Benefits and harms of intensive glycemic control in patients. The accord action to control cardiovascular risk in diabetes. Persons with type 2 diabetes t2d are at risk for cognitive impairment and brain atrophy. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. Ann bullock, md division of diabetes treatment and prevention indian health service.
Action to control cardiovascular risk in diabetes accord. The cause of these unexpected, excess deaths in the accord trial is of great interest. Results of the accord blood sugar clinical trial were reported in 2008. Accord diabetes trial intensive versus standard a1c targets. Patients with type 2 diabetes mellitus t2dm are at high risk of developing cardiovascular disease cvd. The 2008 action to control cardiovascular risk in diabetes accord trial randomized 10,251 patients with longstanding t2dm to either intensive hba1c jun 27, 2019 accord was a randomized cardiovascular clinical trial in 10,251 with type 2 diabetes who were treated and followed for an average of approximately 5 years from 2001 through mid2009. Accord diabetes trial intensive versus standard a1c targets in. 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. The accord study was really the first trial to prospectively test the value of glycemic levels below current targets. In 2008, three shorterterm studies action to control cardiovascular risk in diabetes accord 34, action in diabetes and vascular disease. Implications for patients with type 2 diabetes harlan m. Intensive glycemic control in the accord and advance.
Accord action to control cardiovascular risk in diabetes. The national heart, lung, and blood institute has announced the early termination of one treatment arm of the ongoing action to control cardiovascular risk in diabetes accord trial because of an increased risk for death among patients assigned to intensive glucoselowering therapy press release, february 6, 2008. Participants were assigned to intensive or standard therapy target hba 1c less than 42 or 5363 mmolmol less than 60% or 7079%, respectively. Effects of intensive glucose lowering in type 2 diabetes nejm. A large clinical study designed to determine whether intensively lowering blood glucose levels, intensively lowering blood pressure, or treating blood lipid levels could reduce the risk of heart attack, stroke, or death in people with type 2 diabetes. Has carbohydraterestriction been forgotten as a treatment. In 2008, the results of the glucose control study raised some eyebrows. Department of medicine and the irving institute for clinical and translational research, columbia university college of physicians and surgeons, new york, new york. A third trial, action to control cardiovascular risk in diabetes accord, terminated its glycemic control study early because of the finding of increased mortality in participants randomized to a strategy of very intensive glycemic control with a target a 1c of 2008 letters. In the action to control cardiovascular risk in diabetes accord trial. A study investigating a monoclonal antibody to t cells, teplizumab, in preventing type 1.
The purpose of this study was to determine if intensive glycemic control, multiple lipid management and intensive blood pressure control could prevent major cardiovascular events myocardial infarction, stroke or cardiovascular death in adults with type 2 diabetes. The accord randomized trial diabetes care american. Accord action to control cardiovascular risk in diabetes was specifically designed to determine the effects of intensive treatment of blood glucose, and either blood pressure accord blood pressure or plasma lipids accord lipid, on atherosclerotic cardiovascular disease outcomes in patients with type 2 diabetes who were at high risk of. Diabetes is a chronic illness that requires continuing medical care and patient selfmanagement education to prevent acute complications and to reduce the risk of longterm complications. Landmark accord trial finds intensive blood pressure and. The united kingdom prospective diabetes study ukpds, published in 1999, was the first major study to investigate targets for glucose control in patients with type 2 diabetes. Guidance study 7,597 patients with type 2 diabetes. Prior to the accord trial, several randomized controlled trials had. Accord diabetes trial intensive versus standard a1c. Standards of medical care in diabetes2008 diabetes care. Perspectives in diabetes the barrier of hypoglycemia in diabetes. The accord study investigated whether intensive therapy to target normal glycated hemoglobin hba1c levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors when compared to standard therapy hba1c between 7. The action to control cardiovascular risk in diabetes study group.
The primary microvascular outcome of the trial was tested with 2856 study participants in the accord eye study by measuring whether the progression of diabetic retinopathy could be prevented. Perspectives in diabetes the barrier of hypoglycemia in. Retrospective cohort study 2004 2008 using marketscan database. In the accord bp trial, compared with combined standard treatment. Est page 2 leadership of the accord clinical trial will make statements. Published in 2010, the action to control cardiovascular risk in diabetes accord lipid substudy evaluated addon fenofibrate therapy to simvastatin 2040 mg monotherapy among 5,518 adults with t2dm. Editorial from the new england journal of medicine intensive glycemic control in the accord and advance trials. People with type 2 diabetes are at elevated risk for a. Up to 10% of episodes of severe sulfonylureainduced hypoglycemia in type 2 diabetes may be fatal 17. The accord study data and biospecimens are now available in the nhlbi biological specimen and data repository information coordinating center biolincc overview of accord and accordion. People with type 2 diabetes are at elevated risk for a number of serious health problems. The results of the accord study are not surprising. In the accord trial, the group investigated if intensive blood glucose therapytargeting normal hba1c levelswould reduce cardiovascular events.
Action to control cardiovascular risk in diabetes followon accordion eye study group and the action to control cardiovascular risk in diabetes followon accordion study group. Data available for request include the accord main study data and the accordion ancillary study data. The action to control cardiovascular risk in diabetes accord study group noted that epidemiologic studies have demonstrated a relationship between glycated hemoglobin hba1c levels and cardiovascular events in type 2 diabetics. The action to control cardiovascular disease in diabetes accord study has completed its full 5yr planned followup, and all main results have been published 14.
Accord was a randomized cardiovascular clinical trial in 10,251 with type 2 diabetes who were treated and followed for an average of approximately 5 years from 2001 through mid2009. Dec 18, 2014 while these findings were unexpected and have raised some concerns about diabetes treatment strategies for specific groups of people, they should not trigger a change in therapy for most people with diabetes. Treatment of diabetic dyslipidemia, comprised mainly of hypertriglyceridemia, and low hdlc, with either statin or fibrate monotherapy, is moderately effective at reversing the abnormal lipid levels, but does not completely reverse the risk of cvd. Preterax and diamicron modifiedrelease controlled evaluation advance 35, veterans affairs diabetes trial vadt 36 reported the effects of two levels of glycaemic control on cardiovascular. Accord provides important evidence to help guide treatment recommendations for adults with type 2 diabetes who have had a heart attack or stroke or who are otherwise at especially high risk for cardiovascular disease, said susan b. The recommended total daily energy intake was 1,795. Type 2 diabetes is characterised by relative insulin deficiency caused by pancreatic.
The accord trial was a large north american trial of intense versus standard glucoselowering therapy in people with established type 2 diabetes and additional risk factors for cardiovascular disease. Accord stands for action to control cardiovascular risk in diabetes. Accord blood sugar treatment strategy telebriefing february 06, 2008 10. Diabetes management can differ across the spectrum accord ing to where elderly patients live i. Management of cardiovascular disease in patients with. We assessed 10 251 adults aged 4079 years with established type 2 diabetes, mean glycated haemoglobin a 1c hba 1c concentration of 67 mmolmol 83%, and risk factors for ischaemic heart disease enrolled in the accord trial. Does intensive therapy of type 2 diabetes help or harm. First and foremost, the mean level of glycemic control achieved in the accord trial, i. Targeting this risk group, the memory in diabetes mind substudy embedded in the action to control cardiovascular risk in diabetes accord trial 5, 6 was designed to test the primary hypothesis that at 40 months, persons randomized to an intensive glycaemic therapeutic strategy targeting hba 1c to 2008 guidance in diabetes care the good, the bad, the ugly, and the future 3. Intensive blood glucose control and vascular outcomes in. Re study undercuts diabetes theory front page, feb. Monday, december 3, 2018 american diabetes association. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. Nov 26, 2017 current guidelines from the american diabetes association recommend people with type 2 diabetes discuss their blood glucose goals with their physicians, since intensive control may not be the best approach for everyone with type 2 diabetes.
Type 2 diabetes mellitus is a metabolic disease that is diagnosed on the basis of sustained hyperglycemia. Effects of intensive glucose lowering in type 2 diabetes. Table 2 describes the characteristics of older adults in. A third trial, action to control cardiovascular risk in diabetes accord, terminated its glycemic control study early because of the finding of increased mortality in participants randomized to a strategy of very intensive glycemic control with a target a 1c of diabetes accord study group are listed in the appendix. Accord study group and accord eye study group, effects of medical therapies on retinopathy progression in type 2 diabetes.
While these findings were unexpected and have raised some concerns about diabetes treatment strategies for specific groups of people, they should not trigger a change in therapy for most people with diabetes. Intensive glycemic control in the accord and advance trials. Between 1980 and 2004, the global rise in obesity, sedentary lifestyles, and an ageing population have quadrupled the incidence and prevalence of type 2 diabetes. Guidance study 7,597 patients with type 2 diabetes gap exists between checking hba1c and achieving target hba1c 2008. They also experience increased rates of nonfatal myocardial infarction and stroke. This randomized control trial rct sets out to test if there is a correlation between a1c and.
In the early 20 th century, before any medications were available for the treatment of diabetes mellitus, experts recommended dietary carbohydraterestriction 1, 2. Benefits and harms of intensive glycemic control in. At 4 years, there was a 33% reduction in retinopathy progression in the intensive arm 7. The purpose of this study was to determine if intensive glycemic control, multiple lipid management and intensive blood pressure control could prevent major cardiovascular events myocardial infarction, stroke or cardiovascular death in adults with type 2. Accord trial should also be compared with the 10year followup of the approximately 10year united kingdom prospective diabetes study ukpds trial, which tested the effect of intensive glycemia management during the active phase of the trial in patients with newly diagnosed.
Diabetes control and complications trial dcct21 among patients with type 1 diabetes and the united kingdom prospective diabetes study ukpds22 among patients with newly or recently diagnosed type 2 diabeteswhich showed reductions in the early manifestations of microvascular complications with intensive glycemic control. The action to control cardiovascular risk in diabetes accord study group. The accord action to control cardiovascular risk in. Read about the role of gastric bypass surgery in managing type 2 diabetes and obesity on page 8.
And in this trial there was a positive result with a 33% reduction in progression of retinopathy in patients who were. In the action to control cardiovascular risk in diabetes accord study, 10,251 patients with type 2 diabetes at high cardiovascular risk but with no history of frequent or. The dietary recommendation for diabetes in a prominent internal medicine textbook from 1923 was 75% fat, 17% protein, 6% alcohol and only 2% carbohydrate. The action to control cardiovascular risk in diabetes accord trial sought to explore whether more intensive glucose control regimens were associated with better outcomes in patients with type 2 diabetes mellitus. Followup study li et al, lancet 2008 0 10 20 30 40 50 60 70 80 90 100 012 34567 8910111214151617181920 followup years % with diabetes control group. Clinical implications of the accord trial the journal of. The action to control cardiovascular risk in diabetes accord. The accord memory in diabetes mind study investigated whether persons randomized to an intensive glycaemic therapeutic strategy targeting hba 1c to 2008 guidance in diabetes care the good, the bad, the ugly, and the future 3. The degree of benefit from a medical intervention is based on the absolute risk of vascular events, with patients at higher risk deriving greater benefit. Accord lipid was a substudy of accord and employed 2x2 factorial design in about half of accord s participants. Persistent effects of intensive glycemic control on retinopathy in type 2 diabetes in the action to control cardiovascular risk in diabetes accord followon study. Nineteen of the 41 excess deaths from cardiovascular causes in the study were attributed to unexpected or pre. It is therefore now appropriate to take stock and consider the clinical implications of these results.
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