title: Comparative assessment of the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult indian patients with osteoarthritis of the hip or knee: A 4-week, double-blind, randomized, comparative, multicenter study.
abstract: BACKGROUND
  Reports of cardiovascular adverse events (AEs) associated with the use of cyclooxygenase-2 inhibitors for the treatment of osteoarthritis (OA) have prompted the quest for a better-tolerated NSAID.
  
  
  OBJECTIVE
  The aim of this study was to compare the effectiveness and tolerability of lornoxicam 8 mg BID and diclofenac 50 mg TID in adult Indian patients with OA of the hip or knee.
  
  
  METHODS
  This 4-week, double-blind, randomized, comparative, multicenter study was undertaken to compare oral lornoxicam and diclofenac in patients with OA. Patients who met the selection criteria were enrolled consecutively from the outpatient clinics of each of the participating hospitals in India. Participants completed the Western Ontario and McMasters Individual Osteoarthritis Index (WOMAC-OA), WOMAC Composite Index (WOMAC-CI) (for pain, stiffness, and physical function), and a 10-cm visual analog scale (VAS) (0-10 where 0 = no pain and 10 = worst possible pain or severe or excruciating pain) at each study visit (weeks 0 [baseline], 2, and 4 [or at early termination]). Patients' and physicians' global assessments of arthritis control were measured at each study visit when laboratory and clinical AEs were also monitored. The primary end points were the WOMAC-OA, the WOMAC-CI, and VAS scores for pain among the patients who completed the study.
  
  
  RESULTS
  Of the 273 patients (159 men, 114 women; mean [SD] age, 44.73 [10.72] years; range, 28-68 years) enrolled in the study, 13 (7 in the lornoxicam group and 6 in the diclofenac group) were lost to follow-up and their effectiveness and tolerability results were not included in the study analysis. Over the 4-week study period, both drugs provided significant (P < 0.05) sustained relief of OA symptoms compared with baseline. Compared with baseline, the mean pain score (WOMAC-CI) decreased 90.6% (13.88 [4.47] vs 1.30 [1.49]; P < 0.05) in the lornoxicam group and 88.9% (14.15 [4.56] vs 1.57 [1.49]; P < 0.05) in the diclofenac group after 4 weeks of treatment. After 4 weeks of treatment, the VAS pain score decreased from baseline 83.1% (8.04 [2.70] vs 1.36 [1.43]; P < 0.05) in the lornoxicam group and 79.3% (7.98 [2.98] vs 1.65 [1.47]; P < 0.05) in the diclofenac group. Compared with baseline, the improvement rated at 2 weeks was not significantly different between the 2 groups. Lornoxicam and diclofenac were well tolerated. The rate of mild to moderate adverse gastrointestinal events was not significantly different in the lornoxicam group compared with the diclofenac group (14.6% vs 18.4%). Similarly, overall tolerability between the 2 groups was not significantly different. None of the patients experienced cardiovascular AEs (eg, edema or increased blood pressure).
  
  
  CONCLUSIONS
  The results of the present study suggest that lornoxicam was comparable to diclofenac in effectiveness and tolerability after 4 weeks of treatment in these adult Indian patients with OA of the hip or knee who completed the study.
authors.affiliation: Department of Orthopedics, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai, India.
authors.forename: Arvind
authors.initials: A
authors.lastname: Goregaonkar
authors.affiliation: Department of Orthopedic Surgery, M R Hospital, Chennai, India.
authors.forename: K J
authors.initials: KJ
authors.lastname: Mathiazhagan
authors.affiliation: Department of Orthopedics, Khwaja Banda Nawaz Institute of Medical Sciences, Gulbarga, India.
authors.forename: Ravindra R
authors.initials: RR
authors.lastname: Shah
authors.affiliation: Grecian Super-Specialty Hospital, Mohali, India.
authors.forename: Paramjeet Singh
authors.initials: PS
authors.lastname: Kapoor
authors.affiliation: RGS Healthcare Pvt. Ltd., Mohali, India.
authors.forename: Praveen
authors.initials: P
authors.lastname: Taneja
authors.affiliation: Medical Services Department, Glenmark Pharmaceuticals Ltd., Mumbai, India.
authors.forename: Akhilesh
authors.initials: A
authors.lastname: Sharma
authors.affiliation: Medical Services Department, Glenmark Pharmaceuticals Ltd., Mumbai, India.
authors.forename: Chandrashekhar
authors.initials: C
authors.lastname: Bolmall
authors.affiliation: Medical Services Department, Glenmark Pharmaceuticals Ltd., Mumbai, India.
authors.forename: Vidyagauri P
authors.initials: VP
authors.lastname: Baliga
keywords: India; diclofenac; lornoxicam; osteoarthritis