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

Abstract Background Head-to-head comparison of clinical effectiveness between dulaglutide and liraglutide in Asia is limited. This study was aimed to assess the real-world comparative effectiveness of dulaglutide versus liraglutide. Methods We conducted a retrospective cohort study by utilizing multi-institutional electronic medical records to identify real-world type 2 diabetes patients treated with dulaglutide or liraglutide during 2016-2018 in Taiwan and followed up until 2019. Effectiveness outcomes were assessed at every three months in the one-year follow-up. Propensity score techniques were applied to enhance between-group comparability. Significant differences in changes of effectiveness outcomes between treatment groups during the follow-up were examined and further analyzed using mixed-model repeated-measures approaches. Results A total of 1,512 subjects receiving dulaglutide and 1,513 subjects receiving liraglutide were identified. At 12 months, significant HbA1c changes from baseline were found in both treatments (dulaglutide: -1.06%, p<0.001; liraglutide: -0.83%, p<0.001), with a significant between-group difference (-0.23%, 95% confidence interval: -0.38 to -0.08%, p<0.01). Both treatments yielded significant declines in weight, alanine aminotransferase level, and estimated glomerular filtration rate from baseline (dulaglutide: -1.14 kg, -3.08 U/L and -2.08 ml/min/1.73 m2, p<0.01; liraglutide: -1.64 kg, -3.65 U/L and -2.33 ml/min/1.73 m2, p<0.001), whereas only dulaglutide yielded a significant systolic blood pressure reduction (-2.47 mmHg, p<0.001). Between-group differences in changes of weight, blood pressure, and liver and renal functions at 12 months were not statistically significant. Conclusions In real-world T2D patients, dulaglutide versus liraglutide was associated with better glycemic control and comparable effects on changes of weight, blood pressure, and liver and renal functions.

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The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Design and Baseline Characteristics

10.1055/s-0041-1727304 ◽

2021 ◽

Author(s):

LE Garcia-Pérez ◽

H Sapin ◽

K Norrbacka ◽

B Guerci ◽

F Giorgino ◽

...

Keyword(s):

Type 2 Diabetes ◽

Health Outcomes ◽

Prospective Study ◽

Real World ◽

The Real ◽

Observational Prospective Study ◽

Baseline Characteristics ◽

Diabetes Patients

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The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Baseline Patient-Reported Outcomes

Diabetes Therapy ◽

10.1007/s13300-020-00908-9 ◽

2020 ◽

Vol 11 (10) ◽

pp. 2383-2399

Author(s):

Kristina S. Boye ◽

Hélène Sapin ◽

Luis-Emilio García-Pérez ◽

Myriam Rosilio ◽

Marco Orsini Federici ◽

...

Keyword(s):

Type 2 Diabetes ◽

Health Outcomes ◽

Prospective Study ◽

Real World ◽

Patient Reported Outcomes ◽

The Real ◽

Observational Prospective Study ◽

Patient Reported ◽

Diabetes Patients

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

Applied Clinical Informatics ◽

10.4338/aci-2013-12-ra-0105 ◽

2014 ◽

Vol 05 (02) ◽

pp. 463-479 ◽

Cited By ~ 30

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

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