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Long-Acting Injectable Risperidone Ramps Up Compliance for Schizophrenia Patients: Presented at APA

By Carole Bullock

WASHINGTON, DC -- May 9, 2008 -- Patients with paranoid schizophrenia are more likely to adhere to treatment with the long-acting injectable risperidone (LAIR) than with a second-generation antipsychotic (SGA), according to an interim analysis reported here at the 161st Annual Meeting of the American Psychiatric Association (APA).

In addition, there was evidence of a trend for longer treatment duration, said lead author Bernd Ibach, MD, Director, Medical & Scientific Affairs, Janssen-Cilag, Neuss, Germany.

In an interim, 24-month analysis, the investigators compared LAIR versus SGA for patient adherence to therapy, tolerability, and functionality under clinical practice conditions.

The scheduled interim analysis (ITT population; baseline to endpoint) included 113 patients who began treatment with LAIR and 117 patients prescribed 1 of 6 oral SGAs (amisulpride, aripiprazole, olanzapin, quetiapine, risperidone, ziprasidone). Average age was 34 years, and the majority of patients were diagnosed with paranoid schizophrenia.

The results at 24 months show rates of treatment retention of 42% in the LAIR group and 36% in the SGA group (P = .48), Dr. Ibach said in a poster session on May 6. In addition, median treatment duration in the LAIR group was 91 days longer than in the SGA group (549 vs 458 days, respectively).

"The study suggests that LAIR may be a favorable choice, especially for schizophrenia patients who have trouble adhering to treatment regimens and younger patients with short disease duration," Dr. Ibach said in an interview.

Positive and Negative Syndrome Scale scores improved significantly (LAIR 21.6 vs oral SGA 18.7; P < .000). Extrapyramidal signs scores improved similarly in the 2 cohorts.

Adverse effects were within the norm, noted researchers. Rates of adverse effects were lower in the LAIR group versus the oral SGA group in terms of weight increase (13.3% vs 14.5%), fatigue (6.2% vs 12.8%), agitation (4.4% vs 6.0), and psychosis (5.3% vs 5.1%).

There were strong baseline differences between the LAIR and oral SGA cohort with regard to reasons for starting treatment (noncompliance, 49% vs 17.1%; lack of efficacy 32.7% vs 23.1%).

"This interim analysis of a noninterventional, naturalistic study confirms that lack of compliance in patients with a diagnosis of schizophrenia is still the major reason to be treated with LAIR, and the treatment is associated with few side effects," he said.

Thus, LAIR may be an effective treatment option in case of impaired compliance, he concluded.

Funding for this study was provided by Janssen-Cilag.

[Presentation title: Interim-Analysis of a Long-Term Treatment Adherence Study With Lair and Oral Second Generation Antipsychotics in Patients With Schizophrenia. Abstract NR4-101]

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