Table 2.
Comparison of the demographics and baseline clinical variables of those with and without adverse events
| Characteristic | AEs present (n = 110) | AEs absent (n = 261) | p value |
|---|---|---|---|
| Demographics | |||
| Age at risperidone commencement, years | 7.8 (5.9–10.3) | 7.9 (5.9–10.2) | 0.830a |
| Sex | 0.097b | ||
| Male | 87 (79.8) | 184 (70.0) | |
| Female | 23 (20.2) | 77 (30.0) | |
| Race | 0.030 b | ||
| African-American | 11 (9.6) | 36 (13.7) | |
| Asian/Pacific Island | 1 (0.9) | 7 (2.6) | |
| Caucasian | 92 (84.5) | 216 (83.0) | |
| Native American | 1 (0.9) | 1 (0.4) | |
| Unknown | 5 (4.4) | 1 (0.4) | |
| Ethnicity | 0.652b | ||
| Non-Hispanic | 104 (94.7) | 252 (96.4) | |
| Hispanic | 3 (2.6) | 5 (1.9) | |
| Unknown | 3 (2.6) | 4 (1.5) | |
| Diagnoses | |||
| Presence of comorbid conditions | 0.638b | ||
| Yes | 43 (38.6) | 94 (37.0) | |
| No | 67 (61.4) | 167 (63.0) | |
| Specific comorbidities | |||
| Seizure disorder | 14 (13.2) | 44 (17.4) | 0.351c |
| Asthma | 7 (6.1) | 27 (10.7) | 0.324c |
| Specific psychiatric diagnoses | |||
| Attention deficit hyperactivity disorder | 47 (43.9) | 113 (42.2) | 0.822c |
| Autism | 35 (30.7) | 67 (24.8) | 0.256c |
| Specific indications for risperidone use | |||
| Aggression | 59 (52.6) | 107 (40.0) | 0.030 c |
| Behavioral problems | 30 (28.0) | 84 (32.2) | 0.389c |
| Agitation | 25 (22.8) | 44 (17.8) | 0.191c |
| Irritability | 33 (28.9) | 52 (19.3) | 0.042 c |
| Self-injurious behaviors | 37 (33.3) | 31 (11.5) | < 0.001 c |
| Risperidone prescribing | |||
| Starting dose of risperidone (mg/day) | 0.50 (0.47–1.00) | 0.50 (0.25–1.00) | 0.975a |
| Starting dose frequency (doses/day) | 0.069b | ||
| Once | 48 (48.6) | 112 (43.0) | |
| Two times | 44 (39.5) | 126 (48.1) | |
| Three times | 9 (8.8) | 15 (5.9) | |
| Four times | 8 (7.0) | 4 (1.5) | |
| Five times | 0 (0.0) | 1 (0.4) | |
| Six times | 1 (0.9) | 3 (1.1) | |
| One or more dose modification | < 0.001 c | ||
| Yes | 80 (72.8) | 98 (37.8) | |
| No | 30 (27.2) | 163 (62.6) | |
| Type of dose modification | < 0.001 b | ||
| Increased dose | 33 (30.7) | 61 (24.1) | |
| Decreased dose | 5 (4.4) | 7 (2.6) | |
| Drug discontinuation | 42 (37.7) | 30 (11.1) | |
| No modification | 30 (21.2) | 163 (62.2) | |
| On- and off-label use of risperidone | 0.072b | ||
| On-label | 34 (29.8) | 60 (22.2) | |
| Off-label | 76 (70.2) | 201 (77.8) | |
| Concomitant medications | |||
| Number of co-prescribed drugs | 0.099b | ||
| One | 10 (8.8) | 25 (10.7) | |
| Two | 24 (21.1) | 45 (16.7) | |
| Three | 34 (30.7) | 62 (23.3) | |
| Four | 22 (19.3) | 43 (16.7) | |
| Five | 9 (8.8) | 27 (10.7) | |
| Six and above | 9 (9.6) | 50 (20.0) | |
| None | 2 (1.8) | 9 (3.3) | |
| Type or class of co-prescribed drug | |||
| α2-agonist | 40 (36.8) | 104 (40.0) | 0.561c |
| Anticonvulsant | 37 (33.3) | 84 (33.0) | 0.809c |
| Antidepressant | 48 (43.9) | 97 (36.3) | 0.247c |
| Psychostimulant | 37 (33.3) | 104 (38.5) | 0.293c |
| Analgesic | 6 (7.0) | 44 (17.8) | 0.003 c |
| Antiulcer | 21 (19.3) | 72 (28.9) | 0.090c |
| Hypnotic | 33 (28.9) | 62 (24.4) | 0.241c |
| Antibiotic | 2 (3.5) | 32 (13.2) | 0.001 c |
| Orexigenicd | 13 (11.4) | 41 (15.9) | 0.420c |
| Antihistamine | 14 (13.2) | 55 (20.7) | 0.079c |
Data are presented as n (%) or median (interquartile range) unless otherwise indicated
Significant p values (< 0.05) are in bold
AE adverse event
ap value from Mann–Whitney U test
bp value from Pearson Chi-squared test
cp value from Fisher’s exact test
dMirtazapine, amitriptyline, gabapentin, pregabalin, cyproheptadine, olanzapine, quetiapine, dexamethasone, prednisone, and hydrocortisone