Safety of a Novel Parenteral Formulation of Diclofenac after Major Orthopedic or Abdominal/Pelvic Surgery in a Population Including Anticoagulated, Elderly or Renally Insufficient Patients: An Open‐Label, Multiday, Repeated Dose Clinical Trial. Issue 5 (8th April 2013)

• Record Type: Journal Article
• Authors: Chelly, Jacques E.; Singla, Sonia K.; Melson, Timothy I.; Lacouture, Peter G.; Paadre, Susan; Carr, Daniel B.
• Is Part Of: Pain medicine. Volume 14:Issue 5(2013)
• Page Start: 749
• Page End: 761
• Publication Date: 2013-04-08
• Subjects: Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesics -- Periodicals; Pain -- Periodicals; Pain Management -- Periodicals; Douleur -- Périodiques; Douleur -- Traitement -- Périodiques; Analgésiques -- Périodiques; Analgésique; Soulagement de la douleur; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.047205
• DOI: 10.1111/pme.12076
• Languages: English
• ISSNs: 1526-2375

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="pme12076-sec-0001" sec-type="section"> <title>Objective</title> <p>Decisions to use or avoid nonsteroidal anti‐inflammatory drugs (NSAIDs) for postsurgical pain are often influenced by concerns about bleeding and renal adverse effects. The objective of this study was to evaluate the safety of a novel parenteral NSAID, hydroxypropyl‐β‐cyclodextrin (HPβCD) diclofenac, in a large postsurgical patient population, with particular focus on bleeding and renal effects.</p> </sec> <sec id="pme12076-sec-0002" sec-type="section"> <title>Methods</title> <p>This was a large open‐label study in adult patients with acute moderate‐to‐severe pain following major surgery. Patients received ≥2 days of continuous treatment with HPβCD diclofenac, administered as a small‐volume bolus injection every 6 hours. Few exclusion criteria were applied in order to reflect surgical patient populations commonly managed in clinical practice. Adverse events (AEs) were recorded throughout the study. The incidences of bleeding‐ and renal‐related AEs were examined in patient subpopulations with known risk factors for NSAID‐induced complications: advanced age, pre‐existing renal insufficiency, concomitant anticoagulant use, prolonged exposure, elevated dosage, and major surgeries.</p> </sec> <sec id="pme12076-sec-0003" sec-type="section"> <title>Results</title> <p>Of the total 971 patients studied, 38% were ≥65 years old (12% >75 years), 62% received concomitant anticoagulants, and 6% had pre‐existing renal insufficiency. HPβCD diclofenac was well tolerated by the patient population. AE rates are presented by risk factor to enable clinicians to better describe renal‐ or bleeding‐related AEs.</p> </sec> <sec id="pme12076-sec-0004" sec-type="section"> <title>Conclusions</title> <p>In addition to its previously demonstrated efficacy, this study provides evidence of HPβCD diclofenac's safety in a large postsurgical population including anticoagulated, elderly or renally insufficient patients. Because study exclusion criteria were minimal, these findings may be broadly generalizable to populations commonly treated in clinical practice.</p> </sec> </abstract>