METHODS: This was an open-label, prospective, observational study involving 339 patients from Indonesia, Pakistan, Malaysia, Thailand, and Singapore. Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression Severity scale (CGI-S), and safety parameters were assessed.
RESULTS: 62% of patients responded to olanzapine treatment, defined a priori as a reduction in BPRS of > 40% from baseline. Following the 8-week treatment period, the BPRS total, BPRS positive, BPRS negative, and CGI-S scores decreased by 18.7 (95% CI: 17.4, 20.2), 6.1 (5.6, 6.6), 2.9 (2.6, 3.2), and 1.5 points (median 1.0), respectively (p < 0.0001). In total, 31 of the 339 patients (9.1%) failed to complete the study according to the study description. Loss to follow-up and personal conflict were the most common reasons for discontinuation. There were 30 treatment-emergent adverse events with six serious cases, assessed as unrelated to study drug, reported.
CONCLUSION: This study further demonstrates the effectiveness and safety of olanzapine in actual clinical practice settings, in reducing the severity of psychopathological symptoms in Asian patients with schizophrenia.
METHODS: Patients (N = 281) with schizophrenia who had completed a randomized, double-blind (DB), 6-week comparison of lurasidone (40 and 80 mg/day) and placebo were enrolled in a 26-week extension study in which all patients received open-label (OL), flexible doses of lurasidone (40 or 80 mg/day). Effectiveness was measured using the Positive and Negative Syndrome Scale (PANSS) scale.
RESULTS: Fifty-seven percent of patients completed the OL extension study; 16.7% discontinued early due to lack of effectiveness; and 10.3% due to adverse events. The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%). Adverse events related to weight gain, metabolic parameters, prolactin, and ECG measures were uncommon. Mean change in the PANSS total score from the DB baseline to OL endpoint was -28.4, with mean improvement of -7.5 observed from baseline to OL endpoint, and with a PANSS responder rate of 73.7%.
DISCUSSION: The results of the current 26-week extension study found lurasidone to be a generally safe, well-tolerated, and effective long-term treatment for schizophrenia in Asian patients.
METHODS: A prospective study was performed for a period of 1 year among 180 newly diagnosed schizophrenics, aged 20-60 years to observe the symptoms, medication adherence and side effects. Morisky-Green-Levine Scale was used to evaluate medication adherence, LUNSER for side effects and PANSS to measure positive and negative symptoms. Data were analyzed using SPSS.
RESULTS: Positive symptoms (Male: Baseline 36.14 vs. endpoint 23.58, Female: 35.29 vs. 23.74) and negative symptoms (Males 27.9 vs. 20.05, Females 28.41 vs. 20.2) of schizophrenia were equally reduced after a follow up of 1 year in both the genders. Male population suffered more accumulative side effects (11.4 in males vs. 6.40 in females), extrapyramidal symptoms such as tardive dyskinesia and tremors (1.21 in males vs. 0.57 in females) and other side effects as compared to women (p ≤ .005). Males were found poorly adherent to antipsychotic treatment than females (93.3% in males vs. 6.7% in females (p ≤ .005).
CONCLUSIONS: Prescribing practices should not overlook sex specific factors like hormonal changes, altered brain morphology and socioeconomic factors that may be responsible for the difference in the response to the course of schizophrenia.