Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 37
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
Circulation ; 141(10): 843-862, 2020 Mar 10.
Artigo em Inglês | MEDLINE | ID: mdl-31992065

RESUMO

Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes. The 2008 guidance aimed to ensure the cardiovascular safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new cardiovascular outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated cardiovascular benefits of the newer agents, resulting in the first-ever cardiovascular protection indications for glucose-lowering therapies. Determining whether the guidance continues to have value in its current form is critically important as we move forward after the first decade of implementation. In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance in light of the findings of the completed cardiovascular outcome trials. The group made several recommendations for future regulatory guidance and for cardiovascular outcome trials of glucose-lowering therapies. These recommendations include requiring only the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes mellitus, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.

2.
Am Heart J ; 219: 47-57, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31707324

RESUMO

BACKGROUND: Obesity is a risk factor for type 2 diabetes (T2D) and cardiovascular disease (CVD). Whether obesity affects outcomes among those with T2D and atherosclerotic CVD (ASCVD) remains uncertain. Our objective was to investigate the relationship between body mass index (BMI) and ASCVD outcomes among TECOS participants with T2D and ASCVD. METHODS: BMI categories were defined as underweight/normal weight (BMI <25 kg/m2), overweight (25-29.9 kg/m2), obese class I (30-34.9 kg/m2), obese class II (35-39.9 kg/m2), and obese class III (≥ 40 kg/m2). Asian-specific BMI categories were applied to Asian participants. Kaplan-Meier survival analysis and Cox proportional hazards models were used to examine associations between baseline BMI and a composite CV outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina). RESULTS: For 14,534 TECOS patients with available BMI, mean age was 65.5 years; 29.3% were female, 32.0% non-White, and 23.1% insulin-treated, with median 3 years' follow-up. At baseline, 11.6% (n = 1686) were underweight/normal weight, 38.1% (n = 5532) overweight, 32.2% (n = 4683) obese class I, 12.4% (n = 1806) obese class II, and 5.7% (n = 827) obese class III. The composite CV outcome occurred in 11.4% (n = 1663) of participants; the outcome risk was lower, compared with under/normal weight, in overweight (HR 0.83, 95% CI 0.71-0.98) and obese class I (HR 0.79, 95% CI 0.67-0.93) individuals. Obesity was not associated with worse glycemic control. CONCLUSIONS: The majority of TECOS participants with ASCVD and T2D were overweight or obese, yet overweight or obese class I individuals had lower CV risk than those who were under/normal weight. These results suggest the presence of an obesity paradox, but this paradox may reflect an epidemiological artifact rather than a true negative association between normal weight and clinical outcomes.

3.
Diabetes Care ; 43(2): 374-381, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31806653

RESUMO

OBJECTIVE: To compare medical resource use, costs, and health utilities for 14,752 patients with type 2 diabetes who were randomized to once-weekly exenatide (EQW) or placebo in addition to usual diabetes care in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). RESEARCH DESIGN AND METHODS: Medical resource use data and responses to the EuroQol 5-Dimension (EQ-5D) instrument were collected at baseline and throughout the trial. Medical resources and medications were assigned values by using U.S. Medicare payments and wholesale acquisition costs, respectively. Secondary analyses used English costs. RESULTS: Patients were followed for an average of 3.3 years, during which time those randomized to EQW experienced 0.41 fewer inpatient days (7.05 vs. 7.46 days; relative rate ratio 0.91; P = 0.05). Rates of outpatient medical visits were similar, as were total inpatient and outpatient costs. Mean costs for nonstudy diabetes medications over the study period were ∼$1,600 lower with EQW than with placebo (P = 0.01). Total within-study costs, excluding study medication, were lower in the EQW arm than in the placebo arm ($28,907 vs. $30,914; P ≤ 0.01). When including the estimated cost of EQW, total mean costs were significantly higher in the EQW group than in the placebo group ($42,697 vs. $30,914; P < 0.01). With English costs applied, mean total costs, including exenatide costs, were £1,670 higher in the EQW group than the placebo group (£10,874 vs. £9,204; P < 0.01). There were no significant differences in EQ-5D health utilities between arms over time. CONCLUSIONS: Medical costs were lower in the EQW arm than the placebo arm, but total costs were significantly higher once the cost of branded exenatide was incorporated.

4.
Am Heart J ; 218: 57-65, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31707329

RESUMO

International differences in management/outcomes among patients with type 2 diabetes and heart failure (HF) are not well characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients. METHODS AND RESULTS: Among 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF <40% or EF ≥40%. The majority of participants with HF were enrolled in Eastern Europe (53%). Overall, 1,267 (79.6%) had EF ≥40%. ß-Blocker (83%) and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (86%) use was high across all regions in patients with EF <40%. During a median follow-up of 2.9 years, Eastern European participants had lower rates of ACM/hHF compared with North Americans (adjusted hazard ratio: 0.45; 95% CI: 0.32-0.64). These differences were seen only in the EF ≥40% subgroup and not the EF <40% subgroup. ACM was similar among Eastern European and North American participants (adjusted hazard ratio: 0.79; 95% CI: 0.44-1.45). CONCLUSIONS: Significant variation exists in the clinical features and outcomes of HF patients across regions in TECOS. Patients from Eastern Europe had lower risk-adjusted ACM/hHF than those in North America, driven by those with EF ≥40%. These data may inform the design of future international trials.

5.
Circ Cardiovasc Interv ; 12(12): e008018, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31752517

RESUMO

BACKGROUND: Recent trials have identified anti-diabetes mellitus agents that lower major adverse cardiovascular event (MACE) rates, although some increase rates of lower-extremity amputation (LEA). Patients with peripheral artery disease (PAD) have greater incidence of diabetes mellitus and risk for LEA, prompting this investigation of clinical outcomes in patients with diabetes mellitus and PAD in the EXSCEL trial (Exenatide Study of Cardiovascular Event Lowering). METHODS: EXSCEL evaluated the effects of once-weekly exenatide (a GLP-1 [glucagon-like peptide-1] receptor agonist) versus placebo on the rates of the primary composite MACE end point (cardiovascular death, myocardial infarction, or stroke) among patients with type 2 diabetes mellitus. In this post hoc analysis, we assessed the association of baseline PAD with rates of MACE, LEA, and the effects of exenatide versus placebo in patients with and without PAD. RESULTS: EXSCEL included 2800 patients with PAD (19% of the trial population). These individuals had higher unadjusted and adjusted rates of MACE compared with patients without PAD (13.6% versus 11.4%, respectively) as well as a higher adjusted hazard ratio (adjusted hazard ratio, 1.13 [95% CI, 1.00-1.27]; P=0.047). Patients with PAD had higher all-cause mortality (adjusted hazard ratio 1.38 [95% CI, 1.20-1.60]; P<0.001) and more frequent LEA (adjusted hazard ratio 5.48 [95% CI, 4.16-7.22]; P<0.001). Patients treated with exenatide or placebo had similar rates of MACE and LEA, regardless of PAD status. CONCLUSIONS: EXSCEL participants with PAD had higher rates of all-cause mortality and LEA compared with those without PAD. There were no differences in MACE or LEA rates with exenatide versus placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01144338.

6.
Circulation ; 140(20): 1613-1622, 2019 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-31542942

RESUMO

BACKGROUND: Once-weekly exenatide (EQW) had a neutral effect on hospitalization for heart failure (HHF) in the EXSCEL study (Exenatide Study of Cardiovascular Event Lowering), with no differential treatment effect on major adverse cardiac events by baseline heart failure (HF) status. EQW's effects on secondary end points based on HHF status have not been reported. The objective was to explore the effects of EQW on secondary end points in patients with and without baseline HF and test the effects of EQW on recurrent HHF events. METHODS: The prespecified analysis of the randomized controlled EXSCEL trial, which enrolled patients with type 2 diabetes mellitus with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each major adverse cardiac event component, first HHF, and repeat HHF, by baseline HF status (regardless of ejection fraction). A subgroup analysis of the population stratified by preserved or reduced baseline ejection fraction was performed. RESULTS: Of 14 752 EXSCEL participants, 2389 (16.2%) had HF at baseline. Compared with those without HF at baseline, patients with preexisting HF were older, and more likely to be male and white, with a higher burden of other cardiovascular diseases. Overall, those assigned to EQW had a lower incidence of all-cause death (hazard ratio [HR], 0.86 [95% CI, 0.77-0.97]) and the composite outcome of all-cause death or HHF (HR, 0.89 [95% CI, 0.80-0.99]). When stratified by presence or absence of baseline HF, there was no observed reduction in all-cause death with EQW with baseline HF (HR, 1.05 [95% CI, 0.85-1.29]), while the risk of mortality was reduced with EQW in the no-HF group (HR, 0.79 [95% CI, 0.68-0.92]) with an interaction P value of 0.031. The reduction in all-cause death or HHF seen with EQW in patients without baseline HF (HR, 0.81 [95% CI, 0.71-0.93]) was not seen in patients with baseline HF (HR, 1.07 [95% CI, 0.89-1.29]; interaction P=0.015). First, plus recurrent, HHF was reduced in the exenatide group versus placebo (HR, 0.82 [95% CI, 0.68-0.99]; P=0.038). CONCLUSIONS: In EXSCEL, the use of EQW in patients with or without HF was well tolerated, but benefits of EQW on reduction in all-cause death and first hospitalization for HF were attenuated in patients with baseline HF. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01144338.

7.
J Am Med Inform Assoc ; 26(12): 1609-1617, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31553474

RESUMO

OBJECTIVE: Electronic health records (EHR) data have become a central data source for clinical research. One concern for using EHR data is that the process through which individuals engage with the health system, and find themselves within EHR data, can be informative. We have termed this process informed presence. In this study we use simulation and real data to assess how the informed presence can impact inference. MATERIALS AND METHODS: We first simulated a visit process where a series of biomarkers were observed informatively and uninformatively over time. We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits). RESULTS: We find that only when there is both a strong association between the biomarker and the outcome as well as the biomarker and the visit process is there bias. Moreover, once there are some uninformative visits this bias is mitigated. In the data example we find, that when the "true" associations are null, there is no observed bias. DISCUSSION: These results suggest that an informative visit process can exaggerate an association but cannot induce one. Furthermore, careful study design can, mitigate the potential bias when some noninformative visits are included. CONCLUSIONS: While there are legitimate concerns regarding biases that "messy" EHR data may induce, the conditions for such biases are extreme and can be accounted for.

8.
Prog Cardiovasc Dis ; 62(4): 306-314, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31301314

RESUMO

Cardiovascular disease (CVD) is the most common cause of morbidity and mortality for patients with diabetes mellitus (DM). Although the burden of atherosclerotic CVD (ASCVD) is well documented, heart failure (HF) has been an under-appreciated CVD complication of DM. However, as more patients with DM live longer and survive acute ASCVD events, the distribution of CVD complications has evolved. This review summarizes the epidemiology of DM, the relative risk and prognosis of both ASCVD and HF following a diagnosis of DM, and the likelihood of cause-specific CVD mortality in patients with DM.


Assuntos
Aterosclerose/epidemiologia , Doenças Cardiovasculares/epidemiologia , Causas de Morte , Diabetes Mellitus/epidemiologia , Insuficiência Cardíaca/epidemiologia , Adulto , Idoso , Aterosclerose/diagnóstico , Doenças Cardiovasculares/diagnóstico , Comorbidade , Diabetes Mellitus/diagnóstico , Feminino , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Índice de Gravidade de Doença , Análise de Sobrevida , Estados Unidos/epidemiologia
10.
11.
J Am Med Inform Assoc ; 26(5): 429-437, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30869798

RESUMO

OBJECTIVE: Participants enrolled into randomized controlled trials (RCTs) often do not reflect real-world populations. Previous research in how best to transport RCT results to target populations has focused on weighting RCT data to look like the target data. Simulation work, however, has suggested that an outcome model approach may be preferable. Here, we describe such an approach using source data from the 2 × 2 factorial NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) trial, which evaluated the impact of valsartan and nateglinide on cardiovascular outcomes and new-onset diabetes in a prediabetic population. MATERIALS AND METHODS: Our target data consisted of people with prediabetes serviced at the Duke University Health System. We used random survival forests to develop separate outcome models for each of the 4 treatments, estimating the 5-year risk difference for progression to diabetes, and estimated the treatment effect in our local patient populations, as well as subpopulations, and compared the results with the traditional weighting approach. RESULTS: Our models suggested that the treatment effect for valsartan in our patient population was the same as in the trial, whereas for nateglinide treatment effect was stronger than observed in the original trial. Our effect estimates were more efficient than the weighting approach and we effectively estimated subgroup differences. CONCLUSIONS: The described method represents a straightforward approach to efficiently transporting an RCT result to any target population.


Assuntos
Anti-Hipertensivos/uso terapêutico , Hipoglicemiantes/uso terapêutico , Aprendizado de Máquina , Nateglinida/uso terapêutico , Estado Pré-Diabético/tratamento farmacológico , Valsartana/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2 , Progressão da Doença , Registros Eletrônicos de Saúde , Medicina Baseada em Evidências , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Pesquisa Médica Translacional
12.
J Am Coll Cardiol ; 73(8): 893-902, 2019 03 05.
Artigo em Inglês | MEDLINE | ID: mdl-30819356

RESUMO

BACKGROUND: The optimal noninvasive test (NIT) for patients with diabetes and stable symptoms of coronary artery disease (CAD) is unknown. OBJECTIVES: The purpose of this study was to assess whether a diagnostic strategy based on coronary computed tomographic angiography (CTA) is superior to functional stress testing in reducing adverse cardiovascular (CV) outcomes (CV death or myocardial infarction [MI]) among symptomatic patients with diabetes. METHODS: PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) was a randomized trial evaluating an initial strategy of CTA versus functional testing in stable outpatients with symptoms suggestive of CAD. The study compared CV outcomes in patients with diabetes (n = 1,908 [21%]) and without diabetes (n = 7,058 [79%]) based on their randomization to CTA or functional testing. RESULTS: Patients with diabetes (vs. without) were similar in age (median 61 years vs. 60 years) and sex (female 54% vs. 52%) but had a greater burden of CV comorbidities. Patients with diabetes who underwent CTA had a lower risk of CV death/MI compared with functional stress testing (CTA: 1.1% [10 of 936] vs. stress testing: 2.6% [25 of 972]; adjusted hazard ratio: 0.38; 95% confidence interval: 0.18 to 0.79; p = 0.01). There was no significant difference in nondiabetic patients (CTA: 1.4% [50 of 3,564] vs. stress testing: 1.3% [45 of 3,494]; adjusted hazard ratio: 1.03; 95% confidence interval: 0.69 to 1.54; p = 0.887; interaction term for diabetes p value = 0.02). CONCLUSIONS: In diabetic patients presenting with stable chest pain, a CTA strategy resulted in fewer adverse CV outcomes than a functional testing strategy. CTA may be considered as the initial diagnostic strategy in this subgroup. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550).


Assuntos
Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Diabetes Mellitus , Teste de Esforço/métodos , Idoso , Doença da Artéria Coronariana/complicações , Eletrocardiografia/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada Multidetectores , Pacientes Ambulatoriais , Estudos Prospectivos , Reprodutibilidade dos Testes
13.
Obstet Gynecol ; 133(3): 609, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30801472

RESUMO

Cardiovascular disease (CVD) remains the leading cause of mortality for women, and only a small percentage of women have optimally managed risk factors. One of the strongest risk factors for CVD is an increased lipid level. Many women seek primary care from obstetrician-gynecologists who often identify and provide initial management of dyslipidemia in these women. Thus, it is imperative that obstetrician-gynecologists become familiar with the identification and treatment of women with dyslipidemia to minimize their future risk of CVD. This monograph provides a brief primer on the epidemiology, pathophysiology, diagnosis, and management of dyslipidemia in women, as it pertains to CVD risk.

14.
Am Heart J ; 208: 28-36, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30529930

RESUMO

BACKGROUND: Although sex differences exist in the management of acute coronary syndromes, less is known about the management and outcomes of women and men with suspected coronary artery disease being evaluated with noninvasive testing (NIT). METHODS: We investigated sex-based differences in NIT results and subsequent clinical management in 4,720 women and 4,246 men randomized to CT angiography versus stress testing in the PROMISE trial. Logistic regression models assessed relationships between sex and referral for catheterization, revascularization, and aspirin or statin use. Cox regression models assessed the relationship between sex and the composite of all-cause death, myocardial infarction, or unstable angina. RESULTS: Women more often had normal NITs than men (61.0% vs 49.6%, P < .001) and less often had mild (29.3% vs 35.4%, P < .001), moderate (4.0% vs 6.8%, P < .001), or severe abnormalities (5.7% vs 8.3%, P < .001) found on NIT. Women were less likely to be referred for catheterization than men (7.6% vs 12.6%, adjusted OR 0.75 [0.62-0.90]; P = .002). Of those who underwent catheterization within 90 days of randomization (358 women, 534 men), fewer women than men had obstructive coronary artery disease (40.8% vs 60.9%, P < .001). At a 60-day visit, women were significantly less likely than men to report statin use when indicated (adjusted OR 0.81 [0.73-0.91]; P < .001) but were similarly likely to report aspirin use when indicated (adjusted OR 0.78 [0.56-1.08]; P = .13). Over a median follow-up of 25 months, women had better outcomes than men (adjusted OR 0.73 [0.57-0.94]; P = .017). CONCLUSIONS: Although women more frequently had normal NITs compared with men, those with abnormalities on NIT were less likely to be referred for catheterization or to receive statin therapy. The high rates of negative NIT in women, coupled with the better outcomes compared with men, strongly support the need for a sex-specific algorithm to guide NIT and chest pain management.


Assuntos
Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/terapia , Fatores Sexuais , Aspirina/uso terapêutico , Cateterismo Cardíaco/estatística & dados numéricos , Angiografia por Tomografia Computadorizada , Angiografia Coronária/métodos , Angiografia Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Teste de Esforço/métodos , Teste de Esforço/estatística & dados numéricos , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento
15.
J Am Heart Assoc ; 7(16): e009328, 2018 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-30369327

RESUMO

Background Epidemiological studies demonstrating a relationship between gout and cardiovascular disease are older and predate modern cardiovascular preventive therapy. We assessed the contemporary association between gout and cardiovascular disease in patients with obstructive coronary artery disease. Methods and Results Data were from the Duke Databank for Cardiovascular Diseases, which followed up patients undergoing cardiac catheterization with obstructive coronary artery disease at Duke University Medical Center (1998-2013). We assessed the relationship between gout diagnosis at baseline or during follow-up and the primary composite outcome of cardiovascular death, myocardial infarction, or stroke, adjusting for differences in baseline clinical factors. Secondary end points included cardiovascular death and all-cause mortality. New, postbaseline, gout diagnosis was included as a time-dependent covariate. Among 17 201 patients, 1406 (8.2%) had baseline gout and a high burden of cardiovascular risk factors, but high rates of optimal medical therapy. Over a median follow-up of 6.4 years, gout diagnosis at time of catheterization was not associated with the primary outcome (hazard ratio [95% confidence interval], 1.05 [0.96-1.15]; P=0.31) or cardiovascular death (hazard ratio [95% confidence interval], 1.10 [0.99-1.22]; P=0.08), but was associated with increased all-cause mortality (hazard ratio [95% confidence interval], 1.13 [1.05-1.23]; P=0.002). After including new, postbaseline, gout diagnosis, the instantaneous risk of the primary outcome was significantly associated with prior gout diagnosis (hazard ratio [95% confidence interval], 1.15 [1.07-1.25]; P=0.0004). Conclusions A clinical history of gout is associated with worse outcomes in a contemporary population of patients with obstructive coronary artery disease. This increased risk exists despite high levels of optimal baseline cardiovascular disease medical therapy, suggesting that residual cardiovascular risk is not addressed by standard medical therapy.


Assuntos
Síndrome Coronariana Aguda/epidemiologia , Doenças Cardiovasculares/mortalidade , Doença da Artéria Coronariana/epidemiologia , Gota/epidemiologia , Idoso , Cateterismo Cardíaco , Causas de Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Infarto do Miocárdio/epidemiologia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia
16.
Am Heart J ; 206: 51-60, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30317061

RESUMO

BACKGROUND: Patients with nonobstructive coronary artery disease (CAD) have worse outcomes compared with those without CAD; however, few studies have compared the intermediate- and long-term impact of CAD severity as a function of patient sex. METHODS: We evaluated 5-year and long-term all-cause mortality of women and men undergoing elective coronary angiography at a single center by degree of CAD: no CAD (1%-24% stenosis), nonobstructive CAD (25%-69% epicardial stenosis or 25%-49% left main stenosis), or obstructive CAD (epicardial stenosis ≥70% or left main stenosis ≥50%), both overall and after adjusting for baseline clinical risk factors using Cox proportional-hazards models. RESULTS: Between January 1986 and July 2010, 8,766 women and 11,638 men underwent angiography and were followed for a median of 9.2 years. The majority (67%) of women had no CAD or nonobstructive CAD, whereas the majority of men had obstructive CAD (56%, P < .001). In both sexes, increasing CAD was associated with increased 5-year risk of mortality. Risk-adjusted hazard ratios (vs no CAD) for women were 1.36 (95% CI, 1.16-1.60) and 1.86 (1.61-2.16) for nonobstructive and obstructive CAD, respectively; corresponding hazard ratios for men were 1.24 (1.06-1.45) and 1.38 (1.20-1.59). After risk adjustment, 5-year mortality risk was higher in men than in women at all levels of CAD severity. The relationships between severity of CAD and mortality risk during long-term follow-up in women and men were similar to the 5-year relationships above. CONCLUSIONS: Although women undergoing elective catheterization have less severe CAD than men, nonobstructive CAD is prevalent in both sexes and carries a worse prognosis than no CAD. These data suggest a need for further investigation to establish optimal therapies for this at-risk group of patients with nonobstructive CAD.


Assuntos
Doença da Artéria Coronariana/epidemiologia , Previsões , Medição de Risco , Idoso , Causas de Morte/tendências , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Prognóstico , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Distribuição por Sexo , Fatores Sexuais , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia
17.
J Am Heart Assoc ; 7(19): e009304, 2018 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-30371301

RESUMO

Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients with type 2 diabetes mellitus (T2 DM ) with and without cardiovascular disease. Whether patients at increased risk for events experienced a comparatively greater treatment benefit with exenatide is unknown. Methods and Results In the EXSCEL population, we created risk scores for MACEs and all-cause mortality using step-wise selection of baseline characteristics. A risk score was calculated for each patient, and a time-to-event model for each end point was developed including the risk score, treatment assignment, and risk-treatment interaction. Interaction P values evaluating for a differential treatment effect by baseline risk were reported. Over a median follow-up of 3.2 years (interquartile range, 2.2, 4.4), 1091 (7.4%) patients died and 1744 (11.8%) experienced a MACE . Independent predictors of MACEs and all-cause mortality included age, sex, comorbidities (eg, previous cardiovascular event), body mass index, blood pressure, hemoglobin A1c, and estimated glomerular filtration rate. The all-cause mortality and MACE risk models had modest discrimination with optimism-corrected c-indices of 0.73 and 0.71, respectively. No interaction was observed between treatment effect and risk profile for either end point (both interactions, P>0.1). Conclusions Baseline characteristics (eg, age, previous cardiovascular events) and routine laboratory values (eg, hemoglobin A1c, estimated glomerular filtration rate) provided modest prognostic value for mortality and MACEs in a broad population of patients with type 2 diabetes mellitus. Exenatide's effects on mortality and MACEs were consistent across the spectrum of baseline risk. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01144338.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Exenatida/administração & dosagem , Medição de Risco/métodos , Idoso , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Causas de Morte/tendências , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/complicações , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Seguimentos , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemiantes/administração & dosagem , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
18.
Am Heart J ; 204: 151-155, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30121016

RESUMO

IMPORTANCE: The extent to which levels of high-sensitivity C-reactive protein (hs-CRP), a known marker of increased cardiovascular risk, are elevated and are associated with standard cardiovascular risk factors in patients with a history of myocardial infarction (MI) is unknown. OBJECTIVES: To determine the pattern and determinants of the distribution of hs-CRP in those with a prior MI in the United States using a nationally representative sample. DESIGN AND PARTICIPANTS: Adults with hs-CRP data in the National Health and Nutrition Examination Surveys from 1999-2010. RESULTS: Among 1296 individuals in our cohort, the median age was 65 years and the median hs-CRP level was 2.69 mg/L, measured an average of 7.1 years after the MI. Among these patients, 22% had hs-CRP levels of <1 mg/L, 61% had ≥2 mg/L, and 48% had ≥3 mg/L. Increasing hs-CRP was associated in a multivariable model with increasing body mass index (partial R2 [pR2] 0.113, P < .001), increasing non-high-density lipoprotein [HDL] (pR2 0.030, P < .001), increasing age (pR2 0.008, P = .017), and decreasing HDL (pR2 0.005, P = .046). Adjusted mean hs-CRP was also higher in women (3.6 vs 2.7 mg/L; P < .001), in people with hypertension (3.5 vs. 2.8, P = .030), and among smokers (4.2 vs 2.3 mg/L; P < .001), and lower in people with hyperlipidemia (2.8 vs. 3.5, P = .007). Standard cardiovascular risk factors accounted for only 22% of the variability in hs-CRP levels. CONCLUSIONS AND RELEVANCE: Among patients with prior MI, elevated hs-CRP is prevalent several years after the MI, and standard cardiovascular risk factors explain only a small proportion of hs-CRP variability. In light of emerging evidence on the importance of inflammation in the pathogenesis of cardiovascular disease, the high prevalence of elevated hs-CRP in patients with prior MI in the United States may have public health implications.


Assuntos
Proteína C-Reativa/metabolismo , Infarto do Miocárdio/sangue , Fatores Etários , Idoso , Biomarcadores/sangue , Índice de Massa Corporal , HDL-Colesterol/sangue , Feminino , Humanos , Hiperlipidemias/complicações , Hipertensão/complicações , Lipoproteínas/sangue , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Fatores de Risco , Fatores Sexuais , Fumar/efeitos adversos , Fatores de Tempo , Estados Unidos
19.
J Am Heart Assoc ; 7(13)2018 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-29960995

RESUMO

BACKGROUND: There is limited information about the long-term survival of older patients after myocardial infarction (MI). METHODS AND RESULTS: CRUSADE (Can rapid risk stratification of unstable angina patients suppress adverse outcomes with early implementation of the ACC/AHA guidelines) was a registry of MI patients treated at 568 US hospitals from 2001 to 2006. We linked MI patients aged ≥65 years in CRUSADE to their Medicare data to ascertain long-term mortality (defined as 8 years post index event). Long-term unadjusted Kaplan-Meier mortality curves were examined among patients stratified by revascularization status. A landmark analysis conditioned on surviving the first year post-MI was conducted. We used multivariable Cox regression to compare mortality risks between ST-segment-elevation myocardial infarction and non-ST-segment-elevation myocardial infarction patients. Among 22 295 MI patients ≥ age 65 years (median age 77 years), we observed high rates of evidence-based medication use at discharge: aspirin 95%, ß-blockers 94%, and statins 81%. Despite this, mortality rates were high: 24% at 1 year, 51% at 5 years, and 65% at 8 years. Eight-year mortality remained high among patients who underwent percutaneous coronary intervention (49%), coronary artery bypass graft (46%), and among patients who survived the first year post-MI (59%). Median survival was 4.8 years (25th, 75th percentiles 1.1, 8.5); among patients aged 65-74 years it was 8.2 years (3.3, 8.9) while for patients aged ≥75 years it was 3.1 years (0.6, 7.6). Eight-year mortality was lower among ST-segment-elevation myocardial infarction than non-ST-segment-elevation myocardial infarction patients (53% versus 67%); this difference was not significant after adjustment (hazard ratio 0.94, 95% confidence interval, 0.88-1.00). CONCLUSIONS: Long-term mortality remains high among patients with MI in routine clinical practice, even among revascularized patients and those who survived the first year.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Revascularização Miocárdica/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Fármacos Cardiovasculares/efeitos adversos , Feminino , Humanos , Masculino , Medicare , Revascularização Miocárdica/efeitos adversos , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
20.
J Am Coll Cardiol ; 72(1): 79-95, 2018 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-29957235

RESUMO

This review describes trends in the burden of cardiovascular diseases (CVDs) and risk factors in India compared with the United States; provides potential explanations for these differences; and describes strategies to improve cardiovascular health behaviors, systems, and policies in India. The prevalence of CVD in India has risen over the past 2 decades due to population growth, aging, and a stable age-adjusted CVD mortality rate. Over the same time period, the United States has experienced an overall decline in age-adjusted CVD mortality, although the trend has begun to plateau. These improvements in CVD mortality in the United States are largely due to favorable population-level risk factor trends, specifically with regard to tobacco use, cholesterol, and blood pressure, although improvements in secondary prevention and acute care have also contributed. To realize similar gains in reducing premature death and disability from CVD, India needs to implement population-level policies while strengthening and integrating its local, regional, and national health systems. Achieving universal health coverage that includes financial risk protection should remain a goal to help all Indians realize their right to health.


Assuntos
Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Promoção da Saúde , Humanos , Índia/epidemiologia , Mortalidade/tendências , Fatores de Risco , Estados Unidos/epidemiologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA