Abstract: SA-PO144
Comparison Between Clinical Trial and Real-World Use of Sodium-Glucose Co-Transporter-2 Inhibitors According to CKD Status
Session Information
- Diabetic Kidney Disease: Clinical - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diabetic Kidney Disease
- 602 Diabetic Kidney Disease: Clinical
Authors
- Shin, Jung-Im, Johns Hopkins University, Baltimore, Maryland, United States
- Coresh, Josef, Johns Hopkins University, Baltimore, Maryland, United States
- Selvin, Elizabeth, Johns Hopkins University, Baltimore, Maryland, United States
- Inker, Lesley, Tufts Medical Center, Boston, Massachusetts, United States
- Chang, Alex R., Geisinger Medical Center, Danville, Pennsylvania, United States
- Grams, Morgan, Johns Hopkins University, Baltimore, Maryland, United States
Background
Clinical trials typically enroll highly selective patient populations and often include few participants with chronic kidney disease (CKD). Our objective was to compare participants characteristics and outcomes in trials of sodium-glucose co-transporter-2 inhibitors (SGLT-2i) with SGLT-2i users in real-world settings according to CKD status.
Methods
We compared characteristics, mortality, and HbA1c change at 12 weeks among SGLT-2i users in the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) with patients in the Geisinger Health System from June 2013 to January 2017 according to CKD status. CKD was defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 according to Modification of Diet in Renal Disease equation or macroalbuminuria.
Results
From 2013 to 2016, prescription of SGLT-2i increased in each category of eGFR (G1-2 [0.3% to 5.3%] and G3-5 [0.2% to 2%], all P<0.001). Compared to trial participants, real-world users of SGLT-2i were younger, more obese, with a much lower prevalence of coronary artery disease (Table). Real-world users had lower mortality than their counterparts in the trial, and these differences were present in patients with and without CKD. The magnitude of HbA1c reduction from baseline to 12 weeks was similar between trial participants and real-world users.
Conclusion
Despite the difference in baseline characteristics between trial and real-world users, SGLT-2i appeared to have similar glucose-lowering effect in individuals with diabetes regardless of CKD status. Further research is warranted to investigate the effects of SGLT-2i on cardiovascular and kidney outcomes in patients with CKD.
| Patients with CKD | Patients without CKD | |||
| Baseline characteristics | EMPA-REG OUTCOME trial (N=1,498) | Geisinger (N=288) | EMPA-REG OUTCOME trial (N=3,149) | Geisinger (N=1,603) |
| Age, years | 66.2 (8.0) | 62.5 (10.4)* | 61.6 (8.4) | 56.5 (10.9)* |
| Male | 69.0 | 50.0* | 72.1 | 54.3* |
| Body mass index, kg/m2 | 30.8 (5.4) | 37.1 (7.8)* | 30.5 (5.2) | 36.3 (7.4)* |
| eGFR, mL/min/1.73 m2 | 54.5 (16.2) | 60.3 (22.8)* | 83.4 (17.2) | 96.2 (23.6)* |
| HbA1c, % | 8.11 (0.87) | 8.54 (1.50)* | 8.04 (0.84) | 8.70 (1.44)* |
| Coronary artery disease | 75.9 | 37.5* | 75.5 | 21.3* |
| Outcomes | ||||
| All-cause mortality, per 1000 person-years | 32.5 | 15.4§ | 13.4 | 4.1* |
| Mean HbA1c change (SE) from baseline at week 12, % | -0.46 (0.03) | -0.45 (0.14)† | -0.79 (0.02) | -0.80 (0.05)‡ |
Values are mean (SD) or %, unless indicated otherwise. * p<0.001; § p=0.07; † p=0.93; ‡ p =0.84
Funding
- Other NIH Support