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. 2016 Jan;22(1):9-21.
doi: 10.1097/PRA.0000000000000117.

A Flexible-Dose Study of Paliperidone ER in Patients With Nonacute Schizophrenia Previously Treated Unsuccessfully With Oral Olanzapine

Moshe Kotler  1 , Nesrin Dilbaz, Fernanda Rosa, Periklis Paterakis, Vihra Milanova, Anatoly B Smulevich, Marjolein Lahaye, Andreas Schreiner
Affiliations

A Flexible-Dose Study of Paliperidone ER in Patients With Nonacute Schizophrenia Previously Treated Unsuccessfully With Oral Olanzapine

Moshe Kotler et al. J Psychiatr Pract. 2016 Jan.

Abstract

Objective: The goal of this study was to explore the tolerability, safety, and treatment response of switching from oral olanzapine to paliperidone extended release (ER).

Methods: Adult patients with nonacute schizophrenia who had been treated unsuccessfully with oral olanzapine were switched to flexible doses of paliperidone ER (3 to 12 mg/d). The primary efficacy outcome was a ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to endpoint for patients who switched medications because of lack of efficacy with olanzapine and noninferiority versus previous olanzapine treatment (mean endpoint change in PANSS total scores vs. baseline of ≤ 5 points) for patients who switched for reasons other than lack of efficacy. Safety and tolerability were assessed by monitoring adverse events, extrapyramidal symptoms, and weight change.

Results: Of 396 patients, 65.2% were men, mean age was 40.0 ± 12.0 years, and 75.5% had paranoid schizophrenia. Among the patients whose main reason for switching was lack of efficacy, an improvement in the PANSS total score of ≥ 20% occurred in 57.4% of patients. Noninferiority was confirmed for each subgroup of patients whose main reason for switching was something other than lack of efficacy. Paliperidone ER was generally well tolerated. Extrapyramidal symptoms as measured by total Extrapyramidal Symptom Rating Scale scores showed statistically significant and clinically relevant improvements at endpoint, the average weight decreased by 0.8 ± 5.2 kg at endpoint, and a clinically relevant weight gain of ≥ 7% occurred in 8.0% of patients.

Conclusion: Paliperidone ER flexibly-dosed over 6 months was well tolerated and associated with a meaningful clinical response in patients with nonacute schizophrenia who had previously been unsuccessfully treated with oral olanzapine.

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Conflict of interest statement

N.D. has participated in advisory boards for AstraZeneca, Janssen-Cilag, Lundbeck, Bristol-Myers Squibb, and Pfizer; and has received speaker’s fees from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Pfizer, Sanofi, and Servier. V.M. has participated in advisory boards for AstraZeneca and has received speaker’s fees from AstraZeneca, Lundbeck, Eli Lilly, and Servier. M.L. is an employee and a member of Medical Affairs EMEA at Janssen-Cilag BV, The Netherlands. A.S. is an employee and a member of Medical and Scientific Affairs EMEA at Janssen-Cilag GmbH, Germany, and is a shareholder of Johnson & Johnson. The remaining authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Patient disposition. AE indicates adverse event; ER, extended release.
FIGURE 2
FIGURE 2
PANSS scores over time. PANSS, Positive and Negative Syndrome Scale.
FIGURE 3
FIGURE 3
Mean Extrapyramidal Symptom Rating Scale (ESRS) of the entire cohort. ***P<0.0001. Total scores (95% confidence intervals shown with error bars) obtained with paliperidone ER. Decreasing ESRS scores reflect an improvement in extrapyramidal symptoms. Improvement versus baseline was statistically significant.
See this image and copyright information in PMC

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