Antipsychotics are effective in reducing positive and disorganization symptoms of schizophrenia. Although SGAs initially all
were believed to be more efficacious and tolerable than FGAs, several data show that the SGAs are no more effective than FGAs. In clinical practice, frequent switching of antipsychotic medications is widespread for lack of efficacy, adverse side effects, and partial or not-compliance response. This study suggested that most clinically stable inpatients with schizophrenia maintain their remission states after being switched to another atypical antipsychotic; but that at the end (after 20 years) of the observation period of our study, 11.54% of the patients assumed again typical antipsychotics (haloperidol)

Aldi, Gino

Del Buono, Gianfranco

Franza, Francesco

Solomita, Barbara

English

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S405Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 405-408 Conference paper © Medicinska naklada - Zagreb, CroatiaASSESSING THE CRITICAL ISSUES OF ATYPICAL ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS Francesco Franza1, Barbara Solomita2, Gino Aldi3 & Gianfranco Del Buono41Consultant of Neuropsychiatric Centre “Villa dei Pini”, Avellino, Italy  2Psychotherapist, “Neamente Association”, Avellino, Italy 3Director Training and Research Psychotherapeutic Institute “Zetema”, Caserta, Italy 4Division Psychiatry, "S. Giovanni di Dio and Ruggi D'Aragona” Hospital, University Salerno, Salerno, Italy SUMMARY Antipsychotics are effective in reducing positive and disorganization symptoms of schizophrenia. Although SGAs initially all were believed to be more efficacious and tolerable than FGAs, several data show that the SGAs are no more effective than FGAs. In clinical practice, frequent switching of antipsychotic medications is widespread for lack of efficacy, adverse side effects, and partial or not-compliance response. This study suggested that most clinically stable inpatients with schizophrenia maintain their remission states after being switched to another atypical antipsychotic; but that at the end (after 20 years) of the observation period of our study, 11.54% of the patients assumed again typical antipsychotics (haloperidol). Key words: schizophrenic spectrum – atypical antipsychotics – switching therapy *  *  *  *  *  BACKGROUNDSchizophrenia is a debilitating disease, ranked among the top 20 causes of disability worldwide (Vos 2010). Numerous studies have demonstrated more efficacy, tolerability of atypical than typical antipsychotics in schizophrenic patients. Evidence suggests that although second-generation atypical antipsychotics (SGAs) have a similar efficacy to first-generation typical antipsy-chotic agents (FGAs), they are more favourable in terms of tolerability, especially about extrapyramidal symp-toms (Murray 2017). However, the question of which antipsychotic drug should be preferred for treatment of the disease is controversial. Despite their proven efficacy and tolerability, in many patients clinicians switch several antipsychotic treatments due to the lack of therapeutic response (Kane 2012, Barak 2012). Meta-analyses generally do not support efficacy differences among the other atypical antipsychotics compared with the older typical agents. Some studies emphasise that the differences in efficacy among drugs were small, and smaller overall than those for side-effects (Keating 2017, Leucht 2013). Antipsychotics differ substantially in side-effects, and small but robust differences were seen in efficacy. Adverse effects have a significant impact on quality of life and adherence to medication and residual symptoms have an impact on quality of life too (Haro 2014). In daily clinical practice, frequent switching of antipsychotic medications is widespread for this aim. There are several reasons for switching, including a partial or complete lack of efficacy, adverse side effects, and partial or not-compliance with medica-tion (Correl 2011). Many physicians begin to switch antipsychotics with the original intention to discontinue the drug, but, eventually, continue with more drugs. However, owing to the diverse receptor profile of antipsychotics, it may be observed many adverse events when switching medications and clinicians should be cautious and closely monitor patients for potential ad-verse events during the switch (Su 2012). Several new atypical antipsychotics are now available; increasing clinical experience can provide study to long-time (Citrome 2012). We performed this study to determine the maintenance, effectiveness and tolerability of anti-psychotics demonstrated in a 20-years study comparing atypical vs typical antipsychotics in schizophrenic in/ outpatients. OBJECTIVE AND METHOD The aim of our observational study has been to determine the maintenance, effectiveness and toler-ability of antipsychotics in a 20-years period, comparing atypical (SGAs) vs typical (FGAs) antipsychotics in schizophrenic in/outpatients. This study has been the extension of our previous switching studies (Franza 2012, Franza 2006). Observational study in 78 inpatients with schizo-phrenia or schizoaffective disorder (DSM-IV and sub-sequently DSM-IV-TR and DSM 5) was observed for the first time in 1996 in Neuropsychiatric Centre “Villa dei Pini”, Avellino, Italy. Subsequently, those patients were evaluated clinically until 2016 in an observational ‘clinical routine’ setting and in practice office.Data were collected for effectiveness, remission, side effects, and compared to switching among antipsychotics (from haloperidol to clozapine/risperidone/olanzapine/ quetia-pine/ aripiprazole and/or back). At baseline all 78 inpatients took haloperidol. Francesco Franza, Barbara Solomita, Gino Aldi & Gianfranco Del Buono: ASSESSING THE CRITICAL ISSUES OF ATYPICAL  ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS          Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 405-408 S406Table 1. Epidemiological characteristics in 78 patients  Total Female MalePatients 78 30 48 Mean Age (years)  ± DS at baseline 31.18 ±11.34 33.27 ±10.68 27.83 ±13.36 Mean Education (years)  ± DS 9.42 ± 4.55 8.23 ±3.33 10.77 ±4.65 Mean Number  Admission (years) ± DS 6.21 ±1.91 5.90 ±2.07 6.40 ±1.77 Retrospectively, we evaluated also data collected during the period of observation in routine clinical setting. Some biological parameters such as blood arte-rial pressure, lipidic and glucidic profile, liver enzymes, complete blood count, electrocardiogram and body weight (and body mass index) were collected, too. Data were analyzed regularly and highlighted at the following times: baseline (T0); 1 year (T1); 5 years (T2); 10 years (T3); 15 years (T4); 20 years (T5) during every clinical control visit in relation to antipsychotic therapy. The rating scales administered were the follo-wing: Positive and Negative Syndrome Scale (PANSS) (Kay 1989); Brief Psychiatric Rating Scale; (BPRS) (Overall 1962), Quality of Life Index (QLi); (Ferrans 1985). Partial data were obtained with the Scale for the Assessment of Positive Symptoms (SAPS)(Andreasen 1984) and the Scale for Assessment of Negative Symp-toms (SANS) (Andreasen 1983). These scales were administered to each patient during hospitalization or outpatient control. The overall analysis consisted of the comparison of the upper bound of the 95% confidence interval (CI) baseline and at the end of the study of mean other scales of evaluation (PANSS: completed data; SAPS; SANS: partial data; Quality Life Index). [EZAnalyze© ver.3.0]. RESULTS We have observed discontinuity with substitution of initial treatment with typical antipsychotic (haloperidol) and beginning a new pharmacological treatment with atypical antipsychotics or possible return to a treatment with typical antipsychotics (oral or long–acting medi-cation). In each patient’s interview, we have recorded the following items appraised for every atypical used age; number of admissions/year; therapeutic compliance (family investigation); social operation; scholastic and/ or working activity; poli-drugs abuse. Furthermore, we have recorded the preceding switch treatment with typical to atypical. Table 1 shows the epidemiological data concerning the patients that have assumed atypical antipsychotics. Timetable (Figure 1) reports the sum-mary of antipsychotics switching about observational 20-year-study. Table 2. PANSS EZAnalyze Results Report - Paired T- Test of T (haloperidol) PANSS with T5 or Tn vs T5T0 Tn T5MeanHaloperidol Mean N Pairs: MeanDifferenceSE of Diff. EtaSquared T-Score PHaloperidol 128.818 77.636 11 51.182 10.295 0.692   4.971 0.001 Clozapine 124.370 82.815 27 41.556 2.483 0.912 16.735 0.000 Risperidone 120.478 92.173 23 28.304   7.061 0.411   4.009 0.001 Olanzapine 115.000 90.913 23 24.087   4.698 0.533   5.127 0.000 Quetiapine 109.250 89.750 20 19.500   4.228 0.515   4.612 0.000 Aripiprazole 115.375 88.688 32 26.688   4.186 0.560   6.376 0.000 Figure 1. Timetable: switching antipsychotics 136 schizophrenic patients from 1996 to 2016 Francesco Franza, Barbara Solomita, Gino Aldi & Gianfranco Del Buono: ASSESSING THE CRITICAL ISSUES OF ATYPICAL  ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS          Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 405-408 S407Table 2 reports the results to PANSS for any atypical treatment in each patient who has continued the initial therapy for all the period of observation and the rates of discontinuous therapy after the switch from typical antipsychotic (haloperidol). At the baseline their mean ages, gender distribution, baseline PANSS Scale scoreswere collected. In the clozapine group, the remission rates were higher than in the other groups and the 28.84% of patients that have started the treatment with risperidone and 42.85% with quetiapine have interrupted the therapy, and with the necessity of the assumption of a typical antipsychotic (haloperidol; haloperidol depot). A consistent number of patients (11.54%), who have suspended the “first” therapy with haloperidol, have assumed again the therapy with haloperidol at the end of the observation period. Outcome was good in 28.4%, intermediate in 50,1% and poor in 21%. Other parameterdata will be presented in another study, which is currently being processed. CONCLUSIONS Antipsychotics are effective in both treating the acute psychotic episode and preventing relapses. In addition, both FGAs and SGAs are effective in reducing positive and disorganization symptoms. Although SGAs were all initially believed to be more efficacious and tolerable than FGAs, several data show that the SGAs are no more effective than FGAs (Lieberman 2005). Antipsychotic medications cause a range of neurologic, metabolic, cardiovascular, gastrointestinal, hematologic, genitourinary, musculoskeletal, endocrine, and other side effects. In contrast to their broadly similar efficacy, antipsychotics differ markedly in their adverse effect profiles (Tandon 2014). Our study suggests that most clinically stable schizophrenic inpatients maintain their remission states after being switched to atypical antipsychotics. Therefore, it’s interesting to note that at the end of the period of observation (20 years: III Switching), 11.54% of the patients have assumed again typical antipsychotics, long-acting or oral, and the 51,18% have reported satisfactory and better therapeutic efficacy then previous pharmacological treatments with antipsychotics of second generation. Therefore, guide-lines are important for switching drugs nevertheless few ones are being developed (Poo 2015). When switching patients from one antipsychotic to another, a good clinical judgment and a conservative approach can be used to balance the risk of clinical exacerbation with that of increased adverse effects. It is not currently possible to predict which antipsychotic may be optimal for a given patient. To achieve optimal therapy for schizophrenia, clinicians must balance efficacy, risks, and benefits of treatments in a way that is customized for the needs and vulnerabilities of the individual patient (Tandon 2014). Acknowledgements: NoneConflict of interest: None to declare.Contribution of individual authors:Contribution of individual authors: All authors participated in literature searches and analyses, writing of the manuscript as well as on approval of the final version. References 1. Barak Y, Aizenberg D. 2012 Clinical and psychosocial remission in schizophrenia: correlations with anti-psychotic treatment. BMC Psychiatry 2012; 12:108. 2. Correll CU. Addressing adverse effects of antipsychotic treatment in young patients with schizophrenia. J Clin Psychiatry 2011; 72(1): e01. 3. 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Pharmacological guidelines for schizophrenia: a systematic review and comparison of recommendations for the first episode. BMJ Open 2017; 7:e0138818. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, Samara M, Barbui C, Engel RR, Geddes JR, Kissling W, Stapf MP, Lässig B, Salanti G, Davis JM. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet 2013; 382:951-62. 9. Lieberman JA, Stroup TS, McEvoy JP, et al; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005; 353:1209–122310. Murray R, Correll CU, Reynolds GP, and David Taylor D. Atypical antipsychotics: recent research findings and applications to clinical practice. Ther Adv Psycho-pharmacol 2017; 7(1 Suppl): 1–14.  11. Poo SX, Agius M. Atypical Antipsychotics for Schizophrenia and/or Bipolar Disorder in Pregnancy: Current Recommendations and Updates in the NICE Guidelines. Psychiatr Danub 2015 ;27 Suppl 1:S255-60. Francesco Franza, Barbara Solomita, Gino Aldi & Gianfranco Del Buono: ASSESSING THE CRITICAL ISSUES OF ATYPICAL  ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS          Psychiatria Danubina, 2017; Vol. 29, Suppl. 3, pp 405-408 S40812. Su J, Barr AM, Procyshyn RM. Adverse events associated with switching antipsychotics. J Psychiatry Neurosci. 2012; 37: E1–2. 13. Tandon R. Bridging the Efficacy-Effectiveness Gap in the Antipsychotic Treatment of Schizophrenia: Back to the Basics. J Clin Psychiatry 2014; 75:e1321-e1322. 11  14. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163–96. Correspondence: Francesco Franza, MD Consultant of Neuropsychiatric Centre “Villa dei Pini” Avellino, Italy  E-mail: franza.francesco@virgilio.it 

ASSESSING THE CRITICAL ISSUES OF ATYPICAL ANTIPSYCHOTICS IN SCHIZOPHRENIC INPATIENTS

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