Statin therapy for preventing cardiovascular diseases in patients treated with tacrolimus after kidney transplantation

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Abstract

Background

Lipid abnormalities are prevalent in tacrolimus-treated patients. The aim of the study was to evaluate the preventive effects of statin therapy on major adverse cardiovascular events (MACE) in patients treated with tacrolimus-based immunosuppression after kidney transplantation (KT), and to identify the risk factors.

Methods

This observational cohort study included adult patients who underwent KT and were treated with tacrolimus. Patients who received any lipid-lowering agents except statins, or had a history of immunosuppressant use before transplantation were excluded. The primary outcome was the adjusted risk of the first occurrence of MACE. The secondary outcomes included the risk of individual cardiovascular disease (CVD) and changes in cholesterol level. Subgroup analyses were performed in the statin-user group according to the dosage and/or type of statin.

Results

Compared with the control group (n=73), the statin-users (n=92) had a significantly reduced risk of MACE (adjusted HR, 0.31; 95% CI, 0.13–0.74). In the Cox regression analysis, old age, history of CVD, and comorbid hypertension were identified as independent factors associated with increased MACE. The total cholesterol levels were not significantly different between the two groups. Subjects with higher cumulative defined daily dose of statins had significantly lower risks of MACE.

Conclusion

Statin therapy in patients treated with tacrolimus after KT significantly lowered the risk of MACE. Long-term statin therapy is clearly indicated in older kidney transplant recipients for secondary prevention.

Most cited references 37

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High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial.

Terje R Pedersen, Ole Faergeman, John Kastelein … (2005)

Evidence suggests that more intensive lowering of low-density lipoprotein cholesterol (LDL-C) than is commonly applied clinically will provide further benefit in stable coronary artery disease. To compare the effects of 2 strategies of lipid lowering on the risk of cardiovascular disease among patients with a previous myocardial infarction (MI). The IDEAL study, a prospective, randomized, open-label, blinded end-point evaluation trial conducted at 190 ambulatory cardiology care and specialist practices in northern Europe between March 1999 and March 2005 with a median follow-up of 4.8 years, which enrolled 8888 patients aged 80 years or younger with a history of acute MI. Patients were randomly assigned to receive a high dose of atorvastatin (80 mg/d; n = 4439), or usual-dose simvastatin (20 mg/d; n = 4449). Occurrence of a major coronary event, defined as coronary death, confirmed nonfatal acute MI, or cardiac arrest with resuscitation. During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group. A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07). Nonfatal acute MI occurred in 321 (7.2%) and 267 (6.0%) in the 2 groups (HR, 0.83; 95% CI, 0.71-0.98; P = .02), but no differences were seen in the 2 other components of the primary end point. Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% CI, 0.77-0.98; P = .02). Occurrence of any coronary event was reported in 1059 simvastatin and 898 atorvastatin patients (HR, 0.84; 95% CI, 0.76-0.91; P<.001). Noncardiovascular death occurred in 156 (3.5%) and 143 (3.2%) in the 2 groups (HR, 0.92; 95% CI, 0.73-1.15; P = .47). Death from any cause occurred in 374 (8.4%) in the simvastatin group and 366 (8.2%) in the atorvastatin group (HR, 0.98; 95% CI, 0.85-1.13; P = .81). Patients in the atorvastatin group had higher rates of drug discontinuation due to nonserious adverse events; transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals (P<.001). Serious myopathy and rhabdomyolysis were rare in both groups. In this study of patients with previous MI, intensive lowering of LDL-C did not result in a significant reduction in the primary outcome of major coronary events, but did reduce the risk of other composite secondary end points and nonfatal acute MI. There were no differences in cardiovascular or all-cause mortality. Patients with MI may benefit from intensive lowering of LDL-C without an increase in noncardiovascular mortality or other serious adverse reactions.Trial Registration ClinicalTrials.gov Identifier: NCT00159835.

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KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient.

Christoph Wanner, Marcello Tonelli (2014)

The Kidney Disease: Improving Global Outcomes (KDIGO) organization developed clinical practice guidelines on lipid management for all adults and children with chronic kidney disease (CKD). Thirteen recommendations were obtained from the available evidence outlining a three-step management including assessment in all, treatment in many, and follow-up measurements in few. A key element is the recommendation of statin or statin/ezetimibe treatment in adults aged ⩾50 years with estimated glomerular filtration rate (eGFR) <60 ml/min per 1.73 m(2) but not treated with chronic dialysis or kidney transplantation. In dialysis patients, the magnitude of any relative reduction in risk appears to be substantially smaller than in earlier stages of CKD and initiation of statin treatment is not recommended for most prevalent hemodialysis patients. In the past, clinical practice guidelines suggested the use of targets for LDL cholesterol, which require repeated measurements. Treatment escalation with higher doses of statin would be a consequence when LDL cholesterol targets are not met. The KDIGO Work Group did not recommend this strategy because higher doses of statins have not been proven to be safe in the setting of CKD. Since LDL cholesterol levels do not necessarily suggest the need to increase statin doses, follow-up measurement of lipid levels is not recommended.

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Accelerated atherosclerosis in prolonged maintenance hemodialysis.

A Lindner, B Charra, D J Sherrard … (1974)

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Author and article information

Journal

Journal ID (nlm-ta): Ther Clin Risk Manag

Journal ID (iso-abbrev): Ther Clin Risk Manag

Journal ID (publisher-id): Therapeutics and Clinical Risk Management

Title: Therapeutics and Clinical Risk Management

Publisher: Dove Medical Press

ISSN (Print): 1176-6336

ISSN (Electronic): 1178-203X

Publication date Collection: 2017

Publication date (Electronic): 21 November 2017

Volume: 13

Pages: 1513-1520

Affiliations

[1 ]Research Institute of Pharmaceutical Sciences, College of Pharmacy, Seoul National University, Seoul

[2 ]Department of Pharmacy, Asan Medical Center, Seoul

[3 ]Department of Internal Medicine, Seoul National University Hospital, Seoul

[4 ]College of Medicine, Seoul National University, Seoul, Republic of Korea

Author notes

Correspondence: Jung Mi Oh; In-Wha Kim, College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Republic of Korea, Tel +82 2 880 7997; +82 2 880 7736, Fax +82 2 766 9560; +82 2 882 9560, Email jmoh@ 123456snu.ac.kr ; iwkim2@ 123456hanmail.net

[*]

These authors contributed equally to this work

Article

Publisher ID: tcrm-13-1513

DOI: 10.2147/TCRM.S147327

PMC ID: 5701562

SO-VID: a03a76b0-0d9a-4725-9bf6-21f36d6f2baf

License:

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Statin therapy for preventing cardiovascular diseases in patients treated with tacrolimus after kidney transplantation

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Abstract

Background

Methods

Results

Conclusion

Most cited references 37

High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial.

KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient.

Accelerated atherosclerosis in prolonged maintenance hemodialysis.

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