Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials.
OBJECTIVE
Duloxetine is a serotonergic noradrenergic reuptake inhibitor with demonstrated efficacy in each of three independent studies for treatment of adults with generalized anxiety disorder (GAD). A pooled dataset from all completed trials is provided here to show the most likely clinical outcomes associated with duloxetine treatment for GAD.


METHODS
Data were summed at the individual patient level from three double-blind, placebo-controlled trials of duloxetine treatment: two were 10-week flexible-dose 60-120 mg/day and one was 9-week fixed dose 60 or 120 mg/day. Inclusion/exclusion criteria were consistent across studies.


METHODS
Efficacy measures included the Hamilton Anxiety Scale (HAMA) and Sheehan Disability Scale (SDS). Adverse events were queried at every visit in each study.


RESULTS
Patients were randomly assigned to duloxetine (n = 668) or placebo (n = 495) treatment. Mean age was 42.4 years; 65% were female. Duloxetine-treated patients improved significantly more from baseline to endpoint on HAMA total score (mean = -11.1 points) compared with placebo-treated patients (mean = -8.0 points, p < or = 0.001). On the SDS global functioning score, patients in the duloxetine group had a mean improvement from baseline of 46% compared with 25% in the placebo group (p < or = 0.001). Nausea was the most common of twelve treatment-emergent adverse events that occurred in the duloxetine group.


CONCLUSIONS
Pooled studies were not for long-term treatment and did not include patients with comorbid psychiatric conditions.


CONCLUSIONS
In this sample of more than 1100 patients, duloxetine was efficacious for reducing anxiety severity and for increasing patients' overall role functioning in GAD.
Allgulander
Christer
C
Karolinska Institutet, Stockholm, Sweden. Christer.Allgulander@ki.s
Hartford
James
J
Russell
James
J
Ball
Susan
S
Erickson
Janelle
J
Raskin
Joel
J
Rynn
Moira
M
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D001008:Anxiety Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013223:Statistics as Topic / Q000379:methods; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D010919:Placebos; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride