The use of lipid-lowering therapy and effects of antihyperglycaemic therapy on lipids in subjects with type 2 diabetes with or without cardiovascular disease: a pooled analysis of data from eleven randomized trials with insulin glargine 100 U/mL

Abstract

BackgroundDyslipidaemia is a major contributor to the increased risk of cardiovascular disease (CVD) associated with type 2 diabetes (T2D). This study aimed to characterize the extent of lipid-lowering therapy use and its impact on lipid and glycaemic outcomes in people with T2D uncontrolled on oral agents who were enrolled in insulin glargine 100 units/mL (Gla-100) randomized controlled trials (RCTs).MethodsA post hoc patient-level pooled analysis of eleven RCTs (≥24 weeks’ duration) comparing Gla-100 (±oral antidiabetes drugs [OADs]) with OADs alone in people with T2D was performed. Baseline and Week 24 or study endpoint lipid status (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], non-high-density lipoprotein cholesterol [non-HDL-C] and triglycerides) and indices of glycaemic control (glycosylated haemoglobin, fasting plasma glucose [FPG]) were examined in patient groups according to treatment received and CVD status. Lipid-lowering therapy was provided at the discretion of physicians at baseline and throughout the studies.ResultsOf the 4768 participants included in the analysis, 41% (n = 1940) received lipid-lowering therapy. Only 51% of participants with CVD (1885/3672) were treated with lipid-lowering therapy; these participants had significantly lower levels of LDL-C, HDL-C and non-HDL-C, and higher levels of triglycerides versus patients not treated with lipid-lowering therapy at baseline and study endpoint (P < 0.001 for all). Antihyperglycaemia therapy resulted in decreases in glycosylated haemoglobin (−1.4 to −1.6%) and FPG (−68.9 to −75.3 mg/dL) at Week 24. Furthermore, slight improvements in non-HDL-C (−3.9 to −9.1 mg/dL) and triglyceride levels (−25.8 to −51.2 mg/dL) were observed. Similar changes were seen irrespective of lipid-lowering therapy or CVD status.ConclusionsIn a T2D cohort included in Gla-100 clinical studies, many participants with T2D and CVD did not receive lipid-lowering therapy, and for most categories of lipid the levels were outside the optimal range. Even in patients treated with antihyperglycaemic therapy but not lipid-lowering therapy, there were modest improvements in non-HDL-C and triglyceride levels in all participants with T2D and CVD. There is a need for increased implementation of guideline recommendations such as American College of Cardiology/American Heart Association for the management of dyslipidaemia in patients with T2D.

Factors associated with glycemic control in community-dwelling elderly individuals with type 2 diabetes mellitus in Zhejiang, China: a cross-sectional study

“…Positive correlations between HbA1c and TC and TG were also observed, but HbA1c was not associated with LDL-C or HDL-C in Chinese elderly individuals with T2DM in this cross-sectional study. The inconsistent trend of changes between LDL-C and HbA1c were also reported in previous meta-analysis data [36] and elsewhere [37, 38], appearing to be dependent on the presence of lipid-lowering medication and cardiovascular diseases among individuals with T2DM [39].…”

Suboptimal control of lipid levels: results from the non-interventional Centralized Pan-Russian Survey of the Undertreatment of Hypercholesterolemia II (CEPHEUS II)

“…Other cross-sectional studies conducted in European settings have highlighted the need to optimize statin therapy in patients with type 2 DM before atherosclerotic CVD develops [ 28 ] and to improve control of CV risk factors in patients with DM who have experienced myocardial infarction or stroke [ 29 ]. Baseline data from type 2 DM clinical trials have also shown that many people with type 2 DM and CVD or CV risk factors do not receive lipid-lowering therapy and have suboptimal lipid control [ 30 , 31 ]. Patients with type 2 DM may face a combination of barriers to attaining their treatment goals despite more intensive therapy, particularly if they are obese [ 30 ].…”

“…Patients with type 2 DM may face a combination of barriers to attaining their treatment goals despite more intensive therapy, particularly if they are obese [ 30 ]. In addition to implementing guideline recommendations, new strategies to increase patient motivation and promote healthy behaviors, such as regular participation in physical activity, are required [ 28 , 29 , 31 , 32 ]. Several novel therapies for dyslipidemia and its associated risks are in development that may be effective with respect to CVD prevention [ 33 ] and could increase the options for bespoke treatment programs in the future.…”

Actions of metformin and statins on lipid and glucose metabolism and possible benefit of combination therapy

“…Targeting cholesterol remnants in addition to T2DM patients receiving statins might be beneficial on cardiac function [ 151 ]. From a clinical perspective, it was shown that many patients with T2DM and CVD did not receive lipid lowering therapy while their lipid levels were not in the optimal range [ 152 ]. Increased implementation of guideline recommendations for dyslipidemic T2DM patients is therefore recommended [ 152 ].…”