Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind r...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2012-08-01
|
| Series: | Neuropsychiatric Disease and Treatment |
| Online Access: | http://www.dovepress.com/long-term-tolerability-of-once-monthly-injectable-paliperidone-palmita-a10822 |
| _version_ | 1818846123211620352 |
|---|---|
| author | Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L |
| author_facet | Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L |
| author_sort | Sliwa JK |
| collection | DOAJ |
| description | Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind relapse prevention phase, and an optional open-label extension examined the long-term tolerability with continuous once-monthly injectable paliperidone palmitate 39, 78, 117, or 156 mg (25, 50, 75, or 100 mg equivalents [mg eq] of paliperidone) in subjects with recently diagnosed (≤5 years; n = 216) versus chronic illness (>5 years; n = 429) schizophrenia.Methods: Adverse events reported at a ≥2% margin between subgroups were identified. Relative risks (in the recently diagnosed compared with the chronically ill) and 95% confidence intervals (CI) were determined, and CI not including 1 were considered potentially significant.Results: In both subgroups, the mean monthly dose was 109 mg (69.9 mg eq). Continuous mean exposures were 333.9 ± 271.9 and 308.7 ± 278.3 days in the recently diagnosed and chronic illness subgroups, respectively. Using the criteria outlined in the methods, nasopharyngitis was a potentially significant event reported in more chronically ill than recently diagnosed subjects at months 6, 9, 12, and endpoint (7.2% versus 2.8%; relative risk 0.384; 95% CI 0.163–0.907). Influenza (2.8% versus 0.7%; relative risk 3.9; 95% CI 1.003–15.730) and amenorrhea (3.2% versus 0.9%; relative risk 3.476; 95% CI 1.029–11.744) at endpoint were potentially significant events in more recently diagnosed than chronically ill subjects. Mean weight changes, sedation/somnolence, any extrapyramidal symptom-related or glucose-related events were generally similar between the groups. The mean prolactin level increased in both sexes in both subgroups (changes from baseline of +41.8 ng/mL and +26.5 ng/mL in recently diagnosed and chronic illness females and +12.3 ng/mL and +15.1 ng/mL in recently diagnosed and chronic illness males, respectively), and were higher in females with recently diagnosed illness than in females who were chronically ill (P = 0.0002 at endpoint). Prolactin-related events were reported by 7.9% of recently diagnosed subjects with schizophrenia and 3.5% of those who were chronically ill.Conclusion: The long-term tolerability of paliperidone palmitate was generally similar in recently diagnosed schizophrenia subjects and those with more chronic illness, with the exception of some prolactin-related measures.Keywords: paliperidone palmitate, long-acting antipsychotic, recently diagnosed, early illness, schizophrenia |
| first_indexed | 2024-12-19T05:40:33Z |
| format | Article |
| id | doaj.art-66dd7875e7674fe5b5a049c23e8d9364 |
| institution | Directory Open Access Journal |
| issn | 1176-6328 1178-2021 |
| language | English |
| last_indexed | 2024-12-19T05:40:33Z |
| publishDate | 2012-08-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-66dd7875e7674fe5b5a049c23e8d93642022-12-21T20:34:02ZengDove Medical PressNeuropsychiatric Disease and Treatment1176-63281178-20212012-08-012012default375385Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophreniaSliwa JKBossie CAFu D-JTurkoz IAlphs LJennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind relapse prevention phase, and an optional open-label extension examined the long-term tolerability with continuous once-monthly injectable paliperidone palmitate 39, 78, 117, or 156 mg (25, 50, 75, or 100 mg equivalents [mg eq] of paliperidone) in subjects with recently diagnosed (≤5 years; n = 216) versus chronic illness (>5 years; n = 429) schizophrenia.Methods: Adverse events reported at a ≥2% margin between subgroups were identified. Relative risks (in the recently diagnosed compared with the chronically ill) and 95% confidence intervals (CI) were determined, and CI not including 1 were considered potentially significant.Results: In both subgroups, the mean monthly dose was 109 mg (69.9 mg eq). Continuous mean exposures were 333.9 ± 271.9 and 308.7 ± 278.3 days in the recently diagnosed and chronic illness subgroups, respectively. Using the criteria outlined in the methods, nasopharyngitis was a potentially significant event reported in more chronically ill than recently diagnosed subjects at months 6, 9, 12, and endpoint (7.2% versus 2.8%; relative risk 0.384; 95% CI 0.163–0.907). Influenza (2.8% versus 0.7%; relative risk 3.9; 95% CI 1.003–15.730) and amenorrhea (3.2% versus 0.9%; relative risk 3.476; 95% CI 1.029–11.744) at endpoint were potentially significant events in more recently diagnosed than chronically ill subjects. Mean weight changes, sedation/somnolence, any extrapyramidal symptom-related or glucose-related events were generally similar between the groups. The mean prolactin level increased in both sexes in both subgroups (changes from baseline of +41.8 ng/mL and +26.5 ng/mL in recently diagnosed and chronic illness females and +12.3 ng/mL and +15.1 ng/mL in recently diagnosed and chronic illness males, respectively), and were higher in females with recently diagnosed illness than in females who were chronically ill (P = 0.0002 at endpoint). Prolactin-related events were reported by 7.9% of recently diagnosed subjects with schizophrenia and 3.5% of those who were chronically ill.Conclusion: The long-term tolerability of paliperidone palmitate was generally similar in recently diagnosed schizophrenia subjects and those with more chronic illness, with the exception of some prolactin-related measures.Keywords: paliperidone palmitate, long-acting antipsychotic, recently diagnosed, early illness, schizophreniahttp://www.dovepress.com/long-term-tolerability-of-once-monthly-injectable-paliperidone-palmita-a10822 |
| spellingShingle | Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia Neuropsychiatric Disease and Treatment |
| title | Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| title_full | Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| title_fullStr | Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| title_full_unstemmed | Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| title_short | Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| title_sort | long term tolerability of once monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia |
| url | http://www.dovepress.com/long-term-tolerability-of-once-monthly-injectable-paliperidone-palmita-a10822 |
| work_keys_str_mv | AT sliwajk longtermtolerabilityofoncemonthlyinjectablepaliperidonepalmitateinsubjectswithrecentlydiagnosedschizophrenia AT bossieca longtermtolerabilityofoncemonthlyinjectablepaliperidonepalmitateinsubjectswithrecentlydiagnosedschizophrenia AT fudj longtermtolerabilityofoncemonthlyinjectablepaliperidonepalmitateinsubjectswithrecentlydiagnosedschizophrenia AT turkozi longtermtolerabilityofoncemonthlyinjectablepaliperidonepalmitateinsubjectswithrecentlydiagnosedschizophrenia AT alphsl longtermtolerabilityofoncemonthlyinjectablepaliperidonepalmitateinsubjectswithrecentlydiagnosedschizophrenia |