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. 2018 Jun 25;20(11):2585–2597. doi: 10.1111/dom.13424

Table 3.

Risk of HHF in the overall population for selected comparisons during on‐treatment and intent‐to‐treat time‐at‐risk periodsa

On‐treatment Intent‐to‐treat
Exposure (n/PY) Outcomes Outcomes
Comparison Source Target Comparator Target Comparator HR (95% CI) P Calibrated P Target Comparator HR (95% CI) P Calibrated P
Canagliflozin vs all non‐SGLT2i CCAE 60 073/29 969 217 583/125 090 23 448 0.27 (0.16‐0.44) <.01 <.01 202 1103 0.63 (0.52‐0.75) <.01 <.01
MDCD 5998/1780 38 172/16 353 9 367 0.48 (0.21‐0.95) .06 .09 73 942 0.94 (0.70‐1.25) .70 .93
MDCR 9206/4703 42 744/30 367 28 649 0.52 (0.33‐0.79) <.01 .01 192 1560 0.83 (0.69‐1.00) .05 .17
Optum 36 055/16 663 146 868/83 692 64 1515 0.38 (0.28‐0.51) <.01 <.01 343 3476 0.73 (0.63‐0.83) <.01 <.01
Meta‐analysis 111 332/53 116 445 367/255 504 124 2979 0.39 (0.26‐0.60)I2 = 0.25 .01 <.01 810 7081 I2 = 0.59
Canagliflozin vs select non‐SGLT2i CCAE 64 795/32 246 158 992/76 046 27 206 0.40 (0.24‐0.65) <.01 <.01 245 816 0.76 (0.64‐0.90) <.01 <.01
MDCD 6727/1997 21 355/7374 11 104 0.62 (0.27‐1.27) .23 .26 80 453 0.88 (0.65‐1.17) .38 .41
MDCR 10 217/5218 35 398/20 312 30 425 0.61 (0.38‐0.93) .03 .06 220 1400 0.85 (0.72‐1.01) .07 .10
Optum 39 142/18 069 104 231/45 694 66 767 0.64 (0.46‐0.87) .01 .01 369 2695 0.82 (0.71‐0.93) <.01 .01
Meta‐analysis 120 881/57 531 319 976/149 427 134 1502 0.58 (0.42‐0.80)I2 = 0.00 .01 <.01 914 5364 0.82 (0.75‐0.89)I2 = 0.00 .01 <.01
Canagliflozin vs other SGLT2i CCAE 43 411/20 314 70 519/31 524 19 37 0.85 (0.41‐1.71) .65 .61 142 181 1.02 (0.79‐1.32) .89 .95
MDCD 1424/404 1425/418 2 3 1.00 (0.12‐8.33) 1.00 .86 19 16 1.18 (0.53‐2.69) .69 .62
MDCR 4395/2000 5041/2124 8 12 1.15 (0.39‐3.41) .80 .75 63 54 1.21 (0.78‐1.90) .40 .57
Optum 20 324/8644 21 184/7599 27 21 0.83 (0.37‐1.82) .64 .64 128 130 1.07 (0.79‐1.45) .67 .73
Meta‐analysis 69 554/31 363 98 169/41 667 56 73 0.90 (0.71‐1.13)I2 = 0.00 .22 .28 352 381 1.07 (0.95‐1.20)I2 = 0.00 .16 .32
Other SGLT2i vs all non‐SGLT2i CCAE 54 324/24 645 175 500/96 608 26 336 0.39 (0.24‐0.60) <.01 <.01 131 790 0.54 (0.42‐0.68) <.01 <.01
MDCD 1378/405 25 995/10 044 3 195 0.80 (0.19‐2.21) .72 .73 16 444 0.82 (0.44‐1.41) .51 .49
MDCR 4336/1837 31 228/21 323 11 434 0.54 (0.27‐0.98) .06 .12 50 938 0.66 (0.47‐0.92) .02 .06
Optum 19 588/7072 118 027/63 631 21 1103 0.38 (0.23‐0.59) <.01 <.01 124 2346 0.64 (0.51‐0.79) <.01 <.01
Meta‐analysis 79 626/33 961 350 750/191 607 61 2068 0.43 (0.30‐0.62)
I2 = 0.00 		.01 <.01 321 4518 0.62 (0.50‐0.75)
I2 = 0.00 		<.01 <.01

Abbreviations: BKLE, below‐knee lower extremity; CI, confidence interval; HR, hazard ratio; 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.

a

Time‐to‐first‐post‐index‐event analysis using variable‐ratio propensity score matching.