Citation

Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. Prim. Care Companion J. Clin. Psychiatry 2011; 13(2).

Copyright

(Copyright © 2011, Physicians Postgraduate Press)

DOI

10.4088/PCC.10m00977

PMID

unavailable

Abstract

BACKGROUND: The primary objective was to evaluate the long-term safety of desvenlafaxine (administered as desvenlafaxine succinate) during open-label treatment in adult outpatients with a primary DSM-IV diagnosis of major depressive disorder (MDD).

METHOD: Depressed adult outpatients (≥ 18 years) who had completed 8-week, double-blind therapy (desvenlafaxine, venlafaxine extended release, or placebo) in a phase 3 study of desvenlafaxine for MDD received up to 10 months of open-label treatment with flexible-dose desvenlafaxine (200 to 400 mg/d). Safety assessments included physical examination, measurement of weight and vital signs, laboratory determinations, and 12-lead electrocardiogram recordings. Adverse events (AEs) and discontinuations due to AEs were monitored throughout the trial. The primary efficacy outcome was mean change from baseline on 17-item Hamilton Depression Rating Scale (HDRS-17) total score. The trial was conducted from August 2003 to March 2006.

RESULTS: The safety population included 1,395 patients who took at least 1 dose of open-label desvenlafaxine. Treatment-emergent AEs were reported by 1,238 of 1,395 patients (89%) during the open-label, on-therapy period. Treatment-emergent AEs reported by 10% or more patients were headache, nausea, hyperhidrosis, dizziness, dry mouth, insomnia, upper respiratory infection, nasopharyngitis, and fatigue. Adverse events were the primary reason for study discontinuation in 296 of 1,395 patients (21%). Ten patients (< 1%) had serious AEs that were considered possibly, probably, or definitely related to the study drug during the on-therapy period. No deaths occurred during the study.

CONCLUSIONS: Desvenlafaxine can be safely administered for up to 12 months. No new safety findings were observed in this study. © Copyright 2011 Physicians Postgraduate Press, Inc.

Language: en

Keywords

adult; human; female; male; insomnia; suicidal ideation; suicide attempt; major depression; risk assessment; drug overdose; rhabdomyolysis; fatigue; article; major clinical study; controlled study; syncope; venlafaxine; xerostomia; double blind procedure; headache; phase 3 clinical trial; physical examination; urine retention; convulsion; drug safety; placebo; follow up; drug efficacy; QT interval; drug tolerability; nausea; weight gain; leukopenia; drug withdrawal; Hamilton scale; mania; rash; hypertension; outpatient care; side effect; glucose blood level; erectile dysfunction; heart rate; withdrawal syndrome; asthenia; hematuria; anemia; hyperthyroidism; electrocardiogram; heart muscle ischemia; dose response; remission; drug monitoring; thorax pain; peripheral vascular disease; dizziness; urticaria; drug dose reduction; systolic blood pressure; female sexual dysfunction; drug dose increase; drug dose titration; outcome assessment; colitis; lactation; treatment duration; hyperhidrosis; upper respiratory tract infection; ECG abnormality; leukocyte; PR interval; diastolic blood pressure; pulse rate; liver function test; heart atrium fibrillation; ecchymosis; clinical evaluation; rhinopharyngitis; thyroid function; RR interval; ophthalmoplegia; desvenlafaxine; visual field defect; heart left anterior bundle branch block; parotid enlargement; rectum disease