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01-09-2009 | Original Research Article

Reduction in Opioid-Related Adverse Events and Improvement in Function with Parecoxib followed by Valdecoxib Treatment after Non-Cardiac Surgery

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Authors: Prof. Richard M. Langford, Girish P. Joshi, Tong J. Gan, Maria Stoeckl Mattera, Wen-Hung Chen, Dennis A. Revicki, Connie Chen, Gergana Zlateva

Published in: Clinical Drug Investigation | Issue 9/2009

Abstract

Background: Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control.

Methods: In this randomized, double-blind trial, patients (n=1062) undergoing major non-cardiac elective surgery received either parenteral parecoxib for 3 days or placebo then oral valdecoxib or placebo for a total of 10 days, with both arms being allowed additional opioid analgesia. Clinically meaningful opioid-related adverse events were assessed daily using the Opioid-Related Symptom Distress Scale (OR-SDS). Pain severity and interference with function were evaluated daily using the modified Brief Pain Inventory exploratory form (mBPI-e). Additional validation work was undertaken to understand the psychometric properties of the two PROs. Detailed clinical results were reported elsewhere.

Results: Patients receiving parecoxib/valdecoxib achieved significantly better pain control and consumed 37% and 28% less opioid medication than the placebo group on day 2 and day 3, respectively. Over the 10-day treatment period, patients receiving parecoxib/valdecoxib consumed 31% less opioid medication. This coincided with significantly fewer (p < 0.0001) OR-SDS clinically meaningful events (CMEs) and lower mBPI-e scores from days 2–10 in the parecoxib/valdecoxib group compared with the placebo group. On day 3, the percentage of patients reporting one, two or three CMEs in the parecoxib/valdecoxib versus placebo group was 11.6% versus 13.0%, 2.3% versus 5.1%, and 0.8% versus 2.3%, respectively. The mean (± standard error) mBPI-e pain severity scores over days 2–10 were 2.47 ± 0.04 for the parecoxib/valdecoxib group and 3.01 ±0.04 for the placebo group, and the mean mBPI-e pain interference scores were 1.73±0.04 and 2.19 ± 0.04, respectively.

Conclusions: Patients receiving parecoxib/valdecoxib had less pain interference on physical functioning, required less opioid medication and experienced fewer clinically meaningful opioid-related adverse events than patients receiving placebo.

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Title: Reduction in Opioid-Related Adverse Events and Improvement in Function with Parecoxib followed by Valdecoxib Treatment after Non-Cardiac Surgery
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Authors: Prof. Richard M. Langford
Girish P. Joshi
Tong J. Gan
Maria Stoeckl Mattera
Wen-Hung Chen
Dennis A. Revicki
Connie Chen
Gergana Zlateva
Publication date: 01-09-2009
Publisher: Springer International Publishing
Published in: Clinical Drug Investigation / Issue 9/2009
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.2165/11317570-000000000-00000

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Reduction in Opioid-Related Adverse Events and Improvement in Function with Parecoxib followed by Valdecoxib Treatment after Non-Cardiac Surgery

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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