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LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

ABSTRACT: As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), we examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial.We analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial examining the cardiovascular safety of the glucagon-like peptide-1 receptor agonist liraglutide in 9340 people with T2DM from 32 countries [age (all mean?±?SD) 64?±?7.2 years, BMI 32.5?±?6.3?kg/m, duration of diabetes 12.7?±?8.0 years], all of whom were at high risk for cardiovascular disease (CVD).A total of 81% (n?=?7592) of participants had prior CVD and 90% (n?=?8408) had a prior history of hypertension. Despite prescription of multiple antihypertensive agents at baseline, only 51% were treated to a target BP of less than 140/85?mmHg and only 26% to the recommended baseline BP target of less than 130/80?mmHg. In univariate analyses, those with prior CVD were prescribed more agents (P?

SUBMITTER: Petrie JR

PROVIDER: S-EPMC4856174 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

Petrie John R JR Marso Steven P SP Bain Stephen C SC Franek Edward E Jacob Stephan S Masmiquel Luis L Leiter Lawrence A LA Haluzik Martin M Satman Ilhan I Omar Mohamed M Shestakova Marina M Van Gaal Luc L Mann Johannes F JF Baeres Florian M M FM Zinman Bernard B Poulter Neil R NR

Journal of hypertension 20160601 6

<h4>Objective</h4>As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), we examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial.<h4>Methods</h4>We analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial exa ...[more]

PMID: 26855018

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Project description:BACKGROUND:Epidemiological data on obesity are needed, particularly in patients with type 2 diabetes mellitus (T2DM) and high cardiovascular (CV) risk. We used the baseline data of liraglutide effect and action in diabetes: evaluation of CV outcome results-A long term Evaluation (LEADER) (a clinical trial to assess the CV safety of liraglutide) to investigate: (i) prevalence of overweight and obesity; (ii) relationship of the major cardiometabolic risk factors with anthropometric measures of adiposity [body mass index (BMI) and waist circumference (WC)]; and (iii) cardiometabolic treatment intensity in relation to BMI and WC. METHODS:LEADER enrolled two distinct populations of high-risk patients with T2DM in 32 countries: (1) aged ?50 years with prior CV disease; (2) aged ?60 years with one or more CV risk factors. Associations of metabolic variables, demographic variables and treatment intensity with anthropometric measurements (BMI and WC) were explored using regression models (ClinicalTrials.gov identifier: NCT01179048). RESULTS:Mean BMI was 32.5 ± 6.3 kg/m(2) and only 9.1 % had BMI <25 kg/m(2). The prevalence of healthy WC was also extremely low (6.4 % according to International Joint Interim Statement for the Harmonization of the Metabolic Syndrome criteria). Obesity was associated with being younger, female, previous smoker, Caucasian, American, with shorter diabetes duration, uncontrolled blood pressure (BP), antihypertensive agents, insulin plus oral antihyperglycaemic treatment, higher levels of triglycerides and lower levels of high-density lipoprotein cholesterol. CONCLUSIONS:Overweight and obesity are prevalent in high CV risk patients with T2DM. BMI and WC are related to the major cardiometabolic risk factors. Furthermore, treatment intensity, such as insulin, statins or oral antihypertensive drugs, is higher in those who are overweight or obese; while BP and lipid control in these patients are remarkably suboptimal. LEADER confers a unique opportunity to explore the longitudinal effect of weight on CV risk factors and hard endpoints.

Project description:BackgroundThere is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events.MethodsA total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.ResultsAfter 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001).ConclusionsIn patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)

Project description:To investigate the association of characteristics of type 2 diabetes mellitus (duration and biochemical severity of diabetes) to brain structure measured on magnetic resonance (MR) images, specifically testing whether more severity in metrics of diabetes is inversely correlated with brain volumes and positively correlated with ischemic lesion volumes.This study protocol was approved by the institutional review board of each center and participants provided written informed consent. Baseline severity of diabetes was evaluated by testing fasting plasma glucose levels, hemoglobin A1c levels, and duration of diabetes. MR imaging was performed with fluid-attenuated inversion recovery, proton-density, T2-weighted, and T1-weighted sequences, which were postprocessed with an automated computer algorithm that classified brain tissue as gray or white matter and as normal or ischemic. Separate linear regression models adjusted for potential confounding factors were used to investigate the relationship of the diabetes measures to MR imaging outcomes in 614 participants (mean age, 62 years; mean duration of type 2 diabetes mellitus, 9.9 years).The mean volumes of total gray matter (463.9 cm(3)) and total white matter (463.6 cm(3)) were similar. The mean volume of abnormal tissue was 2.5 cm(3), mostly in the white matter (81% white matter, 5% gray matter, 14% deep gray and white matter). Longer duration of diabetes and higher fasting plasma glucose level were associated with lower normal (? = -0.431 and -0.053, respectively; P < .01) and total gray matter volumes (? = -0.428 and -0.053, respectively; P < .01). Fasting plasma glucose was also inversely correlated with ischemic lesion volume (? = -0.006; P < .04). Hemoglobin A1c level was not associated with any MR imaging measure.Longer duration of diabetes is associated with brain volume loss, particularly in the gray matter, possibly reflecting direct neurologic insult; biochemical measures of glycemia were less consistently related to MR imaging changes. Contrary to common clinical belief, in this sample of patients with type 2 diabetes mellitus, there was no association of diabetes characteristics with small vessel ischemic disease in the brain.

Project description:Background: Both baseline blood pressure (BP) and cumulative BP have been used to estimate cardiovascular event (CVE) risk of higher BP, but which one is more reliable for recommendation to routine clinical practice is unclear. Methods: In this prospective study, conducted in the Kailuan community of Tanshan City, China, a total of 95,702 participants free of CVEs at baseline (2006-2007) were included and followed up until 2017. Time-weighted cumulative BP that expresses the extent of cumulative BP exposure is defined as the sum of the mean of two consecutive systolic or diastolic BP times the interval between the two determinations, then normalized by the total follow-up duration. Incident CVEs during 2006-2017 were confirmed by review of medical records. We performed a competing risk regression analysis to assess CVE risk of the different durations of higher BP exposure. ROC analysis was performed to assess the predictive value of higher BP on CVE occurrence. Results: We found that when the risk of higher BP on CVE occurrence was estimated based on time-weighted cumulative BP, the hazard ratios (HRs) increased with the increase in duration of higher BP exposure in each of the four BP groups: <120/<80, 120-129/<80, 130-139/80-89, and ≥140/≥90 mmHg; this time trend also occurred across the four different BP groups, with the higher BP group exhibiting CVE risk earlier during the follow-up. These results were confirmed by the same analysis performed on participants without baseline hypertension. However, such reasonable time trends did not occur when a single baseline BP was used as the primary estimation. We also demonstrated that the predictive values of baseline systolic and diastolic BP that predict CVE occurrence were only 0.6-3.2 and 0.2-3.1% lower, respectively, than those of cumulative BP combined with baseline BP during follow-up. Conclusions: Baseline BP remains a useful indicator for predicting future occurrence of CVEs. Nevertheless, time-weighted cumulative BP could more reliably estimate the CVE risk of higher BP exposure than baseline BP.

Dataset Information

LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

Publications

LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

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