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.
Real-world effectiveness and tolerability of desvenlafaxine in major depressive disorder: A multicentre prospective Italian national-cohort study
d'Andrea G.;Cavallotto C.;Allegretti R.;Pettorruso M.;Martinotti G.;Persico L.;Santeusanio A.;Panichella S.;D'angola M.;Rosati A.;
2026-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
