A Multicenter Observational Study of Incretin-based Drugs and Heart Failure

Filion, Kristian B.; Azoulay, Laurent; Rw, Platt; Dahl, Matthew; Cr, Dormuth; Kk, Clemens; Hu, Niaoqing; Jm, Paterson; Targownik, Laura E.; Turin, Tanvir Chowdhury; Udell, Jacob A.; Ernst, Pierre

doi:10.1056/nejmoa1506115

Cited by 196 publications

(143 citation statements)

References 19 publications

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“…Several large studies with dipeptidyl peptidase 4 inhibitors (DPP-4is) did not show any cardiovascular benefit. An increase in hospitalizations for CHF was observed with saxagliptin (72); however, a meta-analysis suggested no increase in CHF with any of the oral or injectable incretins (73).…”

Section: Blood Glucosementioning

confidence: 99%

Management of Atherosclerotic Cardiovascular Disease Risk Factors in the Older Adult Patient With Diabetes

Korytkowski

Forman

2017

Diabetes Care

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Older adults with diabetes are at higher risk for atherosclerotic cardiovascular disease (ASCVD) than younger adults with diabetes and older adults without diabetes. The rationale to implement ASCVD risk-lowering therapies in older adults with diabetes is compelling. Recommendations for lifestyle modification, lipidlowering therapy, blood pressure management, blood glucose control, and aspirin therapy are often based on studies that show their efficacy in younger populations. However, the risks associated with each of these interventions increase with age, and favorable risk-to-benefit ratios demonstrated in younger adults with diabetes are less certain in older populations. The variability in health status among older adults is pertinent. Those with robust health are more likely to tolerate and derive benefit from many therapies when compared with those who have more complex health including frailty. Age-and/or frailty-stratified data to help clarify these relationships are sparse. In this Perspective, current recommendations for modifying ASCVD risk are described with a review of the pertinent literature that guides their application in older adults. A pragmatic approach to the treatment of ASCVD risk factors in older adults with diabetes is presented.Diabetes is highly prevalent in the aging population, affecting .25% of individuals aged .65 years and 19% of those aged .75 years (1,2). Physiological changes associated with aging increase susceptibility to coronary heart disease and other atherosclerotic cardiovascular disease (ASCVD) processes (3). The incidence and prevalence of ASCVD-related macrovascular events essentially doubles in older adults with diabetes (4-6). The overlap of older age, diabetes, and other ASCVD risk factors enhances risk for microvascular and macrovascular complications, functional disability, and geriatric syndromes (including frailty, multimorbidity, polypharmacy, cognitive impairment, depression, urinary incontinence, and falls) (1,7-10). As the population of older adults grows, the implications of diabetes on ASCVD risk escalate, and insights regarding optimal care become increasingly important (2).Therapies directed at ASCVD risk factor reduction are important therapeutic priorities for older adults with diabetes as a way of modifying risk for vascular events and improving health-related quality of life (HRQL) (11,12). Therapeutic targets include control of lipids, blood pressure (BP), and blood glucose in combination with antiplatelet agents. The expectation is that these therapies will increase longevity, reduce ASCVD events and need for hospitalizations, and improve HRQL. However, iatrogenic risks and limited life expectancy confound these objectives

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Section: Blood Glucosementioning

confidence: 99%

Management of Atherosclerotic Cardiovascular Disease Risk Factors in the Older Adult Patient With Diabetes

Korytkowski

Forman

2017

Diabetes Care

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“…31 Pooled results with a consistent effect across different RCD data sets and countries can create a very impactful observational study with robust conclusions. 32 Finally, RCD is available in many data sources as far back as the 1970s. This means that the first generation of people born and raised in an electronic healthcare environment are starting families of their own.…”

Section: Future Directionsmentioning

confidence: 99%

A review of routinely collected data studies in urology: Methodological considerations, reporting quality, and future directions

Welk

Kwong

2017

CUAJ

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Studies using routinely collected data (RCD) are common in the urological literature; however, there are important considerations in the creation and review of RCD discoveries. A recent reporting guideline (REporting of studies Conducted using Observational Routinely-collected health Data, RECORD) was developed to improve the reporting of these studies. This narrative review examines important considerations for RCD studies. To assess the current level of reporting in the urological literature, we reviewed all the original research articles published in Journal of Urology and European Urology in 2014, and determined the proportion of the RECORD checklist items that were reported for RCD studies. There were 56 RCD studies identified among the 608 articles. When the RECORD items were considered applicable to the specific study, they were reported in 52.5% of cases. Studies most consistently (>80% of them) reported the names of the data sources, the study time frame, the extent to which the authors could access the database source, the patient selection, and discussed missing data. Few studies (<25%) discussed validation of key coding elements, details on data-linkage, data-cleaning, the impact of changing eligibility over time, or provided the complete list of coding elements used to define key study variables. Reporting factors specifically relevant in RCD studies may serve to increase the quality of these studies in the urological literature. With increased technological integration in healthcare and the proliferation of electronic medical records, RCD will continue to be an important source for urological research. IntroductionRoutinely collected data (RCD, also known as administrative data) is increasingly being used to answer clinical research questions. While there are many sources of observational data (for example, population surveys or patient registries), RCD is specifically defined as data that is routinely collected for a purpose other than research. Common examples of RCD sources include physician billing records, insurance company records, or government-mandated healthcare utilization records. 1There are several important strengths that have driven the increased use of RCD research over the last two decades. These include low study costs (especially when compared to prospective clinical studies or randomized, controlled trials), rapid delivery of results, substantial sample sizes, improved generalizability, long-term patient followup (often across different hospitals and physician practices), and the ability to identify very rare patient populations or outcomes.Given the apparent increase in publications using RCD in many urological journals, we sought to review several key issues related to this research area that are relevant for those conducting these studies, and for clinicians who wish to critically read these studies, understand potential methodological limitations, and evaluate the strength of the study's conclusions. Methodological considerations for the use of RCDAny study using RCD ...

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“…Those treated with GLP-1RAs had lower risks of all-cause hospitalization (HR: 0.17, 95% CI: 0.02-1.23; P = 0.079) and all-cause death (HR: 0.17, 95% CI: 0.02-1.22; P = 0.078), although these estimates did not reach statistical significance [38]. In addition, healthcare data from four Canadian provinces, the US and the UK were used for a nested case -control analysis [39]. The cohorts included a total of 1,499,650 patients, with 29,741 hospitalized for HF.…”

Section: Effects Of Liraglutide On Cardiac Function and Cardiovasculamentioning

confidence: 99%

GLP-1 receptor agonists and heart failure in diabetes

Scheen

2017

Diabetes & Metabolism

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The prevalence of heart failure (HF) is increasing in patients with type 2 diabetes (T2D), and glucose-lowering agents have distinctive effects on the risk of developing HF that requires hospitalization. Such an increased risk has been consistently reported with thiazolidinediones (glitazones) and perhaps also with the dipeptidyl peptidase (DPP)-4 inhibitor saxagliptin (at least in SAVOR -TIMI 53), whereas a markedly decreased risk was highlighted with the sodium -glucose cotransporter type 2 (SGLT2) inhibitor empagliflozin in EMPA-REG OUTCOME. Yet, the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on myocardial function remain controversial. Whereas some promising observations have been reported in various animal models, the effects of GLP-1RAs on myocardial function in humans are more heterogeneous, while the positive effect on left ventricular ejection fraction (LVEF), if any, appears to be inconsistent and rather modest in most patients with HF. However, no increased risk of hospitalization for HF has been reported with GLP-1RAs in meta-analyses of phase-II/III trials (exenatide, albiglutide, dulaglutide, liraglutide), demonstrating the safety of this pharmacological class, and such findings have been confirmed by three large prospective cardiovascular outcome trials (ELIXA with lixisenatide, LEADER with liraglutide and SUSTAIN-6 with semaglutide). In particular, LEADER reported a trend towards a reduction in HF hospitalization (-13%, P = 0.14), together with a significant reduction in cardiovascular and all-cause mortality in patients with T2D at risk of cardiovascular disease. These results are reassuring in the face of the somewhat negative results of the FIGHT trial, which evaluated the effects of liraglutide in patients with advanced HF and low LVEF, such that further studies and caution are now required when using this agent to treat such patients in clinical practice.

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A Multicenter Observational Study of Incretin-based Drugs and Heart Failure

Cited by 196 publications

References 19 publications

Management of Atherosclerotic Cardiovascular Disease Risk Factors in the Older Adult Patient With Diabetes

Management of Atherosclerotic Cardiovascular Disease Risk Factors in the Older Adult Patient With Diabetes

A review of routinely collected data studies in urology: Methodological considerations, reporting quality, and future directions

GLP-1 receptor agonists and heart failure in diabetes

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