[HTML][HTML] A multicenter, randomized, double-blind, duloxetine-controlled, non-inferiority trial of desvenlafaxine succinate extended-release in patients with major …
Q Zhao, B Fu, N Lyu, X Xu, G Huang, Y Tan… - Journal of Affective …, 2023 - Elsevier
Q Zhao, B Fu, N Lyu, X Xu, G Huang, Y Tan, X Xu, X Zhang, X Wang, Z Wang, K Li, ZY Hu…
Journal of Affective Disorders, 2023•ElsevierBackground Desvenlafaxine and duloxetine are selective serotonin and norepinephrine
reuptake inhibitors. Their efficacy has not been directly compared using statistical
hypotheses. This study evaluated the non-inferiority of desvenlafaxine extended-release
(XL) to duloxetine in patients with major depressive disorder (MDD). Methods In this study,
420 adult patients with moderate-to-severe MDD were enrolled and randomly assigned (1:
1) to receive 50 mg (once daily [QD]) of desvenlafaxine XL (n= 212) or 60 mg QD of …
reuptake inhibitors. Their efficacy has not been directly compared using statistical
hypotheses. This study evaluated the non-inferiority of desvenlafaxine extended-release
(XL) to duloxetine in patients with major depressive disorder (MDD). Methods In this study,
420 adult patients with moderate-to-severe MDD were enrolled and randomly assigned (1:
1) to receive 50 mg (once daily [QD]) of desvenlafaxine XL (n= 212) or 60 mg QD of …
Background
Desvenlafaxine and duloxetine are selective serotonin and norepinephrine reuptake inhibitors. Their efficacy has not been directly compared using statistical hypotheses. This study evaluated the non-inferiority of desvenlafaxine extended-release (XL) to duloxetine in patients with major depressive disorder (MDD).
Methods
In this study, 420 adult patients with moderate-to-severe MDD were enrolled and randomly assigned (1:1) to receive 50 mg (once daily [QD]) of desvenlafaxine XL (n = 212) or 60 mg QD of duloxetine (n = 208). The primary endpoint was evaluated using a non-inferiority comparison based on the change from baseline to 8 weeks in the 17-item Hamilton Depression Rating Scale (HAMsingle bondD17) total score. Secondary endpoints and safety were evaluated.
Results
Least-squares mean change in HAM-D17 total score from baseline to 8 weeks was −15.3 (95% confidence interval [CI]: −17.73, −12.89) in the desvenlafaxine XL group and − 15.9 (95% CI, −18.44, −13.39) in the duloxetine group. The least-squares mean difference was 0.6 (95% CI: −0.48, 1.69), and the upper boundary of 95% CI was less than the non-inferiority margin (2.2). No significant between-treatment differences were found in most secondary efficacy endpoints. The incidence of the most common treatment-emergent adverse events (TEAEs) was lower for desvenlafaxine XL than for duloxetine for nausea (27.2% versus 48.8%) and dizziness (18.0% versus 28.8%).
Limitations
A short-term non-inferiority study without a placebo arm.
Conclusions
This study demonstrated that desvenlafaxine XL 50 mg QD was non-inferior to duloxetine 60 mg QD in efficacy in patients with MDD. Desvenlafaxine had a lower incidence of TEAEs than duloxetine did.
Elsevier
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