Title: Randamoized Open Label Comparative Study on Proglumetacindimaleate and Diclofenac Sodium in Osteoarthritis Patients

Authors: L. Madhan, A. Moorthi, K.P. Sampath Kumar

 DOI:  https://dx.doi.org/10.18535/jmscr/v4i11.75

Abstract

The pathogenesis of osteoarthritis (OA) is not clearly understood; inflammatory mediators play an important role in the pathogenesis of OA. Non steroidal anti inflammatory drugs (NSAIDs) the most widely prescribed drugs in OA. The efficacy of two anti-inflammatory drugs proglumetacindimaleate (PRO) and diclofenac sodium (DIC) in controlling the pain response along with diseases was assessed. The study is a progressive study; patients were followed for 4 weeks period to assess the efficacy of the two different treatments.  It is an open labeled, randomized comparative study. The drugs used were PRO (300mg, bid) and DIC (50mg, bid) in osteoarthritis patients. Totally 60 patients of both sexes with moderate to severe osteoarthritis were included in this study. Clinical assessment was done based on the following parameters to assess the efficacy of the drugs and as well as the pain perception. X-ray was done to assess the joints and inflammation including swelling of the joints. The laboratory investigation includes routine haematogram, liver function tests, and kidney function test. The pain perception in the patients was measured using pain scale. The results have indicated that in comparison to PRO, DIC had toxicity in liver as observed by increased SGOT levels. The efficacy index for PRO and DIC was found to be 5.08±3.57 and 6.88±2.60 respectively.  The study can be concluded that both PRO and DIC exhibited similar efficacy and controlled the pain perception in OA patients. In any selection of drug of choice for the treatment and analyzing the risk versus benefit PRO has been preferred as NSAIDs due to its better tolerability in GIT complications as well as pro drug property. The precaution to be taken is periodical liver function tests on prolong use of PRO is required.

Keywords- Inflammation, COX inhibitors, Efficacy,Arthritis, analgesics.

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Corresponding Author

L. Madhan

Department of Pharmacology,

Government Coimbatore Medical College, Coimbatore 641014

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