ABSTRACT
OBJECTIVE: The RED LEVEL study (REnal Disease: LErcanidipine Valuable Effect on urine protein Losses) directly compares, in an explorative fashion, the effects of lercanidipine + enalapril and amlodipine + enalapril combinations on renal parameters in hypertensive subjects. RESEARCH DESIGN AND METHODS: This was a 1 year, prospective, multi-center, randomized, open-label, blinded-endpoint (PROBE) study in hypertensive patients with albuminuria. MAIN OUTCOME MEASURES: Renal function (albuminuria, serum creatinine, creatinine clearance, estimated glomerular filtration rate and proteinuria); blood pressure. RESULTS: Albuminuria was significantly reduced, compared with baseline values, with the lercanidipine + enalapril combination over the entire study period; at month 3, month 6 and month 12, changes from baseline were: -162.5 (p-value = 0.0439), -425.8 (p-value = 0.0010), -329.0 (p-value = 0.0011) mg/24 h), respectively. On the other hand, this improvement was not observed with enalapril + amlodipine. Other parameters of renal function such as serum creatinine, creatinine clearance, estimated glomerular filtration rate and proteinuria did not change over the study. Both lercanidipine + enalapril and amlodipine + enalapril significantly reduced systolic and diastolic blood pressure values from baseline all over the study period with no significant differences between groups. Safety outcomes were comparable between the two groups. CONCLUSIONS: Overall, the results of this explorative study lend support to the anti-albuminuric effect of the lercanidipine + enalapril combination and to the long term renal-protective effects of this combination in patients with hypertension.
Subject(s)
Albuminuria/drug therapy , Amlodipine/therapeutic use , Antihypertensive Agents/therapeutic use , Dihydropyridines/therapeutic use , Enalapril/therapeutic use , Hypertension/drug therapy , Aged , Amlodipine/adverse effects , Antihypertensive Agents/adverse effects , Blood Pressure/drug effects , Dihydropyridines/adverse effects , Double-Blind Method , Enalapril/adverse effects , Female , Humans , Hypertension/complications , Kidney/drug effects , Kidney Diseases/drug therapy , Kidney Function Tests , Male , Middle Aged , Prospective StudiesABSTRACT
The authors publish the first precise, specific, valid questionnaire in Spanish which measures the quality of life related to health for patients who have undergone an intestinal or urological ostomy; furthermore, this questionnaire has been validated in a sample of Spanish population. The OPM Division of B. Braun Medical was the sponsor of the study which led to the creation of this QUALYPOLL questionnaire. Statistical validation of the data complied was performed by Health Outcomes Research Europe which carried out a multi-centric national study to evaluate the measuring properties of the aforementioned QUALYPOLL questionnaire on patients who have undergone an intestinal or urological ostomy.
Subject(s)
Ostomy/psychology , Quality of Life/psychology , Surveys and Questionnaires , Female , Gastrointestinal Diseases/psychology , Gastrointestinal Diseases/surgery , Humans , Male , Middle Aged , Reproducibility of Results , Urologic Diseases/psychology , Urologic Diseases/surgeryABSTRACT
Se presenta el primer cuestionario en castellano, preciso, específico, válido y validado en población española que mide la calidad de vida relacionada con la salud (CVRS) en pacientes ostomizados. La División OPM de B. Braun Medical fue el promotor del estudio que facilitó la elaboración del cuestio-nario de calidad de vida QUALYPOLL®. La validación estadística de los datos estuvo a cargo de la empresa Health Outcomes Research Europe, que puso en marcha un estudio multicéntrico a nivel nacional para evaluar las propiedades de medición de dicho cuestionario en pacientes ostomizados(AU)
The authors publish the first precise, specific, valid questionnaire in Spanish which measures the quality of life related to health for patients who have undergone an intestinal or urological ostomy; furthermore, this questionnaire has been validated in a sample of Spanish population. The OPM Division of B. Braun Medical was the sponsor of the study which led to the creation of this QUALYPOLL® questionnaire. Statistical validation of the data complied was performed by Health Outcomes Research Europe which carried out a multi-centric national study to evaluate the measuring properties of the aforementioned QUALYPOLL® questionnaire on patients who have undergone an intestinal or urological ostomy(AU)
