Background and objectives To describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials.
Methods Safety data and opioid use from subjects with moderate to severe postoperative pain who received ≥1 dose of intravenous meloxicam (5–60 mg) or placebo in 1 of 7 studies (4 phase II; 3 phase III) were pooled. Data from intravenous meloxicam 5 mg, 7.5 mg and 15 mg groups were combined (low-dose subset).
Results A total of 1426 adults (86.6% white; mean age: 45.8 years) received ≥1 dose of meloxicam IV; 517 (77.6% white; mean age: 46.7 years) received placebo. The incidence of treatment-emergent adverse events (TEAEs) in intravenous meloxicam and placebo-treated subjects was 47% and 57%, respectively. The most commonly reported TEAEs across treatment groups (intravenous meloxicam 5–15 mg, 30 mg, 60 mg and placebo, respectively) were nausea (4.3%, 20.8%, 5.8% and 25.3%), headache (1.5%, 5.6%, 1.6% and 10.4%), vomiting (2.8%, 4.6%, 1.6% and 7.4%) and dizziness (0%, 3.5%, 1.1% and 4.8%). TEAE incidence was generally similar in subjects aged >65 years with impaired renal function and the general population. Similar rates of cardiovascular events were reported between treatment groups. One death was reported (placebo group; unrelated to study drug). There were 35 serious adverse events (SAEs); intravenous meloxicam 15 mg (n=5), intravenous meloxicam 30 mg (n=15) and placebo (n=15). The SAEs in meloxicam-treated subjects were determined to be unrelated to study medication. Six subjects withdrew due to TEAEs, including three treated with intravenous meloxicam (rash, localized edema and postprocedural pulmonary embolism). In trials where opioid use was monitored, meloxicam reduced postoperative rescue opioid use.
Conclusions Intravenous meloxicam was generally well tolerated in subjects with moderate to severe postoperative pain.
- COX-2 inhibitor
- postoperative pain
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Funding Funding for this research was provided by Recro Pharma, Inc., Malvern, PA.
Competing interests ERV has received consulting fees from Cara, Mallinckrodt Pharmaceuticals, Merck, Recro, Salix Pharmaceuticals, Inc and Trevena, Inc and has received grants and consulting fees from AcelRx Pharmaceuticals, Inc, Durect and Pacira Pharmaceuticals, Inc, outside this submitted work. TJG has received consulting fees from Edwards, Mallinckrodt, Merck, Recro and Medtronic, Inc. RJM, SWM and SH are employees of Recro Pharma, Inc, Malvern, Pennsylvania. WD receives consultancy fees from Recro Pharma, Inc, Malvern, Pennsylvania. SB is an employee of Ohio State University, which participated in trial NCT02720692. NS is an employee of Lotus Clinical Research, which participated in trials NCT02678286, NCT02675907 and NCT02720692 as a CRO and/or research site; NS and Lotus have also received study grants and other compensation for clinical trial services from multiple pharmaceutical companies.
Patient consent for publication Not required.
Ethics approval Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.
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