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Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia.


ABSTRACT:

Objective

To explore the treatment response, tolerability and safety of once-monthly paliperidone palmitate (PP1M) in non-acute patients switched from oral antipsychotics, stratified by time since diagnosis as recently diagnosed (≤3 years) or chronic patients (>3 years).

Research design and methods

Post hoc analysis of a prospective, interventional, single-arm, multicentre, open-label, 6-month study performed in 233 recently diagnosed and 360 chronic patients.

Main outcome measures

The proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to endpoint) and maintained efficacy (defined as non-inferiority in the change in PANSS total score at endpoint [Schuirmann's test]).

Results

71.4% of recently diagnosed and 59.2% of chronic patients showed a ≥20% decrease in PANSS total score (p = 0.0028 between groups). Changes in PANSS Marder factors, PANSS subscales, and the proportion of patients with a Personal and Social Performance scale (PSP) total score of 71-100 were significantly greater in recently diagnosed compared with chronic patients. PP1M was well tolerated, presenting no unexpected safety findings.

Conclusion

These data show that recently diagnosed patients treated with PP1M had a significantly higher treatment response and improved functioning, as assessed by the PSP total score, than chronic patients.

SUBMITTER: Hargarter L 

PROVIDER: S-EPMC4898156 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Publications

Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia.

Hargarter L L   Bergmans P P   Cherubin P P   Keim S S   Conca A A   Serrano-Blanco A A   Bitter I I   Bilanakis N N   Schreiner A A  

Expert opinion on pharmacotherapy 20160509 8


<h4>Objective</h4>To explore the treatment response, tolerability and safety of once-monthly paliperidone palmitate (PP1M) in non-acute patients switched from oral antipsychotics, stratified by time since diagnosis as recently diagnosed (≤3 years) or chronic patients (>3 years).<h4>Research design and methods</h4>Post hoc analysis of a prospective, interventional, single-arm, multicentre, open-label, 6-month study performed in 233 recently diagnosed and 360 chronic patients.<h4>Main outcome meas  ...[more]

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