Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects

Abstract

Background and objectivesTo describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials.MethodsSafety 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).ResultsA 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.ConclusionsIntravenous meloxicam was generally well tolerated in subjects with moderate to severe postoperative pain.Trial registration numbers NCT01436032, NCT00945763, NCT01084161, NCT02540265, NCT02678286, NCT02675907 and NCT02720692.

Control of pain in the early post-traumatic period in the outpatient practice. Results of the multi-center observational study RAPTOR (Rational Analgesia PostTraumatic: an Observational Research)

“…Успешный контроль ПТБ и низкая частота НР, связанных с приемом анальгетика, которые мы наблюдали в настоящем исследовании, могут объясняться применением оригинального мелоксикама -препарата, который зарекомендовал себя как представитель группы НПВП с хорошим соотношением эффективности и благоприятного профиля безопасности [30]. Несмотря на то, что мелоксикам в основном используется для лечения хронических заболеваний суставов и позвоночника, имеется успешный опыт его применения при острой боли, в частности в хирургической практике [31,32]. Так, эффективность этого препарата показана в серии РКИ при обезболивании стоматологических операций [33][34][35][36].…”