FTY720 at 2.5 mg was found to be as effective as MMF in combination with cyclosporine for the prevention of acute rejection after renal transplantation. FTY720 was well tolerated and not associated with the side effects commonly observed with immunosuppressant therapies.
Physical activity improves the regulation of glucose homeostasis in both type 2 diabetes (T2D) patients and healthy individuals, but the effect on pancreatic β cell function is unknown. We investigated glycaemic control, pancreatic function and total fat mass before and after 8 weeks of low volume high intensity interval training (HIIT) on cycle ergometer in T2D patients and matched healthy control individuals. Study design/method: Elderly (56 yrs±2), non-active T2D patients (n = 10) and matched (52 yrs±2) healthy controls (CON) (n = 13) exercised 3 times (10×60 sec. HIIT) a week over an 8 week period on a cycle ergometer. Participants underwent a 2-hour oral glucose tolerance test (OGTT). On a separate day, resting blood pressure measurement was conducted followed by an incremental maximal oxygen uptake (O2max) cycle ergometer test. Finally, a whole body dual X-ray absorptiometry (DXA) was performed. After 8 weeks of training, the same measurements were performed. Results: in the T2D-group, glycaemic control as determined by average fasting venous glucose concentration (p = 0.01), end point 2-hour OGTT (p = 0.04) and glycosylated haemoglobin (p = 0.04) were significantly reduced. Pancreatic homeostasis as determined by homeostatic model assessment of insulin resistance (HOMA-IR) and HOMA β cell function (HOMA-%β) were both significantly ameliorated (p = 0.03 and p = 0.03, respectively). Whole body insulin sensitivity as determined by the disposition index (DI) was significantly increased (p = 0.03). During OGTT, the glucose continuum was significantly reduced at -15 (p = 0.03), 30 (p = 0.03) and 120 min (p = 0.03) and at -10 (p = 0.003) and 0 min (p = 0.003) with an additional improvement (p = 0.03) of its 1st phase (30 min) area under curve (AUC). Significant abdominal fat mass losses were seen in both groups (T2D: p = 0.004 and CON: p = 0.02) corresponding to a percentage change of -17.84%±5.02 and -9.66%±3.07, respectively. Conclusion: these results demonstrate that HIIT improves overall glycaemic control and pancreatic β cell function in T2D patients. Additionally, both groups experienced abdominal fat mass losses. These findings demonstrate that HIIT is a health beneficial exercise strategy in T2D patients.Trial RegistrationClinicalTrials.gov NCT02333734 http://clinicaltrials.gov/ct2/show/NCT02333734
GI symptoms are associated with impaired HRQoL in the renal transplant population. Managing GI symptoms by careful choice of immunosuppressants should be a focus for improving HRQoL in renal transplant recipients.
Fluvastatin treatment significantly improves lipid values in renal transplant recipients but has no effect on graft loss or doubling of serum creatinine.
Renal transplant recipients have a greatly increased risk of premature cardiovascular disease. The ALERT study was a multicenter, randomized, double-blind, placebo-controlled trial of fluvastatin (40-80 mg/day) in 2102 renal transplant recipients followed for 5-6 years. The main study used a composite cardiac endpoint including myocardial infarction, cardiac death and cardiac interventions. Although reduced by fluvastatin, this primary end-point failed to achieve statistical significance thus precluding analysis of predefined subgroups. Therefore, in the present survival analysis, we used an alternative primary end-point of cardiac death or definite nonfatal myocardial infarction (as used in other cardiac outcome trials) which was significantly reduced by Fluvastatin therapy and permits subgroup analysis. Fluvastatin reduced LDL-cholesterol by 1 mmol/L compared with placebo, and the incidence of cardiac death or definite myocardial infarction was reduced from 104 to 70 events (RR 0.65; 95% CI 0.48, 0.88; p = = 0.005). Fluvastatin use was associated with reduction in cardiac death or nonfatal myocardial infarction, which achieved statistical significance in many subgroups. The subgroups included patients at lower cardiovascular risk, who were younger, nondiabetic, nonsmokers and without pre-existing CVD. These data support the early introduction of statins following renal transplantation.
Background Recent clinical trials of primary and secondary
prevention of cardiovascular disease have demonstrated that lowering plasma
cholesterol with 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase
inhibitors (‘statins’) reduces morbidity and mortality
from coronary heart disease in diverse patient populations.
Study aims The aim of the present ALERT (Assessment of
Lescol® in Renal Transplantation) study is to determine whether renal
transplant recipients would also benefit from statin therapy. ALERT is a
multicentre, randomized, double-blind, placebo-controlled trial to assess the
effect of fluvastatin in renal transplant recipients with mild-to-moderate
hypercholesterolaemia. The primary objective is to investigate the effects of
fluvastatin on major adverse cardiac events (MACE). In addition, the effects on
cardiovascular and all-cause mortality, as well as renal function, will be
addressed.
Study population The study population contains patients with
functioning renal allografts of more than 6 months' duration,
recruited from 75 centres in Northern Europe and Canada. Patients of both sexes,
aged 30-75 years, with a total cholesterol level of 4.0-9.0 mmol/l (155-348
mg/dl) were included, except for those with a history of myocardial infarction,
where the upper limit for inclusion was
7.0∗∗∗mmol/l (270 mg/dl).
Study design A total of 2100 patients were recruited by the end of
October 1997 and will be followed for up to 6 years. This report presents the
design features of the study (recruitment, follow-up, sample size, data analysis
and study organization), along with baseline results. ALERT is the first
large-scale prospective, randomized, double-blind study to address the
prevention of cardiovascular mortality in renal transplant patients receiving an
HMGCoA reductase inhibitor.
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