Researchers Assessed the Efficacy and Safety of Once-Daily Controlled-Release Formulation of Pregabalin in Patients with Postherpetic Neuralgia

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Researchers Assessed the Efficacy and Safety of Once-Daily Controlled-Release Formulation of Pregabalin in Patients with Postherpetic Neuralgia

 A recent randomized withdrawal trial showed that once-daily controlled-release formulation of pregabalin in patients with postherpetic neuralgia showed significant results.

Postherpetic neuralgia (PHN) is a chronic neuropathic pain condition that can occur at the site of a previous attack of shingles, which are caused by the herpes varicella-zoster virus (cause chickenpox). It is characterized by continuous nerve pain (burning, stabbing, shooting, aching or throbbing) in the shingles affected area. Pharmacological management of PHN could be challenging. Pregabalin was approved for the treatment of PHN associated neuropathic pain by the US Food and Drug Administration (FDA) in 2004.

A study was conducted to evaluate the efficacy and safety of once-daily controlled-release (CR) formulation of pregabalin in patients with postherpetic neuralgia.

This study was designed as a randomized withdrawal trial where enriched enrollment was done. It consisted of 6-week single-blind pregabalin treatment phase and 13-week double-blind phase. Here patients were randomized (1:1) to pregabalin CR (82.5 to 660 mg/d) or placebo who showed ≥50% decrease in mean pain score at single-blind endpoint from baseline.

The outcome to measure included primary efficacy outcome, which involved the evaluation of time to loss of therapeutic response (LTR) (<30% decrease in weekly mean pain score from single-blind baseline or discontinuation due to the adverse event or lack of efficacy). Secondary efficacy outcomes were to find out the change in weekly mean pain score (1-wk recall period) at the double-blind endpoint.

From the study, it was found that 801 patients were randomised and treated in the single-blind phase. Around 413 patients were treated in the double-blind phase (208, pregabalin CR; 205, placebo). The findings showed Pregabalin CR significantly increased the time to LTR versus placebo (Kaplan-Meier analysis). Very few LTR events were observed with pregabalin CR than with placebo (29 [13.9%] vs. 63 [30.7%]; P<0.0001). Median time to LTR was not estimable. Pregabalin CR significantly improved weekly mean pain score versus placebo: LS mean difference (95% CI) of −1.11 (−1.47, −0.75) and −1.00 (−1.34, −0.65) (P<0.0001) from single-blind baseline and double-blind baseline, respectively. Adverse events that often reported in the single-blind phase were dizziness, somnolence, and peripheral oedema. Pregabalin CR was well tolerated.

The study estimated that in there was significantly longer time to LTR with pregabalin CR compared to placebo. The safety profile of pregabalin CR was comparable to that reported for the immediate-release formulation in patients with postherpetic neuralgia.

Source:

The Clinical Journal of Pain

Link to the source:

http://journals.lww.com/clinicalpain/Abstract/2017/07000/Efficacy_and_Safety_of_Once_Daily.1.aspx

Original title of article:

Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial

 

Authors

Huffman CL, Goldenberg JN et al.

SearchTags: 
Therapeutic, Pregabalin, Postherpetic Neuralgia, nerves, chronic, anticonvulsants, enriched enrollment, randomized withdrawal trial, efficacy, safety
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