Are the Chicago 3.0 manometric diagnostics consistent with Chicago 4.0?

There is little information on the degree of concordance between the results obtained using the Chicago 3.0 (CCv3.0) and Chicago 4.0 (CCv4.0) protocols to interpret high-resolution manometry (HRM) seeking to determine the value provided by the new swallowing maneuvers included in the last protocol. This is a study of diagnostic tests, evaluating concordance by consistency between the results obtained by the CCv3.0 and CCv4.0 protocols, in patients undergoing HRM. Concordance was assessed with the kappa test. Bland-Altman scatter plots, and Lin's correlation-concordance coefficient (CCC) were used to assess the agreement between IRP measured with swallows in the supine and seated position or with solid swallows. One hundred thirty-two patients were included (65% women, age 53 ± 17 years). The most frequent HRM indication was dysphagia (46.1%). Type I was the most common type of gastroesophageal junction. The most frequent CCv4.0 diagnoses were normal esophageal motility (68.9%), achalasia (15.5%), and ineffective esophageal motility (IEM; 5.3%). The agreement between the results was substantial (Kappa 0.77 ± 0.05), with a total agreement of 87.9%. Diagnostic reclassification occurred in 12.1%, from IEM in CCv3.0 to normal esophageal motility in CCv4.0. Similarly, there was a high level of agreement between the IRP measured in the supine compared to the seated position (CCC0.92) and with solid swallows (CCC0.96). In conclusion, the CCv4.0 protocol presents a high concordance compared to CCv3.0. In the majority of manometric diagnoses there is no reclassification of patients with provocation tests. However, the more restrictive criteria of CCv4.0 achieve a better reclassification of patients with IEM.

Factors associated with in-hospital and outpatient survival of patients with different types of stage IV cancer and venous thromboembolism.

OBJECTIVE: To identify factors associated with in-hospital and outpatient survival of patients with different types of stage IV cancer who present with venous thromboembolic disease (VTE). METHODS: In this prospective cohort, in-hospital and outpatient survival rates up to 180 days were analyzed using Kaplan-Meier curves. Cox regression was used to identify factors associated with different survival functions. RESULTS: One hundred patients were analyzed (median age, 67.5 years; 75% with Charlson index of <10; 69% with Eastern Cooperative Oncology Group (ECOG) score of 3-4). In-hospital mortality was 18%, and the median time from admission to death was 11 days (interquartile range, 1-61 days). Factors significantly associated with in-hospital mortality were the ECOG score and thrombocytopenia. The 180-day mortality rate was 52%, with deaths mainly occurring in the first 90 days since VTE diagnosis. Additional factors significantly associated with outpatient mortality included male sex and neoplasms with a high risk of thrombosis (lung, pancreas, stomach, uterus, bladder, and kidney neoplasms). CONCLUSION: Patients with stage IV cancer and acute VTE have short survival. Poor prognostic factors are thrombocytopenia, the ECOG score, and certain types of cancer. These results may help physicians individualize decisions regarding initiation and continuation of anticoagulant therapy.

Factors associated with different patterns of weight change after bariatric surgery: A longitudinal study.

Background: The mean weight loss (WL) after successful bariatric surgery is approximately one third of the initial body weight, which is mainly achieved between the first 2 years of follow-up. However, 15%-35% of patients do not achieve a significant percentage of total WL (%TWL). Information on factors associated with a higher or lower WL after bariatric surgery is limited. This study aimed to assess the change in %TWL and describe the factors associated with greater or lesser WL over time. Methods: This prospective longitudinal study included patients treated with laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. Baseline data were recorded before surgery. Follow-up was performed at 3 (n = 141), 6 (n = 208), 9 (n = 115), 12 (n = 216), 24 (n = 166), and 36 months (n = 99). Generalized estimating equation analysis was performed to assess the changes in %TWL over time and factors associated with different patterns of WL. Results: In total, 231 patients were included (women, 82.2%; basal body mass index (BMI) 41.4 ± 5.1 kg/m2). The tendencies to increase %TWL (32 ± 6.5) were evident in the first year and stabilized thereafter. Sustained nutritionist follow-up (2.3%, p = 0.004), baseline BMI >40 kg/m2 (0.4%, p < 0.001), and WL ≥ 10 kg before surgery (0.3%, p = 0.001) were associated with a higher %TWL. Patients who performed physical activity >30 min/day after surgery reduced their %TWL by 0.6% (p = 0.002). Conclusions: Modifiable factors such as nutritional monitoring and WL before surgery are associated with a significant increase in %TWL over time. Basal BMI was associated with a significant decrease in %TWL.

A Comparative Study on Graft and Overall Survival Rates Between Diabetic and Nondiabetic Kidney Transplant Patients Through Survival Analysis.

Background: Patients with diabetes mellitus (DM) have worse graft and overall survival, but recent evidence suggests that the difference is no longer significant. Objective: To compare the outcomes between patients with end-stage kidney disease due to DM (ESKD-DM) and ESKD due to nondiabetic etiology (ESKD-non-DM) who underwent kidney transplantation (KT) up to 10 years of follow-up. Design: Survival analysis of a retrospective cohort. Setting and Patients: All patients who underwent KT at the Hospital Universitario San Ignacio, Colombia, between 2004 and 2022. Measurements: Overall and graft survival in ESKD-DM and ESKD-non-DM who received KT. Patients who died with functional graft were censored for the calculation of kidney graft survival. Methods: Log-rank test, Cox proportional hazards model, and competing risk analysis were used to compare overall and graft survival in patients with ESKD-DM and ESKD-non-DM who underwent KT. Results: A total of 375 patients were included: 60 (16%) with ESKD-DM and 315 (84%) with ESKD-non-DM. Median follow-up was 83.3 months. Overall survival was lower in patients with ESKD-DM at 5 (75.0% vs 90.8%, P < .001) and 10 years (55.0% vs 86.7%, P < .001). Cardiovascular death was higher in patients with diabetes (27.3% vs 8.2%, P = .021). Death-censored graft survival was similar in both groups (96.7% vs 93.3% at 5 years, P = .324). On multivariate analysis, the factors associated with global survival were DM (hazard ratio [HR] = 2.11, 95% confidence interval [CI] = 1.23-3.60, P = .006), recipient age (HR = 1.05, 95% CI = 1.02-1.08, P < .001), delayed graft function (HR = 2.07, 95% CI = 1.24-3.46, P = .005), and donor age (HR = 1.03, 95% CI = 1.01-1.05, P = .002). In the competing risk analysis, DM was associated with mortality only in the cardiovascular death group (sub-hazard ratio [SHR] = 6.06, 95% CI = 1.01-36.4, P = .049). Limitations: Change in diabetes treatment received over time and adherence to glycemic targets were not considered. The sample size is relatively small, which limits the precision of our estimates. The Kidney Donor Profile Index and the occurrence of treated acute rejection were not included in the regression models. Conclusion: Overall survival is lower in patients with diabetes, possibly due to older age and cardiovascular comorbidities. Therefore, patients with diabetes should be followed more closely to control cardiovascular risk factors. However, there is no difference in graft survival.

Contexte: Les patients diabétiques (DB) sont ceux qui présentent les pires résultats de greffe et de survie globale, mais des données récentes suggèrent que la différence n'est désormais plus significative. Objectif: Comparer les résultats des patients atteints d'insuffisance rénale terminale causée par le DB (IRT-DB) et ceux des patients non-diabétiques (IRT-nonDB) pour une période de 10 ans après une transplantation rénale (TR). Conception: Analyse de la survie d'une cohorte rétrospective. Sujets et cadre de l'étude: Tous les patients qui ont subi une TR à l'Hôpital Universitario San Ignacio (Colombie) entre 2004 et 2022. Mesures: La survie globale et la survie du greffon chez les patients IRT-DB et IRT-nonDB après une TR. Les patients décédés avec un greffon fonctionnel ont été censurés pour le calcul de la survie du greffon. Méthodologie: Le test logarithmique par rangs, un modèle de régression à effet proportionnel de Cox et une analyse des risques concurrents ont été utilisés pour comparer la survie globale et la survie du greffon des patients atteints d'IRT-DB et d'IRT-nonDB après une TR. Résultats: Au total, 375 patients ont été inclus à l'étude, soit 60 patients (16 %) atteints d'IRT-DB et 315 (84 %) atteints d'IRT-nonDB. La durée médiane du suivi était de 83,3 mois. La survie globale était plus faible chez les patients atteints d'IRT-DB à 5 ans (75,0 c. 90,8 %; p<0,001) et à 10 ans (55,0 % c. 86,7 %; p<0,001). Les décès de causes cardiovasculaires ont été plus nombreux chez les patients diabétiques (27,3 % c. 8,2 %; p=0,021). La survie du greffon censurée pour le décès était similaire pour les deux groupes (96,7 % c. 93,3 % à 5 ans, p=0,324). Dans l'analyse multivariée, les facteurs associés à la survie globale étaient le DB (RR=2,11; IC95 : 1,23-3,60; p=0,006), l'âge du receveur (RR=1,05; IC95 : 1,02-1,08; p<0,001), le retard de fonction du greffon (RR = 2,07; IC95 : 1,24-3,46; p = 0,005) et l'âge du donneur (RR = 1,03; IC95 : 1,01-1,05; p=0,002). Dans l'analyse des risques concurrents, le DB a été associé à la mortalité uniquement dans le groupe de patients décédés de causes cardiovasculaires (RRS=6,06; IC95 : 1,01-36,4; p=0,049). Limites: Les modifications dans le traitement du diabète au fil du temps et l'observance des cibles glycémiques n'ont pas été prises en compte. La taille de l'échantillon est relativement faible, ce qui limite la précision des estimations. L'indice de profil du donneur (Kidney Donor Profile Index­KDPI) et la survenue d'un rejet aigu traité n'ont pas été inclus dans les modèles de régression. Conclusion: La survie globale est plus faible chez les patients diabétiques, peut-être en raison de l'âge avancé et des comorbidités cardiovasculaires de ces patients. Les patients diabétiques devraient par conséquent faire l'objet d'un suivi plus rapproché afin de surveiller les facteurs de risque cardiovasculaire. Aucune différence n'a cependant été observée pour la survie du greffon.

Serial measurements of lymphocytes, D-dimer, LDH, and CRP do not improve the ability to predict COVID-19 adverse outcomes.

OBJECTIVE: We evaluated the discriminatory ability of variations in lymphocyte, D-dimer, C-reactive protein (CRP), and lactate dehydrogenase (LDH) serum levels at 48 to 72 hours of hospitalization compared with baseline measurements to predict unfavorable clinical outcomes in patients with COVID-19. METHODS: We analyzed diagnostic test results based on a retrospective cohort to determine the ability of variations (gradients or ratios) in patients' lymphocyte, D-dimer, CRP, and LDH serum levels taken 48 to 72 hours after hospital admission to predict adverse outcomes such as death, mechanical ventilation, or intensive care unit (ICU) admission developing. RESULTS: Among 810 patients (56.1% men, age 61.6 ± 16.2 years), 37.5% had at least one adverse outcome; 28.2% required ICU admission, 26.5% required mechanical ventilation, and 19.4% died during hospitalization. In comparing baseline measurements with measurements at 48 to 72 hours, D-dimer, lymphocyte delta, LDH, and CRP had similar discriminatory ability (area under the receiver operating characteristic curve [AUC] 0.57 vs. 0.56, 0.53 vs. 0.57, 0.64 vs. 0.66, and 0.62 vs. 0.65, respectively). CONCLUSIONS: Measuring serum risk markers upon hospital admission can be used to evaluate risk of adverse outcomes in hospitalized patients with COVID-19. Repeating these measurements at 48 to 72 hours does not improve discriminatory ability.

Validation of the PESI Scale to Predict in-Hospital Mortality in Patients with Pulmonary Thromboembolism Secondary to SARS CoV - 2 Infection.

OBJECTIVE: To evaluate the discriminative ability and the calibration of the Pulmonary Embolism Severity Index (PESI) to predict in-hospital mortality in patients with Pulmonary Embolism (PE) secondary to COVID 19 in two hospitals in Bogotá. METHODS: External validation study of a prediction model based on a retrospective cohort of patients with PE secondary to COVID-19 treated at Hospital Universitario San Ignacio and Hospital universitario La Samaritana, between March 2020 and August 2021. Calibration of the scale was evaluated using the Hosmer-Lemeshow test and a calibration belt diagram. Discrimination ability was evaluated using a ROC curve. RESULTS: 272 patients were included (median age 61.5 years, male 58.8%). PE was diagnosed in 45.6% of the patients at the time of admission. Of the remaining 54.4%, 95.9% received thromboprophylaxis until the time of diagnosis.17.6% of the patients died. Regarding calibration, the scale systematically underestimates risk in all classes of PESI. For class I, the ratio of observed/expected events was 4.4 vs 0.8%, class II 4.8 vs 1.8%, class III 15.2 vs 4.2%, class IV 14.3 vs 5.9% and class V 46.7 vs 5.8%. The calibration test rejected the adequate calibration hypothesis (p < 0.001). The discriminatory ability was adequate (AUC = 0.7128, 95% CI 0.63-0.79). CONCLUSIONS: The PESI scale in patients with PE secondary to COVID 19 underestimates the risk of in-hospital mortality, while maintaining adequate discrimination. It is suggested not to use the PESI scale until it is recalibrated in this context.

Impact of sensor-augmented pump therapy with predictive low-glucose management on hypoglycemia and glycemic control in patients with type 1 diabetes mellitus: 1-year follow-up.

AIMS: To describe real-life experience with sensor-augmented pump therapy with predictive low-glucose management (SAPT-PLGM), in terms of hypoglycemia and glycemic control after one year of follow-up in T1D patients with hypoglycemia as the main indication of therapy. METHODS: Retrospective cohort study under real life conditions. Baseline and one-year follow-up variables of glycemic control, hypoglycemia and glycemic variability were compared. RESULTS: Fifty patients were included, 31 on prior treatment with SAPT with low-glucose suspend (LGS) feature and 19 on multiple dose insulin injections (MDI). Mean HbA1c decreased in the MDI group (8.24%-7.08%; p = 0.0001). HbA1c change was not significant in the SAPT-LGS group. Area under the curve (AUC) below 70 mg/dl improved in both SAPT-LGS and MDI groups while AUC, %time and events below 54 mg/dl decreased in SAPT-LGS group. Glycemic variability improved in the MDI group. Less patients presented severe hypoglycemia with SAPT-PLGM in both groups, however the change was non-significant. CONCLUSIONS: Under real life conditions, SAPT-PLGM reduced metrics of hypoglycemia in patients previously treaded with MDI and SAPT-LGS without deteriorating glycemic control in SAPT-LGS patients, while improving it in patients treated with MDI.

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes.

INTRODUCTION: Degludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV). METHODS: A prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis. RESULTS: 60 patients with basal bolus therapy and history of hypoglycemia were included. 18 patients had High GV (HGV). In this group a significant reduction of 11.1% of CV (95% CI: 6.3, 15.9, p = 0.01) was found. GEE analysis confirmed a higher impact over time on patients with HGV (p < 0.001). The percentage of patients with at least 1 episode of hypoglycemia decreased from 66.6% to 22.2% (p = 0.02) and from 37.14% to 5.71% (p < 0.01) for global and nocturnal hypoglycemia, respectively. Changes were not significant in patients with low GV. A reduction of A1c was observed in both groups (p < 0.001). CONCLUSIONS: The results suggest that treatment with IDeg reduces GV, A1c levels and the incidence of global and nocturnal hypoglycemia events in patients with HGV, but not in patients with low GV.

The different methods of assessing glycemic variability, quality of glycemic control and glycemic risk cannot be interpreted as equivalent in clinical practice.

OBJECTIVE: Several methods are available to calculate glycemic variability (GV), quality of glycemic control (QGC) and glycemic risk (GR). However, clinicians do not easily interpret these data. This study evaluates whether the results of the different methods can be interpreted as equivalent. METHODS: A prospective study was performed including outpatients with DMT2 evaluated at the San Ignacio Hospital and the Colombian Diabetes Association in Bogotá, Colombia. From six-day continuous glucose monitoring data, GV (SD, CV, IQR, MODD, MAGE), QGC (M-value, J-index) and GR (LBGI, HBGI) were calculated. Reference values ​​were generated, classifying the patients according to GV control quartiles (excellent, good, fair or poor). The concordance between the different indices was evaluated. RESULTS: In total, 140 patients (68.9 ±â€¯11.2 years) were included. The agreement levels (Kappa) between GV indices were moderate, 0.40 (CI 95%:0.29-0.51), 0.42 (CI 95%:0.31-0.53) and 0.39 (CI 95%:0.28-0.50), for CV versus SD, IQR and CONGA respectively. The levels of agreement between GV and QGC indices were minimal (Kappa CV vs. M-value, 0.15CI 95%:0.046-0.26) and weak between the GV and GR indices (Kappa CVvs.LBGI 0.37CI95%:0.26-0.48). The estimators did not improve significantly when the analysis was performed with linearly weighted or quadratic weighted Kappa. CONCLUSIONS: The present study demonstrates that the concordance between the clinical interpretation of the different GV, QGC and GR indices is poor, suggesting that they cannot be assumed as equivalent, so different indices evaluating different concepts, must be evaluated simultaneously to analyze adequately each patient. New studies are needed to evaluate which of the methods better predicts hypoglycemia and microvascular or macrovascular complications.

Different Indexes of Glycemic Variability as Identifiers of Patients with Risk of Hypoglycemia in Type 2 Diabetes Mellitus.

INTRODUCTION: Recent publications frequently introduce new indexes to measure glycemic variability (GV), quality of glycemic control, or glycemic risk; however, there is a lack of evidence supporting the use of one particular parameter, especially in clinical practice. METHODS: A cohort of type 2 diabetes mellitus (T2DM) patients in ambulatory care were followed using continuous glucose monitoring sensors (CGM). Mean glucose (MG), standard deviation, coefficient of variation (CV), interquartile range, CONGA1, 2, and 4, MAGE, M value, J index, high blood glucose index, and low blood glucose index (LBGI) were estimated. Hypoglycemia incidence (<54 mg/dl) was calculated. Area under the curve (AUC) was determined for different indexes as identifiers of patients with risk of hypoglycemia (IRH). Optimal cutoff thresholds were determined from analysis of the receiver operating characteristic curves. RESULTS: CGM data for 657 days from 140 T2DM patients (4.69 average days per patient) were analyzed. Hypoglycemia was present in 50 patients with 144 hypoglycemic events in total (incidence rate of 0.22 events per patient/day). In the multivariate analysis, both CV (OR 1.20, 95% CI 1.12-1.28, P < .001) and LBGI (OR 4.83, 95% CI 2.41-9.71, P < .001) were shown to have a statistically significant association with hypoglycemia. The highest AUC were for CV (0.84; 95% CI 0.77-0.91) and LBGI (0.95; 95% CI 0.92-0.98). The optimal cutoff threshold for CV as IRH was 34%, and 3.4 for LBGI. CONCLUSION: This analysis shows that CV can be recommended as the preferred parameter of GV to be used in clinical practice for T2DM patients. LBGI is the preferred IRH between glycemic risk indexes.

Impact of a Basal-Bolus Insulin Regimen on Metabolic Control and Risk of Hypoglycemia in Patients With Diabetes Undergoing Peritoneal Dialysis.

INTRODUCTION: Clinical interventional studies in diabetes mellitus usually exclude patients undergoing peritoneal dialysis (PD). This study evaluates the impact of an educational program and a basal-bolus insulin regimen on the blood glucose level control and risk of hypoglycemia in this population. METHODS: A before-and-after study was conducted in type 1 and type 2 DM patients undergoing PD at the Renal Therapy Services (RTS) clinic network, Bogota, Colombia. An intervention was instituted consisting of a three-month educational program and a basal-bolus detemir (Levemir, NovoNordisk) and aspart (Novorapid, NovoNordisk) insulin regimen. Prior to the intervention and at the end of treatment were conducted measures of HbA1c levels and continuous glucose monitoring (CGM). RESULTS: Forty-seven patients were recruited. Mean HbA1c level decreased from 8.41% ± 0.83 to 7.68% ± 1.32 (mean difference -0.739, 95% CI -0.419, -1.059; P < .0001). Of subjects, 52% achieved HbA1c levels <7.5% at the end of study. Mean blood glucose level reduced from 194.0 ± 42.5 to 172.9 ± 31.8 mg/dl ( P = .0015) measured by CGM. Significant differences were not observed in incidence of overall ( P = .7739), diurnal ( P = .3701), or nocturnal ( P = .5724) hypoglycemia episodes nor in area under the curve (AUC) <54 mg/dl ( P = .9528), but a reduction in AUC >180 ( P < .01) and AUC >250 ( P = .01) was evidenced for total, diurnal, and nocturnal episodes. CONCLUSIONS: An intervention consisting of an educational program and a basal-bolus insulin regimen in type 1 and type 2 diabetes mellitus patients undergoing PD caused a decrease in HbA1c levels, and mean blood glucose levels as measured from CGM with no significant increases in hypoglycemia episodes.

Relación entre los puntajes del índice de pendiente del segmento ST/frecuencia cardiaca y el índice del cambio del segmento ST sobre el cambio de la frecuencia cardiaca durante la realización de la prueba de esfuerzo convencional con la presentación de nuevos eventos cardiovasculares / Relationship of ST segment/heart rate slope index and ST segment change index scores on the heart rate change during conventional stress test with the presentation of new cardiovascular events

Resumen Introducción: La prueba de esfuerzo convencional es una herramienta diagnóstica de fácil interpretación y accesibilidad que se utiliza de forma frecuente en la evaluación del dolor torácico, no obstante, sus características operativas están influenciadas por múltiples variables resultando en una capacidad limitada para la predicción global de desenlaces cardiovasculares. El uso de los índices y las variables adicionales en su interpretación podrían mejorar la predicción de los desenlaces cardiovasculares. Métodos: Mediante la realización de un estudio descriptivo, analítico y retrospectivo, se evaluó la relación y capacidad de predicción de los índices pendiente ST/FC y ΔST/ΔFC con el desarrollo de eventos cardiovasculares a un año. De un total de 438 estudios, se seleccionaron 138 que cumplían con los criterios para evaluación. Se realizó un análisis descriptivo de las variables de interés y posteriormente se procedió a realizar un análisis univariado y multivariado de las diferentes variables y desenlaces de interés. Conclusiones: Se encontró una relación estadísticamente significativa entre la capacidad del ejercicio, el índice pendiente ST/FC y el desarrollo de los desenlaces cardiovasculares, sin encontrar relación significativa con el índice pendiente ΔST/ΔFC. Se observa discreta mejoría de la capacidad de predicción global de la prueba de esfuerzo convencional con la adición del índice pendiente ST/FC (AUC 0,70 a AUC 0,74). Relationship of ST segment/heart rate slope index and ST segment change index scores on the heart rate change during conventional stress test with the presentation of new cardiovascular events.

Abstract Introduction: Conventional stress test is a diagnostic tool easy to interpret and of easy Access frequently used in the assessment of chest pain; however, its operational characteristics are influenced by multiple variables, resulting in a limited ability for global prediction of cardiovascular outcomes. The use of indexes and additional variables in their interpretation could improve prediction of cardiovascular outcomes. Methods: By conducting a descriptive, analytical and retrospective study, the relationship and prediction ability of the slope ST/HR and ΔST/ΔHR indexes with the development of cardiovascular events were assessed at one year. Out of a total of 438 studies, 138 were selected that complied with the evaluation criteria. A descriptive analysis of the variables of interest was carried out, and later on a univariate and multivariate analysis of the different variables and outcomes of interest. Conclusions: A statistically significant relationship was found between exercise capacity, ST/HR slope index and the development of cardiovascular events, without findings of a significant relationship with the ΔST/ΔHR slope index. A discreet improvement of the global prediction capacity of the conventional stress test with the addition of the ST/HR slope index (AUC 0.70 to AUC 0.74) is observed.

Efecto de las resinas secuestradoras de ácidos biliares en los desenlaces cardiovasculares y en los niveles séricos de lípidos: A systematic review / Effect of bile acid sequestrants on cardiovascular outcomes and seric lipids

Antecedentes: Las guías internacionales recientes proponen el uso de estatinas como piedra angular del manejo de la dislipidemia en adultos. Sin embargo, no se ha definido con claridad el tratamiento de los pacientes con intolerancia o efectos adversos asociados con estas. Las resinas secuestradoras de ácidos biliares son una alternativa interesante, pese a que la evidencia que avala su uso no ha sido evaluada cuidadosamente. Métodos: Se realizó una búsqueda de la literatura en MEDLINE, Embase y en la Biblioteca Cochrane hasta junio de 2013, acerca de artículos publicados en inglés y español, identificando experimentos clínicos aleatorizados y estudios de cohortes que evaluaran el impacto de las resinas secuestradoras de ácidos biliares en mortalidad, eventos cardiovasculares, niveles de lípidos séricos y efectos adversos. Se presenta la información de forma descriptiva. Resultados: Se identificaron cuatro experimentos clínicos aleatorizados y un estudio de cohortes, que incluían 6.833 pacientes. Solo uno de los estudios evaluó el impacto en la mortalidad cardiovascular, evidenciando que no hay diferencia estadísticamente significativa en comparación con placebo (RR de 0,76; IC 95% 0,5:1,15), aunque se observó una reducción del 16% en la incidencia de infarto agudo de miocardio (RR 0,84; IC 95% 0,67:1,00). Tres estudios evaluaron cambios en las fracciones lipídicas, los cuales mostraron disminución moderada en los niveles de colesterol LDL, sin percibir diferencias clínicamente significativas en los niveles de colesterol HDL y triglicéridos. Conclusión: La evidencia que respalda el uso de resinas secuestradoras de ácidos biliares es limitada y no avala su empleo como terapia de primera línea en pacientes con dislipidemia; no obstante, son una alternativa en pacientes con efectos adversos o intolerancia al manejo con estatinas.

Background: Recent international guidelines have proposed statins as the corner stone of dyslipidemia management in adults. However it is not clear if they are best option for patients with statin related intolerance or what their adverse effects are. The bile acid sequestrants are an interesting alternative, however its evidence has not been carefully evaluated. Methods: A search was conducted on MEDLINE, Embase and Cochrane library databases for articles published up to June 2013, limited to Spanish and English language. Randomized clinical trials (RCT) and cohort studies evaluating the impact of bile acid sequestrants on mortality, cardiovascular outcomes, seric lipids and adverse effects were selected. Information was presented in a descriptive way. Results: Four RCT and one cohort study with aggregate data on 6833 people were included. Just one study evaluated cardiovascular mortality showing no statistically significant difference when compared with placebo, (RR 0.76; 95% CI 0.5:1.15), however there was a 16% reduction on acute myocardial infarction incidence. (RR 0.84; 95% IC 0.67: 1.00). Three studies evaluated seric lipids changes showing a moderate reduction in LDL levels without clinical significant differences on HDL and triglyceride levels. Conclusions: The evidence supporting bile acid sequestrants use is lacking and not conclusive to recommend its use as first-line therapy in dyslipidemic patients; however, these are an alternative option for patients with statin-related intolerance or adverse effects.

Precisión numérica y clínica de la monitorización continua de glucosa en pacientes colombianos en terapia con bomba de infusión de insulina con suspensión automática en hipoglucemia / Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia

OBJETIVO: La terapia con bomba de insulina asociada a monitorización continua de glucosa ha demostrado tener un impacto clínico positivo en el control de la diabetes y en la reducción de los episodios de hipoglucemia. Aunque existen descripciones del rendimiento del dispositivo en otras poblaciones, se desconoce su desempeño en Colombia y Latinoamérica en el contexto de la terapia ambulatoria usual. MÉTODOS: Se analizaron los registros de 33 pacientes con diabetes mellitus tipo 1 y 2 en terapia con monitorización continua de glucosa integrada al infusor de insulina con suspensión automática en hipoglucemia (MiniMed Paradigm® Veo™) utilizando el Sensor Sof-Sensor™ (Medtronic, Northridge, California) manejados en el Hospital Universitario San Ignacio (Bogotá, Colombia) y que venían recibiendo tratamiento ambulatorio. Se compararon datos simultáneos provenientes de glucometría capilar y monitorización continua de glucosa, calculando su validez por diferentes técnicas, incluyendo un análisis clínico utilizando la gradilla de error de Clarke. RESULTADOS: Basados en 2.262 datos pareados se encontró una media de la diferencia absoluta relativa para todas las mediciones del 20,1%, siendo mayor a 23% en las mediciones ≤75 mg/dl. El cumplimiento global de los criterios ISO fue de 64,9%, siendo mejor en las mediciones >75 mg/dl (68,3%, 1.308 de 1.916 lecturas), que en aquellas ≤ 75 mg/dl (49,4%, 171 de 346 lecturas). El porcentaje combinado en zonas A y B de la gradilla de error de Clarke fue del 91,77% (75,6% para hipoglucemia). CONCLUSIONES: Se observó un buen desempeño numérico para las determinaciones intersticiales en situaciones de normo- e hiperglucemia, persistiendo poca precisión en el rango de hipoglucemia. La precisión clínica del dispositivo es adecuada, sin comprometer de forma significativa la seguridad de los pacientes

OBJECTIVE: Insulin pump therapy associated with continuous glucose monitoring has shown a positive clinical impact on diabetes control and reduction of hypoglycemia episodes. There are descriptions of the performance of this device in other populations, but its precision and accuracy in Colombia and Latin America are unknown, especially in the routine outpatient setting. METHODS: Data from 33 type 1 and type 2 diabetes patients with sensor-augmented pump therapy with threshold suspend automation, MiniMed Paradigm® Veo™ (Medtronic, Northridge, California), managed at Hospital Universitario San Ignacio (Bogotá, Colombia) and receiving outpatient treatment, were analyzed. Simultaneous data from continuous glucose monitoring and capillary blood glucose were compared, and their precision and accuracy were calculating with different methods, including Clarke error grid RESULTS: Analyses included 2,262 continuous glucose monitoring -reference paired glucose values. A mean absolute relative difference of 20.1% was found for all measurements, with a value higher than 23% for glucose levels ≤75 mg/dL. Global compliance with the ISO criteria was 64.9%. It was higher for values >75 mg/dl (68.3%, 1,308 of 1,916 readings), than for those ≤ 75 mg/dl (49.4%, 171 of 346 readings). Clinical accuracy, as assessed by the Clarke error grid, showed that 91.77% of data were within the A and B zones (75.6% in hypoglycemia). CONCLUSIONS: A good numerical accuracy was found for continuous glucose monitoring in normo and hyperglycemia situations, with low precision in hypoglycemia. The clinical accuracy of the device was adequate, with no significant safety concerns for patients

Numerical and clinical precision of continuous glucose monitoring in Colombian patients treated with insulin infusion pump with automated suspension in hypoglycemia.

OBJECTIVE: Insulin pump therapy associated with continuous glucose monitoring has shown a positive clinical impact on diabetes control and reduction of hypoglycemia episodes. There are descriptions of the performance of this device in other populations, but its precision and accuracy in Colombia and Latin America are unknown, especially in the routine outpatient setting. METHODS: Data from 33 type 1 and type 2 diabetes patients with sensor-augmented pump therapy with threshold suspend automation, MiniMed Paradigm® Veo™ (Medtronic, Northridge, California), managed at Hospital Universitario San Ignacio (Bogotá, Colombia) and receiving outpatient treatment, were analyzed. Simultaneous data from continuous glucose monitoring and capillary blood glucose were compared, and their precision and accuracy were calculating with different methods, including Clarke error grid. RESULTS: Analyses included 2,262 continuous glucose monitoring -reference paired glucose values. A mean absolute relative difference of 20.1% was found for all measurements, with a value higher than 23% for glucose levels ≤75mg/dL. Global compliance with the ISO criteria was 64.9%. It was higher for values >75mg/dl (68.3%, 1,308 of 1,916 readings), than for those ≤ 75mg/dl (49.4%, 171 of 346 readings). Clinical accuracy, as assessed by the Clarke error grid, showed that 91.77% of data were within the A and B zones (75.6% in hypoglycemia). CONCLUSIONS: A good numerical accuracy was found for continuous glucose monitoring in normo and hyperglycemia situations, with low precision in hypoglycemia. The clinical accuracy of the device was adequate, with no significant safety concerns for patients.

Guía de práctica clínica para la prevención, detección temprana, diagnóstico, tratamiento y seguimiento de las dislipidemias: evaluación del riesgo cardiovascular / Clinical practice guidelines for the prevention, early detection, diagnosis, treatment and follow up of dyslipidemia: cardiovascular risk assessment

Objetivo: El tratamiento de la dislipidemia debe ser acorde con el riesgo individual de cada paciente. Existen múltiples ecuaciones de predicción de riesgo cardiovascular, sin embargo, es necesario determinar cuál es la más adecuada para ser utilizada en la población colombiana. Métodos: La alianza CINETS, comisionada por el Ministerio de la Protección Social y Colciencias, revisó la evidencia disponible con respecto a qué métodos de evaluación de riesgo cardiovascular son válidos en la población colombiana. Se generaron recomendaciones utilizando la metodología GRADE. Población: Población adulta con diagnóstico de dislipidemia o en riesgo de desarrollarla. Recomendaciones: En la población de prevención primaria o sin enfermedad cardiovascular clínicamente manifiesta se recomienda utilizar la escala de Framingham recalibrada para Colombia para clasificar el riesgo (Recomendación fuerte a favor de la intervención). Existen personas con condiciones que por sí mismas implican un riesgo mayor y ameritan manejo farmacológico directo.

Aim: The treatment of dyslipidemia must be related with patient's individual risk. There are multiple functions for predicting cardiovascular risk; however, it is necessary to determine the most appropriate for being used in Colombian population. Methods: The CINETS alliance, endorsed by the Colombian Social Protection Ministry and Colciencias, reviewed the evidence available about the validity of cardiovascular risk evaluation methods in Colombian Population. Recommendations were generated using GRADE methodology. Population: General adult population with or at risk of dyslipidemia. Recommendations In primary prevention population, or without clinically evident cardiovascular disease, Framingham risk function recalibrated for Colombia must be used to calculate cardiovascular risk (Strong recommendation). In patients with an especial condition increasing cardiovascular risk, direct pharmacologic treatment must be used.

Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen.

BACKGROUND: Continuous glucose monitoring (CGM) may improve the management of patients with type 2 diabetes hospitalized in the general ward by facilitating the detection of hyper- and hypoglycemic episodes. However, the lack of data on the accuracy and safety of CGM have limited its application. METHODS: A prospective pilot study was conducted including 38 patients hospitalized in the general ward with a known diagnosis of type 2 diabetes mellitus (DM) and hyperglycemic individuals without a history of DM with a blood sugar of 140-400 mg on admission treated with a basal bolus insulin regimen. Inpatient glycemic control and the incidence of hypoglycemic episodes were compared between detection by CGM of interstitial fluid for up to 6 days and point-of-care (POC) capillary blood glucose monitoring performed pre- and postprandially, before bedtime and at 3 am. RESULTS: No differences in average daily glucose levels were observed between CGM and POC (176.2 ± 33.9 vs 176.6 ± 33.7 mg/dl, P = .828). However, CGM detected a higher number of hypoglycemic episodes than POC (55 vs 12, P < .01). Glucose measurements were clinically valid, with 91.9% of patients falling within the Clarke error grid A and B zones. CONCLUSIONS: Our preliminary results indicate that the use of CGM in type 2 patients hospitalized in the general ward provides accurate estimation of blood sugar levels and is more effective than POC for the detection of hypoglycemic episodes and asymptomatic hypoglycemia.

Validación de la escala CRUSADE para evaluar el riesgo de sangrado en pacientes con infarto agudo de miocardio sin elevación del ST / Validation of the CRUSADE scale to assess the risk of bleeding in patients with acute myocardial infarction without ST elevation

Objetivo: Evaluar si la escala CRUSADE es aplicable en la comunidad colombiana. Métodos:Se realizó un estudio de validación externa dentro de una cohorte histórica, en el que se incluyeron pacientes hospitalizados entre los años 2006 y 2012 en el Hospital Universitario San Ignacio, en Bogotá, Colombia. Se tomaron historias clínicas de pacientes mayores de 18 años, que tuvieran asignado el diagnóstico de infarto agudo de miocardio sin supradesnivel del ST. Se comparó el número de eventos (sangrado) predichos y observados durante la hospitalización (calibración). Finalmente, se estimó la capacidad para separar sujetos de alto y bajo riesgo (discriminación). Resultados: Se incluyeron 252 pacientes. El número de eventos mayores fue 30 (11,9%) y el de eventos menores 23 (9,12%); 12 pacientes (7,46%) fallecieron. En el grupo de muy alto riesgo (más de 50 puntos de la escala), se reportó el mayor número de eventos (respecto a la población estudiada). Al evaluar la escala se evidenció una buena capacidad de calibración (X² p = 0,84); sin embargo, la discriminación no fue adecuada (área bajo la curva 0,6128 {IC 95% 0,46-0,76}). Conclusiones: Se encontraron pocos eventos, si bien los datos sugieren que la escala subestima levemente los riesgos. La escala tiene buena calibración, pero no posee capacidad de discriminación adecuada, hecho que probablemente obedece a que se obtuvo un pequeño número de eventos, con desviaciones estándar altas. Por tanto, se requieren estudios adicionales, con mayor poder estadístico.

Objective: To assess whether CRUSADE scale is applicable in the Colombian community. Methods: A study of external validation in a historical cohort, which included patients hospitalized between 2006 and 2012 in the Hospital Universitario San Ignacio in Bogota Colombia, was performed. Medical records of patients older than 18 years, who had been diagnosed as acute myocardial infarction without ST segment elevation, were included. The number of events (bleeding) predicted and observed during hospitalization (calibration) were compared. Finally, the ability to separate subjects at high and low risk (discrimination) was estimated. Results:252 patients were included. The number of major events was 30 (11.9%) and that of minor events 23 (9.12%); 12 patients (7.46%) died. In the group of very high risk (more than 50 points on the scale), the largest number of events (regarding the study population) was reported. At assessing the scale, a good calibration capacity was evidenced (X² p = .84); however, discrimination was not adequate (0.6128 AUC {95% CI 0.46 to 0.76}). Conclusions Few events were found, although the data suggest that the scale slightly underestimates the risks. The scale has good calibration, but lacks adequate discriminatory capacity, probably due to the fact that a small number of events with high standard deviations were obtained. Therefore, further studies with greater statistical power are required.

Validación de los modelos de predicción de Framingham y PROCAM como estimadores del riesgo cardiovascular en una población colombiana / Validation of PROCAM and Framingham prediction models as estimators of cardiovascular risk in a Colombian population

Objetivo: Evaluar si las funciones de riesgo de Framingham y PROCAM son aplicables a la población colombiana. Métodos: Se desarrolló un estudio de validación externa dentro de una cohorte histórica, en la que se incluyeron pacientes de la clínica de prevención primaria del Hospital Militar Central de Bogotá (Colombia). Se evaluaron 1.013 pacientes entre 30 y 74 años, libres de eventos cardiovasculares al ingreso a la cohorte (1984 a 1996) que recibieron seguimiento durante diez años en busca de eventos cardiovasculares (muerte coronaria, infarto del miocardio o angina de pecho). Se comparó el número de eventos cardiovasculares predichos y observados en esos diez años (calibración). Finalmente, se estimó la capacidad de las funciones de riesgo para separar los sujetos de alto y bajo riesgo (discriminación). Resultados: En pacientes de riesgo bajo e intermedio, el número de eventos cardiovasculares predichos por la función de riesgo de Framingham sobrestimó los observados (relación entre eventos esperados y observados de 1,31), con baja capacidad para separar los pacientes de bajo riesgo de los de alto riesgo (AUC 0,65). La función de riesgo de PROCAM ajustada por sexo tuvo mejor capacidad de discriminación (AUC 0,74) con buena calibración (relación entre eventos esperados y observados de 1,07). No se contó con suficientes pacientes de alto riesgo para generalizar los resultados a esta población. Conclusiones: La función de riesgo de Framingham debería usarse con precaución en población colombiana de riesgo bajo e intermedio sin historia previa de eventos cardiovasculares dado que sobrestima el riesgo y tiene baja capacidad de discriminación. La función de riesgo de PROCAM ajustada por sexo es una mejor opción para estimar el riesgo de enfermedad cardiovascular dura.

Aims:To assess whether the Framingham and PROCAM risk functions were applicable to Colombian population. Methods: We performed an external validation study within a historical cohort, including the patients of the primary prevention clinic from the Hospital Militar Central in Bogotá (Colombia). It comprised 1013 patients who were aged 30 to 74 years, free of cardiovascular disease at baseline (1984 to 1996) and followed over 10 years for cardiovascular disease events (coronary death, myocardial infarction, angina pectoris). We compared the number of predicted and observed 10-year cardiovascular disease events (calibration). Finally, we estimated the ability of the risk functions to separate high risk from low risk subjects (discrimination). Results: In patients with low and intermediate risk, the number of cardiovascular disease events predicted by Framingham risk function overestimated those observed (predicted to observed ratio 1.31), with a low ability to separate high risk from low risk subjects (c-statistic 0.65). The PROCAM risk function adjusted by sex had better ability to separate high risk from low risk subjects (c-statistic 0.74) with good calibration (predicted to observed ratio 1.07). We do not have enough high risk patients to extrapolate our results in that population. Conclusion: The Framingham risk function must be used with caution to estimate the absolute cardiovascular disease risk in Colombian low and intermediate risk population without any cardiovascular disease history because of its overestimation and low discrimination abilities. The PROCAM risk function adjusted by sex is a better option to estimate hard cardiovascular disease risk.