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1.
Cardiovasc Diabetol ; 19(1): 51, 2020 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-32359355

RESUMEN

BACKGROUND: Despite the known association between non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD), whether NAFLD predicts future CVD events, especially CVD mortality, remains uncertain. We evaluated the relationship between fatty liver index (FLI), a validated marker of NAFLD, and risk of major adverse cardiac events (MACEs) in a large population-based study. METHODS: We identified 3011,588 subjects in the Korean National Health Insurance System cohort without a history of CVD who underwent health examinations from 2009 to 2011. The primary endpoint was a composite of cardiovascular deaths, non-fatal myocardial infarction (MI), and ischemic stroke. A Cox proportional hazards regression analysis was performed to assess association between the FLI and the primary endpoint. RESULTS: During the median follow-up period of 6 years, there were 46,010 cases of MACEs (7148 cases of cardiovascular death, 16,574 of non-fatal MI, and 22,288 of ischemic stroke). There was a linear association between higher FLI values and higher incidence of the primary endpoint. In the multivariable models adjusted for factors, such as body weight and cholesterol levels, the hazard ratio for the primary endpoint comparing the highest vs. lowest quartiles of the FLI was 1.99 (95% confidence interval [CIs], 1.91-2.07). The corresponding hazard ratios (95% CIs) for cardiovascular death, non-fetal MI, and ischemic stroke were 1.98 (1.9-2.06), 2.16 (2.01-2.31), and 2.01 (1.90-2.13), respectively (p < 0.001). The results were similar when we performed stratified analyses by age, sex, use of dyslipidemia medication, obesity, diabetes, and hypertension. CONCLUSIONS: Our findings indicate that the FLI, which is a surrogate marker of NAFLD, has prognostic value for detecting individuals at higher risk for cardiovascular events.

2.
Artículo en Español | PAHO-IRIS | ID: phr-51862

RESUMEN

[RESUMEN]. La Comisión Lancet de Hipertensión determinó que una medida clave para responder a la carga mundial que representa la hipertensión arterial era mejorar la calidad de las mediciones de la presión arterial, mediante la utilización de dispositivos cuya exactitud haya sido validada. En la actualidad existen 3000 dispositivos comercializados, pero muchos no tienen datos publicados sobre pruebas de exactitud conformes a las normas científicas establecidas. La falta de regulación o su ineficiencia, que permiten la autorización de dispositivos para uso comercial sin una validación oficial, posibilitan este problema. Además, han surgido tecnologías nuevas de medición de la presión arterial (por ejemplo, los sensores sin brazalete) sobre las cuales no existe unanimidad en la comunidad científica con respecto a las normas de exactitud de la medición. En conjunto, estos aspectos contribuyen a la disponibilidad generalizada de tensiómetros de consultorio o domiciliarios que ofrecen una exactitud limitada o incierta, que llevan a diagnósticos, manejo y farmacoterapia inapropiados de la hipertensión a escala mundial. Los problemas más importantes relacionados con la exactitud de los dispositivos de medición de la presión arterial se pueden resolver mediante el requisito regulatorio de una validación independiente obligatoria de los dispositivos, en consonancia con la norma ISO universalmente aceptada. Esta es una recomendación básica y constituye una necesidad internacional acuciante. Otras recomendaciones clave son la elaboración de normas de validación específicas para las tecnologías nuevas de medición de la presión arterial y la publicación en línea de listas de los dispositivos nuevos exactos que están a la disposición de los usuarios y los profesionales de salud. Las recomendaciones están en consonancia con las políticas de la Organización Mundial de la Salud sobre los dispositivos médicos y la atención universal de la salud. El cumplimiento de las recomendaciones aumentará la disponibilidad mundial de dispositivos de medición de la presión arterial que sean exactos y tendrá como efecto un mejor diagnóstico y tratamiento, reduciendo así la carga mundial de la hipertensión.


[ABSTRACT]. The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.


[RESUMO]. A Comissão Lancet sobre Hipertensão Arterial identificou que uma iniciativa central para enfrentar a carga mundial da hipertensão arterial seria a melhoria na qualidade da mensuração da pressão arterial pelo uso aparelhos de pressão arterial validados quanto à acurácia. Atualmente, existem mais de 3 000 aparelhos de pressão arterial disponíveis comercialmente; entretanto, muitos não têm dados publicados sobre testes de acurácia realizados de acordo com padrões científicos estabelecidos. Este problema resulta de regulamentação fraca ou inexistente, o que permite a aprovação para uso comercial de dispositivos sem validação formal. Além disso, surgiram novas tecnologias de mensuração da pressão arterial (por exemplo, sensores sem algemas) sem consenso científico quanto aos padrões de acurácia. No conjunto, essas questões contribuem para a oferta generalizada de dispositivos de pressão arterial clínica e domiciliar com acurácia limitada ou incerta, levando a diagnóstico, gerenciamento e tratamento inadequados da hipertensão em escala global. Os problemas mais significativos relacionados com a acurácia dos dispositivos de pressão arterial podem ser resolvidos por regulamentação que imponha a obrigatoriedade de validação independente dos aparelhos de pressão arterial, de acordo com a norma universalmente aceita pela Organização Internacional de Normalização. Esta é uma recomendação fundamental para a qual existe uma necessidade internacional urgente. Outras recomendações essenciais incluem o desenvolvimento de padrões de validação especificamente para novas tecnologias de mensuração da pressão arterial e listas on-line de aparelhos com acurácia adequada que sejam acessíveis aos consumidores e profissionais de saúde. As recomendações estão alinhadas com as políticas da Organização Mundial da Saúde (OMS) sobre dispositivos médicos e atenção universal à saúde. A adesão às recomendações aumentaria a oferta global de dispositivos de pressão arterial com acurácia adequada e resultaria em melhor diagnóstico e tratamento da hipertensão arterial, diminuindo assim a carga mundial dessa doença.


Asunto(s)
Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico , Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico , Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico
3.
Liver Int ; 40(6): 1303-1315, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32090451

RESUMEN

BACKGROUND & AIMS: In a general population without known liver disease, we tested whether: (a) increased liver fibrosis scores (FIB-4 and APRI) are associated with liver cancer mortality and (b) the probability that a person with a higher score died of liver cancer. METHODS: In a retrospective occupational cohort who underwent annual/biennial health examinations (between 2002 and 2015), subjects were excluded with known chronic liver disease. Based on their baseline FIB-4 and APRI scores, subjects were categorised in low-/intermediate-/high-risk groups for advanced liver fibrosis. Using Cox proportional hazards regression analyses adjusted hazard ratios (aHR) were estimated for liver cancer mortality, with the low-risk FIB-4/APRI group as the reference. Harrell's C statistics were also calculated. RESULTS: In 200 479 participants, mean (SD) age was 36.4 (7.7) years. Median follow-up was 4.1 years (IQR 2.10-8.03) with 80 liver cancer deaths. High baseline FIB-4 or APRI scores occurred in 0.25% and 0.09% of subjects respectively. A high FIB-4 or APRI score was associated with a markedly increased risk of liver cancer mortality (aHRs 629.10 [95% CI 228.74-1730.20] and 80.42 [95% CI 34.37-188.18]) respectively. C statistics were FIB-4 = 0.841 (95% CI 0.735-0.946) and APRI = 0.933 (95% CI 0.864-0.999). CONCLUSIONS: In a general population without known liver disease, high FIB-4 or high APRI (in keeping with a high probability of advanced fibrosis) occurred in 0.25% (FIB-4) and 0.09% (APRI) of subjects. Both scores were associated with a markedly increased risk of liver cancer mortality and FIB-4 and APRI models both strongly predicted liver cancer mortality.

4.
Am J Cardiol ; 125(6): 866-873, 2020 03 15.
Artículo en Inglés | MEDLINE | ID: mdl-31928718

RESUMEN

The purpose of this study was to compare Friedewald-calculated and directly measured low-density lipoprotein cholesterol (LDL-C) levels. LDL-C is routinely estimated by the Friedewald formula in clinical practice. However, unreliability of the Friedewald-calculated LDL-C appears at lower LDL-C level or high triglyceride levels. We examined 147,143 Korean adults who underwent a comprehensive health examination in 2017. After excluding subjects with calculated Friedewald LDL-C <0 and triglyceride levels ≥400 mg/dL, 145,043 subjects (female; 43%, mean age; 42 ± 8) were analyzed. Friedewald-calculated LDL-C levels were approximately 15 mg/dL lower to directly measured LDL-C. Friedewald measurement had high sensitivity (79.2%, 82.2% of sensitivity in males and 74.5% of sensitivity in females) and specificity (100%) for directly measured LDL-C cut-off value of ≥100 mg/dL in all levels of triglyceride. In 82% of total subjects, LCL-C measured by both methods differed by more than 10 mg/dL. The proportion of reclassification between both methods for National Cholesterol Education Program categories of risk was 50.3% of patients with Friedewald measurement of LDL-C <70 mg/dL, 68% had directly measured LDL-C ≥70 mg/dL. Direct and Freidewald measurements of LDL-C levels are well correlated. However, concordance of both methods is low and reclassification between both is substantial for NECP categories of risk. Thus, it is desirable to make a global consensus on the LDL-C measurement.

5.
Hepatology ; 71(3): 861-873, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31325180

RESUMEN

BACKGROUND AND AIMS: The effects of low-level alcohol consumption on fatty liver disease and the potential for effect modification by obesity is uncertain. We investigated associations among low-level alcohol consumption, obesity status, and the development of incident hepatic steatosis (HS), either with or without an increase in noninvasive liver fibrosis score category (from low to intermediate or high category). APPROACH AND RESULTS: A total of 190,048 adults without HS and a low probability of fibrosis with alcohol consumption less than 30 g/day (men) and less than 20 g/day (women) were followed for up to 15.7 years. Alcohol categories of no, light, and moderate consumption were defined as 0, 1-9.9, and 10-29.9 g/day (10-19.9 g/day for women), respectively. HS was diagnosed by ultrasonography, and the probability of fibrosis was estimated using the fibrosis-4 index (FIB-4). Parametric proportional hazards models were used to estimate multivariable-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs). A total of 43,466 participants developed HS, 2,983 of whom developed HS with an increase in FIB-4 index (to intermediate or high scores). Comparing light drinkers and moderate drinkers with nondrinkers, multivariable-adjusted HRs (95% CI) for incident HS were 0.93 (0.90-0.95) and 0.90 (0.87-0.92), respectively. In contrast, comparing light drinkers and moderate drinkers with nondrinkers, multivariable-adjusted HRs (95% CI) for developing HS plus intermediate/high FIB-4 were 1.15 (1.04-1.27) and 1.49 (1.33-1.66), respectively. The association between alcohol consumption categories and incident HS plus intermediate/high FIB-4 was observed in both nonobese and obese individuals, although the association was stronger in nonobese individuals (P for interaction by obesity = 0.017). CONCLUSIONS: Light/moderate alcohol consumption has differential effects on the development of different stages of fatty liver disease, which is modified by the presence of obesity.

6.
J Hypertens ; 38(1): 21-29, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31790375

RESUMEN

: The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organisation for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.

7.
Rev. panam. salud pública ; 44: e21, 2020. tab
Artículo en Español | LILACS-Express | ID: biblio-1101778

RESUMEN

resumen está disponible en el texto completo


ABSTRACT The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.


RESUMO A Comissão Lancet sobre Hipertensão Arterial identificou que uma iniciativa central para enfrentar a carga mundial da hipertensão arterial seria a melhoria na qualidade da mensuração da pressão arterial pelo uso aparelhos de pressão arterial validados quanto à acurácia. Atualmente, existem mais de 3 000 aparelhos de pressão arterial disponíveis comercialmente; entretanto, muitos não têm dados publicados sobre testes de acurácia realizados de acordo com padrões científicos estabelecidos. Este problema resulta de regulamentação fraca ou inexistente, o que permite a aprovação para uso comercial de dispositivos sem validação formal. Além disso, surgiram novas tecnologias de mensuração da pressão arterial (por exemplo, sensores sem algemas) sem consenso científico quanto aos padrões de acurácia. No conjunto, essas questões contribuem para a oferta generalizada de dispositivos de pressão arterial clínica e domiciliar com acurácia limitada ou incerta, levando a diagnóstico, gerenciamento e tratamento inadequados da hipertensão em escala global. Os problemas mais significativos relacionados com a acurácia dos dispositivos de pressão arterial podem ser resolvidos por regulamentação que imponha a obrigatoriedade de validação independente dos aparelhos de pressão arterial, de acordo com a norma universalmente aceita pela Organização Internacional de Normalização. Esta é uma recomendação fundamental para a qual existe uma necessidade internacional urgente. Outras recomendações essenciais incluem o desenvolvimento de padrões de validação especificamente para novas tecnologias de mensuração da pressão arterial e listas on-line de aparelhos com acurácia adequada que sejam acessíveis aos consumidores e profissionais de saúde. As recomendações estão alinhadas com as políticas da Organização Mundial da Saúde (OMS) sobre dispositivos médicos e atenção universal à saúde. A adesão às recomendações aumentaria a oferta global de dispositivos de pressão arterial com acurácia adequada e resultaria em melhor diagnóstico e tratamento da hipertensão arterial, diminuindo assim a carga mundial dessa doença.

8.
J Clin Med ; 8(10)2019 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-31581520

RESUMEN

We aimed to test the association between low-density lipoprotein cholesterol (LDL-C) and cardiovascular disease (CVD), cancer, and all-cause mortality in non-statin users. A total of 347,971 subjects in Kangbuk Samsung Health Study (KSHS.57.4% men, mean follow up: 5.64 ± 3.27 years) were tested. To validate these associations, we analyzed data from another cohort (Korean genome and epidemiology study, KoGES, 182,943 subjects). All subjects treated with any lipid-lowering therapy and who died during the first 3 years of follow up were excluded. Five groups were defined according to baseline LDL-C concentration (<70, 70-99, 100-129, 130-159, ≥160 mg/dL). A total of 2028 deaths occurred during follow-up in KSHS. The lowest LDL-C group (LDL < 70 mg/dL) had a higher risk of all-cause mortality (HR 1.95, 1.55-2.47), CVD mortality (HR 2.02, 1.11-3.64), and cancer mortality (HR 2.06, 1.46-2.90) compared to the reference group (LDL 120-139 mg/dL). In the validation cohort, 2338 deaths occurred during follow-up. The lowest LDL-C group (LDL < 70 mg/dL) had a higher risk of all-cause mortality (HR 1.81, 1.44-2.28) compared to the reference group. Low levels of LDL-C concentration are strongly and independently associated with increased risk of cancer, CVD, and all-cause mortality. These findings suggest that more attention is needed for subjects with no statin-induced decrease in LDL-C concentrations.

9.
J Clin Med ; 8(8)2019 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-31426428

RESUMEN

: No study has reported the relationship between secondhand smoke (SHS) exposure and hypertension in self-reported never-smokers verified by nicotine metabolite. The aim of this study is to determine the relationship between SHS exposure and hypertension in self-reported and cotinine-verified never-smokers. A total of 106,268 self-reported never-smokers, verified as nonsmokers by urinary cotinine, who participated in Kangbuk Samsung Cohort study (KSCS) between 2012 and 2016 were included. Cotinine-verified nonsmokers were defined as individuals having urinary cotinine <50 ng/mL. SHS exposure was defined as current exposure to passive smoke indoors at home or the workplace. The multivariate regression model revealed that SHS exposure was associated with hypertension (odds ratio (OR) (95% confidence interval (CI)), 1.16 (1.08, 1.24)). Current SHS exposure that has been exposed to home SHS (1.22 (1.11, 1.33)) as well as current SHS exposure only at the workplace (1.15 (1.02, 1.29)) significantly increased the ORs for hypertension compared to no SHS exposure. There was no significant gender interaction for the relationships between SHS exposure and hypertension. This study showed that SHS exposure was significantly associated with hypertension in self-reported never-smokers verified as nonsmokers by urinary cotinine, suggesting necessity of health program and stricter smoking regulation to reduce the risk of hypertension.

10.
J Hypertens ; 37(12): 2490-2497, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31373922

RESUMEN

OBJECTIVES: The aim of this study was to identify associations between the smoothness index of central SBP (CSBP) and changes of ambulatory carotid femoral pulse wave velocity in response to 20-week treatments with losartan and amlodipine vs. losartan and hydrochlorthiazide combinations. METHODS: For 142 (losartan and hydrochlorthiazide: 72, losartan and hydrochlorthiazide: 70) patients examined with ambulatory central blood pressure (BP) monitoring device, we calculated smoothness indices and trough-to-peak ratios of brachial SBP, CSBP, ambulatory pulse pressure amplification (APPA), ambulatory augmentation index at heart rate 75 beats per minute (AAIx75) and ambulatory carotid femoral pulse wave velocity (AcfPWV). RESULTS: Mean age was 58.9 ±â€Š12.3 years, and women accounted for 25.9%. Changes in office SBP/DBP were not different between groups (losartan and hydrochlorthiazide: -15.2 ±â€Š15.0/-7.8 ±â€Š8.0 vs. losartan and amlodipine: -14.9 ±â€Š13.7/-9.2 ±â€Š7.5 mmHg). Reduction of 24-h CSBP was not significantly different (losartan and hydrochlorthiazide: 6.4 ±â€Š1.1 vs. losartan and amlodipine: 9.2 ±â€Š1.1 mmHg, P = 0.074). Reduction in nocturnal AcfPWV was greater in the losartan and amlodipine group (losartan and hydrochlorthiazide: 0.09 ±â€Š0.05 vs. losartan and amlodipine: 0.26 ±â€Š0.05 m/s, P = 0.0216). Intraindividual SIs for CSBP were higher in the losartan and amlodipine group (0.40 ±â€Š0.57 vs. 0.65 ±â€Š0.74, P = 0.022). In multivariable regression analysis, smoothness index of CSBP was independently associated with the losartan and amlodipine group. In model additionally considering the changes in arterial stiffness, decrease in AcfPWV instead of the treatment group was independently associated with smoothness indices. In mediation analysis, smoothness index was fully mediated by reduction in night-time AcfPWV. CONCLUSION: Losartan and amlodipine combination was superior to the losartan and hydrochlorthiazide combination in terms of achieving higher smoothness index for CSBP after 20-week treatments. The effect of losartan and amlodipine on smoothness index was fully mediated by reduction of night-time AcfPWV.

11.
J Am Heart Assoc ; 8(16): e013019, 2019 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-31412746

RESUMEN

Background Arterial stiffness predicts both cardiovascular events and incident hypertension. However, whether brachial-ankle pulse wave velocity (baPWV) is predictive of incident hypertension based on the 2017 American College of Cardiology/American Heart Association (ACC/AHA) High Blood Pressure Guidelines has not been established. We performed a large cohort study to investigate whether incident hypertension could be predicted from baPWV measurements as a measure of arterial stiffness, even when applying updated hypertension criteria. Methods and Results A total of 10 360 Korean adults who underwent baPWV examination during a health-screening program between 2010 and 2016 were enrolled. Hypertension was defined according to the 2017 ACC/AHA Guidelines as 130/80 mm Hg. Cox proportional hazard analysis was used to assess the risk of incident hypertension according to baPWV quartiles. The mean age of the study subjects was 40.2 years and 75.6% were men. During the follow-up period (median 2.17 years), 2000 subjects (19.3%) developed hypertension. The subjects in the highest baPWV quartile group showed an increased risk of hypertension compared with the lowest baPWV quartile group as confirmed by multivariate adjusted hazard ratios of 1.64 (95% CI 1.41-1.89; P<0.001) in men and 12.36 (95% CI 4.41-34.62; P=0.005) in women. The increased risk of developing hypertension was consistent after adjusting for several confounding factors. Conclusions Arterial stiffness measured by baPWV is associated with incident hypertension according to the updated 2017 ACC/AHA Guidelines and is a useful independent predictor of incident hypertension among relatively healthy people.

12.
Trials ; 20(1): 389, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-31262348

RESUMEN

BACKGROUND: Hypertension is an important risk factor for cardiovascular disease, even in the elderly. Fimasartan is a new non-peptide angiotensin II receptor blocker with a selective type I receptor blocking effect. The objective of this study is to confirm the safety and the non-inferiority of the blood pressure-lowering effect of fimasartan compared with those of perindopril, which has been proven safe and effective in elderly patients with hypertension. METHODS: This is a randomized, double-blind, active-controlled, two-parallel group, optional-titration, multicenter, phase 3 study comparing the efficacy and safety of fimasartan and perindopril arginine. The study population consists of individuals 70 years old or older with essential hypertension. The primary outcome will be a change in sitting systolic blood pressure from baseline after the administration of the investigational product for 8 weeks. The secondary outcomes will be a change in sitting diastolic blood pressure from baseline and changes in sitting systolic blood pressure and diastolic blood pressure from baseline after the administration of the investigational product for 4, 16, and 24 weeks. The sample size will be 119 subjects for each group to confer enough power to test for the primary outcome. DISCUSSION: Research to confirm the efficacy and safety of a new medicine compared with those of previously proven anti-hypertensive drugs is beneficial to guide physicians in the selection of therapeutic agents. If it is confirmed that the new drug is not inferior to the existing drug, the drug will be considered as an option in the treatment of hypertension in elderly patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03246555 , registered on July 25, 2017.


Asunto(s)
Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antihipertensivos/uso terapéutico , Compuestos de Bifenilo/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Diuréticos/uso terapéutico , Hipertensión Esencial/tratamiento farmacológico , Perindopril/uso terapéutico , Pirimidinas/uso terapéutico , Tetrazoles/uso terapéutico , Factores de Edad , Anciano , Anciano de 80 o más Años , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Inhibidores de la Enzima Convertidora de Angiotensina/efectos adversos , Antihipertensivos/efectos adversos , Compuestos de Bifenilo/efectos adversos , Ensayos Clínicos Fase III como Asunto , Diuréticos/efectos adversos , Método Doble Ciego , Quimioterapia Combinada , Estudios de Equivalencia como Asunto , Hipertensión Esencial/diagnóstico , Hipertensión Esencial/fisiopatología , Femenino , Humanos , Masculino , Estudios Multicéntricos como Asunto , Perindopril/efectos adversos , Pirimidinas/efectos adversos , República de Corea , Tetrazoles/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
13.
Sci Rep ; 9(1): 9062, 2019 07 15.
Artículo en Inglés | MEDLINE | ID: mdl-31308382

RESUMEN

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease, and yet the natural course remains unclear. Study population included 36,195 individuals who participated in a health-screening program and diagnosed with fatty liver by abdominal ultrasound. Participants were provided written information regarding fatty liver and advised to make lifestyle changes. Ultrasound was repeated after at least 6 months. After a mean follow up of 4.9 years (±3.4), 19.6% resolved their fatty liver. Individuals who resolved were more likely female (22.9% vs. 12.3%), thinner (body mass index [BMI], 25.2 ± 2.7 vs. 26 ± 2.7), and with lower HOMA-IR (1.4 vs. 1.7) (P .70.001). Decrease in BMI predicted resolution of fatty liver with 42% of those in the top quartile of BMI decline resolving compared with 5.7% in the lowest quartile (odds ratio [OR] (95% confidence interval [CI]) 15.65 (14.13-17.34), P < 0.001)). Baseline HOMA-IR also predicted resolution with those in the top quartile (most insulin resistant) being least likely to resolve (12%) vs. those in the lowest quartile (25%) (OR 0.36 [0.31-0.42], P < 0.001). Fatty liver disease is persistent. Individuals with higher degree of insulin resistance are also the most likely to have persistent steatosis at follow up.

14.
Sci Rep ; 9(1): 8425, 2019 Jun 05.
Artículo en Inglés | MEDLINE | ID: mdl-31165750

RESUMEN

A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has been fixed in the paper.

15.
J Clin Hypertens (Greenwich) ; 21(8): 1057-1062, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31243882

RESUMEN

The objective of this study was to evaluate the association between sodium intake and blood pressure (BP) control in hypertensive patients taking antihypertensive medications by using 24-hour urine collection and 24-hour ambulatory BP. This is a cross-sectional community-based study and conducted in 2011 and 2012. A total of 1128 participants were recruited from five cities in Korea. Among them, 740 participants who had complete 24-hour urine collection and valid 24-hour ambulatory BP data were included in this study. Participants were divided into four groups: normotensives (NT, n = 441), untreated hypertensive patients (UTHT, n = 174), controlled hypertensive patients (CHT, n = 62), and uncontrolled hypertensive patients (UCHT, n = 63). UCHT and CHT groups showed higher mean age than NT and UTHT groups. UCHT and UTHT groups showed higher 24-hour systolic BP (SBP) and diastolic BP (DBP) than NT and CHT groups. UCHT group had the highest level of 24-hour urine sodium. Multivariate analysis adjusted with age, gender, body mass index, estimated glomerular filtration rate, and use of diuretics showed higher level of 24-hour urine sodium in UCHT group than that in CHT group. Multivariate logistic regression analysis revealed independent association of the amount of 24-hour urine sodium with uncontrolled BP in hypertensive patients on antihypertensive drug treatment. Higher level of 24-hour urine sodium excretion in uncontrolled hypertensive patients suggests that excessive sodium intake could be associated with blunted BP lowering efficacy of antihypertensive medications.

16.
J Clin Med ; 8(5)2019 May 06.
Artículo en Inglés | MEDLINE | ID: mdl-31064105

RESUMEN

Cardiovascular Health (CVH) metrics scores are associated with cardiovascular disease but whether CVH scores are associated with nonalcoholic fatty liver disease (NAFLD) is uncertain. Our aim was to investigate associations between CVH scores and development or regression of NAFLD. A cohort study was performed in Korean adults who underwent a comprehensive health examination. The CVH metrics were defined according to the American Heart Association Life's Simple 7 metrics, ranging from 0 (all metrics considered unhealthy) to 7 (all metrics considered healthy). Fatty liver was diagnosed by ultrasound, and liver fibrosis assessed using NAFLD fibrosis score (NFS). Among 93,500 participants without NAFLD or fibrosis at baseline, 15,899 developed NAFLD, and 998 developed NAFLD plus intermediate/high NFS. Healthy CVH metrics were inversely associated with NAFLD and also NAFLD with fibrosis. In time-dependent models after updating the CVH score and confounders as time-varying covariate, the multivariable-adjusted hazard ratio (95% confidence intervals) for incident NAFLD plus intermediate/high NFS participants with CVH metrics score 2, 3, 4, 5, or 6-7 to those with score 0-1 were 0.86 (0.59-1.25), 0.51 (0.36-0.73), 0.44 (0.31-0.62), 0.20 (0.14-0.29) and 0.09 (0.05-0.14), respectively. Regression of NAFLD occurred in 9742/37,517 participants who had NAFLD at baseline with positive association with CVH metrics. Higher CVH scores were significantly associated with both (a) decreased incidence of NAFLD, and (b) regression of existing NAFLD. Promoting adherence to ideal CVH metrics can be expected to reduce the burden of NAFLD as well as cardiovascular disease.

17.
Am J Hypertens ; 32(10): 992-1002, 2019 09 24.
Artículo en Inglés | MEDLINE | ID: mdl-31099387

RESUMEN

OBJECTIVE: The main objective of this study was to evaluate non-inferiority of office mean systolic blood pressure (BP) reduction efficacy and superiority of 24-hour ambulatory central BP reduction efficacy between losartan combined with fixed dose amlodipine (L/A group) and dose up-titrated hydrochlorothiazide (L/H group) according to office BP. METHODS: We conducted a prospective, randomized, double-blind multicenter trial in 231 patients with hypertensive (mean age = 59.2 ± 12.2 years). Patients received losartan 50 mg monotherapy for 4 weeks, followed by additional use of amlodipine 5 mg or hydrochlorothiazide 12.5 mg for 20 weeks after randomization. The patients who did not achieve the BP goal after 4 weeks' randomization received an increased dose of 100 mg/5 mg for the L/A group and 100 mg/25 mg for L/H group, respectively. The 24-hour ambulatory central BP was measured at baseline and after 20 weeks' treatment. RESULTS: Office mean systolic BP reduction of L/A group was not inferior to L/H group after 4 weeks' treatment (-17.6 ± 13.3 vs. -14.4 ± 12.6 mm Hg, P = 0.0863) and was not significantly different after 20 weeks' treatment. (-15.7 ± 14.0 vs. -14.7 ± 15.1 mm Hg, P = 0.6130) The 24-hour ambulatory central systolic BP was significantly more reduced in the L/A group compared with that in the L/H group after 20 weeks' treatment (-9.37 ± 10.67 vs. -6.28 ± 10.50 mm Hg, P = 0.0407). The 24-hour ambulatory central systolic BP at the completion of the study and its reduction magnitude were independently associated with reductions in aortic pulse wave velocity, pulse pressure, and wave reflection magnitude. CONCLUSION: Office systolic BP reduction with L/A was not inferior to L/H after 4 week's treatment. The combination of losartan and amlodipine was more favorable in 24-hour ambulatory central hemodynamics beyond BP-lowering efficacy than the combination of losartan and hydrochlorothiazide, regardless of office BP. CLINICAL TRIALS REGISTRATION: NCT02294539.

18.
J Am Heart Assoc ; 8(11): e011946, 2019 06 04.
Artículo en Inglés | MEDLINE | ID: mdl-31140347

RESUMEN

Background There are limited outcome studies of hypertension among young adults, especially using the new blood pressure ( BP ) categories from the American College of Cardiology and the American Heart Association. We examined associations between the new BP categories and the risk of incident cardiovascular disease ( CVD ) in low-risk and young adults. Methods and Results A cohort study was performed in 244 837 Korean adults (mean age, 39.0 years; SD , 8.9 years) who underwent a comprehensive health examination at Kangbuk Samsung Hospital from January 1, 2011, to December 31, 2016; they were followed up for incident CVD via linkage to the Health Insurance and Review Agency database until the end of 2016, with a median follow-up of 4.3 years. BP was categorized according to the new American College of Cardiology/American Heart Association (ACC/AHA) hypertension guidelines. During 924 420.7 person-years, 1435 participants developed new-onset  CVD (incidence rate of 16.0 per 104 person-years). The multivariable-adjusted hazard ratios (95% CI s ) for CVD comparing elevated BP , stage 1 hypertension, stage 2 hypertension, treated and strictly controlled (systolic BP /diastolic BP <130/80 mm Hg with antihypertensive use), treated and controlled (systolic BP 130-139 and diastolic BP 80 to 89 mm Hg with antihypertensive use), treated uncontrolled, and untreated hypertension to normal BP were 1.37 (1.11-1.68), 1.45 (1.26-1.68), 2.12 (1.74-2.58), 1.41 (1.12-1.78), 1.97 (1.52-2.56), 2.29 (1.56-3.37) and 1.93 (1.53-2.45), respectively. Conclusions In this large cohort of low-risk and young adults, all categories of higher BP were independently associated with an increased risk of CVD compared with normal BP , underscoring the importance of BP management even in these low-risk populations.

19.
Am J Hypertens ; 32(9): 833-841, 2019 08 14.
Artículo en Inglés | MEDLINE | ID: mdl-31045225

RESUMEN

BACKGROUND: This study aimed to examine longitudinal associations between blood pressure (BP) categories and incident cardiovascular disease (CVD) in treated hypertensive patients without CVD. METHODS: A cohort study was performed in Korean adults who underwent a comprehensive health examination from 1 January 2011 to 31 December 2016 and was followed for incident CVD via linkage to the Health Insurance and Review Agency database until the end of 2016, with a median follow-up of 4.3 years. RESULTS: Among 263,532 participants, 8,418 treated hypertensive patients free of CVD at baseline were included. The incident CVD end point was defined as new hospitalization for CVD, including ischemic heart disease, stroke, and transient ischemic attack. During 32,975.6 person-years of follow-up, 200 participants developed new-onset CVD (incidence rate of 60.6 per 104 person-years). The multivariable-adjusted hazard ratio (HR; 95% confidence intervals [CI]) for CVD according to systolic blood pressure (SBP) levels (comparing SBP < 110, SBP = 120-129, SBP = 130-139, SBP = 140-149, SBP = 150-159, and SBP ≥160 to SBP 110-119 mm Hg [reference]) were 0.83 (0.53-1.30), 1.31 (0.91-1.89), 1.18 (0.74-1.87), 1.46 (0.79-2.72), 3.19 (1.25-8.12), and 5.60 (2.00-15.70), respectively. In multivariable analysis for CVD according to diastolic blood pressure (DBP) levels, HR (95% CI) of DBP < 60, DBP = 70-79, DBP = 80-89, DBP = 90-99, and DBP ≥100 compared to DBP = 60-69 mm Hg [reference]) were 0.51 (0.12-2.14), 1.13 (0.76-1.67), 1.26 (0.83-1.92), 1.62 (0.89-2.97), and 1.68 (0.51-5.55), respectively. CONCLUSIONS: In this large cohort of middle-aged treated hypertensive patients, SBP < 120 mm Hg and/or DBP < 70 mm Hg were acceptable and showed a trend of protection of incident CVD.

20.
Diab Vasc Dis Res ; 16(5): 450-457, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31081361

RESUMEN

OBJECTIVE: Although reported to be independent of obesity, the longitudinal changes of left ventricular structure and function have not been well characterized in normal-weight individuals with type 2 diabetes compared with overweight/obese individuals with type 2 diabetes. METHODS: A total of 558 participants in the Korean Genome and Epidemiology Study who underwent tissue Doppler echocardiography at baseline (cycle 4) and after 8 years (cycle 8) were classified into three groups based on body mass index and diabetes status: (1) normal-weight individuals without type 2 diabetes, (2) normal-weight individuals with type 2 diabetes and (3) overweight/obese individuals with type 2 diabetes. RESULTS: Only overweight/obese individuals with type 2 diabetes group had higher adjusted left ventricular mass index and lower tissue Doppler imaging early diastolic velocity and E/Em ratio compared with the normal-weight individuals without type 2 diabetes group at baseline and after 8 years. Participants in overweight/obese individuals with type 2 diabetes group also showed the higher prevalence and odds of left ventricular hypertrophy (16.0%; adjusted odds ratio: 2.24; 95% confidence interval: 1.22-5.06) and left ventricular diastolic dysfunction (49.1%; 3.45; 1.01-4.32). Among participants with normal left ventricular structure and function at baseline, only overweight/obese individuals with type 2 diabetes group was associated with greater incidence of left ventricular hypertrophy (relative risk: 2.28; 1.04-4.98) over 8 years but not diastolic dysfunction. CONCLUSION: Cross-sectional and longitudinal observations suggest that increasing body mass index category and its associated metabolic abnormalities at baseline are associated with an increased risk for left ventricular hypertrophy and greater impairment in left ventricular diastolic parameters.


Asunto(s)
Diabetes Mellitus Tipo 2/epidemiología , Cardiomiopatías Diabéticas/epidemiología , Hipertrofia Ventricular Izquierda/epidemiología , Obesidad/epidemiología , Disfunción Ventricular Izquierda/epidemiología , Función Ventricular Izquierda , Remodelación Ventricular , Adulto , Anciano , Índice de Masa Corporal , Estudios Transversales , Diabetes Mellitus Tipo 2/diagnóstico , Cardiomiopatías Diabéticas/diagnóstico por imagen , Cardiomiopatías Diabéticas/fisiopatología , Ecocardiografía Doppler , Femenino , Humanos , Hipertrofia Ventricular Izquierda/diagnóstico por imagen , Hipertrofia Ventricular Izquierda/fisiopatología , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Obesidad/diagnóstico , Obesidad/fisiopatología , Prevalencia , Pronóstico , Estudios Prospectivos , República de Corea/epidemiología , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/fisiopatología
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