Wednesday, September 7, 2016

Study Finds Aripiprazole Lauroxil Carries Low Risk of Metabolic Side Effects

Last year, results from a phase 3 clinical trial showed the long-acting injectable aripiprazole lauroxil to be effective and safe in treating symptoms of acute schizophrenia. Now, new findings from the phase 3 trial suggests that the antipsychotic may have an added benefit of having a low risk for metabolic abnormalities.

“[T]hese findings of a low risk for metabolic abnormalities with aripiprazole lauroxil are important when considering overall patient health in the management of schizophrenia,” Henry Nasrallah, M.D., chair of the Department of Psychiatry and Behavioral Neuroscience at St. Louis University School of Medicine, and colleagues wrote.

The study included 622 adult patients with schizophrenia (DSM-IV-TR criteria) who were experiencing an acute exacerbation or relapse of symptoms less than two months prior to the study and who had responded to an antipsychotic medication other than clozapine in the past year. The patients were randomly assigned to aripiprazole lauroxil (441 mg or 882 mg) or placebo intramuscularly on days 1, 29, and 57 of the study. Outcome measures included baseline to week 12 changes in body weight, prolactin, fasting plasma glucose and serum lipids, glycosylated hemoglobin (HbA1c), and incidence of treatment-emergent adverse events. 

The results showed that while body weight increased modestly in both aripiprazole lauroxil groups compared with placebo over the course of the trial (change of mean body weight from baseline to 12 weeks = 0.7 kg [aripiprazole lauroxil, 441 mg], 0.9 kg [aripiprazole lauroxil, 882 mg], and 0.01 kg [placebo]), both doses of aripiprazole lauroxil were associated with reductions in mean prolactin levels from baseline to week 12, whereas placebo was not. No clinically relevant changes from baseline to week 12 were observed for any serum lipid, lipoprotein, plasma glucose, or HbA1c value with either dose of aripiprazole lauroxil or placebo. 

Treatment-emergent adverse events related to metabolic parameters were reported in 2.4%, 1.4%, and 2.4% of patients in the aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. Most common treatment-emergent adverse events related to metabolic parameters included increases in blood glucose and serum triglycerides.

“Aripiprazole lauroxil represents an important option for the treatment of schizophrenia, with demonstrated efficacy and tolerability and a low risk of metabolic side effects that often impede maintenance of long-term antipsychotic treatment and may lead to higher cardiovascular risk,” the authors concluded.

For related information, see the Psychiatric News article “Exposure to Antipsychotics May Increase Risk of Type 2 Diabetes in Youth.”

(Image: iStock/Stepan Popov)


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