Efficacy and safety of duloxetine in the treatment of older adult patients with generalized anxiety disorder: a randomized, double‐blind, placebo‐controlled trial

Abstract

ObjectiveThis was a flexible-dosed study to evaluate the efficacy and safety of duloxetine 30–120 mg once daily in the treatment of generalized anxiety disorder (GAD) in older adult patients.MethodsPatients with GAD, who were at least 65 years of age, were randomly assigned to double-blind treatment with either duloxetine (N = 151) or placebo (N = 140). The primary efficacy measure was the Hamilton Anxiety Rating Scale (HAM-A) total score, and the primary endpoint was at week 10. Global functioning was assessed by the Sheehan Disability Scale (SDS). Safety and tolerability was assessed by the occurrence of treatment-emergent adverse events, serious adverse events, laboratory analyses, and vital signs. Analyses were conducted on an intent-to-treat basis.ResultsThe overall baseline mean HAM-A total score was 24, and SDS global score was 14. Completion rates were 75% for placebo and 76% for duloxetine. At week 10, duloxetine was superior to placebo on mean changes from baseline in HAM-A total scores (−15.9 vs. −11.7, p < 0.001) and in SDS global scores (−8.6 vs. −5.4, p < 0.001). Treatment-emergent adverse events occurred in ≥5% of duloxetine-treated patients and twice the rate than with placebo including constipation (9% vs. 4%, p = 0.06), dry mouth (7% vs. 1%, p = 0.02), and somnolence (6% vs. 2%, p = 0.14).ConclusionDuloxetine treatment was efficacious in the improvement of anxiety and functioning in older adult patients with GAD, and the safety profile was consistent with previous GAD studies. © 2014 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons, Ltd.Key pointsTreatment with duloxetine versus placebo can significantly reduce symptoms of generalized anxiety disorder and was associated with improved global function and increased enjoyment and satisfaction with life in patients 65 years and older.The safety and tolerability profile for duloxetine in this older adult patient population was consistent with the established profile for treatment of generalized anxiety disorder in the broader mostly younger (≥18 years of age) population, and there were no new safety findings.

Medications That Cause Dry Mouth As an Adverse Effect in Older People: A Systematic Review and Metaanalysis

“…Twenty-two placebo-controlled RCTs were deemed eligible for further inclusion in metaanalyses. [10][11][12][15][16][17][19][20][21][22][23][24][25][26][27][29][30][31][32][33] Of the RCTs, included trials investigated drugs used for urinary frequency and incontinence (ATC code G04BD) (n = 13), 12,15,16,19,20,22,[29][30][31][32][33] antidepressants (N06A) (n = 6), 10,11,21,[25][26][27] and psycholeptics (N05) (n = 3). 17,23,24 Statistical heterogeneity was substantial across the trials assessing drugs used for urinary frequency and incontinence (I 2 = 62%).…”

Pharmacological Management of Anxiety Disorders in the Elderly

“…Duloxetine is FDA-approved for GAD and had and has similar efficacy and side effect profile to SSRIs [40]. Additionally, blood pressure effects were not as significant as with venlafaxine [41].…”

Duloxetine in treating generalized anxiety disorder in adults: A meta‐analysis of published randomized, double‐blind, placebo‐controlled trials

“…A total of 278 studies were initially identified through the electronic search. First pass screening eliminated, leaving 30 studies (Stahl et al ., ; Koponen et al ., , ; Allgulander et al ., , ; Hartford et al ., , ; Russell et al ., , ; Davidson et al ., ; De Berardis et al ., ; Hoschl and Svestka, ; Norman and Olver, ; Pollack et al ., ; Rynn et al ., ; Trivedi et al ., ; Katzman, ; Kornstein et al ., ; Nicolini et al ., ; Simon et al ., , ; Pangallo et al ., ; Wu et al ., , ; Bodkin et al ., ; Piero and Locati, ; Sheehan et al ., ; Karaiskos et al ., ; Mavranezouli et al ., ; Alaka et al ., ) were considered potentially relevant for further inspection. After screening the full text, seven randomized controlled trials (RCTs) (Hartford et al ., ; Koponen et al ., ; Davidson et al ., ; Rynn et al ., ; Nicolini et al ., ; Wu et al ., ; Alaka et al ., ) ( n = 2,674) were available for meta‐analyses.…”

“…All included studies were reported as double‐blind RCTs, but only two (Nicolini et al ., ; Alaka et al ., ) explicitly stated the method of random sequence generation. Poor study quality was associated with inadequate or unclear reporting of blinding, randomization protocols, or support by medical company.…”

“…Six studies (Hartford et al ., ; Koponen et al ., ; Rynn et al ., ; Nicolini et al ., ; Wu et al ., ; Alaka et al ., ) ( n = 1,975) reported response rates, and these were included in the meta‐analysis. People treated with duloxetine more frequently responded than those allocated to placebo (6 RCTs, n = 1,975, RR = 1.48, 95% CI, 1.34–1.63) with I 2 value of 36% and no significant heterogeneity ( P = 0.17) (Figure ).…”