Journal of Lipids

Review Article

Cardiovascular Outcomes of PCSK9 Inhibitors: With Special Emphasis on Its Effect beyond LDL-Cholesterol Lowering

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	Participants	Comparison	LDL-C reduction	Comments

	ODYSSEY MONO Completion date: July 2013 [50].	Patients with hypercholesterolemia	A-mAb versus EZE	47.2% versus 15.6%	-

	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%	-

	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 %	-

	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%	-

	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%	-

	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	-

	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	-

	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%	-

	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%

	Phase 2 pooled analysis [51]	Primary hypercholesterolemia on lipid lowering therapy	A-mAb versus placebo	68.4% versus 10.5%	-

	Randomized controlled trial [54]	Hypercholesterolemia on treatment with ATV	A-mAb versus placebo	40% to 70% versus 5%	-

	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%)