Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy

Pollak, Richard; Gottlieb, Ira; Hakakian, Fardin; Zimmerman, J.; McCallum, Stewart W.; Mack, Randall J.; Keller, Rosemary; Freyer, Alex; Du, Wei

doi:10.1097/ajp.0000000000000609

Cited by 17 publications

(15 citation statements)

References 21 publications

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“…31 Subjects randomized to meloxicam IV 30 mg in the bunionectomy study experienced a statistically significant difference in summed PI difference from hour 0 to hour 48 versus the placebo group (-6956.0 versus -4829.3; P = .0034). 32 In both phase 3 studies, meloxicam IV was generally well tolerated, with a safety profile that included a low incidence of adverse events that was comparable to that of placebo.…”

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confidence: 96%

“…The analgesic effect and safety of meloxicam IV were evaluated in 2 phase 3 surgical models, including soft-tissue surgery (abdominoplasty) 31 and hard-tissue surgery (bunionectomy). 32 In the abdominoplasty study, subjects who received meloxicam IV had a statistically significant reduction in PI as measured by the summed PI difference from hour 0 to hour 24 compared with placebo-treated subjects (-4262.1 versus -3535.7; P = .0145). 31 Subjects randomized to meloxicam IV 30 mg in the bunionectomy study experienced a statistically significant difference in summed PI difference from hour 0 to hour 48 versus the placebo group (-6956.0 versus -4829.3; P = .0034).…”

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confidence: 96%

“…In the abdominoplasty study, subjects who received meloxicam IV had a statistically significant reduction in PI as measured by the summed PI difference from hour 0 to hour 24 compared with placebo‐treated subjects (‒4262.1 versus ‒3535.7; P = .0145) . Subjects randomized to meloxicam IV 30 mg in the bunionectomy study experienced a statistically significant difference in summed PI difference from hour 0 to hour 48 versus the placebo group (‒6956.0 versus ‒4829.3; P = .0034) . In both phase 3 studies, meloxicam IV was generally well tolerated, with a safety profile that included a low incidence of adverse events that was comparable to that of placebo.…”

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confidence: 97%

“…In phase 2 trials of subjects with postoperative pain after surgical procedures including removal of impacted third molars, open abdominal hysterectomy, laparoscopic abdominal surgery, and bunionectomy, meloxicam IV exhibited onset of analgesia within 15 minutes or less postdose, with maintenance of the analgesic effect through the 24‐hour dosing period. The analgesic effect and safety of meloxicam IV were evaluated in 2 phase 3 surgical models, including soft‐tissue surgery (abdominoplasty) and hard‐tissue surgery (bunionectomy) . In the abdominoplasty study, subjects who received meloxicam IV had a statistically significant reduction in PI as measured by the summed PI difference from hour 0 to hour 24 compared with placebo‐treated subjects (‒4262.1 versus ‒3535.7; P = .0145) .…”

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confidence: 99%

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A Phase 3, Randomized, Placebo‐Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery

Bergese

Melson

Candiotti

et al. 2019

Clinical Pharm in Drug Dev

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An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double‐blind, placebo‐controlled trial evaluated the safety of once‐daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily. Safety was evaluated via adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption. The incidence of adverse events was similar between meloxicam IV– and placebo‐treated subjects (63.0% versus 65.0%). Investigators assessed most adverse events as mild or moderate in intensity and unrelated to treatment. Adverse events of interest (injection‐site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound‐healing events) were similar between groups. Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo‐treated subjects. The results suggest that meloxicam IV had a safety profile similar to that of placebo with respect to numbers and frequencies of adverse events and reduced opioid consumption in subjects with moderate to severe postoperative pain following major elective surgery.

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confidence: 96%

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confidence: 96%

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confidence: 97%

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confidence: 99%

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A Phase 3, Randomized, Placebo‐Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery

Bergese

Melson

Candiotti

et al. 2019

Clinical Pharm in Drug Dev

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“…A 39-year-old placebo-treated woman died suddenly 55 days after treatment in study NCT02675907 7. Death was attributed to ‘complications of the toxic effects of methamphetamine’ and was considered by the investigator to be unrelated to study drug.…”

Section: Resultsmentioning

confidence: 99%

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

Viscusi

Gan

Bergese

et al. 2019

Regional Anesthesia &Amp; Pain Medicine

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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.

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Platelet Function: Meloxicam Intravenous in Whole Blood Samples From Healthy Volunteers

Jahr

Searle

McCallum³

et al. 2020

Clinical Pharm in Drug Dev

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Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective treatments for pain but may induce bleeding events due to platelet dysfunction associated with inhibition of cyclooxygenase (COX)-1 impairing thromboxane production. An intravenous nanocrystal formulation of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug, is under development for the treatment of moderate to severe pain. This single-center ex vivo study evaluated the effect of meloxicam intravenous and ketorolac on platelet function in whole blood samples from healthy volunteers. Each whole blood sample was aliquoted to allow analysis using a platelet function analyzer under negative control (untreated), positive control (2 therapeutic ketorolac concentrations), and meloxicam intravenous (1 therapeutic, 3 supratherapeutic concentrations) using both collagen with epinephrine and collagen with adenosine diphosphate reagent cartridges. The platelet function analyzer determines closure time by simulating platelet adhesion and aggregation following vascular injury. The final analysis set included data from 8 subjects. The collagen with adenosine diphosphate analysis (sensitive to thrombocytopathies) showed no significant differences in closure time for meloxicam-or ketorolac-treated samples and untreated control. The collagen with epinephrine analysis (sensitive to aspirin-induced platelet abnormalities) produced no significant difference in closure time between any meloxicam concentration and untreated control. Ketorolac was associated with significantly longer closure times vs untreated control at both the 2.5-and 5-µg/mL concentrations (P = .003 and .0257, respectively) and vs meloxicam at several concentrations. Similar results were observed when all analyzed samples were included. Meloxicam intravenous had no significant effect on closure times at therapeutic or supratherapeutic concentrations in this ex vivo study.

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Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy

Abstract: Meloxicam IV doses of 30 mg provided effective pain relief when administered once daily by bolus injection to patients with moderate-to-severe pain following bunionectomy, and had an acceptable safety profile.

Cited by 17 publications

References 21 publications

A Phase 3, Randomized, Placebo‐Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery

A Phase 3, Randomized, Placebo‐Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery

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

Platelet Function: Meloxicam Intravenous in Whole Blood Samples From Healthy Volunteers

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