OBJECTIVE: 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. METHODS: 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. RESULTS: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. CONCLUSIONS: 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. Wiley Periodicals, Inc.
RCT Entities:
OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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 insufficientpatients. Because study exclusion criteria were minimal, these findings may be broadly generalizable to populations commonly treated in clinical practice. Wiley Periodicals, Inc.
Authors: Tasce Bongiovanni; Elizabeth Lancaster; Yeranuí Ledesma; Evans Whitaker; Michael A Steinman; Isabel Elaine Allen; Andrew Auerbach; Elizabeth Wick Journal: J Am Coll Surg Date: 2021-01-27 Impact factor: 6.532
Authors: Ronald Goldwater; William G Kramer; Douglas A Hamilton; Eric Lang; Jianyuan Wang; Donna E Madden; Peter G Lacouture; Atulkumar Ramaiya; Daniel B Carr Journal: Clin Pharmacol Date: 2016-12-15
Authors: Tong J Gan; Neil Singla; Stephen E Daniels; Douglas A Hamilton; Peter G Lacouture; Christian Rd Reyes; Daniel B Carr Journal: J Pain Res Date: 2016-12-20 Impact factor: 3.133
Authors: Douglas A Hamilton; Cynthia C Ernst; William G Kramer; Donna Madden; Eric Lang; Edward Liao; Peter G Lacouture; Atulkumar Ramaiya; Daniel B Carr Journal: Clin Pharmacol Drug Dev Date: 2017-12-02
Authors: Cristina Monteiro; Samuel Silvestre; Ana Paula Duarte; Gilberto Alves Journal: Int J Environ Res Public Health Date: 2022-03-16 Impact factor: 3.390