EFFICACY, TOLERABILITY AND SAFETY OF TIANEPTINE IN SPECIAL POPULATIONS OF DEPRESSIVE PATIENTS

Background: Tianeptine, a new generation antidepressant, possesses a unique mechanism of antidepressive action and has a specific pharmacokinetic profile. The aim of this study was to determine the efficacy, tolerability and safety of tianeptine in a “fragile” population of depressive patients: (1) a group of elderly patients and (2) a group with comorbid alcohol addiction. Subjects and methods: This was an open multicentric eight-week study of tianeptine efficacy, tolerability and safety including patients with mild to moderate depression (DSM-IV), age ≥55 years (group 1; n=45) or with comorbid alcohol addiction (group 2; n=32). Assessments was made with the following rating scales; MADRS, HAM-A and CGI for efficacy and DESS for tolerability. Results: After eight-week tianeptine therapy, remission (MADRS ≤12) was established in 51.1% and 84.4% patients, respectively. On day 7, the therapy led to a significant decrease of MADRS. On endpoint, there were significant differences on HAM-A, CGI-I and CGI-S scores (p<0.01). No adverse effects with frequency ≥ 10%, were registered. A lower tolerability of tianeptine was registered in a group of elderly (nausea 4.5%, leg fatigue 4.4%, irritability 2.2%, bursts of crying and sadness 2.2%), while only 3.1% depressive patients with comorbid alcohol addiction had dizziness. Conclusion: This is the first clinical study to evaluate tolerability, efficacy and safety of tianeptine in a special population of depressive patients in the region. The study showed that tianeptine had good efficacy in treatment of mild to moderate forms of depression in special populations of depressive patients (elderly population and patients with comorbid alcohol addiction). The drug was well tolerated

Olanzapine-high potency antipsychotic drug inducing significant weight gain: A case report

INTRODUCTION Olanzapine is a second generation antipsychotic (SGA) with a high level of therapeutic effectiveness in schizophrenia and other psychotic disorders. Along with the positive therapeutic effects, an increase of the body weight frequently occurs. According to the literature, the average weight gain is about 6-7 kg during several months of treatment. This could be valued as a moderate weight increase. CASE OUTLINE This article presents a case of a young female with schizophrenia, without clinical improvement with several antipsychotics (clozapine, risperidone, haloperidol) and with the occurrence of significant neurological side effects. The treatment started with olanzapine (baseline) was associated with good initial response (PANSS reduction 20% in the first two weeks) and the improvement was maintained further on (PANSS reduction 50% after 16 weeks). Significant increase (20 kg, 40%) in weight appeared during the following 16 weeks (BMI at baseline 17.9 kg/m2; BMI 16 weeks later 25.1 kg/m2). CONCLUSION High effectiveness of olanzapine in schizophrenia symptoms reduction was accompanied by a significant weight gain. However, this drug leads to impaired glucoregulation, dyslipidaemia etc. It also increases the risk of diabetes and cardio-vascular diseases, i.e. the main causes of mortality in schizophrenia after a suicide. Therefore, clinicians are suggested to focus on possible predictors of weight gain during olanzapine therapy, and act accordingly in order to prevent serious health consequences

EFFICACY, TOLERABILITY AND SAFETY OF TIANEPTINE IN SPECIAL POPULATIONS OF DEPRESSIVE PATIENTS

Background: Tianeptine, a new generation antidepressant, possesses a unique mechanism of antidepressive action and has a specific pharmacokinetic profile. The aim of this study was to determine the efficacy, tolerability and safety of tianeptine in a “fragile” population of depressive patients: (1) a group of elderly patients and (2) a group with comorbid alcohol addiction. Subjects and methods: This was an open multicentric eight-week study of tianeptine efficacy, tolerability and safety including patients with mild to moderate depression (DSM-IV), age ≥55 years (group 1; n=45) or with comorbid alcohol addiction (group 2; n=32). Assessments was made with the following rating scales; MADRS, HAM-A and CGI for efficacy and DESS for tolerability. Results: After eight-week tianeptine therapy, remission (MADRS ≤12) was established in 51.1% and 84.4% patients, respectively. On day 7, the therapy led to a significant decrease of MADRS. On endpoint, there were significant differences on HAM-A, CGI-I and CGI-S scores (p<0.01). No adverse effects with frequency ≥ 10%, were registered. A lower tolerability of tianeptine was registered in a group of elderly (nausea 4.5%, leg fatigue 4.4%, irritability 2.2%, bursts of crying and sadness 2.2%), while only 3.1% depressive patients with comorbid alcohol addiction had dizziness. Conclusion: This is the first clinical study to evaluate tolerability, efficacy and safety of tianeptine in a special population of depressive patients in the region. The study showed that tianeptine had good efficacy in treatment of mild to moderate forms of depression in special populations of depressive patients (elderly population and patients with comorbid alcohol addiction). The drug was well tolerated