A phase IV, open-label, multi-center study to evaluate the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia or schizophreniform disorder among Filipino patients

OBJECTIVE: This open-label, multi-center, non-randomized study evaluated the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia or schizophreniform disorder among Filipino patients. METHOD: Filipino outpatients with a DSM-IV diagnosis of either schizophrenia or schizophreniform disorder (N = 382) were enrolled in this study. They were treated with an initial dose of 10 mg/day of olanzapine with eventual titration to 5 to 20 mg/day as clinically indicated and were observed for 8 weeks. Efficacy was assessed with the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression - Severity of Illness Scale (CGI-S). Safety was assessed by collecting adverse event reports and checking vital signs. RESULTS: Statistically significant reductions from baseline to endpoint in both the mean BPRS Total score (from 36.77 +/- 12.12 to 11.43 +/10.39, p0.001) and mean CGI-S score (from 4.64 +/- 0.79 to 2.61 +/- 1.06, p0.001) were seen. The proportion of patients showing 20 percent improvement based on the BPRS Total score was 93.4 percent. Only 51 (13.7 percent) patients reported at least one treatment-emergent adverse event. The most commonly reported were somnolence (3.2 percent), weight loss (2.2 percent), tachycardia (1.3 percent), and headache (1.1 percent). CONCLUSION: The study clearly demonstrates the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia and schizophreniform disorder among Filipino patients.

Geriatric psychiatry in the Philippines

Geriatric psychiatry as a subspecialty is relatively new in our country. However, for a long time, psychiatrists in the Philippines have been treating elderly psychiatric patients.

Zolpidem in insomnia 3-year post-marketing surveillance study in the Philippines

A post-marketing surveillance study was conducted in the Philippines in routine practice and involved 1482 patients treated with zolpidem (Stilnox R), an imidazopyridine hypnotic agent. The patient population was 53.24 percent women and 45.28 percent men with a mean age of 47 years old (18.42 percent were over 65 years old). Of the patients, 44.26 percent were treated with a zolpidem dosage of 10 mg/day and 35.96 percent, 5mg/day. The treatment duration range from 2 to 35 days and a mean of 8 days. All adverse events were collected through spontaneous reporting. Thirty-nine patients (2.6 percent) reported 79 adverse events 20 (1.3 percent) of them discontinued treatment. CNS (central nervous system) related adverse events accounted for 70 percent of the total events. The most common events were headache and drowsiness the next day in 0.88 percent and 0.81 percent of the total cases respectivelv. Dizziness, lack of concentration, restlessness, hallucinations, nightmares, incoherence and disorientation were observed in a lower proportion, with one episode of twitching of the lower extremities. No serious adverse event was reported and no new risk factors or at-risk populations were identified. The safety profile of zolpidem is thus consistent with its known pharmacological properties, the results of previous clinical trials, and the cumulative international experience gained with this short-acting hypnotic drug.