Optimization of Albuminuria-Lowering Treatment in Diabetes by Crossover Rotation to Four Different Drug Classes: A Randomized Crossover Trial
Authors' conclusion
We demonstrated a large and reproducible variation in participants' responses to different UACR-lowering drug classes. These data support systematic rotation through different drug classes to overcome therapy resistance to RAS inhibition.
Study context
- Population
- Adults with T1D or T2D, urinary albumin to creatinine ratio (UACR) 30–500 mg/g and eGFR >45 mL/min/1.73 m²26 T1D, 37 T2D
- Comparison
- Rotation through telmisartan, empagliflozin, linagliptin and baricitinib; individual best-performing drug vs the other three
- Primary endpoint
- Difference in UACR response to the best-performing drug during the confirmation period vs UACR response to the other three drugs
- Follow-up
- Confirmation period
Methodological details4-week treatment periods in random order, 4-week washout periods, 4-week confirmatory re-exposure to best-performing drug
- 4-week treatment periods in random order
- 4-week washout periods
- 4-week confirmatory re-exposure to best-performing drug
Primary result
As reported in the abstract
Change in UACR from baseline: best-performing drug at confirmation vs other three drugs · confirmatory exposure
Best-performing drug
−22.4%
mean · 95% CI −29.7–-12.5
Other three drugs
+1.6%
mean · 95% CI −4.3%–8.0%
Estimate (95% CI)P value
Between Other three drugs and Best-performing drug
difference 30.9%(18.0–45.3)
P < 0.001Best-performing drugconfirmatory exposure
change vs baseline −22.4%(−29.7 to −12.5)
P < 0.001- Other three drugs
- change vs baseline +1.6% (95% CI −4.3% to 8.0%); P = 0.593 versus baseline
Further findings
Change in UACR from baseline with best-performing drug at first exposure
| Values | Change vs baseline (95% CI) | P value | ||
|---|---|---|---|---|
| Best-performing drugFirst exposure | Best-performing drug mean −39.6% (95% CI −44.8–-33.8) | −39.6% (−44.8 to −33.8) | P < 0.001 | |
| −60−40−20020Difference (linear scale) |
Correlation of UACR response, first vs confirmatory exposure
- Pearson correlation
- 0.39 (P = 0.017)
Original publication
Optimization of Albuminuria-Lowering Treatment in Diabetes by Crossover Rotation to Four Different Drug Classes: A Randomized Crossover Trial. Diabetes Care. Published 18 January 2023. doi:10.
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