Received: November 02, 2010
Accepted: January 18, 2011
Ref: Vadgama VK, Gharia R, Mehta K, Sanjiv R, Tripathi CB. A randomized, controlled clinical trial comparing efficacy, safety and cost effectiveness of Lornoxicam with Diclofenac Sodium in patients of osteoarthritis knee. Internet J Med Update. 2011 Jul;6(2):25-9.
A RANDOMIZED, CONTROLLED CLINICAL TRIAL COMPARING EFFICACY, SAFETY AND COST EFFECTIVENESS OF LORNOXICAM WITH DICLOFENAC SODIUM IN PATIENTS OF OSTEOARTHRITIS KNEE
Vishalkumar K. Vadgama* MBBS, Ripal Gharia** MBBS, Kalpesh Mehta† MBBS, Ravisaheb Sanjiv‡ MS and C B Tripathi*** MD
*Resident 3rd Year, **Tutor, ***Head, Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India
†Resident 3rd Year, ‡Assistant Professor, Department of Orthopedics, Sir Takhtsinghji Hospital and Government Medical College, Bhavnagar, Gujarat, India
(Corresponding Author: Dr. Vishalkumar K. Vadgama, Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India; Cell: +917567112664; Email: dr.vishalvadgama@gmail.com)
ABSTRACT
Osteoarthritis is a chronic painful condition affecting larger joints; most commonly knee joint. Pharmacological control of pain is the mainstay of management of osteoarthritis. Many patientsfail to achieve satisfactory reduction in pain with one of the most commonly prescribed drugs, diclofenac sodium, even after maximum daily allowed doses. Lornoxicam is a newer molecule in the Indian market promising better pain relief in context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two drugs for the management of osteoarthritis knee. So, to evaluate the same we carried out this study to compare safety, efficacy and cost effectiveness of lornoxicam and diclofenac sodium in relieving pain in patients of osteoarthritis knee. This study is a randomized, open labeled, controlled clinical trial having 40 newly diagnosed patients with osteoarthritis knee. After random allocation into two groups i.e. group D and group L (each having 20 patients); group D received diclofenac sodium 50 mg 12 hourly and group L received lornoxicam 4 mg 8 hourly for a period of 3 months. All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy. Adverse drug reactions and cost of therapy was monitored during the study period. Mean decrease in visual analogue scale and time of 100 meter walking test was statistically significant in lornoxicam group as compared to diclofenac sodium. Gastric irritation was reported in one patient from group L and two patients from group D. Lornoxicam significantly relieves pain of osteoarthritis knee than diclofenac sodium without adversely affecting the tolerability to the patients.
KEY WORDS: Osteoarthritis knee; Lornoxicam; Diclofenac sodium; Open label RCT