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Investigating the lowest threshold of vascular benefits from LDL cholesterol lowering with a PCSK9 mAb inhibitor (alirocumab) in healthy volunteers - a mechanistic physiological study (INTENSITY-LOW): protocol and study rationale.
Objective: Whether reducing low density lipoprotein cholesterol (LDL-C) is associated with cardiovascular benefits in low risk normocholesterolaemic subjects is unknown. The INTENSITY LOW [Investigating the lowest threshold of vascular benefits from LDL-cholesterol lowering with a PCSK9 mAb inhibitor (alirocumab) in healthy volunteers] study aims to assess whether lowering LDL-C by alirocumab monotherapy can improve endothelial-dependent vascular function compared with placebo (primary objective) in low-risk normocholesterolaemic healthy individuals. Changes in endothelial-dependent or endothelial-independent vascular function, arterial stiffness and biomarkers of systemic inflammation by alirocumab, atorvastatin or their combination are secondary objectives. Study design and methods: This is a single-center, randomized, two-period, single-blind, placebo-controlled clinical trial. The study was registered on clinicaltrials.gov (N03273972). It will include 30 healthy low-risk subjects with LDL-C < 4.1 mmol/l. After passing the screening visit (Visit 1), eligible participants will be randomized 1:1 to either subcutaneous alirocumab 150 mg or placebo. These will be administered as single doses in 2 visits 14 days apart (Visits 2 and 3). Atorvastatin 20 mg once nightly will be prescribed for 14 days at Visit 3 in both groups through to Visit 4. At baseline (Visit 2) and during all post-dose visits (Visits 3-4), endothelial function will be assessed using venous occlusion plethysmography. Specifically, changes in forearm blood flow responses to intra-arterial infusions of acetylcholine, sodium nitroprusside and L-NG-monomethyl-arginine acetate will be assessed as surrogates of endothelial-dependent and -independent vasodilatation. Additionally, arterial stiffness and carotid intima-media thickness will be evaluated at the same timepoints. The above-mentioned changes will be correlated with changes in lipid and systemic inflammation biomarkers
MEASURING LINE CENTERS FROM DIGITALLY RECORDED SPECTRA USING A MINICOMPUTER
Author Institution: Department of Physics, Michigan State University East LansingA procedure has been developed and programmed for measuring spectral line centers from digitally recorded data. A PDP-12 computer is used to measure spectra which have been recorded on line from a high resolution spectrometer. The storage medium is addressable magnetic tape. The method of determining line centers involves mathematically reflecting or folding the spectrum about a line perpendicular to the wave number axis and examining the superposition of the reflected and original spectrum as well as their difference. The technique is similar to one applied to optical comparators for measuring photographic spectra. The computer is programmed to measure automatically the interferometer fringes used for calibration since these fringes are single, symmetrical, and of approximately equal height and spacing. The spectral lines are generally less uniform and are measured from the CRT display with operator interaction. Precision equal to or better than that achieved using other methods is obtained in much less time than previously required. The applicability of the method for measuring incompletely resolved lines will also be discussed. This work was supported by the National Science Foundation
Cardiovascular Risk Factors in an Eastern Caribbean Island: Prevalence of Non-communicable Chronic Diseases and Associated Lifestyle Risk Factors for Cardiovascular Morbidity and Mortality in the British Virgin Islands
Background: The epidemiological transition has seen a trend from communicable to non-com-municable diseases in developing countries. At the pinnacle of these chronic diseases is hypertension, pre-hypertension, diabetes and obesity. This leads to increased cardiovascular morbidity and mortality worldwide. In addition, environmental and behavioural changes such as lifestyle habits represent modifiable risk factors for the development of cardiovascular diseases. The Caribbean is not immune to this trend.
Methods: This was a cross-sectional survey conducted between June and September 2009 and involved individuals 15–74 years of age. Age-gender was weighted to get as close a representative sample of the general population living in the British Virgin Islands (BVI) for more than two years to a total of 301 (n = 301, M: 144, F: 157; CI 95% ± error 5%). The study was carried out using a handout ques-tionnaire that included variables on age, gender, socio-economic status (SES), income level, cigarette smoking, physical activity, weight, height, body mass index (BMI), blood pressure, fasting blood glucose and cholesterol.
Results: This study shows a prevalence of hypertension of 16.6%, pre-hypertension – 29.9%, diabetes mellitus – 10.0% [M: 5.6%, F: 14%, p 30) – 23.6% (M: 17.4%, F: 29.3%, p < 0.001) [all significantly higher in women], smoking habits – 16.6% and alcohol – 51.2% [significantly higher in men: 22.5% and 56.7%, respectively]. Of the respondents, 43.2% had a low/inactive physical activity level. Clustering of greater than one risk factor was more pronounced for women than for men 29.6% (M: 27.1%, F: 31.8%, p < 0.05). Sedentary lifestyle (low/inactive physical activity) and obesity were the only risk factors that had a positive correlation with all four chronic diseases (p < 0.05).
Conclusion: The above results indicate that a national strategy needs to be implemented to control cardiovascular diseases, educate the population and promote healthy lifestyle habits with particular attention to low physical inactivity and obesity.
Keywords: British Virgin Islands, cardiovascular risk, Eastern Caribbean, diabetes mellitus, hypertension, impaired fasting glucose, lifestyle, obesity, pre-hypertension
"Factores de Riesgo Cardiovascular en una isla del Caribe Oriental: Prevalencia de las Enfermedades Crónicas no Comunicables y Factores de Riesgo Asociados con el Estilo de Vida en Relación con la Morbilidad y la Mortalidad Cardiovasculares en las Islas VÃrgenes Británicas"
RESUMEN
Antecedentes: La transición epidemiológica ha visto una tendencia a pasar de enfermedades comunicables a enfermedades no comunicables en los paÃses en vÃas de desarrollo. En la cima de estas enfermedades crónicas se hallan la hipertensión, la pre-hipertensión, la diabetes y la obesidad. Esto conduce al aumento de la morbilidad y la mortalidad cardiovasculares a nivel mundial. Además, los cambios medioambientales y conductuales tales como los hábitos de estilo de vida, representan factores de riesgo modificables para el desarrollo de las enfermedades cardiovasculares. El Caribe no es ajeno a esta tendencia.
Métodos: Se trata de un estudio transversal llevado a cabo entre junio y septiembre de 2009, el cual incluyó individuos de 15–74 años de edad. Se ponderó la edad-género con el propósito de obtener una muestra tan representativa como fuera posible de la población general que vive en las Islas VÃrgenes Británicas (IVB) por más de dos años para un total de 301 (n = 301, M: 144, F: 157; CI 95% error ± 5%). El estudio fue llevado a cabo usando hojas informativas con un cuestionario que incluÃan las variables: edad, género, estatus socioeconómico (ESE), nivel de ingresos, hábito de fumar, actividad fÃsica, peso, altura, Ãndice de masa corporal (IMC), presión sanguÃnea, y prueba de colesterol y de glucosa en sangre en ayunas.
Resultados: Este estudio muestra una prevalencia de hipertensión de 16.6%, pre-hipertensión 29.9%, diabetes mellitus 10.0% [M: 5.6%, F: 14%, p 30) 23.6% (M: 17.4%, F: 29.3%, p < 0.001) [todos significativamente más altos en las mujeres], hábito de fumar 16.6% y consumo de alcohol 51.2% [significativamente más altos en los hombres 22.5% y 56.7%, respectivamente]. De los encuestados, el 43.2% tenÃan un nivel de actividad fÃsica inactivo/bajo. La existencia de más de un factor de riesgo fue más pronunciada en las mujeres que en los hombres 29.6% (M: 27.1%, F: 31.8%, p < 0.05). El estilo de vida sedentario (actividad fÃsica inactiva/baja) y la obesidad fueron los únicos factores de riesgo que tuvieron una correlación positiva con las cuatro enfermedades crónicas (p < 0.05).
Conclusión: Los resultados enumerados indican que es necesario implementar una estrategia nacional a fin de controlar las enfermedades cardiovasculares, educar, y promover hábitos de estilo de vida saludables con atención particular a la actividad fÃsica baja y la obesidad.
Palabras claves: Islas VÃrgenes Británicas, riesgo cardiovascular, Caribe oriental, diabetes mellitus, hipertensión, glucosa en ayunas alterada, estilo de vida, obesidad, pre-hipertensió