Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE

Vladimir E Medvedev Department of Psychiatry, Psychotherapy and Psychosomatic Pathology, RUDN University, Moscow, Russia Background: PULSE was a large, observational, multicenter study designed to evaluate the efficacy and safety of agomelatine in the treatment of major depression in patients with...

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Autor principal:	Medvedev VE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Depression cardiovascular disease agomelatine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/9ecac9d8bbe74d0c9d69023c0f666176
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spelling	oai:doaj.org-article:9ecac9d8bbe74d0c9d69023c0f6661762021-12-02T05:28:29ZAgomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE1178-2021https://doaj.org/article/9ecac9d8bbe74d0c9d69023c0f6661762017-04-01T00:00:00Zhttps://www.dovepress.com/agomelatine-in-the-treatment-of-mild-to-moderate-depression-in-patient-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Vladimir E Medvedev Department of Psychiatry, Psychotherapy and Psychosomatic Pathology, RUDN University, Moscow, Russia Background: PULSE was a large, observational, multicenter study designed to evaluate the efficacy and safety of agomelatine in the treatment of major depression in patients with cardiovascular disease (CVD).Methods: Patients with mild-to-moderate major depressive episodes, without psychotic symptoms, were treated as outpatients or in cardiac facilities in 46 regions of Russia. The patients received antidepressant monotherapy with agomelatine 25 or 50 mg, once daily, for 12 weeks.Results: The mean age of the patients (N=896) was 51.4±9.9 years, and 68.5% were women. A progressive improvement in the total score on both the anxiety and depression subscales of the Hospital Anxiety and Depression Scale (HADS), from 13.1±3.8 and 13.9±3.1 at baseline to 3.7±2.8 and 3.9±3.0, respectively, was observed by 12 weeks. All individual HADS scores improved rapidly; the change between visits was also significant (P<0.0001). The majority (84.6%) were remitters (HADS total score <7) by 12 weeks. The Clinical Global Impression – Severity and Improvement scores also improved quickly. The mean hypochondria index (Whiteley Index) decreased significantly from 48.0±11.8 at baseline to 25.2±9.2 at 12 weeks (P<0.0001). The main hemodynamic indices improved or remained stable, and biochemical parameters reflecting liver function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, total bilirubin) did not exceed three times the upper limits of established norms.Conclusion: Agomelatine resulted in statistically significant improvements in depressive symptoms, anxiety, and hypochondria in depressed patients with CVD, and had good tolerability. Our data suggest that agomelatine is safe to treat depression in patients with CVD. Keywords: depression, cardiovascular disease, agomelatine, anxiety, hypochondria, tolerabilityMedvedev VEDove Medical PressarticleDepressioncardiovascular diseaseagomelatineNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 1141-1151 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Depression cardiovascular disease agomelatine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Depression cardiovascular disease agomelatine Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Medvedev VE Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
description	Vladimir E Medvedev Department of Psychiatry, Psychotherapy and Psychosomatic Pathology, RUDN University, Moscow, Russia Background: PULSE was a large, observational, multicenter study designed to evaluate the efficacy and safety of agomelatine in the treatment of major depression in patients with cardiovascular disease (CVD).Methods: Patients with mild-to-moderate major depressive episodes, without psychotic symptoms, were treated as outpatients or in cardiac facilities in 46 regions of Russia. The patients received antidepressant monotherapy with agomelatine 25 or 50 mg, once daily, for 12 weeks.Results: The mean age of the patients (N=896) was 51.4±9.9 years, and 68.5% were women. A progressive improvement in the total score on both the anxiety and depression subscales of the Hospital Anxiety and Depression Scale (HADS), from 13.1±3.8 and 13.9±3.1 at baseline to 3.7±2.8 and 3.9±3.0, respectively, was observed by 12 weeks. All individual HADS scores improved rapidly; the change between visits was also significant (P<0.0001). The majority (84.6%) were remitters (HADS total score <7) by 12 weeks. The Clinical Global Impression – Severity and Improvement scores also improved quickly. The mean hypochondria index (Whiteley Index) decreased significantly from 48.0±11.8 at baseline to 25.2±9.2 at 12 weeks (P<0.0001). The main hemodynamic indices improved or remained stable, and biochemical parameters reflecting liver function (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, total bilirubin) did not exceed three times the upper limits of established norms.Conclusion: Agomelatine resulted in statistically significant improvements in depressive symptoms, anxiety, and hypochondria in depressed patients with CVD, and had good tolerability. Our data suggest that agomelatine is safe to treat depression in patients with CVD. Keywords: depression, cardiovascular disease, agomelatine, anxiety, hypochondria, tolerability
format	article
author	Medvedev VE
author_facet	Medvedev VE
author_sort	Medvedev VE
title	Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
title_short	Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
title_full	Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
title_fullStr	Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
title_full_unstemmed	Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE
title_sort	agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study pulse
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/9ecac9d8bbe74d0c9d69023c0f666176
work_keys_str_mv	AT medvedevve agomelatineinthetreatmentofmildtomoderatedepressioninpatientswithcardiovasculardiseaseresultsofthenationalmulticenterobservationalstudypulse
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Agomelatine in the treatment of mild-to-moderate depression in patients with cardiovascular disease: results of the national multicenter observational study PULSE

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