Table 2: Baseline Patient Characteristics (Part 1: Assessment of CHD Incidence by LDL-P)

Supplemental Results

Table 1: Attrition

Part 1

Patients with … / Counts
≥1 laboratory result for LDL-P / 74,455
≥1 LDL-C result (any value) on or before the Index Date / 64,709
≥18 years old on Index Date / 64,400
≥6 months of continuous eligibility prior to the Index Date / 57,511
Enrollment in a commercial plan or in Medicare Advantage / 57,025
High-risk status / 15,569

Part 2

LDL-P Goal Cohort
Patients with … / LDL-P <1000 nmol/L
≥1 laboratory result for LDL-P / 74,455
LDL-P target achieved (first occurrence = Index Date) / 12,440
≥1 LDL-C result (any value) on or before the Index Date / 10,081
≥18 years old on Index Date / 9,989
≥6 months of continuous eligibility prior to the Index Date / 8,696
Enrollment in a commercial plan or in Medicare Advantage / 8,500
High-risk status / 3,532
6 m pre- & 12 m post-Index Date eligibility / 2,094
6 m pre- & 24 m post-Index Date eligibility / 1,242
6 m pre- & 36 m post-Index Date eligibility / 705
LDL-C Goal Cohort
Patients with … / LDL-C<100 mg/dL
No LDL-P tests / 3,217,772
LDL-C target achieved (first occurrence = Index Date) / 1,599,687
≥18 years old on Index Date / 1,515,675
≥6 months of continuous eligibility prior to the Index Date / 1,077,965
Enrollment in a commercial plan or in Medicare Advantage / 1,046,596
High-risk status / 277,362
6 m pre- & 12 m post-Index Date eligibility / 193,108
6 m pre- & 24 m post-Index Date eligibility / 132,724
6 m pre- & 36 m post-Index Date eligibility / 86,168

Table 2: Baseline Patient Characteristics (Part 1: Assessment of CHD incidence by LDL-P).

High-Risk Patients
(N=15,569)
No CHD Events / ≥1 CHD Events / p-Value
Sample size, n (%) / 14,278 (91.7) / 1,291 (8.3) / -
Age (on index date), mean (± SD) / 56 (11) / 61 (11) / <.0001
Gender, n (%)
Female / 6,468 (45.3) / 457 (35.4) / <.0001
Geographic region, n (%)
South / 9,796 (68.6) / 807 (62.5) / <.0001
Midwest / 3,158 (22.1) / 360 (27.9) / <.0001
West / 724 (5.1) / 43 (3.3) / <.0001
Northeast / 32 (1.3) / 32 (2.5) / <.0001
Unknown/Missing / 420 (2.9) / 49 (3.8) / <.0001
Types of health plan, n (%)
PPO / 6,046 (42.3) / 524 (40.6) / <.0001
HMO / 5,050 (35.4) / 436 (33.8) / <.0001
Other / 2,697 (18.9) / 304 (23.6) / <.0001
Medicare Advantage, n (%) / 1,477 (10.3) / 312 (24.2) / <.0001
Comorbidities, n (%)
Diabetes mellitus / 11,071 (77.5) / 737 (57.1) / <.0001
Hypertension / 7,806 (54.7) / 923 (71.5) / <.0001
Cardiovascular disease / 4,289 (30.0) / 899 (69.6) / <.0001
Coronary heart disease / 3,229 (22.6) / 830 (64.3) / <.0001
Peripheral vascular disease / 826 (5.8) / 169 (13.1) / <.0001
Stroke/transient ischemic attack / 823 (5.8) / 142 (11.0) / <.0001
Quan-Charlson comorbidity index, mean (± SD) / 1.11 (1.17) / 1.66 (1.76) / <.0001
Laboratory values, n (%) with ≥1 result
HDL-P / 8,856 (62.0) / 534 (41.4) / <.0001
HDL-C / 10,473 (73.4) / 781 (60.5) / <.0001
Total cholesterol / 13,403 (93.9) / 1,211 (93.8) / .922
Triglycerides / 13,501 (94.6) / 1,228 (95.1) / .392
non-HDL-C* / 10,246 (71.8) / 757 (58.6) / <.0001
Laboratory values, mean (± SD)
LDL-P (nmol/L) / 1,443 (465) / 1,426 (481) / .237
HDL-P (umol/L) / 34 (6) / 33 (7) / .003
LDL-C (mg/dL) / 96 (32) / 93 (33) / .021
HDL-C (mg/dL) / 48 (13) / 46 (13) / <.0001
Total cholesterol (mg/dL) / 172 (37) / 169 (38) / .013
Triglycerides (mg/dL) / 140 (79) / 146 (80) / .010
Prescription fills
Any lipid-lowering medications / 9,030 (63.2) / 921 (71.3) / <.0001
Any statins / 7,850 (55.0) / 805 (62.4) / <.0001
*Non-HDL-C includes patients with total cholesterol and HDL-C
CHD=coronary heart disease; HDL-C=high-density lipoprotein cholesterol; HDL-P=high-density lipoprotein particle number; HMO=health maintenance organization; LDL-C=low-density lipoprotein cholesterol; LDL-P=low-density lipoprotein particle number; PPO=preferred provider organization; SD=standard deviation
P-values are from chi-square tests for categorical outcomes and t-tests for continuous outcomes.

Table 3: Baseline Patient Characteristics (Unmatched; Part 2: Comparative Effectiveness Analysis of LDL-P vs. LDL-C on CHD/stroke risk).

12 months follow-up sample
LDL-P Goal Cohort / LDL-C Goal Cohort / p-value
Sample size, n (%) / 2,094 / 193,108
Age (on index date), mean (± SD) / 56.9 / 10.6 / 57.3 / 12.6 / 0.139
Gender, n (%)
Female / 899 / 42.9 / 86,371 / 44.7 / 0.100
Geographic region, n (%)
Northeast / 63 / 3.0 / 57,595 / 29.8 / <.0001
Midwest / 432 / 20.6 / 44,447 / 23.0 / 0.010
South / 1,386 / 66.2 / 55,127 / 28.6 / <.0001
West / 147 / 7.0 / 31,324 / 16.2 / <.0001
Unknown/Missing / 66 / 3.2 / 4,615 / 2.4 / 0.023
Types of Health Plan, n (%)
HMO / 776 / 37.1 / 71,710 / 37.1 / 0.092
PPO / 924 / 44.1 / 88,772 / 46.0 / 0.943
Other / 394 / 18.8 / 32,626 / 16.9 / 0.095
Medicare Advantage, n (%) / 241 / 11.5 / 38,585 / 20.0 / <.0001
Comorbidities, n (%)
Hypertension / 1,553 / 74.2 / 137,946 / 71.4 / 0.006
Diabetes mellitus / 1,183 / 56.5 / 105,993 / 54.9 / 0.142
Cardiovascular disease / 1,313 / 62.7 / 120,217 / 62.3 / 0.673
Coronary heart disease / 1,089 / 52.0 / 96,483 / 50.0 / 0.063
Peripheral vascular disease / 306 / 14.6 / 29,312 / 15.2 / 0.473
Stroke/TIA / 282 / 13.5 / 28,769 / 14.9 / 0.067
Quan-Charlson comorbidity index, mean (± SD) / 1.04 / 1.3 / 1.16 / 1.4 / <.001
Laboratory values, n (%)with ≥1 result
LDL-P (pre-index date) / 827 / 39.5
HDL-P / 833 / 39.8
LDL-C / 2,094 / 100.0 / 193,108 / 100.0
HDL-C / 1,348 / 64.4 / 188,403 / 97.6 / <.0001
Total Cholesterol / 2,015 / 96.2 / 189,237 / 98.0 / <.0001
Triglycerides / 1,979 / 94.5 / 190,214 / 98.5 / <.0001
non-HDL-C / 1,309 / 62.5 / 185,766 / 96.2 / <.0001
Laboratory values, mean (± SD)
LDL-P (pre-index date; nmol/L) / 1,336 / 315
LDL-P (index date; nmol/L) / 858 / 106
HDL-P (umol/L) / 35 / 6
LDL-C(mg/dL) / 73 / 21 / 79 / 15 / <.0001
HDL-C(mg/dL) / 54 / 15 / 50 / 14 / <.0001
Total Cholesterol(mg/dL) / 148 / 29 / 158 / 22 / <.0001
Triglycerides(mg/dL) / 98 / 55 / 141 / 77 / <.0001
non-HDL-C(mg/dL) / 92 / 21 / 108 / 21 / <.0001
Medication utilization, n (%)
Any Anti-hypertensive medications / 1,382 / 66.0 / 127,898 / 66.2 / 0.822
Any Anti-diabetic medications / 892 / 42.6 / 78,837 / 40.8 / 0.101
Any Dyslipidemic medications / 1,524 / 72.8 / 119,783 / 62.0 / <.0001
Statins / 1,365 / 65.2 / 106,465 / 55.1 / <.0001
Potency level 1 / 9 / 0.4 / 1,197 / 0.6 / 0.270
Potency level 2 / 62 / 3.0 / 8,448 / 4.4 / 0.002
Potency level 3 / 383 / 18.3 / 40,684 / 21.1 / 0.002
Potency level 4 / 794 / 37.9 / 54,156 / 28.0 / <.0001
Potency level 5 / 236 / 11.3 / 8,896 / 4.6 / <.0001
Bile Acid Sequestrants / 41 / 2.0 / 1,395 / 0.7 / <.0001
Fibric Acid Derivatives / 159 / 7.6 / 12,416 / 6.4 / 0.031
Intestinal Cholesterol Absorption Inhibitors / 161 / 7.7 / 8,213 / 4.3 / <.0001
Nicotinic Acid Derivatives / 200 / 9.6 / 4,371 / 2.3 / <.0001
Antihyperlipidemics - Combinations / 97 / 4.6 / 7,253 / 3.8 / 0.036
Prescription Omega 3 fatty acids / 84 / 4.0 / 2,845 / 1.5 / <.0001
Antiplatelet agents / 329 / 15.7 / 30,275 / 15.7 / 0.966

*Non-HDL-C includes patients with total cholesterol and HDL-C

CHD=coronary heart disease; HDL-C=high-density lipoprotein cholesterol; HDL-P=high-density lipoprotein particle number; HMO=health maintenance organization; LDL-C=low-density lipoprotein cholesterol; LDL-P=low-density lipoprotein particle number; PPO=preferred provider organization; SD=standard deviation

P-values are from chi-square tests for categorical outcomes and t-tests for continuous outcomes.

Table 4: Baseline Characteristics for Patients With 24 and 36 months of Follow-Up(Matched; Part 2: Comparative Effectiveness Analysis of LDL-P vs. LDL-C on CHD/stroke risk).

24 months follow-up / 36 months follow-up
LDL-P Goal Cohort / LDL-C Goal Cohort / p-value / Standardized Diff. / LDL-P Goal Cohort / LDL-C Goal Cohort / p-value / Standardized Diff.
Sample size, n (%) / 1,242 / 1,242 / 705 / 705
Age (on index date), mean (± SD) / 56.8 / 10.6 / 56.0 / 11.1 / 0.054 / 8 / 56.7 / 10.5 / 56.6 / 10.7 / 0.872 / 1
Age Category, n (%)
18 - 39 / 65 / 5.2 / 85 / 6.8 / 0.092 / -7 / 36 / 5.1 / 30 / 4.3 / 0.449 / 4
40- 64 / 961 / 77.4 / 940 / 75.7 / 0.320 / 4 / 547 / 77.6 / 543 / 77.0 / 0.799 / 1
65 - 74 / 143 / 11.5 / 138 / 11.1 / 0.752 / 1 / 81 / 11.5 / 81 / 11.5 / 1.000 / 0
≥ 75 / 73 / 5.9 / 79 / 6.4 / 0.616 / -2 / 41 / 5.8 / 51 / 7.2 / 0.281 / -6
Gender, n (%)
Female / 526 / 42.4 / 539 / 43.4 / 0.598 / -2 / 302 / 42.8 / 320 / 45.4 / 0.334 / -5
Geographic region, n (%)
Northeast / 41 / 3.3 / 36 / 2.9 / 0.563 / 2 / 28 / 4.0 / 23 / 3.3 / 0.476 / 4
Midwest / 248 / 20.0 / 248 / 20.0 / 1.000 / 0 / 124 / 17.6 / 132 / 18.7 / 0.581 / -3
South / 817 / 65.8 / 795 / 64.0 / 0.355 / 4 / 483 / 68.5 / 472 / 67.0 / 0.531 / 3
West / 99 / 8.0 / 123 / 9.9 / 0.091 / -7 / 54 / 7.7 / 54 / 7.7 / 1.000 / 0
Unknown/Missing / 37 / 3.0 / 40 / 3.2 / 0.728 / -1 / 16 / 2.3 / 24 / 3.4 / 0.199 / -7
Types of Health Plan, n (%)
HMO / 487 / 39.2 / 470 / 37.8 / 0.483 / 3 / 281 / 39.9 / 263 / 37.3 / 0.424 / 5
PPO / 573 / 46.1 / 599 / 48.2 / 0.296 / -4 / 337 / 47.8 / 352 / 49.9 / 0.325 / -4
CDHP / 19 / 1.5 / 17 / 1.4 / 0.737 / 1 / 2 / 0.3 / 3 / 0.4 / 0.654 / -2
Other / 163 / 13.1 / 156 / 12.6 / 0.675 / 2 / 85 / 12.1 / 87 / 12.3 / 0.871 / -1
Medicare Advantage, n (%) / 146 / 11.8 / 171 / 13.8 / 0.133 / -6 / 82 / 11.6 / 95 / 13.5 / 0.296 / -6
Comorbidities, n (%)
Hypertension / 917 / 73.8 / 886 / 71.3 / 0.163 / 6 / 493 / 69.9 / 521 / 73.9 / 0.097 / -9
Diabetes mellitus / 692 / 55.7 / 715 / 2.7 / 0.352 / -4 / 407 / 57.7 / 408 / 57.9 / 0.957 / 0
Cardiovascular disease / 778 / 62.6 / 776 / 62.5 / 0.934 / 0 / 425 / 60.3 / 396 / 56.2 / 0.117 / 8
Coronary heart disease / 654 / 52.7 / 627 / 50.5 / 0.278 / 4 / 357 / 50.6 / 334 / 47.4 / 0.221 / 7
Peripheral vascular disease / 168 / 13.5 / 167 / 13.5 / 0.953 / 0 / 83 / 11.8 / 73 / 10.4 / 0.396 / 5
Stroke/TIA / 151 / 12.2 / 161 / 13.0 / 0.545 / -2 / 67 / 9.5 / 68 / 9.7 / 0.928 / 0
Quan-Charlson comorbidity index, mean (± SD) / 1.03 / 1.3 / 1.10 / 1.3 / 0.175 / -6 / 1.04 / 1.2 / 1.07 / 1.2 / 0.616 / -2
Laboratory values, n (%)with ≥1 result
LDL-P (pre-index date) / 491 / 39.5 / 272 / 38.6
HDL-P / 229 / 18.4 / 3 / 0.4
LDL-C / 1,242 / 100.0 / 1,242 / 100.0 / 705 / 100.0 / 705 / 100.0
HDL-C / 650 / 52.3 / 1,206 / 97.1 / <.0001 / -120 / 298 / 42.3 / 694 / 98.4 / <.0001 / -156
Total Cholesterol / 1,192 / 96.0 / 1,213 / 97.7 / 0.016 / -10 / 672 / 95.3 / 691 / 98.0 / 0.005 / -15
Triglycerides / 1,184 / 95.3 / 1,217 / 98.0 / 0.000 / -15 / 674 / 95.6 / 698 / 99.0 / <.0001 / -21
non-HDL-C / 633 / 51.0 / 1,189 / 95.7 / <.0001 / -117 / 289 / 41.0 / 682 / 96.7 / <.0001 / -151
Laboratory values, mean (± SD)
LDL-P (pre-index date; nmol/L) / 1337 / 315 / 1326 / 312
LDL-P (index date; nmol/L) / 862 / 105 / 864 / 106
HDL-P (umol/L) / 36 / 7 / 30 / 5
LDL-C (mg/dL) / 73 / 21 / 80 / 14 / <.0001 / -34 / 73 / 22 / 79 / 15 / <.0001 / -32
HDL-C (mg/dL) / 53 / 14 / 47 / 13 / 0.001 / 38 / 52 / 14 / 49 / 14 / 0.001 / 24
Total Cholesterol (mg/dL) / 148 / 29 / 157 / 22 / <.0001 / -35 / 149 / 30 / 159 / 23 / <.0001 / -38
Triglycerides (mg/dL) / 96 / 53 / 145 / 76 / <.0001 / -75 / 94 / 50 / 141 / 75 / <.0001 / -74
non-HDL-C (mg/dL) / 93 / 21 / 109 / 20 / <.0001 / -76 / 94 / 23 / 109 / 21 / <.0001 / -72
Medication utilization, n (%)
Any Anti-hypertensive medications / 837 / 67.4 / 856 / 68.9 / 0.413 / -3 / 481 / 68.2 / 508 / 72.1 / 0.116 / -8
Any Anti-diabetic medications / 531 / 42.8 / 545 / 43.9 / 0.571 / -2 / 324 / 46.0 / 334 / 47.4 / 0.594 / -3
Any Dyslipidemic medications / 912 / 73.4 / 838 / 67.5 / 0.001 / 13 / 500 / 70.9 / 485 / 68.8 / 0.384 / 5
Statins / 808 / 65.1 / 755 / 60.8 / 0.001 / 9 / 427 / 60.6 / 425 / 60.3 / 0.913 / 1
Potency level 1 / 5 / 0.4 / 5 / 0.4 / 1.000 / 0 / 3 / 0.4 / 4 / 0.6 / 0.705 / -2
Potency level 2 / 35 / 2.8 / 67 / 5.4 / 0.002 / -13 / 18 / 2.6 / 28 / 4.0 / 0.134 / -8
Potency level 3 / 230 / 18.5 / 259 / 20.9 / 0.158 / -6 / 123 / 17.5 / 158 / 22.4 / 0.020 / -12
Potency level 4 / 460 / 37.0 / 423 / 34.1 / 0.001 / 6 / 252 / 35.7 / 229 / 32.5 / 0.196 / 7
Potency level 5 / 136 / 11.0 / 63 / 5.1 / <.0001 / 22 / 72 / 10.2 / 24 / 3.4 / <.0001 / 27
Bile Acid Sequestrants / 23 / 1.9 / 5 / 0.4 / 0.001 / 14 / 16 / 2.3 / 8 / 1.1 / 0.100 / 9
Fibric Acid Derivatives / 105 / 8.5 / 90 / 7.3 / 0.296 / 4 / 60 / 8.5 / 63 / 8.9 / 0.777 / -2
Intestinal Cholesterol Absorption Inhibitors / 114 / 9.2 / 41 / 3.3 / <.0001 / 24 / 74 / 10.5 / 46 / 6.5 / 0.008 / 14
Nicotinic Acid Derivatives / 128 / 10.3 / 30 / 2.4 / <.0001 / 33 / 67 / 9.5 / 19 / 2.7 / <.0001 / 29
Antihyperlipidemics - Combinations / 66 / 5.3 / 50 / 4.0 / 0.128 / 6 / 48 / 6.8 / 38 / 5.4 / 0.266 / 6
Prescription Omega 3 fatty acids / 47 / 3.8 / 24 / 1.9 / 0.006 / 11 / 22 / 3.1 / 10 / 1.4 / 0.032 / 11
Antiplatelet agents / 187 / 15.1 / 185 / 14.9 / 0.911 / 0 / 94 / 13.3 / 119 / 16.9 / 0.063 / -10
Plavix / 133 / 10.7 / 127 / 10.2 / 0.694 / 2 / 65 / 9.2 / 91 / 12.9 / 0.027 / -12

*Non-HDL-C includes patients with total cholesterol and HDL-C

P-values are from chi-square tests for categorical outcomes and t-tests for continuous outcomes.

Table 5: Laboratory Values for Patients with ≥12 Months of Follow-Up

(Matched; Part 2: Comparative Effectiveness Analysis of LDL-P vs. LDL-C on CHD/stroke risk)

Baseline / 12-Month Follow-Up
LDL-P Cohort
Mean (SD) / LDL-C Cohort
Mean (SD) / p-value / LDL-P Cohort
Mean (SD) / LDL-C Cohort
Mean (SD) / p-value
N / 2,094 / 2,094 / 2,094 / 2,094
LDL-P (index date; nmol/L) / 858 (106) / – / – / 1037 (280) / – / –
HDL-P (umol/L) / 35 (6) / – / – / 36 (6) / – / –
Lipid Panel
LDL-C (mg/dL) / 73 (21) / 79 (15) / <.0001 / 77 (24) / 90 (26) / <.0001
HDL-C (mg/dL) / 54 (15) / 48 (14) / <.0001 / 55 (15) / 49 (13) / <.0001
Total cholesterol (mg/dL) / 148 (28) / 157 (22) / <.0001 / 153 (31) / 168 (32) / <.0001
Triglycerides (mg/dL) / 98 (55) / 141 (77) / <.0001 / 109 (63) / 146 (78) / <.0001
Non-HDL-C (mg/dL) / 92 (21) / 108 (21) / <.0001 / 96 (27) / 119 (31) / <.0001
HDL-C=high-density lipoprotein cholesterol; HDL-P=high-density lipoprotein particle number; LDL-C=low-density lipoprotein cholesterol; LDL-P=low-density lipoprotein particle number; SD=standard deviation
P-values are from chi-square tests for categorical outcomes and t-tests for continuous outcomes.

Table 6: Laboratory values for LDL-P and LDL-C goal cohorts over 24-months and 36-months follow-up periods (Matched; Part 2: Comparative Effectiveness Analysis of LDL-P vs. LDL-C on CHD/stroke risk).

24-months follow-up / 36-months follow-up
LDL-P cohort
(N=1,242) / LDL-C cohort (N=1,242) / p-value / LDL-P cohort
(N=705) / LDL-C cohort
(N=705) / p-value
Mean / S.D. / Mean / S.D. / Mean / S.D. / Mean / S.D.
LDL-P (nmol/L) / 1046 / 308 / 1092 / 377
HDL-P (umol/L) / 37 / 6
Lipid Panel
LDL-C (mg/dL) / 77 / 25 / 91 / 27 / <.0001 / 78 / 28 / 90 / 29 / <.0001
HDL-C (mg/dL) / 55 / 14 / 49 / 14 / <.0001 / 56 / 15 / 49 / 14 / 0.001
Total Cholesterol (mg/dL) / 156 / 30 / 170 / 34 / <.0001 / 156 / 33 / 170 / 37 / .001
Triglycerides (mg/dL) / 107 / 57 / 146 / 79 / <.0001 / 104 / 50 / 151 / 82 / <.0001
non-HDL-C (mg/dL) / 95 / 23 / 120 / 34 / <.0001 / 95 / 29 / 120 / 36 / <.0001

*Non-HDL-C includes patients with total cholesterol and HDL-C

HDL-C=high-density lipoprotein cholesterol; HDL-P=high-density lipoprotein particle number; LDL-C=low-density lipoprotein cholesterol; LDL-P=low-density lipoprotein particle number; SD=standard deviation

P-values are from chi-square tests for categorical outcomes and t-tests for continuous outcomes.