Table 1.
Trials on alirocumab. A-mAb: alirocumab; ATV: atorvastatin; EZE: ezetimibe; RSV: rosuvastatin; ASCVD: atherosclerotic cardiovascular disease; CHD: coronary heart disease; heFH: heterozygous familial hypercholesterolemia.
| S. No | Trial [reference] |
Participants | Comparison | LDL-C reduction | Comments |
|---|---|---|---|---|---|
| (1) | ODYSSEY MONO Completion date: July 2013 [50]. |
Patients with hypercholesterolemia | A-mAb versus EZE | 47.2% versus 15.6% | - |
|
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| (2) | ODYSSEY COMBO I Completion date: April 2014 [46]. |
Hypercholesterolemia + CHD or CHD equivalents, on treatment with maximal tolerated statin dose | A-mAb versus Placebo | 48.2% versus 2.3% | - |
|
| |||||
| (3) | ODYSSEY OPTIONS I Completion date: May 2014 [44]. |
Hyperlipidemia + risk of ASCVD, on baseline treatment with ATV | ATV + A-mAb versus ATV + EZE versus ATV (double dose) versus RSV | 44.1% versus 20.5% versus 5.0% versus 21.4 % | - |
|
| |||||
| (4) | ODYSSEY OPTIONS II Completion date: May 2014 [45]. |
Hyperlipidemia + risk of ASCVD, on baseline treatment with RSV | A-mAb versus EZE versus RSV | 50.6% versus 14.4% versus 16.3% | - |
|
| |||||
| (5) | ODYSSEY LONG TERM TRIAL Completion date: November 2014 [47]. |
Hypercholesterolemia + risk of ASCVD, on treatment with maximally tolerated statin dose | A-mAb versus placebo | 61% versus 0.8% | - |
|
| |||||
| (6) | ODYSSEY FH I Completion date: December 2014 [49] |
Familial heterozygous hypercholesterolemia on maximally tolerated statin dose | A-mAb versus placebo | 57.9% reduction in A-Mab group | - |
|
| |||||
| (7) | ODYSSEY FH II Completion date: January 2015 [49] |
Familial heterozygous hypercholesterolemia on maximally tolerated statin dose | A-mAb versus placebo | 51.4% reduction in A-Mab group | - |
|
| |||||
| (8) | ODYSSEY COMBO II Completion date: July 2015 [48]. |
Hypercholesterolemia + risk of ASCVD, on treatment with maximally tolerated statin dose | A-mAb versus EZE | 50.6% versus 20.7% | - |
|
| |||||
| (9) | ODYSSEY HIGH FH Completion date: 2016 Sep |
Patients having heFH and LDL-C ≥ 160 mg/dl even after maximum tolerated dose of statin | A-mAb versus Placebo | 45.7% versus 6.6% | |
|
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| (9) | Phase 2 pooled analysis [51] | Primary hypercholesterolemia on lipid lowering therapy | A-mAb versus placebo | 68.4% versus 10.5% | - |
|
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| (10) | Randomized controlled trial [54] |
Hypercholesterolemia on treatment with ATV | A-mAb versus placebo | 40% to 70% versus 5% | - |
|
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| (11) | Pooled analysis of 14 randomized controlled trials | _ | A-mAb versus control (placebo or EZE) | LDL-C reduced to as low as 15 mg/dl in A-mAb group | Rates of adverse events in those achieving LDL-C < 25 mg/dl (72.7%) and <15 mg/dl (71.7%) were similar to those who did not (76.7%) |