title: Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study.
abstract: OBJECTIVE
  We aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain.
  
  
  METHODS
  A total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.5 mg) and paracetamol (325 mg) (two tablets every 4-6 hours, up to a maximum of eight tablets daily). The primary efficacy end points were reductions in pain intensity from baseline at day 3 and day 5 as assessed by a Visual Analog Scale (VAS) score.
  
  
  RESULTS
  Group A showed a significant reduction in the VAS score for overall pain from baseline on day 3 (P=0.001) and day 5 (P<0.0001) as compared with group B. The combination of tramadol-diclofenac resulted in few mild to moderate adverse events (nausea, vomiting, epigastric pain, and gastritis), which required minimal management, without any treatment discontinuation. The number of adverse events in group A was nine (8.82%) compared with 22 (21.78%) in group B, after 5 days of treatment.
  
  
  CONCLUSIONS
  An FDC of tramadol-diclofenac showed a significantly greater reduction in pain intensity and was well tolerated compared with tramadol-paracetamol, resulting in better analgesia in patients suffering from moderate to severe pain due to acute musculoskeletal conditions, postoperative pain following orthopedic surgery, or acute flare of osteoarthritis and rheumatoid arthritis.
authors.affiliation: Department of Orthopedics & Traumatology, Byramjee Jeejeebhoy Medical College and Sassoon General Hospital, Pune, Maharashtra, India.
authors.forename: Ajay S
authors.initials: AS
authors.lastname: Chandanwale
authors.affiliation: Vasantha Subramanian Hospital, Chennai, Tamil Nadu, India.
authors.forename: Subramanian
authors.initials: S
authors.lastname: Sundar
authors.affiliation: Vijay Hospital, Pondicherry, India.
authors.forename: Kaliaperumal
authors.initials: K
authors.lastname: Latchoumibady
authors.affiliation: Medical Services Department, Abbott Healthcare Pvt Ltd, Mumbai, India.
authors.forename: Swati
authors.initials: S
authors.lastname: Biswas
authors.affiliation: Medical Services Department, Abbott Healthcare Pvt Ltd, Mumbai, India.
authors.forename: Mukesh
authors.initials: M
authors.lastname: Gabhane
authors.affiliation: Clinical Research Department, Abbott Healthcare Pvt Ltd, Mumbai, India.
authors.forename: Manoj
authors.initials: M
authors.lastname: Naik
authors.affiliation: Medical Services Department, Abbott Healthcare Pvt Ltd, Mumbai, India.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Patel
keywords: moderate to severe pain; tramadol and diclofenac combination