[Cinacalcet treatment for secondary hyperparathyroidism in dialysis patients in real-world clinical practice - the ECHO observational study: French experience]. / Efficacité du cinacalcet en pratique clinique chez les patients dialysés présentant une hyperparathyroïdie secondaire : observatoire ECHO - Expérience française.

UNLABELLED: In chronic kidney disease patients with secondary hyperparathyroidism (SHPT), the recommended K/DOQI™ target serum levels of parathyroid hormone (PTH), calcium (Ca) and phosphorus (P) are difficult to reach and maintain stable. We present the results of the French cohort from the European study ECHO which investigated the use and effectiveness of cinacalcet in real-world clinical practice. METHODS: An observational study of the SHPT management in dialysis patients, partially retrospective (from 6 months prior to cinacalcet initiation) and partially prospective (up to 12 months of cinacalcet treatment). RESULTS: Four hundred and eighty-five French patients were enrolled from 44 centres. Cinacalcet was given in combination with active vitamin D treatment (39%) and phosphate binders (87%). After 12 months, the proportion of patients reaching recommended K/DOQI™ target levels had increased from 2.5% to 28.8% for PTH, from 46.8% to 50.1% for Ca, from 40.0% to 49.9% for P and 54.8% to 77.7% for the CaxP product. The proportions of patients using active vitamin D and sevelamer decreased by 6% and 20% respectively. Adverse events were reported in 37 (7.6%) patients, mainly nausea (2.1%), vomiting (2.1%) and dyspepsia (1.2%). CONCLUSIONS: The results of this study are consistent with data from controlled and randomized studies showing that cinacalcet increases the proportion of patients achieving the K/DOQI™ targets for PTH, Ca, P and CaxP in real-world clinical practice.

The non-insulin-dependent diabetes, hypertension, microalbuminuria or proteinuria, cardiovascular events, and ramipril (DIABHYCAR) study: design, organization, and patient recruitment. DIABHYCAR Study Group.

The non-insulin-dependent DIABetes, HYpertension, microalbuminuria or proteinuria, CARdiovascular events, and Ramipril (DIABHYCAR) study is a randomized, prospective, double-blind, placebo-controlled, multicenter international trial of the ACE inhibitor ramipril (1.25 mg/day) in patients with type II diabetes and micro- or macroalbuminuria. The main outcome of the study is the time to first occurrence of either death from a cardiovascular origin, including sudden death, nonfatal myocardial infarction, stroke, or congestive heart failure, or requirement of hemodialysis or renal transplantation. The study was launched in France in early 1995 with the participation of general practitioners only, but had to be extended to 15 other countries in 1997 due to difficulties in recruitment. Since 2.5 years after the beginning of the trial the observed event rate was much less than anticipated, it was decided to increase recruitment and follow-up duration and to include congestive heart failure in the definition of the main outcome to keep the study power at a satisfactory level. Recruitment ended on April 1, 1998 with 4937 randomized patients. Following the early discontinuation for efficacy of another study of ramipril in high cardiovascular risk patients, the Heart Outcomes Prevention Evaluation study (HOPE), the second interim analysis of DIABHYCAR was performed early (when 406 instead of 500 patients presented a main outcome) and the Data Safety and Monitoring Board recommended that the study continue. Follow-up is planned to end on March 31, 2001.

Determinants of elevated urinary albumin in the 4,937 type 2 diabetic subjects recruited for the DIABHYCAR Study in Western Europe and North Africa.

OBJECTIVE: Whether ACE inhibition is useful for type 2 diabetic patients with micro- and macroalbuminuria remains unknown. The Non-Insulin-Dependent Diabetes, Hypertension, Microalbuminuria, Cardiovascular Events and Ramipril (DIABHYCAR) Study was set up to address this issue through a multicenter double-blind parallel placebo-controlled > or = 3-year trial in Europe and North Africa. In this article, we report the characteristics of the randomized patients. RESEARCH DESIGN AND METHODS: The main selection criteria were as follows: men or women aged > or = 50 years with type 2 diabetes treated with oral antidiabetic drugs, with or without hypertension, with a plasma creatinine level < 150 mumol/l, and with persistent micro- or macroalbuminuria, as assessed centrally by two successive urine samples containing a urinary albumin concentration > or = 20 mg/l. Patient characteristics were studied by comparing patients who were randomized to those who were not, taking their geographical origin into account. RESULTS: There were 25,455 patients screened for urinary albumin (20,296 from France, 918 from Germany, 1,019 from Northwest Europe, 969 from Central Europe, 959 from Mediterranean Europe, and 1,294 from North Africa). Of these patients, 4,937 were randomized. Compared with the nonrandomized patients, the randomized patients were older, more often men, more obese, had higher systolic/diastolic blood pressure and plasma glucose, smoked more tobacco, drank more alcohol, and had complications more frequently. Using a logistic regression analysis, all the above-mentioned items appeared as independent determinants for randomization into the study, with the exception of alcohol intake. The contribution of each item varied slightly from one geographical origin to another. CONCLUSIONS: The physical, biological, and behavioral characteristics create a poor renal and cardiovascular prognosis for the type 2 diabetic patients randomized to the DIABHYCAR Study because of micro- and macroalbuminuria. Testing the usefulness of ACE inhibition for the type 2 diabetic patients with microalbuminuria seems feasible through the DIABHYCAR Study.