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

Abstract

BackgroundPULSE 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).MethodsPatients 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.ResultsThe 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.ConclusionAgomelatine 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.