In: Drug18 Jun 2010
Although minimal side effects from have been reported, complete clinical data have not yet been established. In a 52-week study reported by Bristol-Myers Squibb, 1,294 patients with schizophrenia were evaluated to establish efficacy, safety, and tolerabil-ity. Patients taking aripiprazole experienced significantly fewer extrapyramidal symptoms than patients taking haloperi-dol. The most commonly reported adverse drug events associated with arip-iprazole in this study were insomnia, psychosis, anxiety, and akathisia. The incidence of insomnia, psychosis, and anxiety was similar to that with haloperi-dol, whereas the incidence of akathisia was considerably less with aripiprazole than with haloperidol (P < .001).
In a 26-week study by the manufac-turer,13 aripiprazole was compared with placebo for efficacy and safety in 310 patients. No significant differences were found in the incidence of extrapyramidal side effects or weight gain. The three most commonly reported symptoms associated with aripiprazole were insomnia, anxiety, and headache, with incidence rates similar to those for placebo.
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A study presented at the 155th Annual Meeting of the American Psychiatric Association, held in Philadelphia in May 2002, described how patients who were switched from olanzapine to aripiprazole therapy demonstrated a statistically significant weight loss of 2.03 kg (P < .001) along with a decrease in prolactin levels and an improvement in extrapyramidal side effects. Patients who were switched from risperidone to aripiprazole therapy showed statistically significant decreases in prolactin levels (P< .001), with reductions in weight and in extrapyramidal symptoms. The decreased incidence of side effects can be associated with aripiprazole’s lack of affinity for hista-minergic, alpha-adrenergic, and mus-carinic receptors.
PRECAUTIONS AND CONTRAINDICATIONS
Although no contraindications or precautions have been clearly established for aripiprazole, caution must be exercised for patients who are taking anti-psychotic medications. Because of the limited data available, pregnant patients and patients with cardiovascular disease, hypovolemia, Parkinson’s disease, or renal or hepatic insufficiency should be evaluated on an individual basis.
Both the CYP2D6 and CYP3A4 enzymes are responsible for aripiprazole metabolism. Agents that induce the CYP3A4 enzyme (e.g., carbamazepine) can increase aripiprazole clearance. Medications that inhibit the CYP3A4 enzyme (e.g., ketoconazole) or the CYP2D6 enzyme (e.g., fluoxetine) may hinder aripiprazole elimination. Certain combinations, such as the concomitant use of central nervous system depressants and alcohol, should be monitored. Aripipra-zole should be prescribed with caution for patients who are at risk for torsades des pointes from their use of QT-pro-longing agents, such as antiarrhythmic agents and antidepressants.
Aripiprazole, the first in a new class of antipsychotic medications, shows promise because of its unique mechanism of potent D2 partial agonist activity, coupled with its 5-HT1A-agonist activity. Although the facts are still emerging, most trials have indicated superior performance with aripiprazole in terms of its comparable efficacy and benefits in producing fewer extrapyramidal side effects. One of the most challenging aspects of treating patients with schizophrenia is the problem of compliance. An agent that offers a reduction in adverse effects and that has an efficacy similar to that of other treatments might result in increased long-term adherence. Should aripiprazole live up to expectations, great strides will be made in the treatment of mental illness.
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