Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In F
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ORIGINAL RESEARCH ARTICLE
Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1‑Year Multicentre Observational Study In France Philip Gorwood1 · Jacques Benichou2 · Nicolas Moore3 · Marine Wattez4 · Marie‑Cécile Secouard5 · Xavier Desobry5 · Françoise Picarel‑Blanchot4,5 · Christian de Bodinat5
© The Author(s) 2020
Abstract Background and Objectives Non-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode. Methods This 12-month observational French study included patients initiating agomelatine treatment. The intensity and severity of depression were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17) total score and the Clinical Global Impression-Severity of Illness (CGI-S) scale. Patients’ quality of life and functioning were measured using the Quality of Life in Depression Scale and the Sheehan Disability Scale, respectively. The safety measures included emergent adverse events and biological samplings, with a focus on liver acceptability. Results A total of 1484 patients (70% of women; 49.6 ± 15.4 years of age) were enrolled in the study. Most patients (62.3%) were treated with agomelatine for at least 6 months and 28.8% were treated for at least 1 year. Mean HAM-D17 total score and mean CGI-S scores decreased by 13.6 ± 8.1 and 2.1 ± 1.5 points, respectively, from baseline to last visit on agomelatine. Rates of responders (i.e. with a decrease in HAM-D17 total score by at least 50%) and remitters (HAM-D total score 65 years (n) Male/female (%) Body mass index, kg/m2 (mean ± SD) Time since the first episode, years Number of depressive episodes, including the present episode (mean ± SD) Duration of current MDE, months (mean ± SD) Concomitant diseases (%) HAM-D17 total score (mean ± SD) QLDS total score [0–34] CGI-S [0–7] (mean ± SD) SDS total score [0–30] (mean ± SD) SDS work (mean ± SD) SDS social life (mean ± SD) SDS family life (mean ± SD)
49.6 ± 15.4 235 30/70 25.0 ± 5.0 9.9 ± 9.7 1.9 ± 1.5 7.6 ± 18.6 50.7 21.8 ± 6.4 22.3 ± 7.6 4.9 ± 0.7 16.4 ± 6.0 6.1 ± 2.5 6.3 ± 2.2 6.1 ± 2.2
SD standard deviation, MDE major depressive episode, HAM-D17 17-Item Hamilton Depression Rating Scale, QLDS Quality of Life in Depression Scale, CGI-S Clinical Global Impression–Severity of Illness scale, SDS Sheehan Disability Scale
disorders (1.2%) and psychotic disorders (0.7%). Based on the MINI suicidality items, 33.4% of patients had a suicidal risk, most (15.2%) of whom were at a low level of risk, 8% at a moderate level of risk and 10.1% at a severe level of risk.
Half of the patients (50.7%) had at least one concomitant disease at inclusion, with hypertension, hypercholesterolaemia and anxiety being the most fre
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