Table 1.
Baseline characteristics by risk of CHF
| Characteristic | Placebo | Avosentan | P for Interactiona | ||||
|---|---|---|---|---|---|---|---|
| No CHF (n=440) | CHF (n=19) | P Value | No CHF (n=844) | CHF (n=89) | P Value | ||
| Age, yr | 60.7 (9.0) | 63.2 (7.3) | 0.29 | 60.9 (9.0) | 63.3 (8.2) | 0.01 | 0.93 |
| Women | 149 (33.9) | 6 (31.6) | 1.00 | 265 (31.4) | 32 (36.0) | 0.40 | 0.68 |
| Physical examination | |||||||
| Systolic BP, mmHg | 135.2 (15.1) | 138.4 (16.2) | 0.29 | 136.8 (13.9) | 139.3 (15.9) | 0.07 | 0.80 |
| Diastolic BP, mmHg | 77.0 (9.6) | 79.8 (8.4) | 0.23 | 77.8 (8.8) | 77.0 (9.6) | 0.78 | 0.09 |
| Weight, kg | 83.7 (20.2) | 90.1 (12.0) | 0.06 | 84.1 (21.0) | 91.1 (19.7) | <0.001 | 0.95 |
| Laboratory results | |||||||
| Hemoglobin A1C, % | 8.0 (1.5) | 7.8 (1.6) | 0.56 | 8.1 (1.5) | 7.7 (1.4) | 0.02 | 0.69 |
| Hemoglobin, g/dl | 12.1 (1.7) | 12.0 (1.9) | 0.85 | 12.2 (1.8) | 12.0 (1.8) | 0.37 | 0.98 |
| LDL cholesterol, mg/dl | 107.1 (47.1) | 128.1 (48.9) | 0.07 | 107.3 (46.6) | 95.4 (41.4) | 0.03 | 0.003 |
| eGFR, ml/min per 1.73 m2 | 33.3 (10.5) | 25.6 (8.9) | 0.001 | 33.7 (11.1) | 31.1 (10.8) | 0.05 | 0.04 |
| ACR, mg/mmolb | 1512 (793–2704) | 2830 (1084–4364) | 0.06 | 1414 (731–2444) | 1718 (906–2664) | 0.11 | 0.26 |
| Disease history | |||||||
| Heart failure | 44 (10.0) | 5 (26.3) | 0.04 | 73 (8.6) | 23 (25.8) | <0.001 | 0.61 |
| Cardiovascular diseasec | 130 (29.5) | 8 (42.1) | 0.31 | 221 (26.2) | 43 (48.3) | <0.001 | 0.31 |
| Edema | 58 (13.2) | 4 (21.1) | 0.31 | 115 (13.6) | 14 (15.7) | 0.63 | 0.42 |
| Medication at baseline | |||||||
| ACEI | 264 (60.0) | 10 (52.6) | 0.63 | 539 (63.9) | 55 (61.8) | 0.73 | 0.83 |
| ARB | 202 (45.9) | 7 (36.8) | 0.49 | 389 (46.1) | 44 (49.4) | 0.58 | 0.26 |
| ACEI+ARB | 65 (14.8) | 2 (10.5) | 1.00 | 150 (17.8) | 17 (19.1) | 0.77 | 0.52 |
| CCB | 242 (55.0) | 12 (63.2) | 0.64 | 440 (52.1) | 56 (62.9) | 0.06 | 0.77 |
| β-Blockers | 199 (45.2) | 13 (68.4) | 0.06 | 372 (44.1) | 48 (53.9) | 0.09 | 0.33 |
| Diuretics | 282 (64.1) | 16 (84.2) | 0.09 | 547 (64.8) | 71 (79.8) | 0.004 | 0.64 |
| Loop diuretics | 197 (44.8) | 12 (63.2) | 0.16 | 380 (45.0) | 57 (64.0) | 0.001 | 0.98 |
| Other diuretics | 85 (19.3) | 4 (21.1) | 0.77 | 167 (19.8) | 14 (15.7) | 0.40 | 0.63 |
| Statin | 255 (58.0) | 9 (47.4) | 0.48 | 442 (52.4) | 58 (65.2) | 0.03 | 0.06 |
| Sulfonylurea | 153 (34.8) | 5 (26.3) | 0.62 | 284 (33.6) | 23 (25.8) | 0.16 | 0.98 |
| Glitazone | 50 (11.4) | 2 (10.5) | 1.00 | 88 (10.4) | 10 (11.2) | 0.86 | 0.87 |
| Insulin | 281 (63.9) | 14 (73.7) | 0.47 | 559 (66.2) | 71 (79.8) | 0.01 | 0.60 |
Data are presented as n (%) or median (interquartile range). Comparison testing was performed with Wilcoxon rank-sum tests for continuous variables and Fisher exact tests for dichotomous variables. CHF, congestive heart failure; eGFR, estimated GFR; ACR, albumin-to-creatinine ratio; ACEI, angiotensin converting enzyme inhibitor; ARB angiotensin receptor blocker; CCB, calcium channel blocker.
a
P value for interaction term on the base of an unadjusted Cox regression that also includes main terms.
b
ACR values are log-normalized for testing purposes.
c
History of cardiovascular disease includes coronary artery disease, myocardial infarction, cerebrovascular accidents.