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A Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HP[beta]CD-Diclofenac in Subjects with Acute Postoperative Pain

Objective. While injectable nonsteroidal antiinflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HP[beta]CD-diclofenac when given for [less than or equal to] 5... Full description

Journal Title: Pain medicine (Malden Mass.), 2016-12-01, Vol.17 (12), p.2378
Main Author: Daniels, Stephen E
Other Authors: Gan, Tong J. "TJ" , Hamilton, Douglas A , Singla, Neil , Lacouture, Peter G , Johnson, Olufunmibi , Min, Lauren H , Reyes, Christian R.D , Carr, Daniel B
Format: Electronic Article Electronic Article
Language: English
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Publisher: Oxford: Oxford University Press
ID: ISSN: 1526-2375
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recordid: cdi_proquest_journals_1985956207
title: A Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HP[beta]CD-Diclofenac in Subjects with Acute Postoperative Pain
format: Article
creator:
  • Daniels, Stephen E
  • Gan, Tong J. "TJ"
  • Hamilton, Douglas A
  • Singla, Neil
  • Lacouture, Peter G
  • Johnson, Olufunmibi
  • Min, Lauren H
  • Reyes, Christian R.D
  • Carr, Daniel B
subjects:
  • Analgesia
  • Analgesics
  • Analysis
  • Care and treatment
  • Clinical trials
  • Creatinine
  • Data processing
  • Diclofenac
  • Inflammation
  • Ketorolac
  • Medical research
  • Medicine, Experimental
  • Nonsteroidal anti-inflammatory drugs
  • Pain
  • Pain perception
  • Pain, Postoperative
  • Patients
  • Pharmaceutical industry
  • Product development
  • Renal failure
  • Renal function
  • Safety
  • Surgery
  • Tromethamine
  • Urea
ispartof: Pain medicine (Malden, Mass.), 2016-12-01, Vol.17 (12), p.2378
description: Objective. While injectable nonsteroidal antiinflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HP[beta]CD-diclofenac when given for [less than or equal to] 5 days following orthopedic or abdominal/pelvic surgery. Methods. Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. Results. There were three renal AEs each in the HP[beta]CD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HP[beta]CD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HP[beta]CD-diclofenac) was treatment-related. One incidence of postoperative shift to high (>upper limit of normal) serum creatinine occurred in the HP[beta]CD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HP[beta]CD-diclofenac and placebo. Conclusions. While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HP[beta]CD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population. Key Words. Acute Pain; NSAID; Pain Management; Safety; Diclofenac; Renal
language: eng
source:
identifier: ISSN: 1526-2375
fulltext: no_fulltext
issn:
  • 1526-2375
  • 1526-4637
url: Link


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titleA Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HP[beta]CD-Diclofenac in Subjects with Acute Postoperative Pain
creatorDaniels, Stephen E ; Gan, Tong J. "TJ" ; Hamilton, Douglas A ; Singla, Neil ; Lacouture, Peter G ; Johnson, Olufunmibi ; Min, Lauren H ; Reyes, Christian R.D ; Carr, Daniel B
creatorcontribDaniels, Stephen E ; Gan, Tong J. "TJ" ; Hamilton, Douglas A ; Singla, Neil ; Lacouture, Peter G ; Johnson, Olufunmibi ; Min, Lauren H ; Reyes, Christian R.D ; Carr, Daniel B
descriptionObjective. While injectable nonsteroidal antiinflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HP[beta]CD-diclofenac when given for [less than or equal to] 5 days following orthopedic or abdominal/pelvic surgery. Methods. Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. Results. There were three renal AEs each in the HP[beta]CD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HP[beta]CD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HP[beta]CD-diclofenac) was treatment-related. One incidence of postoperative shift to high (>upper limit of normal) serum creatinine occurred in the HP[beta]CD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HP[beta]CD-diclofenac and placebo. Conclusions. While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HP[beta]CD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population. Key Words. Acute Pain; NSAID; Pain Management; Safety; Diclofenac; Renal
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subjectAnalgesia ; Analgesics ; Analysis ; Care and treatment ; Clinical trials ; Creatinine ; Data processing ; Diclofenac ; Inflammation ; Ketorolac ; Medical research ; Medicine, Experimental ; Nonsteroidal anti-inflammatory drugs ; Pain ; Pain perception ; Pain, Postoperative ; Patients ; Pharmaceutical industry ; Product development ; Renal failure ; Renal function ; Safety ; Surgery ; Tromethamine ; Urea
ispartofPain medicine (Malden, Mass.), 2016-12-01, Vol.17 (12), p.2378
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8Carr, Daniel B
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descriptionObjective. While injectable nonsteroidal antiinflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HP[beta]CD-diclofenac when given for [less than or equal to] 5 days following orthopedic or abdominal/pelvic surgery. Methods. Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. Results. There were three renal AEs each in the HP[beta]CD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HP[beta]CD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HP[beta]CD-diclofenac) was treatment-related. One incidence of postoperative shift to high (>upper limit of normal) serum creatinine occurred in the HP[beta]CD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HP[beta]CD-diclofenac and placebo. Conclusions. While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HP[beta]CD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population. Key Words. Acute Pain; NSAID; Pain Management; Safety; Diclofenac; Renal
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23Tromethamine
24Urea
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titleA Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HP[beta]CD-Diclofenac in Subjects with Acute Postoperative Pain
authorDaniels, Stephen E ; Gan, Tong J. "TJ" ; Hamilton, Douglas A ; Singla, Neil ; Lacouture, Peter G ; Johnson, Olufunmibi ; Min, Lauren H ; Reyes, Christian R.D ; Carr, Daniel B
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atitleA Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HP[beta]CD-Diclofenac in Subjects with Acute Postoperative Pain
jtitlePain medicine (Malden, Mass.)
date2016-12-01
risdate2016
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issue12
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pages2378-
issn1526-2375
eissn1526-4637
abstractObjective. While injectable nonsteroidal antiinflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HP[beta]CD-diclofenac when given for [less than or equal to] 5 days following orthopedic or abdominal/pelvic surgery. Methods. Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. Results. There were three renal AEs each in the HP[beta]CD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HP[beta]CD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HP[beta]CD-diclofenac) was treatment-related. One incidence of postoperative shift to high (>upper limit of normal) serum creatinine occurred in the HP[beta]CD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HP[beta]CD-diclofenac and placebo. Conclusions. While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HP[beta]CD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population. Key Words. Acute Pain; NSAID; Pain Management; Safety; Diclofenac; Renal
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pubOxford University Press
doi10.1093/pm/pnw146