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Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects.
Viscusi, Eugene R; Gan, Tong J; Bergese, Sergio; Singla, Neil; Mack, Randall J; McCallum, Stewart W; Du, Wei; Hobson, Sue.
Afiliación
  • Viscusi ER; Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
  • Gan TJ; Department of Anesthesiology, Stony Brook University, Stony Brook, New York, USA.
  • Bergese S; Department of Anesthesiology, Ohio State University College of Medicine, Columbus, Ohio, USA.
  • Singla N; Lotus Clinical Research, Pasadena, California, USA.
  • Mack RJ; Recro Pharma Inc, Malvern, Pennsylvania, USA rmack@recropharma.com.
  • McCallum SW; Recro Pharma Inc, Malvern, Pennsylvania, USA.
  • Du W; Clinical Statistics Consulting, Blue Bell, Pennsylvania, USA.
  • Hobson S; Recro Pharma Inc, Malvern, Pennsylvania, USA.
Reg Anesth Pain Med ; 44(3): 360-368, 2019 Mar.
Article en En | MEDLINE | ID: mdl-30737315
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. TRIAL REGISTRATION NUMBERS: NCT01436032, NCT00945763, NCT01084161, NCT02540265, NCT02678286, NCT02675907 and NCT02720692.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Reg Anesth Pain Med Asunto de la revista: ANESTESIOLOGIA / NEUROLOGIA / PSICOFISIOLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Reg Anesth Pain Med Asunto de la revista: ANESTESIOLOGIA / NEUROLOGIA / PSICOFISIOLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido