Primary Joint Arthroplasty Surgery: Is the Risk of Major Bleeding Higher in Elderly Patients? A Retrospective Cohort Study.

BACKGROUND: Increased risk of bleeding after major orthopedic surgery (MOS) has been widely documented in general population. However, this complication has not been studied in elderly patients. The purpose of this study is to determine whether the risk of major bleeding after MOS is higher in elderly patients, compared with those operated at a younger age. METHODS: This retrospective cohort study included total hip and total knee arthroplasty patients operated during 5 consecutive years. The main outcome was the occurrence of major bleeding. Patients with other causes of bleeding were excluded. Relative risks (RRs) and confidence intervals (CIs) were calculated, and a multivariate analysis was performed. RESULTS: A total of 1048 patients were included, 56% of patients were hip arthroplasties. At the time of surgery, 553 (53%) patients were older than 70 years. Patients aged >70 years showed an increased risk of major bleeding (RR: 2.42 [95% CI: 1.54-3.81]). For hip arthroplasty, the RR of bleeding was 2.61 (95%CI: 1.50-4.53) and 2.25 (95% CI: 1.03-4.94) for knee arthroplasty. After multivariate analysis, age was found to be independently associated with higher risk of major bleeding. CONCLUSION: According to European Medicines Agency criteria, patients aged ≥70 years are at a higher risk of major bleeding after MOS, result of a higher frequency of blood transfusions in this group of patients. Standardized protocols for blood transfusion in these patients are still required.

Estudio de bioequivalencia de montelukast en tabletas masticables de 5 mg / Bioequivalence study of montelukast 5 mg chewable tablets

Introducción. La importancia de los medicamentos genéricos radica en la posibilidad de la disminución de los costos en el sistema nacional de salud, sin sacrificar la calidad del servicio ni la eficacia y la seguridad de los tratamientos. Es importante resaltar que los estudios de bioequivalencia pretenden demostrar que los perfiles farmacocinéticos del producto de prueba y del producto de referencia son similares e intercambiables. El montelukast sódico está indicado para la profilaxis y el tratamiento crónico del asma, en adultos y pacientes pediátricos de 12 meses de edad o más. En general, es bien tolerado y las reacciones adversas son un poco más frecuentes en los pacientes tratados con el fármaco que en los tratados con placebo. Objetivos. Comparar la biodisponibilidad de Amisped®, montelukast en tabletas masticables de 5 mg fabricadas por Sanofi-Aventis con la de Singulair®, montelukast en tabletas masticables de 5 mg elaboradas por Merck Sharp & Dohme. Materiales y métodos. Se comparó la magnitud y la velocidad de la absorción de montelukast en 18 voluntarios sanos, empleando un diseño cruzado completo al azar. El bioanálisis de las muestras se hizo por cromatografía líquida de alta resolución. Resultados. Los resultados para el genérico y el innovador, respectivamente, fueron: Tmax (horas) 2,17±0,73 y 2,28±0,88; Cmax (ng/ml) 607,42±122,92 y 627,69±134,17; AUC0-t (ng*h/ml) 3.316,39±861,57 y 3.545,40±1.070,07; AUC0-∞ (ng*h/ml) 3.450,92±904,89 y 3.722,03±1120,60; Ke (1/h) 0,25±0,05 y 0,23±0,04 en el intervalo de confianza de 0,99-1,00 para lnCmax y 0,94-1,06 para lnAUC0-∞. Conclusiones. La formulación ensayada de Amisped® de Sanofi-Aventis es bioequivalente a la formulación de referencia Singulair® de Merck Sharp& Dohme.

Introduction. The importance of generic drugs is the possibility of reduced costs in the national health system without sacrificing quality of service and the efficacy and safety of treatments. However, bioequivalence studies must show that the pharmacokinetic profiles of the test product and reference product are similar and interchangeable. Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older. It is generally well tolerated, although adverse reactions are more frequent in patients treated with the drug than in those treated with placebo. Objectives. To compare the bioavailability of Amisped® (5 mg montelukast chewable tablets) manufactured by Sanofi-Aventis and 5 mg chewable tablet montelukast (Singulair®) developed by Merck. Materials and methods. The magnitude and rate of absorption of montelukast was compared in 18 healthy volunteers using a randomized complete crossover design. The bioassay was performed by high performance liquid chromatography. Results. Results are indicated for the generic and innovator, respectively: Tmax (h) 2.17±0.73, 2.28±0.88; Cmax (ng/mL) 607.4±122.9, 627.7±134.2; AUC0-t (ng*h/ml) 3,316±861, 3,545±1,070; AUC0-∞ (ng*h/ml) 3,450±904, 3,722±1121; Ke (1/h) 0.25±0.05, 0.23±0.04 in the confidence range of 0.99-1.00 for lnCmax and 0.94-1.06 for lnAUC0-∞. Conclusions. The formula tested in Amisped® from Sanofi-Aventis is bioequivalent to the reference formulation of Merck Singulair®.

[Bioequivalence study of montelukast 5 mg chewable tablets]. / Estudio de bioequivalencia de montelukast en tabletas masticables de 5 mg.

INTRODUCTION: The importance of generic drugs is the possibility of reduced costs in the national health system without sacrificing quality of service and the efficacy and safety of treatments. However, bioequivalence studies must show that the pharmacokinetic profiles of the test product and reference product are similar and interchangeable. Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older. It is generally well tolerated, although adverse reactions are more frequent in patients treated with the drug than in those treated with placebo. OBJECTIVES: To compare the bioavailability of Amisped® (5 mg montelukast chewable tablets) manufactured by Sanofi-Aventis and 5 mg chewable tablet montelukast (Singulair®) developed by Merck. Materials and methods. The magnitude and rate of absorption of montelukast was compared in 18 healthy volunteers using a randomized complete crossover design. The bioassay was performed by high performance liquid chromatography. RESULTS: Results are indicated for the generic and innovator, respectively: Tmax (h) 2.17±0.73, 2.28±0.88; Cmax (ng/mL) 607.4±122.9, 627.7±134.2; AUC0-t (ng*h/ml) 3,316±861, 3,545±1,070; AUC0-∞ (ng*h/ml) 3,450±904, 3,722±1121; Ke (1/h) 0.25±0.05, 0.23±0.04 in the confidence range of 0.99-1.00 for lnCmax and 0.94-1.06 for lnAUC0-∞. CONCLUSIONS: The formula tested in Amisped® from Sanofi-Aventis is bioequivalent to the reference formulation of Merck Singulair®.

Milk enriched with "healthy fatty acids" improves cardiovascular risk markers and nutritional status in human volunteers.

OBJECTIVE: The main goal of the present study was to evaluate the effect of a commercially available milk containing small amounts of eicosapentaenoic acid and docosahexaenoic acid, oleic acid, and vitamins A, B6, D, E, and folic acid compared with semi-skimmed and skimmed milk in volunteers with moderate cardiovascular risk. METHODS: Two hundred ninety-seven subjects 25 to 65 y of age with moderate cardiovascular risk were randomly allocated into three groups. In addition to their diets, one group consumed 500 mL/d of the enriched milk, another group consumed 500 mL/d of skimmed milk, and a control group consumed 500 mL/d of semi-skimmed milk. All groups consumed the dairy drinks for 1 y and blood samples were taken at 0 and 12 mo. RESULTS: Consumption of enriched milk for 1 y produced significant (P < 0.05) increases in serum folate (58%) and high-density lipoprotein cholesterol (4%). Plasma triacylglycerols (10%), total cholesterol (4%), and low-density lipoprotein cholesterol (6%) were reduced significantly only in the supplemented group. Serum glucose, homocysteine, and C-reactive protein remained unchanged. In the skimmed milk and semi-skimmed milk groups, the only significant decreases were in serum folate (17% and 11%, respectively). CONCLUSION: Daily intake of a milk enriched with fish oil, oleic acid, and vitamins improved the nutritional status and cardiovascular risk markers of volunteers, whereas skimmed milk and semi-skimmed milk did not.

Prueba de caminata de seis minutos / Guidelines for the six-minute walk test

The six-minute walk test has been shown as a very useful tool in the functional assessment of patients with chronic respiratory diseases enclosing patients with pulmonary hypertension. Methodological standardization of this test is fundamental for interpreting its results, as well as for using it in the short and long-term clinical follow up of our patients. The purpose of these guidelines is justly to spread out in our country the proper way to perform this useful test. In this context, indications, contraindications, limitations, security measures and detailed instructions about how to carry out, how to report and how to interpret the 6 minute walk test are described in these guidelines.

La prueba de caminata de 6 minutos ha demostrado ser una herramienta muy útil en la evaluación funcional de los pacientes con enfermedades respiratorias crónicas, incluyendo pacientes con hipertensión pulmonar. Para su correcta interpretación y uso clínico en el seguimiento de pacientes, es fundamental estandarizar la técnica. El propósito de este instructivo es justamente difundir a nivel nacional, la manera de efectuar esta técnica en forma correcta. En este contexto, este instructivo describe las indicaciones, contraindicaciones, limitaciones, medidas de seguridad y entrega detalles sobre la ejecución, informe e interpretación de la prueba de caminata de 6 minutos.

Oral intake of Lactobacillus fermentum CECT5716 enhances the effects of influenza vaccination.

OBJECTIVE: We studied the coadjuvant capability of oral consumption of the breast-milk-isolated strain Lactobacillus fermentum (CECT5716) for an anti-influenza vaccine. METHODS: A randomized, double-blinded, placebo-controlled human clinical trial including 50 volunteers (31 male and 19 female) was performed to address the immunologic effects of an intramuscular anti-influenza vaccine in adults (33.0 +/- 7.7 y old). Fifty percent of volunteers received an oral daily dose of methylcellulose (placebo) or probiotic bacteria (1 x 10(10) colony-forming units/d) 2 wk before vaccination and 2 wk after vaccination. RESULTS: Two weeks after vaccination there was an increase in the proportion of natural killer cells in the probiotic group but not in the placebo group. The vaccination induced an increase in T-helper type 1 cytokine concentrations and in T-helper and T-cytotoxic proportions in both groups; however, the probiotic group showed a significant higher induction in some of these parameters. Regarding the humoral effects, induction of antibody response in the placebo group could not be detected. In the case of the probiotic group, a significant increase in antigen specific immunoglobulin A was detected. Although an increase in total immunoglobulin M was observed, changes in anti-influenza antigen specific immunoglobulin M were not observed. The incidence of an influenza-like illness during 5 mo after vaccination (October to February) was lower in the group consuming the probiotic bacteria. CONCLUSION: Oral administration of the strain L. fermentum CECT5716 potentates the immunologic response of an anti-influenza vaccine and may provide enhanced systemic protection from infection by increasing the T-helper type 1 response and virus-neutralizing antibodies.