Baseline characteristics in the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes (original) (raw)
Related papers
Atherosclerosis, 2000
Hyperlipidemia is common in type 2 diabetic patients and is an independent risk factor for cardiovascular disease. The aim of this trial was to evaluate the efficacy and safety of once-daily atorvastatin 10 − 80 mg for the treatment of hyperlipidemia in type 2 diabetics with plasma low-density lipoprotein cholesterol (LDL-C) levels exceeding 3.4 mmol/l (130 mg/dl). One hundred and two patients met the study criteria and received 10 mg/day atorvastatin. Patients who reached the target LDL-C level of 52.6 mmol/l (100 mg/dl) maintained the same dosage regimen until they had completed 16 weeks of treatment. Patients not reaching the target LDL-C underwent dose titration to atorvastatin 20, 40 and 80 mg/day at Weeks 4, 8 and 12, respectively. All 88 patients who completed the study attained target LDL-C levels and 52 (59%) of patients achieved the target goal at the starting dose of atorvastatin 10 mg/day. In this group the differences between baseline and post-treatment values for LDL-C were 4.390.7 mmol/l (166 926 mg/dl) versus 2.2 90.4 mmol/l (87 914 mg/dl) (PB 0.0001), respectively, a decrease of 47%. Similar trends were observed for total cholesterol, triglycerides, very low-density lipoprotein cholesterol and apolipoprotein B levels. The safety profile of atorvastatin in these patients was highly favorable and similar to those reported with other statins. Only one patient withdrew due to a possible drug-related adverse event. These data confirm the marked efficacy and safety of atorvastatin in type 2 diabetic patients with hyperlipidemia and the efficacy of atorvastatin 10 mg in helping patients attain their LDL-C goal.
Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with Type 2 diabetes
Diabetic Medicine, 2002
Background There are few data on the role of lipid lowering in the primary prevention of coronary heart disease (CHD) in diabetic patients. This paper describes the design of a collaborative clinical trial between Diabetes UK, the NHS Research and Development Directorate and Pfizer UK, that addresses this question. Methods The Collaborative AtoRvastatin Diabetes Study (CARDS) is a multicentre, randomized, placebo-controlled, double-blind clinical trial of primary prevention of cardiovascular disease in patients with Type 2 diabetes. The primary objective is to investigate whether treatment with the hydroxymethylglutaryl coenzyme A reductase inhibitor, atorvastatin, reduces the incidence of major cardiovascular events. At entry patients have at least one other risk factor for CHD in addition to diabetes, namely current smoking, hypertension, retinopathy, or micro-or macroalbuminuria. At randomization patients have been selected for a serum low-density lipoprotein (LDL) cholesterol concentration ≤ 4.14 mmol / l (160 mg/dl) and triglycerides ≤ 6.78 mmol / l (600 mg /dl). Randomization was completed in June 2001. Patients will be followed until 304 primary endpoints have accrued (expected date early 2005). The trial includes 2838 men and women aged 40-75 years. This report describes the design and administration of the study and reviews the evidence to date of the effectiveness of lipid-lowering therapy in Type 2 diabetes. Conclusions The case for lipid-lowering therapy for the primary prevention of CHD in diabetes has not been demonstrated. CARDS will provide essential information on the extent of any benefits and adverse effects of lipid-lowering therapy in diabetic patients without prior CHD.
Atorvastatin Improves Endothelial Dysfunction in Patients with Controlled Type 2 Diabetes Mellitus
2014
Endothelial dysfunction occurs in diabetes which may improve with its control. Statins have been claimed to improve the endothelial dysfunction, independent of control of hyperglycemia in diabetics. Objective behind the study was to evaluate the effect of atorvastatin on endothelial function in patients with type 2 diabetes mellitus after achieving control (HbA1c<7.0%) with antidiabetic therapy. 50 patients with controlled type 2 diabetes mellitus (i.e. HbA1c<7.0%) received fixed dose atorvastatin 40mg/day and diabetic diet. Patients continued their antidiabetic therapy as usual. Target parameters i.e. serum lipids and brachial artery flow mediated vasodilatation (FMD) were measured at the beginning of study and repeated at 12 weeks. Serum lipid levels and flow mediated vasodilatation (FMD) improved significantly after 12 weeks of therapy with atorvastatin (p<0.001). The controlled status of the patients (i.e. HbA1c<7.0%) of the patients was maintained throughout the cou...
2005
The aim of this study was to determine whether HMGCoA reductase inhibitor with atorvastatin can modulate endothelial function in type II diabetics having average cholesterol and no prior cardiovascular disease. Material and Method: Type II diabetics, with no prior cardiovascular events and total cholesterol at admission of < 200 mg/dl or LDL < 140 mg/dl, were randomized to placebo (n = 20) or atorvastatin 20 mg daily (n = 22) for 30 weeks. Brachial artery endothelium-dependent dilatation or flow-mediated dilatation (FMD) and endothelium-independent dilatation or nitroglycerine-mediated dilatation (NTGMD) were measured at baseline and after thirty weeks of treatment. Results: Baseline clinical characteristics were similar at admission in both groups. After thirty weeks of treatment, the FMD did not significantly change in either the atorvastatin or placebo group (4.11 + 1.05% to 3.01 + 1.27% vs 5.75 + 1.93% to 6.45 + 1.41%, respectively; p = 0.46 by analysis of covariance). Similarly, the NTGM did not change in either group. Conclusion: The addition of HMGCoA reductase inhibitor with atorvastatin did not improve endothelial function in type 2 diabetes having average cholesterol with no prior cardiovascular disease, despite an improvement of the lipid profile.
Diabetologia, 2005
Aims/hypothesis: The aim of this study was to determine the pattern of the effect of the 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitor atorvastatin on cardiovascular events in patients with type 2 diabetes and no prior history of cardiovascular disease (CVD). Materials and methods: A post hoc analysis of data from the Collaborative Atorvastatin Diabetes Study (CARDS), a randomised, placebo-controlled trial of 2,838 patients with type 2 diabetes, was performed. Patients received atorvastatin (10 mg daily) or placebo and were evaluated for car-diovascular and other outcomes over a median follow-up period of 3.9 years. Cox proportional hazards modelling was carried out, and the hazard ratios calculated for various times after randomisation to treatment were investigated. Results: A reduction in the primary endpoint of major CVD events was apparent and statistically significant as soon as 18 months after treatment initiation. The effect of atorvastatin on CHD events was apparent by 6 months, and at 1 year was similar to the 37% relative risk reduction observed at trial closure. Conclusions/interpretation: Atorvastatin alters the pathogenesis of CVD rapidly, such that the effect on cardiovascular events is apparent within months of initiation of therapy.
International Journal of Medical Laboratory
Background and Aims: Atorvastatin may alter glycemic traits and lipid profiles. This study aimed to evaluate the effects of atorvastatin on biochemical variables in patients with type 2 diabetes and pre-diabetes (borderline diabetes). Materials and Methods: This study included 80 individuals divided into five groups. Patients with type 2 diabetes mellitus and pre-diabetes used atorvastatin 20 mg/day for three months. After three months, variables such as serum fasting blood glucose (FBS), cholesterol, triglyceride, low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), and glycosylated hemoglobin (HbA1c) levels were measured to assess the status of diabetes and pre-diabetes condition. Linear regression was applied to determine the association between atorvastatin uses and alters of biochemical variables levels. Results: The serum FBS and HbA1c levels in patients with diabetes and pre-diabetes who use atorvastatin were significantly lower than in p...
The lipid-lowering effect of atorvastatin in Taiwanese diabetic patients with hyperlipidemia
Tzu Chi Medical Journal, 2013
Objective: Patients with diabetes mellitus have an increased risk of coronary heart disease; however, many patients with diabetes remain untreated or undertreated for coronary heart disease risk factors. The incidence of type 2 diabetes is rapidly increasing in Taiwan. The aim of this study was to assess the lipid-lowering effects of atorvastatin in Taiwanese diabetic patients with hyperlipidemia. Materials and Methods: This 12-week open-label study, conducted at six hospitals in Taiwan, included 157 outpatients (aged 18e80 years old) with type 2 diabetes and concomitant hyperlipidemia. Individuals were randomized (1:1:1) to three dosage groups, as follows: 52 patients received 10 mg of atorvastatin per day; 52 patients received 20 mg of atorvastatin per day; and the remaining 53 patients received 40 mg of atorvastatin per day. Treatment targets were established according to the recommendations of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III. The response was evaluated by Cochran-Mantel-Haenszel tests. The change from the baseline level of all lipid parameters and high-sensitivity C-reactive protein (hs-CRP) was determined through analysis of covariance and was assessed at each time point. Results: The primary endpointda low-density lipoprotein-cholesterol (LDL-C) response of >100 mg/dL at Week 12dwas achieved in a dose-dependent manner. The percentage of patients improving to this level was higher in the 20 mg/day group (82%) and 40 mg/day group (82%) than in the 10 mg/day group (56%; p ¼ 0.002). The percentage of patients achieving the more aggressive LDL-C goal of >70 mg/dL was 9.6%, 31.4%, and 47.1% in the 10 mg/day, 20 mg/day, and 40 mg/day groups, respectively (p < 0.001 in 10 mg/ day vs. 20 mg/day; p < 0.001 in 10 mg/day vs. 40 mg/day). The co-primary endpointethe percent change from the baseline LDL-C levelealso increased in a dose-dependent manner: by 36.5% in the 10 mg/day group; by 44.7% in the 20 mg/day group, and by 49.3% in the 40 mg/day group. For every 10 mg increase in dose, an estimated 4.0% reduction in LDL-C and 3.5% reduction in total cholesterol could be achieved. Triglyceride levels were also lowered, but there were no clinically meaningful changes in the level of high-density lipoprotein-cholesterol or in hs-CRP. Fasting glucose and glycosylated hemoglobin levels were not affected. Treatment-related adverse events were infrequent and mostly mild. Conclusion: Atorvastatin is an effective and safe treatment for hyperlipidemia in Taiwanese diabetic patients. Most patients taking the drug are able to achieve NCEP ATP III-recommended treatment targets without any measurable effects on glycemic control.
Atorvastatin prevents type 2 diabetes mellitus—An experimental study
European Journal of Pharmacology, 2014
Recent reports of increased diabetes risk have raised concerns regarding the use of statins. The present study was therefore planned to clarify whether atorvastatin can prevent diabetes development in a rat model of type 2 diabetes mellitus. Eight week old male Wistar rats were randomized into three groups (n = 12 each group). Group A was given standard chow diet, while group B and group C were offered high sucrose diet. In addition to high sucrose diet, group C was given atorvastatin (20mg/kg/day) from beginning of study till 26th week. After 26 weeks, a low dose of streptozotocin (15 mg/kg, i.p.) was given to all 3 groups and further followed for 4 weeks. Oral glucose tolerance tests were done at week 4, 26 and week 30. Development of impaired glucose tolerance at week 26 (16.66% vs 100%, P = &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.001) and diabetes at week 30 (16.66% vs 81.81%, P = 0.002) was significantly lower in rats pretreated with atorvastatin along with high sucrose diet viz group C compared to group B rats who received high sucrose diet only respectively. Also, metabolic indices like body weight, hypertriglyceridemia, glucose area under the curve (Gl-AUC) were significantly lower in group C compared to group B (P = &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.05) while insulin resistance (HOMA-IR) was also lower in group C (P = 0.05). This study clearly demonstrates for the first time in a rat model of type 2 diabetes mellitus that atorvastatin prevents development of type 2 diabetes.