Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.

Patients with type 2 diabetes on dialysis are at a substantially increased risk of cardiovascular and cerebrovascular diseases. Dyslipidemia characterized by moderately elevated low-density lipoprotein cholesterol and high triglycerides and low high-density lipoprotein cholesterol levels is common in this population. We hypothesized that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors would reduce vascular morbidity and mortality in this patient group. The ‘Deutsche Diabetes Dialyse Studie’ (4D study) is a prospective, randomized, double-blind study involving 178 dialysis centers throughout Germany. Between March 1998 and October 2002, 1,255 patients were randomized to either atorvastatin 20 mg or placebo; 677 men and 578 women, aged 30–83 years, have been enrolled. The study will be terminated as soon as the predefined number of 424 patients with primary combined end points (i.e., cardiovascular death, nonfatal myocardial infarction, or fatal/nonfatal stroke) will have occurred. The total cohort had the following characteristics at baseline: the mean age was 65.7 years, 54% were men, 89% had a history of hypertension, 21% had coronary artery disease, 17.8% had a history of stroke or a transient ischemic attack, and 45% suffered from peripheral arterial disease. The mean time interval between the diagnosis of diabetes and the onset of dialysis was 17.4 years. On average, the patients were on hemodialysis for 8.3 months. Mean lipid and lipoprotein levels were: total cholesterol 219 ± 43 mg/dl, low-density lipoprotein cholesterol 126 ± 30 mg/dl, high-density lipoprotein cholesterol 36 ± 13 mg/dl, and triglycerides 264 ± 167 mg/dl. The results of the study will provide important information on the efficacy and safety of atorvastatin to support its use in patients with an impaired renal function who are at a high risk of vascular morbidity and mortality.

Our results argue against the controversial TH1/TH2 or TH17/Treg paradigms. In contrast, they suggest that a subpopulation of TH17 cells sharing a TH1 signature may be specifically involved in intestinal inflammation in CD and UC. These findings provide a better understanding of IBD pathogenesis and may help explain the efficacy of anti-IL-12p40/IL-23 and failure of anti-IL-17A therapies despite the enrichment of TH17 cells.

The findings of DETECT underline the considerable burden for primary care doctors in managing a highly morbid patient population, with predominantly complex risk factor constellations, in routine care. Our data provide, in unprecedented detail, a basis for calculating age-, gender- and risk-group-adjusted risk-factor profiles in routine care.

Rationale and design of a trial improving outcome of type 2Cardiovascular and cerebrovascular events are the diabetics on hemodialysis. most important causes of death in diabetic patients onBackground. Non-insulin-dependent diabetes mellitus diallong-term dialysis therapy, accounting for 59% of overall ysis patients have the highest cardiovascular mortality known mortality in this group [1]. Approximately 12 to 19% of in any group of patients. Mixed dyslipidemia with moderately elevated low-density lipoprotein (LDL) cholesterol and high such deaths from cardiovascular causes are due to acute levels of triglyceride-rich lipoproteins is common in this condimyocardial infarction, but 60% of patients die within tion. It is not known, however, whether patients with type 2 one year after acute myocardial infarction [2]. The causdiabetes on dialysis with this form of dyslipidemia derive beneative role for plasma low-density lipoprotein (LDL) in fit from lipid-lowering therapy. Recently, drugs have become available that potently lower triglyceride-rich, apoB-containing the development of coronary artery disease has been lipoproteins and thus permit testing of this issue. This is the first well established in subjects without impairment of renal trial to address specifically the issue of whether the excessive function, but the exact role of dyslipidemia in vascular cardiovascular mortality of patients with type 2 diabetes on dialysis can be lowered by statins. disease of diabetic patients with renal failure remainsMethods. The Die Deutsche Diabetes Dialyse Studie is a to be defined. In diabetes, the pathogenesis of vascular prospective randomized placebo-controlled trial that tests the lesions is likely to be more complex, and clarification of hypothesis that atorvastatin, a hydroxymethyl-glutaryl coenthis point is therefore particularly important. Despite zyme A reductase inhibitor, decreases the rate of cardiovascular mortality and of nonfatal myocardial infarction in patients the burden of cardiac disease among patients on dialysis, with type 2 diabetes who have been on hemodialysis treatment there are currently no published data or no concepts to for no more than two years. The primary endpoint, cardiovascuimprove long-term survival or quality of life. There are lar mortality, includes fatal myocardial infarction, sudden death, several unanswered questions that are critical to knowing death during coronary intervention, death from heart failure, and other coronary causes. Secondary endpoints comprise overhow to manage the plasma lipids of patients with or withall mortality, nonfatal cardiovascular events, fatal and nonfatal out diabetes and on long-term hemodialysis. Approxicerebrovascular disease, and the mean percentage change in mately 8% of hemodialysis patients were prescribed a lipid profile from baseline. The trial enrolls 1200 men and women lipid-lowering medication [3], despite the fact that evion hemodialysis for less than two years and with type 2 diabetes at 150 centers throughout Germany. Inclusion criter...