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Meta-Analysis
. 2014 Jan 28;2014(1):CD005019.
doi: 10.1002/14651858.CD005019.pub4.

HMG CoA reductase inhibitors (statins) for kidney transplant recipients

Suetonia C Palmer  1 , Sankar D Navaneethan, Jonathan C Craig, Vlado Perkovic, David W Johnson, Sagar U Nigwekar, Jorgen Hegbrant, Giovanni Fm Strippoli
Affiliations
Meta-Analysis

HMG CoA reductase inhibitors (statins) for kidney transplant recipients

Suetonia C Palmer et al. Cochrane Database Syst Rev. .

Abstract

Background: People with chronic kidney disease (CKD) have higher risks of cardiovascular disease compared to the general population. Specifically, cardiovascular deaths account most deaths in kidney transplant recipients. Statins are a potentially beneficial intervention for kidney transplant patients given their established benefits in patients at risk of cardiovascular disease in the general population. This is an update of a review first published in 2009.

Objectives: We aimed to evaluate the benefits (reductions in all-cause and cardiovascular mortality, major cardiovascular events, myocardial infarction and stroke, and progression of CKD to requiring dialysis) and harms (muscle or liver dysfunction, withdrawal, cancer) of statins compared to placebo, no treatment, standard care, or another statin in adults with CKD who have a functioning kidney transplant.

Search methods: We searched the Cochrane Renal Group's Specialised Register to 29 February 2012 through contact with the Trials Search Co-ordinator using search terms relevant to this review.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that compared the effects of statins with placebo, no treatment, standard care, or statins on mortality, cardiovascular events, kidney function and toxicity in kidney transplant recipients.

Data collection and analysis: Two authors independently extracted data and assessed risk of bias. Treatment effects were expressed as mean difference (MD) for continuous outcomes (lipids, glomerular filtration rate (GFR), proteinuria) and relative risk (RR) for dichotomous outcomes (major cardiovascular events, mortality, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, elevated muscle or liver enzymes, withdrawal due to adverse events, cancer, end-stage kidney disease (ESKD), acute allograft rejection) together with 95% confidence intervals (CI).

Main results: We identified 22 studies (3465 participants); 17 studies (3282 participants) compared statin with placebo or no treatment, and five studies (183 participants) compared two different statin regimens.From data generally derived from a single high-quality study, it was found that statins may reduce major cardiovascular events (1 study, 2102 participants: RR 0.84, CI 0.66 to 1.06), cardiovascular mortality (4 studies, 2322 participants: RR 0.68, CI 0.45 to 1.01), and fatal or non-fatal myocardial infarction (1 study, 2102 participants: RR 0.70, CI 0.48 to 1.01); although effect estimates lack precision and include the possibility of no effect.Statins had uncertain effects on all-cause mortality (6 studies, 2760 participants: RR 1.08, CI 0.63 to 1.83); fatal or non-fatal stroke (1 study, 2102 participants: RR 1.18, CI 0.85 to 1.63); creatine kinase elevation (3 studies, 2233 participants: RR 0.86, CI 0.39 to 1.89); liver enzyme elevation (4 studies, 608 participants: RR 0.62, CI 0.33 to 1.19); withdrawal due to adverse events (9 studies, 2810 participants: RR 0.89, CI 0.74 to 1.06); and cancer (1 study, 2094 participants: RR 0.94, CI 0.82 to 1.07).Statins significantly reduced serum total cholesterol (12 studies, 3070 participants: MD -42.43 mg/dL, CI -51.22 to -33.65); low-density lipoprotein cholesterol (11 studies, 3004 participants: MD -43.19 mg/dL, CI -52.59 to -33.78); serum triglycerides (11 studies, 3012 participants: MD -27.28 mg/dL, CI -34.29 to -20.27); and lowered high-density lipoprotein cholesterol (11 studies, 3005 participants: MD -5.69 mg/dL, CI -10.35 to -1.03).Statins had uncertain effects on kidney function: ESKD (6 studies, 2740 participants: RR 1.14, CI 0.94 to 1.37); proteinuria (2 studies, 136 participants: MD -0.04 g/24 h, CI -0.17 to 0.25); acute allograft rejection (4 studies, 582 participants: RR 0.88, CI 0.61 to 1.28); and GFR (1 study, 62 participants: MD -1.00 mL/min, CI -9.96 to 7.96).Due to heterogeneity in comparisons, data directly comparing differing statin regimens could not be meta-analysed. Evidence for statins in people who have had a kidney transplant were sparse and lower quality due to imprecise effect estimates and provided limited systematic evaluation of treatment harm.

Authors' conclusions: Statins may reduce cardiovascular events in kidney transplant recipients, although treatment effects are imprecise. Statin treatment has uncertain effects on overall mortality, stroke, kidney function, and toxicity outcomes in kidney transplant recipients. Additional studies would improve our confidence in the treatment benefits and harms of statins on cardiovascular events in this clinical setting.

PubMed Disclaimer

Conflict of interest statement

David Johnson is a consultant for Baxter Healthcare Pty Ltd and has previously received research funds from this company. He has also received speakers’ honoraria and research grants from Fresenius Medical Care and is a current recipient of a Queensland Government Health Research Fellowship. He has also received speakers' honoraria and consultancy fees from Amgen, Janssen‐Cilag, Shire, Lilley, Boehringer‐Ingelheim and Merck Sharpe & Dohme. He has received a research grant from Pfizer.

Suetonia Palmer received a fellowship administered by the Consorzio Mario Negri Sud from Amgen Dompe for assistance with travel for collaboration and supervision.

Vlado Perkovic is supported by a fellowship from the Heart Foundation of Australia and a various grants from the Australian National Health and Medical Research Council. He has received speakers' fees from Roche, Servier and Astra Zeneca, funding for a clinical trial from Baxter, and serves on Steering Committees for trials funded by Johnson and Johnson, Boehringer Ingelheim, Vitae and Abbott. His employer conducts clinical trials funded by Servier, Johnson and Johnson, Roche and Merck.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Statins versus placebo, Outcome 1 Cardiovascular mortality.
1.2
1.2. Analysis
Comparison 1 Statins versus placebo, Outcome 2 All‐cause mortality.
1.3
1.3. Analysis
Comparison 1 Statins versus placebo, Outcome 3 Major cardiovascular events.
1.4
1.4. Analysis
Comparison 1 Statins versus placebo, Outcome 4 Fatal and non‐fatal myocardial infarction.
1.5
1.5. Analysis
Comparison 1 Statins versus placebo, Outcome 5 Fatal and non‐fatal stroke.
1.6
1.6. Analysis
Comparison 1 Statins versus placebo, Outcome 6 Elevated creatine kinase.
1.7
1.7. Analysis
Comparison 1 Statins versus placebo, Outcome 7 Elevated liver enzymes.
1.8
1.8. Analysis
Comparison 1 Statins versus placebo, Outcome 8 Withdrawal due to adverse events.
1.9
1.9. Analysis
Comparison 1 Statins versus placebo, Outcome 9 Cancer.
1.10
1.10. Analysis
Comparison 1 Statins versus placebo, Outcome 10 Total cholesterol.
1.11
1.11. Analysis
Comparison 1 Statins versus placebo, Outcome 11 LDL cholesterol.
1.12
1.12. Analysis
Comparison 1 Statins versus placebo, Outcome 12 HDL cholesterol.
1.13
1.13. Analysis
Comparison 1 Statins versus placebo, Outcome 13 Triglycerides.
1.14
1.14. Analysis
Comparison 1 Statins versus placebo, Outcome 14 End‐stage kidney disease.
1.15
1.15. Analysis
Comparison 1 Statins versus placebo, Outcome 15 Acute allograft rejection.
1.16
1.16. Analysis
Comparison 1 Statins versus placebo, Outcome 16 Proteinuria.
1.17
1.17. Analysis
Comparison 1 Statins versus placebo, Outcome 17 Glomerular filtration rate.
See this image and copyright information in PMC

Update of

Comment in

  • Statins for kidney transplant recipients.
    Webster A, Palmer S, Ruospo M, Strippoli GF. Webster A, et al. Nephrology (Carlton). 2015 Apr;20(4):304-5. doi: 10.1111/nep.12436. Nephrology (Carlton). 2015. PMID: 25810230 No abstract available.

References

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Castelao 1993 {published data only}
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Hausberg 2001 {published data only}
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Kasiske 2001 {published data only}
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Katznelson 1996 {published data only}
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Lepre 1999 {published data only}
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Martinez Hernandez 1993 {published data only}
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Melchor 1998 {published data only}
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Raiola 1998 {published data only}
    1. Raiola P, Manzo M, Saggese A. Comparison of atorvastatin (ATV) with fluvastatin (FLV) in renal transplant patients with dyslipoproteinemia [abstract]. Journal of the American Society of Nephrology 1998;9(Program & Abstracts):693A. [CENTRAL: CN‐00447330]
Renders 2001 {published data only}
    1. Renders L, Mayer‐Kadner I, Koch C. Efficacy and drug interactions of the new HMG‐CoA reductase inhibitors cerivastatin and atorvastatin in CsA‐treated renal transplant recipients. Nephrology Dialysis Transplantation 2001;16(1):141‐6. [MEDLINE: ] - PubMed
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Sahu 2001 {published data only}
    1. Sahu K, Sharma R, Gupta A. Effect of lovastatin, an HMG CoA reductase inhibitor, on acute renal allograft rejection. Clinical Transplantation 2001;15(3):173‐5. [MEDLINE: ] - PubMed
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Santos 2001 {published data only}
    1. Garcia V, Bittar A, Keitel E, Neumann J, Saitovitch D, Santos A. Is cyclosporin microemulsion increasing the lipid‐lowering effect of simvastatin on kidney graft receptors? [abstract no: 1441]. A Transplant Odyssey; 2001 Aug 20‐23; Istanbul (Turkey). 2001. [CENTRAL: CN‐00671773]
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Seron 2008 {published data only}
    1. Seron D, Oppenheimer F, Pallardo LM, Lauzurica R, Errasti P, Gomez‐Huertas E, et al. Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double‐blind, placebo‐controlled trial. Transplantation 2008;86(1):82‐7. [MEDLINE: ] - PubMed
Sharif 2009 {published data only}
    1. Sharif A, Ravindran V, Moore R, Baboolal K. The effects of rosuvastatin on 51CR‐EDTA measured glomerular filtration rate and urinary albumin excretion in non‐diabetic renal transplant recipients [abstract no: 1386]. Transplantation 2008;86(2S):466. [CENTRAL: CN‐00766701]
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SOLAR Study 2001 {published data only}
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Tuncer 2000 {published data only}
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UK‐HARP‐1 2005 {published data only}
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Vergoulas 1999 {published data only}
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References to studies excluded from this review

Bagdade 1979 {published data only}
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Ichimaru 2001 {published data only}
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References to ongoing studies

NCT00565474 {published data only}
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References to other published versions of this review

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