Duration: Median of 2.2 years | |||
Outcome | Empagliflozin | Placebo | Comparisons |
---|---|---|---|
Primary outcome | 13.8% | 17.1% | HR 0.79, 95%CI [0.69 - 0.90], p<0.001 |
Heart failure hospitalization | 8.6% | 11.8% | HR 0.71, 95%CI [0.60 - 0.83] |
Cardiovascular death | 7.3% | 8.2% | HR 0.91, 95%CI [0.76 - 1.09] |
Overall mortality | 14.1% | 14.3% | HR 1.0, 95%CI [0.87 - 1.15] |
Hypotension | 10.4% | 8.6% | N/A |
UTI | 9.9% | 8.1% | N/A |
Genital infections | 2.2% | 0.7% | N/A |
Bone fractures | 4.5% | 4.2% | N/A |
Lower limb amputations | 0.5% | 0.8% | N/A |
Ketoacidosis | 0.1% | 0.2% | N/A |
|
Mild ALT / AST Elevations (<5 X ULN) |
---|
Step 1 - assess patient
|
Step 2 - initial workup
|
Step 3 - extended workup
|
ACR / EULAR 2019 Systemic Lupus Erythematosus (SLE) Classification Criteria | |
---|---|
Entry criteria
|
|
Clinical domains and criteria | Weight |
Constitutional | |
|
2 |
Cutaneous | |
|
2 |
|
2 |
|
4 |
|
6 |
Arthritis | |
|
6 |
Neurological | |
|
2 |
|
3 |
|
5 |
Serositis | |
|
5 |
|
6 |
Hematological | |
|
3 |
|
4 |
|
4 |
Renal | |
|
4 |
|
8 |
|
10 |
Immunological domains and criteria | Weight |
Antiphospholipid antibodies | |
|
2 |
Complement proteins | |
|
3 |
|
4 |
Highly specific antibodies | |
|
6 |
|
6 |