Tolerability aspects in duloxetine-treated patients with depression: Should one use a lower starting dose in clinical practice?
OBJECTIVE
This study questions whether a lower starting dose of duloxetine (DLX) could be beneficial for patients with depression, in terms of tolerability and safety in routine clinical care.


METHODS
Post-hoc analyses of a multicenter, prospective, non-interventional, 6-month study in adult outpatients with a depressive episode was undertaken.


METHODS
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), discontinuations due to TEAEs and hospitalizations due to depression, were all documented at 2 weeks, 4 weeks, 3 months and 6 months after treatment initiation/switch to DLX.


RESULTS
Of 4517 patients enrolled, 4313 were included for TEAE evaluation. TEAEs occurred in 17.2% of patients, and SAEs occurred in 0.79% of patients, including one case of suicidal ideation. 1404 patients discontinued within 6 months (TEAEs: n = 119). Starting treatment with 30 mg/day DLX (72.7%) was favored in females, or after inadequate efficacy of previous antidepressant treatment; 60 mg/day DLX was favored in more severe depression and patients receiving concomitant pain medication.


CONCLUSIONS
Initiating treatment with 60 mg/day DLX was not associated with poorer tolerability in this study. Physicians may be guided by their clinical experience to carefully consider the individual benefit/risk ratio and TEAE susceptibility when deciding to start treatment with a higher or a lower dose of DLX.
Medical Department, Neuroscience, Lilly Deutschland GmbH, Werner-Reimers-Strasse 2-4, 61352 Bad Homburg, Germany. wilhelm_stefan@lilly.com
Stefan
S
Wilhelm
Frank G
FG
Boess
Ulrich
U
Hegerl
Roland
R
Mergl
Michael
M
Linden
Alexander
A
Schacht
Edith
E
Schneider
D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003863:Depression / Q000150:complications / Q000188:drug therapy* / Q000523:psychology / Q000628:therapy; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy* / Q000523:psychology / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D016903:Drug Monitoring; D004361:Drug Tolerance; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications / Q000188:drug therapy; D057285:Precision Medicine; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
D000700:Analgesics; D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes