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Studies Confirm Pregabalin Relieves Pain in Diabetic Neuropathy

Results of a meta-analysis indicate that the antiepileptic agent pregabalin is safe and effective for relieving pain in diabetic peripheral neuropathy (DPN). The analysis of pooled data from seven randomized, placebo-controlled trials of pregabalin, with dosages ranging from 150 mg daily to 600 mg daily and from 5 to 13 weeks in duration, are published in the July issue of Diabetes Care.

Dr. Roy Freeman of Harvard Medical School in Boston and colleagues report that "pregabalin significantly reduced pain and pain-related sleep interference" with 150 mg/day, 300 mg/day and 600 mg/day given in three divided doses.

"Only the 600 mg/day dosage showed efficacy when administered BID," the investigators report.

The greatest effect on pain and sleep interference was seen with the highest dose.

The median time to onset of a sustained improvement in pain, defined as a reduction in pain of 30% or greater by the end of the study period, was four days with 600 mg/day, five days in patients treated with 300 mg/day, 13 days in patients treated with 150 mg/day and 60 days in patients receiving placebo.

"The dose-related increase in efficacy was accompanied by a dose-related increase in incidence of most adverse events," the team notes.

No differences between BID and TID dosing on the rate of adverse events were observed. The most common treatment-related adverse events were dizziness, somnolence, and peripheral edema.

Peripheral edema was dose-related. Weight gain was also related to the dose and to the duration of treatment.

"The underlying cause of the weight gain is not known and does not appear to be related to the presence of peripheral edema. There was no evidence that the weight increase compromised glycemic control," the authors write.

Diabetes Care 2008;31:1448-1454.

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