ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 2149

Safety Of Lower-Dose Diclofenac Submicron Particle Capsules Dosed Up To 12 Weeks In Patients With Osteoarthritis

Clarence Young1 and Marc C. Hochberg2, 1Iroko Pharmaceuticals, Philadelphia, PA, 2Medicine, University of Maryland School of Medicine, Baltimore, MD

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: gastrointestinal complications, Nonsteroidal antiinflammatory drugs (NSAIDs), Osteoarthritis, pain management and safety

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Title: Osteoarthritis - Clinical Aspects II: Symptoms and Therapeutics in Osteoarthritis.

Session Type: Abstract Submissions (ACR)

Background/Purpose: Osteoarthritis (OA) is the most common cause of disability in the US and is frequently managed with non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs, including diclofenac, are associated with dose-related gastrointestinal, cardiovascular, and renal adverse events (AEs). As a result, the US Food and Drug Administration issued a Public Health Advisory encouraging physicians to prescribe NSAIDs at “the lowest effective dose for the shortest duration consistent with individual patient treatment goals.” The efficacy of new, submicron particle NSAIDs is under investigation. These drugs have enhanced absorption and may be efficacious at lower doses than commercially available NSAIDs. We report phase 3 safety data in patients with OA pain dosed up to 12 weeks with diclofenac submicron particle capsules.

Methods: This randomized, multicenter, double-blind, parallel-group study enrolled 305 patients 41 to 90 years of age with OA of the hip or knee, which was documented radiologically (Kellgren-Lawrence grade II–III). Enrolled patients were chronic NSAID and/or acetaminophen users with a WOMAC pain subscore ≥40 mm/100-mm at baseline and a documented OA pain “flare” (increase in WOMAC pain subscale ≥15 mm) following NSAID discontinuation. Patients received either diclofenac submicron particle capsules 35 mg TID or BID, or placebo. The primary endpoint was mean change from baseline in WOMAC pain subscore at week 12. Safety and tolerability were also assessed.

Results: Most patients were female (203/305, 66.6%) with an age (mean ± SD) of 61.6 ± 8.9 years. Diclofenac submicron particle capsules 35 mg TID provided significantly better pain relief than placebo (P = 0.0024) with numerical evidence of pain relief in the diclofenac submicron particle capsules 35 mg BID treatment group, although this did not achieve statistical significance (P = 0.0795). The most frequent AEs (>3% in any treatment group) were generally similar across treatment groups (Table). Serious AEs occurred in 3.0% (9/305) of patients and were generally comparable across treatment groups. No serious gastrointestinal bleeds or cardiovascular or renal AEs occurred in any treatment group. The most frequent AEs in patients who withdrew from the study (≥1% in any treatment group) included diarrhea (3/305, 1.0%), upper abdominal pain (3/305, 1.0%), and alanine aminotransferase elevation (3/305, 1.0%). There was no difference across treatment groups for withdrawals due to AEs.

Conclusion: Investigational, lower-dose diclofenac submicron particle capsules were generally well-tolerated in a phase 3 study of patients with OA. No serious gastrointestinal bleeds or cardiovascular or renal AEs occurred over 12 weeks of treatment.

 


Disclosure:

C. Young,

Iroko Pharmaceuticals LLC,

3;

M. C. Hochberg,

Abbvie, Inc,

5,

Bioiberica SA,

5,

Eli Lilly and Company,

5,

Genentech, Inc,

5,

Iroko Pharmaceuticals, LLC,

5,

Merck, Inc,

5,

Novartis Pharma AG,

5,

Pfizer, Inc,

5,

Savient Pharmaceuticals,

5.

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-lower-dose-diclofenac-submicron-particle-capsules-dosed-up-to-12-weeks-in-patients-with-osteoarthritis/

Advanced Search

Your Favorites

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

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology