Adverse reactions in ≥2% of patients in a 12-week, double-blind, placebo-controlled study
Percentage of patients reporting reaction* | |||
---|---|---|---|
System Organ Class | Preferred Term | Abilify Maintena (n=167) | Placebo (n=172) |
Gastrointestinal Disorders | Constipation | 10 | 7 |
Dry mouth | 4 | 2 | |
Diarrhea | 3 | 2 | |
Vomiting | 3 | 1 | |
Abdominal discomfort | 2 | 1 | |
General disorders and administration site conditions | Injection site pain | 5 | 1 |
Infections and infestations | Upper respiratory tract infection | 4 | 2 |
Investigations | Increased weight | 17 | 7 |
Decreased weight | 4 | 2 | |
Musculoskeletal and connective tissue disorders | Arthralgia | 4 | 1 |
Back pain | 4 | 2 | |
Myalgia | 4 | 2 | |
Musculoskeletal pain | 3 | 1 | |
Nervous system disorders | Akathisia | 11 | 4 |
Sedation | 5 | 1 | |
Dizziness | 4 | 2 | |
Tremor | 3 | 1 | |
Respiratory, thoracic, and mediastinal | Nasal congestion | 2 | 1 |
*Table excludes adverse reactions that had an incidence ≤ placebo.
Adverse reactions with an incidence ≥5% of patients and at least twice that for placebo
on ABILIFY MAINTENA or placebo discontinued due to these 4 adverse reactions1
0
patients
In a 12-week study, 4.2% of patients on ABILIFY MAINTENA discontinued due to all adverse reactions vs 7.6% with placebo2
The following safety information is derived from a 12-week, double-blind study in patients with schizophrenia.1
Prolactin and extrapyramidal symptoms (EPS) in schizophrenia1
ABILIFY MAINTENA 400 mg | Placebo | ||
---|---|---|---|
PROLACTIN1,2 | Mean change from baseline to Week 12, ng/mL (SD) (P=0.0176)† | -6.4 (13.5) | -1.1 (14.5) |
Potentially clinically revelant prolactin levels (>1x upper limit of normal)—any post-baseline visit, % (n/N)‡ | 2.8% (4/142) | 11.4% (16/140) | |
ADVERSE REACTION1,2 | Incidence of EPS-related events, excluding akathisia, % (n/N) | 9.6% (16/167) | 5.2% (9/172) |
†ABILIFY MAINTENA, N=99; placebo, N=66.
‡Incidence for ABILIFY MAINTENA vs placebo in female subjects (6.3% vs 13.8%) and male subjects (1.8% vs 10.8%).1
n=number of patients with event; N=number of patients treated; SD=standard deviation.
Metabolic safety profile in schizophrenia
METABOLIC MEASURE1 | ABILIFY MAINTENA 400 mg | Placebo | |
---|---|---|---|
Glucose | % (n/N) of patients who shifted from normal to high (<100 mg/dL to ≥126 mg/dL) | 8.0% (7/88) | 0.0% (0/75) |
TOTAL CHOLESTEROL | % (n/N) of patients who shifted from normal to high (<200 mg/dL to ≥240 mg/dL) | 3.6% (3/83) | 2.7% (2/73) |
LDL CHOLESTEROL | % (n/N) of patients who shifted from normal to high (<200 mg/dL to ≥240 mg/dL) | 1.7% (1/59) | 2.0% (1/51) |
HDL CHOLESTEROL | % (n/N) of patients who shifted from normal to low (≥40 mg/dL to <40 mg/dL) | 13.5% (14/104) | 12.6% (11/87) |
TRIGLYCERIDES | % (n/N) of patients who shifted from normal to low (≥40 mg/dL to <40 mg/dL) | 7.1% (7/98) | 5.1% (4/78) |
WEIGHT GAIN | Mean change from baseline to Week 12, kg | +3.5 | +0.8 |
Weight gain ≥7% of body weight, % (n/N) | 21.5% (31/144) | 8.5% (12/141) |
HDL=high-density lipoprotein; LDL=low-density lipoprotein.
ABILIFY MAINTENA has been evaluated for safety in multiple studies in more than 800 adult patients living with bipolar I disorder
The following safety information was derived from a 52-week, open-label study in patients with bipolar I disorder initiated on ABILIFY MAINTENA.
Metabolic safety profile in bipolar I disorder
metabolic measure | ||
---|---|---|
GLUCOSE | % of patients who experienced a shift from normal to high fasting glucose | 1.1% |
% of patients who experienced a shift from borderline to high fasting glucose | 9.8% | |
% of patients who experienced shifts from normal to borderline to high fasting glucose | 2.9% | |
TOTAL CHOLESTEROL | % of patients who experienced a shift from normal to high fasting cholesterol | 2.1% |
LDL CHOLESTEROL | % of patients who experienced a shift from normal to high fasting cholesterol | 2.2% |
HDL CHOLESTEROL | % of patients who experienced a shift from normal to low fasting cholesterol | 8.5% |
TRIGLYCERIDES | % of patients who experienced a shift from normal to high fasting triglycerides | 3.6% |
% of patients who experienced a shift from normal to very high fasting triglycerides | 0.0% | |
% of patients who experienced a shift from normal or borderline to very high fasting triglycerides | 1.0% |
These safety data are from those patients who were initiated on ABILIFY MAINTENA during a 52-week, open-label study but did not participate in the 52-week, double-blind study.
- In those patients who initiated ABILIFY MAINTENA, 1.8% discontinued ABILIFY MAINTENA treatment due to weight increase
- ABILIFY MAINTENA was associated with mean increase in weight from baseline of 1.0 kg at Week 52
- 21.4% of these patients demonstrated a ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight
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References: 1. Data on file. ABIMAI-124. 2. Kane JM, Peters-Strickland T, Baker RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260.