Abstract

Objective: Survival of post renal transplant patients has been improved by the suppression of the recipient’s immune system by immunosuppressive agents. However, various adverse drug reactions are also associated with immunosuppressive agents. Keeping this in mind, present study was planned to study the prescriptions pattern of immunosuppressant drugs and to study adverse drug reactions associated with immunosuppressant drugs. Materials and Methods: It was an observational and cross-sectional study. We have collected reported ADRs, prescriptions, IPD files and laboratory reports of 40 patients who had already undergone renal transplant prior to start of this study and 10 patients who undergone renal transplant after start of this study. Result: Most patients were prescribed prednisolone + tacrolimus + MMF as immunosuppressive regimen (70%) followed by prednisolone + cyclosporine + MMF (22%). Prednisolone was prescribed to all patients. Tacrolimus was prescribed to 72% of patients. Total 78 ADRs were reported from 50 patients in our study (incidence rate 68%). Drug MMF was mostly associated with ADRs (35.90%) followed by tacrolimus (29.49%), prednisolone (19.23%) and cyclosporine (15.38%). Most of the ADRs was mild (65.38%) while only one ADR was severe. Conclusion: Corticosteroid continues to be mainstay of therapy in post renal transplant patients. Calcineurin inhibitors were exclusively associated with nephrotoxicity. MMF was associated with most ADRs followed by tacrolimus. Most of the ADRs were mild and treated symptomatically. Keywords: Renal transplant, Immunosuppressant, ADR.

Highlights

  • Kidney transplant is essential in case of ESRD (End Stage Renal Diseases) to improve survival and quality of life and reduce health care cost

  • Calcineurin inhibitors are associated with a number of potentially serious adverse effects, including nephrotoxicity, diabetes, hypertension, and neurotoxicity which contributes to morbidity and mortality after transplantation. 9–13 Cyclosporine has become less relevant in the modern era of organ transplantation

  • Most common cause of ESRD in their study was Diabetes Mellitus followed by hypertension. 25

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Summary

Introduction

Kidney transplant is essential in case of ESRD (End Stage Renal Diseases) to improve survival and quality of life and reduce health care cost. It challenges nephrologist in preventing rejection of the graft and to use immunosuppressant judiciously to avoid their adverse effect and to avoid infection common in immunocompromised host. 4 Chronic allograft nephropathy is significantly affected by various factors such as Calcineurin nephrotoxicity, drug induced hypertension and non-compliance to immunosuppressive therapy.[5] it has been demonstrated from results of various studies that quality of life in renal transplant patient is significantly associated with immunosuppressive ADRs. 6–8. Everolimus have beneficial effect on renal function and may reduce the occurrence of malignancy 16,17 but it can cause impaired wound healing, mouth ulcers, stomatitis, arthralgia, hyperlipidaemia, and anemia. 18–21 In spite of the numerous side effects, most transplant patients are maintained on long-term low-dose steroids. 22

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23. Safety Monitoring of Medicinal Products
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