scholarly journals CVOTs applicability on SGLT-2i in a real world population of type 2 diabetes patients

2019 ◽  
Vol 22 (1-2) ◽  
pp. 6
Author(s):  
Manicardi, V.
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
World Population ◽  
Eligibility Criteria ◽  
The Real ◽  
Major Cardiovascular Events ◽  
Cerebrovascular Events ◽  
Glomerular Filtrate ◽  
Design And Methods

OBJECTIVE OF THE STUDY To evaluate the generalizability of the results of recent CVOTs on SGLT2i (EMPA-REG OUTCOMES, CANVAS, DECLARE-TIMI 58 and VERTIS-CV) in patients with T2DM in the real world. DESIGN AND METHODS Database of AMD Annals 2018 was used in this study, including all patients cared for by 222 diabetes centers during 2016. Starting from the eligibility criteria adopted in the different trials, the analysis aimed to identify the subjects potentially eligible for each trial, compare their characteristics with those of the population recruited in the trials, and evaluate the current use of these drugs among the potentially eligible patients registered in AMD Annals database. RESULTS The evaluable cases (i.e. presence of information on all eligibility criteria) ranged from 149.064 for the CANVAS to the 342.205 subjects for the EMPAREG-OUTCOME. Overall, the eligible patients in AMD Annals ranged from 40,039 for the EMPAREG OUTCOME study (11.7%) to 144,166 (55.9%) for DECLARE-TIMI 58. The percentage of patients actually treated ranged from 4.4% (6.373) for DECLARE-TIMI 58 to 6.6% (2.917) for CANVAS. As compared to RCTs’ populations, AMD Annals population was older, included a larger proportion of women, showed slightly lower BMI and better metabolic control, and longer diabetes duration. Prevalence of major cardio-cerebrovascular events was lower, while the percentage of subjects with peripheral vasculopathy was higher; the proportion of subjects with reduced glomerular filtrate or albuminuria and diabetic retinopathy was higher. CONCLUSIONS The generalizability of CVOTs’ results to the real world patients is only partial, because the populations are quite different. A very low clinical use of SGLT-2i is documented. This is at least in part due to the strict AIFA criteria for reimbursement, which reduce the proportion of patients who could benefit from treatment with SGLT2i on major cardiovascular events and mortality; however, an identical advantage of the treatment obtained in RCTs cannot be hypothesized in the AMD Annals population. KEY WORDS type 2 diabetes; CVOT; real world; generalizability; SGLT2i

scholarly journals Transposition of cardiovascular outcome trial effects to the real-world population of patients with type 2 diabetes

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
V. Sciannameo ◽  
◽  
P. Berchialla ◽  
A. Avogaro ◽  
G. P. Fadini
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
Target Population ◽  
Cardiovascular Outcome ◽  
World Population ◽  
The Real ◽  
Specific Effects ◽  
Cardiovascular Outcome Trial ◽  
Post Stratification

Abstract Background Transferring results obtained in cardiovascular outcome trials (CVOTs) to the real-world setting is challenging. We herein transposed CVOT results to the population of patients with type 2 diabetes (T2D) seen in routine clinical practice and who may receive the medications tested in CVOTs. Methods We implemented the post-stratification approach based on aggregate data of CVOTs and individual data of a target population of diabetic outpatients. We used stratum-specific estimates available from CVOTs to calculate expected effect size for the target population by weighting the average of the stratum-specific treatment effects according to proportions of a given characteristic in the target population. Data are presented as hazard ratio (HR) and 95% confidence intervals. Results Compared to the target population (n = 139,708), the CVOT population (n = 95,816) was younger and had a two to threefold greater prevalence of cardiovascular disease. EMPA-REG was the CVOT with the largest variety of details on stratum-specific effects, followed by TECOS, whereas DECLARE and PIONEER-6 had more limited stratum-specific information. The post-stratification HR estimate for 3 point major adverse cardiovascular event (MACE) based on EMPA-REG was 0.88 (0.74–1.03) in the target population, compared to 0.86 (0.74–0.99) in the trial. The HR estimate based on LEADER was 0.88 (0.77–0.99) in the target population compared to 0.87 (0.78–0.97) in the trial. Consistent results were obtained for SUSTAIN-6, EXSCEL, PIONEER-6 and DECLARE. The effect of DPP-4 inhibitors observed in CVOTs remained neutral in the target population. Conclusions Based on CVOT stratum-specific effects, cardiovascular protective actions of glucose lowering medications tested in CVOTs are transferrable to a much different real-world population of patients with T2D.

scholarly journals Effect of Diabetes Treatment-Related Attributes on Costs to Type 2 Diabetes Patients in a Real-World Population

2017 ◽  
Vol 23 (4) ◽  
pp. 446-452 ◽  
Author(s):  
Jie Meng ◽  
Roman Casciano ◽  
Yi-Chien Lee ◽  
Lee Stern ◽  
Dmitry Gultyaev ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
World Population ◽  
Diabetes Treatment ◽  
Diabetes Patients

scholarly journals A Distribution-based Method for Assessing The Differences between Clinical Trial Target Populations and Patient Populations in Electronic Health Records

2014 ◽  
Vol 05 (02) ◽  
pp. 463-479 ◽  
Author(s):  
P. Ryan ◽  
Y. Zhang ◽  
F. Liu ◽  
J. Gao ◽  
J.T. Bigger ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
Real World ◽  
World Population ◽  
Health Records ◽  
Target Populations ◽  
Electronic Health

SummaryObjective: To improve the transparency of clinical trial generalizability and to illustrate the method using Type 2 diabetes as an example.Methods: Our data included 1,761 diabetes clinical trials and the electronic health records (EHR) of 26,120 patients with Type 2 diabetes who visited Columbia University Medical Center of New-York Presbyterian Hospital. The two populations were compared using the Generalizability Index for Study Traits (GIST) on the earliest diagnosis age and the mean hemoglobin A1c (HbA1c) values.Results: Greater than 70% of Type 2 diabetes studies allow patients with HbA1c measures between 7 and 10.5, but less than 40% of studies allow HbA1c<7 and fewer than 45% of studies allow HbA1c>10.5. In the real-world population, only 38% of patients had HbA1c between 7 and 10.5, with 12% having values above the range and 52% having HbA1c<7. The GIST for HbA1c was 0.51. Most studies adopted broad age value ranges, with the most common restrictions excluding patients >80 or <18 years. Most of the real-world population fell within this range, but 2% of patients were <18 at time of first diagnosis and 8% were >80. The GIST for age was 0.75. Conclusions: We contribute a scalable method to profile and compare aggregated clinical trial target populations with EHR patient populations. We demonstrate that Type 2 diabetes studies are more generalizable with regard to age than they are with regard to HbA1c. We found that the generalizability of age increased from Phase 1 to Phase 3 while the generalizability of HbA1c decreased during those same phases. This method can generalize to other medical conditions and other continuous or binary variables. We envision the potential use of EHR data for examining the generaliz-ability of clinical trials and for defining population-representative clinical trial eligibility criteria.Citation: Weng C, Li Y, Ryan P, Zhang Y, Liu F, Gao J, Bigger JT, Hripcsak G. A distribution-based method for assessing the differences between clinical trial target populations and patient populations in electronic health records. Appl Clin Inf 2014; 5: 463–479 http://dx.doi.org/10.4338/ACI-2013-12-RA-0105

scholarly journals Rates of glycaemic deterioration in a real-world population with type 2 diabetes

Diabetologia ◽  
2017 ◽  
Vol 61 (3) ◽  
pp. 607-615 ◽  
Author(s):  
Louise A. Donnelly ◽  
Kaixin Zhou ◽  
Alex S. F. Doney ◽  
Chris Jennison ◽  
Paul W. Franks ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Real World ◽  
World Population

scholarly journals Use of Hemoglobin A1c and Fasting Plasma Glucose to Diagnose Type 2 Diabetes in the Real World

2012 ◽  
Vol 6 (3) ◽  
pp. 721-722
Author(s):  
B. Shivananda Nayak ◽  
Kameel Mungrue ◽  
Shawn Seepersad ◽  
Justin Sookram ◽  
Shalina Singh ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Plasma Glucose ◽  
Real World ◽  
Fasting Plasma Glucose ◽  
Hemoglobin A1c ◽  
The Real ◽  
Fasting Plasma
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