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A long-acting injectable antipsychotic delayed hospitalization for patients with schizophrenia in a manufacturer-sponsored cluster-randomized trial.

Among 489 patients with schizophrenia and no prior long-term antipsychotic use, patients on once-monthly aripiprazole (Abilify Maintena) cut risk of a first hospitalization by nearly half compared to usual care at 2 years (hazard ratio 0.56, 95% CI 0.34-0.92, P=0.02), reported John M. Kane, MD, of Zucker Hillside Hospital in Glen Oaks, New York, and colleagues.

Overall, the number needed to treat in order to prevent one hospitalization was 7 with aripiprazole, they wrote in .

"Many clinicians want to see patients relapse due to nonadherence before they consider [long-acting injectables] and we think it's unfortunate to have to wait for that kind of event," Kane told 口袋女优. "So many patients have trouble taking medication on a regular basis and we should try to prevent those relapses due to nonadherence."

Stabilizing early phase illness is important for later prognosis. However, younger patients frequently stop taking traditional antipsychotic medications early on, leading to a cycle of instability, commented Christian G. Kohler, MD, of University of Pennsylvania Hospital, who was not involved in this research.

Although long-acting injectables have traditionally been used in patients with chronic illness, they are gaining traction as an early-phase treatment. Second-generation (or "atypical") antipsychotics like aripiprazole also tend to provide a more even delivery over time with fewer side effects, Kohler said.

"The data reflects there is a place for long-acting injectables early in the course of illness, with a real-world outcome of longer time to hospitalization," Kohler told 口袋女优.

The so-called involved 39 clinics in 19 states, which were randomized to administer either the long-acting aripiprazole or usual care to consenting eligible patients. Inclusion criteria were age 18-35, less than 5 years of lifetime antipsychotic use, and no prior clozapine use or unstable comorbidity.

Physicians in the aripiprazole arm were trained on its administration, and the regimen included oral aripiprazole therapy before long-acting injectable therapy. Medications (including long-acting injectables) for the usual care group were left to treating clinicians' discretion; Kane and colleagues did not indicate what was actually prescribed.

In total, the patient sample -- 75.3% male, mean age 25 -- was 40.8% Black and 35.7% white. The study arms were well balanced for prior hospitalizations and duration of previous antipsychotic therapy.

At baseline, less than half of both groups had 1 year or less of lifetime antipsychotic treatment (43.6% vs 48.2%). Among patients in the aripiprazole group, 30.8% were receiving aripiprazole or another long acting injectable at baseline, whereas 27.4% of patients in the usual care group were.

Because there was a relatively high rate of long-acting injectable use among patients in the usual care arm, the findings may demonstrate a "conservative bias," Kane said.

"We wanted to do this in a large sample of community mental health centers so the results would be generalizable to the broader population of patients," Kane said.

Overall, a lower proportion of patients experienced psychiatric hospitalizations across the study period in the aripiprazole group compared to usual care (39% vs 61%), and the mean survival time until first hospitalization was higher (613.7 vs 530.6 days), Kane and co-authors reported.

Aripiprazole was also associated with a greater reduction in the rate of total hospitalizations compared to the usual care arm, but this difference was not significant (relative risk 0.64, 95% CI 0.33-1.26, P=0.20), they noted.

Patients did not have significantly different scores on the Heinrich Carpenter Quality of Life scale or the Brief Psychiatric Rating Scale, perhaps because "the long duration between assessments limited the ability to capture the trajectories of these domains," Kane and co-authors wrote.

Two deaths occurred in the usual care group: one suicide and one with cause unknown. Four patients in each arm attempted suicide. The most common adverse events in the aripiprazole and usual treatment groups were worsening of psychotic symptoms (23% and 40.2%), weight gain (14.4% vs 19.5%), and suicidal ideation (8.6% vs 9.5%), respectively.

Selection bias may have played a role in the findings because of the cluster randomization, which is a limitation, the authors noted. Also, this trial did not evaluate other second-generation long-acting injectables, so the findings may not be generalizable to all formulas, they added.

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