Table 1

Study characteristics of included randomised controlled trials.

StudyYearPhaseInclusion criteriaPatients
(n)
ArmMean age (years)Male
%
Mean hs-CRP at baseline mg/Lhs-CRP reduction
(mg/L)
% LDL-C reductionDrugs/controlTreatment durationJadad Score
RUTHERFORD22 2012IIHeFH167(1)47.654.51.09±1.37−0.06±0.9442.7E:350 mg/PBO, Q4W12W5
(2)51.862.51.07±1.240.00±0.3055.2E:420 mg/PBO, Q4W
Stein EA 201224 2012IIHeFH77(1)56.381.31·40±1.78−0.40±2.0467.9A:150 mg/PBO, Q2W12W5
(2)51.360.00·60±0.82−0.20±0.8128.9A:150 mg/PBO, Q4W
(3)52.956.30·70±1.480.00±1.2931.5A:200 mg/PBO, Q4W
(4)54.346.70.70±0.59−0.10±0.8442.5A:300 mg/PBO, Q4W
DESCARTES25 2014IIHC894(1)50.747.32.00±3.700.00±2.5751.5E:420 mg/PBO, Q4W52W5
(2)57.242.91.00±1.480.00±1.4854.7E:420 mg+ATV 10 mg/PBO, Q4W
(3)57.852.41.00±1.480.00±1.4846.7E:420 mg+ATV 80 mg/PBO, Q4W
(4)54.255.61.00±1.480.00±1.4846.8E:420 mg+ATV 80 mg+Eze 10 mg /PBO, Q4W
GAUSS-226 2014IIIHC307(1)61.055.31.40±2.000.30±2.6756.1E:140 mg/Eze, Q2W12W4
(2)63.054.91.80±1.78−0.30±1.7852.6E:420 mg/Eze, Q4W
RUTHERFORD-223 2014IIIHeFH329(1)52.640.00.92±1.03−0.05±0.3961.3E:140 mg/PBO,Q2W12W4
(2)51.941.81.04±1.240.03±0.7355.7E:420 mg/PBO,Q4W
TESLA Part B27 2014IIIHoFH4931.051.50.70±1.04−0.02±0.5223.1E:140 mg/PBO, Q4W12W4
ODYSSEY COMBO II28 2015IIIHC720(1)61.775.23.58±7.78−0.39±6.9550.6A: 75 mg/Eze, Q2W24W4
(2)61.775.23.58±7.78−0.07±8.5751.8A: 75 mg/Eze, Q2W52W
GLAGOV29 2016IIIHC96859.872.11.60±1.93−0.40±10.6760.8E:420 mg/PBO, Q4W78W4
Kastelein 201620 2016IIHC519(1)57.251.71.03±1.41−0.20±2.0714.9LY:20 mg/PBO, Q4W16W4
(2)57.152.31.34±1.111.60±2.0040.5LY:120 mg/PBO, Q4W
(3)59.754.71.63±1.78−0.30±2.0050.5LY:300 mg/PBO, Q4W
(4)59.658.11.39±1.70−0.30±2.0714.9LY:100 mg/PBO, Q8W
(5)58.750.61.10±1.63−0.70±2.0737.1LY:300 mg/PBO, Q8W
EQUATOR30 2017IIHC168(1)65.057.91.60±2.700.34±1.9323.3RG:400 mg/PBO, Q4W24W4
(2)64.051.02.00±5.90−0.16±2.9244.3RG:800 mg/PBO,Q8W
  • Data presented as mean ±SD.

  • A, alirocumab; ATV, atorvastatin; DESCARTES, Durable Effect of PCSK9 Antibody Compared with Placebo Study ; E, evolocumab; EQUATOR: Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease; Eze, ezetimibe; GAUSS-2, Goal Achievement after Utilizing an Anti[1]PCSK9 Antibody in Statin Intolerant Subjects-2; GLAGOV, Global Assessment of Plaque Regression With a PCSK9 Antibody as Measured by Intravascular Ultrasound; HC, hypercholesterolaemia; HeFH, heterozygous familial hypercholesterolaemia; HoFH, homozygous  familial hypercholesterolaemia; hs-CRP, high-sensitivity C-reactive protein ; LDL-C, low -density lipoprotein cholesterol; LY: LY3015014; ODYSSEY COMBO II: Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins; RG, RG7652; RUTHERFORD, Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder ; RUTHERFORD-2, Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder-2;  PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; W, weeks.