Total cohort (N=152 358) | Statin non-users | Statin users | Effect size or p value* | ||||||
Statin non-users N=143 505 | Statin users N=8853 | ≤5.6% (N=83 593) | 5.7%–5.9% (N=36 771) | 6.0%–6.4% (N=23 141) | ≤5.6% (N=4594) | 5.7%–5.9% (N=2731) | 6.0%–6.4% (N=1528) | ||
Mean age (SD), year | 51.5 (16.8) | 57.9 (11.6) | 47.3 (16.8) | 55.6 (15.4) | 59.7 (14.0) | 56.0 (12.3) | 59.5 (10.5) | 60.7 (10.3) | 0.096 |
Gender, male, n (%) | 126 868 (88.0) | 8284 (94.0) | 72 178 (86.0) | 33 253 (90.0) | 21 437 (93.0) | 4281 (93.0) | 2559 (94.0) | 1444 (95.0) | 0.087 |
Ethnicity, n (%) | 0.090 | ||||||||
Caucasian | 110 647 (77.0) | 7450 (84.0) | 67 455 (81.0) | 27 366 (74.0) | 15 826 (68.0) | 4000 (87.0) | 2289 (84.0) | 1161 (76.0) | |
African American | 27 919 (19.0) | 1159 (13.0) | 13 166 (16.0) | 8185 (22.0) | 6568 (28.0) | 472 (10.0) | 367 (13.0) | 320 (21.0) | |
Other | 4939 (3.0) | 244 (3.0) | 2972 (4.0) | 1220 (3.0) | 747 (3.0) | 122 (3.0) | 75 (3.0) | 47 (3.0) | |
Mean follow-up (SD), years | 6.9 (2.3) | 3.8 (2.3) | 7.3 (1.8) | 6.8 (2.2) | 5.5 (3.0) | 3.9 (2.3) | 3.9 (2.3) | 3.7 (2.3) | 0.167 |
Mean BMI (SD), kg/m2 | 28.5 (5.4) | 28.9 (5.2) | 27.9 (5.1) | 28.8 (5.5) | 29.9 (5.9) | 28.6 (5.0) | 29.1 (5.2) | 29.9 (5.5) | 0.018 |
Mean HbA1c (SD), % | 5.6 (0.4) | 5.6 (0.3) | 5.3 (0.3) | 5.8 (0.1) | 6.1 (0.1) | 5.3 (0.2) | 5.8 (0.1) | 6.1 (0.1) | 0.695 |
Hypertension, n (%) | 48 475 (34.0) | 4406 (50.0) | 22 736 (27.0) | 14 272 (39.0) | 11 467 (50.0) | 2112 (46.0) | 1414 (52.0) | 880 (58.0) | 0.191 |
Mean LDL-C, (SD), mg/dL | 101.8 (30.9) | 114.4 (31.9) | 100.6 (30.7) | 104.0 (31.0) | 103.0 (31.4) | 113.4 (31.6) | 114.9 (32.0) | 116.4 (32.5) | 0.012 |
Cerebrovascular disease, n (%) | 2525 (2.0) | 253 (3.0) | 1252 (1.0) | 692 (2.0) | 601 (3.0) | 139 (3.0) | 70 (3.0) | 44 (3.0) | 0.034 |
Coronary artery disease, n (%) | 5772 (4.0) | 501 (6.0) | 2227 (3.0) | 1744 (5.0) | 1801 (8.0) | 207 (5.0) | 165 (6.0) | 129 (8.0) | 0.095 |
Metformin use, n (%) | 2532 (2.0) | 209 (2.0) | 849 (1.0) | 663 (2.0) | 1020 (4.0) | 72 (2.0) | 77 (3.0) | 60 (4.0) | 0.090 |
Type of statin | |||||||||
Atorvastatin, n (%) | – | 4394 (50.0) | – | – | – | 2387 (52.0) | 1285 (47.0) | 722 (47.0) | |
Simvastatin, n (%) | – | 3189 (36.0) | – | – | – | 1599 (35.0) | 999 (37.0) | 591 (39.0) | |
Pravastatin, n (%) | – | 1270 (14.0) | – | – | – | 608 (13.0) | 447 (16.0) | 215 (14.0) | |
Unadjusted HR of NODM compared with A1c ≤5.6% in non-users | 1.00 (ref) | 1.68 (1.58 to 1.80) | 1.00 (ref) | 2.6 (2.5 to 2.8) | 9.3 (8.9 to 9.7) | 2.5 (2.2 to 2.8) | 4.6 (4.1 to 5.2) | 9.7 (8.7 to 10.8) | <0.0001 |
Unadjusted HR of NODM for all statin users compared with respective A1c category in non-users | 1.00 (ref) | 1.68 (1.58 to 1.80) | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 2.50 (2.22 to 2.82) | 1.75 (1.56 to 1.96) | 1.04 (0.94 to 1.16) | <0.0001 |
Adjusted HR of NODM for all statin users compared with respective A1c category in non-users | 1.00 (ref) | 1.40 (1.31 to 1.50) | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 2.08 (1.85 to 2.35) | 1.57 (1.40 to 1.75) | 1.03 (0.93 to 1.15) | <0.0001 |
Adjusted HR of NODM for individual statin groups | |||||||||
Atorvastatin | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 2.28 (1.91 to 2.71) | 1.85 (1.56 to 2.19) | 1.21 (1.03 to 1.41) | <0.0001 | ||
Simvastatin | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 2.05 (1.72 to 2.46) | 1.45 (1.22 to 1.72) | 0.98 (0.84 to 1.15) | 0.015 | ||
Pravastatin | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 1.69 (1.23 to 2.32) | 1.30 (0.98 to 1.71) | 0.78 (0.58 to 1.04) | 0.13 | ||
Adjusted HR of NODM for statin intensity groups | |||||||||
High intensity | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 2.62 (1.94 to 3.54) | 1.93 (1.43 to 2.61) | 1.30 (0.99 to 1.71) | 0.21 | ||
Moderate intensity | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 1.92 (1.64 to 2.27) | 1.61 (1.38 to 1.87) | 0.99 (0.86 to 1.14) | <0.0001 | ||
Low intensity | 1.00 (ref) | 1.00 (ref) | 1.00 (ref) | 1.96 (1.49 to 2.57) | 1.19 (0.91 to 1.56) | 0.78 (0.60 to 1.03) | 0.71 |
*Effect sizes for baseline characteristics to assess confounding or p values for testing significance in the HR trends between non-users and statin users across A1c ranges.
BMI, body mass index; HbA1c, hemoglobin A1c; LDL-C, low-density lipoprotein cholesterol; NODM, new-onset diabetes mellitus.