Cardiovascular Outcomes of PCSK9 Inhibitors: With Special Emphasis on Its Effect beyond LDL-Cholesterol Lowering
Table 2
Studies on evolocumab. E-mAb: evolocumab; EZE: ezetimibe; ATV: atorvastatin.
S. No.
Trial
Participants
Comparison
LDL-C reduction
Adverse events (AE)
MENDEL-2 Completion date: October 2013
Hypercholesterolemia
E-mAb versus Placebo versus EZE
Reduction in E-mab group; 55–57% more than placebo & 38–40% more than EZE
44% versus 44% versus 46%
DESCARATES Completion date: November 2013
Hypercholesterolemia, on background therapy with diet or ATV (10 mg or 80 mg) or EZE singly or in combination.
E-mAb versus Placebo
50.1% versus 6.8%
74.8% versus 74.2%
GAUSS-2 Completion date: November 2013
Hypercholesterolemia
E-mAb versus EZE
53–56% versus 37–39%
Muscle AE’s; more frequent in EZE group (23%) versus E-mab group (12%)
RUTHERFORD-2 Primary completion date: November 2013
Familial Hypercholesterolemia
E-mAb versus placebo
60% in E-mAb group
Similar adverse events profile
LAPLACE-2 Completion date: Dec. 2013
Hypercholesterolemia
E-mAb versus EZE versus Placebo
−66% to 75% in E-mAb group
36% versus 40% versus 39%
FOURIER Completion date: 2017
Patient with h/o CVD on maximum tolerated statin therapy but LDL is more than 70 mg/dl
E-mAb versus placebo in statin treated patients
59% reduction of LDL in comparison to placebo
Primary end point. that is, Cv events was 9.8% versus 11.3%; Injection site reaction was more in E-mAb 2.1% versus 1.6%
OSLER I & OSLER II Expected completion date: June 2018 & August 2018, respectively
Patients who completed “parent trials” of evolocumab and eligible patients were randomly assigned in 2 : 1 ratio to receive either evolocumab plus standard therapy or standard therapy alone
