Ludger Hargarter1, Marjolein Lahaye2, Pierre Cherubin3, Martin Lambert4, Marnina Swarz5, Gali Joldygulov6, Flavio Vischia7, Veronica Chomskaya8, Vasilis P Bozikas9, Eva-Maria Tsapakis10, Andreas Schreiner1. 1. a Medical & Scientific Affairs , Janssen Cilag EMEA , Neuss , Germany. 2. b Biostatistics & Programming , Janssen Cilag Benelux , Tilburg , The Netherlands. 3. c Medical Affairs , Janssen Cilag EMEA , Issy-les-Moulineaux , France. 4. d University Medical Center, Eppendorf , Hamburg , Germany. 5. e Abarbanel Mental Health Center , Bat Yam , Israel. 6. f Republican Scientific Center of Psychiatry , Almaty , Kazakhstan. 7. g Dipartimento di Salute Mentale , Ospedale Amedeo di Savoia , Torino , Italy. 8. h State Institution of Healthcare City Psychoneurological Dispensary #3 , St Petersburg , Russia. 9. i 1st Psychiatric Clinic of the Aristotle University of Thessaloniki, General Hospital "Papageorgiou" , Thessaloniki , Greece. 10. j Aghios Charalambos' Mental Health Clinic , Heraklion , Crete , Greece.
Abstract
OBJECTIVES: Partial or non-adherence in patients with schizophrenia is common and increases the risk of relapse. This study explored safety, tolerability and treatment outcomes in patients hospitalised for an exacerbation of schizophrenia initiated on maintenance treatment of once-monthly paliperidone palmitate (PP1M). METHODS: A 6-week, observational cohort study of patients initiated on PP1M within 3 weeks after hospital admission. RESULTS: Overall, 367 patients were documented, 85.8% with paranoid schizophrenia subtype. Mean time from hospital admission to PP1M initiation was 9.4 ± 7.7 days. Treatment-emergent adverse events were reported by 22.9% of patients. From baseline to endpoint, significant improvements were observed in psychotic symptoms (Brief Psychiatric Rating Scale total score mean change -19.3 ± 12.6, P < .0001) and functioning (Personal and Social Performance scale total score mean change 14.3 ± 12.4, P < .0001). Overall, 6.0% of patients were very or extremely satisfied with their prior antipsychotic medication at baseline compared with 47.2% very or extremely satisfied with PP1M treatment at endpoint. CONCLUSIONS: Initiating PP1M in patients with exacerbated schizophrenia shortly after hospital admission was well tolerated and resulted in statistically significant and clinically relevant improvements in symptoms and patient functioning, suggesting that patients may benefit from early initiation of PP1M during their hospital stay.
OBJECTIVES: Partial or non-adherence in patients with schizophrenia is common and increases the risk of relapse. This study explored safety, tolerability and treatment outcomes in patients hospitalised for an exacerbation of schizophrenia initiated on maintenance treatment of once-monthly paliperidone palmitate (PP1M). METHODS: A 6-week, observational cohort study of patients initiated on PP1M within 3 weeks after hospital admission. RESULTS: Overall, 367 patients were documented, 85.8% with paranoid schizophrenia subtype. Mean time from hospital admission to PP1M initiation was 9.4 ± 7.7 days. Treatment-emergent adverse events were reported by 22.9% of patients. From baseline to endpoint, significant improvements were observed in psychotic symptoms (Brief Psychiatric Rating Scale total score mean change -19.3 ± 12.6, P < .0001) and functioning (Personal and Social Performance scale total score mean change 14.3 ± 12.4, P < .0001). Overall, 6.0% of patients were very or extremely satisfied with their prior antipsychotic medication at baseline compared with 47.2% very or extremely satisfied with PP1M treatment at endpoint. CONCLUSIONS: Initiating PP1M in patients with exacerbated schizophrenia shortly after hospital admission was well tolerated and resulted in statistically significant and clinically relevant improvements in symptoms and patient functioning, suggesting that patients may benefit from early initiation of PP1M during their hospital stay.