Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking
| Autor: | Chunming Li, Lynne Pauer, Michael Tuchman, Cynthia Huffman, Bruce Parsons, Joseph M. Scavone, Claire Burbridge, Brett R. Stacey, Regina Behar, Lorraine Yurkewicz |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Pregabalin Pain Walking Washout period law.invention Diabetic Neuropathies Double-Blind Method Quality of life Randomized controlled trial law medicine Humans In patient Aged Pain Measurement Aged 80 and over Analgesics Cross-Over Studies business.industry Middle Aged medicine.disease Crossover study Treatment Outcome Anesthesiology and Pain Medicine Peripheral neuropathy Multicenter study Anesthesia Quality of Life Physical therapy Female Neurology (clinical) Sleep business medicine.drug |
| Zdroj: | The Clinical Journal of Pain. 31:946-958 |
| ISSN: | 0749-8047 |
| DOI: | 10.1097/ajp.0000000000000198 |
| Popis: | This randomized, double-blind, placebo-controlled, multicenter, 2-period crossover study (two 6-week treatment periods separated by a 2-week washout period) evaluated the efficacy and safety of pregabalin (150 to 300 mg/d) for treatment of pain and pain on walking in patients with painful diabetic peripheral neuropathy (DPN) who experienced pain while walking.Co-primary efficacy endpoints were: (1) mean pain score (last 7 daily pain diary scores, 0 to 10 numeric rating scale at end of each treatment period) and (2) DPN pain on walking (0 to 10 numeric rating scale immediately after walking 50 feet [15.2 m] on flat surface). Secondary endpoints included other pain parameters, patient-reported sleep, health-related quality of life, and safety measures.Two hundred three patients were treated (pregabalin, n=198; placebo, n=186), with no statistically significant treatment difference for pregabalin versus placebo in the co-primary efficacy endpoints, mean DPN pain (P=0.0656) and mean DPN pain on walking (P=0.412). A carryover effect was observed. Analysis of co-primary endpoints for period 1 showed significant treatment difference for DPN pain (P=0.034) and DPN pain on walking (P=0.001). Treatment with pregabalin resulted in significant improvements versus placebo on prespecified patient global impression of change (end of period 1; P=0.002), and sleep interference rating scale (end of period 2; P=0.011). Adverse events were more frequent with pregabalin than with placebo and caused discontinuation in 13 (6.6%) pregabalin patients versus 5 (2.7%) placebo patients.Failure to meet the co-primary objectives may be related to carryover effect from period 1 to period 2, lower pregabalin dose (150 to 300 mg/d), and/or placebo response in painful DPN. |
| Databáze: | OpenAIRE |
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