Optimal target of LDL cholesterol level for statin treatment: challenges to monotonic relationship with cardiovascular events

Table 2 LDL-C category-specific event rates

Endpoint	Achieved on-trial LDL-C level (mg/dl)
	LDL-C < 50	50 ≤ LDL-C < 75	75 ≤ LDL-C < 100	100 ≤ LDL-C < 125	125 ≤ LDL-C < 150	150 ≤ LDL-C
	n = 659	n = 3831	n = 4559	n = 1719	n = 306	n = 31
Primary composite outcome, n	32	157	230	97	15	2
Rate (/1000 person-years)	13.1	10.9	13.6	15.3	13.5	18.6
Adjusted HR (95% CI)	0.78 (0.49, 1.22)	0.70 (0.52, 0.93)	0.87 (0.67, 1.13)	Ref	1.01 (0.57, 1.79)	1.11 (0.27, 4.52)
Cardiovascular death, n	12	58	64	28	7	1
Rate (/1000 person-years)	4.8	4.0	3.7	4.3	6.2	9.2
Adjusted HR (95% CI)	0.92 (0.42, 2.00)	0.87 (0.52, 1.47)	0.87 (0.53, 1.42)	Ref	1.65 (0.67, 4.08)	1.93 (0.26, 14.44)
Myocardial infarction, n	5	25	47	23	3	0
Rate (/1000 person-years)	2.0	1.7	2.7	3.6	2.7	-
Adjusted HR (95% CI)	0.56 (0.18, 1.72)	0.49 (0.25, 0.94)	0.72 (0.41, 1.24)	Ref	0.90 (0.27, 3.05)	-
Ischemic stroke, n	10	47	60	21	4	0
Rate (/1000 person-years)	4.1	3.2	3.5	3.3	3.6	-
Adjusted HR (95% CI)	1.12 (0.50, 2.52)	0.89 (0.50, 1.60)	0.98 (0.57, 1.69)	Ref	1.26 (0.43, 3.74)	-
Hemorrhagic stroke, n	3	34	13	11	2	0
Rate (/1000 person-years)	1.2	2.3	0.8	1.7	1.8	-
Adjusted HR (95% CI)	0.97 (0.24, 3.86)	1.69 (0.74, 3.87)	0.50 (0.20, 1.26)	Ref	0.77 (0.10, 6.17)	-

Adjusted for gender, age (<65 or 65≤ years), obesity (body mass index <25 or 25≤ kg/m²), diabetes mellitus, hsCRP (<1.0 or 1.0≤ mg/dl), TG (<150 or 150≤ mg/dl), HDL-C (<40 or 40≤ mg/dl), drug use (beta blocker, DAPT, or ACEI/ARB), disease history (MI, unstable angina, PCI, CABG, stroke, AF, malignant tumor, chronic heart failure, hypertension, chronic kidney disease), current smoking, and randomized group (pitavastatin 1 mg/day or 4 mg/day). Adjusted HR and 95% CI in each category are shown as the values when the category 100≤ LDL-C <125 was used as a reference
CI confidence interval, HR hazard ratio, LDL-C low-density lipoprotein cholesterol

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