Safety and tolerability of duloxetine at 60 mg once daily in elderly patients with major depressive disorder.
OBJECTIVE
To compare the safety and tolerability profile of duloxetine versus placebo in elderly (> or = 65 years) patients with major depressive disorder (MDD).


METHODS
Patients were randomized (2:1) to duloxetine 60 mg/d (once daily) (n = 207) or placebo (n = 104) for 8 weeks. Safety and tolerability measures were analyzed in the total cohort of patients, as well as in subgroups defined by age and preexisting hypertension.


RESULTS
Patients had a median age of 72 years (65-90 years). No deaths occurred in the study. Discontinuation rates due to adverse events were similar for duloxetine and placebo (9.7% vs 8.7%). Treatment-emergent dry mouth, nausea, and diarrhea occurred significantly (P < or = 0.05) more frequently with duloxetine compared with placebo. Changes in supine and standing blood pressure (BP) and pulse and in corrected QT (QTc) interval were not significantly different between duloxetine and placebo, except for change in orthostatic systolic BP (-2.45 vs 0.93 mm Hg; P = .017). Incidences of sustained elevation in BP and treatment-emergent orthostatic hypotension were similar for duloxetine compared with placebo (0.5% vs 1.0% and 15.6% vs 20.5%, respectively). The duloxetine group showed significant weight loss compared with the placebo group (-0.73 kg vs -0.13 kg; P = 0.009). Of 5 hepatic analytes, the only significant difference was an increase in alkaline phosphatase in duloxetine compared with placebo (P = 0.017); this difference was not considered clinically relevant. The incidence of 1 or more discontinuation-emergent adverse events was not significantly different between the duloxetine and placebo groups (17.3% vs 11.3%).


CONCLUSIONS
This study suggests that duloxetine is safe and well tolerated in elderly patients with major depressive disorder.
Raskin
Joel
J
Lilly Research Laboratories, Eli Lilly Canada, Toronto, Ontario, Canada. joel.raskin@lilly.com
Wiltse
Curtis G
CG
Dinkel
James J
JJ
Walker
Daniel J
DJ
Desaiah
Durisala
D
Katona
Cornelius
C
D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride