Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE).

INTRODUCTION: Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE). METHODS: A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61). RESULTS: The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated. CONCLUSION: Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP. DANTE STUDY REGISTRATION: EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain / Estudio observacional, retrospectivo y prospectivo a 12 meses del coste socioeconómico del síndrome del intestino irritable moderado a grave con estreñimiento en España

Introduction: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. Patients and methods: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). Results: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. Discussion: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources

Introducción: El coste socioeconómico del síndrome del intestino irritable con estreñimiento (SII-E) no ha sido evaluado formalmente en España. Pacientes y métodos: Este estudio observacional, multicéntrico a 12 meses (periodos retrospectivo y prospectivo de 6 meses) evaluó el coste del SII-E moderado-grave en España. Se incluyeron pacientes diagnosticados con SII-E (criterios Roma III) en los últimos 5 años y SII-E moderado-grave (puntuación IBS-Symptom Severity Scale [IBS-SSS]≥175) en la inclusión. El objetivo principal fue evaluar el coste directo para el sistema sanitario (SS) español. Resultados: Se incluyeron un total de 112 pacientes, 64 (57%) de los cuales presentaban SII-E grave en la inclusión. En el momento basal, 89 (80%) pacientes presentaron dolor y distensión abdominal. La calidad de vida del paciente, medida mediante los instrumentos IBS-C QoL y EQ-5D, estaba deteriorada, con una puntuación de 59 y 57 (0-100, peor-mejor), respectivamente. En el periodo prospectivo la gravedad media del SII-E, medida mediante IBS-SSS, mostró alguna mejoría (315 a 234 [0-500, mejor-peor]). Durante el periodo a studio, 89 (80%) pacientes usaron fármacos prescritos para el SII-E, principalmente laxantes (n=70; 63%). El coste directo anual fue de 1.067€ y 568€ para el SS y el paciente, respectivamente. El coste total directo del SII-E moderado-grave fue de 1.635€. Discusión: La mayoría de pacientes presentaron síntomas continuos del SII-E pese a que el 80% tomaban medicación específica. El uso de recursos sanitarios y los costes directos globales fueron asimétricos, con un pequeño grupo de pacientes consumiendo la mayoría de los recursos

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain.

INTRODUCTION: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. PATIENTS AND METHODS: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). RESULTS: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. DISCUSSION: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources.

Assessment study of the nutritional status, eating habits and physical activity of the schooled population of Centelles, Hostalets de Balenyà and Sant Martí de Centelles (ALIN 2014 Study). / Estudio de la valoración del estado nutricional y los hábitos alimentarios y de actividad física de la población escolarizada de Centelles, Hostalets de Balenyà y Sant Martí de Centelles (Estudio ALIN 2014).

BACKGROUND AND OBJECTIVE: Malnourishment can be caused by either a lack of food or an excess of low-nutrient foods. Due to several factors, this predisposes children to academic failure. The objective of this study is to estimate the prevalence of school children with eating problems, study their nutrition level, food quality in the diet, and level of physical activity. MATERIAL AND METHODS: The study involved the school children between 3 months and 16.5 years of age in the municipalities of Centelles, Hostalets de Balenyà and Sant Martí de Centelles. Personal, age, nutrition and physical activity data were collected for the descriptive and bivariate analyses. RESULTS: A total of 1,374 children were included, of which 122 were under 3 years of age (8.9%). Obesity was recorded in 2.5%, while 17.2, 15.6 and 64.8% were overweight, underweight and of normal weight, respectively. The remaining 1,252 children were over 3 years of age (91.1%), and obesity was recorded in 8.1%, while 26.1, 11.0 and 62.9% were overweight, underweight and of normal weight, respectively. Adherence to the Mediterranean diet decreased significantly with increasing age. The maintenance of body weight was significantly correlated to the consumption of carbohydrates for breakfast before going to school, daily fruit consumption, and not having a need for care from the social services. The differences in physical activity and a sedentary lifestyle proved significant between males and females. CONCLUSION: Being underweight and overweight are factors related to eating habits and dependency upon the social services.

Estudio de la valoración del estado nutricional y los hábitos alimentarios y de actividad física de la población escolarizada de Centelles, Hostalets de Balenyà y Sant Martí de Centelles (Estudio ALIN 2014) / Assessment study of the nutritional status, eating habits and physical activity of the schooled population of Centelles, Hostalets de Balenyà and Sant Martí de Centelles (ALIN 2014 Study)

Antecedentes y objetivo: La malnutrición puede deberse tanto a la falta de alimentos como al exceso de alimentos poco nutritivos. Ello predispone al niño, por diversos factores, a un fracaso escolar. El objetivo de este estudio es estimar la prevalencia de niños escolarizados con dificultades alimentarias, estudiar el grado de nutrición, la calidad alimentaria de la dieta y el grado de actividad física. Material y métodos: Se estudió la población escolarizada de las poblaciones de Centelles, Hostalets de Balenyà y Sant Martí de Centelles, de 3 meses a 16,5 años. Se recogieron datos personales, antropométricos, nutricionales y de actividad física para la valoración por análisis descriptivo y bivariante. Resultados: Se estudiaron 1.374 niños, 122 menores de 3 años (8,9%), observándose obesidad en el 2,5%, sobrepeso en el 17,2%, infrapeso en el 15,6% y normopeso en el 64,8% de la muestra, y 1.252 mayores de 3 años (91,1%), observándose un 62,9% de normopeso, un 11,0% de infrapeso y un 26,1% de exceso de peso, del cual un 8,1% se trataba de obesidad. La adherencia a la dieta mediterránea se reduce significativamente con la edad. Se observa una relación significativa para el mantenimiento de un peso corporal el consumo de hidratos de carbono para desayunar antes de ir a la escuela, consumir fruta diariamente y no precisar atención de los servicios sociales. Es significativa la diferencia de actividad física y sedentarismo entre sexos. Conclusión: El infrapeso y el exceso de peso son factores relacionados con los hábitos alimentarios y la dependencia de los servicios sociales (AU)

Background and objective: Malnourishment can be caused by either a lack of food or an excess of low-nutrient foods. Due to several factors, this predisposes children to academic failure. The objective of this study is to estimate the prevalence of school children with eating problems, study their nutrition level, food quality in the diet, and level of physical activity. Material and methods: The study involved the school children between 3 months and 16.5 years of age in the municipalities of Centelles, Hostalets de Balenyà and Sant Martí de Centelles. Personal, age, nutrition and physical activity data were collected for the descriptive and bivariate analyses. Results: A total of 1,374 children were included, of which 122 were under 3 years of age (8.9%). Obesity was recorded in 2.5%, while 17.2, 15.6 and 64.8% were overweight, underweight and of normal weight, respectively. The remaining 1,252 children were over 3 years of age (91.1%), and obesity was recorded in 8.1%, while 26.1, 11.0 and 62.9% were overweight, underweight and of normal weight, respectively. Adherence to the Mediterranean diet decreased significantly with increasing age. The maintenance of body weight was significantly correlated to the consumption of carbohydrates for breakfast before going to school, daily fruit consumption, and not having a need for care from the social services. The differences in physical activity and a sedentary lifestyle proved significant between males and females. Conclusion: Being underweight and overweight are factors related to eating habits and dependency upon the social services (AU)

Prevención secundaria de la cardiopatía isquémica en España. ¿Quo vadis? / Secondary prevention of ischaemic cardiopathy in Spain. Quo vadis?

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