title: Efficacy, safety, and tolerability of vortioxetine for the treatment of major depressive disorder in patients aged 55 years or older.
abstract: These post hoc analyses evaluate the efficacy, safety, and tolerability of vortioxetine versus placebo in patients aged ≥55 years with major depressive disorder (MDD).
  
  
  
  Study-level efficacy data from 12 short-term, fixed-dose, randomized, placebo-controlled trials of vortioxetine 5-20 mg/day were assessed using a random-effects meta-analysis. Adverse events (AEs), vital signs, ECG values, liver enzymes, and body weight were pooled from the same studies. Patients had baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total scores ranging from 22-30.
  
  
  
  1508 patients (mean age=62.4 years; range, 55-88 years) were included. Mean differences from placebo in change from baseline to study end (6/8 weeks) in MADRS were -2.56 (5 mg, n=324, P=0.035), -2.87 (10 mg, n=222, P=0.007), -1.32 (15 mg, n=90, P=NS), and -4.65 (20 mg, n=165, P=0.012). Odds ratios for response versus placebo were 1.6 (5 mg, P=NS), 1.8 (10 mg, P=0.002), 1.2 (15 mg, P=NS), and 2.5 (20 mg, P<0.001), and for remission versus placebo were 1.5 (5 mg, P=NS), 1.5 (10 mg, P=NS), 1.4 (15 mg, P=NS), and 2.7 (20 mg, P=0.001). The proportion of patients with AEs for placebo and vortioxetine 5-20 mg was 61.5% and 62.3%, respectively, with no increase at increased doses. Vortioxetine demonstrated a placebo-level incidence of serious AEs (1.2%). AEs occurring in ≥5% of any treatment group were nausea, headache, diarrhea, dizziness, dry mouth, constipation, fatigue, vomiting, and anxiety. No clinically significant mean changes in vital signs, ECG values, liver enzymes, or body weight emerged during treatment.
  
  
  
  Vortioxetine 5-20 mg/day is efficacious and well tolerated in MDD patients aged ≥55 years, a group that is often comorbid with other conditions and treated with other medications.
authors.affiliation: 1Clinical Science, Takeda Development Center Americas,Deerfield,Illinois,USA.
authors.forename: George G
authors.initials: GG
authors.lastname: Nomikos
authors.affiliation: 2U.S. Medical Affairs,Takeda Development Center Americas,Deerfield,Illinois,USA.
authors.forename: Dapo
authors.initials: D
authors.lastname: Tomori
authors.affiliation: 3Statistics,Takeda Development Center Americas,Deerfield,Illinois,USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhong
authors.affiliation: 4Pharmacovigilance,Takeda Development Center Americas,Deerfield,Illinois,USA.
authors.forename: John
authors.initials: J
authors.lastname: Affinito
authors.affiliation: 5Safety Statistics,Takeda Development Center Americas,Deerfield,Illinois,USA.
authors.forename: William
authors.initials: W
authors.lastname: Palo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000139:chemically induced; D003248:Constipation / Q000139:chemically induced; D003865:Major Depressive Disorder / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D004244:Dizziness / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D016017:Odds Ratio; D010879:Piperazines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013440:Sulfides / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced; D000078784:Vortioxetine; D014987:Xerostomia / Q000139:chemically induced
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D013440:Sulfides; D000078784:Vortioxetine
keywords: Late-life depression; major depressive disorder; meta-analysis; multimodal antidepressant; older adults; vortioxetine