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Table 1 Risk of amputation, PAD and DF events in patients with SGLT2i treatment

From: SGLT2 inhibitors and lower limb complications: an updated meta‐analysis

Subgroup No. of participants
(SGLT2i/control)
OR 95% CI P value I2 (%)
Risk of amputation by SGLT2i subtypes
 In total* 40,925/33,414 1.23 1.08, 1.40 0.002 2
 Canagliflozin* 7992/6543 1.60 1.04, 2.46 0.03 67
 Dapagliflozin 13,394/13,236 1.08 0.85, 1.37 0.54 0
 Empagliflozin 7101/4467 1.07 0.76, 1.49 0.71 0
 Ertugliflozin 5493/2745 1.24 0.87, 1.76 0.23 NA
 Sotagliflozin 6945/6423 1.08 0.68, 1.70 0.75 0
Risk of amputation by study types
 CVOT and ROT* 39,025/32,473 1.23 1.07, 1.40 0.003 29
 Efficacy and safety evaluation 1900/941 1.74 0.36, 8.39 0.49 0
Risk of amputation by population
 DM only* 34,872/27,196 1.24 1.08, 1.42 0.002 14
 Including patients without DM 6383/6386 1.08 0.62, 1.88 0.78 0
Risk of amputation by control types
 Active agent 551/267 1.46 0.06, 35.90 0.82 NA
 Placebo* 40,374/33,147 1.23 1.08, 1.40 0.002 9
Risk of amputation by study duration
 < 26 weeks 300/148 2.49 0.12, 52.14 0.56 0
 26–52 weeks 2205/1404 2.34 0.58, 9.52 0.23 0
 > 52 weeks* 33,129/26,576 1.24 1.08, 1.43 0.002 33
Risk of PAD by SGLT2i subtypes
 In total* 36,446/28,685 1.21 1.03, 1.42 0.02 0
 Canagliflozin* 10,467/7967 1.53 1.14, 2.05 0.005 0
 Dapagliflozin 15,668/14,657 1.03 0.81, 1.30 0.83 0
 Empagliflozin 7999/4558 1.26 0.88, 1.78 0.20 0
 Ertugliflozin 1613/800 1.50 0.30, 7.43 0.62 0
 Sotagliflozin 699/703 0.33 0.01, 8.23 0.50 NA
Risk of PAD by study types
 CVOT and ROT* 25,773/21,964 1.24 1.05, 1.46 0.01 6
 Efficacy and safety evaluation 10,673/6721 0.96 0.55, 1.68 0.90 0
Risk of PAD by population
 DM only* 31,926/24,166 1.23 1.03, 1.45 0.02 0
 Including patients without DM 4520/4519 1.10 0.67, 1.79 0.71 0
Risk of PAD by control types
 Active agent 3856/2619 1.00 0.33, 3.06 1.00 0
 Placebo* 32,590/26,066 1.22 1.03, 1.43 0.02 0
Risk of PAD by study duration
 < 26 weeks 5043/3159 0.91 0.43, 1.90 0.80 0
 26–52 weeks 2766/1725 1.70 0.50, 5.76 0.40 0
 > 52 weeks* 28,637/23,801 1.22 1.03, 1.44 0.02 0
Risk of DF by SGLT2i subtypes
 In total 31,907/25,570 1.24 0.93, 1.64 0.14 0
 Canagliflozin 9139/7115 1.55 0.94, 2.54 0.09 0
 Dapagliflozin 14,638/13,809 1.20 0.79, 1.83 0.40 0
 Empagliflozin 7029/4055 0.90 0.48, 1.67 0.74 0
Ertugliflozin 1201/591 1.48 0.15, 14.28 0.73 0
Risk of DF by study types
 CVOT and ROT 25,773/21,964 1.23 0.91, 1.66 0.17 0
 Efficacy and safety evaluation 6134/3606 1.26 0.55, 2.92 0.59 0
Risk of DF by population
 DM only 27,387/21,051 1.28 0.95, 1.72 0.11 0
 Including patients without DM 4520/4519 0.89 0.34, 2.31 0.81 0
 Risk of DF by control types
 Active agent 4173/2467 1.54 0.44, 5.34 0.50 0
 Placebo 27,734/23,103 1.22 0.91, 1.63 0.18 0
Risk of DF by study duration
 < 26 weeks 1131/562 1.49 0.23, 9.51 0.67 0
 26–52 weeks 2940/1614 1.51 0.44, 5.16 0.51 0
 > 52 weeks 27,836/23,394 1.22 0.91, 1.63 0.19 0
  1. *P < 0.05
  2. PAD peripheral arterial disease, SGLT2i sodium glucose co-transporter 2 inhibitor, DF diabetic foot, DM diabetes mellitus, CVOT cardiovascular outcome trial, ROT renal outcome trial, OR odd ratio, CI confidence interval, NA not applicable