Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-severe Pain Following Abdominoplasty

Singla, Neil; Bindewald, Matthew; Singla, Sonia; Leiman, David; Minkowitz, Harold S.; McCallum, Stewart W.; Mack, Randall J.; Keller, Rosemary; Freyer, Alex; Du, Wei

doi:10.1097/gox.0000000000001846

Cited by 26 publications

(33 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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). 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.…”

mentioning

confidence: 93%

“…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) .…”

mentioning

confidence: 99%

“…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) . 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) .…”

mentioning

confidence: 99%

See 2 more Smart Citations

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

Self Cite

View full text Add to dashboard Cite

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.

show abstract

mentioning

confidence: 93%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

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

Self Cite

View full text Add to dashboard Cite

show abstract

“…It belongs to the oxicam family of chemicals and blocks COX-2 more than it does COX-1, thus having fewer gastrointestinal side effects compared to nonselective NSAIDs, and without interfering with platelet function [29,30]. Its e cacy and safety have been evaluated in seven Phase 2/3 randomized controlled clinical trials (RCTs) following procedures including dental surgery, abdominal hysterectomy, bunionectomy, abdominoplasty, and other major procedures [31][32][33][34][35][36][37]. Since these trials did not allow concomitant NSAID use and were placebo controlled, MIV has not yet been compared to other non-opioid IV analgesics.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of non-opioid analgesics to control postoperative pain: A network meta-analysis

Carter¹,

Black²,

Sharma

et al. 2020

Preprint

View full text Add to dashboard Cite

BACKGROUND The aim of this network meta-analysis (NMA) was to evaluate the safety and efficacy of intravenous (IV) Meloxicam 30mg (MIV), an investigational non-steroidal anti-inflammatory drug (NSAID), and certain other IV non-opioid analgesics for moderate-severe acute postoperative pain. METHODS We searched PubMed and CENTRAL for Randomized Controlled Trials (RCT) (years 2000-2019, adult human subjects) of IV non-opioid analgesics (IV NSAIDs or IV Acetaminophen) used to treat acute pain after abdominal, hysterectomy, bunionectomy or orthopedic procedures. A Bayesian NMA was conducted in STATA (v15.0) to rank treatments based on the standardized mean differences in sum of pain intensity difference from baseline up to 24 hours postoperatively (Sum of pain intensity difference: SPID 24). The probability and the cumulative probability of rank for each treatment were calculated, and the surface under the cumulative ranking curve (SUCRA) was applied to distinguish each treatment by efficacy and safety where higher SUCRA values indicated better outcomes. Treatments were also compared by frequency of opioid-related adverse events (ORADEs) including gastrointestinal and respiratory and reduction in morphine milligram equivalents (MME). The study protocol was prospectively registered with by PROSPERO (CRD42019117360). RESULTS Out of 2,313 screened studies, 27 studies with 36 comparative observations were included, producing a treatment network that included the four non-opioid IV pain medications of interest (MIV, ketorolac, acetaminophen, and ibuprofen). MIV was associated with the largest SPID 24 for all procedure categories and comparators. The SUCRA ranking table indicated that MIV had the highest probability for the most effective treatment for abdominal (89.5%), bunionectomy (100%), and hysterectomy (99.8%). Significantly lower MME was associated with MIV for abdominal (vs acetaminophen, ibuprofen and ketorolac), bunionectomy (vs acetaminophen), hysterectomy (vs acetaminophen and ketorolac) and orthopedic procedures (vs acetaminophen and ibuprofen). Odds of ORADEs were significantly higher for all comparators vs MIV for orthopedic (gastrointestinal) and hysterectomy (respiratory). CONCLUSIONS MIV 30mg may provide better pain reduction with similar or better safety compared to other approved IV non-opioid analgesics. Caution is warranted in interpreting these results, as all comparisons involving MIV were indirect.

show abstract

“…A nanocrystal formulation of meloxicam that can be administered by intravenous bolus injection was developed for the management of moderate to severe pain. Intravenous meloxicam was evaluated in four phase II and three phase III postoperative studies, comprising subjects undergoing dental impaction surgery,3 open abdominal hysterectomy,4 abdominal laparoscopic surgery,5 bunionectomy,6 7 abdominoplasty8 and major surgery 9. In these studies, intravenous meloxicam demonstrated onset of analgesia within 15 min after administration with maintenance over a 24-hour dosing interval 3 4 6–8.…”

Section: Introductionmentioning

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

Reg Anesth Pain Med

Self Cite

View full text Add to dashboard Cite

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.

show abstract

Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-severe Pain Following Abdominoplasty

Cited by 26 publications

References 20 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

Efficacy of non-opioid analgesics to control postoperative pain: A network meta-analysis

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

Contact Info

Product

Resources

About