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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
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
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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1Gan, Tong J. "TJ"
2Hamilton, Douglas A
3Singla, Neil
4Lacouture, Peter G
5Johnson, Olufunmibi
6Min, Lauren H
7Reyes, Christian R.D
8Carr, Daniel B
title
0A 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
1Pain medicine (Malden, Mass.)
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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14Pain perception
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16Patients
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20Renal function
21Safety
22Surgery
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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1Analgesics
2Analysis
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5Creatinine
6Data processing
7Diclofenac
8Inflammation
9Ketorolac
10Medical research
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13Pain
14Pain perception
15Pain, Postoperative
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19Renal failure
20Renal function
21Safety
22Surgery
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24Urea
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1Gan, Tong J. "TJ"
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1Gan, Tong J. "TJ"
2Hamilton, Douglas A
3Singla, Neil
4Lacouture, Peter G
5Johnson, Olufunmibi
6Min, Lauren H
7Reyes, Christian R.D
8Carr, 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
volume17
issue12
spage2378
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
copOxford
pubOxford University Press
doi10.1093/pm/pnw146