Neuropathic Pain Associated With Spinal Cord Injury (NeP SCI)

EFFICACY IN NeP SCI
In a 16-week study, LYRICA (pregabalin) provided significant relief of NeP SCI1,2
16 week relief of NeP SCI chart
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
For some patients, LYRICA provided a 13% reduction in pain as early as Week 1 vs 5% for placebo (P=.0001)2†
LYRICA: n=111; 150 mg/day to 600 mg/day, divided BID. Placebo: n=108.
Study description
Adapted from Cardenas et al. Neurology. 20131; Pfizer data on file.2
Results from a 16-week, randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study of 219 patients with neuropathic pain associated with traumatic and nontraumatic spinal cord injury. Patients had pain for an average of 8 years. Eligible subjects had to be experiencing pain below the level of their injury. Subjects were randomized to receive LYRICA 150, 300, 450, or 600 mg/day divided BID, or placebo.
The primary efficacy measure was duration-adjusted average change in pain, defined as: (weighted mean of all daily pain scores post baseline minus mean baseline pain score) x (total post baseline days/planned study duration). Pain was assessed on an 11-point scale. Mean pain scores for LYRICA and placebo were, respectively: 6.5 and 6.5 baseline, and 4.6 and 5.3 at endpoint.
In a 12-week study, LYRICA provided significant relief of NeP SCI2,3
12 week relief of NeP SCI chart
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
For some patients, LYRICA provided a 21% reduction in pain as early as Week 1 vs 4% for placebo (P<.0001)2†
LYRICA: n=69; 150 mg/day to 600 mg/day, divided BID. Placebo: n=67.
Study description
DOSING IN NeP SCI
Consider your next steps for LYRICA titration, based on efficacy and tolerability
dosing in NeP SCI chart
Dosage may be increased to 300 mg/day based on efficacy and tolerability within 1 week
Patients may be titrated to 600 mg/day if they are not experiencing sufficient pain relief after 2 to 3 weeks of treatment with 300 mg/day
When discontinuing LYRICA, taper gradually over a minimum of 1 week
Adjust the LYRICA daily dose based on renal function
SAFETY IN NeP SCI
In controlled NeP SCI trials,
Adverse reactions were generally mild to moderate
safety in NeP SCI chart
*LYRICA 150 mg/day to 600 mg/day, divided BID.
Additional Information
LYRICA treatment may cause weight gain. In 2 controlled clinical LYRICA NeP SCI trials, 3.3% of LYRICA patients experienced an increase in weight vs 1.1% of the placebo group
  • In both trials, mean change from baseline was up to 4.4 lb for LYRICA patients, vs -1.8 lb for placebo patients1,3
In 2 clinical trials of patients with NeP SCI, 13% of patients treated with LYRICA and 10% of patients treated with placebo discontinued due to adverse reactions
  • The most common reasons for discontinuation of LYRICA-treated patients in NeP SCI trials due to adverse reactions were somnolence (3%) and edema (2%), vs no discontinuations due to these reactions for placebo-treated patients
Clinical Background
With the Co-Pay Savings Card, eligible patients may pay as little as $4 per Rx for branded LYRICA.
 
See terms and conditions below for full eligibility requirements.
Includes patients who received any study dose of LYRICA in placebo-controlled studies of fibromyalgia, painful diabetic peripheral neuropathy, postherpetic neuralgia, and neuropathic pain associated with spinal cord injury, as well as open-label extensions of those studies.
References: 1. Cardenas DD, Neishoff EC, Suda K, et al. A randomized trial of pregabalin with neuropathic pain due to spinal cord injury. Neurology. 2013;80(6):533-539. 2. Data on file. Pfizer Inc., New York, NY. 3. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology. 2006;67(10):1792-1800.