Skip to main content

Advertisement

Table 1 Baseline characteristics (randomized population)

From: Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

 DM-DYSLIPIDEMIADM-INSULIN
Alirocumab (n = 95)UC (n = 47)Alirocumab (n = 119)Placebo (n = 58)
Age, years, mean (SD)64.9 (9.1)65.4 (8.1)66.2 (8.7)64.9 (8.9)
Gender, male, n (%)65 (68.4)31 (66.0)79 (66.4)32 (55.2)
BMI, kg/m2, mean (SD)33.0 (5.4)32.7 (4.9)32.6 (4.5)33.4 (5.8)
CHD, n (%)90 (94.7)45 (95.7)102 (85.7)51 (87.9)
 Acute MI43 (45.3)20 (42.6)59 (49.6)18 (31.0)
 Silent MI5 (5.3)1 (2.1)4 (3.4)4 (6.9)
 Unstable angina15 (15.8)9 (19.1)15 (12.6)4 (6.9)
 Coronary revascularization77 (81.1)35 (74.5)80 (67.2)37 (63.8)
 Other clinically significant CHDa20 (21.1)14 (29.8)31 (26.1)15 (25.9)
Ischemic stroke, n (%)14 (14.7)5 (10.6)27 (22.7)9 (15.5)
PAD, n (%)6 (6.3)4 (8.5)13 (10.9)6 (10.3)
HTNb, n (%)89 (93.7)44 (93.6)105 (88.2)53 (91.4)
CKDc, n (%)15 (15.8)11 (23.4)37 (31.1)13 (22.4)
Diabetes target organ damaged, n (%)31 (32.6)15 (31.9)60 (50.4)28 (48.3)
Statin, n (%)80 (84.2)41 (87.2)92 (77.3)42 (72.4)
 Low intensity6 (7.5)03 (3.3)1 (2.4)
 Moderate intensity21 (26.3)20 (48.8)46 (50.0)24 (57.1)
 High intensity53 (66.3)21 (51.2)43 (46.7)16 (38.1)
LLT other than statine, n (%)02 (4.3)34 (28.6)11 (19.0)
HbA1c, %, mean (SD)7.0 (0.8)7.2 (0.8)7.5 (0.9)7.4 (1.0)
FPG, mg/dL [mmol/L], mean (SD)144.1 (39.3) [8.0 (2.2)]152.6 (41.7) [8.5 (2.3)]162.6 (52.5) [9.0 (2.9)]146.7 (45.2) [8.1 (2.5)]
Insulin, n (%)40 (42.1)19 (40.4)119 (100)57 (98.3)f
Non-insulin GLT, n (%)
 Biguanides72 (75.8)34 (72.3)57 (47.9)33 (56.9)
 Sulfonylureas29 (30.5)18 (38.3)11 (9.2)7 (12.1)
 DPP-4 inhibitor12 (12.6)8 (17.0)21 (17.6)7 (12.1)
 GLP-1 receptor agonist16 (16.8)6 (12.8)11 (9.2)8 (13.8)
 SGLT2 inhibitor10 (10.5)5 (10.6)10 (8.4)11 (19.0)
Lipids, mg/dL [mmol/L], mean (SD)
 Non-HDL-C156.5 (48.4) [4.05 (1.26)]156.8 (43.3) [4.06 (1.12)]142.8 (41.5) [3.70 (1.08)]147.0 (54.9) [3.81 (1.42)]
 LDL-C108.3 (46.3) [2.81 (1.20)]109.4 (44.0) [2.83 (1.14)]107.2 (35.1) [2.78 (0.91)]111.9 (46.4) [2.90 (1.20)]
 ApoB103.0 (26.7)104.3 (27.8)96.4 (25.1)98.7 (32.0)
 LDL-PN, nmol/L, mean (SD)1400.2 (489.8)1437.4 (479.4)1339.5 (408.5)1425.0 (467.9)
  1. Apo apolipoprotein, BMI body mass index, CHD coronary heart disease, CKD chronic kidney disease, DPP-4 dipeptidyl peptidase-4, GLP-1 glucagon-like peptide-1, GLT glucose-lowering treatment, FPG fasting plasma glucose, HbA1c glycated hemoglobin, HDL-C high-density lipoprotein cholesterol, HTN hypertension, LDL-C low-density lipoprotein cholesterol, LDL-PN low-density lipoprotein particle number, LLT lipid-lowering therapy, MI myocardial infarction, PAD peripheral artery disease, SD standard deviation, SGLT2 sodium glucose cotransporter 2
  2. aDiagnosis by invasive/non-invasive testing
  3. bIncludes patients with established HTN on anti-HTN medication
  4. cDefined as estimated glomerular filtration rate 15–60 mL/min/1.73 m2
  5. dDefined as microalbuminuria, macroalbuminuria, retinopathy, and/or CKD
  6. eLLT other than statins were not allowed per protocol in DM DYSLIPIDEMIA
  7. fOne individual in the placebo group was not receiving insulin at the time of randomization and remained without insulin treatment for the duration of the study