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- W2113561569 abstract "Pregabalin is an alpha-2-delta ligand proven effective for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), fibromyalgia, and spinal-cord injury. In trials studying pregabalin as treatment for DPN and PHN, pregabalin was shown to consistently reduce the often difficult-to-treat pain experienced by DPN and PHN patients and to improve their overall health status. Eleven double-blind, placebo-controlled, trials were conducted to study pregabalin’s analgesic effects on DPN and PHN patients. We investigated pregabalin’s safety, and tolerability characteristics in the overall patient sample, and efficacy in 9 completed studies (excluding 2 that were terminated early). A total of 2688 patients were studied (857 received placebo while 161, 514, 633, and 523 received 75, 150, 300, and 600mg/day pregabalin). The primary efficacy measure was endpoint mean pain score derived from patient-recorded daily-pain diaries (11-point scale; 0=no pain; 10=worst possible pain). Findings for 150–600 mg/day pregabalin, the therapeutic dose range, are described. Pregabalin treatment is started at 150 mg/day and, based on individual response/tolerability, may be increased to 300 mg/day, and if needed, to a maximum of 600 mg/day. Significant endpoint pain reductions (pregabalin-placebo) were observed in 7 of 9 trials (0.9–1.8 points; p<.0077). Pain reductions were positively correlated with dose. Forty, 51%, and 61% of patients on 150, 300, and 600mg/day pregabalin, reported pain reductions ≥30% while only 30% of placebo patients reported similar reductions (p<0.0001). Treatment-emergent adverse events (AEs) were generally mild to moderate. Dizziness and somnolence were the most common AEs (23.2% and 14.0% for pregabalin patients; 6.8% and 3.9% for placebo patients). AEs led to withdrawals in only 11.4% of pregabalin patients and 5.0% of placebo patients demonstrating that pregabalin is well tolerated. Treatment with pregabalin yielded significant pain reductions, with as many as 61% of patients reporting clinically meaningful responses (≥30%)." @default.
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- W2113561569 date "2005-03-01" @default.
- W2113561569 modified "2023-09-26" @default.
- W2113561569 title "Efficacy, safety, and tolerability of pregabalin treatment for neuropathic pain: Findings from 11 clinical trials" @default.
- W2113561569 doi "https://doi.org/10.1016/j.jpain.2005.01.112" @default.
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