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1.
N Engl J Med ; 386(19): 1781-1792, 2022 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-35363951

RESUMO

BACKGROUND: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth. METHODS: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth. RESULTS: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99). CONCLUSIONS: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).


Assuntos
Anti-Hipertensivos/uso terapêutico , Hipertensão Induzida pela Gravidez/tratamento farmacológico , Hipertensão , Resultado da Gravidez , Descolamento Prematuro da Placenta/epidemiologia , Descolamento Prematuro da Placenta/prevenção & controle , Peso ao Nascer , Doença Crônica , Feminino , Retardo do Crescimento Fetal/epidemiologia , Retardo do Crescimento Fetal/prevenção & controle , Humanos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Recém-Nascido , Pré-Eclâmpsia/epidemiologia , Pré-Eclâmpsia/prevenção & controle , Gravidez , Resultado da Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle
2.
Br J Haematol ; 204(2): 658-667, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-37803527

RESUMO

In this retrospective cohort study of singleton pregnancies in people with sickle cell disease (SCD) delivered at two academic centres between 1990 and 2021, we collected demographic and SCD-related data, pregnancy outcomes, and the highest systolic and diastolic blood pressure (SBP and DBP) at seven time periods. We compared blood pressure values and trajectories in the composite cohort and in each genotype group to control values in a non-SCD pregnancy dataset. There were 290 pregnancies among 197 patients with SCD. Sixteen per cent (n = 47) of pregnancies had a hypertensive disorder of pregnancy (HDP); the rates did not differ by genotype. The mean SBP and DBP were lower in the HbSS/HbSß0 group than in the non-SCD control group at all timepoints. Mean SBP and DBP trajectories were similar between the HbSS/HbSß0 group and non-SCD controls, whereas the mean SBP and DBP in the HbSC/HbSß+ group decreased between the first and second trimesters and plateaued between the second and third trimesters. There were no differences in blood pressure trajectory by haemoglobin >/< 10 gm/dL or by chronic transfusion status. Overall, pregnant people with SCD have lower blood pressure than unaffected pregnant people, raising the possibility that HDP are underdiagnosed, particularly in people with HbSS/HbSß0 .


Assuntos
Anemia Falciforme , Doença da Hemoglobina SC , Pré-Eclâmpsia , Gravidez , Feminino , Humanos , Pressão Sanguínea , Estudos Retrospectivos , Hemoglobina Falciforme
4.
N Engl J Med ; 369(1): 20-31, 2013 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-23822777

RESUMO

BACKGROUND: The standard test for the diagnosis of acute rejection in kidney transplants is the renal biopsy. Noninvasive tests would be preferable. METHODS: We prospectively collected 4300 urine specimens from 485 kidney-graft recipients from day 3 through month 12 after transplantation. Messenger RNA (mRNA) levels were measured in urinary cells and correlated with allograft-rejection status with the use of logistic regression. RESULTS: A three-gene signature of 18S ribosomal (rRNA)-normalized measures of CD3ε mRNA and interferon-inducible protein 10 (IP-10) mRNA, and 18S rRNA discriminated between biopsy specimens showing acute cellular rejection and those not showing rejection (area under the curve [AUC], 0.85; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 by receiver-operating-characteristic curve analysis). The cross-validation estimate of the AUC was 0.83 by bootstrap resampling, and the Hosmer-Lemeshow test indicated good fit (P=0.77). In an external-validation data set, the AUC was 0.74 (95% CI, 0.61 to 0.86; P<0.001) and did not differ significantly from the AUC in our primary data set (P=0.13). The signature distinguished acute cellular rejection from acute antibody-mediated rejection and borderline rejection (AUC, 0.78; 95% CI, 0.68 to 0.89; P<0.001). It also distinguished patients who received anti-interleukin-2 receptor antibodies from those who received T-cell-depleting antibodies (P<0.001) and was diagnostic of acute cellular rejection in both groups. Urinary tract infection did not affect the signature (P=0.69). The average trajectory of the signature in repeated urine samples remained below the diagnostic threshold for acute cellular rejection in the group of patients with no rejection, but in the group with rejection, there was a sharp rise during the weeks before the biopsy showing rejection (P<0.001). CONCLUSIONS: A molecular signature of CD3ε mRNA, IP-10 mRNA, and 18S rRNA levels in urinary cells appears to be diagnostic and prognostic of acute cellular rejection in kidney allografts. (Funded by the National Institutes of Health and others.).


Assuntos
Quimiocina CXCL10/genética , Rejeição de Enxerto/diagnóstico , Peptídeos e Proteínas de Sinalização Intracelular/genética , Transplante de Rim , RNA Mensageiro/urina , RNA Ribossômico/urina , Doença Aguda , Adulto , Área Sob a Curva , Quimiocina CXCL10/urina , Feminino , Rejeição de Enxerto/genética , Humanos , Peptídeos e Proteínas de Sinalização Intracelular/urina , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , RNA Polimerase I , RNA Ribossômico 18S/urina , Curva ROC , Reação em Cadeia da Polimerase em Tempo Real , Sensibilidade e Especificidade , Transcriptoma
5.
Curr Hypertens Rep ; 17(7): 53, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26068655

RESUMO

Hypertension is a common medical complication of pregnancy. Although 75-80 % of women with preexisting essential hypertension will have uncomplicated pregnancies, the presence of secondary forms of hypertension adds considerably to both maternal and fetal morbidity and mortality. Renovascular hypertension, pheochromocytoma, and Cushing's syndrome in particular are associated with accelerating hypertension, superimposed preeclampsia, preterm delivery, and fetal loss. Primary aldosteronism is a more heterogeneous disorder; there are well-documented cases where blood pressure and hypokalemia are improved during pregnancy due to elevated levels of progesterone. However, superimposed preeclampsia, worsening hypertension, and early delivery are also reported. When possible, secondary forms of hypertension should be diagnosed and treated prior to conception in order to avoid these complications.


Assuntos
Pré-Eclâmpsia , Síndrome de Cushing/complicações , Feminino , Humanos , Hiperaldosteronismo/complicações , Rim/irrigação sanguínea , Feocromocitoma/complicações , Gravidez , Apneia Obstrutiva do Sono/complicações
6.
Obstet Gynecol ; 144(1): 126-134, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38949541

RESUMO

OBJECTIVE: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSION: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.


Assuntos
Anti-Hipertensivos , Hipertensão , Labetalol , Nifedipino , Resultado da Gravidez , Humanos , Gravidez , Feminino , Labetalol/administração & dosagem , Labetalol/efeitos adversos , Labetalol/uso terapêutico , Nifedipino/administração & dosagem , Nifedipino/efeitos adversos , Nifedipino/uso terapêutico , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Adulto , Hipertensão/tratamento farmacológico , Recém-Nascido , Complicações Cardiovasculares na Gravidez/tratamento farmacológico , Hipertensão Induzida pela Gravidez/tratamento farmacológico , Administração Oral , Recém-Nascido Pequeno para a Idade Gestacional , Pré-Eclâmpsia/tratamento farmacológico , Doença Crônica
7.
Obstet Gynecol ; 144(1): 101-108, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38781591

RESUMO

OBJECTIVE: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial. METHODS: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated. RESULTS: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations. CONCLUSION: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.


Assuntos
Anti-Hipertensivos , Hipertensão , Complicações Cardiovasculares na Gravidez , Humanos , Feminino , Gravidez , Recém-Nascido , Adulto , Anti-Hipertensivos/uso terapêutico , Hipertensão/tratamento farmacológico , Resultado da Gravidez , Pressão Arterial , Hipertensão Induzida pela Gravidez/tratamento farmacológico
8.
Curr Hypertens Rep ; 15(2): 114-21, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23397213

RESUMO

Cardiovascular death rates continue to rise for women under age 55, underlying the importance of focusing on female-specific conditions that may increase cardiovascular risk, including pregnancy-related disorders. Hypertension complicates about 5-10 % of pregnancies. Preeclampsia, a pregnancy-specific condition, is characterized by hypertension and proteinuria after 20 weeks of gestation and remains one of the major causes of maternal deaths in the United States. In addition, preeclampsia may have an impact on women's health beyond their pregnancies, and has been associated with increased risks for future hypertension and cardiovascular disease, such as coronary heart disease and stroke. In this review, we discuss the evidence supporting the association between preeclampsia and future hypertension; possible mechanisms that underlie this association; current approach to women with a history of preeclampsia; and future research that is needed in this field in order to deliver optimal and timely medical care to the affected women.


Assuntos
Hipertensão/fisiopatologia , Pré-Eclâmpsia/fisiopatologia , Feminino , Previsões , Humanos , Hipertensão/etiologia , Gravidez , Fatores de Risco
11.
Artigo em Inglês | MEDLINE | ID: mdl-36833628

RESUMO

Frontline clinicians responding to the COVID-19 pandemic are at increased risk of burnout, but less is known about the trajectory of clinician burnout as caseloads increase and decrease. Personal and professional resources, including self-efficacy and hospital support, can attenuate the risk of burnout. Yet, empirical data documenting how burnout and resources changed as the pandemic waxed and waned are limited. This intensive longitudinal prospective study employed ecological momentary assessment methods to examine trajectories of burnout and resources over the pandemic's first year in a New York City hospital. A 10-item survey was emailed every 5 days to frontline clinicians (physicians, nurses, and physician assistants). The primary outcome was a single-item validated measure of burnout; predictors included daily hospital COVID-19-related caseloads and personal and professional resources. Clinicians (n = 398) completed the initial survey and an average of 12 surveys over the year. Initially, 45.3% of staff reported burnout; over the year, 58.7% reported burnout. Following the initial COVID peak, caseloads declined, and burnout levels declined. During the second wave of COVID, as caseloads increased and remained elevated and personal and professional resource levels decreased, burnout increased. This novel application of intensive longitudinal assessment enabled ongoing surveillance of burnout and permitted us to evaluate how fluctuations in caseload intensity and personal and professional resources related to burnout over time. The surveillance data support the need for intensified resource allocation during prolonged pandemics.


Assuntos
Esgotamento Profissional , COVID-19 , Humanos , Pandemias , Estudos Prospectivos , Esgotamento Psicológico , Avaliação Momentânea Ecológica , Inquéritos e Questionários
12.
Hypertension ; 80(5): e75-e89, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36951054

RESUMO

There is increasing interest in the long-term cardiovascular health of women with complicated pregnancies and their affected offspring. Emerging antenatal risk factors such as preeclampsia appear to increase the risk of hypertension and cardiovascular disease across the life course in both the offspring and women after pregnancy. However, the antenatal programming mechanisms responsible are complex and incompletely understood, with roots in alterations in the development, structure, and function of the kidney, heart, vasculature, and brain. The renin-angiotensin-aldosterone system is a major regulator of maternal-fetal health through the placental interface, as well as kidney and cardiovascular tissue development and function. Renin-angiotensin-aldosterone system dysregulation plays a critical role in the development of pregnancy complications such as preeclampsia and programming of long-term adverse cardiovascular health in both the mother and the offspring. An improved understanding of antenatal renin-angiotensin-aldosterone system programming is crucial to identify at-risk individuals and to facilitate development of novel therapies to prevent and treat disease across the life course. Given the inherent complexities of the renin-angiotensin-aldosterone system, it is imperative that preclinical and translational research studies adhere to best practices to accurately and rigorously measure components of the renin-angiotensin-aldosterone system. This comprehensive synthesis of preclinical and translational scientific evidence of the mechanistic role of the renin-angiotensin-aldosterone system in antenatal programming of hypertension and cardiovascular disease will help (1) to ensure that future research uses best research practices, (2) to identify pressing needs, and (3) to guide future investigations to maximize potential outcomes. This will facilitate more rapid and efficient translation to clinical care and improve health outcomes.


Assuntos
Doenças Cardiovasculares , Hipertensão , Pré-Eclâmpsia , Feminino , Gravidez , Humanos , Sistema Renina-Angiotensina/fisiologia , Doenças Cardiovasculares/complicações , American Heart Association , Placenta , Mães , Renina , Aldosterona
13.
Eur Heart J Cardiovasc Pharmacother ; 9(2): 183-191, 2023 02 02.
Artigo em Inglês | MEDLINE | ID: mdl-36639130

RESUMO

AIMS: Finerenone reduces the risk of cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). We investigated the causes of mortality in the FIDELITY population. METHODS AND RESULTS: The FIDELITY prespecified pooled data analysis from FIDELIO-DKD and FIGARO-DKD excluded patients with heart failure and reduced ejection fraction. Outcomes included intention-to-treat and prespecified on-treatment analyses of the risk of all-cause and cardiovascular mortality. Of 13 026 patients [mean age, 64.8 years; mean estimated glomerular filtration rate (eGFR), 57.6 mL/min/1.73 m2], 99.8% were on renin-angiotensin system inhibitors. Finerenone reduced the incidence of all-cause and cardiovascular mortality vs. placebo (8.5% vs. 9.4% and 4.9% vs. 5.6%, respectively) and demonstrated significant on-treatment reductions [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.70-0.96; P = 0.014 and HR, 0.82; 95% CI, 0.67-0.99; P = 0.040, respectively]. Cardiovascular-related mortality was most common, and finerenone lowered the incidence of sudden cardiac death vs. placebo [1.3% (incidence rate 0.44/100 patient-years) vs. 1.8% (0.58/100 patient-years), respectively; HR, 0.75; 95% CI, 0.57-0.996; P = 0.046]. The effects of finerenone on mortality were similar across all Kidney Disease: Improving Global Outcomes risk groups. Event probability with finerenone at 4 years was consistent irrespective of baseline urine albumin-to-creatinine ratio, but seemingly more pronounced in patients with higher baseline eGFR. CONCLUSION: In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population. CLINICAL TRIALS REGISTRATION: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).


Assuntos
Diabetes Mellitus Tipo 2 , Nefropatias Diabéticas , Insuficiência Cardíaca , Insuficiência Renal Crônica , Humanos , Pessoa de Meia-Idade , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Nefropatias Diabéticas/diagnóstico , Nefropatias Diabéticas/tratamento farmacológico , Nefropatias Diabéticas/etiologia , Método Duplo-Cego , Antagonistas de Receptores de Mineralocorticoides/efeitos adversos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/tratamento farmacológico , Insuficiência Renal Crônica/complicações , Insuficiência Cardíaca/tratamento farmacológico , Morte Súbita Cardíaca
14.
Am J Obstet Gynecol MFM ; 5(6): 100861, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-36669562

RESUMO

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.


Assuntos
Comitês de Ética em Pesquisa , Feminino , Gravidez , Humanos , Estudos Retrospectivos , Inquéritos e Questionários
15.
Obstet Gynecol ; 142(6): 1395-1404, 2023 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-37769314

RESUMO

OBJECTIVE: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130-139/80-89 mm Hg and pregnancy outcomes. METHODS: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130-139/80-89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA). RESULTS: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130-139/80-89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38-0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA. CONCLUSION: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.


Assuntos
Hipertensão , Pré-Eclâmpsia , Nascimento Prematuro , Gravidez , Humanos , Recém-Nascido , Feminino , Pré-Eclâmpsia/epidemiologia , Pré-Eclâmpsia/etiologia , Nascimento Prematuro/epidemiologia , Placenta , Resultado da Gravidez , Retardo do Crescimento Fetal , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipertensão/complicações
16.
N Engl J Med ; 360(24): 2503-15, 2009 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-19502645

RESUMO

BACKGROUND: Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. METHODS: We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. RESULTS: At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). CONCLUSIONS: Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.)


Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença das Coronárias/terapia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Terapia Combinada , Angiografia Coronária , Doença das Coronárias/complicações , Doença das Coronárias/cirurgia , Diabetes Mellitus Tipo 2/complicações , Feminino , Hemoglobinas Glicadas , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Estimativa de Kaplan-Meier , Masculino , Metformina/uso terapêutico , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Compostos de Sulfonilureia/uso terapêutico , Tiazolidinedionas/uso terapêutico
17.
Ann Surg Oncol ; 19(13): 4085-93, 2012 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22732838

RESUMO

Although there is considerable controversy regarding the role of race in the etiology of human disease, evidence suggests that breast cancers are racially distinct diseases. Clinical features and genetic alterations are different in Chinese women with breast cancer compared with white women. These differences are significant and may influence clinical care. In this review, we summarize the literature addressing genetic heterogeneity in Chinese women with breast cancer. Data support important variations in genes involved in tumorigenic pathways of DNA repair, steroid synthesis and receptor expression, apoptosis, immunity, inflammation, cell cycle control, cancer growth and metastasis, and growth receptor signaling. These genetic differences contribute to our understanding of the molecular origins of breast cancer and may accelerate the development of personalized disease prevention strategies.


Assuntos
Povo Asiático/genética , Neoplasias da Mama/genética , Predisposição Genética para Doença , Grupos Raciais/genética , Feminino , Humanos
18.
J Cardiovasc Electrophysiol ; 23(10): 1123-9, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22882572

RESUMO

INTRODUCTION: Registry data demonstrate considerably low complication rates after implantable cardioverter-defibrillator (ICD) procedures for primary prevention of sudden death. Yet standard of care includes postimplant overnight in-hospital observation that may levy substantial unnecessary financial burden on health care systems. In appropriate patients, discharge soon after implant could translate into significant cost savings, if such practice does not result in complications. We applied a simple clinical algorithm to assess feasibility of discharge on the same day of ICD implantation in patients at low risk for procedural complications. METHODS: We prospectively randomized primary prevention ICD candidates at low risk for complications (not pacing-dependent or requiring bridging heparin anticoagulation) to next-day discharge with overnight in-hospital observation, or same-day discharge with remote monitoring for 24 hours after ICD implant. Implants were performed via cephalic vein access, and randomization occurred after 4-hours clinical observation and device interrogation. All patients were followed for a minimum of 6 weeks to assess acute procedural complications. RESULTS: 71 patients comprised the study cohort (mean age 62, 79% male) after 3 were excluded. The most common indication for ICD implant was ischemic cardiomyopathy with ejection fraction ≤35%. Device data obtained through 24-hour remote monitoring was comparable to 4-hour postimplant parameters in same-day discharge patients. No acute complications occurred in same-day discharge patients; 1 next-day discharge patient developed pneumothorax. CONCLUSION: ICD implantation with same-day discharge is reasonable in patients at low risk for complications. Remote monitoring can be useful in indicating lead-parameter stability during the immediate postoperative period.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Insuficiência Cardíaca/terapia , Idoso , Algoritmos , Morte Súbita Cardíaca/etiologia , Cardioversão Elétrica/efeitos adversos , Estudos de Viabilidade , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Tempo de Internação , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque , Alta do Paciente , Projetos Piloto , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Telemetria/instrumentação , Fatores de Tempo , Resultado do Tratamento
20.
Hypertension ; 79(2): e21-e41, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34905954

RESUMO

Hypertensive disorders of pregnancy (HDP) remain one of the major causes of pregnancy-related maternal and fetal morbidity and mortality worldwide. Affected women are also at increased risk for cardiovascular disease later in life, independently of traditional cardiovascular disease risks. Despite the immediate and long-term cardiovascular disease risks, recommendations for diagnosis and treatment of HDP in the United States have changed little, if at all, over past decades, unlike hypertension guidelines for the general population. The reasons for this approach include the question of benefit from normalization of blood pressure treatment for pregnant women, coupled with theoretical concerns for fetal well-being from a reduction in utero-placental perfusion and in utero exposure to antihypertensive medication. This report is based on a review of current literature and includes normal physiological changes in pregnancy that may affect clinical presentation of HDP; HDP epidemiology and the immediate and long-term sequelae of HDP; the pathophysiology of preeclampsia, an HDP commonly associated with proteinuria and increasingly recognized as a heterogeneous disease with different clinical phenotypes and likely distinct pathological mechanisms; a critical overview of current national and international HDP guidelines; emerging evidence that reducing blood pressure treatment goals in pregnancy may reduce maternal severe hypertension without increasing the risk of pregnancy loss, high-level neonatal care, or overall maternal complications; and the increasingly recognized morbidity associated with postpartum hypertension/preeclampsia. Finally, we discuss the future of research in the field and the pressing need to study socioeconomic and biological factors that may contribute to racial and ethnic maternal health care disparities.


Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Hipertensão Induzida pela Gravidez/diagnóstico , American Heart Association , Anti-Hipertensivos/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Feminino , Humanos , Hipertensão Induzida pela Gravidez/tratamento farmacológico , Hipertensão Induzida pela Gravidez/fisiopatologia , Gravidez , Estados Unidos
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