Fran Lowry

June 23, 2014

HOLLYWOOD, Florida — Patients with schizophrenia who were switched from their oral antipsychotics to once-monthly aripiprazole (Abilify Maintena, Otsuka/Lundbeck), a long-acting injectable antipsychotic, saw a significant drop in their rates of psychiatric hospitalizations compared with their experience with the oral medications they had been taking.

Total psychiatric hospitalization rates were 27.1% when patients received oral antipsychotics and 2.7% when the same patients received aripiprazole injections, said John Kane, MD, chairman of psychiatry at the Zucker Hillside Hospital and Hofstra North Shore–LIJ School of Medicine, Glen Oaks, New York.

"This was a very significant reduction in the rate of hospitalization after being switched to the long-acting injectable formulation," Dr. Kane told Medscape Medical News. "We believe that the use of a long-acting injectable formulation can help the patient benefit from the advantages of antipsychotic medication because they don't have to remember to take pills every day, and there are a variety of reasons why people have difficulty taking medicine on a regular basis."

The results were reported here at the American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting.

Mirror Study

Dr. Kane and his group used a mirror image study design in which each patient served as his or her own control to assess the efficacy of 400 mg aripiprazole once monthly vs standard oral antipsychotic treatment.

Dr. John Kane

The study was divided into 2 treatment periods, a retrospective period that assessed total psychiatric hospitalizations with standard, oral treatment for the past 3 months, and a prospective period that assessed the same outcome 3 months after the patients were switched to the long-acting injectable formulation.

It analyzed outcomes in 336 patients, aged 18 to 65 years (mean, 42 years), with a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria of more than 1 year's duration. All patients required a change in their oral medication, either because of problems with efficacy, side effects, or adherence, and agreed to receive a long-acting injectable formulation of aripiprazole.

Total psychiatric hospitalization rates dropped from 27.1%, which was the rate when patients received oral antipsychotics, to 2.7% when the same patients received aripiprazole injections (P < .0001).

The significant reduction in psychiatric hospitalization rates seen at 3 months continued out to 6 months, Dr. Kane reported.

Compared with the retrospective period when the patients were on oral medication, the total psychiatric hospitalization rate with long-acting aripiprazole was 8.8% vs 38.1%, according to the 6 -month analysis.

The most common treatment-emergent adverse events with greater than 5% incidence with long-acting aripiprazole were insomnia (6.7%) and akathisia (6.5%).

"We believe that this is another example of a promising approach that can help reduce rates of hospitalization and also costs associated with treating this illness. But in addition, and very importantly, it can help reduce the personal suffering and deterioration of the patient's condition that can result from repeated relapses or rehospitalizations," Dr. Kane said.

"It's my personal belief that long-acting injectable drugs are underutilized as a treatment of schizophrenia and that more patients would benefit from receiving a long-acting injectable," he said. "There has been a reluctance to use these formulations, and I think we sometimes wait much too long, until the patient has had multiple relapses, and at that point the patient has suffered a lot of loss of functioning.

"Unfortunately, the guidelines say that we should wait until the patient has demonstrated nonadherence and repeated relapses, and I think that is waiting too long," he added.

Dr. Alan Gelenberg

Commenting on this study for Medscape Medical News, Alan J. Gelenberg, MD, Shively/Tan Professor and chair, Department of Psychiatry, Penn State University College of Medicine, Hershey, Pennsylvania, called it "a well-conducted pharmaceutical trial by a respected group of investigators."

Dr. Gelenberg, who was not part of the study, added: "Now that there is an array of long-acting injectable antipsychotics, one must wonder how a less-expensive long-acting medicine would do in comparison with aripiprazole in efficacy, tolerability, and economically."

The study was funded by Otsuka Pharmaceutical Development and Commercialization, Inc, and Lundbeck LLC. Dr. Kane disclosed financial relationships with Alkermes, Amgen, Bristol-Myers Squibb, Cephalon, Eisai, Boehringer Ingelheim, Eli Lilly, Forrest, Genentech, Intracellular Therapeutics, Janssen, Johnson & Johnson, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Pierre Fabre, Proteus, Reviva, Roche, Sunovion, and Targacet, and that he owns shares in MedAvante. Dr. Gelenberg disclosed financial relationships with Allergan, Forest Pharmaceutical, Healthcare Technology Systems, Inc, Pfizer, and Zynx Health.

American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting. Presented June 16, 2014.

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