The association of on study lowdensity lipoprotein ldl cholesterol and cv events by gender was evaluated in the combined studies and the impact of gender on adverse events in each study separately. Patients with type 2 diabetes mellitus have a high risk of developing cardiovascular cv disease. Are statin trials in diabetes representative of realworld. Action to control cardiovascular risk in diabetes eye study research group. Population 56 963 patients with diabetes initiating statin use from 2005 to 2008. Cards is designed to show if lowering cholesterol with atorvastatin in type 2 diabetics without cv disease reduces the risk of cv events cards the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Statin use and risk of diabetes mellitus in postmenopausal. The collaborative atorvastatin diabetes study cards was a doubleblind, randomized, placebocontrolled, multicenter trial of atorvastatin 10 mgday for the primary prevention of cvd in type 2 diabetes.
Pdf effects of atorvastatin on kidney outcomes and. Reduce the risk of mi, stroke, revascularization procedures, and angina in patients without chd, but with multiple risk factors reduce the risk of mi and stroke in patients with type 2 diabetes without chd, but with multiple risk factors. Safety of atorvastatin in the collaborative atorvastatin. Stroke prediction and stroke prevention with atorvastatin in. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes cards overview 1 a multicenter randomized placebo controlled trial to determine hard outcomes of atorvastatin 10mg vs. Comparison of rosuvastatin and atorvastatin for lipid. The primary objective is to investigate whether treatment with the hydroxymethylglutaryl coenzyme a reductase inhibitor, atorvastatin, reduces the incidence of major cardiovascular events. We examined whether atorvastatin affects diabetic kidney disease and whether the effect of atorvastatin on cardiovascular disease cvd varies by kidney status in patients with diabetes.
Ezetimibe added to statin therapy after acute coronary. The collaborative atorvastatin diabetes study cards is the first large primary prevention study to focus specifically on the role of a statin in patients aged 4075 years with type 2 diabetes, but no signs or symptoms of pre. Dec 17, 2008 apolipoproteins, cardiovascular risk and statin response in type 2 diabetes. In the collaborative atorvastatin diabetes study cards, the effect of lipitor atorvastatin calcium on cardiovascular disease cvd endpoints was assessed in 2838. Atorvastatin was recently approved for the latter indication in france, based on the results of the collaborative atorvastatin diabetes study cards 2 3 4. The collaborative atorvastatin diabetes study cards is the first large primary prevention study to focus specifically on the role of a statin in patients aged 4075 years with type 2 diabetes, but no signs or symptoms of preexisting vascular disease and who had only average or below average cholesterol levels. Pdf design of the collaborative atorvastatin diabetes study. Abstract background there are few data on the role of lipid lowering in the primary prevention of coronary heart disease chd in diabetic. An overview of cards collaborative atorvastatin diabetes study.
Pdf baseline characteristics in the collaborative atorvastatin. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Atorvastatin reduced major cardiovascular disease events in type 2 diabetes mellitus colhoun hm, betteridge dj, durrington pn, et al. Atorvastatin reduced major cardiovascular disease events in. Collaborative atorvastatin diabetes study american. In the collaborative atorvastatin diabetes study cards, the effect of lipitor atorvastatin calcium on cardiovascular disease cvd endpoints was assessed in 2838 5. An analysis from the collaborative atorvastatin diabetes study cards author links open overlay panel helen m. The goal of the collaborative atorvastatin diabetes study cards trial was to determine the effectiveness of the lipidlowering agent atorvastatin in reducing cardiovascular events and death among diabetic patients with at least one heart disease risk factor, but without elevated cholesterol. Apr 23, 2019 lipitor passes into breast milk and could harm a nursing baby. Breastfeeding while taking lipitor is not recommended. The clinical benefit of use of statins in patients with type 2 diabetes has been demonstrated in several randomized, controlled trials, including the cards clinical trial. Trials like the collaborative atorvastatin diabetes study cards, proved beyond doubt that patients with type 2 diabetes and other risk factors for cvd should be treated with a statin, apparently disregarding their. This enzyme catalyzes the conversion of hmgcoa to mevalonate, an early and ratelimiting step in cholesterol biosynthesis.
Costeffectiveness of primary prevention of cardiovascular. Objective to assess the representativeness of the heart protection study hps and the collaborative atorvastatin diabetes study cards for incident statin users. Major cv events occurred in 3,083 of 30,000 men 10. No justification is available for having a particular threshold level of ldlcholesterol as the sole arbiter of which patients with type 2 diabetes should receive statins. The collaborative atorvastatin diabetes study cards is the first large primary prevention study to focus specifically on the role of a statin in patients aged 4075 years with type 2 diabetes. Atorvastatin calcium tablet is an inhibitor of hmgcoa reductase statin indicated as an adjunct therapy to diet to. The trial was stopped 2 years earlier than planned because of significant benefit at the second interim analysis. Analysis of efficacy and safety in patients aged 65.
The collaborative atorvastatin diabetes study cards recently established that treatment of type 2 diabetic patients with atorvastatin 10 mg. Safety of atorvastatin in the collaborative atorvastatin diabetes study cards the safety and efficacy of sta the safety and efficacy of statins for cvd prevention is well established, yet some physicians have concerns about the longterm safety of this class. Lipitor atorvastatin calcium tablets description lipitor atorvastatin calcium is a synthetic lipidlowering agent. Pdf primary prevention of cardiovascular disease with. Based on the clinical cards data, the favourable cost effectiveness of atorvastatin 10mg in.
The aim of this study was to evaluate the effect of atorvastatin on lipid lowering, cardiovascular cv events, and adverse events in women compared with men in 6 clinical trials. Baseline characteristics in the collaborative atorvastatin. Aug 21, 2004 atorvastatin 10 mg daily is safe and efficacious in reducing the risk of first cardiovascular disease events, including stroke, in patients with type 2 diabetes without high ldlcholesterol. An overview of cards collaborative atorvastatin diabetes study primary prevention of cardiovascular disease with atorvastatin in type 2. Cvd 46, but the costeffectiveness of statins in the primary prevention of cvd in people with diabetes has not been assessed adequately. The aim of the collaborative atorvastatin diabetes. Rapid emergence of effect of atorvastatin on cardiovascular. Development of lifeexpectancy tables for people with type 2. To estimate the costeffectiveness of atorvastatin 10 mg compared with no treatment for the primary prevention of. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the collaborative atovastatin diabetes study cards. Hitman was copi and rotating chair of the academically led cards study in type 2 diabetes 5. The overall safety profile of atorvastatin was similar between agegroups. Atorvastatin reduced cv events even in low ldl dm patients.
Study cards was to assess the effectiveness of 10 mg of atorvastatin daily versus placebo. Primary prevention of cardiovascular disease with atorvastatin in. The collaborative atorvastatin diabetes study cards is a multicentre, randomized, placebocontrolled, doubleblind clinical trial of primary prevention of cardiovascular disease in patients with type 2 diabetes. Colhoun hm1, betteridge dj, durrington pn, hitman ga, neil ha, livingstone sj, thomason mj, mackness mi, charltonmenys v, fuller jh. Impact of female sex on lipid lowering, clinical outcomes. Lipitor atorvastatin calcium clinical studies pfizer. Collaborative atorvastatin diabetes study american college. The safety and tolerability of atorvastatin 10 mg in the collaborative. The collaborative atorvastatin diabetes study cards, comparing treatment with atorvastatin lipitor, pfizer inc with placebo in 2800 patients with type 2 diabetes but without overt heart.
Patients with type 2 diabetes and no prior cvd n 2,838. Openurl1crossref2pubmed3web of science4 q in patients with type 2 diabetes mellitus, is atorvastatin better than. Ironically, there is a very compelling clinical trial showing the value of one statin, lipitor atorvastatin, in type 2 diabetes the collaborative atorvastatin diabetes study known as cards. Effects of atorvastatin on kidney outcomes and cardiovascular disease in patients with diabetes. Based on the clinical cards data, the favourable cost effectiveness of atorvastatin 10 mg in patients with type 2 diabetes has been demonstrated in countries such as the uk and france. Design of the collaborative atorvastatin diabetes study. Feb 11, 2011 the american diabetes association has recommended using statins a class of drug used to lower cholesterol levels for patients with type 2 diabetes. The primary objective is to investigate whether treatment with the hydroxymethylglutaryl coenzyme a reductase inhibitor.
The collaborative atorvastatin diabetes study cards is the first large primary prevention study to focus specifically on the role of a statin in patients aged 4075 years with type 2 diabetes, but no signs or symptoms of preexisting vascular disease and who had only. Colhoun hm, betteridge dj, durrington pn, hitman ga, neil ha, livingstone sj, thomason mj, mackness mi, charltonmenys v, fuller jh and cards investigators. The forecasts of this model have been shown to closely predict events in other diabetic populations such as patients participating in the collaborative atorvastatin diabetes study 19 and in the proactive study. An analysis from the collaborative atorvastatin diabetes study cards. Our lipitor side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. In the collaborative atorvastatin diabetes study cards, the effect of lipitor on cardiovascular disease cvd endpoints was assessed in 2838 subjects 94% white, 68% male, ages 4075 with type 2 diabetes based on who criteria, without prior history of cardiovascular disease and with ldl. The collaborative atorvastatin diabetes study cards is a multicentre, randomized, placebocontrolled, doubleblind clinical trial of primary. Atorvastatin, sold under the brand name lipitor among others, is a statin medication used to prevent cardiovascular disease in those at high risk and treat abnormal lipid levels. American diabetes association indications for statins in. We conducted a post hoc analysis to compare the efficacy and safety of atorvastatin among 1,129 patients aged 6575 years at randomization with 1,709 younger patients in the collaborative atorvastatin diabetes study cards. The objective of this study was to evaluate the safety and tolerability of atorvastatin 10 mg compared with placebo in 2,838 patients with type 2 diabetes and no history of coronary heart disease who were enrolled in the collaborative atorvastatin diabetes study cards. Oct 30, 2008 controversy surrounds whether the ratio of apolipoprotein b apob to apolipoprotein ai apoai is the best lipoprotein discriminator of chd risk in nondiabetic populations, but the issue has never been investigated in type 2 diabetes. This is not a complete list of side effects and others may occur. Effects of atorvastatin on kidney outcomes and cardiovascular.
Ofthe collaborative atorvastatin diabetes study cards inthe belgian population marbaix s1,vandenberghe h1,van gaal l2 1p. Atorvastatin is an inhibitor of 3hydroxy3methylglutarylcoenzyme a hmgcoa reductase. Collaborative atorvastatin diabetes study cards and fol lowed for 3. The collaborative atorvastatin diabetes study cards is the first randomized controlled trial that assessed the effectiveness and safety of using atorvastatin in patients with type 2 diabetes. Although the study was not powered for a direct comparison between the two statins, results of both planet i and ii suggest that atorvastatin and rosuvastatin have different renal profiles in patients with proteinuria, whereas the effects on lipids are similar, with a larger effect of rosuvastatin 40 mg than of atorvastatin 80 mg. The american diabetes association has recommended using statins a class of drug used to lower cholesterol levels for patients with type 2 diabetes. A post hoc analysis of data from the collaborative atorvastatin diabetes study cards, a randomised, placebocontrolled trial of 2,838. Aug 01, 2004 read baseline characteristics in the collaborative atorvastatin diabetes study cards in patients with type 2 diabetes, diabetic medicine on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Mar 05, 2012 ironically, there is a very compelling clinical trial showing the value of one statin, lipitor atorvastatin, in type 2 diabetes the collaborative atorvastatin diabetes study known as cards. For the prevention of cardiovascular disease, statins are a firstline treatment. The aim of the collaborative atorvastatin diabetes study cards was to assess the effectiveness of 10 mg of atorvastatin daily versus placebo in the primary prevention of cardiovascular disease in patients with type 2 diabetes. The collaborative atorvastatin diabetes study cards recently investigated the effects of lipid lowering with statin therapy specifically in patients with type 2 diabetes. These guidelines are based on numerous trials showing a benefit for statin therapy both as primary and secondary prevention of cardiovascular disease and mortality 27. Collaborative atorvastatin diabetes study cards 2838 primary prevention patients no ascvd with type 2 diabetes at least 1 other cv risk factor such as smoking, hypertension, retinopathy, or microalbuminuria ldlc levels.
To describe baseline characteristics of patients in the collaborative atorvastatin diabetes study cards, a randomized. This study aimed to estimate the cost effectiveness in the belgian setting of atorvastatin 10 mg compared with no treatment for the primary prevention of cv. Cards is designed to show if lowering cholesterol with. The safety and tolerability of atorvastatin 10 mg in the. A landmark lipitor study of patients with type 2 diabetes. In the collaborative atorvastatin diabetes study cards, the effect of atorvastatin calcium on cardiovascular disease cvd endpoints was assessed in 2838 subjects 94% white, 68% male, ages 40 to 75 with type 2 diabetes based on who criteria, without prior history of cardiovascular disease and with ldl. Statin use and risk of diabetes mellitus in postmenopausal women in the womens health initiative. May 18, 2006 cards is designed to show if lowering cholesterol with atorvastatin in type 2 diabetics without cv disease reduces the risk of cv events cards the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Renal effects of atorvastatin and rosuvastatin in patients.
Atorvastatin reduced major cardiovascular disease events. Cost effectiveness of atorvastatin in patients with type 2. The study received ethical approval both centrally and at each participating institution, and each patient gave written. The primary endpoint, time to the first occurrence of acute coronary events, coronary revascularisation or stroke, was significantly reduced by 37% in patients treated with. Cards, 2004 trial summary pdf trial summary a randomised clinical trial investigating the effect of atorvastatin versus placebo in patients with type 2 diabetes without high concentrations of ldlcholesterol and at least one of the following. Methods the collaborative atorvastatin diabetes study cards is a multicentre, randomized, placebocontrolled, doubleblind clinical trial of primary prevention of cardiovascular disease in patients with type 2 diabetes. Design of the collaborative atorvastatin diabetes study cards in patients with type 2 diabetes article pdf available in diabetic medicine 193. The collaborative atorvastatin diabetes study cards. Collaborative atorvastatin diabetes study listed as cards. Design a populationbased analysis with linked register data. Baseline characteristics in the collaborative atorvastatin diabetes study cards in patients with type 2 diabetes. Common side effects include joint pain, diarrhea, heartburn, nausea, and muscle pains. Rapid emergence of effect of atorvastatin on cardiovascular outcomes in the collaborative atorvastatin diabetes study cards diabetologia, dec 2005 h. In 2,627 participants without known vascular disease in the collaborative atorvastatin diabetes study, apob, apoai, ldlcholesterol ldlc and hdl.
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