| 1. |
- Fellström, Bengt, et al.
(författare)
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No detrimental effect on renal function during long-term use of fluvastatin in renal transplant recipients in the Assessment of Lescol in Renal Transplantation (ALERT) study
- 2006
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Ingår i: Clinical Transplantation. - : Wiley. - 0902-0063 .- 1399-0012. ; 20:6, s. 732-739
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Tidskriftsartikel (refereegranskat)abstract
- Background: Concerns have recently been raised regarding a potential harmful effect of statins on renal function. This study investigated the effect of fluvastatin treatment on renal function in renal transplant recipients enrolled in the Assessment of Lescol in Renal Transplantation (ALERT) trial. Methods: ALERT was a randomized, double-blind, placebo-controlled study of the effect of fluvastatin, 40-80 mg daily (n = 1050) or placebo (n = 1052) on cardiac and renal outcomes in renal transplant recipients over a follow-up period of five to six years. The incidence of graft loss, changes in serum creatinine, calculated creatinine clearance and proteinuria, and the incidence of renal adverse events (AEs) were assessed in both treatment groups. Results: Fluvastatin treatment in ALERT had no significant effect compared with placebo on renal function, assessed by serum creatinine (overall adjusted mean +/- SEM: fluvastatin, 175.4 +/- 2.20 mu mol/L; placebo, 172.7 +/- 2.20 mu mol/L; p = 0.39), creatinine clearance (fluvastatin, 55.3 +/- 0.30 mL/min; placebo, 55.8 +/- 0.30 mL/min; p = 0.26) or proteinuria (fluvastatin, 0.58 +/- 0.03 g/24 h; placebo, 0.53 +/- 0.03 g/24 h; p = 0.31). There were no significant differences between treatment groups when the 283 patients suffering graft loss were excluded from the analysis. Fluvastatin also had no detrimental effect on creatinine clearance or proteinuria in the subgroup of 340 diabetic patients without graft loss in ALERT. No notable differences in the rate of renal or musculoskeletal AEs were observed between fluvastatin and placebo groups. Conclusions: Fluvastatin had no detrimental effect on renal function, or the risk of renal AEs, in renal transplant recipients with or without diabetes enrolled in ALERT. Fluvastatin treatment for the prevention of cardiac events may therefore be used without fear of jeopardizing renal function.
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| 2. |
- Oien, Cecilia Montgomery, et al.
(författare)
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Gender-associated risk factors for cardiac end points and total mortality after renal transplantation : post hoc analysis of the ALERT study
- 2006
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Ingår i: Clinical Transplantation. - : Wiley. - 0902-0063 .- 1399-0012. ; 20:3, s. 374-82
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Female gender offers a cardioprotective effect over men in the general population, but is lost in the dialysis population. Whether renal transplantation restores the gender-dependent cardiac protection and whether there is a difference in the impact of risk factors is not known. METHODS: This is a post hoc analysis of pre-defined end points in the placebo arm in the Assessment of Lescol in Renal Transplantation (ALERT) study, a study in renal transplant recipients. Cox regression was performed to estimate the association between different risk factors at baseline and non-fatal myocardial infarction (MI) or cardiac death and total mortality, and specifically assess whether there are gender differences. RESULTS: The placebo arm included 1052 patients (mean age 50.1 +/- 11.1 yr, 65.3% males) with a mean follow-up of 65 months. The incidence of non-fatal MI or cardiac death was 10.9% vs. 7.9% (NS) and total mortality 13.3% vs. 12.8% (NS) in men and women. In multivariate analysis, previous coronary heart disease (CHD), diabetes, treatment for rejection and serum triglycerides were predictive for cardiac events in men, and low-density lipoprotein (LDL)/high-density lipoprotein (HDL) ratio only in women. A slightly different risk-factor pattern appeared for total mortality. Diabetes, ECG abnormalities, plasma triglycerides, serum creatinine, time on dialysis and age predicted total mortality in men, while ECG abnormalities, LDL/HDL ratio and age were predictors in women. CONCLUSION: In this relatively low-risk population of renal transplant recipients, no gender difference in cardiac events or total mortality was observed, suggesting that female gender advantage regarding CHD is not restored following transplantation. The predictive value of risk factors differed in men and women.
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| 3. |
- Soveri, Inga, et al.
(författare)
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Renal transplant dysfunction - importance quantified in comparison with traditional risk factors for cardiovascular disease and mortality
- 2006
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Ingår i: Nephrology, Dialysis and Transplantation. - : Oxford University Press (OUP). - 0931-0509 .- 1460-2385. ; 21:8, s. 2282-2289
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Tidskriftsartikel (refereegranskat)abstract
- Background. Renal transplant recipients (RTR) mainly die of premature cardiovascular disease. Traditional cardiovascular disease risk factors are prevalent in RTR. Additionally, non-traditional risk factors seem to contribute to the high risk. The impact of renal dysfunction was compared with traditional risk factors for cardiovascular morbidity and mortality in 1052 placebo-treated patients of the ALERT trial.Methods. All patients were on cyclosporine-based immunosuppressive therapy, follow-up was 5-6 years and captured endpoints included cardiac death, non-cardiovascular death, all-cause mortality, major adverse cardiac event (MACE), non-fatal myocardial infarction (MI) and stroke.Results. A calculated 84 mu mol/l increase in serum creatinine was needed to double the risk for cardiac death, an increase of 104 mu mol/l to double the risk for non-cardiovascular death and an increase of 92 mu mol/l to double the risk for all-cause mortality. MACE risk was doubled if serum creatinine was elevated by 141 mu mol/l, age was increased by 23 years, or LDL-cholesterol by 2 mmol/l. Diabetes increased the incidences of cardiac death, all-cause mortality, MACE, stroke and non-fatal MI. A serum creatinine increase of similar to 130 mu mol/l, or similar to 20 years increase in age was calculated as similar in risk for cardiac death, all-cause mortality and MACE, and comparable to risk of diabetes in RTR.Conclusion. An increase in serum creatinine of 80-100 mu mol/l doubles the risk for cardiac death, non-cardiovascular death and all-cause mortality in RTR. An increase of 130 mu mol/l in serum creatinine or similar to 20 years increase in age is comparable to risk of diabetes.
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