Zaltoprofen, a noninferior alternative to diclofenac for the treatment of primary knee osteoarthritis - a comparative evaluation of efficacy and safety in a 4-week, multicentric, randomized, double-blind, double-dummy trial.
Summary of "Zaltoprofen, a noninferior alternative to diclofenac for the treatment of primary knee osteoarthritis - a comparative evaluation of efficacy and safety in a 4-week, multicentric, randomized, double-blind, double-dummy trial."
Objective: To demonstrate the clinical noninferiority of the analgesic effect of zaltoprofen (80 mg t.i.d.) compared with diclofenac (50 mg t.i.d.) in active knee osteoarthritis patients. Method: In this multicentric, double-blind, double-dummy, randomized, parallel-group, comparative study, 213 patients of either sex, aged 40 - 65 years having radiological and clinically confirmed primary knee osteoarthritis were randomized either to zaltoprofen (n = 105) or diclofenac (n = 108) and were followed-up at weeks 1, 2, 3 and 4. The treatment period was preceded by a washout period of 1 week. Results: Patients in both the zaltoprofen and diclofenac groups exhibited significant improvement (p < 0.001) in pain intensity, functional status and pain relief at each visit from baseline with no statistically significant difference between the two treatment groups. There was no statistically significant difference between the treatment groups for global assessment rating done by the patient and investigator at the end of therapy (p > 0.05) and the proportion of patients who consumed ranitidine (p = 0.135) and paracetamol (p = 0.086) tablets during the treatment period on both the treatment arms. Both the study medications were well tolerated with no incidence of serious adverse events. Conclusions: This study demonstrated that efficacy and safety of zaltoprofen is clinically noninferior to that of diclofenac.
Affiliation
Medical Affairs and Clinical Research, Ipca Laboratories Ltd, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India +91 22 6647 4641 ; +91 22 2868 6954 ; anilpareek@ipca.co.in.
Journal Details
This article was published in the following journal.
Name: Expert opinion on pharmacotherapy
ISSN: 1744-7666
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21470071
- DOI: http://dx.doi.org/10.1517/14656566.2011.566867
Medical and Biotech [MESH] Definitions
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)
Knee Injuries
Injuries to the knee or the knee joint.
Viscosupplementation
A therapeutic treatment typically involving INTRA-ARTICULAR INJECTIONS of HYALURONIC ACID and related compounds. The procedure is commonly used in the treatment of OSTEOARTHRITIS with the therapeutic goal to restore the viscoelasticity of SYNOVIAL FLUID, decrease pain, improve mobility and restore the natural protective functions of hyaluronan in the joint.
Knee Prosthesis
Replacement for a knee joint.
Ketoprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
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