ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • Register
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 39

Effects of Pregabalin (Lyrica®) on Cerebrospinal Fluid Substance P in Human Subjects with Fibromyalgia Syndrome

Irwin Jon Russell1, Joel E. Michalek2 and Sorleen Trevino-Mendez3, 1Affiliated with Arthritis & Osteoporosis Center of South Texas, Medical Director, Fibromyalgia Research and Consulting, San Antonio, Texas, San Antonio, TX, 2Professor, Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, Texas, San Antonio, TX, 3Medical Student, Texas Tech University School of Medicine, Lubbock, TX

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biomarkers, central nervous system involvement, Fibromyalgia and treatment

  • Tweet
  • Email
  • Print
Save to PDF
Session Information

Date: Sunday, November 13, 2016

Session Title: Fibromyalgia, Soft Tissue Disorders, Regional and Specific Clinical Pain Syndromes - Poster I: Basic Science Focus

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Fibromyalgia Syndrome [FMS] is a common chronic pain disorder. Pregabalin (PGB) is one of three medications approved by the FDA for treatment of FMS. Substance P (SP), a neuropeptide known to facilitate pain transmission, is elevated in the cerebrospinal fluid (CSF) of FMS. The mechanism of PGB benefit in FMS is uncertain, but it is known to inhibit SP production by neurons in vitro. Our objective was to measure PGB’s effect, if any, on CSF SP in FMS.

Methods: This study was investigator-initiated, -designed, -conducted, and –analyzed. It was randomized (2:1, PGB:PBO), double-blinded, placebo (PBO)-controlled, and involved only FMS females, 18-65 years of age. Funding was provided by a research grant from Pfizer Inc., which also provided the study medications (150mg PGB capsules, identical-appearing PBO). It was not an efficacy or safety clinical trial, since the primary outcome variable was biological (mean change in CSF SP level with PGB therapy). The 1990 ACR Research Classification Criteria were required for entry. At Screening (Visit #1), informed consent was obtained, patients were examined for diagnosis, validated self-report measures were completed, a blood sample was obtained, participants began to taper-off potentially-interfering medications, and were off for 5+ half-lives. At Baseline (Visit #2), the self-report measures were repeated, CSF was collected for storage at -70°C, and patients were randomized to PGB or PBO, at bedtime. The dosage was increased over a period of 2 weeks to therapeutic (300-450 mg/24 hrs). After 6 full weeks of therapeutic dosage (Visit #4), the Patient Global Impression of Change (PGIC) was assessed, and a second CSF was stored. Numbered CSF samples were analyzed in-blind for SP and biogenic amines. Treatment groups were contrasted on the mean, using analysis of variance, and on categorical outcomes with Fisher’s Exact Test. All statistical testing was two-sided with a significance at 5%.

Results: The study was originally powered for 90 randomized subjects, but, a budget cut limited the sample size, leaving the study inadequately powered. Eighty four patients signed informed consent; 38 screen failed; 46 were randomized (PGB n=31, PBO n=15), five randomized patients later withdrew consent (PGB n=3, PBO n=2). A total of 41 completed the study (PGB n=28, PBO 13), each with 2 stored CSF samples. At Baseline, treatment groups did not differ in any respect (demographic, clinical, laboratory). At Visit #4, the PGIC distribution varied significantly (p=0.02) with treatment [PGB 60.7% (17/28) cf. PBO 30.7% (4/13) reporting being Much- to Very Much-Improved] while CSF SP had increased numerically in both groups (CSF SP, fmol/ml, PGB +15.8±56.7, PBO +10.8±60.2, p=0.94). Correlations between clinical outcomes and spinal fluid measures were noted. A statistical model was developed. The observed adverse events had been anticipated, and were generally mild. One post-spinal headache was considered serious, as it required blood patch treatment.

Conclusion: The study design produced comparable treatment groups. PGB affected clinically relevant improvement in more than half of the PGB-treated patients but the CSF SP concentration trended to rise.


Disclosure: I. J. Russell, Pfizer Inc., 2; J. E. Michalek, Pfizer Inc, 2; S. Trevino-Mendez, Pfizer Inc, 2.

To cite this abstract in AMA style:

Russell IJ, Michalek JE, Trevino-Mendez S. Effects of Pregabalin (Lyrica®) on Cerebrospinal Fluid Substance P in Human Subjects with Fibromyalgia Syndrome [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/effects-of-pregabalin-lyrica-on-cerebrospinal-fluid-substance-p-in-human-subjects-with-fibromyalgia-syndrome/. Accessed January 20, 2021.
  • Tweet
  • Email
  • Print
Save to PDF

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-pregabalin-lyrica-on-cerebrospinal-fluid-substance-p-in-human-subjects-with-fibromyalgia-syndrome/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Convergence: Where Rheumatology Meets. All Virtual. November 5-9.

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2021 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies
loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.