From: CVOT Summit Report 2023: new cardiovascular, kidney, and metabolic outcomes
SELECT | ||
---|---|---|
Class & Cardiovascular (CV) outcomes | HR (95% CI) | p-value‡ |
Primary efficacy endpoint | Â | Â |
Composite of 3P-MACE: CV death, nonfatal MI, or nonfatal stroke | 0.80 (0.72 to 0.90) | < 0.001 |
Confirmatory secondary efficacy endpoints | Â | Â |
CV death | 0.85 (0.71 to 1.01) | 0.07 |
Composite of HF: CV death, HHF, or urgent medical visit for HF | 0.82 (0.71 to 0.96) | Â |
Death from any cause | 0.81 (0.71 to 0.93) | Â |
Adverse events | Event rate (%) active vs. placebo group | p-value |
Serious adverse events | 33.4 vs. 36.4 | < 0.001 |
Cardiac disorders | 11.5 vs. 13.5 | < 0.001 |
Infections and infestations | 7.1 vs. 8.4 | 0.001 |
Nervous system disorders | 5.0 vs. 5.6 | 0.08 |
Surgical and medical procedures | 4.9 vs. 6.2 | < 0.001 |
Neoplasms benign, malignant, and unspecified | 4.6 vs. 4.6 | 0.94 |
Gastrointestinal disorders | 3.9 vs. 3.7 | 0.48 |
Adverse events leading to treatment discontinuation | 16.6 vs. 8.2 | < 0.001 |
Gastrointestinal disorders | 10.0 vs. 2.0 | < 0.001 |
Nervous system disorders | 1.4 vs. 1.0 | 0.03 |
Metabolism and nutrition disorders | 1.2 vs. 0.3 | < 0.001 |
General disorders and administration-site conditions | 1.2 vs. 0.5 | < 0.001 |
Neoplasms benign, malignant, and unspecified | 0.9 vs. 1.2 | 0.07 |
Infections and infestations | 0.9 vs. 1.0 | 0.47 |
Other adverse events of interest | Â | Â |
Gallbladder-related disorders | 2.8 vs. 2.3 | 0.04 |
Acute kidney failure | 1.9 vs. 2.3 | 0.13 |
Acute pancreatitis | 0.2 vs. 0.3 | 0.28 |