Comparative Experimental Evaluation of L-carnitine and Cholecalciferol on Amikacin Induced Nephrotoxicity and Clinical Evaluation of Amikacin Induced Adverse Drug Reactions

Abstract

Background: Reduction of health cost burden with existing low-cost drug and thereby improving patient compliance is utmost necessary. Keeping in mind the above, we started with low cost, broad spectrum, WHO enlisted essential drug amikacin. We tried to revaluate it with another two low-cost drugs, L-carnitine, and Cholecalciferol. Objectives: Measurement of amikacin induced nephrotoxicity by means of abnormal renal biochemical parameters on albino rats and comparison of improvement after administration of L-carnitine & Cholecalciferol along with renal histopathology examination (HPE) of amikacin treated rats and causality assessment of amikacin induced adverse drug reactions (ADR) in hospitalized patient. Materials and Methods: Healthy albino male rats (N=40) were taken from Institutional animal house of Burdwan medical College and Hospital (BMCH) and were randomly divided into 4 groups. CPCSEA acclimatization guideline followed. IEAC and CREC clearances taken. Renal biochemical parameters from blood samples were analysed. Sterile water for injection was given to all group. Group I is control (only vehicle), Amikacin added to Group II, III and IV. L carnitine & Cholecalciferol was added to Group III & Group IV respectively. Post test measurement of renal biochemical parameters and HPE were done. Clinical observation of amikacin treated hospitalised patients and collection of their ADR in BMCH were done to find out correlations with animal experiment. Results: Statistical analyses were done using Graph Pad Prism version.4 software. Minimisation of amikacin induced nephropathy were seen, more in Group IV than Group III. HPE found the same conclusion. WHO UMC causality assessment revealed, 94.35% ADR were “probable/likely” whereas 5.65% were “possible”. The Naranjo’s adverse reaction probability scale revealed almost the same. Conclusion: Interventional animal experiment, biochemical parameters, histopathology along with open label, non-interventional, prospective observational study clearly indicates cholecalciferol is significantly better than L carnitine to minimise the effects of amikacin induced nephropathy.