Painful Diabetic Peripheral Neuropathy (pDPN)

EFFICACY IN PAINFUL DPN
In an 8-week pivotal study,
LYRICA (pregabalin) provided powerful DPN pain relief1,2
*LYRICA 300 mg/day divided TID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
In some patients, LYRICA provided rapid and significant relief as early as Week 1 (35% median pain reduction from baseline, vs 4% for placebo)1,2
Study description
Adapted from Rosenstock et al. Pain. 20041; Pfizer data on file.2
Results from a randomized, double-blind, placebo-controlled, multicenter study conducted in 2 phases: baseline (1 week) and a double-blind treatment phase (8 weeks). Patients (N=146) had moderate to severe DPN pain (≥4 on a 0-to-10 scale) and were required to have a visual analog scale (VAS) score ≥40 mm to be eligible for the double-blind treatment phase. At the end of the baseline phase, eligible patients received LYRICA 300 mg/day divided TID or placebo. Medications that could affect painful symptoms of DPN were prohibited, with the exception of acetaminophen (up to 4 g/day), aspirin (up to 325 mg/day for myocardial infarction or transient ischemic attack prophylaxis), and serotonin reuptake inhibitors (provided no dose changes occurred within 30 days prior to randomization or during the study).
The primary efficacy measure was mean pain score at endpoint, defined as the mean of the last 7 daily self-assessments entered into the patient's daily pain diary. For this analysis, pain was assessed on an 11-point scale: 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain. Mean pain scores for LYRICA and placebo were, respectively: 6.5 and 6.1 at baseline; 4.3 and 5.9 at Week 1; and 4.0 and 5.3 at endpoint.
In a 5-week pivotal study, more than twice as many patients on LYRICA achieved a DPN pain reduction of 50% or more vs those on placebo2,3
*LYRICA 300 mg/day divided TID.
Baseline observation carried forward (BOCF) analysis of intent-to-treat population.
In the same 5-week study, there was a statistically significant reduction in endpoint mean pain score with LYRICA 300 mg/day vs placebo (P=.0002)2,3
Study description
Adapted from Lesser et al. Neurology. 20043; Pfizer data on file.2
Results from a randomized, double-blind, placebo-controlled, parallel-group, multicenter study conducted in 2 phases: baseline (1 week) and a double-blind treatment phase (5 weeks). Patients (N=337) had moderate to severe DPN pain (≥4 on a 0-to-10 scale) and were required to have a visual analog scale (VAS) score of ≥40 mm to be eligible for the double-blind treatment phase. At the end of the baseline phase, eligible patients were randomized to receive LYRICA 75 mg/day, 300 mg/day, or 600 mg/day, all divided TID, or placebo given 3 times daily. Only patients randomized to receive LYRICA 300 mg/day (n=81) and the placebo group (n=97) were included in this analysis. Medications that could affect painful symptoms of DPN were prohibited, with the exception of acetaminophen (up to 3 g/day), aspirin (up to 325 mg/day for myocardial infarction or transient ischemic attack prophylaxis), and serotonin reuptake inhibitors (provided no dose changes occurred within 30 days prior to randomization or during the study).
The primary efficacy measure was mean pain score at endpoint, defined as the mean of the last 7 daily self-assessments entered into the patient’s daily pain diary. For this analysis, pain was assessed on an 11-point scale: 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain. Patients who experienced a 50% or greater reduction in pain from baseline were considered responders; for the responder rate analysis, patients who did not complete the study were assigned 0% improvement.
DOSING IN PAINFUL DPN
Consider your next steps for LYRICA titration, based on efficacy and tolerability
Dosage may be increased to 300 mg/day based on efficacy and tolerability within 1 week
When discontinuing LYRICA, taper gradually over a minimum of 1 week
Adjust the LYRICA daily dose based on renal function
For adult patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment
Supplementary dosage following hemodialysis
  • Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg
  • Patients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg
  • Patients on the 50-75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg
  • Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg
The use of LYRICA in pediatric patients with compromised renal function has not been studied.
*Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
Supplementary dose is a single additional dose.
SAFETY IN PAINFUL DPN
In controlled trials in adults with painful DPN,
Adverse reactions were generally mild to moderate2
In controlled painful DPN trials
3% discontinuation rate for LYRICA vs <1% for placebo
  • Occurred within 1 to 2 days
  • Dizziness resolved by study end for 60% of patients
  • In some patients, dizziness persisted through the course of treatment
  • Median duration across doses: 9 to 16 days
In controlled painful DPN trials
2% discontinuation rate for LYRICA vs <1% for placebo
  • Occurred within 1 to 4 days
  • Median duration across doses: 28 to 43 days
  • Somnolence resolved by study end for 44% of patients
  • In some patients, somnolence persisted through the course of treatment
In controlled painful DPN trials
<1% discontinuation rate for LYRICA vs <1% for placebo
  • Peripheral edema had no apparent association with:
    • Cardiovascular complications (eg, hypertension or congestive heart failure)§
    • Laboratory changes in renal or hepatic function
§These data are from short-term trials of patients without clinically significant heart or peripheral vascular disease. LYRICA should be used with caution in patients with congestive heart failure with New York Heart Association Class III and Class IV cardiac status.
In controlled painful DPN trials
<1% of patients discontinued due to LYRICA-associated weight gain
In controlled painful DPN trials
  • Mean weight gain: LYRICA 3.5 lb vs placebo 0.7 lb
  • Weight gain ≥7% of baseline body weight: LYRICA 5.2% vs placebo 1.4%
  • Weight gain appeared to be dose related and was not associated with clinically important changes in blood pressure in these studies; the long-term cardiovascular effects of LYRICA-associated weight gain are unknown
LYRICA was administered in doses BID or TID.
*Although studied, 600 mg/day is not a recommended dose for the management of painful DPN.
Includes all doses of LYRICA that were studied in painful DPN (eg, 75 mg/day).
Reactions in ≥5% of all LYRICA-treated patients and occurring at least twice the rate of placebo.
Clinical Background
With the Co-Pay Savings Card, eligible patients pay as little as $4 per Rx for branded LYRICA
*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. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110(3):628-638. 2. Data on file. Pfizer Inc, New York, NY. 3. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63(11):2104-2110.
*TERMS AND CONDITIONS
Offer Terms & Conditions:
By using the Co-Pay Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the following terms and conditions:
Patients are not eligible to use this card or participate in this program if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Patient must have private insurance. Offer is not valid for cash paying patients. The value of this card is limited to $175 per month per prescription (“offering period”) or the amount of your co-pay, whichever is less (Maximum annual savings of $2100). This program is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs. You must deduct the value received under this program from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of this program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required. You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay cards. You must be 18 years of age or older to accept this offer. This offer is not valid where prohibited by law.
For Massachusetts residents:
This co-pay offer is not valid if an A/B generic is available for Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance.
For California residents:
This co-pay offer is not valid if a generic is available for California residents whose prescriptions are covered in whole or in part by third-party insurance.
Please check with your healthcare professional or insurer to confirm eligibility. This offer cannot be combined with any other savings, free trial or similar offer for the specified prescription. The co-pay card will be accepted only at participating pharmacies. The co-pay card is not health insurance. Offer good only in the U.S. and Puerto Rico. The co-pay card is limited to one per person during this offering period and is not transferable. A co-pay card may not be redeemed more than once per offering period per patient. No other purchase is necessary. Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you. Pfizer reserves the right to rescind, revoke or amend this offer without notice. No membership fee. For more information, visit our website www.lyrica.com, call
1-866-954-1475,
or contact us at 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.
Offer expires 12/31/2020.
For reimbursement when using a nonparticipating pharmacy/mail order:
Pay for prescription, and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: Co-Pay Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your activated Co-Pay Savings Card, your name and mailing address.