A pooled analysis evaluating the efficacy and tolerability of tapentadol extended release for chronic, painful diabetic peripheral neuropathy.

ABSTRACT:

Background and objective

Data from two similarly designed studies of tapentadol extended release (ER) for managing neuropathic pain associated with diabetic peripheral neuropathy (DPN; NCT00455520, NCT01041859) in adults were pooled for this analysis, allowing a detailed evaluation of efficacy in patient subgroups and secondary endpoints.

Methods

In each study, patients were titrated to their optimal dose of open-label tapentadol ER [100-250 mg twice daily (bid)] over 3 weeks. Patients with ≥1-point improvement in average pain intensity [11-point numerical rating scale (NRS)] were randomized (1:1) to receive placebo or tapentadol ER during a 12-week, double-blind maintenance period.

Results

Mean (standard deviation [SD]) changes in pain intensity from baseline to week

SUBMITTER: Schwartz S 

PROVIDER: S-EPMC4300409 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature