Safety of Parecoxib When Used For More Than 3 Days For The Management of Postoperative Pain

Abstract

Aim: To assess parecoxib safety when used for >3 days for postoperative pain management. Methods: Treatment-emergent adverse event (TEAE) occurrence after day 3 was examined in a pooled analysis of three placebo-controlled trials of parecoxib following general or gynecologic surgery, or total hip arthroplasty. A total of 358 patients received parecoxib, and 318 placebo. Results: Mean treatment duration was similar between treatment groups. The overall frequency of all TEAEs after day 3 was also similar between treatment groups. Most TEAEs occurred in <1% of patients after day 3; frequencies were similar between treatment groups. Most TEAEs were considered mild or moderate in severity. Conclusion: TEAE occurrence in patients receiving parecoxib for >3 days was low and similar to placebo after treatment day 3.

KEYWORDS:

• adverse events
• COX-2 inhibitor
• parecoxib
• postoperative pain
• safety

Financial & competing interests disclosure

The studies included in this analysis were sponsored by Pfizer. MN Essex, R Cheung and C Li are all full-time employees of, and own stock in, Pfizer. L Xie was a full-time employee of Pfizer during the conduct of the study and development of the manuscript. L Xie’s current affiliation is Takeda Pharmaceutical (China) Company Limited. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support was provided by Matt Soulsby of Engage Scientific Solutions and was funded by Pfizer.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved. The three trials included in this analysis were conducted prior to 26 December 2007 and, as such, are not required to be registered in clinicaltrials.gov.

Additional information

Funding

The studies included in this analysis were sponsored by Pfizer. MN Essex, R Cheung and C Li are all full-time employees of, and own stock in, Pfizer. L Xie was a full-time employee of Pfizer during the conduct of the study and development of the manuscript. L Xie’s current affiliation is Takeda Pharmaceutical (China) Company Limited. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by Matt Soulsby of Engage Scientific Solutions and was funded by Pfizer.