scholarly journals Lower is better: ENHANCE affair

2016 ◽  
Vol 70 (2) ◽  
Author(s):  
Sabino Scardi ◽  
Paolo Umari ◽  
Bianca Maria D’Agata
Keyword(s):  
Carotid Arteries ◽  
Ldl Cholesterol ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Pharmaceutical Companies ◽  
Atherosclerotic Plaques ◽  
American Government ◽  
Wall Street ◽  
Media Thickness ◽  
Scientific Associations

Ezetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of atherosclerotic plaques. The protocol tested the use of simvastatin 80 mg + placebo versus simvastatin 80 mg + ezetimibe 10 mg in 720 randomized patients. Both drugs were well tolerated. Combination therapy was associated with a larger reduction in LDL cholesterol, but there were no differences in the intima-media thickness measured at three sites in the carotid arteries, nor differences in cardiovascular events between the two groups in the trial. These results provoked disappointment of sponsors (Merck, Schering Plough) who, although the results of the trial were available since march 2007, delayed official communication of about 18 months. This led to speculations and rumors among media, American Government, cardiologic scientific associations, and consequences in the Ezetimibe market and at Wall Street. In particular, the American College of Cardiology didn’t accept the communication of ENHANCE results to the Late Breaking Trial Session of the Chicago congress, diverting it to another secondary forum. In conclusion, the experience of the ENHANCE trial suggests to pharmaceutical companies, researchers, clinicians, scientific companies and media a deep meditation in order to avoid in the future similar problems in the management of results of medical research.

scholarly journals Evaluation of Clinical Variables Associated with Increased Carotid Intima-Media Thickness in Middle-Aged Hypertensive Women

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Michelle Trindade ◽  
Renata Brum Martucci ◽  
Adriana K. Burlá ◽  
Wille Oigman ◽  
Mario Fritsch Neves ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Pulse Pressure ◽  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Independent Variables ◽  
Vascular Ultrasound ◽  
Media Thickness

It has been previously documented that carotid intima-media thickness (cIMT) is a predictor of cardiovascular disease. The aim of this study was to identify clinical parameters associated with an increased cIMT treated hypertensive women. Female patients (n=116) with essential hypertension, aged 40–65 years, were included in this study. Vascular ultrasound was performed and the patients were divided into two groups according to the values of cIMT (< or ≥0.9 mm). Patients with greater cIMT presented significantly higher systolic blood pressure and pulse pressure. Serum HDL-cholesterol was significantly lower and CRP was significantly higher in the same group. There was a significant correlation between cIMT and age (r=0.25,P=0.007), systolic blood pressure (r=0.19,P=0.009), pulse pressure (r=0.30,P=0.001), and LDL-cholesterol (r=0.19,P=0.043). cIMT was correlated to CRP (r=0.31,P=0.007) and negatively correlated to HDL-cholesterol (r=0.33,P=0.001). In logistic regression, only HDL-cholesterol, CRP, and pulse pressure were shown to be independent variables associated to increased cIMT. In conclusion, pulse pressure, HDL-cholesterol, and CRP are variables correlated with cIMT in treated hypertensive women.

Effects of magnesium supplementation on carotid intima–media thickness and metabolic profiles in diabetic haemodialysis patients: a randomised, double-blind, placebo-controlled trial

2019 ◽  
Vol 121 (7) ◽  
pp. 809-817 ◽  
Author(s):  
Hamid Reza Talari ◽  
Mehrafrouz Zakizade ◽  
Alireza Soleimani ◽  
Fereshteh Bahmani ◽  
Amir Ghaderi ◽  
...  
Keyword(s):  
Total Cholesterol ◽  
Ldl Cholesterol ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Insulin Metabolism ◽  
Double Blind Placebo ◽  
Media Thickness ◽  
Hs Crp

AbstractThis study evaluated the effects of Mg administration on carotid intima–media thickness (CIMT), glycaemic control and markers of cardio-metabolic risk in diabetic haemodialysis (HD) patients. This randomised, double-blind, placebo-controlled clinical trial was conducted in fifty-four diabetic HD patients. Participants were randomly divided into two groups to take either 250 mg/d Mg as magnesium oxide (n27) or placebo (n27) for 24 weeks. Mg supplementation resulted in a significant reduction in mean (P<0·001) and maximum levels of left CIMT (P=0·02) and mean levels of right CIMT (P=0·004) compared with the placebo. In addition, taking Mg supplements significantly reduced serum insulin levels (β=–9·42 pmol/l; 95% CI –14·94, –3·90;P=0·001), homoeostasis model of assessment-insulin resistance (β=–0·56; 95 % CI –0·89, –0·24;P=0·001) and HbA1c (β=–0·74 %; 95 % CI –1·10, –0·39;P<0·001) and significantly increased the quantitative insulin sensitivity check index (β=0·008; 95 % CI 0·002, 0·01;P=0·002) compared with the placebo. In addition, Mg administration led to a significant reduction in serum total cholesterol (β=–0·30 mmol/l; 95% CI –0·56, –0·04;P=0·02), LDL-cholesterol (β=–0·29 mmol/l; 95% CI –0·52, –0·05;P=0·01), high-sensitivity C-reactive protein (hs-CRP) (P<0·001) and plasma malondialdehyde (MDA) (P=0·04) and a significant rise in plasma total antioxidant capacity (TAC) levels (P<0·001) compared with the placebo. Overall, we found that taking Mg for 24 weeks by diabetic HD patients significantly improved mean and maximum levels of left and mean levels of right CIMT, insulin metabolism, HbA1c, total cholesterol and LDL-cholesterol, hs-CRP, TAC and MDA levels.

Abstract P298: Relationship Of Plasma Asymmetrical Dimethylarginine To Carotid Intima-media Thickness In General Japanese Population: The ERA-JUMP And The SESSA

Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Shin-ya Nagasawa ◽  
Katsuyuki Miura ◽  
Akira Fujiyoshi ◽  
Aya Kadota ◽  
Takayoshi Ohkubo ◽  
...  
Keyword(s):  
Linear Regression ◽  
Regression Models ◽  
Carotid Arteries ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Population Based ◽  
Linear Regression Models ◽  
Media Thickness ◽  
Plasma Adma ◽  
Relationship Of

Objective: Asymmetrical dimethylarginine (ADMA), an endogenous nitric oxide synthase inhibitor, is known as a mediator of endothelial cell dysfunction. Some clinical studies have found evidence that increased plasma ADMA levels are associated with a higher risk of cerebrovascular events. However, studies on the relationship of plasma ADMA to subclinical atherosclerosis have been scarce. We evaluated the association of ADMA with carotid intima-media thickness (IMT) in population-based samples in Japan. Methods: Population-based Japanese samples composed of 313 men aged 40-49 (40s men) from the ERA-JUMP and 732 men aged 60-79 (60s+70s men) from the SESSA were examined with physical examinations, life-style questionnaires, laboratory assessment and IMT using standardized methods. Plasma samples were stored at -80°C, and concentration of ADMA was determined using a validated high-throughput liquid chromatographic-tandem mass spectrometric assay. The IMTs of the right and left common carotid arteries, the carotid bulbs, and the internal carotid arteries were examined. Statistical associations were evaluated using multiple linear regression models with adjustment for age, body mass index, systolic blood pressure, LDL-cholesterol, HDL-cholesterol, fasting blood glucose, smoking, alcohol intake, medications for hypertension, hyperlipidemia, or diabetes, and estimated glomerular filtration rate (eGFR) . Results: The average concentrations and standard deviation (SD) of plasma ADMA in men aged 40-49 and 60-79 were 0.39 ± 0.06 and 0.43 ± 0.06 μmol/L, respectively. The mean and SD of IMT in men aged 40-49 and 60-79 were 0.61 ± 0.07 and 0.91 ± 0.20 mm, respectively. Higher level of ADMA was significantly and positively associated with proportion of current smoking both in 40s and 60s+70s men (correlation coefficient: both p <0.001). It was also significantly and positively associated with eGFR in 60s+70s men (p <0.001) but not associated with eGFR in 40s men (p = 0.429). In full adjusted linear regression models, 1 SD increase in ADMA was associated with 0.14mm increase in IMT in 40s men (p=0.01) but only 0.04mm increase in IMT in 60s+70s men (p=0.26). Conclusions: Higher level of ADMA was associated with more IMT independently of traditional risk factors and renal function in young adult men, but not in elderly men.

Relation of Intima-Media Thickness to Atherosclerotic Plaques in Carotid Arteries

1996 ◽  
Vol 16 (2) ◽  
pp. 310-316 ◽  
Author(s):  
Claire Bonithon-Kopp ◽  
Pierre-Jean Touboul ◽  
Claudine Berr ◽  
Chantal Leroux ◽  
Francine Mainard ◽  
...  
Keyword(s):  
Carotid Arteries ◽  
Intima Media Thickness ◽  
Atherosclerotic Plaques ◽  
Media Thickness

scholarly journals Intima-media thickness of the common carotid arteryas an early marker of atherosclerosis in patients withabdominal obesity

2008 ◽  
Vol 14 (1) ◽  
pp. 71-76
Author(s):  
O. Belyaeva ◽  
V. Mandal ◽  
N. Ananyeva ◽  
O. Berkovich ◽  
E. I. Baranova ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Carotid Arteries ◽  
Internal Carotid ◽  
Intima Media Thickness ◽  
Atherosclerotic Plaques ◽  
Duplex Scan ◽  
Media Thickness ◽  
The Common ◽  
Common Carotid Arteries ◽  
Internal Carotid Arteries

Severity of atherosclerosis of common carotid arteries in patients with abdominal obesity (aged from 30 to 55 years old) was evaluated by ultrasound duplex scan. Atherosclerotic plaques of common and/or internal carotid arteries were revealed in 35% of patients. Correlations were observed between intima-media thickness of the common carotid artery, blood pressure levels, waist circumference and metabolic parameters.

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