The accordlipid trial did this, but we suggest that the group of. The trial had a double, 2 3 2 factorial design, with 4,733 patients additionally randomized to a blood pressure trial accord bp 20 and 5,518 to a lipid trial accord lipid 4. Leiter, md,h daniel weiss, md, cde,i edward lipkin, md, phd,j and jerome l. The accord action to control cardiovascular risk in. Trials fats, posch, score, starts, ornish, mars metaanalyses holmes rossouw ncep atp iii 2001 4s woscops care lipid afcaps texcaps ncep atp iii update 2004 hps proveit ascotlla prosper allhatllt accaha, ias, nla 202014 tnt ideal accord jupiter ctt metaanalyses enhance sharp aurora corona expandedmodified treatment recommendations.
In addition, 5518 of the accord participants were also randomly assigned in a 2by2 factorial design to either simvastatin plus fenofibrate or simvastatin plus placebo the accord lipid trial. Landmark accord trial finds intensive blood pressure and. Research design and methods the rationale, design, and primary results of the accord lipid trial have been previously reported 1,68. Pharmaceutical strategies for reducing ldlc and risk of. Bp trial participants were more likely to be black, to be female, and to have higher bp levels.
Jensen june 12, 2008 accord diabetes trial1 intensive versus standard a1c targets in t2dm mortality with a very intensive glucose lowering strategy in high cv risk t2dm patients research question. Overview of the accord lipid trial design and principal results. Accord design and details of allocation to blood pressure and lipid trials details from accord protocol, found on. Apr 28, 2010 pressure and lipid trials details from accord protocol, found on. Landmark clinical trials national lipid association.
Patients were enrolled from 11 january 2001 to 29 october 2005 and followed. Rationale and design for the blood pressure intervention. Pdf on apr 1, 2010, glenn matfin and others published no accord for the accordlipid trial results find, read and cite all the research you need on researchgate. Accord lipid study latest medical news, clinical trials.
Accord lipid accord bp n for both trials as part of the accord glycemia. Ppara polymorphism influences the cardiovascular benefit of. Example 2 accord the accord was a randomized trial using double 2 x 2 factorial design for patients with type 2 diabetes mellitus, which included three components glycemia trial, lipid trial, and systolic blood pressure sbp trial. Legacy effect of fibrate addon therapy in diabetic patients with. Evolution of the lipid trial protocol of the action to. Using data collected in the accord lipid trial we examined the relationship between concomitant administration of fenofibrate and tzd, primarily rosiglitazone, and the occurrence of low hdlc. Rationale and design for the blood pressure intervention of. Published in 2010, the action to control cardiovascular risk in diabetes accord lipid substudy. Descriptions and interpretations of the accordlipid trial. Accord was designed as a double 2x2 factorial trial of 10,000 eligible participants. Clinical trial updates impacting your practice lipid. Jul 27, 2012 accord lipid action to control cardiovascular risk indiabetes lipid lowering armh ginsberg columbia university, new york, nyamerican college of cardiology 2010 scientific sessions goal. Research design and methods the accord lipid trial was a randomized, doubleblind, placebocontrolled study conducted in patients with type 2 diabetes at 77 clinical centers across the u. The lipid trial of accord was composed of 5518 participants who were treated with openlabel simvastatin to an average.
Accord diabetes trial intensive versus standard a1c. The accord lipid trial involved 5,518 participants. Protocol accord action to control cardiovascular risk in. Evolution of the lipid trial protocol of the action to control cardiovascular risk in diabetes accord trial henry n. Accord lipid sub trial l the lipid sub trial did not provide evidence supporting the use of combination fenofibrate and simvastatin therapy in reducing cv events in the majority of people with type 2 diabetes who had hdlcholesterol and triglyceride levels within the normal range compared to statin monotherapy accord study group, 2010b. Fibrates are lipidmodifying drugs that act mainly to elevate triglycerides tg. Descriptions and interpretations of the accordlipid trial in.
To test whether the treatment of blood lipids with a fibrate plus a statin can reduce the risk of major cvd events in patients with type 2 diabetes who. Nov 12, 20 trials fats, posch, score, starts, ornish, mars metaanalyses holmes rossouw ncep atp iii 2001 4s woscops care lipid afcaps texcaps ncep atp iii update 2004 hps proveit ascotlla prosper allhatllt accaha, ias 20 tnt ideal accord jupiter ctt metaanalyses enhance sharp aurora corona expandedmodified treatment recommendations. Use of subgroups to rescue a trial or improve benefitrisk. The new england journal of medicine 1564 n engl j med 362. The action to control cardiovascular risk in diabetes accord lipid trial was a 2. Subjects were specifically enrolled in accord lipid if they had hdlc accord study design overall accord glycemia trial. Effects of combination lipid therapy in the management of patients.
The accord lipid trial used fenofibrate because 1 data from the fenofibrate intervention and event lowering in diabetes field trial indicated that the risk of myositis when fenofibrate was combined with a statin was negligible. The accord lipid study was a randomized controlled trial of 5518 participants assigned to receive simvastatin plus fenofibrate vs simvastatin. Review the clinical trials of lipid altering drug therapies. Effect of combination therapy with fenofibrate and simvastatin on postprandial lipemia in the accord lipid trial. In addition, one 2 x 2 trial addressed the lipid question in 5,518 participants and the other 2 x 2 trial addressed the blood pressure question in 4,733 participants. What we learn from subgroup analyses find, read and cite all the. Action to control cardiovascular risk in diabetes accord. Accord lipid study in the northeast clinical network were recruited for a study of ppl. Effects of intensive bloodpressure control in type 2. Results could reflect real risk or could be due to chance future trials may also help.
Accord action to control cardiovascular risk in diabetes. Understanding this is key as statins are the primary lipid lowering agents and. Effect of intensive glycemic and blood pressure control on qt. Pdf paradoxical reduction in hdlc with fenofibrate and. Jun 18, 2007 the action to control cardiovascular risk in diabetes accord lipid trial aims to test whether a 3hydroxy3methylglutaryl coenzyme a reductase inhibitor statin plus a fibrate is more efficacious in reducing cardiovascular events than a statin plus placebo in patients with type 2 diabetes mellitus with defined glycemic control. The action to control cardiovascular risk in diabetes accord lipid trial. Clinical implications of the accord trial the journal of. Mar 14, 2010 accord is the first large clinical trial to compare the cardiovascular effects of a statin simvastatin and placebo, or inactive pill, to combination therapy of a statin simvastatin and a fibrate fenofibrate in highrisk adults with type 2 diabetes. Cardiovascular cv risk in type 2 diabetes mellitus t2dm.
Accord diabetes trial intensive versus standard a1c targets. Although statins are efficacious in patients with type 2 diabetes, rates. The results of this comparison have been reported previously. Effects of combination lipid therapy in type 2 diabetes mellitus. A 52 year old asymptomatic man with a history of venous thrombosis in 2003 had a cxr showing. Accord lipid trial, in which they were randomized to either simvastatin plus feno. The accord primary outcome was the first occurrence of a major. Lipidaholics case 254 combination therapy in t2dm accord trial. We randomly assigned 5518 patients with type 2 diabetes who were being treated with openlabel simvastatin to receive either.
Accord lipid trial, leaving participants who were at lower. We investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease. There is no evidence from this trial to indicate that feno. Lipidomic and proteomic predictors of drastic reductions of hdl in the accord lipid trial.
Pdf the accord action to control cardiovascular risk in. Table of contents challenges 2 feasibility questionnaire 4. The accord lipid trial, conducted in 5518 participants, was a randomized, placebocontrolled, doubleblind treatment arm of accord in which all participants received simvastatin to attain contemporary guidelinebased lowdensity lipoprotein cholesterol ldlc treatment goals 7,15 and were randomly assigned to receive either fenofibrate or. Protocol accord action to control cardiovascular risk. Aug, 20 the accord lipid therapy trial was designed to test the effect of a therapeutic strategy that uses a fibrate to raise hdlc and lower triglyceride levels and uses a statin for treatment of ldlc reduce the rate of cvd events compared to a strategy that only uses a statin for treatment of ldlc on cardiovascular outcomes in patients with type 2. The accord action to control cardiovascular risk in diabetes lipid trial. Lipidomic and proteomic predictors of drastic reductions of hdl in. The accord action to control cardiovascular risk in diabetes. The action to control cardiovascular risk in diabetes accord lipid trial tested the hypothesis that combination therapy with a fibrate and statin would more effectively prevent major cvd events in a highrisk population of patients with t2dm compared with statin monotherapy. In addition, one 2 x 2 trial will also address the lipid question in 5,800 of the participants and the other 2 x 2 trial will address the blood pressure question in 4,200 of the participants. Pdf on may 1, 2011, henry n ginsberg published the accord action to control cardiovascular risk in diabetes lipid trial. The hypothesis tested was whether, on a background of simvastatin. Lipid case 254 combination therapy in t2dm the accord trial i want to share a case that will get us into a discussion of the results from the action to control cardiovascular risk in diabetes accord study at acc last sunday. This randomized control trial rct sets out to test if there is a correlation between a1c and.
Pdf evolution of the lipid trial protocol of the action. While recruiting the subjects, we were blind to their randomization within accord lipid and to anyclinical data. Clinical implications of the accord trial the journal of clinical. Jan 01, 2012 both lipid trial groups maintained a lowdensity lipoprotein level of 80 mgdl, whereas the fenofibrate group maintained a 22 mgdl lower tg and 1 mgdl higher hdl than the placebo group. Paradoxical reduction in hdlc with feno thiazolidinedione. Diabetes accord trial was specifically designed to determine whether a therapeutic strategy targeting normal glycated hemoglobin levels i.
Fenofibric acid approved us with coadministration with statins. In this example, we used the victor platform to estimate the value of information for lipid trial. The accord trial, reported extensively by heartwire, was conducted in 10 251 highrisk patients with type 2 diabetes who were randomly assigned to either intensive or standard glycemic control. The three specific primary accord hypotheses are as follow. The remaining 4,733 participants were enrolled in the accord blood pressure trial. In 2017, a posttrial observation of the accordlipid trial, the. Pdf abstract the action to control cardiovascular risks in diabetes study. Research design and methodsthe rationale, design, and primary results of the accord lipid have been previously reported 1,678. Here we present the findings of the accord lipid trial. Combined use of fibrates and statins, therefore, can be considered for use in patients with high ldlc.
Pdf effect of combination therapy with fenofibrate and. Table of contents challenges 2 feasibility questionnaire. They also had lower triglyceride levels and higher hdl and ldl cholesterol concentrations. Thus, there is a strong case for the use of a fibrate to reduce the cardiovascular risk in people with high. Participants in the bp trial and the lipid trial differed on several characteristics. Paradoxical reduction in hdlc with fenofibrate and.
Accord is the first large clinical trial to compare the cardiovascular effects of a statin simvastatin and placebo, or inactive pill, to combination therapy of a statin simvastatin and a fibrate fenofibrate in highrisk adults with type 2 diabetes. The new england journal medicine accord action to control. The accord study was a landmark clinical trial that. The overall accord inclusion criteria, in addition to the following criteria, are con. Glance at the following table from the accord trial supplement data n engl j med 2010. The action to control cardiovascular risk in diabetes memory. The main outcome measures for these descriptive, post hoc analyses was the occurrence of extremely low hdlc defined as trial.
In the action to control cardiovascular risk in diabetes study trial, the. Table 1 summarizes the main findings of the accord glycemic trial. In accord lipid, over 5000 patients were treated with fenofibrate. The action to control cardiovascular risk in diabetes accord lipid trial aims to test whether a 3hydroxy3methylglutaryl coenzyme a reductase inhibitor. The action to control cardiovascular risk in diabetes accord lipid trial tested the hypothesis that combination therapy with a fibrate and statin would more. In each of those trials, analysis of a dyslipidemic subgroup revealed either signi. Discuss clinical trials and their role in lipid and lipoprotein treatment in. Effects of combination lipid therapy in type 2 diabetes. Request pdf on oct 1, 2010, nicola abate and others published the accord lipid trial find, read and cite all the research you need on researchgate.
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