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New Study Shows Tapentadol Extended Release (ER) May Significantly Reduce Average Pain Intensity for Diabetic Patients Suffering From Painful Peripheral Neuropathy
Date:1/28/2011

hase, during which all patients were titrated to their individually optimal tapentadol ER dose (100–250 mg two times per day), followed by a 12-week, double-blind maintenance phase, during which patients were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo.

The primary efficacy endpoint of the study was to measure the change in average pain intensity, as determined by a twice-daily, 11-point pain rating scale or numerical rating scale (NRS; 0='no pain,' 10='pain as bad as you can imagine'), from the point of randomization.  Safety was also assessed throughout the study.

At the start of the 3-week, open-label phase, the majority of patients (79.4%) reported severe pain (greater than or equal to 6 on the 11-point NRS) with a mean pain intensity of 7.3. By the end of the open-label phase, the mean pain intensity was reduced to 3.5. Following randomization, over the double-blind treatment phase to week 12, pain increased in the placebo group (as demonstrated by the average change in pain intensity of 1.4), while in the tapentadol ER group, pain relief was maintained, as indicated by the change in pain intensity value of 0.0. The mean difference between the tapentadol ER and placebo groups in the change in average pain intensity was -1.3 on the 11-point NRS (95 percent CI; p<0.001, tapentadol ER vs. placebo).  Researchers observed statistically significant differences in favor of tapentadol ER using all imputation methods.

In a secondary analysis, where rates of those who responded to treatment were calculated, 53.6 percent of patients receiving tapentadol ER and 42.2 percent of patients receiving placebo (p=0.017) experienced at least a 30 percent improvement in pain intensity measured from pre-titration to week 12 of the double-blind treatment period.

The patient's global impression of change (PGIC) provided an additional secondary analysis where patients evaluated on a 7-
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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