A randomized withdrawal, placebo-controlled study evaluating the efficacy and tolerability of tapentadol extended release in patients with chronic painful diabetic peripheral neuropathy.
OBJECTIVE
This study evaluated the efficacy and tolerability of tapentadol extended release (ER) for the management of chronic pain associated with diabetic peripheral neuropathy (DPN).


METHODS
Adults with moderate to severe DPN pain were titrated to tapentadol ER 100-250 mg bid during a 3-week open-label period; patients with ≥1-point reduction in pain intensity (11-point numerical rating scale) at end of titration were randomized to receive placebo or tapentadol ER (optimal dose from titration) for 12 weeks (double-blind, fixed-dose maintenance phase). The primary end point was mean change in average pain intensity from the start to week 12 (last observation carried forward [LOCF]) of the double-blind maintenance phase.


RESULTS
A total of 358 patients completed the titration period; 318 patients (placebo, n = 152; tapentadol ER, n = 166) were randomized and received one or more doses of double-blind study medication. Mean (SD) pain intensity (observed case) was 7.33 (1.30) at the start and 4.16 (2.12) at week 3 of the open-label titration period (mean [SD] change, -3.22 [1.97]). The mean (SD) change in pain intensity (LOCF) from start of double-blind treatment to week 12 was as follows: placebo, 1.30 (2.43); tapentadol ER, 0.28 (2.04; least squares mean difference, -0.95 [95% CI -1.42 to -0.49]; P < 0.001). Treatment-emergent adverse events (≥10%) in the tapentadol ER group during the double-blind maintenance phase were nausea (21.1%) and vomiting (12.7%).


CONCLUSIONS
Tapentadol ER (100-250 mg bid) was effective and well tolerated for the management of moderate to severe chronic pain associated with DPN.
EVMS Strelitz Diabetes Center and Neuroendocrine Unit, Norfolk, VA vinikai@evms.edu.
Aaron I
AI
Vinik
Janssen Research & Development, LLC, Raritan, NJ.
Douglas Y
DY
Shapiro
Janssen Research & Development, LLC, Raritan, NJ.
Christine
C
Rauschkolb
Grünenthal GmbH, Aachen, Germany.
Bernd
B
Lange
Janssen Research & Development, LLC, Raritan, NJ.
Keith
K
Karcher
Janssen Research & Development, LLC, Raritan, NJ.
Deborah
D
Pennett
Janssen Research & Development, LLC, Raritan, NJ.
Mila S
MS
Etropolski
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D010636:Phenols / Q000627:therapeutic use*; D010919:Placebos; D000077432:Tapentadol; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology; D028761:Withholding Treatment; D055815:Young Adult
D003692:Delayed-Action Preparations; D010636:Phenols; D010919:Placebos; D000077432:Tapentadol