PMID- 36863965
OWN - NLM
STAT- MEDLINE
DCOM- 20230522
LR  - 20230607
IS  - 1544-3450 (Electronic)
IS  - 1086-5802 (Linking)
VI  - 63
IP  - 3
DP  - 2023 May-Jun
TI  - Comparative safety of generic versus brand calcineurin inhibitors in solid organ 
      transplant patients: A systematic review and meta-analysis.
PG  - 709-719
LID - S1544-3191(23)00022-5 [pii]
LID - 10.1016/j.japh.2023.02.006 [doi]
AB  - BACKGROUND: Although generic ciclosporin-A (CsA) and tacrolimus (TAC) have been 
      used for the prophylaxis of organ rejection in transplant patients for decades, 
      evidence in their safety profile compared to reference listed drugs (RLDs) in 
      real-world transplant patients remains limited. OBJECTIVES: To compare safety 
      outcomes of generic CsA and TAC with the reference-listed drugs in solid organ 
      transplant patients. METHODS: We systematically searched MEDLINE, International 
      Pharmaceutical Abstracts, PsycINFO, and Cumulative Index of Nursing and Allied 
      Health Literature from inception until March 15, 2022, to select randomized and 
      observational studies comparing safety profiles of generic versus brand CsA and 
      TAC in de novo and/or stable solid organ transplant patients. Primary safety 
      outcomes were changes in serum creatinine (Scr) and glomerular filtration rate 
      (GFR). Secondary outcomes included incidences of infection, hypertension, 
      diabetes, other serious adverse events (AEs), hospitalization, and death. Mean 
      difference (MD) and relative risk (RR) with 95% confidence intervals (CIs) were 
      calculated using random-effects meta-analyses. RESULTS: Of 2612 publications 
      identified, 32 studies met inclusion criteria. Seventeen studies had a moderate 
      risk of bias. Scr was statistically significantly lower in patients using generic 
      CsA compared to brand at 1 month (MD = -0.07; 95% CI: -0.11, -0.04), while there 
      were no statistically significant differences at 4 months, 6 months, and 12 
      months. No differences were detected in Scr (MD = -0.04; 95% CI: -0.13, 0.04) and 
      estimated GFR (MD = -2.06; 95% CI: -8.89, 4.77) between patients using generic 
      and brand TAC at 6 months. No statistically significant differences between 
      generic CsA and TAC with their RLDs were observed for secondary outcomes. 
      CONCLUSION: Findings support similarity in safety outcomes between generic and 
      brand CsA and TAC in real-world solid organ transplant patients.
CI  - Copyright (c) 2023 American Pharmacists Association(R). Published by Elsevier Inc. 
      All rights reserved.
FAU - Tanni, Kaniz Afroz
AU  - Tanni KA
FAU - Qian, Jingjing
AU  - Qian J
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20230210
PL  - United States
TA  - J Am Pharm Assoc (2003)
JT  - Journal of the American Pharmacists Association : JAPhA
JID - 101176252
RN  - 0 (Calcineurin Inhibitors)
RN  - 0 (Immunosuppressive Agents)
RN  - HU9DX48N0T (Mycophenolic Acid)
RN  - WM0HAQ4WNM (Tacrolimus)
RN  - 83HN0GTJ6D (Cyclosporine)
SB  - IM
MH  - Humans
MH  - *Calcineurin Inhibitors/adverse effects
MH  - Immunosuppressive Agents/adverse effects
MH  - Mycophenolic Acid/adverse effects
MH  - Tacrolimus/adverse effects
MH  - Cyclosporine/adverse effects
MH  - *Organ Transplantation
EDAT- 2023/03/03 06:00
MHDA- 2023/05/22 06:42
CRDT- 2023/03/02 22:06
PHST- 2022/10/06 00:00 [received]
PHST- 2023/02/02 00:00 [revised]
PHST- 2023/02/06 00:00 [accepted]
PHST- 2023/05/22 06:42 [medline]
PHST- 2023/03/03 06:00 [pubmed]
PHST- 2023/03/02 22:06 [entrez]
AID - S1544-3191(23)00022-5 [pii]
AID - 10.1016/j.japh.2023.02.006 [doi]
PST - ppublish
SO  - J Am Pharm Assoc (2003). 2023 May-Jun;63(3):709-719. doi: 
      10.1016/j.japh.2023.02.006. Epub 2023 Feb 10.