PMID- 28828306
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2229-3485 (Print)
IS  - 2229-5488 (Electronic)
IS  - 2229-3485 (Linking)
VI  - 8
IP  - 3
DP  - 2017 Jul-Sep
TI  - Active surveillance for adverse events among patients who underwent renal 
      transplantation: A prospective observational study.
PG  - 118-123
LID - 10.4103/2229-3485.210447 [doi]
AB  - AIM: Renal transplantation is the treatment of choice for end-stage renal disease 
      patients. Renal transplant recipients, however, have to be on lifelong therapy 
      with immunosuppressants, which are associated with a number of adverse events 
      (AEs). The safety profile of these immunosuppressants is not clear with respect 
      to the Indian population. This study was conducted to find the frequency and 
      pattern of all AEs experienced by Indian renal transplant recipients during the 
      initial 3 months posttransplantation. METHODS: Adults undergoing their first 
      renal transplantation were enrolled in the study. All enrolled subjects were 
      followed up for a maximum period of 3 months. All AEs were graded for severity 
      and classified according to the Common Terminology Criteria for AEs criteria. 
      RESULTS: Ninety-eight renal transplant recipients enrolled in the study. There 
      was a loss of follow-up of 7%. Five subjects died during the study. Subjects 
      experienced on an average 9 AEs during the study. There was no difference in 
      frequency of AEs between those on tacrolimus and cyclosporine. Most commonly 
      observed AEs belonged to "Investigational" and "Metabolism and Nutrition" system 
      organ classes. The most common AE was hypokalemia. New-onset diabetes after 
      transplantation (NODAT) developed in 28% of subjects. There were 27 episodes of 
      acute nephrotoxicity. CONCLUSION: The incidence of NODAT in the Indian population 
      is substantially higher than that observed in the Western population. The 
      incidence of nephrotoxicity may indicate higher sensitivity of the Indian 
      population to calcineurin inhibitors.
FAU - Guruprasad, Padmanabhan
AU  - Guruprasad P
AD  - Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, 
      India.
FAU - Kishore, Kamal
AU  - Kishore K
AD  - Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, 
      India.
FAU - Mahajan, Sandeep
AU  - Mahajan S
AD  - Department of Nephrology, All India Institute of Medical Sciences, New Delhi, 
      India.
FAU - Aggarwal, Sandeep
AU  - Aggarwal S
AD  - Department of Surgical Disciplines, All India Institute of Medical Sciences, New 
      Delhi, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Perspect Clin Res
JT  - Perspectives in clinical research
JID - 101551517
PMC - PMC5543762
OTO - NOTNLM
OT  - Calcineurin inhibitor
OT  - diabetes
OT  - mycophenolate
OT  - nephrotoxicity
OT  - renal transplantation
OT  - tacrolimus
COIS- There are no conflicts of interest.
EDAT- 2017/08/23 06:00
MHDA- 2017/08/23 06:01
PMCR- 2017/07/01
CRDT- 2017/08/23 06:00
PHST- 2017/08/23 06:00 [entrez]
PHST- 2017/08/23 06:00 [pubmed]
PHST- 2017/08/23 06:01 [medline]
PHST- 2017/07/01 00:00 [pmc-release]
AID - PCR-8-118 [pii]
AID - 10.4103/2229-3485.210447 [doi]
PST - ppublish
SO  - Perspect Clin Res. 2017 Jul-Sep;8(3):118-123. doi: 10.4103/2229-3485.210447.