Table 1.
Baseline characteristics and PP1M dosing (N = 472)
| Patients switched to PP1M from | ARI | OLA | Pali ER | QUE | RIS | p value |
|---|---|---|---|---|---|---|
| ITT population, n | 46 | 87 | 104 | 44 | 191 | |
| Mean age, years (SD) | 34.4 (9.4) | 36.8 (11.6) | 37.7 (11.7) | 40.8 (11.7) | 38.7 (12.5) | 0.0773a |
| Male, % | 73.9 | 67.8 | 70.2 | 50.0 | 61.8 | 0.0861b |
| Mean age at diagnosis, years (SD) | 27.6 (6.7) | 28.4 (9.7) | 29.0 (9.5) | 30.7 (10.3) | 30.7 (10.4) | |
| Diagnosis of paranoid schizophrenia, % | 78.3 | 79.3 | 81.7 | 72.7 | 74.9 | |
| Mean baseline weight, kg (SD) | 89.1 (22.1) | 79.8 (16.4) | 80.0 (17.3) | 80.4 (16.0) | 79.7 (17.3) | 0.1018a |
| Mean baseline BMI, kg/m2 (SD; range) | 29.9 (7.5; 17, 51) | 27.2 (6.1; 18, 46) | 27.0 (5.5; 17, 51) | 28.1 (5.3; 18, 39) | 27.0 (5.5; 17, 54) | 0.1120a |
| Patients with ≥1 comorbidity, %c | 78.3 | 63.2 | 58.7 | 52.3 | 59.2 | |
| Number of previous hospitalizations, % | ||||||
| None | 10.9 | 18.4 | 21.2 | 18.2 | 19.9 | |
| 1–3 | 45.7 | 47.1 | 35.6 | 36.4 | 48.7 | |
| ≥4 | 43.5 | 34.5 | 43.3 | 45.5 | 31.4 | |
| Patients with diagnosed substance abuse (with or without impairment), % | 9.8 | 10.5 | 6.4 | 5.4 | 11.1 | |
| Mean daily dose of prior antipsychotic, mg (SD) | 22.7 (10.7) | 15.6 (8.2) | 7.6 (2.6) | 482.4 (277.1) | 4.3 (2.3) | |
| Patients receiving PP1M initiation regimen at day 1 and day 8 according to label, %d | 93.5 | 95.4 | 92.3 | 97.7 | 96.3 | |
| Mean modal PP1M maintenance dose, mg eq (SD)e | 94.9 (35.0) | 104.2 (33.6) | 100.5 (32.3) | 105.0 (36.8) | 98.9 (32.3) | |
| Last PP1M dose received, % of patients | ||||||
| 50 mg eq | 19.6 | 6.9 | 8.7 | 13.6 | 8.4 | |
| 75 mg eq | 19.6 | 32.2 | 32.7 | 15.9 | 35.1 | |
| 100 mg eq | 30.4 | 31.0 | 35.6 | 40.9 | 33.0 | |
| 150 mg eq | 30.4 | 29.9 | 23.1 | 29.5 | 23.6 | |
| Relevant co-medications | ||||||
| Number (%) of patients using benzodiazepines | ||||||
| At baseline | 12 (26.1) | 25 (28.7) | 28 (26.9) | 9 (20.5) | 39 (20.4) | |
| Newly initiated during study | 11 (23.9) | 21 (24.1) | 26 (25.0) | 14 (31.8) | 30 (15.7) | |
| At endpoint | 12 (26.1) | 21 (24.1) | 21 (20.2) | 8 (18.2) | 36 (18.8) | |
| At 6 months for completersf | 9 (29.0) | 10 (17.5) | 15 (18.1) | 6 (18.8) | 29 (18.2) | |
| Number (%) of patients using anticholinergics | ||||||
| At baseline | 2 (4.3) | 8 (9.2) | 10 (9.6) | 4 (9.1) | 23 (12.0) | |
| Newly initiated during study | 2 (4.3) | 9 (10.3) | 7 (6.7) | 4 (9.1) | 14 (7.3) | |
| At endpoint | 2 (4.3) | 8 (9.2) | 5 (4.8) | 4 (9.1) | 14 (7.3) | |
| At 6 months for completersf | 2 (6.5) | 5 (8.8) | 4 (4.8) | 2 (6.3) | 12 (7.5) | |
ARI aripiprazole, BMI body mass index, ITT intent to treat, OLA olanzapine, Pali ER paliperidone extended-release, PP1M once-monthly paliperidone palmitate, QUE quetiapine, RIS risperidone, SD standard deviation. p values indicate differences between prior oral antipsychotic treatment subgroups
aKruskal–Wallis test
bFisher’s exact test
cIndividual patients can be labelled for >1 comorbidity
dThe recommended initiation regimen was PP1M 150 mg eq on day 1 and 100 mg eq on day 8, given in the deltoid muscle
eExcluding the initiation regimen (day 1/day 8)
fARI n = 31; OLA n = 57; Pali ER n = 83; QUE n = 32; RIS n = 159