Placebo, n=4111 | Fluticasone furoate, n=4135 | Vilanterol, n=4118 | Combination therapy, n=4121 | Total, n=16 485 | |
Age, years | 65 (8) | 65 (8) | 65 (8) | 65 (8) | 65 (8) |
Female | 1040 (25%)* | 1082 (26%) | 1065 (26%) | 1009 (24%) | 4196 (25%) |
Race | |||||
White | 3328 (81%) | 3358 (81%) | 3339 (81%) | 3332 (81%) | 13 357 (81%) |
Asian | 682 (17%) | 683 (17%) | 680 (17%) | 679 (16%) | 2724 (17%) |
Other | 101 (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 smokers | 1936 (47%) | 1945 (47%) | 1929 (47%) | 1868 (45%) | 7678 (47%) |
Systolic blood pressure, mm Hg | 135 (15) | 135 (15) | 135 (15) | 135 (15) | 135 (15) |
Diastolic blood pressure, mm Hg | 81 (10) | 80 (10) | 80 (10) | 81 (10) | 80 (10) |
Heart rate, beats/min | 76 (10) | 76 (10) | 76 (10) | 76 (10) | 76 (10) |
Cardiovascular inclusion criteria† | |||||
Cardiovascular disease | |||||
Coronary artery disease | 2103 (51%) | 2119 (51%) | 2044 (50%) | 2113 (51%) | 8379 (51%) |
Peripheral arterial disease | 766 (19%) | 755 (18%) | 817 (20%) | 807 (20%) | 3145 (19%) |
Previous stroke | 404 (10%) | 418 (10%) | 387 (9%) | 386 (9%) | 1595 (10%) |
Previous myocardial infarction | 658 (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): | |||||
Hypercholesterolaemia | 2112 (51%) | 2051 (50%) | 2191 (53%) | 2125 (52%) | 8479 (51%) |
Hypertension | 2861 (70%) | 2835 (69%) | 2900 (70%) | 2882 (70%) | 11 478 (70%) |
Diabetes mellitus | 850 (21%) | 870 (21%) | 874 (21%) | 886 (21%) | 3480 (21%) |
Peripheral arterial disease | 279 (7%) | 264 (6%) | 301 (7%) | 310 (8%) | 1154 (7%) |
Concomitant cardiovascular therapy (taken >30 days) | |||||
Any medication | 3996 (97%) | 4009 (97%) | 3996 (97%) | 4021 (98%) | 16 022 (97%) |
Antithrombotic/coagulant | 2292 (56%) | 2316 (56%) | 2295 (56%) | 2384 (58%) | 9287 (56%) |
Antiplatelet therapy§ | 2101 (51%) | 2123 (51%) | 2093 (51%) | 2200 (53%) | 8517 (52%) |
Lipid-lowering medication | 2751 (67%) | 2746 (66%) | 2797 (68%) | 2829 (69%) | 11 123 (67%) |
Statin | 2647 (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-blockers | 1389 (34%) | 1458 (35%) | 1376 (33%) | 1444 (35%) | 5667 (34%) |
Beta1 selective | 1151 (28%) | 1205 (29%) | 1141 (28%) | 1166 (28%) | 4663 (28%) |
Calcium channel blockers | 1551 (38%) | 1606 (39%) | 1569 (38%) | 1593 (39%) | 6319 (38%) |
Dihydropyridine | 1188 (29%) | 1258 (30%) | 1206 (29%) | 1222 (30%) | 4874 (30%) |
Long-acting or short-acting nitrates | 613 (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.