The results suggest that these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia.
“It’s important not to assume that antipsychotics decrease hostility by having people feel more sedated and that the only way to treat someone hostile is by sedating them,” lead investigator Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences, New York Medical College, Valhalla, told this news organization.
“Our findings suggest that transdermal asenapine has a specific antihostility effect in patients with schizophrenia,” he added.
Dr. Leslie Citrome
The study was published online in the Journal of Clinical Psychiatry.
A complex disorder
“Patients with schizophrenia are known to potentially exhibit aggressive, hostile behavior, especially during the acute phase of the illness, thus making effective management critical,” the authors write.
Dr. Citrome said schizophrenia is a complex condition that consists of five different symptom domains. These include positive (hallucinations, delusions), negative (amotivation, apathy), disorganization (cognitive symptoms), depression/anxiety, and excitability/hostility symptoms.
“These five domains are more or less independent of each other, in terms of treatment effects,” he noted.
Dr. Citrome has long been interested in the activity of antipsychotics and their impact on these various symptoms – particularly hostility – and recently published a review focusing on the impact of an array of antipsychotics on this symptom domain.
“What struck me here is that this is a transdermal system, a patch,” Dr. Citrome said. “None of the sedation that would ordinarily be associated with a sublingual asenapine would be present here.”
Dr. Citrome wanted to investigate whether the transdermal system would have an impact on hostility because, if so, “it would support the notion that hostility is an independent treatment target in schizophrenia.”
To investigate, Dr. Citrome and co-authors analyzed data from the pivotal HP-3070 phase 3 randomized, double-blind, placebo-controlled study of adults with schizophrenia who were randomly selected to receive either HP-3070 7.6 mg/24h, HP-3070 3.8 mg/24h, or placebo for 6 weeks.
The trial found that once-daily applications of HP-3070 demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores after 2-3 weeks of treatment, with the improvements sustained through week 6.
The current study was a post hoc analysis focusing specifically on 442 patients with hostility and agitation (defined as PANSS hostility item score > 1).
The outcome was the least-squares mean (LSM) changes in the PANSS hostility item. They also analyzed PANSS–Excited Component (PANSS-EC) from baseline to week 6 in all study participants. Findings were adjusted for the presence of somnolence or akathisia.
Demographic and baseline disease characteristics were “balanced” between the HP-3070–6.6-mg and the HP-3070–3.8-mg groups (n = 151 and n = 147, respectively) and the placebo group (n = 144) in the intent-to-treat analysis, with a mean (standard deviation) age of between 41.5 and 42.3 (11.6-11.9) years. Roughly three-quarters of participants were White, and most participants had a mean duration of between 15 and 16 years since diagnosis.