Effects of fluvastatin on cardiac events in renal transplant patients: ALERT (Assessment of Lescol in Renal Transplantation) study design and baseline data.

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.

[Treatment of renal artery stenosis]. / Behandling av nyrearteriestenose.

BACKGROUND: Treatment of renal artery stenosis with angioplasty may be performed in patients with renovascular hypertension, ischaemic renal failure, or to preserve renal function. MATERIAL AND METHODS: From 1982 to 1993 Rikshospitalet performed 591 renal angioplasties in 419 patients with significant renal artery stenoses. Clinical and angiographic follow-ups were performed up until 1996. RESULTS: In patients with atherosclerotic disease, the acute success rate was 94%, primary patency 60%, and secondary patency 74%. The results were better for fibromuscular dysplasia. Patients with the highest blood pressure and those with recent onset of hypertension had the largest decrease in blood pressure. Renal angioplasty of bilateral stenosis or stenosis to a single functioning kidney preserved renal function in patients with normal to moderately reduced renal function. There were no overall positive effects on blood pressure and renal function in patients with serum creatinine > 250 mumol/l. CONCLUSION: Renal angioplasty can be done in selected patients with renal artery stenosis. The selection of patients for renal angioplasty is important in order to increase the clinical success rate. Clinical as well as angiographic follow-ups for detection of restenosis are mandatory.

[Costs of care in uremia. How much does kidney transplantation cost?]. / Kostnader ved uremikeromsorg. Hva koster nyretransplantasjon?

The cost of kidney transplantation and hemodialysis have been recorded (in 1986). Tissue typing, operation and initial stay in hospital cost NOK 103,000 per patient, and further treatment for the first year after operation NOK 114,000. Subsequent annual costs were NOK 70,000, mainly for drugs. Hemodialysis costs NOK 287,000 per year. Transplantation was cost-effective by almost NOK one million per patient over a five-year period. If the current high national rate of transplantation (42 patients per million), which keeps both the national waiting list (23 patients per million) and the dialysis population at a low level, is sustained over the next five years, then total national expenditures for dialysis and transplantation are predicted to be approx. NOK 400 millions. If no transplants were performed during this period the waiting list would increase to 175 patients per million, and expenditures (for dialysis) to approx. NOK 750 millions. Additional huge investments would be needed in order to expand the facilities for dialysis. Because of high transplant rate, only 18 per cent of all treated uremics in Norway are now on dialysis, versus 73 per cent in Western Europe. Since transplantation is much cheaper than dialysis, national expenditures per treated patient are lower in Norway than in any other country.