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

Table 4.

Risk of BKLE amputation 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 60 073/29 965 217 583/125 189 24 190 0.56 (0.32‐0.92) .03 .06 144 467 1.01 (0.80‐1.28) .92 .85
MDCD 5998/1775 38 172/16 482 10 61 1.35 (0.46‐3.41) .56 .46 30 236 1.05 (0.62‐1.73) .84 .71
MDCR 9206/4707 42 744/30 668 9 57 1.16 (0.48‐2.66) .73 .62 26 138 0.88 (0.51‐1.47) .65 .77
Optum 36 055/16 676 146 868/84 306 17 173 0.67 (0.35‐1.18) .19 .31 95 467 1.03 (0.78‐1.36) .82 .71
Meta‐analysis 111 332/53 125 445 367/256 646 60 481 0.75 (0.40‐1.41)I2 = 0.18 .25 .30 295 1308 1.01 (0.93‐1.10)I2 = 0.00 .71 .51
Canagliflozin vs select non‐SGLT2i CCAE 64 795/32 238 158 992/76 081 34 86 1.08 (0.65‐1.75) .76 .68 171 382 0.96 (0.77‐1.21) .75 .78
MDCD 6727/1993 21 355/7401 10 15 3.11 (0.87‐11.70) .09 .08 34 109 1.21 (0.73‐1.97) .45 .43
MDCR 10 217/5222 35 398/20 471 11 37 0.60 (0.19‐1.64) .36 .42 34 142 0.78 (0.48‐1.24) .31 .33
Optum 39 142/18 081 104 231/45 912 23 71 1.30 (0.64‐2.55) .46 .42 110 363 1.10 (0.84‐1.44) .49 .46
Meta‐analysis 120 881/57 536 319 976/149 866 78 209 1.17 (0.55‐2.47)I2 = 0.21 .56 .43 349 996 1.01 (0.81‐1.25)I2 = 0.00 .93 .86
Canagliflozin vs other SGLT2i CCAE 43 411/20 312 70 519/31 520 19 34 0.88 (0.38‐2.01) .77 .73 102 135 1.13 (0.81‐1.57) .46 .50
MDCD 1424/403 1425/419 3 1 2.00 (0.19‐43.01) .62 .52 8 7 1.25 (0.33‐5.05) .75 .70
MDCR 4395/2000 5041/2123 6 5 1.73 (0.28‐13.34) .58 .55 15 15 1.38 (0.58‐3.39) .47 .56
Optum 20 324/8652 21 184/7603 12 13 1.40 (0.49‐4.28) .54 .54 46 52 1.06 (0.67‐1.68) .82 .85
Meta‐analysis 69 554/31 369 98 169/41 666 40 53 1.14 (0.67‐1.93)I2 = 0.00 .48 .53 171 209 1.13 (0.99‐1.29)I2 = 0.00 .06 .06
Other SGLT2i vs all non‐SGLT2i CCAE 54 324/24 642 175 500/96 683 23 143 0.59 (0.32‐1.04) .08 .14 87 327 0.78 (0.57‐1.04) .09 .15
MDCD 1378/405 25 995/10 106 0 28 0.36 (NA‐5.96) — — 5 111 0.99 (0.33‐2.39) .98 .96
MDCR 4336/1837 31 228/21 522 4 37 1.65 (0.37‐5.26) .46 .39 13 85 1.56 (0.72‐3.12) .23 .17
Optum 19 588/7076 118 027/64 041 12 115 1.02 (0.49‐1.98) .95 .77 45 306 1.31 (0.88‐1.89) .17 .13
Meta‐analysis 78 248/33 556 324 755/182 247 39 295 0.84 (0.27‐2.55)I2 = 0.23 .57 .68 150 829 I2 = 0.51

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; NA, not available; PY, patient‐years; SGLT2i, sodium glucose co‐transporter 2 inhibitors.

a

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