Table 1.
Demographic and Baseline Characteristics for the RCT
| Characteristic | MNTX 8 mg or 12 mg QOD (n=116) | Placebo (n=114) |
|---|---|---|
| Age, years, mean (SD) | 65.3 (12.9) | 65.7 (13.0) |
| Sex, n (%) | ||
| Male | 60 (51.7) | 58 (50.9) |
| Female | 56 (48.3) | 56 (49.1) |
| Race, n (%) | ||
| White | 108 (93.1) | 108 (94.7) |
| Black | 5 (4.3) | 3 (2.6) |
| Other | 3 (2.6) | 3 (2.7) |
| Primary diagnosis, n (%) | ||
| Cancer | 79 (68.1) | 73 (64.0) |
| Pulmonary disease | 14 (12.1) | 13 (11.4) |
| Cardiovascular disease | 13 (11.2) | 11 (9.6) |
| Neurologic disease | 4 (3.4) | 3 (2.6) |
| Other | 6 (5.2) | 14 (12.3) |
| Duration of underlying advanced illness, years, mean (SD) | 4.2 (6.0) | 5.0 (7.0) |
| Morphine equivalent, mg/d | ||
| Mean (SD) | 369.5 (656.8) | 404.6 (887.6) |
| Median (range) | 180.0 (4.5–4427.0) | 160.8 (9.0–7228.6) |
| Weight category, n (%) | ||
| <62 kg | 45 (38.8) | 41 (36.0) |
| ≥62 kg | 71 (61.2) | 73 (64.0) |
| Weight, kg | ||
| Mean (SD) | 72.2 (20.8) | 73.4 (24.1) |
| Median (range) | 68.0 (38.1–158.8) | 68.5 (38.6–225.9) |
| Duration of OIC, weeks, mean (SD) | 75.1 (152.9) | 78.1 (227.4) |
| Number of BMs in the last seven days before first dose, mean (SD) | 1.7 (0.9) | 1.7 (0.9) |
| Prior laxative use, n (%)a | ||
| Any laxative | 116 (100.0) | 114 (100.0) |
| Docusate sodium with senna | 40 (34.5) | 36 (31.6) |
| Bisacodyl | 34 (29.3) | 40 (35.1) |
| Lactulose | 32 (27.6) | 26 (22.8) |
| Polyethylene glycol 3350 | 28 (24.1) | 30 (26.3) |
| Docusate sodium | 21 (18.1) | 25 (21.9) |
| Magnesium hydroxide | 19 (16.4) | 22 (19.3) |
| Sodium phosphate enema | 13 (11.2) | 10 (8.8) |
| Senna | 12 (10.3) | 22 (19.3) |
| Concomitant laxative use, n (%)a | ||
| Any laxative | 107 (92.2) | 111 (97.4) |
| Docusate sodium with senna | 38 (32.8) | 37 (32.5) |
| Docusate sodium | 18 (15.5) | 28 (24.6) |
| Senna | 16 (13.8) | 27 (23.7) |
| Bisacodyl | 14 (12.1) | 24 (21.1) |
| Polyethylene glycol 3350 | 21 (18.1) | 23 (20.2) |
| Lactulose | 20 (17.2) | 20 (17.5) |
a
Patients could have taken ≥1 laxative.
BM, bowel movement; MNTX, methylnaltrexone; OIC, opioid-induced constipation; QOD, every other day; RCT, randomized, placebo-controlled trial; SD, standard deviation.