Key result
Aripiprazole administration resulted in a significantly higher number of adverse drug reactions compared to olanzapine (91 vs 60, p<0.035), though olanzapine induced more initial cardiovascular changes.
Why the study?
This study was conducted to assess adverse events and safety of aripiprazole and olanzapine treatment.
Does multiple-dose administration of aripiprazole compared to olanzapine affect cardiovascular safety and adverse events in healthy volunteers?
RCT (n=24)
Open-label
Block randomization
No
Does multiple-dose administration of aripiprazole compared to olanzapine affect cardiovascular safety and adverse events in healthy volunteers?
Absolute Event Rate: 91% vs 60%
p-value: p=<0.035
In healthy volunteers, olanzapine induced more pronounced early cardiovascular changes (hypotension, bradycardia), whereas aripiprazole was associated with a higher overall incidence of adverse drug reactions, with effects modulated by genetic polymorphisms.
May warrant BP monitoring during aripiprazole initiation; leaves open relevance in psychiatric populations.
Objective To assess adverse events and safety of aripiprazole and olanzapine treatment. Methods Twenty-four healthy volunteers receiving 5 daily oral doses of 10 mg aripiprazole and 5 mg olanzapine in a crossover clinical trial were genotyped for 46 polymorphisms in 14 genes by qPCR. Drug plasma concentrations were measured by HPLC-MS/MS. Blood pressure and 12-lead ECG were measured in supine position. Adverse events were also recorded. Results Aripiprazole decreased diastolic blood pressure on the first day and decreased QTc on the third and fifth day. Olanzapine had a systolic and diastolic blood pressure, heart rate and QTc lowering effect on the first day. Polymorphisms in ADRA2A, COMT, DRD3 and HTR2A genes were significantly associated to these changes. The most frequent adverse drug reactions to aripiprazole were somnolence, headache, insomnia, dizziness, restlessness, palpitations, akathisia and nausea while were somnolence, dizziness, asthenia, constipation, dry mouth, headache and nausea to olanzapine. Additionally, HTR2A, HTR2C, DRD2, DRD3, OPRM1, UGT1A1 and CYP1A2 polymorphisms had a role in the development of adverse drug reactions. Conclusions Olanzapine induced more cardiovascular changes; however, more adverse drug reactions were registered to aripiprazole. In addition, some polymorphisms may explain the difference in the incidence of these effects among subjects.
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Koller et al. (2020) conducted an RCT in Healthy volunteers (n=24). Aripiprazole vs. Olanzapine (5 mg/day) was evaluated on Total number of adverse drug reactions (p=<0.035). Aripiprazole administration resulted in a significantly higher number of adverse drug reactions compared to olanzapine (91 vs 60, p<0.035), though olanzapine induced more initial cardiovascular changes.
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