"And it didn't matter which of the effective doses a patient used. The lowest dose showed efficacy within 24 hours," said presenter and lead investigator Brett Stacey, MD, Medical Director, Comprehensive Pain Center, and Associate Professor of Medicine, Oregon Health and Science University, Portland, Oregon, United States. "So patients can expect relief very, very quickly with this drug and the relief continues to increase over the first week. It also appears to be well tolerated."

Dr. Stacey and colleagues gathered retrospective data from six randomized, double-blind, placebo-controlled trials of patients with painful diabetic peripheral neuropathy. They analyzed data for time to significant pain reduction after initiation of pregabalin treatment according to target dosing and titration speed. Treatment cohorts were as follows: 473 placebo and 873 pregabalin (all doses).

Pregabalin subgroups were as follows: low (minimum therapeutic dose: 150 mg/day); "slow" (300 and 600 mg/day, titrated slowly so that less than half of target dose was reached after the fourth day of treatment) and "fast" (300 and 600 mg/day titrated rapidly so that at least half of target dose was reached on or before the fourth day of treatment).

For each subgroup, the investigators assessed data for time to significant effect by measuring changes from baseline in daily pain scores taken from patient-recorded diaries (11-point scale; 0=no pain; 10=worst possible pain).

Significant pain score reductions appeared as early as day 1 for the three pregabalin groups. Reductions in daily pain score were -2.04 for "low" dosing, -2.56 for "slow" dosing, and -2.60 for "fast" dosing of pregabalin, compared to -1.49 for patients on placebo (P < .0081).

The authors concluded that pregabalin demonstrated statistically significant improvement over placebo in painful diabetic peripheral neuropathy patients after 1 day of treatment."

Dr. Stacey noted that although the US Food and Drug Administration approved pregabalin in December of 2004 for treatment of the pain associated with diabetic peripheral neuropathy, it is not yet available in US drugstores. "We expect to see it here in late summer or early fall," he said.


[Presentation title: Pregabalin Significantly Reduces the Pain Associated with Diabetic Peripheral Neuropathy by Day One of Treatment. Abstract 602-P]

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