Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain.
BACKGROUND
Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. In the present open-label study, the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks was evaluated and compared to routine care in the therapy of patients diagnosed with diabetic peripheral neuropathic pain (DPNP).


METHODS
Patients who completed a 13-week, double-blind, duloxetine and placebo acute therapy period were rerandomly assigned in a 2:1 ratio to therapy with duloxetine 60 mg BID (N=161) or routine care (N=76) for an additional 52 weeks. Routine care consisted primarily of gabapentin, amitriptyline, and venlafaxine. The study included male or female outpatients 18 years of age or older with a diagnosis of DPNP caused by type 1 or type 2 diabetes.


RESULTS
A higher percentage of routine care-treated patients experienced 1 or more serious adverse events. No statistically significant therapy-group difference was observed in the overall incidence of treatment-emergent adverse events (TEAEs). The TEAEs reported by 10% or more of duloxetine 60 mg BID-treated patients were nausea, and by the routine care-treated patients were peripheral edema, pain in the extremity, somnolence, and dizziness. Duloxetine did not appear to adversely affect glycemic control, lipid profiles, nerve function, or the course of DPNP. There were no statistically significant therapy-group differences observed in the 36-item Short-Form Health Survey subscales or in the EuroQol 5-Dimension Questionnaire.


CONCLUSIONS
In this study, duloxetine was safe and well tolerated compared to routine care in the long-term management of patients with DPNP.
Raskin
Joel
J
Lilly Research Laboratories, Toronto, Canada. raskin_joel@lilly.com
Smith
Timothy R
TR
Wong
Kar
K
Pritchett
Yili Lu
YL
D'Souza
Deborah N
DN
Iyengar
Smriti
S
Wernicke
J F
JF
D000588:Amines / Q000009:adverse effects / Q000627:therapeutic use; D000639:Amitriptyline / Q000009:adverse effects / Q000627:therapeutic use; D000704:Analysis of Variance; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects / Q000627:therapeutic use; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068736:Duloxetine Hydrochloride; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000627:therapeutic use
D000588:Amines; D000639:Amitriptyline; D003509:Cyclohexanecarboxylic Acids; D003511:Cyclohexanols; D000068736:Duloxetine Hydrochloride; D000077206:Gabapentin; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes; D000069470:Venlafaxine Hydrochloride; D005680:gamma-Aminobutyric Acid