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Efficacy of paliperidone palmitate 3-month formulation in preventing hospital admissions and emergency room visits. 66 months of follow-up
- S. L. Romero Guillena, B. O. Plasencia Garcia de Diego, J. Gomez Gonzalez, F. Gotor Sánchez-Luengo
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S487
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Introduction
Paliperidone Palmitate 3-month formulation (PP3M) has shown a significantly longer time to relapse compared to placebo, with similar efficacy and safety to Paliperidone Palmitate 1-month (PP1M) (Carpiniello et al. Drug Des. Devel. Ther. 2016; 10 1731–1742).
ObjectivesThe main objective of this study was to determine the effectiveness of PP3M in preventing hospital admissions and emergency room visits, in people with non-acute schizophrenia in a naturalistic psychiatric outpatient setting
MethodsSample: 30 people with diagnosis of schizophrenia (DSM 5 criteria), who had started treatment with PP3M, after being stabilized with PP1M (the dose was not modified in the four months prior to inclusion in the study)
Quarterly basis, the following evaluations were performed during a follow-up period of 66 months:
The Clinical Global Impression-Schizophrenia scale (CGI-SCH)
Treatment adherence, concomitant medication and the number of hospitalizations and emergency visits
Efficacy values: Percentage of patients who remained free of admissions at the end of 66 months of follow-up.
Other evaluation criteria: Percentage of patients who never visited the emergency department at the end of 66 months of follow-up. Average change from baseline visit to the final evaluation as assessed by score obtained on the following scale: GSI-SCH, percentage of patients on antipsychotic monotherapy and treatment adherence rate.
ResultsThe mean dose of PP3M was 401. 55 mg
The percentage of patients who remained free of admissions at the end of the 66 months was 83.25% and the percentage of patients who never visited the emergency department at the end of 66 months was 79.92%
Mean variations from baseline scores at 66 months were: (-0.36 ±0-37) on the GCI-SCH.
The percentage of patients on antipsychotic monotherapy at the end of the 66 months was 76.56%
The rate of adherence was 86.58%
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ConclusionsIn our study, we found that paliperidone palmitate 3-month formulation was effective in reducing the number of admissions and visits to the emergency department, under conditions of daily clinical practice.
Disclosure of InterestNone Declared
PALIPERIDONE PALMITATE 6-MONTH FORMULATION FOR THE TREATMENT OF SCHIZOPHRENIA: A 4-MONTH FOLLOW-UP STUDY
- S. L. Romero Guillena, G. Rodriguez Menendez, A. I. Florido Puerto, A. S. Fernández Flores
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, pp. S1086-S1087
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Introduction
Relapse prevention is critical because psychopathology and functionality can worsen in patients with schizophrenia because the repeated episodes and we have strong evidence of antipsychotics efficacy for relapse prevention, but nonadherence rates in patients with schizophrenia are very high, even in comparison with other illness. The literature speaks of average rates of 42% in schizophrenia. For that, long-acting injectable antipsychotics (LAIs) are considered important treatment option, but they are underutilized (Taipale et al. Schizophrenia Bulletin 2017; 44, 1381–1387) (Garcia et al. J Clin Psychopharmacol 2016; 36(4)355-371).
There is extensive clinical trial evidence for the use of paliperidone palmitate 1-month (PP1M) and paliperidone palmitate 3-month (PP3M) formulations for maintaining treatment continuity and preventing relapses and risk of hospitalizations in patients with schizophrenia. (Najarian et al. Int J Neuropsychopharmacol 2022; 25(3) 238-251).
Paliperidone palmitate 6-month (PP6M) formulation is a presentation that provides a dosing interval of once every six months. It is the first and only antipsychotic to be administered twice a year.
ObjectivesThe principal aim of this study was to evaluate the effectiveness, safety, and tolerability of the PP6M in people with non-acute schizophrenia in a naturalistic psychiatric outpatient setting
MethodsSample: 22 patients diagnosed with schizophrenia (DSM 5 criteria) that started treatment with PP6M after being stabilized with PP1M (N:10) or PP3M (N:12) (the treatment dose was not changed in the four months before study inclusion)
The mean dose of PP6M was 822.727 mg
Bimonthly, the following evaluations were performed during a follow-up period of 4 months:
The Clinical Global Impression-Schizophrenia scale (CGI-SCH)
Treatment adherence, concomitant medication, adverse events and the number of hospitalizations and emergency visits
Efficacy values: Percentage of patients who remained free of admissions at the end of 4months of follow-up.
Other evaluation criteria: Percentage of patients who never visited the emergency department at the end of 4 months of follow-up, average change from baseline visit to the final evaluation as assessed by score obtained on the following scale: GSI-SCH, treatment adherence rate and tolerability.
ResultsThe percentage of patients who remained free of admissions at the end of the 4 months was 100% and the percentage of patients who never visited the emergency department at the end of 4 months was 100 %
Mean variations from baseline scores at 4 months were: (-0.21 ±0.31) on the GCI-SCH.
The rate of adherence to treatment with PP6M after 4 months was 100%.
Tolerability was good. None of the patients experienced an adverse event.
ConclusionsIn our study, we found that short-term treatment with paliperidone palmitate 6-month formulation is effective and well tolerated in clinical practice conditions
Disclosure of InterestNone Declared
Barriers and facilitators associated with pharmacological treatment in bipolar disorder patients
- J.Á. Alcalá Partera, A. Fontalba Navas, M. Company Morales, S.L. Romero Guillena, T. Gutiérrez Higueras, F. Calera Cortés, S. Vicent Forés, L. Gutiérrez Rojas
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- Journal:
- European Psychiatry / Volume 64 / Issue S1 / April 2021
- Published online by Cambridge University Press:
- 13 August 2021, p. S196
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Introduction
The main factors that are involved in a correct adherence to the therapeutic recommendations in Bipolar Disorder includes aspects related to age, sex, ethnicity, socioeconomic level and characteristics of the illness associated with the severity, comorbidity and adverse effects related to previous medicine.
ObjectivesTo analyse the individual perception that the patient with Bipolar Disorder has regarding the positive and negative aspects of taking the recommended medication.
MethodsDescriptive and interpretative observational study under the qualitative paradigm of research, extracting the data through the completion of four focus groups with ten patients everyone. To complete the codification of the content of the participant’s discourses, we rely on the QRS NVivo 10 computer program.
ResultsIn the participant’s discourse concerning the main barriers to pharmacological treatment, for example “It’s because we live in a society and, because of that, we don’t go without medicine; if we didn’t live in society, we wouldn’t take medicine because we wouldn’t bother anyone”. Some examples of patient’s discourse, about perceived facilitators were: “I have to take medicine for my bipolar disorder, that’s it, I have a treatment, my illness has a name”.
ConclusionsThe main facilitators regarding the use of pharmacological treatment in Bipolar Disorder are the perceived need for treatment in the acute phase and the recognition of the illness, the shared clinical decision and the causal biological attribution in the chronic phase. About perceived barriers, social control is identified in both phases, adverse effects in the acute cases and the absence of effective treatment in the chronic state.