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Table 1 Baseline characteristics (ITT population)

From: Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial

 FF/UMEC/VI
N = 4151
FF/VI
N = 4134
UMEC/VI
N = 2070
Overall
N = 10,355
Age, mean (SD), years65.3 (8.2)65.3 (8.3)65.2 (8.3)65.3 (8.3)
Gender, male, n (%)2766 (67)2748 (66)1356 (66)6870 (66)
BMI, mean (SD), kg/m226.6 (6.2)26.7 (6.1)26.6 (5.9)26.6 (6.1)
Smoking status, n (%)
 Current smoker1436 (35)1423 (34)728 (35)3587 (35)
 Former smoker2715 (65)2711 (66)1342 (65)6768 (65)
Moderate or severe COPD exacerbations in previous year, n (%)
 02 (< 1)5 (< 1)2 (< 1)9 (< 1)
 11853 (45)1907 (46)931 (45)4691 (45)
 21829 (44)1768 (43)890 (43)4487 (43)
  ≥3467 (11)454 (11)247 (12)1168 (11)
Post-bronchodilator FEV1% predicted, mean (SD)47.5 (15.0)45.5 (14.8)45.4 (14.7)45.5 (14.8)
Current/past Cardiac disordersa, n (%)1194 (29)1173 (28)597 (29)2964 (29)
Current/past Vascular disordersa, n (%)2362 (57)2438 (59)1221 (59)6021 (58)
CV risk factorsa, n (%)
 01365 (33)1322 (32)656 (32)3343 (32)
 11147 (28)1158 (28)580 (28)2885 (28)
  ≥12786 (67)2812 (68)1414 (68)7012 (68)
  ≥21639 (39)1654 (40)834 (40)4127 (40)
CV risk factorsa, n (%)
 Hypertension2132 (51)2207 (53)1107 (53)5446 (53)
 Hypercholesterolemia1354 (33)1332 (32)681 (33)3367 (33)
 Diabetes mellitus641 (15)645 (16)313 (15)1599 (15)
 Coronary artery disease510 (12)488 (12)254 (12)1252 (12)
 Arrhythmia335 (8)323 (8)158 (8)816 (8)
 Angina pectoris291 (7)307 (7)139 (7)737 (7)
 Myocardial infarction270 (7)274 (7)137 (7)681 (7)
 Congestive heart failure223 (5)192 (5)124 (6)539 (5)
 Cerebrovascular accident199 (5)165 (4)94 (5)458 (4)
 Vascular diseaseb133 (3)148 (4)61 (3)342 (3)
Family history of CV risk factorsa, n (%)c
 Premature coronary artery diseased
  Yes432 (10)430 (10)234 (11)1096 (11)
  No3160 (76)3097 (75)1529 (74)7786 (75)
  Unknown559 (13)607 (15)307 (15)1473 (14)
 Myocardial infarction
  Yes651 (16)673 (16)361 (17)1685 (16)
  No3004 (72)2954 (71)1431 (69)7389 (71)
  Unknown496 (12)507 (12)278 (13)1281 (12)
 Stroke
  Yes448 (11)464 (11)230 (11)1142 (11)
  No3191 (77)3150 (76)1565 (76)7906 (76)
  Unknown512 (12)520 (13)275 (13)1307 (13)
  1. aAs captured in the electronic case report form; bcarotid or aorto-femoral vascular disease; chistory in first degree relatives only; dwomen < 65 years-old, men < 55 years-old.
  2. BMI Body mass index; COPD Chronic obstructive pulmonary disease; CV Cardiovascular; FEV1 Forced expiratory volume in 1 s; FF Fluticasone furoate; ITT Intent-to-treat; SD Standard deviation; UMEC Umeclidinium; VI Vilanterol