Table 1

Screening characteristics of study participants

Placebo,
n=4111
Fluticasone furoate,
n=4135
Vilanterol,
n=4118
Combination therapy,
n=4121
Total,
n=16 485
Age, years65 (8)65 (8)65 (8)65 (8)65 (8)
Female1040 (25%)*1082 (26%)1065 (26%)1009 (24%)4196 (25%)
Race
 White3328 (81%)3358 (81%)3339 (81%)3332 (81%)13 357 (81%)
 Asian682 (17%)683 (17%)680 (17%)679 (16%)2724 (17%)
 Other101 (2%)94 (2%)99 (2%)110 (3%)404 (2%)
Body mass index, kg/m2 28 (6)28 (6)28 (6)28 (6)28 (6)
Current smokers1936 (47%)1945 (47%)1929 (47%)1868 (45%)7678 (47%)
Systolic blood pressure, mm Hg135 (15)135 (15)135 (15)135 (15)135 (15)
Diastolic blood pressure, mm Hg81 (10)80 (10)80 (10)81 (10)80 (10)
Heart rate, beats/min76 (10)76 (10)76 (10)76 (10)76 (10)
Cardiovascular inclusion criteria
 Cardiovascular disease
 Coronary artery disease2103 (51%)2119 (51%)2044 (50%)2113 (51%)8379 (51%)
 Peripheral arterial disease766 (19%)755 (18%)817 (20%)807 (20%)3145 (19%)
 Previous stroke404 (10%)418 (10%)387 (9%)386 (9%)1595 (10%)
 Previous myocardial infarction658 (16%)664 (16%)722 (18%)730 (18%)2774 (17%)
 Diabetes with target organ disease 374 (9%)355 (9%)377 (9%)397 (10%)1503 (9%)
High risk (receiving treatment for):
 Hypercholesterolaemia2112 (51%)2051 (50%)2191 (53%)2125 (52%)8479 (51%)
 Hypertension2861 (70%)2835 (69%)2900 (70%)2882 (70%)11 478 (70%)
 Diabetes mellitus850 (21%)870 (21%)874 (21%)886 (21%)3480 (21%)
 Peripheral arterial disease279 (7%)264 (6%)301 (7%)310 (8%)1154 (7%)
Concomitant cardiovascular therapy (taken >30 days)
 Any medication3996 (97%)4009 (97%)3996 (97%)4021 (98%)16 022 (97%)
 Antithrombotic/coagulant2292 (56%)2316 (56%)2295 (56%)2384 (58%)9287 (56%)
 Antiplatelet therapy§ 2101 (51%)2123 (51%)2093 (51%)2200 (53%)8517 (52%)
 Lipid-lowering medication2751 (67%)2746 (66%)2797 (68%)2829 (69%)11 123 (67%)
 Statin2647 (64%)2652 (64%)2693 (65%)2729 (66%)10 721 (65%)
 RAS-aldosterone inhibitor 2887 (70%)2841 (69%)2862 (69%)2932 (71%)11 522 (70%)
 Beta-blockers1389 (34%)1458 (35%)1376 (33%)1444 (35%)5667 (34%)
 Beta1 selective1151 (28%)1205 (29%)1141 (28%)1166 (28%)4663 (28%)
 Calcium channel blockers1551 (38%)1606 (39%)1569 (38%)1593 (39%)6319 (38%)
 Dihydropyridine1188 (29%)1258 (30%)1206 (29%)1222 (30%)4874 (30%)
 Long-acting or short-acting nitrates613 (15%)556 (13%)569 (14%)556 (13%)2294 (14%)
 Diuretics**1508 (37%)1541 (37%)1549 (38%)1550 (38%)6148 (37%)
  • Age, body mass index, blood pressure and heart rate are given in mean (SD).

  • * Represents the percentage of all patients within the individual treatment group.

  • †Patients can have multiple cardiovascular diseases or risks at study entry.

  • ‡Target organ disease: diagnosed nephropathy, retinopathy or neuropathy.

  • §Monotherapy or combination therapy with aspirin, P2Y12 receptor antagonist, other antiplatelet agent.

  • ¶Monotherapy or combination therapy with ACE inhibitors, angiotensin receptor blockers, mineralocorticoid receptor blockers, direct renin inhibitors.

  • **Monotherapy or combination therapy with thiazide, thiazide-like, loop or other diuretic.

  • RAS, renin–angiotensin system.