October 17, 2016
By Anne Harding
NEW YORK (Reuters Health) - Injectable aripiprazole lauroxil is equally effective in adults with schizophrenia regardless of age or gender, a new post-hoc analysis shows.
"It is a useful intramuscular medication for all age groups," Dr. Steven Targum of Clintara LLC in Boston, the first author of the new study, told Reuters Health. The study was funded by Alkermes (Waltham, Mass.) which makes the drug, sold as Aristada.
A number of long-acting injectable antipsychotics are now available and have been shown to reduce hospitalization among patients with schizophrenia, Dr. Targum and his team note in their report, published online October 1 in Schizophrenia Research. In a 2015 trial, two different doses of Aristada were found to be more effective than placebo for up to 85 days of treatment in adult patients who had experienced an acute exacerbation of schizophrenia within the previous 2 months.
Aristada is administered by a health care professional every four to six weeks.
To investigate whether age or gender influenced the effectiveness of the drug, the researchers performed a post-hoc analysis of the trial comparing the effects of both dosages (441 mg and 882 mg) in four different age groups: 18 to 30 (n=128); 30 to 39 (n=170); 40 to 49 (n=165); and 50 to 69 (n=133).
There was no effect of age on effectiveness of either dose, either as a continuous variable or across the four age groups. The youngest patients had a lower placebo response by day 8 compared to other age groups, but by week two the placebo responses were equivalent.
Furthermore, "there were no interaction effects between gender and treatment outcome," the authors reported.
"These are patients who are less experienced with clinical trials, have probably spent less time in hospitals, and by virtue of their acute illness were probably less likely to have the expectation biases that older patients who've been in clinical trials and have been in hospitals would have when they enter a trial," Dr. Targum said.
"Medication adherence is a major concern in all patients regardless of diagnosis, regardless of age, but it's a particularly big issue in a younger population with schizophrenia," he added.
Based on the new findings and concerns about adherence, Dr. Targum said, "I might want to introduce an intramuscular preparation earlier in the course of treatment to ensure sustained adherence to pharmacotherapy."
Schizophr Res 2016.
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