[Albuminuria and cardiovascular risk: basal results of the KORAL-CARDIO study]. / Albuminuria y riesgo cardiovascular. Estudio KORAL-CARDIO.

BACKGROUND AND OBJECTIVES: Albuminuria is a marker of higher cardiovascular and renal risk in hypertension; it also indicates the need of a tighter control of blood pressure with drugs blocking the renin-angiotensin system. The objective of the KORAL-CARDIO study was to assess the clinical picture and management of patients with hypertension and cardiac disease and albuminuria not previously treated with angiotensin inhibitors. METHODS: A total of 2711 hypertensive patients (44% female) with ischemic or hypertensive cardiopathy or atrial fibrillation and with a positive screening test for albuminuria was included. Type 2 diabetes was also present in 42%. RESULTS: Macroalbuminuria was present in 7.2% of non diabetic and 12.7% of diabetic patients, respectively. Associated complications were: 25% and 35% body mass index over 30 kg/m2; 22% and 39% ischemic heart disease; 4% and 8% stroke; 19% and 22% atrial fibrillation; 42% and 53% high cholesterol levels; 8% and 8% grade 3 hypertension, for non-diabetics and diabetics respectively. Antihypertensive monotherapy was used in 66% of non-diabetics and in 63% of diabetics; only 7% of patients in both groups were treated with triple antihypertensive therapy. CONCLUSIONS: Cardiovascular complications are very frequently associated to albuminuria in patients with hypertension and heart disease not previously treated with angiotensin inhibitors. Blood pressure control was clearly inadequate in this group.

Impacto del tratamiento con irbesartán sobre la reducción del riesgo cardiovascular de pacientes hipertensos en España. Estudio KORAL-HTA / Impact of treatment with irbesartan on reduction of cardiovascular risk in hypertensive patients in Spain. Koral-HTA study

Objetivos. Evaluar la eficacia de irbesartán para alcanzar los objetivos de presión arterial (PA) establecidos por las guías y en reducir la microalbuminuria (MAU) en pacientes hipertensos no controlados. Evaluar este efecto tanto en pacientes diabéticos como no diabéticos y en diferentes rangos de índice de masa corporal (IMC). Estudiar el impacto de este tratamiento sobre el riesgo coronario global (RCG) valorado mediante las tablas REGICOR. Métodos. KORAL-HTA es un estudio observacional, prospectivo y abierto de 1 año de seguimiento en pacientes hipertensos no controlados con al menos otro factor de riesgo cardiovascular atendidos en Unidades de Hipertensión en toda España. Resultados. Estudiamos 1.657 pacientes (el 59,5 % de hombres; edad media (desviación estándar [DE]): 60,3 [12,0] años). Un 48,4 % presentaba diabetes mellitus (DM), un 48,2 % dislipemia y MAU un 63,6 %. Un 70 % de los pacientes alcanzó los objetivos de PA (< 140/90 mmHg y < 130/80 mmHg en no DM y DM, respectivamente). La proporción de pacientes con MAU y proteinuria se redujo del 63,6 % al 48,3 % y del 19,4 % al 10,8 %, respectivamente; p < 0,01, en el grupo global, así como en los pacientes con y sin DM, y en los diferentes rangos del IMC. El RCG disminuyó desde (mediana [perc 25-75]) 5,9 (3,0-8,0) y 9,7 (5,0-12,0) basalmente, en no diabéticos y diabéticos, respectivamente, a 4,0 (3,0-5,0) y 5,0 (3,8-7,0), respectivamente, a los 12 meses (p < 0,001). Conclusiones. La reducción de la PA y la MAU con el tratamiento con irbesartán se asocia a una reducción del RCG en los pacientes hipertensos. Este estudio confirma además, en condiciones de práctica clínica, que los beneficios sobre la MAU no se limitan únicamente a los pacientes con DM, sino también a aquellos no diabéticos y son constantes en los diferentes rangos del IMC

Objectives. Evaluate the efficacy of irbesartan to reach the blood pressure objectives established in the guides and reduce microalbuminuria (MAU) in uncontrolled hypertensive patients. Evaluate this effect in both diabetic and non-diabetic patients and in different BMI ranges. Study the impact of this treatment on global coronary risk (GCR) assessed with the REGICOR tables. Methods. KORAL-HTA is an observational, prospective, open-label 1-year follow-up study in uncontrolled hypertensive patients with at least one other cardiovascular risk factor seen in hypertensive units in all Spain. Results. We studied 1,657 patients (59.5 % men; mean age (SD): 60.3 (12.0) years). A total of 48.4 % had DM, 48.2 % dyslipidemia and 63.6 % MAU. Seventy percent of the patients achieved the BP objectives (< 140/90 mmHg and < 130/80 mmHg in non-DM and DM, respectively). The proportion of patients with MAU and proteinuria decreased from 63.6 % to 48.3 % and from 19.4 % to 10.8 %, respectively; p < 0.01, in the global group and in patients with and without DM, and in the different BMI ranges. GCR decreased from (median [perc 25-75]) 5.9 (3.0-8.0) and 9.7 (5.0-12.0) at baseline, in non-diabetics and diabetics, respectively to 4.0 (3.0-5.0) and 5.0 (3.8-7.0), respectively, at 12 months (p < 0.001). Conclusions. BP and MAU decrease with Irbesartan treatment is associated to a decrease in GCR in hypertensive patients. This study also confirms under clinical practice conditions that the benefits on MAU are not only limited to patients with DM but also to the non-diabetics and are constant in the different BMI ranges

Albuminuria y riesgo cardiovascular. Estudio KORAL-CARDIO / Albuminuria and cardiovascular risk: basal results of the Koral-Cardio study

Introducción y objetivos: La presencia de albuminuria identifica a un grupo dehipertensos con mayor riesgo cardiovascular y renal y obliga a controlar mejor lapresión arterial con fármacos que bloqueen el sistema renina-angiotensina. El objetivodel estudio KORAL-CARDIO fue determinar las características clínicas y demanejo de pacientes con hipertensión, albuminuria y cardiopatía no tratados previamentecon inhibidores angiotensínicos.Pacientes y métodos: Se incluyen prospectivamente 2.711 pacientes (44% mujeres)de 64 años de media con hipertensión arterial, cardiopatía isquémica o hipertensivao fibrilación auricular con positividad en la detección cualitativa de albuminuria.El 42% tenían además diabetes mellitus de tipo 2.Resultados: El 7,2% de los no diabéticos y el 12,7% de los diabéticos teníanmacroalbuminuria; el 25% y el 35% respectivamente tenían índice de masa corporalde más de 30 kg/m2. Las complicaciones asociadas fueron: cardiopatía isquémica(22 y 39%), ictus (4 y 8%), fibrilación auricular (19 y 22%), hipercolesterolemia(42 y 53%), hipertensión de grado 3 (8% en ambos casos). Recibíantratamiento antihipertensivo monofármaco el 66% de los no diabéticos y el 63%de los diabéticos, y sólo el 7% triple terapia; otros tratamientos fueron: hipolipemiantes(41 y 57%) y antiagregantes (37 y 58% respectivamente).Conclusiones: Las complicaciones asociadas a la albuminuria en hipertensos concardiopatías, diabéticos y no diabéticos, no tratados con inhibidores angiotensínicosson muy frecuentes. El grado de control tensional fue escaso en este grupo

Background and objectives: Albuminuria is a marker of higher cardiovascularand renal risk in hypertension; it also indicates the need of a tighter control of blood pressure with drugs blocking the renin-angiotensin system. The objective ofthe KORAL-CARDIO study was to assess the clinical picture and management ofpatients with hypertension and cardiac disease and albuminuria not previously treatedwith angiotensin inhibitors.Methods: A total of 2,711 hypertensive patients (44% female) with ischemic orhypertensive cardiopathy or atrial fibrillation and with a positive screening test foralbuminuria was included. Type 2 diabetes was also present in 42%.Results: Macroalbuminuria was present in 7.2% of non diabetic and 12.7% ofdiabetic patients, respectively. Associated complications were: 25% and 35% bodymass index over 30 kg/m2; 22% and 39% ischemic heart disease; 4% and 8%stroke; 19% and 22% atrial fibrillation; 42% and 53% high cholesterol levels; 8%and 8% grade 3 hypertension, for non-diabetics and diabetics respectively. Antihypertensivemonotherapy was used in 66% of non-diabetics and in 63% of diabetics;only 7% of patients in both groups were treated with triple antihypertensivetherapy.Conclusions: Cardiovascular complications are very frequently associated to albuminuriain patients with hypertension and heart disease not previously treatedwith angiotensin inhibitors. Blood pressure control was clearly inadequate in thisgroup

Alipase versus nonenteric-coated enzymes in pancreatic insufficiency. A french multicenter crossover comparative study.

Pancreatic enzymes (PE) are prepared as pH-sensitive enteric coated microspheres [Pancrease, Alipase in France (P)], to prevent gastric inactivation of orally administered enzymes. The efficacy and tolerability of P were compared to those of Eurobiol (E) (PE lacking enteric coating) in patients with exocrine pancreatic insufficiency (PI) via an open crossover study conducted at 16 centers in France. Pancreatic insufficiency was diagnosed in patients with signs of chronic pancreatitis who showed steatorrhea (fecal fat excretion greater than 8.0 g/24 h). The dosage of P was 9 capsules/d and that of E, 3 vials/d. Stools were collected for 3 consecutive days at each of the following periods: after 10 d without any PE, and after 21 d of P and E administration. Results were analyzed statistically by the method of Hills and Armitage. Chronic pancreatitis was alcohol-induced in 33 of 35 patients (94%) who entered the study. The group that received P before E (n = 20) was comparable to the group that received E before P (n = 15) in patient and disease characteristics. Eight of 35 patients failed to complete the study for the following reasons: adverse reactions 2 cases, lost to followup 4 cases, dropped out of study 2 cases. The degree of steatorrhea was similar after P and E. However, symptomatic improvement was noted far more frequently with P than with E. Moreover, patients preferred P to E because of drug taste (p less than 10(-4] and ease of drug administration (p less than 10(-3). Drug safety was comparable in the two groups of patients.