Table 1.

Crude incidence rate (per 1000 patient‐years) of HHF and BKLE amputation in the overall population of new users of: (1) canagliflozin, (2) empagliflozin or dapagliflozin (other SGLT2i), (3) all non‐SGLT2i, and (4) select non‐SGLT2i (DPP‐4i, GLP‐1 receptor agonists or other AHAs) during the on‐treatment and intent‐to‐treat time‐at‐risk periods

		CCAE				MDCD				MDCR				Optum
		Persons	PY	Events	IR	Persons	PY	Events	IR	Persons	PY	Events	IR	Persons	PY	Events	IR
HHF
On‐treatment	Canagliflozin	73 024	36 013	32	0.9	6793	2015	11	5.5	10 802	5485	30	5.5	42 309	19 483	69	3.5
	Other SGLT2i	70 522	31 526	37	1.2	1425	419	3	7.2	5041	2124	12	5.6	21 184	7600	21	2.8
	All non‐SGLT2i	218 512	125 334	456	3.6	42 565	18 486	470	25.4	43 615	30 687	677	22.1	149 999	84 927	1695	20.0
	Select non‐SGLT2i	159 012	76 054	206	2.7	21 369	7377	105	14.2	35 501	20 360	431	21.2	104 354	45 742	783	17.1
Intent‐to‐treat	Canagliflozin	78 414	129 998	276	2.1	7467	7527	81	10.8	11 663	19 156	226	11.8	45 256	64 333	391	6.1
	Other SGLT2i	80 295	96 864	181	1.9	1625	1660	16	9.6	5707	6639	54	8.1	23 270	26 477	130	4.9
	All non‐SGLT2i	221 744	322 365	1122	3.5	43 061	57 151	1255	22.0	45 018	68 780	1643	23.9	151 062	215 847	3793	17.6
	Select non‐SGLT2i	172 583	252 343	816	3.2	23 443	29 478	456	15.5	38 408	60 762	1405	23.1	111 433	164 365	2713	16.5
BKLE amputation
On‐treatment	Canagliflozin	73 024	36 004	37	1.0	6793	2011	10	5.0	10 802	5489	11	2.0	42 309	19 496	25	1.3
	Other SGLT2i	70 522	31 521	34	1.1	1425	419	1	2.4	5041	2124	5	2.4	21 184	7603	13	1.7
	All non‐SGLT2i	218 512	125 434	192	1.5	42 565	18 659	77	4.1	43 615	30 996	58	1.9	149 999	85 604	179	2.1
	Select non‐SGLT2i	159 012	76 088	86	1.1	21 369	7405	15	2.0	35 501	20 522	38	1.9	104 354	45 961	71	1.5
Intent‐to‐treat	Canagliflozin	78 414	130 064	200	1.5	7467	7567	34	4.5	11 663	19 347	35	1.8	45 256	64 555	119	1.8
	Other SGLT2i	80 295	96 911	135	1.4	1625	1665	7	4.2	5707	6665	15	2.3	23 270	26 536	52	2.0
	All non‐SGLT2i	221 744	323 048	470	1.5	43 061	58 119	291	5.0	45 018	70 280	143	2.0	151 062	219 005	480	2.2
	Select non‐SGLT2i	172 583	252 804	382	1.5	23 443	29 837	109	3.7	38 408	62 038	142	2.3	111 433	166 698	363	2.2

Abbreviations: AHA, antihyperglycaemic agent; BKLE, below‐knee lower extremity; DPP‐4i, dipeptidyl peptidase‐4 inhibitor; GLP‐1, glucagon‐like peptide‐1; HHF, heart failure hospitalization; IR, incidence rate per 1000 patient‐years; CCAE, Truven MarketScan Commercial Claims and Encounters; MDCD, Truven MarketScan Multi‐state Medicaid; MDCR, Truven MarketScan Medicare Supplemental Beneficiaries; PY,patient‐years; SGLT2i, sodium glucose co‐transporter 2 inhibitors