Romanian Society of Pharmaceutical Sciences

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Clinical Hospital of Psychiatry “Prof.Dr.Alexandru Obregia”, Bucharest, Romania

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The symptoms of depression and those of cardiovascular disease (CVD) overlap substantially. Differentiating between dimensions of depressive symptoms may improve our understanding of the relationship between depression and physical health, in order to find a more adequate antidepressant treatment for patients having both depression and cardiovascular disease. Our aim was to assess the efficacy, tolerability and safety of tianeptine in depressed patients with moderate and severe cardio-vascular disorders. The present survey is an observational naturalistic study conducted in patients with important cardio-vascular disorders who underwent evaluation for depressive symptoms, using the Montgomery Asberg Depression Rating Scale (MADRS) and the selfevaluation Hospital Anxiety and Depression Scale (HADS). The MADRS and HADS were used to examine the efficacy of tianeptine after 28 days of antidepressant therapy. Tolerability of tianeptine and its effects on cardiovascular system was assesed. Fifty eight hospitalized patients meeting DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, forth edition, text revision) criteria for major depressive disorder, severe or moderate episode, who also had important cardio-vascular disorders: arterial hypertension, cardiac failure and ischemic heart disease were included in the study. The cardio-vascular disorders were clinically stable under specific treatment. Two ECG were performed: one at baseline and one after two weeks of treatment. The patients received 3 tablets of tianeptine 12.5 mg per day, and were monitored for 28 days regarding both efficacy and tolerability of the treatment. The efficacy of the treatment was assessed using the Montgomery Asberg Depression Rating Scale (MADRS), the self-evaluation Hospital Anxiety and Depression Scale (HADS) and the Clinical Global Impression Improvement Scale (CGI-I), in the first day and after 7, 14, 21 and 28 days of tianeptine treatment. The tolerability and safety were observed by monitoring the vital signs (blood pressure, pulse, respiratory frequency) and the adverse effects. For all patients, an ECG was performed after 2 weeks of treatment with tianeptine and was compared with the one made before admission, in order to monitor possible changes in heart conduction. After 4 weeks, 76% of the patients presented a very good improvement at CGI-I Scale, as 21% presented a good improvement. The mean MADRS total score decreased by 40% from baseline in patients with severe depressive episodes, and by 50%, in those who had moderate depressive episodes. There were no significant changes registered on the ECGs. There was a good tolerability of tianeptine, the adverse effects registered had mild intensity and left no sequelaes. Tianeptine appears to be as an efficient treatment in severe and moderate depression in patients with concomitant serious cardio-vascular disorders, and was well tolerated, with no important cardio-vascular adverse effects. Further studies are necessary to confirm these observations regarding the efficacy and tolerability of tianeptine in this group of patients.