Cardiovascular safety of insulin: Between real-world data and reality.

Published on Sep 1, 2017in Diabetes, Obesity and Metabolism5.9
· DOI :10.1111/DOM.12967
Edoardo Mannucci98
Estimated H-index: 98
(UniFI: University of Florence),
Ele Ferrannini14
Estimated H-index: 14
,
Ele Ferrannini110
Estimated H-index: 110
Sources
Abstract
References37
Newest
A demonstration of cardiovascular safety is mandatory for all newly developed glucose-lowering agents, including insulin analogues. The vascular benefit of insulin is evident from the Diabetes Control and Complication Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS), and the cardiovascular safety of insulin glargine has been demonstrated in individuals with newly diagnosed diabetes or prediabetes in the ORIGIN trial (Outcome Reduction with an Initial Glargine Intervention). The...
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Abstract Background Diabetes is a known risk predictor for thromboembolic events in patients with atrial fibrillation (AF), but no study has explored the prognostic weight of insulin in this setting. Objectives This study evaluated the differential role of insulin versus no insulin therapy on thromboembolic risk in patients with diabetes and AF. Methods We accessed individual patient data from the prospective, real-world, multicenter, PREFER in AF (European Prevention of thromboembolic events-Eu...
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#1John-Michael Gamble (MUN: Memorial University of Newfoundland)H-Index: 17
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Last. Sumit R. Majumdar (U of A: University of Alberta)H-Index: 92
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Summary Background Existing studies have shown conflicting evidence regarding the safety of exogenous insulin therapy in patients with type 2 diabetes. In particular, observational studies have reported an increased risk of death and cardiovascular disease among users of higher versus lower doses of insulin. We aimed to quantify the association between increasing dosage of insulin exposure and death and cardiovascular events, while taking into account time-dependent confounding and mediation tha...
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Abstract Registry-based randomized controlled trials are defined as pragmatic trials that use registries as a platform for case records, data collection, randomization, and follow-up. Recently, the application of registry-based randomized controlled trials has attracted increasing attention in health research to address comparative effectiveness research questions in real-world settings, mainly due to their low cost, enhanced generalizability of findings, rapid consecutive enrollment, and the po...
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#1W. Schuyler Jones (Duke University)H-Index: 27
#2Matthew T. Roe (Duke University)H-Index: 104
Last. Frederick A. Masoudi (Anschutz Medical Campus)H-Index: 107
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Abstract Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length...
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#1Sylvie ErpeldingerH-Index: 6
Last. Rémy Boussageon (University of Poitiers)H-Index: 11
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Background It is essential to anticipate and limit the social, economic and sanitary cost of type 2 diabetes (T2D), which is in constant progression worldwide. When blood glucose targets are not achieved with diet and lifestyle intervention, insulin is recommended whether or not the patient is already taking hypoglycaemic drugs. However, the benefit/risk balance of insulin remains controversial. Our aim was to determine the efficacy and safety of insulin vs. hypoglycaemic drugs or diet/placebo o...
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#1Sarah E. Holden (Cardiff University)H-Index: 13
#2Sara Jenkins-Jones (Cardiff University)H-Index: 20
Last. Craig John Currie (Cardiff University)H-Index: 31
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Aims To determine if concomitant metformin reduced the risk of death, major adverse cardiac events (MACE), and cancer in people with type 2 diabetes treated with insulin.
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#1Anushka Patel (The George Institute for Global Health)H-Index: 75
#2Ruth Webster (The George Institute for Global Health)H-Index: 23
At the 65th World Health Assembly in 2012, all World Health Organization member states made a historic commitment to reduce premature deaths from noncommunicable diseases (NCDs, including cardiovascular diseases, diabetes, cancer, and chronic respiratory diseases) by 25% by 2025. Subsequently, the World Health Assembly in 2013 agreed to adopt a global monitoring framework that included nine ambitious global NCD targets for 2025 [1]. These targets address key risk factors including tobacco and al...
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Last. Chantal Mathieu (Katholieke Universiteit Leuven)H-Index: 113
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Context: Several observational studies and meta-analyses have reported increased mortality of patients taking sulfonylurea and insulin. The impact of patient profiles and concomitant therapies often remains unclear. Objective: The objective of the study was to quantify survival of patients after starting glucose-lowering agents (GLAs) and compare it with control subjects, matched for risk profiles and concomitant therapies. Design: This was a retrospective, controlled, cohort study. Setting: The...
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#1Dane J. DicksonH-Index: 1
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Real-world data (RWD) promises to provide a pivotal element to the understanding of personalized medicine. However, without true representation (or the reality) of the patient-disease biosystem and its molecular contributors, RWD may hamper rather than help this advancement. In this review article, we discuss RWD vs. clinical reality and the disconnects that exist currently (emphasizing molecular medicine), and methods of closing the gaps between RWD and reality.
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Abstract Aim In 2019, the Italian Society of Diabetology and the Italian Association of Clinical Diabetologists nominated an expert panel to develop guidelines for drug treatment of type 2 diabetes. This expert panel, after identifying the effects of glucose-lowering agents on major adverse cardiovascular events (MACEs) and all-cause mortality as critical outcomes, decided to perform a systematic review and meta-analysis on the effect of insulin secretagogues (sulfonylureas and glinides) with th...
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#1M. Harada (Kobe University)
#1Mayuko Harada (Niigata University)H-Index: 2
Last. Hirohito Sone (Niigata University)H-Index: 72
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Abstract Aim To examine the association between treatment-achieved HbA1c values and incidence of both coronary artery disease (CAD) and severe eye disease with different diabetes treatments. Methods Associations of treatment-achieved HbA1c were investigated in various treatment groups [diet only; insulin; sulphonylurea (SU) alone; SU with glinides; and antihyperglycaemic agents other than glinides, SU or insulin] taken from a nationwide claims database of 14,633 Japanese diabetes patients. Cox’s...
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BACKGROUND: It is unknown whether observational studies evaluating the association between antidiabetic medications and mortality adequately account for frailty. Our objectives were to evaluate if frailty was a potential confounder in the relationship between antidiabetic medication regimen and mortality and how well administrative and clinical electronic health record (EHR) data account for frailty. METHODS: We conducted a retrospective cohort study in a single Veterans Health Administration (V...
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Abstract Dypeptidylpeptidase-4 (DPP-4) inhibitors are a therapeutic option for improving glucose control in patients with type 2 diabetes. They can be prescribed at different stages of the natural history of the disease because of their low risk for hypoglycemia and associated weight gain. For all new drugs for diabetes, the US Food and Drug Administration requires the demonstration of the cardiovascular (CV) safety profile through pooled analyses of phase 3 studies or specifically designed tria...
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As has been well established, the Diabetes Care journal’s most visible signature event is the Diabetes Care Symposium held each year during the American Diabetes Association’s Scientific Sessions. Held this past year on 10 June 2017 in San Diego, California, at the 77th Scientific Sessions, this event has become one of the most attended sessions during the Scientific Sessions. Each year, in order to continue to have the symposium generate interest, we revise the format and content of this event....
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Aim Statins may increase the risk of new-onset diabetes and adversely affect glycaemic control, but their effects on the glycemic response and mortality outcomes following commencement of insulin therapy in patients with Type 2 Diabetes (T2D) are unclear.
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