. Braunwald participo en el simposio “Futuro de la cardiologia como especialidad” y impartio la conferencia “Cardiologia como profesion en 2020 y ademas”, en la que enfoco su presentacion en los aspectos de la prevencion como el mejor camino para el abordaje de enfermedad cardiovascular, y actitud prioritaria de los cardiologos en el proximo siglo.The comprehension of the mechanisms of disease has led Medicine to intensely develop new therapeutic strategies in the last decades, strategies based mainly on intervention. However, these indisputable achievements in mortality and quality of life have not promoted the cure or complete remission of the disease symptoms and have been accompanied by a significant increase in healthcare costs that affect even the wealthier countries. These questions are setting the Medicine of the XXI century in motion toward the search for a new strategy to face Man’s sickness and again have as the main focus the prevention of diseases, instead of waiting for the diseases to appear and treat them after they have set in. This path is becoming irreversible, as demonstrated by a lecture given by Professor Eugene Braunwald, at the last European Congress of Cardiology in the city of Barcelona, Spain. Dr. Braunwald participated in the symposium “Future of Cardiology as a Medical Specialty” and presented the lecture “Cardiology as a Profession in 2020 and beyond” and focused his presentation on the aspects of prevention as the best way to approach cardiovascular disease and the cardiologists’ high priority in the next century. The concept of prevention is not new and it is currently being used in our country. The Ministry and State Secretaries of Health have already developed several programs of health promotion that currently reach children and adolescents, women and the elderly. However, some questions have arisen: for which diseases should prevention be prioritized and which population should be the focus?Brazil is rapidly going through a demographic transition, in which the mean age of the population is older. In 2000, approximately 15% of the population (27 million people) was 50 years or older. This percentage should increase to 42% (96 million people) in 2050. The mean age of the Brazilian individual, which in 2000 was 26 years, will be 44 years in 2050. As the population ages, the non-transmissible diseases will result in a burden to the Public Health System, considering that the cost of these diseases already represents half the costs of all hospital admissions in Brazil. These diseases are already responsible for a large and increasing part of the disease burden in Brazil, reaching a percentage of 66%, compared to 24% of transmissible diseases and 10% of wounds. The change in this profile, with a higher burden of non-transmissible diseases is due to the urbanization, improvement in healthcare quality, changes in life style, specific policies and globalization itself, expanding and disseminating technical-scientific knowledge. This burden of non-transmissible diseases is not necessarily an inevitable result of a modern society, but of a harm that can be prevented. For most of these diseases (coronary diseases, strokes, diabetes and several types of cancer), the main cause is not found in genetics, but in modifiable environmental and behavioral risk factors. Among the non-transmissible diseases, the main focus is on the cardiovascular diseases, due to their current morbimortality rate as well as the somber perspectives for the following years. The World Health Organization, in a study that projects a worldwide increase in the morbimortality of cardiovascular diseases, having as basis for this analysis the year 2040, elevates us to the tragic condition of world champions, by estimating that Brazil will reach an incremental rate of 250% when compared to China (200%) and India (180%)


Arquivos Brasileiros De Cardiologia | 2009

Combination of amlodipine and enalapril in hypertensive patients with coronary disease

Marcos Rienzo; José Francisco Kerr Saraiva; Paulo Roberto Nogueira; Everli Pinheiro de Souza Gonçalves Gomes; Miguel Antonio Moretti; Joäo Fernando Monteiro Ferreira; Antonio de Padua Mansur; José Antonio Franchini Ramires; Luiz Antonio Machado César

FUNDAMENTO: Pacientes (pts) com doenca coronariana (DAC) estavel podem se beneficiar de menor pressao arterial (PA), conforme estudos recentes. OBJETIVO: Avaliar a eficacia e a tolerabilidade da combinacao fixa anlodipino + enalaprila, comparada a anlodipino na normalizacao da PA diastolica (PAD) ( 90 e 110 mmHg durante o wash-out de quatro semanas, em uso so de atenolol. Apos wash-out randomizamos para combinacao (A) ou anlodipino (B) e seguimos de quatro em quatro semanas ate 98 dias. As doses (mg) iniciais foram, respectivamente: A- 2,5/10 e B- 2,5, sendo incrementadas se PAD> 85mmHg, nas visitas. Estatistica com χ2, Fischer e analise de variância, para p< 0,05. RESULTADOS:de 110 pts selecionados, randomizamos 72 (A= 32, B= 40). As reducoes da PAD e da PA sistolica (PAS) foram intensas (p< 0,01), mas sem diferencas entre os grupos em mmHg: PAS, A (127,7 ± 13,4) e B (125,3 ± 12,6) (p= 0,45) e PAD, A (74,5 ± 6,7 mmHg) e B (75,5 ± 6,7 mmHg) (p= 0,32). Houve menos edema de membros inferiores no A (7,1% vs 30,6%, p=0,02) no 98o dia. CONCLUSAO: A combinacao fixa de enalaprila com anlodipino, tal qual anlodipino isolado, em pts com DAC e HAS estagios I e II foi eficaz na normalizacao da pressao, adicionando bloqueio ao sistema renina-angiotensina.BACKGROUND Patients (pts) with stable coronary artery disease (CAD) can benefit from a decrease in the blood pressure (BP), according to recent studies. OBJECTIVE To evaluate the efficacy and tolerability of the fixed combination: amlodipine + enalapril, when compared to amlodipine in the normalization of the diastolic arterial pressure (DAP) (<85 mmHg), in pts with CAD and systemic arterial hypertension (SAH). METHODS Double-blind and randomized study, with two groups of pts with DAP > or =90 and <110 mmHg and CAD. Patients with left ventricular ejection fraction (LVEF) < 40%, symptoms of heart failure or angina class III and IV, severe diseases and DAP > or =110 mmHg during the four-week wash-out with atenolol treatment alone, were excluded. After the wash-out, pts were randomly distributed for the use of the combination (A) or amlodipine (B) and were followed every four weeks up to 98 days. The initial doses (in mg) were, respectively: A- 2.5/10 and B- 2.5; the doses were increased when DAP > 85mmHg, at the visits. Statistical analysis was carried out with chi2, Fischer and analysis of variance, for p< 0.05. RESULTS Of the 110 selected pts, 72 (A= 32, B= 40) were randomized. The decreases in DAP and systolic arterial pressure (SAP) were significant (p< 0.01), but with no difference between the groups in mmHg: SAP, A (127.7 +/- 13.4) and B (125.3 +/- 12.6) (p= 0.45) and DAP, A (74.5 +/- 6.7 mmHg) and B (75.5 +/- 6.7 mmHg) (p= 0.32). Group A presented a lower incidence of lower-limb edema: (7.1% vs 30.6%, p=0.02) on the 98th day of follow-up. CONCLUSION The fixed combination of enalapril and amlodipine, as well as isolated amlodipine, was effective in the normalization of BP in pts with CAD and SAH stages I and II, adding blockage of the renin-angiotensin system.


Arquivos Brasileiros De Cardiologia | 2005

Análise do atendimento intra-hospitalar de eventos simulados de fibrilação ventricular/taquicardia ventricular

Miguel Antonio Moretti; André Moreira Bento; Ana Paula Quilici; Márcia Martins; Luís Francisco Cardoso; Sergio Timerman

OBJECTIVE To analyze the time intervals between the beginning of the Ventricular Fibrilation/Ventricular Taquicardia (VF/VT) and the main procedures made. METHODS Twenty VF/VT simulations were performed and filmed in a hospital environment, using a static mannequin, on random days at random times. All teams had the same level of skills. The times (in sec.) related to basic life support (BLS) - arrival of the team (AT), confirmation of the arrest (CAT), beginning of the CPR (IT) and the times related to the advanced life support (ALS) - 1st defibrillation (DT), 1st dose of adrenalin (AT) and orotracheal intubation (OTIT). The variables were analyzed and compared in two groups: intensive care unit (ICU) and wards with telemetry (TLW). RESULTS The results in both groups was in that order (GW x ICU ) - AT (70.2+38.7 x 38.6+49.2); CCA (89.4+57.1 x 71+63.9); SC (166.8+81.1 x 142+66.2); FD (282.5+142.8 x 108.4+52.5); FE (401.4+161.7 x 263.3+122.8) e OI (470.3+150.6 x 278.8+98.8). Shows the comparison of the average times between the two groups. CONCLUSION The differences noted in relation to DT, AT and OTIT favorable to ICU are associated to the facility of performance of the ALS maneuvers in such environment. The BLS-related times were similar in both groups, which reinforce the need for the use of semi-automatic defibrillators, even in a hospital environment.


Arquivos Brasileiros De Cardiologia | 2010

Análise crítica dos critérios para a avaliação de biossimilares de heparina de baixo peso molecular

Valdair F. Pinto; Miguel Antonio Moretti; Antonio Carlos Palandri Chagas

Biological products; similar/drug effects; heparin, low molecular weight; guidelines; drug evaluation. and hip arthroplasty), as a clinical model of higher sensitivity to detect potential effectiveness differences. The incidence of events in these indications is higher and reasonably well known, which allows a better study planning. It is estimated that in major orthopedic surgeries, the risk of venous thromboembolism without prevention is around 40 to 70%3 and that the use of LMWH decreases this risk by about 60%4. Thus, it can be estimated that in prevention studies in these cases, the incidence of events must be around 15 to 25% and that in these conditions, studies of non-inferiority with a margin of 5 to 10% must require clinical studies with 600 to 1,200 patients. If the expected incidence of events is decreased to, for instance, 5%, as it occurs in low-risk interventions, the sample size necessary for the study, while maintaining the same statistical properties, will be around 3,700 patients.Correspondencia: Valdair F. Pinto • Alameda dos Aicás, 229 04086-000 Indianópolis São Paulo, SP Brasil E-mail: [email protected] Artículo recibido en 30/07/10; revisado recibido en 19/08/10; aceptado en 27/08/10. Palabras clave Productos biológicos, similar/efectos de drogas, heparina de bajo peso molecular, directrices, evaluación de medicamentos. las cirugías ortopédicas de alto riesgo de tromboembolismo (artroplastia de rodilla y cadera), como modelo clínico de mayor sensibilidad para detectar potenciales diferencias de eficacia. La incidencia de eventos en esas indicaciones es más alta y razonablemente bien conocida, lo que permite una mejor planificación del estudio. Se estima que, en cirugías ortopédicas de gran porte, el riesgo de tromboembolismo venoso sin prevención es del orden de 40-70%3 y que el uso de HBPM reduce ese riesgo en cerca de 60%4. Así, se puede estimar que, en estudios de prevención en esos casos, la incidencia de eventos debe ser del orden de 15-25% y que, en esas condiciones, estudios de no inferioridad con un margen de 5-10% deben requerir estudios clínicos con 600 a 1.200 pacientes. Si la incidencia esperada de eventos se reduce a, por ejemplo, 5%, como ocurre en intervenciones de bajo riesgo, el tamaño de la muestra necesaria para el estudio, manteniendo las mismas propiedades estadísticas, será del orden de 3.700 pacientes.


Arquivos Brasileiros De Cardiologia | 2009

Combinação de anlodipino e enalaprila em pacientes hipertensos com doença coronariana

Marcos Rienzo; José Francisco Kerr Saraiva; Paulo Roberto Nogueira; Everli Pinheiro de Souza Gonçalves Gomes; Miguel Antonio Moretti; Joäo Fernando Monteiro Ferreira; Antonio de Padua Mansur; José Antonio Franchini Ramires; Luiz Antonio Machado César

FUNDAMENTO: Pacientes (pts) com doenca coronariana (DAC) estavel podem se beneficiar de menor pressao arterial (PA), conforme estudos recentes. OBJETIVO: Avaliar a eficacia e a tolerabilidade da combinacao fixa anlodipino + enalaprila, comparada a anlodipino na normalizacao da PA diastolica (PAD) ( 90 e 110 mmHg durante o wash-out de quatro semanas, em uso so de atenolol. Apos wash-out randomizamos para combinacao (A) ou anlodipino (B) e seguimos de quatro em quatro semanas ate 98 dias. As doses (mg) iniciais foram, respectivamente: A- 2,5/10 e B- 2,5, sendo incrementadas se PAD> 85mmHg, nas visitas. Estatistica com χ2, Fischer e analise de variância, para p< 0,05. RESULTADOS:de 110 pts selecionados, randomizamos 72 (A= 32, B= 40). As reducoes da PAD e da PA sistolica (PAS) foram intensas (p< 0,01), mas sem diferencas entre os grupos em mmHg: PAS, A (127,7 ± 13,4) e B (125,3 ± 12,6) (p= 0,45) e PAD, A (74,5 ± 6,7 mmHg) e B (75,5 ± 6,7 mmHg) (p= 0,32). Houve menos edema de membros inferiores no A (7,1% vs 30,6%, p=0,02) no 98o dia. CONCLUSAO: A combinacao fixa de enalaprila com anlodipino, tal qual anlodipino isolado, em pts com DAC e HAS estagios I e II foi eficaz na normalizacao da pressao, adicionando bloqueio ao sistema renina-angiotensina.BACKGROUND Patients (pts) with stable coronary artery disease (CAD) can benefit from a decrease in the blood pressure (BP), according to recent studies. OBJECTIVE To evaluate the efficacy and tolerability of the fixed combination: amlodipine + enalapril, when compared to amlodipine in the normalization of the diastolic arterial pressure (DAP) (<85 mmHg), in pts with CAD and systemic arterial hypertension (SAH). METHODS Double-blind and randomized study, with two groups of pts with DAP > or =90 and <110 mmHg and CAD. Patients with left ventricular ejection fraction (LVEF) < 40%, symptoms of heart failure or angina class III and IV, severe diseases and DAP > or =110 mmHg during the four-week wash-out with atenolol treatment alone, were excluded. After the wash-out, pts were randomly distributed for the use of the combination (A) or amlodipine (B) and were followed every four weeks up to 98 days. The initial doses (in mg) were, respectively: A- 2.5/10 and B- 2.5; the doses were increased when DAP > 85mmHg, at the visits. Statistical analysis was carried out with chi2, Fischer and analysis of variance, for p< 0.05. RESULTS Of the 110 selected pts, 72 (A= 32, B= 40) were randomized. The decreases in DAP and systolic arterial pressure (SAP) were significant (p< 0.01), but with no difference between the groups in mmHg: SAP, A (127.7 +/- 13.4) and B (125.3 +/- 12.6) (p= 0.45) and DAP, A (74.5 +/- 6.7 mmHg) and B (75.5 +/- 6.7 mmHg) (p= 0.32). Group A presented a lower incidence of lower-limb edema: (7.1% vs 30.6%, p=0.02) on the 98th day of follow-up. CONCLUSION The fixed combination of enalapril and amlodipine, as well as isolated amlodipine, was effective in the normalization of BP in pts with CAD and SAH stages I and II, adding blockage of the renin-angiotensin system.


Arquivos Brasileiros De Cardiologia | 2010

Critical analysis of criteria for the evaluation of low-molecular weight heparin biosimilars

Valdair F. Pinto; Miguel Antonio Moretti; Antonio Carlos Palandri Chagas

Biological products; similar/drug effects; heparin, low molecular weight; guidelines; drug evaluation. and hip arthroplasty), as a clinical model of higher sensitivity to detect potential effectiveness differences. The incidence of events in these indications is higher and reasonably well known, which allows a better study planning. It is estimated that in major orthopedic surgeries, the risk of venous thromboembolism without prevention is around 40 to 70%3 and that the use of LMWH decreases this risk by about 60%4. Thus, it can be estimated that in prevention studies in these cases, the incidence of events must be around 15 to 25% and that in these conditions, studies of non-inferiority with a margin of 5 to 10% must require clinical studies with 600 to 1,200 patients. If the expected incidence of events is decreased to, for instance, 5%, as it occurs in low-risk interventions, the sample size necessary for the study, while maintaining the same statistical properties, will be around 3,700 patients.Correspondencia: Valdair F. Pinto • Alameda dos Aicás, 229 04086-000 Indianópolis São Paulo, SP Brasil E-mail: [email protected] Artículo recibido en 30/07/10; revisado recibido en 19/08/10; aceptado en 27/08/10. Palabras clave Productos biológicos, similar/efectos de drogas, heparina de bajo peso molecular, directrices, evaluación de medicamentos. las cirugías ortopédicas de alto riesgo de tromboembolismo (artroplastia de rodilla y cadera), como modelo clínico de mayor sensibilidad para detectar potenciales diferencias de eficacia. La incidencia de eventos en esas indicaciones es más alta y razonablemente bien conocida, lo que permite una mejor planificación del estudio. Se estima que, en cirugías ortopédicas de gran porte, el riesgo de tromboembolismo venoso sin prevención es del orden de 40-70%3 y que el uso de HBPM reduce ese riesgo en cerca de 60%4. Así, se puede estimar que, en estudios de prevención en esos casos, la incidencia de eventos debe ser del orden de 15-25% y que, en esas condiciones, estudios de no inferioridad con un margen de 5-10% deben requerir estudios clínicos con 600 a 1.200 pacientes. Si la incidencia esperada de eventos se reduce a, por ejemplo, 5%, como ocurre en intervenciones de bajo riesgo, el tamaño de la muestra necesaria para el estudio, manteniendo las mismas propiedades estadísticas, será del orden de 3.700 pacientes.


Arquivos Brasileiros De Cardiologia | 2010

Análisis crítico de los criterios para la evaluación de biosimilares de heparina de bajo peso molecular

Valdair F. Pinto; Miguel Antonio Moretti; Antonio Carlos Palandri Chagas

Biological products; similar/drug effects; heparin, low molecular weight; guidelines; drug evaluation. and hip arthroplasty), as a clinical model of higher sensitivity to detect potential effectiveness differences. The incidence of events in these indications is higher and reasonably well known, which allows a better study planning. It is estimated that in major orthopedic surgeries, the risk of venous thromboembolism without prevention is around 40 to 70%3 and that the use of LMWH decreases this risk by about 60%4. Thus, it can be estimated that in prevention studies in these cases, the incidence of events must be around 15 to 25% and that in these conditions, studies of non-inferiority with a margin of 5 to 10% must require clinical studies with 600 to 1,200 patients. If the expected incidence of events is decreased to, for instance, 5%, as it occurs in low-risk interventions, the sample size necessary for the study, while maintaining the same statistical properties, will be around 3,700 patients.Correspondencia: Valdair F. Pinto • Alameda dos Aicás, 229 04086-000 Indianópolis São Paulo, SP Brasil E-mail: [email protected] Artículo recibido en 30/07/10; revisado recibido en 19/08/10; aceptado en 27/08/10. Palabras clave Productos biológicos, similar/efectos de drogas, heparina de bajo peso molecular, directrices, evaluación de medicamentos. las cirugías ortopédicas de alto riesgo de tromboembolismo (artroplastia de rodilla y cadera), como modelo clínico de mayor sensibilidad para detectar potenciales diferencias de eficacia. La incidencia de eventos en esas indicaciones es más alta y razonablemente bien conocida, lo que permite una mejor planificación del estudio. Se estima que, en cirugías ortopédicas de gran porte, el riesgo de tromboembolismo venoso sin prevención es del orden de 40-70%3 y que el uso de HBPM reduce ese riesgo en cerca de 60%4. Así, se puede estimar que, en estudios de prevención en esos casos, la incidencia de eventos debe ser del orden de 15-25% y que, en esas condiciones, estudios de no inferioridad con un margen de 5-10% deben requerir estudios clínicos con 600 a 1.200 pacientes. Si la incidencia esperada de eventos se reduce a, por ejemplo, 5%, como ocurre en intervenciones de bajo riesgo, el tamaño de la muestra necesaria para el estudio, manteniendo las mismas propiedades estadísticas, será del orden de 3.700 pacientes.


Arquivos Brasileiros De Cardiologia | 2009

Combinación de amlodipino y enalapril en pacientes hipertensos con enfermedad coronaria

Marcos Rienzo; José Francisco Kerr Saraiva; Paulo Roberto Nogueira; Everli Pinheiro de Souza Gonçalves Gomes; Miguel Antonio Moretti; Joäo Fernando Monteiro Ferreira; Antonio de Padua Mansur; José Antonio Franchini Ramires; Luiz Antonio Machado César

FUNDAMENTO: Pacientes (pts) com doenca coronariana (DAC) estavel podem se beneficiar de menor pressao arterial (PA), conforme estudos recentes. OBJETIVO: Avaliar a eficacia e a tolerabilidade da combinacao fixa anlodipino + enalaprila, comparada a anlodipino na normalizacao da PA diastolica (PAD) ( 90 e 110 mmHg durante o wash-out de quatro semanas, em uso so de atenolol. Apos wash-out randomizamos para combinacao (A) ou anlodipino (B) e seguimos de quatro em quatro semanas ate 98 dias. As doses (mg) iniciais foram, respectivamente: A- 2,5/10 e B- 2,5, sendo incrementadas se PAD> 85mmHg, nas visitas. Estatistica com χ2, Fischer e analise de variância, para p< 0,05. RESULTADOS:de 110 pts selecionados, randomizamos 72 (A= 32, B= 40). As reducoes da PAD e da PA sistolica (PAS) foram intensas (p< 0,01), mas sem diferencas entre os grupos em mmHg: PAS, A (127,7 ± 13,4) e B (125,3 ± 12,6) (p= 0,45) e PAD, A (74,5 ± 6,7 mmHg) e B (75,5 ± 6,7 mmHg) (p= 0,32). Houve menos edema de membros inferiores no A (7,1% vs 30,6%, p=0,02) no 98o dia. CONCLUSAO: A combinacao fixa de enalaprila com anlodipino, tal qual anlodipino isolado, em pts com DAC e HAS estagios I e II foi eficaz na normalizacao da pressao, adicionando bloqueio ao sistema renina-angiotensina.BACKGROUND Patients (pts) with stable coronary artery disease (CAD) can benefit from a decrease in the blood pressure (BP), according to recent studies. OBJECTIVE To evaluate the efficacy and tolerability of the fixed combination: amlodipine + enalapril, when compared to amlodipine in the normalization of the diastolic arterial pressure (DAP) (<85 mmHg), in pts with CAD and systemic arterial hypertension (SAH). METHODS Double-blind and randomized study, with two groups of pts with DAP > or =90 and <110 mmHg and CAD. Patients with left ventricular ejection fraction (LVEF) < 40%, symptoms of heart failure or angina class III and IV, severe diseases and DAP > or =110 mmHg during the four-week wash-out with atenolol treatment alone, were excluded. After the wash-out, pts were randomly distributed for the use of the combination (A) or amlodipine (B) and were followed every four weeks up to 98 days. The initial doses (in mg) were, respectively: A- 2.5/10 and B- 2.5; the doses were increased when DAP > 85mmHg, at the visits. Statistical analysis was carried out with chi2, Fischer and analysis of variance, for p< 0.05. RESULTS Of the 110 selected pts, 72 (A= 32, B= 40) were randomized. The decreases in DAP and systolic arterial pressure (SAP) were significant (p< 0.01), but with no difference between the groups in mmHg: SAP, A (127.7 +/- 13.4) and B (125.3 +/- 12.6) (p= 0.45) and DAP, A (74.5 +/- 6.7 mmHg) and B (75.5 +/- 6.7 mmHg) (p= 0.32). Group A presented a lower incidence of lower-limb edema: (7.1% vs 30.6%, p=0.02) on the 98th day of follow-up. CONCLUSION The fixed combination of enalapril and amlodipine, as well as isolated amlodipine, was effective in the normalization of BP in pts with CAD and SAH stages I and II, adding blockage of the renin-angiotensin system.


Arquivos Brasileiros De Cardiologia | 2009

Salud cardiovascular del varón brasileño: una mirada de la Sociedad Brasileña de Cardiología

Antonio Carlos Palandri Chagas; Emilio César Zilli; Joäo Fernando Monteiro Ferreira; Miguel Antonio Moretti; Rui Fernando Ramos

Correspondencia: Antonio Carlos Palandri Chagas• Avenida Marechal Câmara, 160/330, Centro 20020-907, Rio de Janeiro, RJ Brasil E-mail: [email protected] Articulo recibido el 08/12/09; revisado recibido el 08/12/09; aceptado el 08/12/09. La comprension de los mecanismos de la enfermedad ha llevado la medicina a desarrollar intensamente nuevas estrategias terapeuticas en las ultimas decadas, estrategias basadas principalmente en intervencion. Sin embargo, estas indiscutibles conquistas en mortalidad y calidad de vida no llegan a promover la curacion o remision completa de los sintomas de la enfermedad, y se acompanan de significativo aumento de los costes de la salud, lo que convierte en universal el problema del financiamiento de la salud, que alcanza incluso a los paises mas ricos. Estas cuestiones mueven de forma intensa la medicina del siglo XXI hacia la busqueda de una nueva estrategia de encarar el padecimiento del varon, y volver a tener como enfoque principal la prevencion de las enfermedades, en lugar de aguardarlas y tratarlas tras su instalacion. Este camino esta volviendose irreversible, como puede se ejemplifica por conferencia impartida por el profesor Eugene Braunwald, en el ultimo congreso europeo de cardiologia, en la ciudad de Barcelona. Dr. Braunwald participo en el simposio “Futuro de la cardiologia como especialidad” y impartio la conferencia “Cardiologia como profesion en 2020 y ademas”, en la que enfoco su presentacion en los aspectos de la prevencion como el mejor camino para el abordaje de enfermedad cardiovascular, y actitud prioritaria de los cardiologos en el proximo siglo.The comprehension of the mechanisms of disease has led Medicine to intensely develop new therapeutic strategies in the last decades, strategies based mainly on intervention. However, these indisputable achievements in mortality and quality of life have not promoted the cure or complete remission of the disease symptoms and have been accompanied by a significant increase in healthcare costs that affect even the wealthier countries. These questions are setting the Medicine of the XXI century in motion toward the search for a new strategy to face Man’s sickness and again have as the main focus the prevention of diseases, instead of waiting for the diseases to appear and treat them after they have set in. This path is becoming irreversible, as demonstrated by a lecture given by Professor Eugene Braunwald, at the last European Congress of Cardiology in the city of Barcelona, Spain. Dr. Braunwald participated in the symposium “Future of Cardiology as a Medical Specialty” and presented the lecture “Cardiology as a Profession in 2020 and beyond” and focused his presentation on the aspects of prevention as the best way to approach cardiovascular disease and the cardiologists’ high priority in the next century. The concept of prevention is not new and it is currently being used in our country. The Ministry and State Secretaries of Health have already developed several programs of health promotion that currently reach children and adolescents, women and the elderly. However, some questions have arisen: for which diseases should prevention be prioritized and which population should be the focus?Brazil is rapidly going through a demographic transition, in which the mean age of the population is older. In 2000, approximately 15% of the population (27 million people) was 50 years or older. This percentage should increase to 42% (96 million people) in 2050. The mean age of the Brazilian individual, which in 2000 was 26 years, will be 44 years in 2050. As the population ages, the non-transmissible diseases will result in a burden to the Public Health System, considering that the cost of these diseases already represents half the costs of all hospital admissions in Brazil. These diseases are already responsible for a large and increasing part of the disease burden in Brazil, reaching a percentage of 66%, compared to 24% of transmissible diseases and 10% of wounds. The change in this profile, with a higher burden of non-transmissible diseases is due to the urbanization, improvement in healthcare quality, changes in life style, specific policies and globalization itself, expanding and disseminating technical-scientific knowledge. This burden of non-transmissible diseases is not necessarily an inevitable result of a modern society, but of a harm that can be prevented. For most of these diseases (coronary diseases, strokes, diabetes and several types of cancer), the main cause is not found in genetics, but in modifiable environmental and behavioral risk factors. Among the non-transmissible diseases, the main focus is on the cardiovascular diseases, due to their current morbimortality rate as well as the somber perspectives for the following years. The World Health Organization, in a study that projects a worldwide increase in the morbimortality of cardiovascular diseases, having as basis for this analysis the year 2040, elevates us to the tragic condition of world champions, by estimating that Brazil will reach an incremental rate of 250% when compared to China (200%) and India (180%)

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Dive into the Miguel Antonio Moretti's collaboration.

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José Francisco Kerr Saraiva

Pontifícia Universidade Católica de Campinas

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Marcos Rienzo

University of São Paulo

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Paulo Roberto Nogueira

Faculdade de Medicina de São José do Rio Preto

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