scholarly journals Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Jelena P. Seferovic ◽  
Rhonda Bentley-Lewis ◽  
Brian Claggett ◽  
Rafael Diaz ◽  
Hertzel C. Gerstein ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Acute Coronary Syndrome ◽  
Proportional Hazards ◽  
Clinical Markers ◽  
Coronary Syndrome ◽  
Proportional Hazards Regression ◽  
Increased Risk ◽  
Registration Number ◽  
History Of

Introduction. We investigated the association of diabetic retinopathy and neuropathy with increased risk of recurrent cardiovascular (CV) events in 6068 patients with type 2 diabetes mellitus (T2DM) and recent acute coronary syndrome (ACS) enrolled in the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA). Methods. History of retinopathy and neuropathy as well as duration of T2DM were self-reported at screening. Proportional hazards regression models were used to assess relationships between retinopathy, neuropathy, and recurrent CV events. Results. At screening, retinopathy and neuropathy were reported in 10.7% and 17.5% of patients, respectively, while 5.7% reported both. When adjusted for randomized treatment only, both retinopathy and neuropathy were associated with a primary composite outcome (CV death, nonfatal MI, stroke, or hospitalization for unstable angina) (retinopathy: HR 1.44, 95% CI 1.19–1.75; neuropathy: HR 1.33, 95% CI 1.12–1.57), CV composite (CV death, nonfatal MI, stroke, hospitalization for heart failure (HF)) (retinopathy: HR 1.57, 95% CI 1.31–1.88; neuropathy: HR 1.38, 95% CI 1.19–1.62), myocardial infarction (retinopathy: HR 1.38, 95% CI 1.08–1.76; neuropathy: HR 1.26, 95% CI 1.02–1.54), HF hospitalization (retinopathy: HR 2.03, 95% CI 1.48–2.78; neuropathy: HR 1.71, 95% CI 1.30–2.27), and all-cause mortality (retinopathy: HR 1.65, 95% CI 1.28–2.12; neuropathy: HR 1.43, 95% CI 1.14–1.78). When included in the same model, and adjusted for T2DM duration, there were no independent associations of either with CV outcomes, while T2DM duration remained strongly associated with all outcomes. Addition of demographic characteristics and CV risk factors did not further alter these relationships. Conclusions. In patients with T2DM and recent ACS, a history of retinopathy and/or neuropathy and longer T2DM duration could be considered clinical markers for high risk of recurrent CV events. This trial is registered with the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome), ClinicalTrials.gov registration number NCT01147250.

scholarly journals Pain in Patients With Type 2 Diabetes-Related Polyneuropathy Is Associated With Vascular Events and Mortality

2020 ◽  
Vol 105 (9) ◽  
pp. 3005-3014
Author(s):  
Brittany R Lapin ◽  
Kevin M Pantalone ◽  
Alex Milinovich ◽  
Shannon Morrison ◽  
Andrew Schuster ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Proportional Hazards ◽  
Negative Binomial ◽  
Cox Proportional Hazards ◽  
Vascular Events ◽  
Proportional Hazards Regression ◽  
Increased Risk ◽  
History Of ◽  
Mortality Hazard Ratio

Abstract Purpose Type 2 diabetes–related polyneuropathy (DPN) is associated with increased vascular events and mortality, but determinants and outcomes of pain in DPN are poorly understood. We sought to examine the effect of neuropathic pain on vascular events and mortality in patients without DPN, DPN with pain (DPN + P), and DPN without pain (DPN-P). Methods A retrospective cohort study was conducted within a large health system of adult patients with type 2 diabetes from January 1, 2009 through December 31, 2016. Using an electronic algorithm, patients were classified as no DPN, DPN + P, or DPN-P. Primary outcomes included number of vascular events and time to mortality. Independent associations with DPN + P were evaluated using multivariable negative binomial and Cox proportional hazards regression models, adjusting for demographics, socioeconomic characteristics, and comorbidities. Results Of 43 945 patients with type 2 diabetes (age 64.6 ± 14.0 years; 52.1% female), 13 910 (31.7%) had DPN: 9104 DPN + P (65.4%) vs 4806 DPN-P (34.6%). Vascular events occurred in 4538 (15.1%) of no DPN patients, 2401 (26.4%) DPN + P, and 1006 (20.9%) DPN-P. After adjustment, DPN + P remained a significant predictor of number of vascular events (incidence rate ratio [IRR] = 1.55, 95% CI, 1.29-1.85), whereas no DPN was protective (IRR = 0.70, 95% CI, 0.60-0.82), as compared to DPN-P. Compared to DPN-P, DPN + P was also a significant predictor of mortality (hazard ratio = 1.42, 95% CI, 1.25-1.61). Conclusions Our study found a significant association between pain in DPN and an increased risk of vascular events and mortality. This observation warrants longitudinal study of the risk factors and natural history of pain in DPN.

scholarly journals Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Magnus O. Wijkman ◽  
Brian Claggett ◽  
Rafael Diaz ◽  
Hertzel C. Gerstein ◽  
Lars Køber ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Acute Coronary Syndrome ◽  
Coronary Event ◽  
Hazard Ratio ◽  
Risk Of Death ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
The Relationship

Abstract Background The relationship between blood pressure and mortality in type 2 diabetes (T2DM) is controversial, with concern for increased risk associated with excessively lowered blood pressure. Methods We evaluated whether prior cardiovascular disease (CVD) altered the relationship between baseline blood pressure and all-cause mortality in 5852 patients with T2DM and a recent acute coronary syndrome (ACS) who participated in the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial. Risk of death was assessed in Cox models adjusted for age, sex, race, heart rate, BMI, smoking, diabetes duration, insulin use, HbA1c, eGFR, brain natriuretic peptide (BNP), urine albumin/creatinine ratio, treatment allocation and prior coronary revascularization. Results Although overall there was no significant association between systolic blood pressure (SBP) and mortality (hazard ratio per 10 mmHg lower SBP 1.05 (95% CI 0.99–1.12) P = 0.10), lower SBP was significantly associated with higher risk of death (hazard ratio per 10 mmHg lower SBP 1.13 (95% CI 1.04–1.22) P = 0.002) in 2325 patients with additional CVD (index ACS+ at least one of the following prior to randomization: myocardial infarction other than the index ACS, stroke or heart failure). In 3527 patients with only the index ACS no significant association was observed (hazard ratio per 10 mmHg lower SBP 0.95 (0.86–1.04) P = 0.26; P for interaction 0.005). Conclusions The association between blood pressure and mortality was modified by additional CVD history in patients with type 2 diabetes and a recent coronary event. When blood pressures measured after an acute coronary event are used to assess the risk of death in patients with type 2 diabetes, the cardiovascular history needs to be taken into consideration. Trial registration ClinicalTrials.gov number NCT01147250, first posted June 22, 2010

scholarly journals Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David G. Marrero ◽  
Robert M. Blew ◽  
Kelly N. B. Palmer ◽  
Kyla James ◽  
Denise J. Roe ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
At Risk ◽  
Cardiovascular Health ◽  
Excess Body Weight ◽  
Lifestyle Behaviors ◽  
Increased Risk ◽  
Group Randomized Trial ◽  
Prevention Model ◽  
History Of

Abstract Background Exposure to gestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes (T2DM) in mothers, and poor cardiovascular health among offspring. Identifying effective methods to mitigate T2DM risk has the potential to improve health outcomes for mothers with a history of GDM and their children. The goal of the EPIC El Rio Families Study is to implement and evaluate the effects of a 13-week behavioral lifestyle intervention on T2DM risk factors in at-risk mothers and their 8- to 12-year-old children. We describe herein the rationale for our specific approach, the adaption of the DPP-based curriculum for delivery to patients of a Federally Qualified Health Center (FQHC), and the study design and methodology. Methods The effects of the intervention on reduction in excess body weight (primary outcome), hemoglobin A1c, blood pressure, and changes in lifestyle behaviors associated with weight trajectory and T2DM risk in mother-child dyads will be evaluated during a 13-week, group randomized trial wherein 60 mothers and their children will be recruited to the intervention or wait-listed control conditions at one of two FQHC locations. Intervention participants (n = 30) will begin the group program immediately, whereas the wait-listed controls (n = 30) will receive a booklet describing self-guided strategies for behavior change. Associated program delivery costs, acceptability of the program to participants and FQHC staff, and potential for long-term sustainability will also be evaluated. Discussion Successful completion in our aims will produce a scalable program with high potential for replication and dissemination, and estimated intervention effects to inform T2DM prevention efforts on families who use the FQHC system. The results from this study will be critical in developing a T2DM prevention model that can be implemented and scaled across FQHCs serving populations disproportionately burdened by T2DM. Trial registration ClinicalTrials.gov NCT03781102; Date of registration: 19 December 2018.

scholarly journals Vitamin D status and risk of type 2 diabetes in the Norwegian HUNT cohort study: does family history or genetic predisposition modify the association?

2021 ◽  
Vol 9 (1) ◽  
pp. e001948
Author(s):  
Marion Denos ◽  
Xiao-Mei Mai ◽  
Bjørn Olav Åsvold ◽  
Elin Pettersen Sørgjerd ◽  
Yue Chen ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Family History ◽  
Genetic Predisposition ◽  
Effect Modification ◽  
P Value ◽  
Family History Of Diabetes ◽  
Increased Risk ◽  
History Of

IntroductionWe sought to investigate the relationship between serum 25-hydroxyvitamin D (25(OH)D) level and the risk of type 2 diabetes mellitus (T2DM) in adults who participated in the Trøndelag Health Study (HUNT), and the possible effect modification by family history and genetic predisposition.Research design and methodsThis prospective study included 3574 diabetes-free adults at baseline who participated in the HUNT2 (1995–1997) and HUNT3 (2006–2008) surveys. Serum 25(OH)D levels were determined at baseline and classified as <50 and ≥50 nmol/L. Family history of diabetes was defined as self-reported diabetes among parents and siblings. A Polygenic Risk Score (PRS) for T2DM based on 166 single-nucleotide polymorphisms was generated. Incident T2DM was defined by self-report and/or non-fasting glucose levels greater than 11 mmol/L and serum glutamic acid decarboxylase antibody level of <0.08 antibody index at the follow-up. Multivariable logistic regression models were applied to calculate adjusted ORs with 95% CIs. Effect modification by family history or PRS was assessed by likelihood ratio test (LRT).ResultsOver 11 years of follow-up, 92 (2.6%) participants developed T2DM. A higher risk of incident T2DM was observed in participants with serum 25(OH)D level of<50 nmol/L compared with those of ≥50 nmol/L (OR 1.72, 95% CI 1.03 to 2.86). Level of 25(OH)D<50 nmol/L was associated with an increased risk of T2DM in adults without family history of diabetes (OR 3.87, 95% CI 1.62 to 9.24) but not in those with a family history (OR 0.72, 95% CI 0.32 to 1.62, p value for LRT=0.003). There was no effect modification by PRS (p value for LRT>0.23).ConclusionSerum 25(OH)D<50 nmol/L was associated with an increased risk of T2DM in Norwegian adults. The inverse association was modified by family history of diabetes but not by genetic predisposition to T2DM.

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

scholarly journals Type 2 Diabetes Mellitus. From the start – combination therapy

2018 ◽  
Vol 21 (5) ◽  
pp. 386-394 ◽  
Author(s):  
Francesco Indovina ◽  
Pierpaolo Falcetta ◽  
Stefano Del Prato
Keyword(s):  
Type 2 Diabetes ◽  
Combination Therapy ◽  
Diabetes Diagnosis ◽  
Good Glycemic Control ◽  
Chronic Hyperglycemia ◽  
Increased Risk ◽  
History Of ◽  
First Time ◽  
Early Combination Therapy

Modern treatment of T2DM requires a shift in paradigm with appropriate intensification of therapy from the very first time of diabetes diagnosis. This is supported by data showing how even a moderate delay in achieving good glycemic control can translate into a later increased risk of developing diabetic complications. The recognition of the complexity of the pathogenesis of T2DM leads to the appreciation of the importance of attacking the disease from different angles, i.e. simultaneous tackling of multiple mechanisms contributing to hyperglycemia. From the turn of century a growing number of new anti-hyperglycemic agents have been made available. As compared to the older ones, these new medicines have a more targeted mechanism of action as they act at the level of the specific pathophysiologic disturbances accounting the development and progression of hyperglycemia. Because of that drugs can be use in combination taking advantage of their complementary mechanisms of action and synergistic. If introduced earlier in the natural history of the disease combination therapy may contribute avoiding undesirable exposure to even mild chronic hyperglycemia and provide early benefits. With respect to that in this review we will discuss advantages, disadvantages and still unanswered questions related to the use of early combination therapy in type 2 diabetes.

THE EMERGENCE OF FRAILTY MAY LEAD TO A STATE OF BURNT OUT TYPE 2 DIABETES

2016 ◽  
pp. 1-6
Author(s):  
A.H. ABDELHAFIZ ◽  
L. KOAY ◽  
A.J. SINCLAIR
Keyword(s):  
Type 2 Diabetes ◽  
Β Cells ◽  
Risk Of Mortality ◽  
Vulnerable Patients ◽  
Increased Risk ◽  
History Of ◽  
The One ◽  
And Function ◽  
Glucose Dynamics

Ageing is associated with hyperglycaemic tendency due to the change in body composition leading to accumulation of visceral fat and increased insulin resistance on the one hand and reduced insulin secretion due to decreased number and function of the β-cells of the pancreas on the other. However, with the emergence of frailty there may be a tendency towards normoglycaemia or even hypoglycaemia due to malnutrition, weight loss and reduced physiologic reserve. This shift in glucose metabolism induced by frailty may change the natural history of type 2 diabetes from a progressive to a regressive course. Studies which showed increased risk of mortality with low HbA1c included frail patients in the lower HbA1c categories and healthier patients in the higher HbA1c categories suggesting that frailty is a possible confounding factor. Therefore, hypoglycemia may be a prognostic tool to identify vulnerable patients who may be at increased risk of mortality. The metabolic changes of insulin/glucose dynamics associated with frailty need further research.

Diagnosis and Early Management of Type 2 Diabetes in Patient with Acute Coronary Syndrome

2010 ◽  
pp. 44-44
Author(s):  
Maggie Sinclair Hammersley ◽  
Daniel Hammersley
Keyword(s):  
Type 2 Diabetes ◽  
Acute Coronary Syndrome ◽  
Early Management ◽  
Coronary Syndrome
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