Aged garlic extract supplemented with B vitamins, folic acid and L-arginine retards the progression of subclinical atherosclerosis: a randomized clinical trial.

OBJECTIVES: Previous studies demonstrated that aged garlic extract reduces multiple cardiovascular risk factors. This study was designed to assess whether aged garlic extract therapy with supplements (AGE+S) favorably affects inflammatory and oxidation biomarkers, vascular function and progression of atherosclerosis as compared to placebo. METHODS: In this placebo-controlled, double-blind, randomized trial (conducted 2005-2007), 65 intermediate risk patients (age 60+/-9 years, 79% male) were treated with a placebo capsule or a capsule containing aged garlic extract (250 mg) plus Vitamin B12 (100 microg), folic acid (300 microg), Vitamin B6 (12.5 mg) and l-arginine (100 mg) given daily for a 1 year. All patients underwent coronary artery calcium scanning (CAC), temperature rebound (TR) as an index of vascular reactivity using Digital Thermal Monitoring (DTM), and measurement of lipid profile, autoantibodies to malondialdehyde (MDA)-LDL, apoB-immune complexes, oxidized phospholipids (OxPL) on apolipoprotein B-100 (OxPL/apoB), lipoprotein (a) [Lp (a)], C-reactive protein (CRP), homocysteine were measured at baseline and 12 months. CAC progression was defined as an increase in CAC>15% per year and an increase in TR above baseline was considered a favorable response. RESULTS: At 1 year, CAC progression was significantly lower and TR significantly higher in the AGE+S compared to the placebo group after adjustment of cardiovascular risk factors (p<0.05). Total cholesterol, LDL-C, homocysteine, IgG and IgM autoantibodies to MDA-LDL and apoB-immune complexes were decreased, whereas HDL, OxPL/apoB, and Lp (a) were significantly increased in AGE+S to placebo. CONCLUSION: AGE+S is associated with a favorable improvement in oxidative biomarkers, vascular function, and reduced progression of atherosclerosis.

Cardiac computed tomographic angiography in an outpatient setting: an analysis of clinical outcomes over a 40-month period.

BACKGROUND: Cardiac computed tomographic angiography (CTA) provides for accurate noninvasive diagnosis of coronary artery disease (CAD). OBJECTIVES: We analyzed the clinical outcomes over 40 months in patients with and without CAD as determined by CTA in an outpatient setting. METHODS: Consecutive symptomatic patients (n = 493; mean age, 58 +/- 15 years; 70% men) with an intermediate likelihood of CAD referred for outpatient CTA evaluation were prospectively followed for a mean of 40 +/- 9 months. RESULTS: Results of CTA included as normal (defined as normal coronary lumen), found in 32% (157), nonobstructive disease (<50% luminal stenosis) in 41% (204), obstructive disease (>or=50% luminal stenosis) in 19% (93). Eight percent (n = 39) had >or=1 major nondiagnostic coronary artery segment. Follow-up identified 21 patients with myocardial infarction (MI) in the significant obstructive CAD and nondiagnostic group. No patients with either normal coronary arteries or nonobstructive disease experienced an MI during follow-up. The 40-month event-free survival was 100% for both the normal and nonobstructive disease groups, 97.5% for the nondiagnostic study group, and 79% for the group with obstructive CAD. After adjustment for age, sex, diabetes mellitus, hypertension, hypercholesterolemia, and baseline coronary artery calcium (CAC), a stepwise multivariable model (Cox regression) showed that obstructive CAD was an independent predictor of cardiac events and had significant incremental value over clinical risk factors and CAC (HR = 16.6; 95% CI, 4.9-55.2; P = 0.0001). CONCLUSION: In symptomatic patients with an intermediate likelihood of CAD referred for CTA, normal coronary arteries or nonobstructive CAD portends an excellent prognosis. The finding of obstructive CAD identifies patients at higher risk of subsequent MI, independent of cardiovascular risk factors and coronary artery calcium.

Effects of sevelamer and calcium-based phosphate binders on lipid and inflammatory markers in hemodialysis patients.

INTRODUCTION: Cardiovascular disease accounts for almost half of all deaths in individuals with chronic kidney disease stage 5 despite advances in both dialysis treatment and cardiology. A combination of lipid-lowering and anti-inflammatory effects along with avoidance of hypercalcemia should be taken into account when choosing phosphorus binders for maintenance hemodialysis (MHD) patients. METHODS: We examined the association of sevelamer versus calcium-based phosphorus binders with lipid profile, inflammatory markers including C-reactive protein (CRP), and mineral metabolism in MHD patients who participated in the Nutritional and Inflammatory Evaluation of Dialysis Patients (NIED) study from October 2001 to July 2005. RESULTS: Of the 787 MHD patients in the NIED study, 697 were on either sevelamer, a calcium-based binder, or both and eligible for this study. We compared the groups based on taking sevelamer monotherapy (n = 283) or calcium binder monotherapy (n = 266) for serum phosphate control. There were no differences between the groups on dialysis vintage. There were significant differences in age, serum calcium and phosphorus levels, as well as intact parathyroid hormone levels. Using a logistic regression models, the sevelamer group had a higher odds of serum CRP <10 mg/l [odds ratio (OR): 1.06, 95% CI: 1.02-1.11] and LDL cholesterol <70 mg/dl (OR: 1.33, 95% CI: 1.19-1.47) when compared to the calcium binder group independent of age, vintage, body mass index, statin use or other variables. CONCLUSION: The improvements in multiple surrogate markers of inflammation and lipids in the NIED study make sevelamer a promising therapy for treatment in MHD patients with high risk of cardiovascular disease and mortality.