Takeaway
- Treatment of patients with chronic kidney disease and/or atherosclerotic cardiovascular (CV) disease is warranted even in patients who have type 2 diabetes (T2D) that is “well-controlled” (HbA1c 6.5%-7.0%).
Why this matters
- Initial clinical trials included mostly patients with baseline HbA1c >7%, so current guidelines have recommended sodium glucose co-transporter 2 inhibitors (SGLT2is) as add-on therapy for patients with HbA1c >7%.
Study design
- Analysis of results from the double-blind, randomized Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial by baseline HbA1c: 650 with <7%, 1406 with 7.0%-7.9%, 2343 with ≥8%.
- Overall, canagliflozin (Invokana) was tied to a significant reduction in the primary composite outcome (end-stage kidney disease, serum creatinine doubling, or renal or CV death) and other CV endpoints including hospitalization for heart failure (HHF).
- Funding: Janssen Research and Development, LLC.
Key results
- No differences in primary outcome reduction across baseline HbA1c levels, with HRs 0.63, 0.84, and 0.63 for <7%, 7%-7.9%, and ≥8%, respectively (Pinteraction=.277).
- No differences by baseline HbA1c across composite or singular secondary outcomes, including HHF (0.41, 0.73, and 0.59, respectively, Pinteraction=.462).
- No differences in serious adverse events by baseline HbA1c, including amputation, hypoglycemia, or acute kidney injury.
Limitations
- Early termination may have limited power for some secondary outcomes.
References
References
