scholarly journals Composite Primary End Points in Cardiovascular Outcomes Trials Involving Type 2 Diabetes Patients: Should Unstable Angina Be Included in the Primary End Point?

Diabetes Care ◽  
2017 ◽  
Vol 40 (9) ◽  
pp. 1144-1151 ◽  
Author(s):  
Nikolaus Marx ◽  
Darren K. McGuire ◽  
Vlado Perkovic ◽  
Hans-Juergen Woerle ◽  
Uli C. Broedl ◽  
...  
2020 ◽  
Author(s):  
Ga Eun Nam ◽  
Wonsock Kim ◽  
Kyungdo Han ◽  
Chung-woo Lee ◽  
Yeongkeun Kwon ◽  
...  

<b>Objective: </b>Obesity and type 2 diabetes are risk factors for cardiovascular diseases and mortality, and that commonly result in weight variabilities. We aimed to investigate the association between body weight variability and risk of major cardiovascular outcomes and mortality in individuals with type 2 diabetes using large-scale, nationwide cohort data on the Korean population. <div><p><b>Research Design and Methods: </b>We enrolled 624,237 individuals with type 2 diabetes who underwent health examinations provided by the Korean National Health Insurance System between 2009 and 2010, with ≥3 body weight measurements within 5 years since enrollment and followed up until the end of 2017. We assessed body weight variability using four indices, including variability independent of the mean (VIM). Multivariable-adjusted Cox proportional hazards regression analysis was performed.</p> <p><b>Results: </b>During the follow-up, 15,832, 25,038, and 44,716 cases of myocardial infarction (MI), stroke, and all-cause mortality, respectively, were recorded. Body weight variability was associated with increased risks of major cardiovascular outcomes after adjusting for confounding variables. Compared with the hazard ratios (HRs) of the lowest quartile group, the HRs (95% CIs) of the highest quartile group of VIM for body weight were 1.15 (1.10–1.20), 1.22 (1.18–1.26), and 1.58 (1.53–1.62) for MI, stroke, and all-cause mortality, respectively.</p> <p><b>Conclusions: </b>Body weight variability was associated with increased risks of MI, stroke, and all-cause mortality in type 2 diabetes patients and may be a predictor of cardiovascular outcomes in such patients. Appropriate interventions to maintain stable weight could positively influence health outcomes in type 2 diabetes patients.</p> </div> <br>


Diabetes Care ◽  
2020 ◽  
Vol 43 (9) ◽  
pp. e108-e110 ◽  
Author(s):  
Matthew J. Crowley ◽  
Darren K. McGuire ◽  
Anastasia-Stefania Alexopoulos ◽  
Thomas Jon Jensen ◽  
Søren Rasmussen ◽  
...  

2019 ◽  
Vol 10 (4) ◽  
pp. 1041-1049 ◽  
Author(s):  
Miho Shimizu ◽  
Kengo Furuichi ◽  
Tadashi Toyama ◽  
Tomoaki Funamoto ◽  
Shinji Kitajima ◽  
...  

2018 ◽  
Vol 20 (7) ◽  
pp. 1732-1739 ◽  
Author(s):  
Shelby D. Reed ◽  
Yanhong Li ◽  
Jose Leal ◽  
Larry Radican ◽  
Amanda I. Adler ◽  
...  

2021 ◽  
Vol 10 (3) ◽  
pp. 169-173
Author(s):  
Chakrapani Balijepalli ◽  
Kevin Yan ◽  
Michael Zoratti ◽  
Meg Franklin ◽  
Eric Druyts

Composite renal end points and end stage renal disease (ESRD) are frequently included as prespecified secondary end points in the cardiovascular outcomes trials (CVOTs) of diabetes medications. We examined the heterogeneity in the definitions of composite renal end point and ESRD in CVOTs. Five criteria (macroalbuminuria, doubling of serum creatinine, estimated glomerular filtration rate [GFR], ESRD and renal death), were considered for the renal composite end point across the trials. Only three of the 12 trials included all five criteria, whereas the other trials included different combinations of four, three and two criteria. ESRD definition also showed considerable heterogeneity across the trials. Heterogeneity exists in the definitions of renal composite and ESRD end points in CVOTs making it challenging to assess comparative efficacy of the active treatments for reimbursement purposes.


2020 ◽  
Author(s):  
Ga Eun Nam ◽  
Wonsock Kim ◽  
Kyungdo Han ◽  
Chung-woo Lee ◽  
Yeongkeun Kwon ◽  
...  

<b>Objective: </b>Obesity and type 2 diabetes are risk factors for cardiovascular diseases and mortality, and that commonly result in weight variabilities. We aimed to investigate the association between body weight variability and risk of major cardiovascular outcomes and mortality in individuals with type 2 diabetes using large-scale, nationwide cohort data on the Korean population. <div><p><b>Research Design and Methods: </b>We enrolled 624,237 individuals with type 2 diabetes who underwent health examinations provided by the Korean National Health Insurance System between 2009 and 2010, with ≥3 body weight measurements within 5 years since enrollment and followed up until the end of 2017. We assessed body weight variability using four indices, including variability independent of the mean (VIM). Multivariable-adjusted Cox proportional hazards regression analysis was performed.</p> <p><b>Results: </b>During the follow-up, 15,832, 25,038, and 44,716 cases of myocardial infarction (MI), stroke, and all-cause mortality, respectively, were recorded. Body weight variability was associated with increased risks of major cardiovascular outcomes after adjusting for confounding variables. Compared with the hazard ratios (HRs) of the lowest quartile group, the HRs (95% CIs) of the highest quartile group of VIM for body weight were 1.15 (1.10–1.20), 1.22 (1.18–1.26), and 1.58 (1.53–1.62) for MI, stroke, and all-cause mortality, respectively.</p> <p><b>Conclusions: </b>Body weight variability was associated with increased risks of MI, stroke, and all-cause mortality in type 2 diabetes patients and may be a predictor of cardiovascular outcomes in such patients. Appropriate interventions to maintain stable weight could positively influence health outcomes in type 2 diabetes patients.</p> </div> <br>


2020 ◽  
Vol 11 (1) ◽  
pp. 7-10
Author(s):  
Khadiza Begum ◽  
Fahmida Islam ◽  
Farjana Aktar ◽  
Murshida Aziz ◽  
Tohfa E Ayub Tahiya

Background: In recent times much is talked about of serum ferritin, an acute phase reactant a marker of iron stores in the body and its association with diabetes mellitus. Studies implicate that increased body iron stores and subclinical hemochromatosis has been associated with the development of glucose intolerance, type 2 diabetes and its micro as well as macrovascular complications. Material & Methods: This study was carried out to examine and to observe for any relationship between serum ferritin with Type 2 diabetes mellitus. Our study populations were included 163. Among them 81 type 2 diabetes patients as a case (M=49,F=32, mean 44.68 age in years)and 82 normal healthy individual as a control ( M=35, F=47 , mean 34.71 in years). Results: Majority were healthy outpatients who had come for regular checkup and were matched with controls. Serum ferritin and FBS were estimated and other investigations. Results showed that although Serum ferritin was in the normal range value it was increased in type 2 diabetes patients than in controls and was statistically significant, we did get a positive correlation with duration of diabetes. It can be concluded that there were positive associations between serum ferritin and FBG, age, sex among study groups. Conclusion: In conclusion our study shows that there is significant correlation between increased serum ferritin in diabetes compared to individuals with normal blood sugars in this part and hyper ferritinemia may be one of the causes for development of insulin resistance before overt diabetes. Anwer Khan Modern Medical College Journal Vol. 11, No. 1: Jan 2020, P 7-10


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