Učinkovitost in varnost tablet paliperidona (Parnido®) v klinični praksi pri bolnikih s shizofrenijo ali shizoafektivno motnjo

Efficacy and Safety of Paliperidone Tablets (Parnido®) in Clinical Practice in Patients with Schizophrenia or Schizoaffective Disorder

Povzetek

Izhodišča Shizofrenija in shizoafektivna motnja sta psihotični motnji, ki v klasifikacijah nastopata kot ločeni diagnozi. Zaradi podobnosti ju je težko razlikovati, zlasti v zgodnji fazi, kar otežuje postavitev pravilne dia- gnoze in vpliva tudi na izbiro zdravljenja. Paliperidon v obliki tablet s podaljšanim sproščanjem je edini ati- pični antipsihotik na trgu, ki je indiciran za zdravljenje shizofrenije in shizoafektivne motnje. Namen nein- tervencijske študije je bil spremljati klinično učinkovitost in varnost tablet paliperidona v redni klinični praksi pri bolnikih s shizofrenijo in shizoafektivno motnjo.

Metode V neintervencijsko študijo je bilo vključenih 153 bolnikov. Spremljanje posameznega bolnika je trajalo dva meseca. Bolnik je imel tri obiske, kar je v skladu s klinično prakso. Pred spremljanjem je bila večina bolnikov (83,0 %) že zdravljena z drugim antipsihotikom. Tablete paliperidona (Parnido®) so bile pri skoraj polovici spremljanih bolnikov (49,3 %) uvedene v odmerku po 3 mg. Na drugem obisku se je že 72,5 % bol- nikov zdravilo s terapevtskim odmerkom po 6 mg ali več. Raziskovalci so učinkovitost zdravljenja ocenje- vali na podlagi globalnega kliničnega kazalnika resnosti bolezni (CGI-S) na vseh obiskih, globalnega klinič- nega kazalnika izboljšanja kliničnega stanja (CGI-I) na drugem in tretjem obisku ter na podlagi 7-stopenjskih lestvic, ki sta vrednotili socialno in poklicno funkcioniranje na vseh obiskih ter izboljšanje socialnega in poklicnega funkcioniranja na drugem in tretjem obisku. Neželeni dogodki so se spremljali od začetka vklju- čitve bolnika v študijo.

Rezultati Na podlagi rezultatov neintervencijske študije je bila potrjena učinkovitost tablet paliperidona, saj so se vsi štirje parametri, s katerimi so raziskovalci ocenjevali učinkovitost zdravljenja (ocena CGI-S, ocena CGI-I, ocena socialnega in poklicnega funkcioniranja bolnikov, ocena izboljšanja socialnega in poklicnega funkcioniranja bolnikov), statistično pomembno izboljšali. Po dveh mesecih spremljanja se je resnost bole- zni statistično značilno zmanjšala za 32 %. Delež bolnikov, ki niso bili več bolni oziroma so bili mejno do blago bolni, se je povečal na 57,6 % bolnikov. Klinično stanje se je izboljšalo pri 87,8 % bolnikov. Statistično pomembno, za 29 %, se je izboljšala ocena poklicnega in socialnega funkcioniranja. Ob koncu spremljanja je izboljšanje funkcioniranja doseglo 87,6 % bolnikov. Učinkovitost tablet s paliperidonom je bila dodatno potrjena tudi pri skupini bolnikov, ki so bili predhodno zdravljeni z risperidonom. Po dveh mesecih se je pri njih resnost bolezni relativno zmanjšala za 33 %, klinično stanje se je izboljšalo pri 93,1 % bolnikov, izbolj- šanje socialnega in poklicnega funkcioniranja pa je doseglo 92,9 % bolnikov. Bolniki so tablete paliperidona dobro prenašali, saj pri 84,3 % bolnikov med dvomesečnim spremljanjem ni bilo zabeleženih neželenih dogodkov. Vzročno povezani neželeni dogodki so se pojavili pri 14,4 % bolnikov, najpogosteje v prvem mesecu zdravljenja. Zaradi vzročno povezanih neželenih dogodkov je bilo zdravilo ukinjeno pri 3,3 % bolnikov.

Zaključki Neintervencijska študija je potrdila varnost in učinkovitost tablet paliperidona pri bolnikih s shi- zofrenijo in shizoafektivno motnjo v redni klinični praksi, ne glede na to, da je bila večina bolnikov z antip- sihotikom že zdravljena. Uvedba tablet s paliperidonom lahko vodi do izboljšanja kliničnih izidov zdravlje- nja tudi pri bolnikih, ki so bili predhodno zdravljeni z risperidonom.

Background Schizophrenia and schizoaffective disorder are psychotic disorders that are classified as two separate diagnoses. Owing to their similarities, it is difficult to distinguish between them, particularly at an early stage. This makes it difficult to give a correct diagnosis and also affects the choice of treatment. Pali- peridone prolonged-release tablets are the only atypical antipsychotic indicated for the treatment of schi- zophrenia and schizoaffective disorder that is available in the market. The purpose of the non-interventi- onal study was to monitor the clinical efficacy and safety of paliperidone tablets in regular clinical practice in patients with schizophrenia and schizoaffective disorder.

Methods The non-interventional study included 153 patients. Each patient was monitored for two months and was scheduled for three visits, which is in line with clinical practice. Most of the patients (83.0%) were treated with some other antipsychotic before inclusion in the study. Paliperidone (Parnido®) tablets were initiated at a dose of 3 mg in almost a half (49.3%) of the monitored patients. At visit 2, as many as 72.5% of the patients were treated with a therapeutic dose of 6 mg or higher. Investigators assessed the efficacy of treatment based on the Clinical Global Impression Rating Scale for Severity (CGI-S) at all visits and the Cli- nical Global Impression Scale for Improvement (CGI-I) at visits 2 and 3; based on the 7-point scales, they also evaluated the social and occupational functioning at all visits and the improvement of social and occu- pational functioning at visits 2 and 3. Adverse events were monitored from the start of the patient inclu- sion in the study.

Results The results of the non-interventional study confirmed the efficacy of paliperidone tablets as all four parameters used by the investigators for assessing the efficacy of treatment (CGI-S score, CGI-I score, scores for patients’ social and occupational functioning and scores for improvement in patients’ social and occupational functioning) were statistically significantly improved. After two months of monitoring, a sta- tistically significant reduction, by 32%, was observed in the severity of the disease. The percentage of the patients who were not at all ill or were borderline or mildly ill increased to 57.6%. The clinical condition improved in 87.8% of patients. Statistically significant improvement, by 29%, was observed in social and occupational functioning. At the end of the observation period, functioning was improved in 87.6% of the patients. The efficacy of paliperidone tablets was further confirmed in the group of patients who were pre- viously treated with risperidone. After two months, the severity of the disease in these patients was relati- vely reduced by 33%. In addition, the clinical condition improved in 93.1% of the patients and the social and occupational functioning in 92.9%. The treatment with paliperidone tablets was well tolerated as in 84.3% of the patients no adverse events were recorded. Causally related adverse events occurred in 14.4% of the patients, most frequently in the first month of the treatment. Owing to the causally related adverse events, the medicine was discontinued in 3.3% of the patients.

Conclusions The non-interventional study confirmed the safety and efficacy of paliperidone tablets used in regular clinical practice in the patients with schizophrenia and schizoaffective disorder regardless of the fact that most of them had been previously treated with an antipsychotic. The initiation of tablets contai- ning paliperidone may improve the clinical outcome of the treatment also in patients who had been pre- viously treated with risperidone.