Table 1.
Baseline Demographics and Medical Characteristics (Integrated Safety and Intent-to-Treat Populations)
| Attribute | Safety Population (COMPOSE-1/COMPOSE-2/COMPOSE-3) | Intent-to-Treat Population (COMPOSE-1/COMPOSE-2) | ||
|---|---|---|---|---|
| Naldemedine 0.2 mg/day (n=1163) | Placebo (n=1165) | Naldemedine 0.2 mg/day (n=549) | Placebo (n=546) | |
| Mean age, years (SD) | 53.6 (11.1) | 52.9 (10.9) | 53.7 (10.5) | 53.1 (11.2) |
| Female, % (n) | 60.6 (705) | 63.3 (738) | 59.4 (326) | 61.5 (336) |
| Mean BMI, kg/m2 (SD) | 31.5 (7.4)a | 31.4 (7.4)a | 31.4 (7.2) | 31.3 (7.2) |
| Region, % (n) | ||||
| North America | 85.8 (998) | 86.4 (1007) | 85.8 (471) | 85.7 (468) |
| Rest of world | 14.2 (165) | 13.6 (158) | 14.2 (78) | 14.3 (78) |
| Race, % (n) | ||||
| White | 79.4 (924) | 80.9 (943) | 79.8 (438) | 81.9 (447) |
| Black | 19.0 (221) | 16.7 (195) | 18.6 (102) | 15.9 (87) |
| Other | 1.5 (18) | 2.3 (27) | 1.6 (9) | 2.2 (12) |
| Opioid use | ||||
| Mean duration of opioid use, months (SD) | 61.8 (65.4) | 58.1 (56.4) | 61.1 (61.7) | 59.2 (57.1) |
| Mean daily opioid dose, MED, mg (SD) | 122.2 (134.5) | 126.1 (157.3) | 131.8 (150.0) | 126.7 (135.8) |
| Patients with daily opioid dose, % (n) | ||||
| <30 mg | 1.4 (16) | 1.2 (14) | 1.1 (6) | 0.5 (3) |
| 30 to 100 mg | 59.1 (687) | 58.2 (678) | 56.8 (312) | 56.6 (309) |
| >100 mg to ≤200 mg | 23.0 (268) | 24.4 (284) | 25.3 (139) | 24.7 (135) |
| >200 mg to ≤400 mg | 12.6 (147) | 11.5 (134) | 13.1 (72) | 13.4 (73) |
| >400 mg | 3.9 (45) | 4.7 (55) | 3.6 (20) | 4.8 (26) |
| Mean duration of treatment exposure, days (SD) | 76.6 (20.8) | 77.2 (18.9) | 77.5 (22.0) | 77.9 (20.4) |
| Mean eGFRb, mL/min/1.73 m2 (SD) | 85.2 (21.9) | 85.0 (21.2) | 85.0 (22.0) | 85.1 (21.5) |
| eGFRb, % (n) | ||||
| ≥90 mL/min/1.73 m2 (normal) | 37.4 (435) | 39.7 (463) | 35.7 (196) | 40.1 (219) |
| ≥60 to <90 mL/min/1.73 m2 (mild RI) | 51.1 (594) | 49.2 (573) | 53.2 (292) | 48.9 (267) |
| ≥30 to <60 mL/min/1.73 m2 (moderate RI) | 11.4 (133) | 10.9 (127) | 11.1 (61) | 11.0 (60) |
| <30 mL/min/1.73 m2 (severe RI)c | 0.1 (1) | 0.2 (2) | 0 (0) | 0 (0) |
Notes: an=1162. bCalculated by the Modification of Diet in Renal Disease equation. cPatients with severe renal impairment are not included in safety or efficacy analyses due to small sample size.
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; MED, morphine equivalent dose; RI, renal impairment; SD, standard deviation.