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Table 1 Baseline clinic characteristics of study participants (mITT Population)

From: Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

Characteristic

CNIC-Polypill

(N = 218)

Usual care

(N = 221)

Age (years), mean (SD)

65.4 (8.6)

64.1 (9.2)

Sex (male), n (%)

124 (56.9)

138 (62.4)

BMI (kg/m2), mean (SD)

30.8 (5.1)

30.5 (4.6)

Medical history

 Current smoker, n (%)

26 (11.9)

33 (14.9)

 Years of smoking, mean (SD)

36.7 (15,3)

41.0 (12.3)

 Cigarettes per day, mean (SD)

13.0 (9.2)

19.3 (39.6)

 Hypertension, n (%)

216 (99.1)

221 (100.0)

 Diabetes Mellitus, n (%)

170 (78.0)

170 (76.9)

 Type 1

3 (1.8)

0 (0.0)

 Type 2

167 (98.2)

170 (100.0)

 Diabetes Mellitus + hypertension

170 (78.0)

169 (76.5)

 Hypercholesterolaemia*, n (%)

212 (97.2)

213 (96.4)

 Hypertriglyceridaemia**, n (%)

38 (17.4)

48 (21.7)

 Chronic kidney disease, n (%)

30 (13.8)

21 (9.5)

Stage of kidney damage, eGFR (mL/min/1,73m2), n (%)

 Stage I: > 90

0 (0.0)

1 (4.8)

 Stage II: 60–89

1 (3.3)

0 (0.0)

 Stage III: 45–59

29 (96.7)

20 (95.2)

Evidence of TOD, n (%)

 Subclinical atherosclerosis

48 (22.0)

50 (22.6)

 Diabetes Mellitus + albuminuria

60 (27.5)

55 (24.9)

 HT + LVH/albuminuria/CKD

107 (49.1)

113 (51.1)

Current medication, n (%)

 Taking statins

218 (100.0)

221 (100.0)

 Taking ACEi/ARB

218 (100.0)

221 (100.0)

 Taking aspirin

115 (52.8)

118 (53.4)

 Taking glucose-lowering drugs

166 (75.1)

166 (75.1)

  1. ACEi, angiotensin-converting-enzyme inhibitor; ARB, angiotensin II receptor blocker; CDK, chronic kidney disease; DM, diabetes mellitus; HT, hypertension; LVH, left ventricular hypertrophy; TOD, target organ damage
  2. *Hipercholesterolemia was defined as total cholesterol ≥ 200 mg/dL
  3. **Hypertrygliceridemia was defined as triglycerides ≥ 150 mg/dL