[Determination of urinary albumin excretion in arterial hypertension]. / Determinación de la excreción urinaria de albúmina en la hipertensión arterial.

BACKGROUND AND AIM: Urinary albumin excretion (UAE) measurement is recommended in the diagnosis and follow-up of the hypertensive patient. The aim of the study was to evaluate the proportion of hypertensives attended in Primary Care who had an evaluation of UAE in the last year, along with the methodology of the measurement. PATIENTS AND METHODS: A total of 958 investigators consecutively recruited 4786 hypertensives (first five patients who attended). When present, the measurement of UAE during the last year was obtained from clinical records. In those having this measurement, the type of urine collection (24hours, nighttime or morning spot), as well as the value and units of measure (mg/24h, µg/min, mg/g or mg/L) were recorded. RESULTS: Mean age was 66 years. 51% were men and 49% women. UAE was determined in 2301 patients (48.1%). In 329, 24-hour urine was collected, nighttime urine in 122 and in 1850 the collection came from a morning spot sample. However, only 696 patients from the latter group had the value of albumin corrected by the creatinine excretion. Thus, only 24% of hypertensive patients had a valid UAE measurement (mg/24h, µg/min or mg/g). Prevalence of microalbuminuria was 36%. The UAE determination was associated with older age, obesity, diabetes and better blood pressure control rates. CONCLUSION: Only half of hypertensive patients have a UAE measurement and in only 1 out of 4 a validated methodology has been used. It seems necessary a reinforcement of the messages contained in guidelines, as well as its applicability to any particular setting in order to promote a generalized and correct evaluation of UAE in hypertension.

Amlodipine reduces predicted risk of coronary heart disease in high-risk patients with hypertension in Spain (The CORONARIA Study).

We evaluated the efficacy and safety of amlodipine besylate alone or in combination with other antihypertensive agents in high-risk hypertensive patients in Spanish primary care. In this 1-year, open-label, prospective cohort study, 7468 patients were treated with amlodipine 5 - 10 mg as a monotherapy or as an add-on therapy to attain blood pressure control (target of < 140/90 mmHg or, in patients with conditions such as diabetes or chronic kidney disease, < 130/85 mmHg). At 12 months, the primary outcome (change from baseline in predicted 10-year coronary heart disease risk) was -8.6%, down from 24.7% at baseline (relative risk reduction, 31.6%). Change in blood pressure from baseline (162.5/95.3 mmHg) was -26.7/-14.6 mmHg, and 38.6% of patients achieved their blood pressure target. In summary, significant reductions in predicted coronary heart disease risk and blood pressure were observed with amlodipine both as a monotherapy and as an add-on therapy. Amlodipine was well tolerated and compliance with treatment was good.

Efficacy and safety of amlodipine: a comparative study of hypertensive patients treated at primary- and specialised-care centres.

BACKGROUND: This study set out to assess the safety and efficacy of amlodipine in two cohorts of patients who were attended in primary- and specialised-care centres, respectively. METHODS: Prospective, observational, multicentre pharmacovigilance study including patients aged >18 years who presented with a diagnosis of hypertension (systolic blood pressure [SBP] >or=140 mm Hg and diastolic blood pressure [DBP] >or=90 mm Hg) of >6 months' duration, which was either untreated or uncontrolled, and who were followed up by general practitioners and specialists over a period of 4-6 months. RESULTS: Of the total of 4277 patients included in the study, 2520 (58.9%) were attended in primary care and 1757 (41.1%) in specialised care. 2982 patients (69.7%) were receiving monotherapy, the rest were receiving combined therapy. Over the course of the study, 308 patients (7.2%) experienced adverse events related to the study drug, mostly mild to moderate in nature. There were 20 serious events, although none was related to the study drug. By the end of the study, 1617 patients (37.8%) had achieved the therapeutic goal (SBP <140 mm Hg and DBP <90 mm Hg), with the greatest degree of control being registered among patients receiving combined therapy compared with monotherapy (38.7% vs 35.7%), and in those treated in a specialised-care setting versus a primary-care setting (43.5% vs 33.8%; p < 0.005). CONCLUSIONS: Amlodipine was shown to be a well tolerated and effective drug in one in three patients, and achieved the therapeutic goal in a higher proportion of patients at specialised-care centres compared with those in primary care, and in those receiving combined therapy compared with monotherapy.

Chitotriosidase genotype and serum activity in subjects with combined hyperlipidemia: effect of the lipid-lowering agents, atorvastatin and bezafibrate.

Chitotriosidase, an enzyme involved in the degradation of chitin-containing pathogens with unclear function in humans, has been proposed as a marker of lipid accumulation in macrophages in different lipid-storage diseases, including atherosclerosis. To evaluate (1) if lipid-lowering treatment could modify serum chitotriosidase activity and (2) be useful in monitoring lipid-lowering treatment, we have analyzed this enzyme activity in the participants in the Atozvastatin Versus Bezafibrate in Mixed Hyperlipidemia (ATOMIX) study, a double-blind, comparative, and randomized study comparing the efficacy of atorvastatin and bezafibrate in mixed hyperlipidemia. Because a common genetic deficiency of chitotriosidase modifies serum quitotriosidase activity, this genetic variation was also studied. Seven subjects of 116 (6.03%) were homozygous, and 46 (39.6%) were heterozygous for the defective allele. Mean serum quitotriosidase activity correlated with allele dosage, as it was found to be of 0, 59.8 +/- 52.6 and 81.2 +/- 41.6 nmol/mL/h, in homozygotes for the defective allele, heterozygotes, and homozygotes for the wild-type allele, respectively (P =.0011 for the difference between the last 2 groups). However, this enzyme activity was not found to correlate with lipid levels before and after treatment with either atorvastatin or bezafibrate, and neither with the intensity of the lipid lowering. These results do not support the use of serum chitotriosidase activity as a biologic marker of atherosclerotic plaque modification related to hypolipidemic treatment.

Probucol, incorporated into LDL particles in vivo, inhibits generation of lipid peroxides more effectively than endogenous antioxidants alone.

One of the first steps in lipid autoxidation leads to the generation of lipid peroxides (LPO). The time course of LPO generation during Cu++ catalyzed oxidation of LDL before and after treatment with probucol was determined in this study. Before analysis the samples had been stored for about 3 years at -20 degrees C. The results show that in LDL samples without probucol the total antioxidative potential had been depleted during the long-term storage. In contrast, LDL containing probucol showed almost no signs of lipid autoxidation. In addition, the ratio of vitamin E to cholesterol was significantly higher in serum samples containing probucol. We conclude that, in vivo, probucol is incorporated into LDL particles in concentrations high enough to inhibit even early steps of lipid autoxidation.

137Cs contamination in tea and yerba mate in South America.

Gamma-ray spectra from more than 50 samples of food products available in stores of Buenos Aires city were measured using a germanium detector. Activity concentrations of 137Cs up to 10 Bq/kg were found in tea and yerba mate manufactured in Apóstoles, Argentina. Further measurements of tea leaves, yerba mate leaves and soils, all coming from a cultivated area in that region, also show the presence of 137Cs contamination. The results suggest that the area was fertilized with a product that originated in a region affected by the fallout from the Chernobyl nuclear plant accident.

Effectiveness and Safety of Amlodipine in Newly Diagnosed Hypertensive Patients and in Previously Diagnosed Hypertensive Patients not Controlled with their Usual Treatment (NOTA Study).

OBJECTIVE: To evaluate the effectiveness and safety of amlodipine in two cohorts of hypertensive patients, one newly diagnosed and the other previously diagnosed but not controlled with drug therapy, and to assess the risk factors for the entire sample at the outset of the study. PATIENTS AND DESIGN: We designed a postmarketing, multicentre, open-label, prospective, observational surveillance study with a 6-month follow-up, which included hypertensive patients (systolic blood pressure [SBP] >/=140mm Hg and/or diastolic blood pressure [DBP] >/=90mm Hg) who attended specialised units and had either newly diagnosed or previously diagnosed pharmacologically uncontrolled arterial hypertension. RESULTS: Of the total of 1797 patients eligible for evaluation, 760 (42.3%) were newly and 1037 (57.7%) were previously diagnosed. Of these, 22.9% were classified as being in the high-risk and 43.2% in the very high-risk groups at the outset of the study (WHO-ISH [International Society of Hypertension]). On conclusion of the 6-month follow-up, 54.3% of newly diagnosed and 44.4% of previously treated patients had attained the BP therapy targets defined as SBP <140mm Hg and DBP <90mm Hg, representing a statistically significant difference (p < 0.0001). A total of 8% of patients experienced some adverse event during the course of the study, with this percentage being somewhat higher in the previously treated than in the newly diagnosed group (10.8% vs 5.1%, p < 0.0001). Only 0.3% experienced some severe adverse event, although in no case was this linked to the drug under evaluation. CONCLUSIONS: We conclude that amlodipine has shown itself to be an effective and safe drug for the control of hypertension, whether isolated or associated with other cardiovascular risk factors, both in patients without a previous diagnosis of arterial hypertension and in those previously diagnosed although not controlled under a prior treatment regimen.

Allelic polymorphism -491A/T in apo E gene modulates the lipid-lowering response in combined hyperlipidemia treatment.

BACKGROUND: Combined hyperlipidemia (CHL) is one of the dyslipidemias more frequently found in clinical practice, and lipid-lowering drugs are often necessary in its management. Some genetic loci have been associated with CHL expression, and some studies have shown modulation of drugs efficiency in the treatment of dyslipidemias by genetic polymorphisms. We have investigated whether common polymorphisms and mutations in the apolipoprotein (apo) E, lipoprotein lipase (LPL), and apo CIII genes influence atorvastatin or bezafibrate responses in patients with CHL. DESIGN: One hundred and sixteen subjects participating in the ATOMIX study (Atorvastatin in Mixed dyslipidemia) were randomized to treatment with either atorvastatin or bezafibrate. Apolipoprotein E genotype and common -491A/T and -219T/G polymorphisms in the apo E gene promoter region, Sst I polymorphism in the apo CIII gene (3238C/G), and D9N and N291S common mutations in the LPL gene were determined by polymerase chain reaction (PCR) and restriction enzyme digestion. RESULTS: Statistical analysis showed the influence of the -491A/T polymorphism in atorvastatin and bezafibrate treatments. Subjects carrying the -491T allele showed an increased LDL-cholesterol-lowering effect with atorvastatin compared with -491T allele noncarriers (-35% vs. -27%, P = 0.037). Subjects carrying the -491T allele, when on bezafibrate treatment, showed a lower triglyceride reduction compared with -491T allele noncarriers (-23% vs. -39%, P = 0.05). CONCLUSIONS: In our study, the -491A/T polymorphism in the apo E gene promoter region modulated the lipid-lowering efficiency of atorvastatin and bezafibrate in CHL patients. Such influence might explain some of the interindividual response variabilities observed for the two drugs, and could help in CHL management.

Determinación de la excreción urinaria de albúmina en la hipertensión arterial / Determination of urinary albumin excretion in arterial hypertension

Antecedentes y objetivo. La determinación de la excreción urinaria de albúmina (EUA) está recomendada en el paciente con hipertensión arterial (HTA). Hemos evaluado la proporción de hipertensos en Atención Primaria con al menos una determinación de EUA en el último año, así como la metodología empleada para su cuantificación. Pacientes y métodos. Un total de 958 investigadores evaluaron de forma consecutiva (los 5 primeros pacientes que acudieron a la consulta un día determinado) 4.786 enfermos con HTA esencial. Se recogió la determinación (o falta de ella) de una EUA en el último año. Se evaluó el tipo de recogida (24 horas, nocturna o matinal), así como el valor y las unidades de medida (mg/24h, μg/min, mg/g o mg/L). Resultados. La edad media (±DE) de los pacientes fue de 66±11 años (51% varones). Se disponía de una determinación de la EUA en 2.301 pacientes (48,1%). En 329 (14%) el resultado de la EUA procedía de una orina de 24 horas, en 122 (5%) de una orina nocturna y en 1.850 (80%) de una orina de la mañana, aunque solo en 696 (30% del total) el resultado estaba corregido por la creatinina urinaria. Tan solo un 24% de los pacientes disponían de una medida válida de la EUA (mg/24h, μg/min o mg/g creatinina). La prevalencia global de microalbuminuria fue del 36%. La determinación de la EUA se asoció con la edad, obesidad, diabetes y un mejor control de la presión arterial. Conclusión. En el ámbito de la Atención Primaria, solamente uno de cada 4 enfermos con HTA esencial dispone de una determinación correcta de la EUA(AU)

Background and aim. Urinary albumin excretion (UAE) measurement is recommended in the diagnosis and follow-up of the hypertensive patient. The aim of the study was to evaluate the proportion of hypertensives attended in Primary Care who had an evaluation of UAE in the last year, along with the methodology of the measurement. Patients and methods. A total of 958 investigators consecutively recruited 4786 hypertensives (first five patients who attended). When present, the measurement of UAE during the last year was obtained from clinical records. In those having this measurement, the type of urine collection (24hours, nighttime or morning spot), as well as the value and units of measure (mg/24h, μg/min, mg/g or mg/L) were recorded. Results. Mean age was 66 years. 51% were men and 49% women. UAE was determined in 2301 patients (48.1%). In 329, 24-hour urine was collected, nighttime urine in 122 and in 1850 the collection came from a morning spot sample. However, only 696 patients from the latter group had the value of albumin corrected by the creatinine excretion. Thus, only 24% of hypertensive patients had a valid UAE measurement (mg/24h, μg/min or mg/g). Prevalence of microalbuminuria was 36%. The UAE determination was associated with older age, obesity, diabetes and better blood pressure control rates. Conclusion. Only half of hypertensive patients have a UAE measurement and in only 1 out of 4 a validated methodology has been used. It seems necessary a reinforcement of the messages contained in guidelines, as well as its applicability to any particular setting in order to promote a generalized and correct evaluation of UAE in hypertension(AU)

Estudio de farmacovigilancia para evaluar la seguridad y la efectividad de amlodipino en pacientes ancianos hipertensos / Pharmacovigilance study to evaluate the safety and effectiveness of amlodipine in elderly patients with hypertension

Objetivo: evaluar la seguridad y efectividad de amlodipino en pacientes ancianos hipertensos de nuevo diagnóstico o de diagnóstico previo, no controlados farmacológicamente. Método: estudio multicéntrico, observacional, prospectivo de farmacovigilancia. Se realizó en pacientes mayores de 64 años, diagnosticados de hipertensión, de nuevo diagnóstico o con diagnóstico previo, que fueron atendidos por médicos especialistas en el manejo de la hipertensión. Resultados: se evaluó a 726 pacientes; de ellos, 234 (32,2 por ciento) eran de nuevo diagnóstico y 492 (67,8 por ciento) estaban siendo tratados con otros fármacos antihipertensivos. Según la clasificación de riesgo cardiovascular de la OMS, el 25,3 por ciento se encontraba en riesgo alto y el 52,4 por ciento, en riesgo muy alto. A los 6 meses de seguimiento, el porcentaje de pacientes que alcanzaba el control, según los criterios de la OMS, fue del 45,7 por ciento. La reducción de la presión arterial sistólica (PAS) fue de 30,03 mmHg, lo que indica una reducción del 17,6 por ciento, mientras que para la presión arterial diastólica (PAD) la reducción fue de 14,96 mmHg, lo que indica una reducción del 15,6 por ciento. La presión de pulso se redujo en 19,06 mmHg, lo que supuso una reducción del 23,1 por ciento. Un total de 42 pacientes (6 por ciento) presentó acontecimientos adversos, la mayoría de carácter leve-moderado, y sólo en 6 pacientes se observó algún efecto adverso serio (en todo caso, ninguno relacionado con el fármaco en estudio).Conclusiones: el amlodipino ha mostrado ser un fármaco efectivo y seguro (en monoterapia o terapia combinada) en el control de la presión arterial en ancianos con otros factores de riesgo cardiovascular asociados (AU)