Background
Updates on CVOTs
Study name | Study status | Drug | Drug class | Intervention | Primary outcome | n | Follow up [years] | Start and end date | Clinicaltrials. gov ID |
---|---|---|---|---|---|---|---|---|---|
CARMELINA | Completed | Linagliptin | DPP-4 inhibitor | Linagliptin 5 mg daily vs. placebo | CV death, non-fatal MI, non-fatal stroke | 6.980 | 4.5 | 07.2013–01.2018 | NCT01897532 |
Harmony Outcomes | Completed | Albiglutide | GLP-1 receptor agonist | Albiglutide 30 mg to 50 mg weekly vs. placebo | CV death, non-fatal MI, non-fatal stroke | 9.574 | ≥ 1.5 | 07.2015–02.2018 | NCT02465515 |
DECLARE-TIMI 58 | Completed | Dapagliflozin | SGLT-2 inhibitor | Dapagliflozin 10 mg daily vs. placebo | CV death, MI, ischemic stroke, hospitalisation due to heart failure | 17.276 | 6 | 04.2013–07.2018 | NCT01730534 |
ODYSSEY OUTCOMES | Completed | Alirocumab | PCSK9 inhibitor | Alirocumab 75 mg or 150 mg two-weekly vs. placebo | CHD death, non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalisation | 18.924 | 2.8 | 10.2012–01.2018 | NCT01663402 |
Cardiovascular endpoints | CARMELINA | Harmony Outcomes | DECLARE-TIMI 58 | ODYSSEY OUTCOMES | ||||
---|---|---|---|---|---|---|---|---|
Class | HR (95% CI) p-value | Class | HR (95% CI) p-value | Class | HR (95% CI) p-value | Class | HR (95% CI) p-value | |
Primary composite MACE | CV death, non-fatal MI or non-fatal stroke | 1.02 (0.89–1.17) p < 0.001a p = 0.74b | CV death, non-fatal MI or non-fatal stroke | 0.78 (0.68–0.90) p < 0.0001a p = 0.0006b | CV death, non-fatal MI or non-fatal stroke | 0.93 (0.84–1.03) p = 0.17b | CV death, non-fatal MI, non-/fatal stroke or unstable angina | 0.85 (0.78–0.93) p < 0.001 |
Cardiovascular death | Exploratory outcome | 0.96 (0.81–1.14) p = 0.63 | Secondary endpoint | 0.93 (0.73–1.19) p = 0.578 | Primary endpoint | 0.83 (0.73–0.95)c p = 0.005c | Secondary endpoint | 0.88 (0.74–1.05) – |
Myocardial infarction | Exploratory outcome | 1.12 (0.90–1.14) p = 0.30 | Secondary endpoint | 0.75 (0.61–0.90) p = 0.003 | Primary endpoint | 0.89 (0.77–1.01) – | Additional endpoint | 0.86 (0.77–0.96) – |
Stroke | Exploratory outcome | 0.88 (0.63–1.23) p = 0.45 | Secondary endpoint | 0.86 (0.66–1.14) p = 0.300 | Primary endpoint | 1.01 (0.84–1.21) – | Additional endpoint | 0.73 (0.57–0.93) – |
Hospitalisation for unstable angina | Exploratory outcome | 0.87 (0.57–1.31) p = 0.50 | – | – – | – | – – | Additional endpoint | 0.61 (0.41–0.92) – |
Hospitalisation for heart failure | Exploratory outcome | 0.90 (0.74–1.08) p = 0.26 | – | – – | Primary endpoint | 0.73 (0.61–0.88) – | Additional endpoint | 0.98 (0.79–1.20) – |
Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | Event rate (%) active group | |||||
---|---|---|---|---|---|---|---|---|
Primary composite MACE | 12.4 | 4.57 | 8.8 | 9.5 |
No. (%) p-value | No. (%) p-value | No. (%) p-value | No. (%) p-value | |||||
---|---|---|---|---|---|---|---|---|
Renal event | 6.6d 0.87 | 6 – | 0.76e – | – – | ||||
Acute pancreatitis | 0.3 – | < 1 – | – – | – – | ||||
Severe hypoglycaemic events | 3.0 – | 1 – | 0.7 0.02 | – – |