Duloxetine for the management of diabetic peripheral neuropathic pain: evaluation of functional outcomes.
OBJECTIVE
To assess the effectiveness of duloxetine, compared with placebo, on patient-reported health outcomes over a 12-week period, in the management of diabetic peripheral neuropathic pain (DPNP).


METHODS
The results were pooled from three 12-week multicenter, double-blind studies. In study 1 (N = 457), patients with DPNP were randomly assigned to treatment with duloxetine 20 mg once daily (QD), 60 mg QD, 60 mg twice daily (BID), or placebo. In studies 2 (N = 334) and 3 (N = 348), patients with DPNP were randomly assigned to treatment with duloxetine 60 mg QD, 60 mg BID, or placebo. Patient-reported functional outcomes were measured by the Short Form 36 (SF-36), the interference portion of the Brief Pain Inventory (BPI), and EuroQol 5D Health Questionnaire (EQ-5D). Results for all functional outcomes from the intent-to-treat and completer populations are discussed.


RESULTS
In the SF-36 health survey and the BPI interference, duloxetine 60 mg QD and 60 mg BID were significantly superior to placebo in all the domains (P <or= 0.03). In the analysis of the EQ-5D, duloxetine 60 mg QD (P = 0.004) and 60 mg BID (P < 0.001) were significantly better than placebo on all items.


CONCLUSIONS
Acute treatment with duloxetine was associated with significant improvement in functional outcomes in persons with DPNP.
Scholl's Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, USA.
David G
DG
Armstrong
Amy S
AS
Chappell
Trong K
TK
Le
Daniel K
DK
Kajdasz
Miroslav
M
Backonja
Deborah N
DN
D'Souza
James M
JM
Russell
D000368:Aged; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D017060:Patient Satisfaction; D010525:Peripheral Nerves / Q000187:drug effects* / Q000503:physiopathology; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000068736:Duloxetine Hydrochloride; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes