Table 1.
Baseline characteristics (per protocol population)
| Baseline characteristics | Treatment (n = 58) | Control (n = 73) | Pooled 24 months* (n = 109) | Pooled 36 months† (n = 60) |
|---|---|---|---|---|
| Age (years) | 63 ± 12 | 64 ± 14 | 64 ± 13 | 64 ± 13 |
| Men | 51 (88%) | 68 (93%) | 99 (91%) | 52 (87%) |
| White | 57 (98%) | 69 (95%) | 106 (97%) | 58 (97%) |
| Body mass index (kg/m2) | 30 ± 5 | 31 ± 7 | 31 ± 6 | 32 ± 6 |
| Neck circumference (cm) | 42 ± 5 | 43 ± 5 | 43 ± 5 | 42 ± 5 |
| Heart rate (beats per minute) | 76 ± 13 | 73 ± 14 | 75 ± 14 | 76 ± 15 |
| Systolic blood pressure (mm Hg) | 124 ± 18 | 124 ± 18 | 126 ± 18 | 126 ± 18 |
| Diastolic blood pressure (mm Hg) | 74 ± 11 | 75 ± 12 | 76 ± 11 | 76 ± 10 |
| Respiration rate (breaths per minute) | 18 ± 3 | 17 ± 3 | 17 ± 3 | 17 ± 3 |
| AHI (events/hour) | 50 ± 19 | 44 ± 17 | 47 ± 19 | 48 ± 19 |
| CAI (events/hour) | 32 ± 19 | 26 ± 16 | 29 ± 17 | 29 ± 17 |
| OAI (events/hour) | 2 ± 2 | 2 ± 3 | 2 ± 3 | 3 ± 3 |
| MAI (events/hour) | 3 ± 4 | 2 ± 3 | 3 ± 4 | 3 ± 4 |
| HI (events/hour) | 13 ± 11 | 13 ± 12 | 13 ± 12 | 15 ± 13 |
| Percent of sleep with oxygen saturation <90% (%) | 17 ± 18 | 11 ± 12 | 14 ± 16 | 16 ± 18 |
| Oxygen desaturation ≥4% index (events/hour) | 44 ± 22 | 37 ± 18 | 41 ± 20 | 42 ± 20 |
| Epworth Sleepiness Scale (points) | 11 ± 5 | 9 ± 6 | 10 ± 6 | 10 ± 5 |
| Atrial fibrillation | 22 (38%) | 29 (40%) | 39 (36%) | 19 (32%) |
| LVEF ≤ 45% | 32/57 (56%) | 42/70 (60%) | 59/106 (56%) | 34/60 (57%) |
| HF | 35 (60%) | 45 (62%) | 62 (57%) | 32 (53%) |
| New York Heart Association class | ||||
| I | 5 (9%) | 12 (16%) | 15 (14%) | 11 (18%) |
| II | 14 (24%) | 20 (27%) | 27 (25%) | 16 (27%) |
| III | 16 (28%) | 13 (18%) | 20 (18%) | 5 (8%) |
| IV | 0% | 0% | 0% | 0% |
| Coronary artery disease | 33 (57%) | 42 (58%) | 61 (56%) | 33 (55%) |
| Hypertension | 42 (72%) | 55 (75%) | 79 (72%) | 41 (68%) |
| Diabetes mellitus | 20 (34%) | 17 (23%) | 31 (28%) | 18 (30%) |
| Prior stroke | 4 (7%) | 5 (7%) | 7 (6%) | 4 (7%) |
| Renal impairment | 11 (19%) | 20 (27%) | 23 (21%) | 9 (15%) |
| Concomitant cardiac devices | 24 (41%) | 30 (41%) | 40 (37%) | 20 (33%) |
| Implantable cardioverter defibrillator | 14 (24%) | 13 (18%) | 20 (18%) | 12 (20%) |
| Cardiac resynchronization therapy defibrillator | 8 (14%) | 9 (12%) | 11 (10%) | 4 (6%) |
| Noncardiac resynchronization therapy pacemaker | 2 (3%) | 8 (11%) | 9 (8%) | 4 (6%) |
| Medications | ||||
| Angiotensin-converting enzyme inhibitor | 28 (48%) | 35 (48%) | 52 (48%) | 29 (48%) |
| Angiotensin receptor blocker | 9 (16%) | 13 (18%) | 17 (16%) | 8 (13%) |
| Aldosterone-blocking agent | 25 (43%) | 17 (23%) | 30 (28%) | 12 (20%) |
| Beta-blocker | 36 (62%) | 47 (64%) | 66 (61%) | 36 (60%) |
| Loop diuretic | 26 (45%) | 26 (36%) | 40 (37%) | 18 (30%) |
| Thiazide diuretic | 15 (26%) | 16 (22%) | 23 (21%) | 8 (13%) |
| Thiazide-like diuretic | 5 (9%) | 2 (3%) | 6% (6) | 4 (7%) |
| Antiarrhythmic | 4 (7%) | 7 (10%) | 8 (7%) | 2 (3%) |
| Digoxin | 10 (17%) | 12 (16%) | 17 (16%) | 8 (13%) |
Continuous variables reported as mean ± SD and categorical display n (percent).
*24-month visit represents 24 months of therapy for treatment and 18 for former control.
†The 36-month visit represents 36 months of therapy for treatment and 30 months for former control; 33 subjects remaining in the trial at time of FDA approval and study closure had not reached the 36-month visit.