Randomized Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium dobesilate with placebo in the treatment of Chronic Venous Disease

Producción CientíficaObjective. To assess the efficacy of calcium dobesilate on the quality-of-life (QoL) of patients with chronic venous disease (CVD). Design. Randomised, parallel, double blind, placebo-controlled clinical trial. Methods. Patients were recruited from vascular surgery clinics and randomised to 500 mg capsules of calcium dobesilate twice a day for 3 months or placebo. The primary outcome measure was ‘QoL after 3 months’ treatment measured by the specific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 months and assessment of the CVD signs and symptoms. The principal analysis was undertaken on the intention-to-treat (ITT) data. Results. Five hundred and nine patients were recruited (246 to calcium dobesilate and 263 to placebo). The analysis of the ‘QoL after 3 months’ showed no significant differences between groups ( p ¼ 0.07). For secondary outcomes, oedema and symptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the ‘QoL at 12 months’ was better in the calcium dobesilate group than in placebo group ( p ¼ 0.02). Conclusions. Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies. 2007 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Variation in the choice of elective surgical procedure for abdominal aortic aneurysm in Spain

Abdominal aortic aneurysm; Endovascular aneurysm repair; Open surgical repairAneurisma aòrtic abdominal; Reparació endovascular d'aneurismes; Reparació quirúrgica obertaAneurisma aórtico abdominal; Reparación endovascular de aneurismas; Reparación quirúrgica abiertaOBJECTIVE: The two main surgical treatments for abdominal aortic aneurysm (AAA) are open surgical repair (OSR) and endovascular aneurysm repair (EVAR). The aim of this study was to analyze variation among Spanish hospitals in the use of OSR or EVAR for AAA. A secondary aim was to assess changes in preferences for these two procedures over time. METHODS: This was a retrospective longitudinal study based on discharge data from public hospitals in Spain during 2002-2012. Patient inclusion criteria were: age >18 years, elective admission, primary diagnosis of unruptured AAA, and surgical treatment with OSR or EVAR. The characteristics of the treating center, patients, and in-hospital mortality were recorded. RESULTS: We included 16,737 patients from 114 hospitals; 6,809 (40.7%) underwent EVAR and 9,928 (59.3%) underwent OSR. The total volume of surgeries increased throughout the period, and the probability that any given procedure was EVAR increased by 20% per year (OR 1.20, P<0.001). The volume and distribution of the two procedures varied highly across the participating hospitals. Overall, in-hospital mortality rate was 3.6% and it decreased during the study period (5.3% in 2002 and 3.2% in 2012), mainly due to a decrease in OSR-related mortality, despite a slight increase in EVAR-related mortality. Hospitals with higher surgical volumes were more likely to use EVAR and have lower in-hospital mortality rates. CONCLUSION: This study reveals high variability in the surgical treatment of unruptured AAA across Spanish hospitals. The number of interventions has increased in recent years, with EVAR accounting for a growing percentage of these surgical procedures. Overall in-hospital mortality rates decreased significantly during this period, mainly due to lower mortality among patients undergoing OSR. In-hospital mortality rates were lower in higher-volume centers, regardless of the surgical approach used. Further research on variability and appropriateness of surgical management of AAA is required to assess the suitability of concentrating elective AAA repair in more experienced centers to potentially achieve better outcomes

Glibenclamide, metformin, and insulin for the treatment of gestational diabetes : a systematic review and meta-analysis

Objective To summarize short term outcomes in randomized controlled trials comparing glibenclamide or metformin versus insulin or versus each other in women with gestational diabetes requiring drug treatment. Design Systematic review and meta-analysis. Eligibility criteria for selecting studies Randomized controlled trials that fulfilled all the following: (1) published as full text; (2) addressed women with gestational diabetes requiring drug treatment; (3) compared glibenclamide v insulin, metformin v insulin, or metformin v glibenclamide; and (4) provided information on maternal or fetal outcomes. Data sources Medline, CENTRAL, and Embase were searched up to 20 May 2014. Outcomes measures We considered 14 primary outcomes (6 maternal, 8 fetal) and 16 secondary (5 maternal, 11 fetal) outcomes. Results We analyzed 15 articles, including 2509 subjects. Significant differences for primary outcomes in glibenclamide v insulin were obtained in birth weight (mean difference 109 g (95% confidence interval 35.9 to 181)), macrosomia (risk ratio 2.62 (1.35 to 5.08)), and neonatal hypoglycaemia (risk ratio 2.04 (1.30 to 3.20)). In metformin v insulin, significance was reached for maternal weight gain (mean difference −1.14 kg (−2.22 to −0.06)), gestational age at delivery (mean difference −0.16 weeks (−0.30 to −0.02)), and preterm birth (risk ratio 1.50 (1.04 to 2.16)), with a trend for neonatal hypoglycaemia (risk ratio 0.78 (0.60 to 1.01)). In metformin v glibenclamide, significance was reached for maternal weight gain (mean difference −2.06 kg (−3.98 to −0.14)), birth weight (mean difference −209 g (−314 to −104)), macrosomia (risk ratio 0.33 (0.13 to 0.81)), and large for gestational age newborn (risk ratio 0.44 (0.21 to 0.92)). Four secondary outcomes were better for metformin in metformin v insulin, and one was worse for metformin in metformin v glibenclamide. Treatment failure was higher with metformin than with glibenclamide. Conclusions At short term, in women with gestational diabetes requiring drug treatment, glibenclamide is clearly inferior to both insulin and metformin, while metformin (plus insulin when required) performs slightly better than insulin. According to these results, glibenclamide should not be used for the treatment of women with gestational diabetes if insulin or metformin is available. Systematic review registration NCT0199811

Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure

Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096±0.03 mmol/μg vs 0.015±0.0007 mmol/μg; P <0.0001). Mictional urgency was lower and more delayed with torasemide-PR than with furosemide-IR. In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to assess its impact on clinical therapeutics

Pelvic MRI findings in relapsed prostate cancer after radical prostatectomy

Little is known about the clinical impact of using multiparametric MRI to plan early salvage radiotherapy after radical prostatectomy. We aimed to evaluate the incidence and location of recurrence based on pelvic multiparametric MRI findings and to identify clinical variables predictive of positive imaging results. We defined radiological criteria of local and lymph node malignancy and reviewed records and MRI studies of 70 patients with PSA recurrence after radical prostatectomy. We performed univariate and multivariate analysis to identify any association between clinical, pathological and treatment-related variables and imaging results. Multiparametric MRI was positive in 33/70 patients. We found local and lymph node recurrence in 27 patients and 7 patients, respectively, with a median PSA value of 0.38 ng/ml. We found no statistically significant differences between patients with positive and negative multiparametric MRI for any variable. Shorter PSADT was associated with positive lymph nodes (median PSADT: 5.12 vs 12.70 months; p: 0.017). Nearly half the patients had visible disease in multiparametric MRI despite low PSA. Positive lymph nodes incidence should be considered when planning salvage radiotherapy, particularly in patients with a short PSADT

Chromosome 17 Centromere Duplication and Responsiveness to Anthracycline-Based Neoadjuvant Chemotherapy in Breast Cancer

Human epidermal growth factor receptor 2 (HER2) and topoisomerase II alpha (TOP2A) genes have been proposed as predictive biomarkers of sensitivity to anthracycline chemotherapy. Recently, chromosome 17 centromere enumeration probe (CEP17) duplication has also been associated with increased responsiveness to anthracyclines. However, reports are conflicting and none of these tumor markers can yet be considered a clinically reliable predictor of response to anthracyclines. We studied the association of TOP2A gene alterations, HER2 gene amplification, and CEP17 duplication with response to anthracycline-based neoadjuvant chemotherapy in 140 patients with operable or locally advanced breast cancer. HER2 was tested by fluorescence in situ hybridization and TOP2A and CEP17 by chromogenic in situ hybridization. Thirteen patients (9.3%) achieved pathologic complete response (pCR). HER2 amplification was present in 24 (17.5%) of the tumors. TOP2A amplification occurred in seven tumors (5.1%). CEP17 duplication was detected in 13 patients (9.5%). CEP17 duplication correlated with a higher rate of pCR [odds ratio (OR) 6.55, 95% confidence interval (95% CI) 1.25-34.29, P =.026], and analysis of TOP2A amplification showed a trend bordering on statistical significance (OR 6.97, 95% CI 0.96-50.12, P =.054). TOP2A amplification and CEP17 duplication combined were strongly associated with pCR (OR 6.71, 95% CI 1.66-27.01, P =.007). HER2 amplification did not correlate with pCR. Our results suggest that CEP17 duplication predicts pCR to primary anthracycline-based chemotherapy. CEP17 duplication, TOP2A amplifications, and HER2 amplifications were not associated with prognosis

God, Suffering, and Belief [review] / Burkle, Howard R.

OBJETIVOS: analisar a relação entre o estado emocional pré-operatório e a prevalência e a intensidade da dor pós-operatória e explorar fatores preditivos de dor pós-operatória. MÉTODO: estudo retrospectivo observacional, realizado com 127 pacientes adultos submetidos a cirurgias ortopédicas e traumatológicas. A dor pós-operatória foi avaliada usando a escala numérica verbal e cinco variáveis do estado emocional: ansiedade, sudorese, estresse, medo e choro. Para a análise estatística, foram utilizados os testes do qui-quadrado, teste t de Student ou análise de variância e uma análise de regressão logística multivariada. RESULTADOS: a prevalência de dor pós-operatória imediata foi de 28%. A ansiedade foi o fator emocional mais comum (72%) e fator preditivo de risco para dor pós-operatória severa (OR: 4,60, IC 95%: 1,38 a 15,3, pOBJETIVOS: analizar la relación entre el estado emocional preoperatorio y la prevalencia e intensidad de dolor postoperatorio inmediato y explorar los factores predictivos de dolor postoperatorio. MÉTODO: estudio observacional y retrospectivo realizado a 127 pacientes adultos de cirugía ortopédica y traumatológica. El dolor postoperatorio se evaluó con la escala verbal numérica y el estado emocional con 5 variables: ansiedad, sudor, tensión, miedo, lloros. Para el análisis estadístico se utilizaron las pruebas de χ2, t de Student o ANOVA y un análisis multivariado con regresión logística. RESULTADOS: la prevalencia de dolor postoperatorio inmediato fue del 28%. La ansiedad fue el factor emocional más frecuente (72%) y un factor de riesgo predictivo para el dolor postoperatorio moderado-intenso (OR: 4,60, IC95%: 1,38-15,3, pOBJECTIVES: to analyze the relationship between preoperative emotional state and the prevalence and intensity of postoperative pain and to explore predictors of postoperative pain. METHOD: observational retrospective study undertaken among 127 adult patients of orthopedic and trauma surgery. Postoperative pain was assessed with the verbal numeric scale and with five variables of emotional state: anxiety, sweating, stress, fear, and crying. The Chi-squared test, Student's t test or ANOVA and a multivariate logistic regression analysis were used for the statistical analysis. RESULTS: the prevalence of immediate postoperative pain was 28%. Anxiety was the most common emotional factor (72%) and a predictive risk factor for moderate to severe postoperative pain (OR: 4.60, 95% CI 1.38 to 15.3,

Radial extracorporeal shock wave device appearance does not influence clinical outcomes : A randomized controlled trial

Objective: To determine whether the appearance of a radial extracorporeal shock wave device affects clinical outcomes in chronic plantar fasciitis. Study design: Randomized controlled parallel assessor- blinded clinical trial. Material and methods: A total of 135 patients were assigned to 3 groups: Group I, standard radial extracorporeal shock wave device; group II, standard radial extracorporeal shock wave device modified to give a more sophisticated appearance; group III, standard radial extracorporeal shock wave device modified to give a more austere appearance. The radial extracorporeal shock waves emitted by the 3 devices were identical. Primary outcome was foot function, measured with the Foot Function Index. Secondary outcomes were pain at different times, measured with a visual analogue scale, and plantar fascia thickness, measured with ultrasound. Results: All variables decreased significantly from baseline assessment, in all 3 groups and at all timepoints: 1, 2, 4 and 14 months after the last session (p < 0.001). There were no significant differences between groups for any of the variables assessed. Conclusion: Device appearance had no statistically significant influence on clinical outcomes in patients with chronic plantar fasciitis treated with radial extracorporeal shock wave therapy

Mortalidad por accidentes de tráfico en Colombia. Estudio comparativo con otros países

ABSTRACT Background: Traffic accidents (TA) are a global problem with mortality of 1.25 million each year. The objective of this study was to compare adjusted mortality rates (AMR) by AT of Colombia, with Spain and the United States (US). The selection is justified because Colombia is a country with less development in road safety, Spain a nation that has adhered to European guidelines and US for having little adherence to international guidelines. Methods: A descriptive cross-sectional study was carried out for five-year periods, by calculating the AMRs by the direct method of standardization according to sex and age groups, as well as the adjustment of the motorization index. The mean values, the 95% confidence interval for each country and the relative change between the periods studied were calculated. Results: The AMR of periods P1 and P2 in all countries decreased significantly (p <0.005). In periods P2 and P3 also decreased significantly in Spain, by 52.0% (p = 0.010), and in the US, by 23.6% p = 0.001), while in Colombia the difference of 4.0% it was not significant (p = 0.724). Spain stood out for the reduction in mortality (P1-P3), by 69.0%. Conclusions: Colombia presented a less favorable evolution of mortality due to AT than Spain and the US. Men aged 15 to 44, motorcyclists and cyclists were the most committed. The TAs are a public health problem that Colombia has raised and must adapt to its reality those successful measures in other countries.RESUMEN Fundamentos: Los accidentes de tráfico (AT) son un problema mundial con mortalidad de 1,25 millones cada año. El objetivo de este estudio fue comparar tasas ajustadas de mortalidad (TAM) por AT de Colombia, con España y Estados Unidos (EEUU). La selección se justifica por ser Colombia un país con menor desarrollo en seguridad vial, España una nación que se ha adherido a directrices Europeas y EEUU por tener poca adherencia a directrices internacionales. Métodos: Se realizó un estudio descriptivo de corte transversal por quinquenios, mediante el cálculo de las TAM por el método directo de estandarización según sexo y grupos de edad, así como el ajuste del índice de motorización. Se calcularon los valores medios, el intervalo de confianza al 95% por cada país y el cambio relativo entre los períodos estudiados. Resultados: Las TAM de los períodos P1 y P2 en todos los países disminuyeron significativamente (p<0.005). En los períodos P2 y P3 también disminuyeron significativamente en España, en un 52,0% (p=0,010), y en EU, en un 23,6% p=0,001), mientras que en Colombia la diferencia de 4,0% no fue significativa (p=0,724). Destacó España por la reducción de su mortalidad (P1-P3), en un 69.0%. Conclusiones: Colombia presentó una evolución menos favorable de mortalidad por AT que España y EEUU. Los hombres de 15 a 44 años, motociclistas y ciclistas fueron los más comprometidos. Los AT son un problema de salud pública que tiene planteado Colombia y debe adaptar a su realidad aquellas medidas exitosas en otros países

Variation in the choice of elective surgical procedure for abdominal aortic aneurysm in Spain

The two main surgical treatments for abdominal aortic aneurysm (AAA) are open surgical repair (OSR) and endovascular aneurysm repair (EVAR). The aim of this study was to analyze variation among Spanish hospitals in the use of OSR or EVAR for AAA. A secondary aim was to assess changes in preferences for these two procedures over time. This was a retrospective longitudinal study based on discharge data from public hospitals in Spain during 2002-2012. Patient inclusion criteria were: age >18 years, elective admission, primary diagnosis of unruptured AAA, and surgical treatment with OSR or EVAR. The characteristics of the treating center, patients, and in-hospital mortality were recorded. We included 16,737 patients from 114 hospitals; 6,809 (40.7%) underwent EVAR and 9,928 (59.3%) underwent OSR. The total volume of surgeries increased throughout the period, and the probability that any given procedure was EVAR increased by 20% per year (OR 1.20, P <0.001). The volume and distribution of the two procedures varied highly across the participating hospitals. Overall, in-hospital mortality rate was 3.6% and it decreased during the study period (5.3% in 2002 and 3.2% in 2012), mainly due to a decrease in OSR-related mortality, despite a slight increase in EVAR-related mortality. Hospitals with higher surgical volumes were more likely to use EVAR and have lower in-hospital mortality rates. This study reveals high variability in the surgical treatment of unruptured AAA across Spanish hospitals. The number of interventions has increased in recent years, with EVAR accounting for a growing percentage of these surgical procedures. Overall in-hospital mortality rates decreased significantly during this period, mainly due to lower mortality among patients undergoing OSR. In-hospital mortality rates were lower in higher-volume centers, regardless of the surgical approach used. Further research on variability and appropriateness of surgical management of AAA is required to assess the suitability of concentrating elective AAA repair in more experienced centers to potentially achieve better outcomes