Comparative effectiveness of canagliflozin, SGLT2 inhibitors and non‐SGLT2 inhibitors on the risk of hospitalization for heart failure and amputation in patients with type 2 diabetes mellitus: A real‐world meta‐analysis of 4 observational databases (OBSERVE‐4D)
Why the study?
Do canagliflozin and other SGLT2 inhibitors reduce hospitalization for heart failure or increase amputation risk compared to non-SGLT2 inhibitors in patients with type 2 diabetes mellitus?
Population
714,582 patients with type 2 diabetes mellitus, including a subpopulation with established cardiovascular…
Comparison
Canagliflozin and other SGLT2 inhibitors vs Non-SGLT2i antihyperglycaemic agents (n=460,885)
Design
Meta-analysis
Authors
Discussion
Loading...
Member takes
Implication
No amputation signal in claims data supports ongoing SGLT2i use; leaves open need for longer prospective confirmation.
Key Points
- To compare the real-world effectiveness and safety of canagliflozin versus other SGLT2 inhibitors and non-SGLT2 inhibitors on hospitalization for heart failure and below-knee lower extremity amputation in type 2 diabetes.
- Analyzed data from 4 US administrative claims databases comprising 142,800 new users of canagliflozin, 110,897 new users of other SGLT2 inhibitors, and 460,885 new users of non-SGLT2 inhibitors.
- Employed a propensity score-adjusted new-user cohort design to calculate hazard ratios across the entire cohort and in a subgroup with established cardiovascular disease.
- Canagliflozin was associated with a significant reduction in hospitalization for heart failure compared with non-SGLT2 inhibitors in on-treatment analysis (HR 0.39; 95% CI, 0.26–0.60).
- Risk of below-knee lower extremity amputation with canagliflozin versus non-SGLT2 inhibitors showed no significant difference in on-treatment (HR 0.75; 95% CI, 0.40–1.41) or intent-to-treat analyses (HR 1.01; 95% CI, 0.93–1.10).
- Results were consistent in patients with established cardiovascular disease, with no consistent differences identified between canagliflozin and other SGLT2 inhibitors.
Structured PICO
Do canagliflozin and other SGLT2 inhibitors reduce hospitalization for heart failure or increase amputation risk compared to non-SGLT2 inhibitors in patients with type 2 diabetes mellitus?
P
Population
714,582 patients with type 2 diabetes mellitus (T2DM), including a subpopulation with established cardiovascular disease, from 4 large US administrative claims databases.
I
Intervention
Canagliflozin (n=142,800) and other SGLT2 inhibitors (n=110,897)
C
Comparator
Non-SGLT2i antihyperglycaemic agents (n=460,885)
O
Outcome
Hospitalization for heart failure (HHF) and below-knee lower extremity (BKLE) amputationhard clinical
In a real-world setting, canagliflozin and other SGLT2 inhibitors are associated with a reduced risk of heart failure hospitalization without an increased risk of below-knee amputation compared to non-SGLT2 inhibitors.
Cite This Study
Ryan et al. (2018) studied this question.