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Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

ABSTRACT: To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of <6.0% (<42 mmol/mol; intensive glycemia) or 7.0-7.9% (53-63 mmol/mol; standard glycemia) and then randomized a second time to either 1) systolic BP goals of <120 mmHg (intensive BP) or <140 mmHg (standard BP) or 2) simvastatin plus fenofibrate (intensive lipid) or simvastatin plus placebo (standard lipid). Proportional hazards models were used to assess combinations of treatment assignments on the composite primary (deaths due to CVD, nonfatal myocardial infarction [MI], and nonfatal stroke) and secondary outcomes.In the BP trial, risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group.In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality.

SUBMITTER: Margolis KL

PROVIDER: S-EPMC4030092 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

Margolis Karen L KL O'Connor Patrick J PJ Morgan Timothy M TM Buse John B JB Cohen Robert M RM Cushman William C WC Cutler Jeffrey A JA Evans Gregory W GW Gerstein Hertzel C HC Grimm Richard H RH Lipkin Edward W EW Narayan K M Venkat KM Riddle Matthew C MC Sood Ajay A Goff David C DC

Diabetes care 20140304 6

<h4>Objective</h4>To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.<h4>Research design and methods</h4>ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of <6.0% (<42 mmol/mol; intensive glycemia) or 7.0-7.9% (53-63 mmol/mol ...[more]

PMID: 24595629

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Project description:To report additional ocular outcomes of intensive treatment of hyperglycemia, blood pressure, and dyslipidemia in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.Double 2×2 factorial, multicenter, randomized clinical trials in people with type 2 diabetes who had cardiovascular disease or cardiovascular risk factors. In the glycemia trial, targets of intensive and standard treatment were: hemoglobin A1c <6.0% and 7.0% to 7.9%, respectively, and in the blood pressure trial: systolic blood pressures of <120 and <140 mmHg, respectively. The dyslipidemia trial compared fenofibrate plus simvastatin with placebo plus simvastatin.Of the 3472 ACCORD Eye Study participants enrolled, 2856 had 4-year data (85% of survivors).Eye examinations and fundus photographs were taken at baseline and year 4. Photographs were graded centrally for retinopathy severity and macular edema using the Early Treatment Diabetic Retinopathy Study (ETDRS) methods.Three or more steps of progression on the ETDRS person scale or treatment of retinopathy with photocoagulation or vitrectomy.As previously reported, there were significant reductions in the primary outcome in the glycemia and dyslipidemia trials, but no significant effect in the blood pressure trial. Results were similar for retinopathy progression by 1, 2, and 4 or more steps on the person scale and for ? 2 steps on the eye scale. In the subgroup of patients with mild retinopathy at baseline, effect estimates were large (odds ratios, ?0.30; P < 0.001), but did not reach nominal significance for participants with no retinopathy or for those with moderate to severe retinopathy at baseline.Slowing of progression of retinopathy by intensive treatment of glycemia was observed in ACCORD participants, whose average age and diabetes duration were 62 and 10 years, respectively, and who had cardiovascular disease or cardiovascular risk factors. The effect seemed stronger in patients with mild retinopathy. Similar slowing of progression was observed in patients treated with fenofibrate, with no effect observed with intensive blood pressure treatment. This is the second study to confirm the benefits of fenofibrate in reducing diabetic retinopathy progression, and fenofibrate should be considered for treatment of diabetic retinopathy.

Project description:BackgroundCardiovascular disease (CVD) has become a major cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Although there is also evidence that multifactorial interventions to control blood glucose, blood pressure, and lipid profiles can reduce macrovascular complications and mortality in patients with T2DM, the link between these risk factors has not been established.MethodsOn 10 December 2018, 1,920 people in four cities in Anhui Province were included. Latent category analysis (LCA) was used to explore the clustering mode of HRBs (health risk behaviors). The primary exposure was HRBs and exercise and diet interventions, and the primary outcome was CVD and other variables, including zMS, triglyceride-glucose index (TyG), TyG-WC (waist circumference), TyG-BMI, TG/HDL, and cardiovascular health (CVH). A multivariable logistic regression model was used to establish the relationship between HRBs, exercise, diet interventions, and CVD. Moderate analysis and mediation moderation analysis were employed by the PROCESS method to explore the relationship between these variables. Sensitivity analysis explored the robustness of the model.ResultsThe mean age was 57.10 ± 10.0 years old. Overall, CVD affects approximately 19.9% of all persons with T2DM. Macrovascular complications of T2DM include coronary heart disease, myocardial infarction (MI), cardiac insufficiency, and cerebrovascular disease. Elderly age (χ 2 = 22.70), no occupation (χ 2 = 20.97), medium and high socioeconomic status (SES) (χ 2 = 19.92), higher level of TyG-WC (χ 2 = 6.60), and higher zMS (χ 2 = 7.59) were correlated with high CVD. Many metabolic indices have shown a connection with T2DM combined with CVD, and there was a dose-response relationship between HRB co-occurrence and clustering of HRBs and zMS; there was a dose-response relationship between multifactorial intervention and CVH. In the mediation moderation analysis, there was an association between HRB, gender, TyG, TyG-BMI, and CVD. From an intervention management perspective, exercise and no diet intervention were more significant with CVD; moreover, there was an association between intervention management, gender, zMS, TyG-WC, TyG-BMI, TG/HDL, and CVD. Finally, there was an association between sex, CVH, and CVD. Sensitivity analysis demonstrated that our results were robust.ConclusionsCVD is one of the common complications in patients with type 2 diabetes, and its long-term outcome will have more or less impact on patients. Our findings suggest the potential benefits of scaling up multifactorial and multifaceted interventions to prevent CVD in patients with T2DM.

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Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

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Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

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