Table 1.
Baseline characteristics of included trials
| Record | Trial* | NCT number | Year | Active treatment | Comparator | Centers (n) | Patients (n) | Patients with HF (n, %) | Duration (weeks) | FU in patients with HF (py) |
|---|---|---|---|---|---|---|---|---|---|---|
| Bhatt [8] | SOLOIST-WHF | NCT03521934 | 2020 | Sotagliflozin | Placebo | 306 | 1222 | 1222 (100) | 39 | 916.5 |
| Butler [25], Fitchett [26, 27] | EMPA-REG-OUTCOME | NCT01131676 | 2016–2019 | Empagliflozin | Placebo | 590 | 7020 | 706 (10.1) | 164 | 1835.6 |
| Cannon [28], Cosentino [29] | VERTIS CV | NCT01986881 | 2020 | Ertugliflozin | Placebo | 567 | 8238 | 1958 | 42 | 1581.5 |
| Carbone [30] | CANA-HF | NCT02920918 | 2019 | Canagliflozin | Sitagliptin | 1 | 36 | 36 (100) | 12 | 8.3 |
| de Boer [31] | Licogliflozin vs. empagliflozin vs. placebo | NCT03152552 | 2020 | Licogliflozin | Empagliflozin, Placebo | 55 | 124 b | 124 (100) | 12 b | 28.6† |
| Jensen [32] | EMPIRE-HF | NCT03198585 | 2020 | Empagliflozin | Placebo | 2 | 190 | 190 (100) | 12 | 43.8 |
| Kato [33] | DECLARE | NCT01730534 | 2019 | Dapagliflozin | Placebo | 882 | 17,160 | 1987 (11.6) | 218.4 | 8345.4 |
| Kosiborod [34] ‡ |
1. Moderate KD (56) 2. Add-on to sulfonylurea [57] 3. Add-on to insulin [58] 4. High CV risk [59] 5. High CV risk [60] |
1. NCT00663260 2. NCT00680745 3. NCT00673231 4. NCT01031680 5. NCT01042977 |
2014 2011 2012 2015 2014 |
Dapagliflozin | Placebo |
111 84 126 141 173 |
252 592 808 922 964 |
19 (7.5) 13 (2.2) 18 (14.3) 118 (12.8) 152 (15.8) |
52 48 48 52 § 52 § |
19 12 16.6 922 964 |
| Lee [35] | SUGAR-DM-HF | NCT0348509 | 2020 | Empagliflozin | Placebo | 15 | 105 | 105 (100) | 36 | 72.7 |
| McMurray [6, 36], Petrie [37] | DAPA-HF | NCT03036124 | 2019 | Dapagliflozin | Placebo | 417 | 4744 | 4744 (100) | 78.8 | 7195.1 |
| Nassif [38] | DEFINE-HF | NCT 02653482 | 2019 | Dapagliflozin | Placebo | 26 | 263 | 263 (100) | 12 | 60.7 |
| Packer [7], Anker [39] | EMPEROR-Reduced | NCT03057977 | 2020 | Empagliflozin | Placebo | 520 | 3730 | 3730 (100) | 69 | 4973.3 |
| Perkovic [40] | CREDENCE | NCT02065791 | 2019 | Canagliflozin | Placebo | 690 | 4397 | 652 (14.8) | 136 | 1708.2 |
| Radholm [41] | CANVAS Program | NCT01032629 and NCT01989754 | 2018 | Canagliflozin | Placebo | 667 | 10,142 | 1461 (14.4) | 188.2 | 5282.1 |
| Santos-Gallego [42] | EMPA-TROPISM | NCT 03485222 | 2020 | Empagliflozin | Placebo | 1 | 84 | 84 | 26 | 42 |
| Singh [43] | REFORM | NCT02397421 | 2020 | Dapagliflozin | Placebo | 1 | 56 | 56 | 52 | 56 |
| Boehringer Ingelheim [44] ∥ | EMPERIAL-Reduced | NCT03448419 | 2020 | Empagliflozin | Placebo | 109 | 312 | 312 | 12 | 72 |
| Boehringer Ingelheim [45]∥ | EMPERIAL-Preserved | NCT03448406 | 2020 | Empagliflozin | Placebo | 108 | 315 | 315 | 12 | 72.7 |
HF heart failure, KD kidney disease, T2D type 2 diabetes mellitus
*Acronym/short title
†Of the 124 patients randomized in the study, 80 were discontinued due to early study termination, with 44 patients completing the 12-weeks study
‡This record presents a HF subgroup meta-analysis from five randomized controlled trials. Patients with HF included in any of the five trials have been identified retrospectively and data have been pooled for joint analyses
§24-week trial plus 28-week (52-week) plus 52-week (104-week) extension period
∥At the time of the literature search, results have not been published in a journal but were extracted from www.clinicaltrials.gov