Table 2.

Primary and selected secondary efficacy endpoints (intention-to-treat analysis)

	FH I			FH II
	Alirocumab (n = 322)	Placebo (n = 163)	% Difference vs. placebo	Alirocumab (n = 166)	Placebo (n = 81)	% Difference vs. placebo
Calculated LDL-C, LS mean ± SE
Baseline, mmol/L [mg/dL]	3.7 ± 0.1 [144.7 ± 2.9]	3.7 ± 0.1 [144.4 ± 3.7]		3.5 ± 0.1 [134.6 ± 3.2]	3.5 ± 0.1 [134.0 ± 4.6]
Week 24, mmol/L [mg/dL]	1.8 ± 0.1 [71.3 ± 2.3]	4.0 ± 0.1 [155.6 ± 3.2]		1.8 ± 0.1 [67.7 ± 2.8]	3.5 ± 0.1 [136.6 ± 4.0]
% Change from baseline to Week 24 (primary endpoint)	−48.8 ± 1.6	9.1 ± 2.2	−57.9 ± 2.7**	−48.7 ± 1.9	2.8 ± 2.8	−51.4 ± 3.4**
95% confidence interval			−63.3 to −52.6			−58.1 to −44.8
Selected secondary efficacy endpoints
Patients (%) with or without prior CV events achieving LDL-C <1.8 mmol/L (<70 mg/dL) or <2.6 mmol/L (<100 mg/dL), respectively, at Week 24	72.2**	2.4		81.4**	11.3
Patients (%) achieving LDL-C <1.8 mmol/L at Week 24 (regardless of prior CV events)	59.8**	0.8		68.2**	1.2
Calculated LDL-C % change from baseline to Week 12, LS mean ± SE	−43.5 ± 1.4	5.7 ± 2.0	−49.2 ± 2.4**	−43.8 ± 1.8	4.6 ± 2.6	−48.4 ± 3.2**
% Change from baseline to Week 24 in secondary lipid variables, LS mean ± SE
Apolipoprotein B	−41.1 ± 1.2	4.7 ± 1.6	−45.8 ± 2.0**	−42.8 ± 1.4	−3.5 ± 2.0	−39.3 ± 2.4**
Non-HDL-C	−42.8 ± 1.4	9.6 ± 2.0	−52.4 ± 2.4**	−42.6 ± 1.8	3.1 ± 2.5	−45.7 ± 3.1**
Lipoprotein(a)	−25.2 ± 1.4	−7.5 ± 2.0	−17.7 ± 2.5**	−30.3 ± 1.8	−10.0 ± 2.5	−20.3 ± 3.1**
Fasting triglycerides	−9.6 ± 1.6	6.3 ± 2.2	−16.0 ± 2.7**	−10.4 ± 2.0	0.5 ± 2.8	−10.9 ± 3.4*
HDL-C	8.8 ± 0.9	0.8 ± 1.2	8.0 ± 1.5**	6.0 ± 1.2	−0.8 ± 1.6	6.8 ± 2.0*
Apolipoprotein A1	5.0 ± 0.7	0.3 ± 1.0	4.7 ± 1.2*	2.8 ± 0.9	−1.6 ± 1.3	4.4 ± 1.6*

LS, least squares.

*P < 0.05; **P < 0.0001 vs. placebo.