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Clinical insights from the Treating to New Targets trial.
Waters, DD
Progress in cardiovascular diseases. 2009;(6):487-502
Abstract
The Treating to New Targets (TNT) trial enrolled 10,001 patients with coronary disease to treatment with atorvastatin, 80 or 10 mg/d, and observed them for a median of 4.9 years. Mean low-density lipoprotein cholesterol (LDL-C) levels were 77 mg/dL in the 80-mg group and 101 mg/dL in the 10-mg group. The primary end point, a composite of cardiovascular death, myocardial infraction, resuscitated cardiac arrest, and stroke, occurred in 10.9% of patients in the 10-mg and 8.7% of patients in the 80-mg group (P = .0002). In large subgroups of patients in TNT, specifically those with diabetes, the metabolic syndrome, chronic kidney disease, or previous coronary bypass (CABG) surgery, the risk of an event was significantly higher than in patients without these features. The absolute risk reduction in the 80-mg group was greater in each of these subgroups than in other TNT patients. The rates of stroke and hospitalization for heart failure were significantly lower in the more aggressively treated patients. A total of 18,696 patients have taken 80 mg of atorvastatin in clinical trials, usually for 4 to 5 years, with an excellent safety record. Pharmacoeconomic studies indicate that treatment with the 80-mg dose instead of the 10-mg dose almost costs neutral in US TNT-like patients (additional cost $181 for 5 years). In summary, wider use of the 80-mg dose of atorvastatin in patients with stable coronary disease is safe, cost-effective, and provides an incremental reduction in coronary events.
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Improvement in lipid profiles over 6 years of follow-up in adults with AIDS and immune reconstitution.
Williams, P, Wu, J, Cohn, S, Koletar, S, McCutchan, J, Murphy, R, Currier, J, ,
HIV medicine. 2009;(5):290-301
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Abstract
OBJECTIVES The aim of the study was to evaluate long-term changes in lipids and to assess other coronary heart disease (CHD) risk factors in highly experienced AIDS patients with immune reconstitution, and to examine their association with antiretroviral therapy (ART). METHODS We evaluated 433 AIDS patients with prior severe immunosuppression and ART-based immune reconstitution, followed in a multicentre prospective observational study between 2000 and 2006. We estimated the prevalence at entry of hypercholesterolaemia and metabolic syndrome, and 10-year CHD risks. Trends in total cholesterol (TC), triglycerides (TG) and high-density lipoprotein (HDL) cholesterol were evaluated over time, and use of specific ART drugs at each study visit was assessed using mixed effect models, adjusting for CHD risk factors and use of lipid-lowering agents. RESULTS At entry to observational follow-up, 28% of the 433 subjects had hypercholesterolaemia and 15% had a predicted 10-year CHD risk above 20%. Average TC and fasting TG levels declined over the follow-up period (median=5.8 years), and these declines were associated with increased use of physician-prescribed lipid-lowering agents and changes in ART regimens. After adjustment for CHD risk factors, TC and TG levels were significantly higher for those on ritonavir-boosted protease inhibitors and those on nonnucleoside reverse transcriptase inhibitors (NNRTIs), particularly efavirenz, than for other patients. CONCLUSIONS Abnormalities in serum lipids were common at baseline but became less so over time, and this improvement was associated with increased use of lipid-lowering agents and selection of ART agents with less deleterious effects on lipids.
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Metformin improves skin capillary reactivity in normoglycaemic subjects with the metabolic syndrome.
Kraemer de Aguiar, LG, Laflor, CM, Bahia, L, Villela, NR, Wiernsperger, N, Bottino, DA, Bouskela, E
Diabetic medicine : a journal of the British Diabetic Association. 2007;(3):272-9
Abstract
AIMS: Insulin resistance and a parental history of diabetes mellitus are independently associated with endothelial dysfunction. Oxidative stress has a pivotal role in the pathophysiology of vascular injury. Metformin, in addition to its glucose-lowering properties, has vasculoprotective effects. We investigated whether metformin has beneficial effects on the nutritive skin capillary circulation and deceases oxidative stress in a group at high risk for Type 2 diabetes mellitus (T2DM) and cardiovascular disease. METHODS Thirty normoglycaemic subjects with the metabolic syndrome (MS),who had first-degree relatives with T2DM, participated. The mean age was 39.1 +/- 8.4 years and body mass index (BMI) 35.7 +/- 4.8 kg/m2 (mean +/- SD). SUBJECTS were randomized 1 : 1 to receive placebo (n=14) or metformin (n=16; 1700 mg/day) in a double-blind study. At baseline and post treatment, blood and urine samples were collected for biochemical and 8-epi-prostaglandin F2alpha (8-epi-PGF2alpha) analysis, respectively. Microcirculation was assessed by nailfold videocapillaroscopy, analysing afferent (AF), efferent (EF) and apical (AP) diameters of capillary loops, functional capillary density (FCD), red blood cell velocity at rest (RBCV), after 1 min arterial occlusion (RBCVmax) and time (TRBCVmax)taken to reach it. RESULTS Groups did not differ significantly in anthropometric, clinical, laboratory or microvascular measurements at baseline. In the metformin group, weight,BMI, systolic blood pressure and fasting plasma glucose fell, and lipid profile and microcirculatory parameters FCD, AF, EF, AP, RBCVmaxand TRBCVmax improved (all P<0.01). No relationship between clinico-laboratory parameters and microvascular reactivity was observed, except for changes in total and low density lipoprotein-cholesterol and RBCVmax* 8-epi-PGF2alpha did not change significantly in either group. CONCLUSIONS Metformin improved skin capillary reactivity in normoglycaemic MS subjects independently of significant changes in 8-epi-PGF2alpha levels.
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Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial.
Kuller, LH, Kinzel, LS, Pettee, KK, Kriska, AM, Simkin-Silverman, LR, Conroy, MB, Averbach, F, Pappert, WS, Johnson, BD
Journal of women's health (2002). 2006;(8):962-74
Abstract
OBJECTIVES In this paper, we present the results of changes in risk factors by use of hormone therapy (HT) at 18 months in the Women On the Move through Activity and Nutrition (WOMAN) randomized trial. METHODS The trial was designed to test the hypothesis that aggressive dietary changes and increased physical activity to reduce weight, waist circumference (WC), glucose, insulin, and lipoproteins would reduce progression of subclinical atherosclerosis, carotid intimal media thickness and plaque, coronary artery calcification, and pulse wave velocity (PWV). The study focused on postmenopausal women (n = 508), mean age of 57, who were randomized to the Lifestyle Change (LC) or Health Education (HE) group. RESULTS At 18 months of follow-up, there was significant, 17 lb, weight loss and 10 cm WC decrease in the LC group. There were significant differences in changes in low-density lipoprotein cholesterol (LDL-C), insulin, glucose, large LDL, and LDL particles between the LC and HE groups. Risk factor changes were greater for women in the LC who lost a significant amount of weight (>or=18.8 lb). Participants at 18 months were subdivided into women who had stayed on HT, 125 (28%); stopped HT after randomization, 145 (33%); and not on HT at baseline but stopped an average of 7 months prior to randomization, 173 (39%). Weight loss in the LC was similar for all three groups, but LDL lipoprotein response was better for women who stopped HT after randomization or were not on HT at baseline. CONCLUSIONS The trial has been successful in increasing exercise and diet changes and reduction in weight and WC and variables related to metabolic syndrome.
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Reduction of cardiovascular events by simvastatin in nondiabetic coronary heart disease patients with and without the metabolic syndrome: subgroup analyses of the Scandinavian Simvastatin Survival Study (4S).
Pyörälä, K, Ballantyne, CM, Gumbiner, B, Lee, MW, Shah, A, Davies, MJ, Mitchel, YB, Pedersen, TR, Kjekshus, J, ,
Diabetes care. 2004;(7):1735-40
Abstract
OBJECTIVE To assess the effect of simvastatin treatment on the risk of cardiovascular events in nondiabetic patients with coronary heart disease (CHD) with and without the metabolic syndrome, as defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP-III). RESEARCH DESIGN AND METHODS Subgroup analyses were performed on data from 3933 nondiabetic patients with clinically established CHD, serum total cholesterol level 5.5-8.0 mmol/l, and serum triglyceride level RESULTS Over the 5.4-year median follow-up period, simvastatin produced similar changes in serum lipid levels in 893 patients with the metabolic syndrome and in 3040 patients without the metabolic syndrome. The relative risks of main end points in simvastatin-treated patients compared with placebo-treated patients with the metabolic syndrome were as follows: total mortality 0.54 (95% CI 0.36-0.82), coronary mortality 0.39 (0.23-0.65), major CHD event 0.59 (0.45-0.77), and any atherosclerotic event 0.69 (0.56-0.84). The corresponding RRs in patients without the metabolic syndrome were 0.72 (0.56-0.91), 0.62 (0.45-0.84), 0.71 (0.61-0.82), and 0.76 (0.68-0.85). CONCLUSIONS Nondiabetic CHD patients with or without the metabolic syndrome realize from simvastatin treatment a similar, substantial relative reduction in the risk of cardiovascular events. The absolute benefit may be greater in patients with the metabolic syndrome because they are at a higher absolute risk.