Prevalence, risk factors and evolution of diabetes mellitus after treatment in primary aldosteronism. Results from the SPAIN-ALDO registry.

PURPOSE: To evaluate the prevalence, risk factors and evolution of diabetes mellitus (DM) after targeted treatment in patients with primary aldosteronism (PA). METHODS: A retrospective multicenter study of PA patients in follow-up at 27 Spanish tertiary hospitals (SPAIN-ALDO Register). RESULTS: Overall, 646 patients with PA were included. At diagnosis, 21.2% (n = 137) had DM and 67% of them had HbA1c levels < 7%. In multivariate analysis, family history of DM (OR 4.00 [1.68-9.53]), the coexistence of dyslipidemia (OR 3.57 [1.51-8.43]) and advanced age (OR 1.04 per year of increase [1.00-1.09]) were identified as independent predictive factors of DM. Diabetic patients were on beta blockers (46.7% (n = 64) vs. 27.5% (n = 140), P < 0.001) and diuretics (51.1% (n = 70) vs. 33.2% (n = 169), p < 0.001) more frequently than non-diabetics. After a median follow-up of 22 months [IQR 7.5-63.0], 6.9% of patients developed DM, with no difference between those undergoing adrenalectomy and those treated medically (HR 1.07 [0.49-2.36], p = 0.866). There was also no significant difference in the evolution of glycemic control between DM patients who underwent surgery and those medically treated (p > 0.05). CONCLUSION: DM affects about one quarter of patients with PA and the risk factors for its development are common to those of the general population. Medical and surgical treatment provides similar benefit in glycemic control in patients with PA and DM.

Detección de nefrotóxicos y ajuste de dosis en pacientes con filtrado glomerular bajo realizado en farmacia comunitaria: metodología / Detection of nephrotoxicants and dose adjustment in patients with low glomerular filtration rate performed in community pharmacy: methodology

La enfermedad renal crónica es un problema prevalente y sin tratamiento específico. La detección tem prana es importante, siendo el Filtrado Glomerular estimado (FGe) una prueba muy asequible que puede realizarse en farmacia comunitaria. Si se presenta, es muy importante no dañar más el riñón evitando el uso de medicamentos nefrotóxicos y ajustar las dosis de otros medicamentos de eliminación renal, y la farmacia comunitaria está muy bien posicionada para ello. Objetivo: describir la metodología utilizada para detectar nefrotóxicos y ajustar dosis de otros medica mentos en farmacia comunitaria para su posterior derivación a atención primaria. Método: estudio experimental de seguimiento no controlado multicéntrico realizado en farmacias comunitarias de 4 comunidades autónomas de España. Se incluyen pacientes que cumplen criterios de inclusión y firman el consentimiento informado. Se estudian aquellos con FGe<60 ml/min/1,73m2 y se analiza su medicación utilizando el BOT Plus y otras 4 fuentes de información. Resultado: se incluyen 670 pacientes, 215 de ellos con FGe<60ml/min/1,73m2. De ellos 90 (41,9 %) necesitaron algún tipo de ajuste a juicio del farmacéutico. De estos 90 el 43,3 % (39) tuvieron algún tipo de cambio posteriormente a la intervención del farmacéutico. Conclusión: en pacientes con filtrado glomerular bajo, con la metodología adecuada, el farmacéutico comunitario es capaz de detectar la utilización de medicamentos nefrotóxicos o la utilización de medicamentos a dosis superiores a las recomendadas en función de su estado renal. Detección de nefrotóxicos y ajuste de dosis en pacientes con filtrado glomerular bajo realizado en farmacia comunitaria: metodología (AU)

Chronic kidney disease is a prevalent problem without specific treatment. Early detection is important and estimated glomerular filtration rate (eGFR) is a very affordable test that can be performed in community pharmacies. If present, it is very important not to further damage the kidney by avoiding the use of neph rotoxic drugs and adjusting the doses of other renal elimination drugs and the community pharmacy is very well positioned to do this. Objective: To describe the methodology used to detect nephrotoxic drugs and adjust doses of other drugs in community pharmacies for subsequent referral to primary care. Method: Multicentre experimental multicentre uncontrolled follow-up study carried out in communi ty pharmacies in 4 autonomous communities in Spain. Patients who met the inclusion criteria and signed the informed consent form were included. Those with eGFR <60 ml/min/1.73m2 were studied and their medication was analysed using the BOT Plus and 4 other sources of information. Result: 670 patients were included, 215 of them with eGFR<60ml/min/1.73m2. Of these 90 (41.9%) needed some type of adjustment in the pharmacist’s judgement. Of these 90, 43.3% (39) had some kind of change after the pharmacist’s intervention C onclusion: In patients with low glomerular filtration rate, with the appropriate methodology, the community pharmacist is able to detect the use of nephrotoxic drugs or the use of drugs at doses higher than those recommended according to their renal status (AU)

Use of basiliximab induction in low-immunological risk renal transplant recipients receiving tacrolimus-based immunosuppression.

Basiliximab induction treatment has been shown to reduce the incidence of acute rejection episodes without the secondary side effects observed with antilymphocyte polyclonal antibodies. We analyzed our experience with basiliximab induction associated with tacrolimus-based immunosuppression among low-immunological risk renal transplant recipients. We retrospectively analyzed 55 renal transplantation patients of low inmunological risk who received organs from donors younger than 55 years. We compared a group of 21 patients (38.9%; group 1) treated with basiliximab (Simulect, Novartis, Basel, Switzerland) with 33 patients (61.1%; group 2) without induction. The patient groups did not differ in recipient age (46.39 +/- 11.1 in group 1 vs 41.82 +/- 11.02 years in group 2; P = .25), donor age (36.71 +/- 14.72 vs 35.09 +/- 14.63 years; P = .69), or recipient and donor gender. No differences were observed in dose or tacrolimus levels during follow-up. The incidences of delayed graft function (DGF; 28.6% vs 28.1%; P = .97) and of acute rejection episodes (9.5% vs 15.6%; P = .52) were similar in both groups. Serum creatinine and proteinuria levels (P > .05) and hospital admissions due to infections (36.4 vs 35.7%; P = .97) were also similar in both groups. At 1 year graft survival rates were 92% and 96% (P = .97) in groups 1 and 2, respectively. Considering our findings and the costs of basiliximab treatment, we conclude that routine administration of basiliximab cannot be justified in young, low-immunological risk transplant recipients undergoing tacrolimus-based immunosuppression.

[Analysis of variability in determining intact parathyroid hormone (iPTH) according to the method used to process the sample]. / Análisis de la variabilidad en la determinación de la hormona paratiroidea (PTH-i) según el método empleado para procesar la muestra.

BACKGROUND: The measurement of i-PTH circulating is not easy due to its analytical variablity. Variability that appears in the process that goes from the sample collection to the final result determination. There are several important aspects that can influence within the pre-test variability: type of sample (serum o plasma), temperature, time elapses from blood extraction to freezing and from freezing to i-PTH quantification. Blood coming from centres far from our laboratory do not always meet the required processing conditions. Our aim was to study the stability of i-PTH with varying conditions of temperature and time until freezing in patients with chronic kidney disease (CKD). METHODS: We have analyzed 294 blood samples of 49 patients with chronic kidney disease (18 transplantated patients (36.7%) and 31 patients in haemodyalisis (63.3%)). The blood samples were collected using tubes treated with ethylenediaminotetraacetic acid (EDTA); these samples were subjected to different conditions of temperature and time before they were frozen, constituting 6 groups: blood centrifuged and plasma immediately frozen (group A or reference group); blood maintained 1 hour at room temperature and plasma stored at 2-8 masculineC during 0, 8 and 24 hours (groups B,C,D); blood maintained 3 hours at room temperature and plasma stored at 2-8 masculineC during 0 and 8 hours (groups E,F). The intact PTH (i-PTH) was measured using the immunoradiometric assay (IRMA Total Intact Scantibodies assay). We have analyzed the differences between the PTH-i mean values in the referenced groud and the others. We have applied the tests of homogeneity variance and normality and we have perform a comparation by pairs with the t-test including the Bonferroni correction. RESULTS: The mean value of intact-PTH in the referente Group was 202.5+/-199.72 pg/ml. The means values of intact-PTH in the other groups were 196 +/- 203.23 pg/ml, 202.8 +/- 200.2 pg/ml, 200.06 +/- 194.87 pg/ml, 204.08 +/- 204.073 pg/ml, 197.94 +/- 182.31 pg/ml. The results were practically identical for each group. We did not find important differences with respect to the reference group (p = 0.87, p = 0,99, p = 0,95, p = 0,96, p = 0,90 when comparing with groups 2a, 2b, 2c, 3a y 3b). CONCLUSIONS: The use of EDTA maintain the PTH stability during a longer period without the necessity of freezing the samples immediately. These results can help to state strategies to management the samples in patients with ERC.

Analysis of variability in determining intact parathyroid hormone (iPTH) according to the method used to process the sample

Background: The measurement of i-PTH circulating is not easy due to its analytical variablity. Variability that appears in the process that goes from the sample collection to the final result determination. There are several important aspects that can influence within the pre-test variability: type of sample (serum o plasma),temperature, time elapses from blood extraction to freezing and from freezing to i-PTH quantification. Blood coming from centres far from our laboratory do not always meet the required processing conditions. Our aim was to study the stability of i-PTH with varying conditions of temperature and time until freezing in patients with chronic kidney disease (CKD). Method: We have analyzed294 blood samples of 49 patients with chronic kidney disease (18 transplantated patients (36.7%) and 31 patients in haemodyalisis (63.3%)). The blood samples were collected using tubes treated with ethylenediamino tetraacetic acid(EDTA); these samples were subjected to different conditions of temperature and time before they were frozen, constituting 6 groups: blood centrifuged and plasma immediately frozen (group A or reference group);blood maintained 1 hour at room temperature and (..) (AU)

Background: The measurement of i-PTH circulating is not easy due to its analytical variablity. Variability that appears in the process that goes from the sample collection to the final result determination. There are several important aspects that can influence within the pre-test variability: type of sample (serum o plasma), temperature, time elapses from blood extraction to freezing and from freezing to i-PTH quantification. Blood coming from centres far from our laboratory do not always meet the required processing conditions. Our aim was to study the stability of i-PTH with varying conditions of temperature and time until freezing in patients with chronic kidney disease (CKD). Method: We have analyzed 294 blood samples of 49 patients with chronic kidney disease (18 transplantated patients (36.7%) and 31 patients in haemodyalisis (63.3%)). The blood samples were collected using tubes treated with ethylenediaminotetraacetic acid (EDTA); these samples were subjected to different conditions of temperature and time before they were frozen, constituting 6 groups: blood centrifuged and plasma immediately frozen (group A or reference group); blood maintained 1 hour at room temperature and plasma stored at 2-8 ºC during 0, 8 and 24 hours (groups B,C,D); blood maintained 3 hours at room temperature and plasma stored at 2-8 ºC during 0 and 8 hours (groups E,F). The intact PTH (i-PTH) was measured using the immunoradiometric assay (IRMA Total Intact Scantibodies assay). We have analyzed the differences between the PTH-i mean values in the referenced groud and the others. We have applied the tests of homogeneity variance and normality and we have perform a comparation by pairs with the t-test including the Bonferroni correction. Results: The mean value of intact- PTH in the referente Group was 202.5±199.72 pg/ml. The means values of intact-PTH in the other groups were 196 ± 203.23 pg/ml, 202.8 ± 200.2 pg/ml, 200.06 ± 194.87 pg/ml, 204.08 ± 204.073 pg/ml, 197.94 ± 182.31 pg/ml. The results were practically identical for each group. We did not find important differences with respect to the reference group (p = 0.87, p = 0,99, p = 0,95, p = 0,96, p = 0,90 when comparing with groups 2a, 2b, 2c, 3a y 3b). Conclusions: The use of EDTA maintain the PTH stability during a longer period without the necessity of freezing the samples immediately. These results can help to state strategies to management the samples in patients with ERC (AU)

Introducción: Las alteraciones del metabolismo óseo-mineral presentan una alta prevalencia en los pacientes con enfermedad renal crónica (ERC), siendo mayor conforme avanza el estadio de enfermedad. El diagnóstico de dichas alteraciones se basa fundamentalmente en la determinación de niveles de hormona paratiroide (PTH-i). Sin embargo, la determinación de esta hormona no es sencilla y está sometida a gran variabilidad. Los métodos para procesar las muestras de PTH-i no están estandarizados, hecho que podría ser una fuente importante de variabilidad preanalítica. Objetivo: Analizar la variabilidad en los resultados de la determinación de la PTH-i comparando distintas formas de procesar la misma muestra de plasma tratado conácido etilendiaminotetraacético (EDTA) en pacientes con ERC. Material y métodos: Se han analizado 294 muestras, correspondientes a 49 pacientes con ERC, 18 procedentes de la Consulta de Trasplante Renal (36,7%) y 31 del programa de Hemodiálisis Crónica de nuestro Centro (63,3%). Se ha procesado la misma muestra de cada uno de nuestros pacientes de seis maneras distintas, comparando las medias entre el grupo de referencia o gold standard y los otros grupos a estudio. Las muestras se procesaron con diferentes condiciones de temperatura y tiempo antes de ser congeladas, constituyendo seis grupos: centrifugación y congelación inmediata (grupo 1, de referencia); muestra a temperatura ambiente una hora, centrifugación y mantenimiento en nevera (2-8 ºC) durante 0, 8 o 24 horas (grupos 2 A, 2B y 2C, respectivamente); mantenimiento de sangre a temperatura ambiente 3 horas, mantenimiento en nevera (2-8 ºC) durante 0 y 8 horas (grupos 3A y 3B). La PTH-i se ha determinado mediante Inmunoradiometria (IRMA Total Intact Scantibodies assay). Se ha realizado el test de homogeneidad de varianzas y normalidad, y depués comparaciones por pares con el t-test con la corrección de Bonferroni. Resultados: La PTH-intacta media en el grupo de referencia fue 202,5 ± 199,72 pg/ml. Las medias de PTH-intacta en distintos grupos analizados fueron 196 ± 203,23 pg/ml, 202,8 ± 200,2 pg/ml, 200,06 ± 194,87 pg/ml, 204,08 ± 204,073 pg/ml, 197,94 ± 182,31 pg/ml. Los resultados fueron prácticamente superponibles, no encontrando diferencias significativas respecto al grupo de referencia (p = 0,87, p = 0,99, p = 0,95, p = 0,96, p = 0,90 al comparar con grupos 2A, 2B, 2C, 3A y 3B, respectivamente). Conclusiones: La utilización de EDTA como conservante en el procesamiento de las muestras analíticas para la determinación sanguínea de PTH-i permite un mayor tiempo de procesamiento de la misma, sin la exigencia de su congelación inmediata, mostrando una mínima variabilidad en los resultados obtenidos según diferentes formas de procesamiento. Estos resultados pueden ayudar a establecer estrategias logísticas para el procesamiento de muestras sanguíneas en los pacientes con ERC (AU)

Induction treatment with low-dose thymoglobulin or basiliximab in renal transplants from older donors.

Transplantation of kidneys from older donors is followed by an increase in delayed graft function (DGF) and acute rejection episodes (ARE). In these circumstances, induction treatment, whether with antithymocyte globulin or with interleukin-2 receptor blockers, may delay the introduction of calcineurin inhibitors (CNI) with effective prevention of ARE. We examined the efficacy and safety of induction treatment with 2 low doses of thymoglobulin compared with 2 doses of basiliximab. A group of 27 patients were treated with thymoglobulin and another 36 with basiliximab. CNI introduction was delayed until day 3 posttransplantation. The thymoglobulin group received 2 doses of 1.25 mg/kg on alternate days and the basiliximab group 2 doses of 20 mg. A trend to a lower incidence of DGF was observed in the thymoglobulin group (33% vs 55.6%; P = .08), with lower levels of serum creatinine on days 7 (P = .02) and 14 (P = .02) posttransplantation. No patient in the thymoglobulin group experienced ARE, but 11 patients (30.6%) in the basiliximab group did (P < .001), and 5 needed rescue treatment with thymoglobulin. We found no differences in the incidence of cytomegalovirus (CMV) disease (P = .945), admission due to infections (P = .274), or neoplasia (P = .340), or differences in graft (P = .69) and patient (P = .21) survivals at 1 and 3 years. Low-dose thymoglobulin was more effective at preventing DGF and ARE in renal transplant recipients of organs from older donors, with no differences in infectious complications or graft and patient survivals.