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1. Prevalence and correlates of QTc prolongation in Italian psychiatric care: cross-sectional multicentre study

Author

Nosè, M., Bighelli, I., Castellazzi, M., Martinotti, G., Carrà, G., Lucii, C., Ostuzzi, G., Sozzi, F., Barbui, C., Acciavatti, T., Adamo, A., Aguglia, A., Albanese, C., Baccaglini, S., Bardicchia, F., Barone, R., Barone, Y., Bartoli, F., Bergamini, C., Bertolini, F., Bolognesi, S., Bordone, A., Bortolaso, P., Bugliani, M., Calandra, C., Calò, S., Cardamone, G., Caroleo, M., Carra, E., Carretta, D., Chiocchi, L., Clerici, M., Corbo, M., Corsi, E., Costanzo, R., Costoloni, G., D'Arienzo, F., Debolini, S., De Capua, A., Di Napoli, W. A., Dinelli, M., Facchi, E., Fargnoli, F., Fiori, F., Franchi, A., Gardellin, F., Gazzoletti, E., Ghio, L., Giacomin, M., Gregis, M., Iovieno, N., Koukouna, D., Lax, A., Lintas, C., Luca, A., Luca, M., Lussetti, M., Madrucci, M., Magnani, N., Magni, L., Manca, E., Martorelli, C., Mattafirri, R., Percudani, M., Perini, G., Petrosemolo, P., Pezzullo, M., Piantanida, S., Pinna, F., Prato, K., Prestia, D., Quattrone, D., Reggianini, C., Restaino, F., Ribolsi, M., Rinosi, G., Rizzo, C., Rizzo, R., Roggi, M., Rossi, G., Rossi, S., Ruberto, S., Santoro, R., Santi, M., Signorelli, M. S., Soscia, F., Staffa, P., Stilo, M., Strizzolo, S., Suraniti, F., Tavian, N., Tortelli, L., Tosoni, F., Valdagno, M., Zanobini, V., Nosè, M, Bighelli, I, Castellazzi, M, Martinotti, G, Carra', G, Lucii, C, Ostuzzi, G, Sozzi, F, Barbui, C, Acciavatti, T, Adamo, A, Aguglia, A, Albanese, C, Baccaglini, S, Bardicchia, F, Barone, R, Barone, Y, Bartoli, F, Bergamini, C, Bertolini, F, Bolognesi, S, Bordone, A, Bortolaso, P, Bugliani, M, Calandra, C, Calò, S, Cardamone, G, Caroleo, M, Carra, E, Carretta, D, Chiocchi, L, Clerici, M, Corbo, M, Corsi, E, Costanzo, R, Costoloni, G, D'Arienzo, F, Debolini, S, De Capua, A, Di Napoli, W, Dinelli, M, Facchi, E, Fargnoli, F, Fiori, F, Franchi, A, Gardellin, F, Gazzoletti, E, Ghio, L, Giacomin, M, Gregis, M, Iovieno, N, Koukouna, D, Lax, A, Lintas, C, Luca, A, Luca, M, Lussetti, M, Madrucci, M, Magnani, N, Magni, L, Manca, E, Martorelli, C, Mattafirri, R, Percudani, M, Perini, G, Petrosemolo, P, Pezzullo, M, Piantanida, S, Pinna, F, Prato, K, Prestia, D, Quattrone, D, Reggianini, C, Restaino, F, Ribolsi, M, Rinosi, G, Rizzo, C, Rizzo, R, Roggi, M, Rossi, G, Rossi, S, Ruberto, S, Santoro, R, Santi, M, Signorelli, M, Soscia, F, Staffa, P, Stilo, M, Strizzolo, S, Suraniti, F, Tavian, N, Tortelli, L, Tosoni, F, Valdagno, M, and Zanobini, V

Subjects
Adult, Male, medicine.medical_specialty, Psychotropic drugs, Epidemiology, medicine.medical_treatment, Long QT syndrome, Antidepressant, Drug overdose, Adverse effect, QT interval, Antipsychotic, 03 medical and health sciences, Electrocardiography, 0302 clinical medicine, Risk Factors, Psychotropic drug, medicine, Prevalence, Humans, cardiovascular diseases, Psychiatry, Settore MED/25 - Psichiatria, Polypharmacy, business.industry, Environmental and Occupational Health, Public Health, Environmental and Occupational Health, Public Health, Psychiatry and Mental Health, Original Articles, medicine.disease, 030227 psychiatry, Substance abuse, Long QT Syndrome, Cross-Sectional Studies, Italy, Aripiprazole, Female, business, adverse effect, antipsychotic, psychotropic drugs, Antipsychotic Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract

Aims.In recent years several warnings have been issued by regulatory authorities on the risk of electrocardiogram abnormalities in individuals exposed to psychotropic drugs. As a consequence of these warnings, monitoring of the QT interval corrected for heart rate (QTc) has become increasingly common. This study was conducted to measure the frequency of QTc prolongation in unselected psychiatric patients, and to document the associated factors using a cross-sectional approach.Method.The study was carried out in 35 Italian psychiatric services that are part of the STAR (Servizi Territoriali Associati per la Ricerca) Network, a research group established to produce scientific knowledge by collecting data under ordinary circumstances. During a three-month period, a consecutive unselected series of both in- and out-patients were enrolled if they performed an ECG during the recruitment period and were receiving psychotropic drugs on the day ECG was recorded.Results.During the recruitment period a total of 2411 patients were included in the study. The prevalence of QTc prolongation ranged from 14.7% (men) and 18.6% (women) for the cut-off of 450 ms, to 1.26% (men) and 1.01% (women) for the cut-off of 500 ms. In the multivariate model conducted in the whole sample of patients exposed to psychotropic drugs, female sex, age, heart rate, alcohol and/or substance abuse, cardiovascular diseases and cardiovascular drug treatment, and drug overdose were significantly associated with QTc prolongation. In patients exposed to antipsychotic drugs, polypharmacy was positively associated with QTc prolongation, whereas use of aripiprazole decreased the risk. In patients exposed to antidepressant drugs, use of citalopram, citalopram dose and use of haloperidol in addition to antidepressant drugs, were all positively associated with QTc prolongation.Conclusions.The confirmation of a link between antipsychotic polypharmacy and QTc prolongation supports the current guidelines that recommend avoiding the concurrent use of two or more antipsychotic drugs, and the confirmation of a link between citalopram and QTc prolongation supports the need for routine QTc monitoring. The relatively low proportion of patients with QTc prolongation not only suggests compliance with current safety warnings issued by regulatory authorities, but also casts some doubts on the clinical relevance of QTc prolongation related to some psychotropic drugs.

Published
2016

2. First-generation antipsychotics and QTc: any role for mediating variables?

Author

Carrà, G., Crocamo, Cristina, Bartoli, F., Lax, A., Tremolada, Martina, Lucii, C., Martinotti, G., Nosè, M., Bighelli, I., Ostuzzi, G., Castellazzi, M., Clerici, M., Barbui, C., Acciavatti, T., Adamo, A., Aguglia, A., Albanese, C., Baccaglini, S., Bardicchia, F., Barone, R., Barone, Y., Bergamini, C., Bertolini, F., Bolognesi, S., Bordone, A., Bortolaso, P., Bugliani, M., Calandra, C., Calò, S., Cardamone, G., Caroleo, M., Carra, E., Carretta, D., Chiocchi, L., Cinosi, E., Corbo, M., Corsi, E., Costanzo, R., Costoloni, G., D’Arienzo, F., Debolini, S., De Capua, A., Di Napoli, W. A., Dinelli, M., Facchi, E., Fargnoli, F., Fiori, F., Franchi, A., Gardellin, F., Gastaldon, C., Gazzoletti, E., Ghio, L., Giacomin, M., Gregis, M., Iovieno, N., Koukouna, D., Lintas, C., Luca, A., Luca, M., Lussetti, M., Madrucci, M., Magnani, N., Magni, L., Manca, E., Martorelli, C., Mattafirri, R., Paladini, C., Papola, D., Percudani, M., Perini, G., Petrosemolo, P., Pezzullo, M., Piantanida, S., Pinna, F., Prato, K., Prestia, D., Quattrone, D., Reggianini, C., Restaino, F., Ribolsi, M., Rinosi, G., Rizzo, C., Rizzo, R., Roggi, M., Rossi, G., Rossi, S., Ruberto, S., Santi, M., Santoro, R., Sepede, G., Signorelli, M. S., Soscia, F., Sozzi, F., Staffa, P., Stilo, M., Strizzolo, S., Suraniti, F., Tavian, N., Tortelli, L., Tosoni, F., Valdagno, M., Zanobini, V., Carra', G, Crocamo, C, Bartoli, F, Lax, A, Tremolada, M, Lucii, C, Martinotti, G, Nosè, M, Bighelli, I, Ostuzzi, G, Castellazzi, M, Clerici, M, and Barbui, C

Subjects
Adult, Male, QT prolongation, alcohol, antipsychotic agents, drug therapy combination, risk factors, Antipsychotic Agents, Cross-Sectional Studies, Electrocardiography, Female, Heart Rate, Humans, Italy, Long QT Syndrome, Mental Disorders, Middle Aged, Pharmacology (medical), Settore MED/25 - Psichiatria, Neurology, Neurology (clinical), Psychiatry and Mental Health, antipsychotic agent, risk factor
Abstract

Objective: Corrected QT (QTc) interval prolongation is often associated with use of first-generation antipsychotics (FGAs). However, other factors require appropriate consideration, including age and gender, the role of other known medications associated with QTc prolongation, and severe comorbid conditions, such as co-occurring alcohol abuse/dependence. We aimed to study potential mediating roles of different, related, candidate variables on QTc. Methods: We capitalized on data from a large (N = 2366), cross-sectional, national survey, the STAR Network QTc study, using a representative sample of people taking FGAs, and recruited from mental health services across Italy. Results: About one-third of the sample was treated with FGAs, and almost one-tenth of the subjects took a different, additional, drug known to cause QTc prolongation. Our findings confirmed that there is an impact from FGAs, age, gender, alcohol misuse, and concurrent risky drugs on QTc. However, comorbid alcohol abuse/dependence and concurrent risky drugs did not mediate the effect of FGAs on QTc. Conclusions: Our findings showed that FGAs, concurrent risky drugs, and alcohol use disorders prolonged QTc. FGAs had a direct effect on QTc, confirming the need for clinicians to monitor a risk that could lead to sudden unexplained death. Copyright © 2016 John Wiley & Sons, Ltd.

Published
2016

3. Reasons for initiating long-acting antipsychotics in psychiatric practice: findings from the STAR Network Depot Study

Author

Barbui, Corrado, Bertolini, Federico, Bartoli, Francesco, Calandra, Carmela, Callegari, Camilla, Carrà, Giuseppe, D’Agostino, Armando, Lucii, Claudio, Martinotti, Giovanni, Mastromo, Daniele, Moretti, Daniele, Monzani, Emiliano, Porcellana, Matteo, Prestia, Davide, Ostuzzi, Giovanni, Nose, Michela, Purgato, Marianna, Turrini, Giulia, Mazzi, Maria, Angela, Papola, Davide, Gastaldon, Chiara, Terlizzi, Samira, Piccoli, Alberto, Ruggeri, Mirella, De Fazio, Pasquale, Magliocco, Fabio, Caroleo, Mariarita, Raffaele, Gaetano, D'Agostino, Armando, Ostinelli, Edoardo, Giuseppe, Chirico, Margherita, Cavallotti, Simone, Bolognesi, Simone, Debolini, Sara, Pierantozzi, Elisa, Fargnoli, Francesco, Del Zanna, Maria, Giannini, Alessandra, Luccarelli, Livia, De Capua, Alberto, Annese, Pasqua, Maria, Cerretini, Massimiliano, Tozzi, Fiorella, Magnani, Nadia, Cardamone, Giuseppe, Bardicchia, Francesco, Facchi, Edvige, Soscia, Federica, Zotos, Spyridon, Biancosino, Bruno, Zonta, Filippo, Pompei, Francesco, Zizolfi, Daniele, Poloni, Nicola, Ielmini, Marta, Caselli, Ivano, Giana, Edoardo, Buzzi, Aldo, Emanuele, Diurni, Marcello, Milano, Anna, Sani, Emanuele, Calzolari, Roberta, Bortolaso, Paola, Piccinelli, Marco, Cazzamalli, Sara, Caterina, Alberini, Gabro, Piantanida, Silvia, Costantini, Chiara, Paronelli, Chiara, Di Caro, Angela, Moretti, Valentina, Gozzi, Mauro, D'Ippolito, Chiara, Barbanti Silva, Veronica, Papalini, Alessandro, Corbo, Mariangela, Campese, Ornella, Fiori, Federica, Lorusso, Marco, Di Capro, Lucia, Viceconte, Daniela, Mancini, Valerio, Suraniti, Francesco, Signorelli, Maria, Salvina, Rossi, Eugenio, Lupoli, Pasqualino, Menchetti, Marco, Terzi, Laura, Boso, Marianna, Risaro, Paolo, De Paoli, Giuseppe, Catania, Cristina, Tarricone, Ilaria, Caretto, Valentina, Storbini, Viviana, Emiliani, Roberta, Balzarro, Beatrice, Carra, Giuseppe, Tabacchi, Tommaso, Nava, Roberto, Bono, Adele, Provenzi, Milena, Brambilla, Giulia, Aspesi, Flora, Tremolada, Martina, Castagna, Gloria, Bava, Mattia, Verrengia, Enrica, Lucchi, Sara, Oriani, Maria, Ginevra, Barchiesi, Michela, Pacetti, Monica, Aguglia, Andrea, Magni, Laura, Rosa, Rossi, Giuseppe, Beneduce, Rossella, Tura, Giovanni, Battista, Laffranchini, Laura, Ferrato, Farida, Restaino, Francesco, Limosani, Ivan, Ghio, Lucio, Ferro, Maurizio, Parise, Vincenzo, Fricchione, Balletta, Giovanni, Addeo, Lelio, De Vivo, Elisa, Di Benedetto, Rossella, Pinna, Federica, Carpiniello, Bernardo, Spano, Mariangela, Giacomin, Marzio, Pecile, Damiano, Mattei, Chiara, Fabrici, Elisabetta, Pascolo, Panarello, Sofia, Peresson, Giulia, Vitucci, Claudio, Bonavigo, Tommaso, Perini, Giovanni, Boschello, Filippo, Strizzolo, Stefania, Gardellin, Francesco, Di Giannantonio, Massimo, Fizzotti, Carlo, Cossetta, Edoardo, Di Gregorio, Luana, Sozzi, Francesca, Boncompagni, Giancarlo, La Barbera, Daniele, Colli, Giuseppe, Laurenzi, Sabrina, Luca, Maria, Crocamo, Carlo, Barbui, C, Bertolini, F, Bartoli, F, Calandra, C, Callegari, C, Carrà, G, D'Agostino, A, Lucii, C, Martinotti, G, Mastromo, D, Moretti, D, Monzani, E, Porcellana, M, Prestia, D, and Ostuzzi, G

Subjects
medicine.medical_specialty, psychiatric practice, lcsh:RC435-571, Treatment adherence, viruses, medicine.medical_treatment, antipsychotic, long-acting injectable, prescribing attitudes, survey, immune system diseases, lcsh:Psychiatry, medicine, Psychiatry, Antipsychotic, prescribing attitude, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Original Research, business.industry, lcsh:RM1-950, virus diseases, lcsh:Therapeutics. Pharmacology, Long acting, Psychology (miscellaneous), business
Abstract

Background: Long acting injectable (LAI) antipsychotics have been claimed to ensure treatment adherence and possibly reduce the daily burden of oral formulations. So far, only surveys investigating the theoretical prescribing attitudes of clinicians have been employed. On this basis, we aimed to investigate reasons for prescribing LAIs in a real-world, unselected sample of patients. Methods: The STAR Network Depot Study is an observational, multicentre study consecutively enrolling adults initiating a LAI over a 12-months period. Clinical severity was assessed with the Brief Psychiatric Rating Scale, and patient’s attitude toward medications with the Drug Attitude Inventory 10 items. Psychiatrists recorded reasons for LAI prescribing for each study participant. Responses were grouped into six non-mutually exclusive categories: aggressiveness, patient engagement, ease of drug taking, side-effects, stigma, adherence. Results: Of the 451 patients included, two-thirds suffered from chronic psychoses. Improving patient engagement with the outpatient psychiatric service was the most common reason for prescribing LAIs (almost 80% of participants), followed by increasing treatment adherence (57%), decreasing aggressiveness (54%), and improving ease of drug taking (52%). After adjusting for confounders, logistic regression analyses showed that reasons for LAI use were associated with LAI choice (e.g. first-generation LAIs for reducing aggressiveness). Conclusion: Despite the wide availability of novel LAI formulation and the emphasis on their wider use, our data suggest that the main reasons for LAI use have remained substantially unchanged over the years, focusing mostly on improving patient’s engagement. Further, clinicians follow implicit prescribing patterns when choosing LAIs, and this may generate hypotheses for future experimental studies.

Published
2020

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