TABLE 1.
Baseline demographic and clinical characteristics of patients
| Variable | Nonrandomly assigned patients, acute phase only* (n=63) | Maintenance phase
|
||
|---|---|---|---|---|
| COT (n=137) | ODT (n=131) | Total (n=331) | ||
| Sex – female, n (%) | 38 (60) | 63 (46) | 70 (53) | 171 (52) |
| Race – Caucasian, n (%) | 59 (94) | 134 (98) | 124 (95) | 317 (96) |
| Mean age, years (SD) | 48 (11.5) | 49 (11.0) | 47 (11.0) | 48 (11.1) |
| Mean body mass index, kg/m2 (SD) | 30 (10.3) | 30 (5.9) | 30 (6.8) | 30 (6.4) |
| Risk factors | ||||
| Alcohol: none to moderate (≤2 units/day) consumption, n (%) | 61 (97) | 134 (98) | 129 (98) | 324 (98) |
| Smokers, n (%) | 15 (24) | 28 (20) | 36 (28) | 79 (24) |
| Heartburn duration, n (%): | ||||
| 0–3 months | – | 3 (2) | – | 3 (1) |
| 3–6 months | 2 (3) | 6 (4) | 6 (5) | 14 (4) |
| 6–12 months | 4 (6) | 8 (6) | 7 (5) | 19 (6) |
| >12 months | 56 (89) | 120 (88) | 118 (90) | 294 (89) |
| Heartburn severity†, n (%) | ||||
| None (no heartburn) | 27 (43) | 89 (65) | 75 (57) | 191 (58) |
| Mild | 14 (22) | 23 (17) | 37 (28) | 74 (22) |
| Moderate | 19 (30) | 25 (18) | 19 (15) | 63 (19) |
| Severe | 1 (2) | 0 | 0 | 1 (0.3) |
| Very severe | 0 | 0 | 0 | 0 |
| Duration of proton pump inhibitor therapy, mean months (SD) | 16.3 (24.3) | 17.6 (23.5) | 17.6 (23.0) | 17.4 (23.4) |
| Proton pump inhibitor therapy at study entry, n (%) | ||||
| Esomeprazole | 20 (32) | 36 (26) | 38 (29) | 94 (28) |
| Rabeprazole | 15 (24) | 33 (24) | 35 (27) | 83 (25) |
| Omeprazole | 12 (19) | 27 (20) | 18 (14) | 57 (17) |
| Pantoprazole | 9 (14) | 31 (23) | 26 (20) | 66 (20) |
| Lansoprazole | 6 (10) | 10 (7) | 14 (11) | 30 (9) |
*
Received rabeprazole in the acute phase, but was not randomized to the maintenance phase;
†
Based on the maximum reported severity at baseline. COT Continuous therapy; ODT On-demand therapy