Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis

Figures & data

Figure 1. Study design. *Patients who were already receiving oral aripiprazole treatment entered the open-label treatment phase (Phase B) without entering the oral conversion phase (Phase A).

Figure 2. Patient disposition during the prospective period. *Patients met withdrawal criteria, were withdrawn by the study investigator, or had a protocol deviation. AE = adverse event.

Table 1. Demographics and baseline characteristics by study phase.

	Phase A (n = 325)	Phase B (n = 433)
Age, mean (SD), years	42.7 (11.9)	42.1 (12.0)
Men/women, n	239/86	301/132
Body weight, mean (SD), kg*	90.6 (20.9)	91.2 (21.2)
BMI, mean (SD), kg/m^2*	30.4 (6.9)	30.8 (7.1)
Race, n (%)
White	150 (46.2)	216 (49.9)
Black	159 (48.9)	198 (45.7)
American Indian or Alaska Native	2 (0.6)	3 (0.7)
Asian	8 (2.5)	10 (2.3)
Other	6 (1.8)	6 (1.4)
Ethnicity
Hispanic or Latino	77 (23.7)	94 (21.7)
Not Hispanic or Latino	248 (76.3)	339 (78.3)
PANSS total score, mean (SD)†	N/A	75.0 (18.3)
Conceptual disorganization (P2)		2.8 (1.2)
Suspiciousness (P6)		3.2 (1.1)
Hallucinatory (P3)		3.0 (1.4)
Unusual thought content (G9)		2.6 (1.1)
CGI severity score, mean (SD)‡	N/A	3.7 (0.8)
Age at first diagnosis, mean (SD), years§	26.8 (10.7)	26.7 (10.5)

BMI, body mass index; CGI, Clinical Global Impressions; N/A, not available; PANSS, Positive and Negative Syndrome Scale.

*n = 312 (Phase A), n = 422 (Phase B).

†n = 427 (Phase B).

‡n = 425 (Phase B).

§n = 318 (Phase A), n = 427 (Phase B).

Data represent all patients who enrolled in each study phase.

Figure 3. Total psychiatric hospitalization rates following the switch to aripiprazole once-monthly 400 mg (prospective) compared with the same patients treated with oral antipsychotics (retrospective). P value derived from exact McNemar test. AOM 400 = aripiprazole once-monthly 400 mg.

Table 2. Hospitalization data.

	Retrospective months –4 to –1 (n = 336)	Prospective months 4–6 (n = 336)
Inpatient psychiatric hospitalizations
Total number of events/patients with event	104/91	10/9
Mean cumulative duration (range), days	11.1 (2–57)	7.0 (2–16)
Inpatient hospitalizations for psychosocial reasons
Total number of events/patients with event	7/7	0/0
Mean number of events per patient (range)	1.0 (1–1)	–
Mean cumulative duration (range), days	15.6 (4–31)	–
Psychiatric partial hospitalizations
Total number of events/patients with event	2/2	0/0
Mean number of events per patient (range)	1 (1–1)	–
Mean cumulative duration (range), days	5.9 (0.4–11.4)	–
Psychiatric intensive outpatient programs
Total number of events/patients with event	4/4	0/0
Mean number of events per patient (range)	1 (1–1)	–
Psychiatric ER visits
Total number of events/patients with event	34/23	4/4
Mean number of events per patient (range)	1.5 (1–5)	1 (1–1)

ER, emergency room; n, number of patients.

Table 3. Incidence of treatment-emergent adverse events occurring in ≥2% of all patients treated in phase B (n = 431).

Adverse event	n (%)
Insomnia	29 (6.7)
Akathisia	28 (6.5)
Psychotic disorder	21 (4.9)
Schizophrenia	20 (4.6)
Injection-site pain	19 (4.4)
Anxiety	17 (3.9)
Back pain	15 (3.5)
Headache	14 (3.2)
Schizophrenia, paranoid type	14 (3.2)
Hallucination, auditory	13 (3.0)
Tremor	13 (3.0)
Sedation	12 (2.8)
Nausea	11 (2.6)
Depression	10 (2.3)
Diarrhea	10 (2.3)
Somnolence	10 (2.3)
Suicidal ideation	10 (2.3)
Weight increased	10 (2.3)
Dizziness	9 (2.1)
Toothache	9 (2.1)

Data represent patients from the Phase B safety population, patients receiving ≥1 dose of study medication in the corresponding study phase. Treatment-emergent adverse events were defined as adverse events that occurred after the start of study drug treatment, or if the event was continuous from baseline and was serious, study drug related, or resulted in death, discontinuation, interruption, or reduction of study therapy.

Table 4. Incidence of potentially clinically relevant treatment-emergent changes in lipids, prolactin levels, and weight in phase B (n = 431).

Parameter	Number examined*	n†(%)
Total fasting cholesterol ≥240 mg/dL	350	46 (13.1)
Fasting LDL cholesterol ≥160 mg/dL	344	35 (10.2)
Fasting HDL cholesterol ≤30 mg/dL	350	12 (3.4)
Fasting triglycerides ≥120 mg/dL (women) or ≥160 mg/dL (men)	350	134 (38.3)
Fasting glucose ≥115 mg/dL	350	70 (20.0)
Prolactin level >1 × ULN	375	15 (4.0)
Weight gain ≥7%	359	22 (6.1)
Weight loss ≥7%	359	25 (7.0)

HDL, high-density lipoprotein; LDL, low-density lipoprotein; ULN, upper limit of normal.

*Total number of patients with baseline value and ≥1 post-baseline value in Phase B.

†n = number of patients with a potentially clinically relevant change; the denominator for percentage calculation is number examined.