Prevalencia de insuficiencia renal «oculta» en población diabética tipo 2

ObjetivoDeterminar la prevalencia de insuficiencia renal en diabéticos tipo 2 y comparar dos criterios de definición: el basado en la estimación del filtrado glomerular por la fórmula de Cockcroft-Gault corregida para la superficie corporal y el basado en la creatinina sérica.DiseñoEstudio descriptivo y transversal.EmplazamientoZona básica del Centro de Salud de El Cristo, Oviedo.ParticipantesLa totalidad de pacientes diabéticos tipo 2 diagnosticados de la zona básica.Mediciones principalesSe recogieron datos demográficos, clínicos, factores de riesgo y enfermedad cardiovascular. Se diagnosticó insuficiencia renal (IR) según unas cifras de creatinina plasmática ≥ 1,3 mg/dl en mujeres y ≥ 1,4 mg/dl en varones y según el filtrado glomerular (FG) estimado mediante la fórmula de Cockcroft-Gault: moderada para FG, 60-30 ml/min/1,73 m2; grave para FG, 29-15 ml/min/1,73 m2, y terminal para FG, < 15 ml/min/1,73 m2.ResultadosSe incluyó a 499 pacientes. El 52,3% era mujer con una edad de 69,7 ± 0,4 años. La prevalencia de IR según la creatinina sérica fue del 12%, y según la fórmula de Cockcroft-Gault del 40,5%. Los pacientes con FG reducido y creatinina normal tenían mayor edad (75,5 ± 7,9 frente a 65,4 ± 9,8 años; p < 0,001), predominaban las mujeres (76,3 frente a 41,7%; p < 0,001), tenían un menor índice de masa corporal (27,3 ± 3,7 frente a 30,9 ± 4,4), presentaban un peor control glucémico (HbA1c 7,1 ± 1,8 frente a 6,9 ± 1,9%; p = 0,007) y la prevalencia de insuficiencia cardíaca era superior (6,4 frente a 2,1%; IC del 95%, 1,1-8,8; p = 0,02) en comparación con los pacientes con FG y creatinina normales.ConclusiónLa estimación del FG por la fórmula de Cockcroft-Gault corregida para la superficie corporal muestra una insuficiencia renal no conocida en uno de cada 3 pacientes diabéticos tipo 2.ObjectiveTo determine the prevalence of renal failure (RF) in type-2 diabetics and to compare two criteria of definition: that based on the calculation of glomerular filtration by the Cockcroft-Gault formula corrected for body surface area and that based on serous creatinine.DesignCross-sectional, descriptive study.SettingEl Cristo Health Centre,Oviedo, north of Spain.ParticipantsAll patients in the catchment area diagnosed with type-2 diabetes.MethodDemographic, clinical, risk factor, and cardiovascular pathology details were gathered. Renal failure was diagnosed on figures of plasma creatinine ≥1.3 mg/dL in women and ≥1.4 mg/dL in men, and glomerular filtration (GF) calculated by means of the Cockcroft-Gault formula: moderate GF, 60-30 mL/min/1.73 m2; severe GF, 29-15 mL/min/1.73 m2, and terminal GF: <15 mL/min/1.73 m2.Results499 patients were included. 52.3% were women, aged 69.7±10.4 years old. Prevalence of RF by serous creatinine was 12%; and by the Cockcroft-Gault formula, 40.5%. Patients with lower glomerular filtration and normal creatinine were older (75.5±7.9 vs 65.4±9.8; P<.001), mainly female (76.3% vs 41.7%; P<.001), had lower BMI (27.3±3.7 vs 30.9±4.4) and had worse glucaemia control (HbA1c 7.1±1.8% vs 6.9±1.9%; P=.007) and higher indices of cardiac failure (6.4% vs 2.1%; 95% CI, 1.1- 8.8; P=.02) than patients with normal glomerular filtration and creatinine.ConclusionCalculation of glomerular filtration by the Cockcroft-Gault formula corrected for body surface area revealed unknown renal failure in 1 in 3 type-2 diabetes patients

Chronic kidney disease in the type 2 diabetic patients: prevalence and associated variables in a random sample of 2642 patients of a Mediterranean area

Background: Kidney disease is associated with an increased total mortality and cardiovascular morbimortality in the general population and in patients with Type 2 diabetes. The aim of this study is to determine the prevalence of kidney disease and different types of renal disease in patients with type 2 diabetes (T2DM). Methods: Cross-sectional study in a random sample of 2,642 T2DM patients cared for in primary care during 2007. Studied variables: demographic and clinical characteristics, pharmacological treatments and T2DM complications (diabetic foot, retinopathy, coronary heart disease and stroke). Variables of renal function were defined as follows: 1) Microalbuminuria: albumin excretion rate & 30 mg/g or 3.5 mg/mmol, 2) Macroalbuminuria: albumin excretion rate & 300 mg/g or 35 mg/mmol, 3) Kidney disease (KD): glomerular filtration rate according to Modification of Diet in Renal Disease < 60 ml/min/1.73 m2 and/or the presence of albuminuria, 4) Renal impairment (RI): glomerular filtration rate < 60 ml/min/1.73 m2, 5) Nonalbuminuric RI: glomerular filtration rate < 60 ml/min/1.73 m2 without albuminuria and, 5) Diabetic nephropathy (DN): macroalbuminuria or microalbuminuria plus diabetic retinopathy. Results: The prevalence of different types of renal disease in patients was: 34.1% KD, 22.9% RI, 19.5% albuminuria and 16.4% diabetic nephropathy (DN). The prevalence of albuminuria without RI (13.5%) and nonalbuminuric RI (14.7%) was similar. After adjusting per age, BMI, cholesterol, blood pressure and macrovascular disease, RI was significantly associated with the female gender (OR 2.20; CI 95% 1.86-2.59), microvascular disease (OR 2.14; CI 95% 1.8-2.54) and insulin treatment (OR 1.82; CI 95% 1.39-2.38), and inversely associated with HbA1c (OR 0.85 for every 1% increase; CI 95% 0.80-0.91). Albuminuria without RI was inversely associated with the female gender (OR 0.27; CI 95% 0.21-0.35), duration of diabetes (OR 0.94 per year; CI 95% 0.91-0.97) and directly associated with HbA1c (OR 1.19 for every 1% increase; CI 95% 1.09-1.3). Conclusions: One-third of the sample population in this study has KD. The presence or absence of albuminuria identifies two subgroups with different characteristics related to gender, the duration of diabetes and metabolic status of the patient. It is important to determine both albuminuria and GFR estimation to diagnose KD

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Tolerabilidad y efectividad de almotriptán en atención primaria

ObjetivoEvaluar la tolerabilidad y efectividad de almotriptán en atención primaria.DiseñoEstudio observacional postautorización, multicéntrico, prospectivo, de cohorte única, con un período de seguimiento de 3 meses.EmplazamientoUn total de 640 médicos de atención primaria en España.ParticipantesSe incluyó a 2.074 pacientes con diagnóstico de migraña (criterios IHS) con datos de 4.183 ataques de migraña.IntervencionesUn único grupo de tratamiento con almotriptán.Mediciones principalesPara cada ataque se evaluaron el alivio y la remisión completa del dolor a las 2 h, la percepción subjetiva de alivio a los 30 y 60 min, la recurrencia del dolor y la respuesta completa a las 24 h y, finalmente, uso de remedicación y de medicación de rescate.ResultadosSe incluyó a 2.074 pacientes reclutados entre enero y octubre del año 2001 por 640 médicos de atención primaria en España. Se excluyó a 190 (9,2%) de todos los análisis, la mayoría por ausencia de información de las crisis de migraña presentadas (4,6%) o por disponer únicamente de datos de la visita basal (3,8%). El análisis de seguridad se llevó a cabo a partir de la muestra de 1.884 pacientes valorables que presentaron 4.183 ataques (media±desviación estándar [DE], 3,1±2 ataques/paciente). De estos pacientes, 302 (16,0%) interrumpieron el tratamiento antes de finalizar los 3 meses de seguimiento. En relación con la tolerabilidad, se registraron 21 pacientes con reacciones adversas (1,11%), la mayoría gastrointestinales, ninguna considerada grave. El análisis de efectividad por intención de tratar (ITT) se llevó a cabo a partir de los resultados de 1.287 pacientes valorables que presentaron 3.952 ataques, muestra obtenida tras excluirse, además de los 190 pacientes ya mencionados, otros sin al menos una medida de la variable principal de efectividad. En la tabla 1 se presentan las principales evaluaciones de efectividad observadas en los 3.450 ataques tratados con una dosis inicial de 12,5 mg de almotriptán.Discusión y conclusionesLos resultados del uso de almotriptán en condiciones de práctica clínica habitual en atención primaria superan los obtenidos en ensayos clínicos1-5 y en estudios observacionales efectuados en consultas de neurología6, y señalan que almotriptán 12,5 mg es una opción terapéutica de elección para el tratamiento sintomático de los ataques de migraña por su buena efectividad y su excelente perfil de tolerabilidad.Financiación del trabajo. Este estudio ha sido financiado por Almirall Prodesfarma S.A., Barcelona. España