RESUMO
BACKGROUND: The risk of cardiovascular mortality is higher among black women than white women, and the reasons for this disparity are largely unexplored. We sought to evaluate differences in medical care and clinical outcomes among black and white women with established coronary artery disease. METHODS AND RESULTS: Among the 2699 women enrolled in the Heart and Estrogen/progestin Replacement Study (HERS), we used Cox proportional hazards models to determine the association of race with risk of coronary heart disease (CHD) events independent of major cardiovascular risk factors or medical therapies. During an average of 4.1 years of follow-up, CHD events were twice as likely in black compared with white women (6.4 versus 3.1 per 100 person-years, hazard ratio, 2.1; 95% confidence interval, 1.5 to 2.8; P<0.001). Black women had higher rates of hypertension, diabetes, and hypercholesterolemia, yet were less likely to receive aspirin or statins. Black women less often had optimal blood pressure (56% versus 63%; P=0.01) and LDL cholesterol (30% versus 38%; P=0.04) control at baseline and during follow-up. After adjusting for these and other differences, black women still had >50% higher CHD event risk (hazard ratio, 1.52; 95% confidence interval, 1.1 to 2.1; P=0.03). CONCLUSIONS: In a large cohort of women with heart disease, black women less often received appropriate preventive therapy and adequate risk factor control despite a greater CHD event risk. Interventions to improve appropriate therapy and risk factor control in all women, and especially black women, are needed.
Assuntos
Negro ou Afro-Americano , Doença das Coronárias/etnologia , Atenção à Saúde , Avaliação de Resultados em Cuidados de Saúde , Grupos Raciais , População Branca , Idoso , Estudos de Coortes , Doença da Artéria Coronariana/terapia , Doença das Coronárias/epidemiologia , Doença das Coronárias/prevenção & controle , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Modelos de Riscos Proporcionais , Fatores de RiscoRESUMO
BACKGROUND: Although effects of statins on cardiovascular outcomes are well established in men, fewer data exist for women. Furthermore, the effects of statins plus hormone replacement therapy (HRT) on cardiovascular outcomes are uncertain. METHODS AND RESULTS: We examined statin use, cardiovascular events, and total mortality in the Heart and Estrogen/progestin Replacement Study (HERS), a randomized clinical trial of estrogen plus progestin versus placebo in postmenopausal women with heart disease (n=2763). A nonrandomized comparison of statin users and nonusers revealed lower rates of the primary outcome, nonfatal myocardial infarction or coronary heart disease death (relative hazard [RH]=0.79, 95% confidence intervals [CI] 0.63 to 0.99, P=0.04), and total mortality (RH=0.67, 95% CI 0.51 to 0.87, P=0.003). Rates of venous thromboembolic events were also lower among statin users (RH=0.45, 95% CI 0.23 to 0.88, P=0.02). HRT resulted in a significant increase in early risk for primary events in women who did not use statins (RH=1.75, 95% CI 1.02 to 3.03, P=0.04) but not in statin users (RH=1.34, 95% CI 0.63 to 2.86, P=0.45). Adjustment for postrandomization statin use showed no effect of HRT on risk for the primary outcome (RH=0.96, 95% CI 0.77 to 1.29; P=0.72). CONCLUSIONS: In HERS, statin use was associated with lower rates of cardiovascular events, venous thromboembolic events, and total mortality. These data provide strong support for statin use in eligible women with coronary disease.
Assuntos
Doenças Cardiovasculares/prevenção & controle , Doença das Coronárias/tratamento farmacológico , Doença das Coronárias/mortalidade , Terapia de Reposição de Estrogênios , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Idoso , Interações Medicamentosas , Estrogênios Conjugados (USP)/uso terapêutico , Feminino , Seguimentos , Humanos , Acetato de Medroxiprogesterona/uso terapêutico , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Pós-Menopausa , Tromboembolia/epidemiologia , Tromboembolia/prevenção & controleRESUMO
The Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program issued an evidence-based set of guidelines on cholesterol management in 2001. Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published. These trials addressed issues that were not examined in previous clinical trials of cholesterol-lowering therapy. The present document reviews the results of these recent trials and assesses their implications for cholesterol management. Therapeutic lifestyle changes (TLC) remain an essential modality in clinical management. The trials confirm the benefit of cholesterol-lowering therapy in high-risk patients and support the ATP III treatment goal of low-density lipoprotein cholesterol (LDL-C) <100 mg/dL. They support the inclusion of patients with diabetes in the high-risk category and confirm the benefits of LDL-lowering therapy in these patients. They further confirm that older persons benefit from therapeutic lowering of LDL-C. The major recommendations for modifications to footnote the ATP III treatment algorithm are the following. In high-risk persons, the recommended LDL-C goal is <100 mg/dL, but when risk is very high, an LDL-C goal of <70 mg/dL is a therapeutic option, ie, a reasonable clinical strategy, on the basis of available clinical trial evidence. This therapeutic option extends also to patients at very high risk who have a baseline LDL-C <100 mg/dL. Moreover, when a high-risk patient has high triglycerides or low high-density lipoprotein cholesterol (HDL-C), consideration can be given to combining a fibrate or nicotinic acid with an LDL-lowering drug. For moderately high-risk persons (2+ risk factors and 10-year risk 10% to 20%), the recommended LDL-C goal is <130 mg/dL, but an LDL-C goal <100 mg/dL is a therapeutic option on the basis of recent trial evidence. The latter option extends also to moderately high-risk persons with a baseline LDL-C of 100 to 129 mg/dL. When LDL-lowering drug therapy is employed in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30% to 40% reduction in LDL-C levels. Moreover, any person at high risk or moderately high risk who has lifestyle-related risk factors (eg, obesity, physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level. Finally, for people in lower-risk categories, recent clinical trials do not modify the goals and cutpoints of therapy.
Assuntos
Anticolesterolemiantes/uso terapêutico , Hipercolesterolemia/prevenção & controle , Guias de Prática Clínica como Assunto , Idoso , Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , LDL-Colesterol/sangue , Ensaios Clínicos como Assunto/estatística & dados numéricos , Comorbidade , Diabetes Mellitus/epidemiologia , Medicina Baseada em Evidências , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/epidemiologia , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipolipemiantes/uso terapêutico , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Educação de Pacientes como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Risco , Fatores de Risco , Terapia TrombolíticaRESUMO
OBJECTIVES: This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings. BACKGROUND: Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a "real-world" setting. METHODS: A total of 2,442 CHD patients with hyperlipidemia were randomized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average. Atorvastatin-group patients were titrated to LDL-C goals of <80 mg/dl (2.1 mmol/l) or a maximum atorvastatin dose of 80 mg/day. Usual-care patients received any treatment deemed appropriate by their regular physicians. End point assessments were complete in 958 atorvastatin-group and 941 usual-care patients. Partial assessments occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss. The primary efficacy parameter was time to first cardiovascular event. RESULTS: A total of 289 (23.7%) patients in the atorvastatin group compared with 333 (27.7%) patients in the usual care group experienced a primary outcome (hazard ratio, 0.83; 95% confidence interval 0.71 to 0.97, p = 0.02). This reduction in morbidity was largely due to fewer non-fatal myocardial infarctions (4.3% vs. 7.7%, p = 0.0002). Levels of LDL-C were reduced more (34.3% vs. 23.3%, p < 0.0001) and National Cholesterol Education Program goals (LDL-C <100 mg/dl) more likely met at end-of-study visits (72.4% vs. 40.0%) in patients receiving atorvastatin compared with those receiving usual care. CONCLUSIONS: An aggressive, focused statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD.
Assuntos
Instituições de Assistência Ambulatorial , Doença das Coronárias/terapia , Hipolipemiantes/uso terapêutico , Programas de Assistência Gerenciada , Adulto , Idoso , Atorvastatina , Biomarcadores/sangue , HDL-Colesterol/sangue , HDL-Colesterol/efeitos dos fármacos , LDL-Colesterol/sangue , LDL-Colesterol/efeitos dos fármacos , Gerenciamento Clínico , Feminino , Seguimentos , Ácidos Heptanoicos/efeitos adversos , Ácidos Heptanoicos/uso terapêutico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/tratamento farmacológico , Hipolipemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pirróis/efeitos adversos , Pirróis/uso terapêutico , Fatores de Tempo , Resultado do Tratamento , Triglicerídeos/sangue , Estados Unidos/epidemiologiaRESUMO
The Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program issued an evidence-based set of guidelines on cholesterol management in 2001. Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published. These trials addressed issues that were not examined in previous clinical trials of cholesterol-lowering therapy. The present document reviews the results of these recent trials and assesses their implications for cholesterol management. Therapeutic lifestyle changes (TLC) remain an essential modality in clinical management. The trials confirm the benefit of cholesterol-lowering therapy in high-risk patients and support the ATP III treatment goal of low-density lipoprotein cholesterol (LDL-C) <100 mg/dL. They support the inclusion of patients with diabetes in the high-risk category and confirm the benefits of LDL-lowering therapy in these patients. They further confirm that older persons benefit from therapeutic lowering of LDL-C. The major recommendations for modifications to footnote the ATP III treatment algorithm are the following. In high-risk persons, the recommended LDL-C goal is <100 mg/dL, but when risk is very high, an LDL-C goal of <70 mg/dL is a therapeutic option, ie, a reasonable clinical strategy, on the basis of available clinical trial evidence. This therapeutic option extends also to patients at very high risk who have a baseline LDL-C < 100 mg/dL. Moreover, when a high-risk patient has high triglycerides or low high-density lipoprotein cholesterol (HDL-C), consideration can be given to combining a fibrate or nicotinic acid with an LDL-lowering drug. For moderately high-risk persons (2+ risk factors and 10-year risk 10% to 20%), the recommended LDL-C goal is <130 mg/dL, but an LDL-C goal <100 mg/dL is a therapeutic option on the basis of recent trial evidence. The latter option extends also to moderately high-risk persons with a baseline LDL-C of 100 to 129 mg/dL. When LDL-lowering drug therapy is employed in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30% to 40% reduction in LDL-C levels. Moreover, any person at high risk or moderately high risk who has lifestyle-related risk factors (eg, obesity, physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level. Finally, for people in lower-risk categories, recent clinical trials do not modify the goals and cutpoints of therapy.
Assuntos
Anticolesterolemiantes/uso terapêutico , Hipercolesterolemia/prevenção & controle , Guias de Prática Clínica como Assunto , Idoso , Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , LDL-Colesterol/sangue , Ensaios Clínicos como Assunto/estatística & dados numéricos , Comorbidade , Diabetes Mellitus/epidemiologia , Medicina Baseada em Evidências , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/epidemiologia , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipolipemiantes/uso terapêutico , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Educação de Pacientes como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Risco , Fatores de Risco , Terapia TrombolíticaRESUMO
The metabolic syndrome (MS) is a constellation of coronary risk factors. Atherogenic dyslipidemia is an important factor in cardiovascular risk in these patients, and treatment of atherogenic dyslipidemia has been identified as an important goal of therapy in patients with MS. This post hoc analysis of data from a 6-week, randomized, open-label, parallel-group, comparative trial (Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin [STELLAR]) assessed the effects of rosuvastatin 10, 20, and 40 mg, atorvastatin 10, 20, 40, and 80 mg, simvastatin 10, 20, 40, and 80 mg, and pravastatin 10, 20, and 40 mg on plasma lipids in hypercholesterolemic patients (low-density lipoprotein cholesterol >/=160 and <250 mg/dl; triglycerides <400 mg/dl) who had >/=3 of the 5 National Cholesterol Education Program Adult Treatment Panel III criteria for MS (body mass index >30 kg/m(2) substituted for waist circumference). Of 2,268 patients, 811 met criteria for MS. Percent reductions in low-density lipoprotein cholesterol ranged from 20% in the pravastatin 10-mg group to 55% in the rosuvastatin 40-mg group. In patients with MS, triglyceride reductions were 22% to 34% with rosuvastatin, 23% to 33% with atorvastatin, 15% to 23% with simvastatin, and 12% to 15% with pravastatin. High-density lipoprotein cholesterol increased by 8% to 11% with rosuvastatin, 5% to 9% with atorvastatin, 8% to 10% with simvastatin, and 3% to 7% with pravastatin. Rosuvastatin, atorvastatin, simvastatin, and pravastatin treatment had favorable effects in hypercholesterolemic patients on the atherogenic dyslipidemia associated with MS. Rosuvastatin had the most favorable effect on the atherogenic lipid profile of MS overall.
Assuntos
Arteriosclerose/complicações , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/tratamento farmacológico , Síndrome Metabólica/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Atorvastatina , Feminino , Fluorbenzenos/uso terapêutico , Ácidos Heptanoicos/uso terapêutico , Humanos , Hiperlipidemias/etiologia , Masculino , Pessoa de Meia-Idade , Pravastatina/uso terapêutico , Pirimidinas/uso terapêutico , Pirróis/uso terapêutico , Rosuvastatina Cálcica , Sinvastatina/uso terapêutico , Sulfonamidas/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVE: The Heart and Estrogen/Progestin Replacement Study (HERS) found no overall effect of estrogen plus progestin (compared with placebo) on coronary event rates in 2763 postmenopausal women with established coronary disease (mean 4.1 years of follow-up). In addition to the events trial, a carotid ultrasound substudy was established in 1993 to be conducted concurrently to determine whether hormone therapy affects the progression of the underlying atherosclerotic process. METHODS AND RESULTS: Within the larger HERS, a subset of 362 participants underwent carotid B-mode ultrasound examinations at baseline and the end of follow-up. Progression of carotid atherosclerosis was measured as the temporal change in intimal-medial thickness (IMT). CONCLUSIONS: IMT progressed in the hormone treatment and placebo groups, although there was no statistical difference between the rates: IMT progressed 26 microm/y (95% CI 18 to 34 microm/y) in the hormone group and 31 microm/y (95% CI 21 to 40 microm/y) in the placebo group (P=0.44). There were also no significant treatment effects when the results were examined by carotid segment or were adjusted for covariates. These data support the American Heart Association recommendation that women with established coronary disease should not initiate hormone therapy with an expectation of atherosclerotic benefit.
Assuntos
Doenças das Artérias Carótidas/etiologia , Estrogênios/efeitos adversos , Cardiopatias/patologia , Pós-Menopausa/efeitos dos fármacos , Progestinas/efeitos adversos , Idoso , Doenças das Artérias Carótidas/patologia , Contraindicações , Progressão da Doença , Método Duplo-Cego , Terapia de Reposição de Estrogênios/efeitos adversos , Estrogênios/uso terapêutico , Feminino , Seguimentos , Cardiopatias/complicações , Humanos , Progestinas/uso terapêutico , Túnica Íntima/efeitos dos fármacos , Túnica Íntima/patologia , Túnica Média/efeitos dos fármacos , Túnica Média/patologiaRESUMO
The Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program issued an evidence-based set of guidelines on cholesterol management in 2001. Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published. These trials addressed issues that were not examined in previous clinical trials of cholesterol-lowering therapy. The present document reviews the results of these recent trials and assesses their implications for cholesterol management. Therapeutic lifestyle changes (TLC) remain an essential modality in clinical management. The trials confirm the benefit of cholesterol-lowering therapy in high-risk patients and support the ATP III treatment goal of low-density lipoprotein cholesterol (LDL-C) <100 mg/dL. They support the inclusion of patients with diabetes in the high-risk category and confirm the benefits of LDL-lowering therapy in these patients. They further confirm that older persons benefit from therapeutic lowering of LDL-C. The major recommendations for modifications to footnote the ATP III treatment algorithm are the following. In high-risk persons, the recommended LDL-C goal is <100 mg/dL, but when risk is very high, an LDL-C goal of <70 mg/dL is a therapeutic option, ie, a reasonable clinical strategy, on the basis of available clinical trial evidence. This therapeutic option extends also to patients at very high risk who have a baseline LDL-C <100 mg/dL. Moreover, when a high-risk patient has high triglycerides or low high-density lipoprotein cholesterol (HDL-C), consideration can be given to combining a fibrate or nicotinic acid with an LDL-lowering drug. For moderately high-risk persons (2+ risk factors and 10-year risk 10% to 20%), the recommended LDL-C goal is <130 mg/dL, but an LDL-C goal <100 mg/dL is a therapeutic option on the basis of recent trial evidence. The latter option extends also to moderately high-risk persons with a baseline LDL-C of 100 to 129 mg/dL. When LDL-lowering drug therapy is employed in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30% to 40% reduction in LDL-C levels. Moreover, any person at high risk or moderately high risk who has lifestyle-related risk factors (eg, obesity, physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level. Finally, for people in lower-risk categories, recent clinical trials do not modify the goals and cutpoints of therapy.
Assuntos
Anticolesterolemiantes/uso terapêutico , Hipercolesterolemia/prevenção & controle , Guias de Prática Clínica como Assunto , Idoso , Anti-Hipertensivos/uso terapêutico , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , LDL-Colesterol/sangue , Ensaios Clínicos como Assunto/estatística & dados numéricos , Comorbidade , Diabetes Mellitus/epidemiologia , Medicina Baseada em Evidências , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/epidemiologia , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipolipemiantes/uso terapêutico , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Educação de Pacientes como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Risco , Fatores de Risco , Terapia TrombolíticaRESUMO
BACKGROUND: Previous studies have shown that effects on high-density lipoprotein cholesterol (HDL-C) may differ among statins. METHODS: A multicenter, randomized, double-blind, parallel-dose study was conducted in 917 hypercholesterolemic patients to compare the efficacy of 80 mg/d simvastatin versus 80 mg/d atorvastatin on HDL-C and apolipoprotein (apo) A-I for 24 weeks. Efficacy was assessed as the means of weeks 6 and 12 and weeks 18 and 24. Prespecified subgroups analyzed were patients with low HDL-C levels and with the metabolic syndrome. RESULTS: Simvastatin increased HDL-C and apo A-I values significantly more than did atorvastatin for the mean of weeks 6 and 12 (8.9% vs 3.6% and 4.9% vs -0.9%, respectively) and the mean of weeks 18 and 24 (8.3% vs 4.2% and 3.7% vs -1.4%). These differences were observed across both baseline HDL-C subgroups (<40 mg/dL, > or =40 mg/dL) and in patients with the metabolic syndrome. Low-density lipoprotein cholesterol and triglyceride reductions were greater with atorvastatin. Consecutive elevations >3x the upper limit of normal in alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) occurred in significantly fewer patients treated with simvastatin than with atorvastatin (2/453 [0.4%] vs 13/464 [2.8%]), with most elevations observed in women taking atorvastatin (11/209 [5.3%] vs 1/199 [0.5%] for simvastatin). CONCLUSIONS: Simvastatin (80 mg) increased HDL-C and apo A-I significantly more than did atorvastatin (80 mg) in patients with hypercholesterolemia. This advantage was observed regardless of HDL-C level at baseline or the presence of the metabolic syndrome. Significantly fewer consecutive elevations >3x the upper limit of normal in ALT and/or AST occurred in patients receiving simvastatin.
Assuntos
Apolipoproteína A-I/efeitos dos fármacos , HDL-Colesterol/efeitos dos fármacos , Ácidos Heptanoicos/administração & dosagem , Hipercolesterolemia/tratamento farmacológico , Pirróis/administração & dosagem , Sinvastatina/administração & dosagem , Adulto , Idoso , Fosfatase Alcalina/metabolismo , Atorvastatina , Diarreia/induzido quimicamente , Método Duplo-Cego , Feminino , Ácidos Heptanoicos/efeitos adversos , Humanos , Hipercolesterolemia/metabolismo , Masculino , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/induzido quimicamente , Náusea/induzido quimicamente , Pirróis/efeitos adversos , Sinvastatina/efeitos adversosRESUMO
BACKGROUND: Women undergoing coronary artery bypass graft (CABG) surgery have a worse medical condition and fewer social and financial resources than men. Some studies have found that women recover less well than men after CABG, whereas others have found women's outcomes comparable to those of men. Past studies of health-related quality of life after CABG have too few women for adequate comparison with men and have not included patients whose data are not available at baseline (eg, emergency CABG), limiting generalizability. METHODS: A longitudinal study of symptoms and health-related quality of life was conducted among patients from four clinical centers enrolling both men (n = 405) and women (n = 269) in the Post CABG Biobehavioral Study in the United States and Canada. RESULTS: After 6 weeks from CABG (average 81 days), both men and women had less anxiety and symptoms related to depression than before surgery (P <.001). After 6 months (average 294 days), both men and women improved in physical and social functioning (P <.001). Although changes in scale scores were similar for men and women at each time point, women scored lower than men on these domains (P <.001, adjusted for baseline medical and sociodemographic differences) and had more symptoms related to depression through 1 year after CABG (P =.003). CONCLUSIONS: Both male and female patients improve in physical, social, and emotional functioning after CABG, and recovery over time is similar in men and women. However, women's health-related quality-of-life scale scores remained less favorable than men's through 1 year after surgery.
Assuntos
Ponte de Artéria Coronária , Nível de Saúde , Qualidade de Vida , Adulto , Idoso , Doenças Cardiovasculares/complicações , Ponte de Artéria Coronária/psicologia , Depressão/etiologia , Feminino , Humanos , Renda , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores Sexuais , Apoio Social , Fatores Socioeconômicos , Estatística como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: Previous studies have suggested that angiographic evidence of disease progression in coronary arteries increases the risk of subsequent coronary clinical events. This study ascertained whether patients enrolled in the Post Coronary Artery Bypass Graft Clinical Trial (POST CABG) who had substantial progression of atherosclerosis in >or=1 saphenous vein grafts (on the basis of assessment of baseline and follow-up angiograms obtained 4-5 years after study entry), but who had not reported clinical symptoms before follow-up angiography, were at a higher risk of subsequent events than patients who did not have substantial progression of atherosclerosis (decrease >or=0.6 mm in lumen diameter at site of greatest change from baseline). METHODS: All 1351 patients enrolled in the trial underwent baseline angiography; only the 961 patients who had follow-up angiography and no coronary events before the follow-up study were included in this analysis. The clinical center staff contacted patients to ascertain the events that had occurred after follow-up angiography (approximately 3.4 years later). RESULTS: Sixty-nine patients had died; 870 patients or relatives were interviewed, and 22 patients could not be contacted. Univariable estimates of relative risk associated with substantial progression ranged from 2.2 (P <.001) for cardiovascular death or nonfatal myocardial infarction to 3.3 (P <.001) for revascularization. Multivariable and univariable estimates of risk were similar. CONCLUSIONS: The findings provide evidence that patients who had substantial progression of atherosclerosis in vein grafts are at an increased risk for subsequent coronary events and suggest that angiographic changes in vein grafts are appropriate surrogate measures for clinical outcomes.
Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Oclusão de Enxerto Vascular/diagnóstico por imagem , Veia Safena/diagnóstico por imagem , Veia Safena/transplante , Idoso , Análise de Variância , Angiografia Coronária , Progressão da Doença , Feminino , Oclusão de Enxerto Vascular/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/mortalidade , Prognóstico , Risco , Resultado do TratamentoRESUMO
The metabolic syndrome (MS) poses an increased risk for the development of diabetes mellitus and cardiovascular events. The syndrome typically includes dyslipidemia, characterized by elevated plasma triglycerides and low high-density lipoprotein cholesterol concentrations. Retrospective analyses of coronary artery disease outcomes trials in patient subpopulations with diabetes or the MS indicate that lipid-altering therapies provide benefits for patients with the MS at least as much as observed in patients without diabetes or the MS. Analyses of the effects of lipid-altering therapy on the lipid profile in patients with the MS also indicate that beneficial lipid changes are similar in patients with the MS compared with those in patients without the MS. The benefits of statin treatment in patients with the MS have become increasingly clear, and it is likely that further improvements in treatment may be achieved with newer statins or a combination of lipid-altering drugs. Prospective data from clinical trials examining the preventive effects of lipid-altering therapy in MS patients are needed to better define potential benefits and optimal treatment in this population.
Assuntos
Doença das Coronárias/prevenção & controle , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Síndrome Metabólica/tratamento farmacológico , Síndrome Metabólica/epidemiologia , Adulto , HDL-Colesterol/análise , HDL-Colesterol/efeitos dos fármacos , LDL-Colesterol/análise , LDL-Colesterol/efeitos dos fármacos , Comorbidade , Diabetes Mellitus/diagnóstico , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Síndrome Metabólica/diagnóstico , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
Both the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III and the Second Joint Task Force of European Societies guidelines have established low-density lipoprotein (LDL) cholesterol goals for lipid-lowering treatment to reduce the risk of coronary artery disease. Data from 3 trials that compared rosuvastatin 10 mg (n = 389) with atorvastatin 10 mg (n = 393) and 2 trials that compared rosuvastatin 10 mg (n = 226) with pravastatin 20 mg (n = 252) and simvastatin 20 mg (n = 249) were pooled separately to compare the achievement of LDL cholesterol goals over 12 weeks of treatment in hypercholesterolemic patients. Noncomparative pooling of rosuvastatin 10 mg results from all 5 trials (n = 615) showed that 80% achieved NCEP ATP III goals and 81% achieved the European goal of <3.0 mmol/L. Compared with atorvastatin 10 mg, significantly more patients treated with rosuvastatin 10 mg achieved their ATP III (76% vs 53%) and European (82% vs 51%) goals (p <0.001). Also, in comparisons with simvastatin 20 mg and pravastatin 20 mg, 86% of patients treated with rosuvastatin 10 mg achieved ATP III goals, compared with 64% of simvastatin-treated patients and 49% of pravastatin-treated patients (p <0.001). The proportions of patients who achieved the European goal were 80%, 48%, and 16% for rosuvastatin 10 mg, simvastatin 20 mg, and pravastatin 20 mg, respectively, in this comparison (all p <0.001). A total of 71% of patients treated with rosuvastatin 10 mg who had triglyceride levels > or =200 mg/dL met both their LDL cholesterol and their non-high-density lipoprotein cholesterol goals.
Assuntos
Anticolesterolemiantes/uso terapêutico , LDL-Colesterol/sangue , Doença das Coronárias/prevenção & controle , Fluorbenzenos/uso terapêutico , Ácidos Heptanoicos/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Pravastatina/uso terapêutico , Pirimidinas , Pirróis/uso terapêutico , Sinvastatina/uso terapêutico , Sulfonamidas , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/administração & dosagem , Atorvastatina , Doença das Coronárias/sangue , Doença das Coronárias/etiologia , Método Duplo-Cego , Esquema de Medicação , Europa (Continente) , Feminino , Fluorbenzenos/administração & dosagem , Ácidos Heptanoicos/administração & dosagem , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/sangue , Hipercolesterolemia/complicações , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Guias de Prática Clínica como Assunto , Pravastatina/administração & dosagem , Estudos Prospectivos , Pirróis/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco , Rosuvastatina Cálcica , Sinvastatina/administração & dosagem , Resultado do TratamentoRESUMO
The safety and tolerability of rosuvastatin were assessed (as of August 2003) using data from 12,400 patients who received 5 to 40 mg of rosuvastatin in a multinational phase II/III program, which represented 12,212 patient-years of continuous exposure to rosuvastatin. An integrated database was used to examine adverse events and laboratory data. In placebo-controlled trials, adverse events, irrespective of causality assessment, occurred in 57.4% of patients who received 5 to 40 mg of rosuvastatin (n = 744) and 56.8% of patients who received placebo (n = 382). In fixed-dose trials with comparator statins, 5 to 40 mg of rosuvastatin showed an adverse event profile similar to those for 10 to 80 mg of atorvastatin, 10 to 80 mg of simvastatin, and 10 to 40 mg of pravastatin. Clinically significant elevations in alanine aminotransferase (>3 times the upper limit of normal) and creatine kinase (>10 times the upper limit of normal) were uncommon (Assuntos
Fluorbenzenos/administração & dosagem
, Fluorbenzenos/efeitos adversos
, Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem
, Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos
, Pirimidinas/administração & dosagem
, Pirimidinas/efeitos adversos
, Sulfonamidas/administração & dosagem
, Sulfonamidas/efeitos adversos
, Adolescente
, Adulto
, Idoso
, Idoso de 80 Anos ou mais
, Alanina Transaminase/efeitos dos fármacos
, Alanina Transaminase/metabolismo
, Biomarcadores/sangue
, Criança
, LDL-Colesterol/efeitos dos fármacos
, LDL-Colesterol/metabolismo
, Creatina Quinase/efeitos dos fármacos
, Creatina Quinase/metabolismo
, Relação Dose-Resposta a Droga
, Olho/efeitos dos fármacos
, Feminino
, Humanos
, Hiperlipidemias/tratamento farmacológico
, Rim/efeitos dos fármacos
, Rim/metabolismo
, Fígado/efeitos dos fármacos
, Fígado/metabolismo
, Masculino
, Pessoa de Meia-Idade
, Músculo Esquelético/efeitos dos fármacos
, Músculo Esquelético/metabolismo
, Proteinúria/induzido quimicamente
, Rosuvastatina Cálcica
, Resultado do Tratamento
RESUMO
BACKGROUND: Hypercholesterolemic patients with metabolic syndrome (MS) are at high risk for coronary heart disease. The National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) guidelines provide the option of aggressively lowering low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic patients with MS. OBJECTIVE: The lipid-modifying efficacy of simvastatin and atorvastatin in hypercholesterolemic patients with MS as defined by NCEP ATP III was assessed. METHODS: A post hoc subgroup analysis was performed on data from a 36-week, multicenter (54 sites worldwide), randomized, double-blind, parallel-group, dose-escalation (forced-titration) study designed to assess the effects of simvastatin (40-80 mg) and atorvastatin (20-80 mg) on high-density lipoprotein cholesterol (HDL-C) and apolipoprotein (apo) A-I levels in patients with LDL-C > or = 160 mg/dL. Patients were classified as having MS if they met >/=3 of the following criteria: (1) triglyceride (TG) level > or =150 mg/dL; (2) HDL-C <40 mg/dL (men) or <50 mg/dL (women); (3) secondary diagnosis of type 2 diabetes mellitus and/or taking antidiabetic medication and/or fasting serum glucose (FSG) level > or =110 mg/dL; (4) secondary diagnosis of hypertension and/or taking antihypertensive medication and/or systolic blood pressure (SBP)/diastolic blood pressure (DBP) > or =130/ > or =85 mm Hg; and (5) body mass index (BMI) > or =30 kg/m(2) (surrogate for waist circumference). RESULTS: Of 808 evaluable patients, 212 (26.2%) were classified as having MS at baseline. Compared with the non-MS subgroup, MS patients were slightly older and more likely to be female. They also had higher BMI, SBP/DBP, FSG, and TG levels, and lower HDL-C and apo A-I levels than non-MS patients. The simvastatin group contained 99 patients; the atorvastatin group, 113 patients. Both drugs produced large reductions in total cholesterol, LDL-C, non-HDL-C, TG, and apo B, with atorvastatin producing slightly greater reductions in TG. However, simvastatin consistently produced larger increases in HDL-C and apo A-I than atorvastatin, especially at higher doses. After 36 weeks of treatment, 47.7% and 48.5% in the simvastatin and atorvastatin groups, respectively, no longer met > or =3 of the MS criteria. CONCLUSIONS: In hypercholesterolemic patients with characteristics of MS, simvastatin and atorvastatin had comparable beneficial effects on apo B-containing atherogenic lipids and lipoproteins, and MS status was effectively modified by both drugs. However, although atorvastatin produced slightly larger decreases in TG, simvastatin produced larger increases in HDL-C.
Assuntos
Anticolesterolemiantes/uso terapêutico , Ácidos Heptanoicos/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Síndrome Metabólica/tratamento farmacológico , Pirróis/uso terapêutico , Sinvastatina/uso terapêutico , Adulto , Idoso , Anticolesterolemiantes/administração & dosagem , Anticolesterolemiantes/metabolismo , Atorvastatina , HDL-Colesterol/sangue , LDL-Colesterol/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Ácidos Heptanoicos/administração & dosagem , Ácidos Heptanoicos/metabolismo , Humanos , Masculino , Síndrome Metabólica/sangue , Pessoa de Meia-Idade , Pirróis/administração & dosagem , Pirróis/metabolismo , Fatores de Risco , Sinvastatina/administração & dosagem , Sinvastatina/metabolismo , Fatores de Tempo , Triglicerídeos/sangueRESUMO
BACKGROUND: Non-high-density lipoprotein cholesterol (HDL-C), apolipoprotein (apo) B, and lipid and apolipoprotein ratios that include both atherogenic and antiatherogenic lipid components have been found to be strong predictors of coronary heart disease risk. OBJECTIVE: The goal of this study was to examine prospectively the effects of rosuvastatin, atorvastatin, simvastatin, and pravastatin across dose ranges on non-HDL-C, apo B, apo A-I, and total cholesterol (TC):HDL-C, low-density lipoprotein cholesterol (LDL-C):HDL-C, non-HDL-C:HDL-C, and apo B:apo A-I ratios in patients with hypercholesterolemia (LDL-C > or =160 mg/dL and <250 mg/dL and triglycerides <400 mg/dL) in the Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin (STELLAR) trial. METHODS: In this randomized, Multicenter, parallel-group, open-label trial (4522IL/0065), patients > or =18 years of age received rosuvastatin 10, 20, 40, or 80 mg; atorvastatin 10, 20, 40, or 80 mg; simvastatin 10, 20, 40, or 80 mg; or pravastatin 10, 20, or 40 mg for 6 weeks. Pairwise comparisons were prospectively planned and performed between rosuvastatin 10, 20, and 40 mg and milligram-equivalent or higher doses of comparators. RESULTS: A total of 2268 patients were randomized to the rosuvastatin 10- to 40-mg, atorvastatin, simvastatin, and pravastatin groups. Fifty-one percent of patients were women, the mean (SD) age was 57 (12) years, and 19% had a documented history of atherosclerotic disease. Over 6 weeks, rosuvastatin significantly reduced non-HDL-C, apo B, and all lipid and apolipoprotein ratios assessed, compared with milligram-equivalent doses of atorvastatin and milligram-equivalent or higher doses of simvastatin and pravastatin (all, P < 0.002). Rosuvastatin reduced non-HDL-C by 42.0% to 50.9% compared with 34.4% to 48.1% with atorvastatin, 26.0% to 41.8% with simvastatin, and 18.6% to 27.4% with pravastatin. Rosuvastatin reduced apo B by 36.7% to 45.3% compared with 29.4% to 42.9% with atorvastatin, 22.2% to 34.7% with simvastatin, and 14.7% to 23.0% with pravastatin. The highest increase in apo A-I (8.8%) was observed in the rosuvastatin 20-mg group, and this increase was significantly greater than in the atorvastatin 40-mg and 80-mg groups (both, P < 0.002). CONCLUSION: Rosuvastatin 10 to 40 mg was more efficacious in improving the lipid profile of patients with hypercholesterolemia than milligram-equivalent doses of atorvastatin and milligram-equivalent or higher doses of simvastatin and pravastatin.
Assuntos
Anticolesterolemiantes/uso terapêutico , Apolipoproteínas/sangue , LDL-Colesterol/sangue , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Idoso , Anticolesterolemiantes/administração & dosagem , Atorvastatina , Relação Dose-Resposta a Droga , Feminino , Fluorbenzenos/administração & dosagem , Fluorbenzenos/uso terapêutico , Ácidos Heptanoicos/administração & dosagem , Ácidos Heptanoicos/uso terapêutico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Hipercolesterolemia/sangue , Masculino , Pessoa de Meia-Idade , Pravastatina/administração & dosagem , Pravastatina/uso terapêutico , Estudos Prospectivos , Pirimidinas/administração & dosagem , Pirimidinas/uso terapêutico , Pirróis/administração & dosagem , Pirróis/uso terapêutico , Rosuvastatina Cálcica , Sinvastatina/administração & dosagem , Sinvastatina/uso terapêutico , Sulfonamidas/administração & dosagem , Sulfonamidas/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: We examined the effects of rosuvastatin treatment on triglyceride levels and lipid measures in a parallel-group multicenter trial (4522IL/0035) in patients with hypertriglyceridemia (Fredrickson Type IIb or IV). METHODS: After a 6-week dietary lead-in period while on a National Cholesterol Education Program step I diet, 156 patients with fasting triglyceride levels >/= 300 and < 800 mg/dl were randomized to 6 weeks of double-blinded treatment: once-daily rosuvastatin of 5, 10, 20, 40 or 80 mg or placebo. The primary end point was mean percentage change from baseline in total serum triglyceride levels at week 6 as determined by analysis of variance. RESULTS: Rosuvastatin at all doses produced significant mean reductions in triglycerides compared with placebo (-18 to -40 compared with +2.9%, P = 0.001); median reductions in triglycerides with rosuvastatin at 5-80 mg ranged from -21 to -46%. All doses of rosuvastatin significantly reduced levels of atherogenic lipoprotein and apolipoproteins over placebo, including low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, apolipoprotein B and apolipoprotein C-III. Statistically significant increases in high-density lipoprotein cholesterol were observed with rosuvastatin doses > 5 mg. The occurrence of adverse events was generally low and not dose related, although some adverse events occurred more frequently in the rosuvastatin 80 mg group. CONCLUSIONS: Rosuvastatin reduced triglyceride levels and improved the overall atherogenic and atheroprotective lipid profiles in hypertriglyceridemic patients.
Assuntos
Fluorbenzenos/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipertrigliceridemia/tratamento farmacológico , Pirimidinas/uso terapêutico , Sulfonamidas/uso terapêutico , Análise de Variância , Apolipoproteínas/efeitos dos fármacos , Método Duplo-Cego , Humanos , Lipoproteínas/efeitos dos fármacos , Pessoa de Meia-Idade , Rosuvastatina Cálcica , Resultado do TratamentoRESUMO
The purpose of the study was to evaluate the efficacy and safety of a new formulation of colestipol provided in table form. This was a randomized, double-blind, placebo-controlled, multicenter, dose-ranging study. A total of 196 patients with primary hypercholesterolemia who were following a low-fat, low-cholesterol diet (NCEP Step I diet), and having mean low-density lipoprotein cholesterol (LDL-C) levels greater-than-or-equal4.14 mmol L(minus sign1) (160 mg dl(minus sign1)) and less-than-or-equal6.46 mmol L(minus sign1) (250 mg dl(minus sign1)) were studied. Study medication was taken twice daily, with breakfast and supper, for 8 weeks. The five parallel treatment groups consisted of colestipol tablets 1, 2, 4, and 8 g BID, and matching placebo tablets BID. The main outcome measures were absolute change and percent change from baseline in selected lipid, lipoprotein, and apolipoprotein measurements; LDL-C was considered primary. Statistically significant (p less-than-or-equal 0.05) dose-dependent reductions in LDL-C from 5.2% to 25.8% and in total cholesterol from 2.8% to 16.8% were observed. Colestipol tablet treatment also resulted in statistically significant dose-dependent increases in LpAl levels reaching 25.8% at 16 g day(minus sign1). The treatment was well tolerated, and no serious adverse events were reported. Colestipol administered in tablet form was efficacious in lowering LDL-C and total cholesterol and was well tolerated in patients with primary hypercholesterolemia.
RESUMO
BACKGROUND: Combination therapy for dyslipidemia holds promise as effective treatment for patients with multiple lipid disorders, especially those at high risk. HYPOTHESIS: This study evaluated dose-response relationships and safety of a new dual-component drug product containing niacin extended-release (niacin ER) and lovastatin. METHODS: The 28-week double-blind multicenter trial randomized 237 patients with type IIA or IIB hyperlipidemia to one of four escalating-dose treatment groups: niacin ER/lovastatin 1,000/20 mg, niacin ER/lovastatin 2,000/40 mg, niacin ER 2,000 mg, or lovastatin 40 mg. RESULTS: Niacin ER/lovastatin was more effective than each of its components for improving levels of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), and exhibited a clear dose-response effect and additivity across the dosage range. The 2,000/40 dose achieved greater mean reductions in LDL-C (-42%) than 1,000/20 (-28%, p < 0.001), lovastatin 40 mg (-32%, p < 0.05), or niacin ER 2,000 mg (-14%, p < 0.05). The 2,000/40 dose was significantly more effective in increasing HDL-C levels (+30%) than the 1,000/20 dose (+21%, p = 0.016). The decrease in TG was greater with 2,000/40 (-43%) than with 1,000/20 (-26%, p = 0.009). All three niacin-containing treatments were more effective than lovastatin monotherapy in reducing lipoprotein (a) [Lp(a)] levels. Flushing caused 12 (11%) patients receiving niacin ER/lovastatin and I patient receiving lovastatin alone to withdraw. No drug-related myopathy was noted. One patient each in the 2,000/40 group and the lovastatin 40-mg group had reversible elevations in liver transaminases. CONCLUSIONS: Niacin ER/lovastatin is well tolerated and effective for patients with multiple lipid disorders.
Assuntos
Hiperlipidemias/diagnóstico , Hiperlipidemias/tratamento farmacológico , Hipolipemiantes/administração & dosagem , Lovastatina/administração & dosagem , Niacina/administração & dosagem , Análise de Variância , Distribuição de Qui-Quadrado , Preparações de Ação Retardada , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Combinação de Medicamentos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Probabilidade , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
BACKGROUND: Patients with elevated levels of serum triglycerides (TG) often have other associated lipid abnormalities (e.g., low levels of high-density lipoprotein cholesterol [HDL-C]) and are at increased risk of developing coronary heart disease. Although the therapeutic benefits of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) in hypercholesterolemic patients have been well established, less is known about the effects of statins in patient populations with hypertriglyceridemia. HYPOTHESIS: The purpose of this study was to evaluate the lipoprotein-altering efficacy of simvastatin in hypertriglyceridemic patients. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. In all, 195 patients with fasting serum triglyceride levels between 300 and 900 mg/dl received once daily doses of placebo or simvastatin 20, 40, or 80 mg for 6 weeks. RESULTS: Compared with placebo, simvastatin treatment across all doses resulted in significant reductions (p < 0.05 - < 0.001) in serum levels of triglycerides (-20 to -31% decrease) and TG-rich lipoprotein particles. Significant (p < 0.001) reductions were also seen in low-density lipoprotein cholesterol (-25 to -35%) and non-HDL-C (-26 to -40%). Levels of HDL-C were increased (7-11%) in the simvastatin groups compared with placebo (p < 0.05 - < 0.001). CONCLUSION: The results of this study demonstrate the beneficial effects of simvastatin in patients with hypertriglyceridemia.