Giacomo d'Andrea, Clara Cavallotto, Rita Allegretti, Matteo Lupi, Claudia Carmassi, Antonio Ventriglio, Diego Quattrone, Raffaella Zanardi, Stefano Barlati, Vassilis Martiadis, Valerio Ricci, Marco Di Nicola, Ileana Andriola, Stefania Chiappini, Beatrice Benatti, Andrea Barra, Domenico De Berardis, Maria Salvina Signorelli, Giorgio Di Lorenzo, Antonello Bellomo, Bernardo Maria Dell'Osso, Antonio Vita, Giuseppe Maina, Mauro Pettorruso, Giovanni Martinotti, REMEDY-MDD Study Group, Antonio D'Attilio, Giovanna Mammarella, Luca Persico, Alessia Santeusanio, Serena Panichella, Michela D'angola, Arianna Rosati, Gianfranco Tamagnini, Alessandro Carano, Virginia Pedrinelli, Valerio Dell'Oste, Valeria Lumetta, Matteo Carminati, Fabiola Raffone, Maria Pepe, Federica Cuccia, Alessandro Rodolico
In this multicentre real-world cohort, desvenlafaxine was associated with substantial improvements in depressive and anxiety symptoms, increasing response and remission rates, favourable tolerability. These findings support desvenlafaxine as an effective and well-tolerated treatment option in routine clinical practice.
INTRODUCTION: Real-world evidence on desvenlafaxine effectiveness and tolerability in Major Depressive Disorder (MDD) remains limited, particularly in clinically heterogeneous populations. This multicentre observational study evaluated the real-world effectiveness and tolerability of desvenlafaxine, focusing on depressive and anxiety symptoms, response, remission, and side-effects burden.
METHODS: This multicentre prospective observational study included 197 outpatients with DSM-5-TR Major Depressive Episode initiating desvenlafaxine. Assessments were conducted at baseline (T0), one month (T1), and three months (T2). Depressive symptoms (MADRS) were the primary outcome; anxiety (HAM-A), manic symptoms (YMRS), and tolerability (ASEC) were secondary outcomes. Response was defined as ≥50% MADRS reduction and remission as MADRS <10.
RESULTS: Participants (mean age 46.1 ± 14.6 years; 55.3% female) showed clinically relevant baseline severity (MADRS 30.8 ± 7.3). MADRS scores decreased significantly over time in both unadjusted and adjusted models (both p < 0.005), with greater reductions at T2. A significant time × dose association was observed at T1 (p = 0.013), although no dose-related difference persisted at T2; prior hospitalisation was associated with attenuated improvement (p < 0.005). Anxiety symptoms improved significantly across follow-up (p < 0.005). Response and remission rates increased markedly from T1 to T2 (response: 12.4% to 66.7%; remission: 3.9% to 32.6%; both p < 0.005). Overall side-effect burden decreased significantly (p < 0.005), with reduced prevalence of most adverse events. Mean YMRS scores remained low throughout follow-up, with no clinically meaningful increase from baseline.
CONCLUSIONS: In this multicentre real-world cohort, desvenlafaxine was associated with substantial improvements in depressive and anxiety symptoms, increasing response and remission rates, favourable tolerability. These findings support desvenlafaxine as an effective and well-tolerated treatment option in routine clinical practice.