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1. Comparing Long-Acting Antipsychotic Discontinuation Rates Under Ordinary Clinical Circumstances: A Survival Analysis from an Observational, Pragmatic Study

Author

Bertolini, F., Ostuzzi, G., Pievani, M., Aguglia, A., Bartoli, F., Bortolaso, P., Callegari, C., Caroleo, M., Carra, G., Corbo, M., D'Agostino, A., De Fazio, P., Magliocco, F., Martinotti, G., Ostinelli, E. G., Piccinelli, M. P., Tedeschi, F., Barbui, C., Boschello, F., Gastaldon, C., Mazzi, M. A., Nose, M., Papola, D., Perini, G., Piccoli, A., Purgato, M., Ruggeri, M., Terlizzi, S., Turrini, G., Raffaele, G., Cavallotti, S., Chirico, M., Ferrato, F., Limosani, I., Mastromo, D., Monzani, E., Porcellana, M., Restaino, F., Annese, P. M., Bolognesi, S., Cerretini, M., De Capua, A., Debolini, S., Del Zanna, M., Fargnoli, F., Giannini, A., Luccarelli, L., Lucii, C., Pierantozzi, E., Tozzi, F., Bardicchia, F., Cardamone, G., Facchi, E., Magnani, N., Soscia, F., Biancosino, B., Zotos, S., Giacomin, M., Pompei, F., Spano, M., Zonta, F., Buzzi, A., Callegred, C., Calzolari, R., Caselli, I., Diurni, M., Giana, E., Ielmini, M., Milano, A., Poloni, N., Sani, E., Zizolfi, D., Alberini, G., Cazzamalli, S., Costantini, C., Di Caro, A., Paronelli, C., Piantanida, S., Piccinelli, M., Alessandro, P., Barbanti, S. V., D'Ippolito, C., Gozzi, M., Moretti, V., Campese, O., Di Capro, L., di Giannantonio, M., Fiori, F., Lorusso, M., Mancini, V., Viceconte, D., Calandra, C., Luca, M., Signorelli, M. S., Suraniti, F., Balzarro, B., Boncompagni, G., Caretto, V., Emiliani, R., Lupoli, P., Menchetti, M., Rossi, E., Storbini, V., Tarricone, I., Terzi, L., Boso, M., Catania, C., De Paoli, G., Risaro, P., Aspesi, F., Bava, M., Bono, A., Brambilla, G., Castagna, G., Lucchi, S., Nava, R., Provenzi, M., Tabacchi, T., Tremolada, M., Verrengia, E., Barchiesi, M., Oriani, M. G., Pacetti, M., Ferro, M., Ghio, L., Beneduce, R., Laffranchini, L., Magni, L. R., Rossi, G., Tura, G. B., Addeo, L., Balletta, G., De Vivo, E., Di Benedetto, R., Parise, V. F., Carpiniello, B., Pinna, F., Pecile, D., Mattei, C., Bonavigo, T., Fabrici, E. P., Panarello, S., Peresson, G., Vitucci, C., Gardellin, F., Strizzolo, S., Cossetta, E., Fizzotti, C., Moretti, D., Di Gregorio, L., Sozzi, F., Colli, G., La Barbera, D., Laurenzi, S., Bertolini, F, Ostuzzi, G, Pievani, M, Aguglia, A, Bartoli, F, Bortolaso, P, Callegari, C, Caroleo, M, Carra, G, Corbo, M, D'Agostino, A, De Fazio, P, Magliocco, F, Martinotti, G, Ostinelli, E, Piccinelli, M, Tedeschi, F, Barbui, C, Boschello, F, Gastaldon, C, Mazzi, M, Nose, M, Papola, D, Perini, G, Piccoli, A, Purgato, M, Ruggeri, M, Terlizzi, S, Turrini, G, Raffaele, G, Cavallotti, S, Chirico, M, Ferrato, F, Limosani, I, Mastromo, D, Monzani, E, Porcellana, M, Restaino, F, Annese, P, Bolognesi, S, Cerretini, M, De Capua, A, Debolini, S, Del Zanna, M, Fargnoli, F, Giannini, A, Luccarelli, L, Lucii, C, Pierantozzi, E, Tozzi, F, Bardicchia, F, Cardamone, G, Facchi, E, Magnani, N, Soscia, F, Biancosino, B, Zotos, S, Giacomin, M, Pompei, F, Spano, M, Zonta, F, Buzzi, A, Calzolari, R, Caselli, I, Diurni, M, Giana, E, Ielmini, M, Milano, A, Poloni, N, Sani, E, Zizolfi, D, Alberini, G, Cazzamalli, S, Costantini, C, Di Caro, A, Paronelli, C, Piantanida, S, Alessandro, P, Barbanti, S, D'Ippolito, C, Gozzi, M, Moretti, V, Campese, O, Di Capro, L, di Giannantonio, M, Fiori, F, Lorusso, M, Mancini, V, Viceconte, D, Calandra, C, Luca, M, Signorelli, M, Suraniti, F, Balzarro, B, Boncompagni, G, Caretto, V, Emiliani, R, Lupoli, P, Menchetti, M, Rossi, E, Storbini, V, Tarricone, I, Terzi, L, Boso, M, Catania, C, De Paoli, G, Risaro, P, Aspesi, F, Bava, M, Bono, A, Brambilla, G, Castagna, G, Lucchi, S, Nava, R, Provenzi, M, Tabacchi, T, Tremolada, M, Verrengia, E, Barchiesi, M, Oriani, M, Pacetti, M, Ferro, M, Ghio, L, Beneduce, R, Laffranchini, L, Magni, L, Rossi, G, Tura, G, Addeo, L, Balletta, G, De Vivo, E, Di Benedetto, R, Parise, V, Carpiniello, B, Pinna, F, Pecile, D, Mattei, C, Bonavigo, T, Fabrici, E, Panarello, S, Peresson, G, Vitucci, C, Gardellin, F, Strizzolo, S, Cossetta, E, Fizzotti, C, Moretti, D, Di Gregorio, L, Sozzi, F, Colli, G, La Barbera, D, Laurenzi, S, Bertolini F., Ostuzzi G., Pievani M., Aguglia A., Bartoli F., Bortolaso P., Callegari C., Caroleo M., Carra G., Corbo M., D'Agostino A., De Fazio P., Magliocco F., Martinotti G., Ostinelli E.G., Piccinelli M.P., Tedeschi F., Barbui C., Boschello F., Gastaldon C., Mazzi M.A., Nose M., Papola D., Perini G., Piccoli A., Purgato M., Ruggeri M., Terlizzi S., Turrini G., Raffaele G., Cavallotti S., Chirico M., Ferrato F., Limosani I., Mastromo D., Monzani E., Porcellana M., Restaino F., Annese P.M., Bolognesi S., Cerretini M., De Capua A., Debolini S., Del Zanna M., Fargnoli F., Giannini A., Luccarelli L., Lucii C., Pierantozzi E., Tozzi F., Bardicchia F., Cardamone G., Facchi E., Magnani N., Soscia F., Biancosino B., Zotos S., Giacomin M., Pompei F., Spano M., Zonta F., Buzzi A., Callegred C., Calzolari R., Caselli I., Diurni M., Giana E., Ielmini M., Milano A., Poloni N., Sani E., Zizolfi D., Alberini G., Cazzamalli S., Costantini C., Di Caro A., Paronelli C., Piantanida S., Piccinelli M., Alessandro P., Barbanti S.V., D'Ippolito C., Gozzi M., Moretti V., Campese O., Di Capro L., di Giannantonio M., Fiori F., Lorusso M., Mancini V., Viceconte D., Calandra C., Luca M., Signorelli M.S., Suraniti F., Balzarro B., Boncompagni G., Caretto V., Emiliani R., Lupoli P., Menchetti M., Rossi E., Storbini V., Tarricone I., Terzi L., Boso M., Catania C., De Paoli G., Risaro P., Aspesi F., Bava M., Bono A., Brambilla G., Castagna G., Lucchi S., Nava R., Provenzi M., Tabacchi T., Tremolada M., Verrengia E., Barchiesi M., Oriani M.G., Pacetti M., Ferro M., Ghio L., Beneduce R., Laffranchini L., Magni L.R., Rossi G., Tura G.B., Addeo L., Balletta G., De Vivo E., Di Benedetto R., Parise V.F., Carpiniello B., Pinna F., Pecile D., Mattei C., Bonavigo T., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Gardellin F., Strizzolo S., Cossetta E., Fizzotti C., Moretti D., Di Gregorio L., Sozzi F., Colli G., La Barbera D., and Laurenzi S.

Subjects
Male, Pediatrics, respectively), 0302 clinical medicine, Delayed-Action Preparation, Brief Psychiatric Rating Scale, Pharmacology (medical), he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, Original Research Article, Prospective Studies, Prospective cohort study, treatment, Mental Disorders, Hazard ratio, whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, Psychiatric Status Rating Scale, Middle Aged, side efects, Psychiatry and Mental health, Italy, Mental Disorder, Female, he STAR Network ‘Depot Study’ prospectively followed 394 subjects initiating treatment with long-acting injections (LAIs) of antipsychotics under naturalistic conditions for 12 months. LAI discontinuation was frequent in everyday clinical practice in Italy, occurring in almost 40% of the entire sample, side efects, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, respectively), whereas more than half of participants initiating risperidone LAI and olanzapine LAI discontinued during the 12 months of follow-up (51.4 and 62.5%, respectively). In multivariate analysis, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Human, Antipsychotic Agents, medicine.drug, Psychopathology, Adult, medicine.medical_specialty, Discontinuation, Follow-Up Studie, Medication Adherence, 03 medical and health sciences, medicine, Humans, Paliperidone, Adverse effect, Settore MED/25 - Psichiatria, discontinuation rates, Psychiatric Status Rating Scales, respectively). In multivariate analysis, business.industry, Long-Acting Antipsychotic, long-acting injectable antipsychotics, Survival Analysis, Confidence interval, participant refusal to continue LAIs and LAIs no longer being required were the most frequently reported reasons for discontinuation. Paliperidone LAI and aripiprazole LAI were the least discontinued medications (33.9 and 35.4%, 030227 psychiatry, Prospective Studie, Antipsychotic Agent, occurring in almost 40% of the entire sample, Delayed-Action Preparations, Neurology (clinical), business, 030217 neurology & neurosurgery, being prescribed olanzapine LAI and poor medication adherence at baseline were signifcantly associated with higher discontinuation risk, Follow-Up Studies
Abstract

Background Recent guidelines suggested a wider use of long-acting injectable antipsychotics (LAI) than previously, but naturalistic data on the consequences of LAI use in terms of discontinuation rates and associated factors are still sparse, making it hard for clinicians to be informed on plausible treatment courses. Objective Our objective was to assess, under real-world clinical circumstances, LAI discontinuation rates over a period of 12 months after a first prescription, reasons for discontinuation, and associated factors. Methods The STAR Network ‘Depot Study’ was a naturalistic, multicentre, observational prospective study that enrolled subjects initiating a LAI without restrictions on diagnosis, clinical severity or setting. Participants from 32 Italian centres were assessed at baseline and at 6 and 12 months of follow-up. Psychopathology, drug attitude and treatment adherence were measured using the Brief Psychiatric Rating Scale, the Drug Attitude Inventory and the Kemp scale, respectively. Results The study followed 394 participants for 12 months. The overall discontinuation rate at 12 months was 39.3% (95% confidence interval [CI] 34.4–44.3), with paliperidone LAI being the least discontinued LAI (33.9%; 95% CI 25.3–43.5) and olanzapine LAI the most discontinued (62.5%; 95% CI 35.4–84.8). The most frequent reason for discontinuation was onset of adverse events (32.9%; 95% CI 25.6–40.9) followed by participant refusal of the medication (20.6%; 95% CI 14.6–27.9). Medication adherence at baseline was negatively associated with discontinuation risk (hazard ratio [HR] 0.853; 95% CI 0.742–0.981; p = 0.026), whereas being prescribed olanzapine LAI was associated with increased discontinuation risk compared with being prescribed paliperidone LAI (HR 2.156; 95% CI 1.003–4.634; p = 0.049). Conclusions Clinicians should be aware that LAI discontinuation is a frequent occurrence. LAI choice should be carefully discussed with the patient, taking into account individual characteristics and possible obstacles related to the practicalities of each formulation. Supplementary Information The online version contains supplementary material available at 10.1007/s40263-021-00809-w.

Published
2021

2. Clinical correlates of paliperidone palmitate and aripiprazole monohydrate prescription for subjects with schizophreniaspectrum disorders: Findings from the STAR Network Depot Study

Author

Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli F., Ostuzzi G., Crocamo C., Corbo M., D'Agostino A., Martinotti G., Ostinelli E.G., Tabacchi T., Barbui C., Carr G., Nose M., Purgato M., Turrini G., Mazzi M.A., Papola D., Gastaldon C., Terlizzi S., Bertolini F., Piccoli A., Ruggeri M., De Fazio P., Magliocco F., Caroleo M., Raffaele G., Chirico M., Cavallotti S., Lucii C., Bolognesi S., Debolini S., Pierantozzi E., Fargnoli F., Del Zanna M., Giannini A., Luccarelli L., De Capua A., Annese P.M., Cerretini M., Tozzi F., Magnani N., Cardamone G., Bardicchia F., Facchi E., Soscia F., Zotos S., Biancosino B., Zonta F., Pompei F., Callegari C., Zizolfi D., Poloni N., Ielmini M., Caselli I., Giana E., Buzzi A., Diurni M., Milano A., Sani E., Calzolari R., Bortolaso P., Piccinelli M., Cazzamalli S., Alberini G., Piantanida S., Costantini C., Paronelli C., Di Caro A., Moretti V., Gozzi M., D'Ippolito C., Barbanti S.V., Papalini A., Campese O., Fiori F., Lorusso M., Di Capro L., Viceconte D., Mancini V., Suraniti F., Signorelli M.S., Rossi E., Lupoli P., Menchetti M., Terzi L., Boso M., Risaro P., De Paoli G., Catania C., Tarricone I., Caretto V., Storbini V., Emiliani R., Balzarro B., Carra G., Nava R., Bono A., Provenzi M., Brambilla G., Aspesi F., Trotta G., Tremolada M., Castagna G., Bava M., Verrengia E., Lucchi S., Oriani M.G., Barchiesi M., Pacetti M., Aguglia A., Magni L.R., Rossi G., Beneduce R., Tura G.B., Laffranchini L., Mastromo D., Ferrato F., Restaino F., Monzani E., Porcellana M., Limosani I., Ghio L., Ferro M., Parise V.F., Balletta G., Addeo L., De Vivo E., Di Benedetto R., Pinna F., Carpiniello B., Spano M., Giacomin M., Pecile D., Mattei C., Fabrici E.P., Panarello S., Peresson G., Vitucci C., Bonavigo T., Perini G., Boschello F., Strizzolo S., Gardellin F., Di Giannantonio M., Moretti D., Fizzotti C., Cossetta E., Di Gregorio L., Sozzi F., Boncompagni G., La Barbera D., Colli G., Laurenzi S., Calandra C., Luca M., Barbui C, Nosè M, Purgato M, Turrini G, Ostuzzi G, Mazzi MA, Papola D, Gastaldon C, Terlizzi S, Bertolini F, Piccoli A, Ruggeri M, De Fazio P, Magliocco F, Caroleo M, Raffaele G, D'Agostino A, Ostinelli EG, Chirico M, Cavallotti S, Lucii C, Bolognesi S, Debolini S, Pierantozzi E, Fargnoli F, Del Zanna M, Giannini A, Luccarelli L, De Capua A, Annese PM, Cerretini M, Tozzi F, Magnani N, Cardamone G, Bardicchia F, Facchi E, Soscia F, Zotos S, Biancosino B, Zonta F, Pompei F, Callegari C, Zizolfi D, Poloni N, Ielmini M, Caselli I, Giana E, Buzzi A, Diurni M, Milano A, Sani E, Calzolari R, Bortolaso P, Piccinelli M, Cazzamalli S, Alberini G, Piantanida S, Costantini C, Paronelli C, Di Caro A, Moretti V, Gozzi M, D'Ippolito C, Barbanti SV, Papalini A, Corbo M, Martinotti G, Campese O, Fiori F, Lorusso M, Di Capro L, Viceconte D, Mancini V, Suraniti F, Signorelli MSI, Rossi E, Lupoli P, Menchetti M, Terzi L, Boso M, Risaro P, De Paoli G, Catania C, Tarricone I, Caretto V, Storbini V, Emiliani R, Balzarro B, Carrà G, Bartoli F, Tabacchi T, Nava R, Bono A, Provenzi M, Brambilla G, Aspesi F, Trotta G, Tremolada M, Castagna G, Bava M, Verrengia E, Lucchi S, Oriani MG, Barchiesi M, Pacetti M, Aguglia A, Magni LR, Rossi G, Beneduce R, Tura GB, Laffranchini L, Mastromo D, Ferrato F, Restaino F, Monzani E, Porcellana M, Limosani I, Ghio L, Ferro M, Parise VF, Balletta G, Addeo L, De Vivo E, Di Benedetto R, Pinna F, Carpiniello B, Spano M, Giacomin M, Pecile D, Mattei C, Fabrici EP, Panarello S, Peresson G, Vitucci C, Bonavigo T, Perini G, Boschello F, Strizzolo S, Gardellin F, Di Giannantonio M, Moretti D, Fizzotti C, Cossetta E, Di Gregorio L, Sozzi F, Boncompagni G, La Barbera D, Colli G, Laurenzi S, Calandra C, Luca M, Crocamo C, STAR Network Depot Investigators, Bartoli, F, Ostuzzi, G, Crocamo, C, Corbo, M, D'Agostino, A, Martinotti, G, Ostinelli, E, Tabacchi, T, Barbui, C, and Carra, G

Subjects
Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Adult, Antipsychotic Agents, Aripiprazole, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Medication Adherence, Paliperidone Palmitate, Practice Patterns, Physicians', Schizophrenic Psychology, Young Adult, Long-acting injectable antipsychotic, medicine.medical_specialty, medicine.medical_treatment, Aripiprazole monohydrate, Long-acting injectable antipsychotics, Paliperidone palmitate, Schizophrenia, Practice Patterns, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Brief Psychiatric Rating Scale, medicine, Pharmacology (medical), Antipsychotic, Settore MED/25 - Psichiatria, Practice, Physicians', business.industry, Health Knowledge, medicine.disease, 030227 psychiatry, Psychiatry and Mental health, Attitudes, Propensity score matching, Observational study, business, 030217 neurology & neurosurgery, medicine.drug, Psychopathology
Abstract

This study, based on the 'Servizi Territoriali Associati per la Ricerca' (STAR) Network Depot Study nationwide baseline data, explored whether individual symptoms severity and clusters might influence the prescription of paliperidone palmitate 1-month (PP1M) vs. aripiprazole monohydrate. The Brief Psychiatric Rating Scale (BPRS) was used to assess psychopathology and relevant symptoms clusters. Drug Attitude Inventory, 10 items, was used to test attitude towards medications. Adherence to treatments was rated according to the Kemp seven-point scale. We assessed for eligibility 451 individuals and, among them, we included 195 subjects (n = 117 who started PPM1 and n = 78 aripiprazole monohydrate). Individuals were comparable in terms of age, gender, treatment years, recent hospitalizations, previous long-acting injectable antipsychotic treatments, additional oral treatments, attitude toward drugs, medication adherence, and alcohol/substance-related comorbidities. Subjects starting PP1M presented higher BPRS overall (P = 0.009), positive (P = 0.015), and negative (P = 0.010) symptom scores compared to subjects starting aripiprazole monohydrate. Results were confirmed by appropriate regression models and propensity score matching analysis. No differences were found comparing the other BPRS subscale scores: affect, resistance, and activation. Clinicians may be more prone to prescribe PPM1, rather than aripiprazole monohydrate, to subjects showing higher overall symptom severity, including positive and negative symptoms. No additional clinical factors influenced prescribing attitudes in our sample.

Published
2020

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