Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study

Background. Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life (∼130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis

Comparación de distintas estrategias para la predicción de muerte a corto plazo en el paciente anciano infectado

Objective. The aim of this study was to determine the utility of a post hoc lactate added to SIRS and qSOFA score to predict 30-day mortality in older non-severely dependent patients attended for infection in the Emergency Department (ED). Methods. We performed an analytical, observational, prospective cohort study including patients of 75 years of age or older, without severe functional dependence, attended for an infectious disease in 69 Spanish ED for 2-day three seasonal periods. Demographic, clinical and analytical data were collected. The primary outcome was 30-day mortality after the index event. Results. We included 739 patients with a mean age of 84.9 (SD 6.0) years; 375 (50.7%) were women. Ninety-one (12.3%) died within 30 days. The AUC was 0.637 (IC 95% 0.587-0.688; p= 2 and 0.698 (IC 95% 0.635- 0.761; p= 2. Comparing receiver operating characteristic (ROC) there was a better accuracy of qSOFA vs SIRS (p=0.041). Both scales improve the prognosis accuracy with lactate inclusion. The AUC was 0.705 (IC95% 0.652-0.758; p<0.001) for SIRS plus lactate and 0.755 (IC95% 0.696-0.814; p<0.001) for qSOFA plus lactate, showing a trend to statistical significance for the second strategy (p=0.0727). Charlson index not added prognosis accuracy to SIRS (p=0.2269) or qSOFA (p=0.2573). Conclusions. Lactate added to SIRS and qSOFA score improve the accuracy of SIRS and qSOFA to predict short-term mortality in older non-severely dependent patients attended for infection. There is not effect in adding Charlson index

Effect of antihypertensive treatment on progression of renal insufficiency in non-diabetics patients. (Espiral trial)

A three year randomized, multicenter, prospective, open trial, will be developed with the aim of studying the influence of antihypertensive therapy on chronic renal failure progression in non-diabetics patients. The study will compare the effects of an angiotensin converting enzyme inhibitor, fosinopril, with a slow release calcium antagonist, nifedipine slow release. Two hundred and fifty patients, with progressively fallug renal function, shom by an increase of serum creatinine (SCr) of at least 25 % in the 2 years preceding entry to the study, and SCr levels between 1.5 and 4.0 mg/dl, will be included. The primary end point of the trial will be the rate of change of SCr (mg/dl/month) and of the reciprocal of serum creatinine concentration (1/SCr) over time. The secondary end point will be the percentage of patients with a doubling of SCr, progreswith to dialytic therapy, or deah during the study. Patients with nephrotic syndrome (serum albumin concentration < 3 g %), systemic disease (including diabetes), severe cardiac or hepatic dysfunction, malignant or renovascular hypertension, obstructive nephropathy, initial serum potassium concentration > 5.8 mmol/l and initial serum total cholesterol level ³ 270 mg/dl, will be excluded. After a «wash out» period of four weeks, patients with arterial blood pressure ³ 140/90 will be assigned either to fosinopril (10-30 mg/day) or nifedipine slow release (30-60 mg/day). In case of insufficient blood pressure control, furosemide (20- 100 mg/d) will be added as a first step and then atenolol (25-100 mg/d) and/or doxazosine (1-12 mg/d) in order to maintain arterial blood pressure control under 140/90. All patients will receive a diet with 4-5 g/day salt content and a protein content of 0.8-1 g/kg body weight. At the begining of the study, at 2, 4 and 8 weeks, and every 4 months, the following parameters will be measured: supine blood pressure after 5 minutes rest, body weight, SCr, 1/SCr, serum albumin, electrolytes and lipid pattern; urinary protein and urea concentrations and creatinine clearange. The relation between the progression chronic renal failure and ambulatory blood presure during 24 hours will be studied in some patients

Effect of antihypertensive treatment on progression of renal insufficiency in non-diabetics patients. (Espiral trial)

A three year randomized, multicenter, prospective, open trial, will be developed with the aim of studying the influence of antihypertensive therapy on chronic renal failure progression in non-diabetics patients. The study will compare the effects of an angiotensin converting enzyme inhibitor, fosinopril, with a slow release calcium antagonist, nifedipine slow release. Two hundred and fifty patients, with progressively fallug renal function, shom by an increase of serum creatinine (SCr) of at least 25 % in the 2 years preceding entry to the study, and SCr levels between 1.5 and 4.0 mg/dl, will be included. The primary end point of the trial will be the rate of change of SCr (mg/dl/month) and of the reciprocal of serum creatinine concentration (1/SCr) over time. The secondary end point will be the percentage of patients with a doubling of SCr, progreswith to dialytic therapy, or deah during the study. Patients with nephrotic syndrome (serum albumin concentration < 3 g %), systemic disease (including diabetes), severe cardiac or hepatic dysfunction, malignant or renovascular hypertension, obstructive nephropathy, initial serum potassium concentration > 5.8 mmol/l and initial serum total cholesterol level ³ 270 mg/dl, will be excluded. After a «wash out» period of four weeks, patients with arterial blood pressure ³ 140/90 will be assigned either to fosinopril (10-30 mg/day) or nifedipine slow release (30-60 mg/day). In case of insufficient blood pressure control, furosemide (20- 100 mg/d) will be added as a first step and then atenolol (25-100 mg/d) and/or doxazosine (1-12 mg/d) in order to maintain arterial blood pressure control under 140/90. All patients will receive a diet with 4-5 g/day salt content and a protein content of 0.8-1 g/kg body weight. At the begining of the study, at 2, 4 and 8 weeks, and every 4 months, the following parameters will be measured: supine blood pressure after 5 minutes rest, body weight, SCr, 1/SCr, serum albumin, electrolytes and lipid pattern; urinary protein and urea concentrations and creatinine clearange. The relation between the progression chronic renal failure and ambulatory blood presure during 24 hours will be studied in some patients

A random comparison of fosinopril and nifedipine GITS in patients with primary renal disease

OBJECTIVE: To investigate in a random comparison the capacity of an angiotensin converting enzyme inhibitor (fosinopril), and that of a long-acting dihydropiridine (nifedipine GITS) to modify the decay in renal function in patients with primary renal disease, exhibiting a progressive increase in serum creatinine during the previous 2 years. METHODS: A randomized, open-label, multicenter study with a minimum follow-up of 3 years. A total of 241 patients were included in the study. All of them were hypertensive and had a 25% or at least 0.5 mg/dl increase in the value of serum creatinine during the 24 months prior to entering the study. Initial doses of fosinopril and nifedipine GITS were 10 and 30 mg respectively, and titration to 30 and 60 mg was performed if needed to obtain the expected blood pressure goal (< 140/90 mmHg). Furosemide, atenolol, and doxazosin were added as second, third, and fourth drugs if necessary, for blood pressure control. The primary end-point of the study was the appearance of double the serum creatinine values and/or the need to enter a dialysis programme. Secondary end-points were cardiovascular events, death, changes in 24 h proteinuria, and the evolution of serum creatinine. Data reflect the analysis performed by intention to treat. RESULTS: Mean age of the group was 54 +/- 14, and 59% were males. Primary glomerulonephritis (31%), nephrosclerosis (26%) and polycystic kidney disease (19%) were the three most frequent diagnostic findings. After 3 years of follow-up, 21% (27/127) of patients treated with fosinopril, and 36% (40/112) of those receiving nifedipine GITS presented a primary end-point, (OR 0.47, 95% confidence intervals 0.26-0.84, P = 0.01). Renal survival was significantly better when fosinopril constituted the first step therapy (P = 0.002). These results did not seem to be influenced by the type of primary renal disease. Proteinuria decreased at the end of the study by a mean of 57% in the fosinopril group and increased by 7% in the group receiving dihydropiridine. Blood pressure control did not differ among groups for diastolic values. During follow-up, however, the patients receiving ACEi showed systolic blood pressure values 4-6 mmHg lower. CONCLUSION: In patients with chronic renal failure and hypertension due to primary renal disease, fosinopril significantly differed from nifedipine GITS by its capacity to slow the progressive decay in renal function. The drugs also differed by their capacity to lower blood pressure. The better control, in particular of systolic blood pressure, in the fosinopril arm could have contributed in a relevant manner to the attainment of a better outcome when the ACEi was employed