Non-pharmacologic direct cost of a simplified strategy with glecaprevir/pibrentasvir for 8 weeks in naïve non-cirrhotic patients with hepatitis C implemented in clinical practice. The Just SIMPLE Study.

BACKGROUND AND OBJECTIVE: The emergence of highly tolerable, effective, and shorter duration direct-acting antivirals (DAAs) regimens offers the opportunity to simplify hepatitis C virus management but medical costs are unknown. Thus, we aimed to determine the direct medical costs associated with a combo-simplified strategy (one-step diagnosis and low monitoring) to manage HCV infection within an 8-week glecaprevir/pibrentasvir (GLE/PIB) regimen in clinical practice in Spain. PATIENTS AND METHODS: Healthcare resources and clinical data were collected retrospectively from medical charts of 101 eligible patients at 11 hospitals. Participants were adult, treatment naïve subjects with HCV infection without cirrhosis in whom a combo-simplified strategy with GLE/PIB for 8 weeks were programmed between Apr-2018 and Nov-2018. RESULTS: The GLE/PIB effectiveness was 100% (CI95%: 96.2-100%) in the mITT population and 94.1% (CI95%: 87.5-97.8%) in the ITT population. Three subjects discontinued the combo-simplified strategy prematurely, none of them due to safety reasons. Five subjects reported 8 adverse events, all of mild-moderate intensity. Combo-simplified strategy mean direct costs were 754.35±103.60€ compared to 1689.42€ and 2007.89€ of a theoretical 12-week treatment with 4 or 5 monitoring visits, respectively; and 1370.95€ and 1689.42€ of a theoretical 8-week with 3 or 4 monitoring visits, respectively. Only 4.9% of the subjects used unexpected health care resources. CONCLUSIONS: 8-week treatment with GLE/PIB combined with a combo simplified strategy in real-life offers substantial cost savings without affecting the effectiveness and safety compared to traditional approaches.

Associations of major depressive disorder with chronic physical conditions, obesity and medication use: Results from the PISMA-ep study.

BACKGROUND: Life expectancy of people with depression is on average 15 years less than that of the general population. This excess of mortality is largely attributed to a deteriorated physical health. Evidence about the association between major depressive disorder (MDD) and physical health is still lacking in some areas. The aim of this study was to explore the association between MDD and physical health-related variables in southern Spain. METHODS: The PISMA-ep is a cross-sectional study based on community-dwelling adult population. Our main outcome was current prevalence of MDD. Independent variables explored were: lifetime prevalence of twenty-one chronic physical conditions (CPCs), anthropometric measures (height, weight, body max index, and hip and waist circumferences), general health status, and medication use. RESULTS: MDD was significantly associated with any CPC (OR = 2.60; 95% CI: 2.01-3.35; p < 0.001). Increases in BMI were associated with MDD in women (OR=1.08; 95% CI: 1.05-1.11; p < 0.001), but not in men (OR=0.99; 95% CI: 0.95-1.05; p = 0.916). Variables associated with MDD in the multivariate model were: female gender, obesity, general health status, cancer, peptic ulcer, tinnitus and vertigo. 21.4% of participants with MDD received antidepressant treatment. CONCLUSIONS: MDD is associated with CPCs, obesity, and increased use of medication. The high rates of comorbidity between MDD and CPCs call for a more holistic management of patients in the clinical practice. The low rate of antidepressant use may be indicating underdiagnosis. Anthropometric variables were differently associated with MDD depending on gender, suggesting a strong influence of psychosocial factors.

Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study.

AIM: To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. METHODS: This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. RESULTS: Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001). CONCLUSION: TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.

Unfavourable life-course social gradient of coronary heart disease within Spain: a low-incidence welfare-state country.

OBJECTIVE: Social position has yet to be established as a risk factor of coronary heart disease (CHD). Our aim was to investigate an individual life-course social position gradient link with CHD incidence in the EPIC-Spain cohort. METHODS: 41,066 participants, mostly 30-65 years old, and free of cardiovascular disease at baseline (1992-1996) were followed up for a mean of 10.4 years. A combined score of paternal occupation in childhood and own adult education was used to assess individual life-course risk accumulation. Hazard ratios of CHD were estimated using Cox models, stratifying by centre, and age, and adjusting for cardiovascular risk factors. RESULTS: 583 participants (80 % men) developed a definite CHD event. Paternal occupational class IV was associated with CHD in all models in men. The educational gradient remained significant after adjusting for diet and physical activity (p = 0.01). All adjusted risk of incident CHD rose by 23 % (95 % CI 6-42 %) per category increase of life-course social position score in men. No significant associations were found in women. CONCLUSIONS: Individual life-course social position gradient was adversely related to incident CHD in Spanish men.

The association of education with body mass index and waist circumference in the EPIC-PANACEA study.

BACKGROUND: To examine the association of education with body mass index (BMI) and waist circumference (WC) in the European Prospective Investigation into Cancer and Nutrition (EPIC). METHOD: This study included 141,230 male and 336,637 female EPIC-participants, who were recruited between 1992 and 2000. Education, which was assessed by questionnaire, was classified into four categories; BMI and WC, measured by trained personnel in most participating centers, were modeled as continuous dependent variables. Associations were estimated using multilevel mixed effects linear regression models. RESULTS: Compared with the lowest education level, BMI and WC were significantly lower for all three higher education categories, which was consistent for all countries. Women with university degree had a 2.1 kg/m2 lower BMI compared with women with lowest education level. For men, a statistically significant, but less pronounced difference was observed (1.3 kg/m2). The association between WC and education level was also of greater magnitude for women: compared with the lowest education level, average WC of women was lower by 5.2 cm for women in the highest category. For men the difference was 2.9 cm. CONCLUSION: In this European cohort, there is an inverse association between higher BMI as well as higher WC and lower education level. Public Health Programs that aim to reduce overweight and obesity should primarily focus on the lower educated population.

Evaluación del estado nutricional antropométrico de niños, niñas menores de 5 años y gestantes / Anthropometric assessment of nutritional status of children under 5 years and pregnant

Objetivo. Evaluar el estado nutricional antropométrico de los niños, niñas menores de 5 años y gestantes según el patrón internacional de crecimiento infantil de la Organización Mundial de la Salud (OMS) y CENAN respectivamente. Materiales y Metodología. El estudio fue de tipo retrospectivo de corte longitudinal de seguimiento. Se tomaron pesos y tallas de 107 niños menores de 5 años y 27 gestantes, evaluados desde enero a diciembre del 2010 que acudieron al consultorio de nutrición del CAP II de Chalhuanca. Se consideraron como límites de normalidad hasta más menos 2 desviaciones estándar de la OMS. Resultados. Se evaluó un total de 107 niños y niñas menores de 5 años, de los cuales 53 (49,5%) fueron de sexo femenino y 54 (50,5%) de sexo masculino. Los diagnósticos nutricionales fueron: retardo en el crecimiento (22,4%), de los cuales un 1.8% corresponde talla baja severa y un 20.6% a talla baja, el 75,6% corresponde a niños con talla adecuada, de ello se extrae niños y niñas menores de 5 años normales, con riesgo de talla baja y riesgo de desnutrición siendo 33,6%, 36,4% y un 5,6% respectivamente, en cuanto a los porcentajes de obesidad y sobrepeso los porcentajes son mínimos encontrándose un 0,9% para ambos casos. Además la prevalencia del estado nutricional antropométrico de las gestantes con adecuada ganancia de peso es de 51,8%, mientras que las gestantes con baja ganancia de peso son de 29,6% y sólo un 18,5% presenta alta ganancia de peso. Conclusión. La alta prevalencia de retardo en el crecimiento (a pesar que en comparación a los indicadores nacionales son menores) y gestantes con baja ganancia de peso en esta población de extrema pobreza, plantea la necesidad de abordar el problema (de la alimentación infantil y en edad de gestión) de forma prioritaria, integral y efectiva.

High-activity variants of the uMAOA polymorphism increase the risk for depression in a large primary care sample.

Studies on the association between the functional uMAOA polymorphism and depression have yielded non-conclusive results up till now. One thousand two hundred twenty eight consecutive Spanish primary care attendees, participating in the PREDICT study, agreed to take part in this genetic PREDICT-Gene study. We explored the association between depression and either high-activity uMAOA alleles or genotypes. Depression was diagnosed using the Composite International Diagnostic Interview (CIDI) to establish three different depressive outcomes (ICD-10 Depressive Episode (DE), ICD-10 Severe Depressive Episode (SDE) and DSM-IV Major Depression (MD)). uMAOA genetic variation was determined by PCR amplification and subsequent electrophoresis. Crude and adjusted (gender and/or age) odds ratios, with 95% confidence intervals, were calculated for the associations between allele or genotype frequencies and all three depressive outcomes. We found associations between all three depressive phenotypes and either high-activity alleles or high-activity genotypes in both sexes. The associations were statistically significant for females but not for males. Testing the same associations on the entire sample (males and females) also yielded significant associations between depression and either high-activity alleles or high-activity genotype distribution that were independent of age and/or gender (ICD-10 DE: OR = 1.98; 95% CI: 1.42-1.77; P = 0.00002; ICD-10-SDE: OR = 2.05; 95% CI: 1.38-3.05; P = 0.0002; DSM-IV MD: OR = 1.91; 95% CI: (1.26-2.91); P = 0.0014). Our results provide fairly consistent evidence that high-activity variants of the MAOA promoter polymorphism confer a modestly higher risk for depression.

Day case oral surgery in pediatric patients during the year 2000 in the University of Barcelona Dental Clinic (Spain).

AIM: A study is made to show that most pediatric oral surgical interventions can be performed on a day case surgery or ambulatory basis, and to describe the activity of the Master of Oral Surgery and Implantology (Barcelona University Dental School, Spain) in the year 2000. DESIGN: The study documents the surgical activity of the Units of Oral Surgery and Laser Surgery in pediatric patients, in the context of the Master of Oral Surgery and Implantology (Barcelona University Dental School, Spain). RESULTS: Of the 3187 operations carried out in our Service in this period, 489 involved patients under 18 years of age. The surgical removal of third molars was the most common intervention (55.6%), followed by other surgical or non-surgical tooth extractions (33.6%) and other interventions (10.6%) comprising fenestration of impacted canines or other teeth, frenectomies, the removal of mucoceles, and tooth relocations. Complications after surgical third molar extraction were recorded in 15.93% of cases, the most frequent problem being the pain and swelling (4.35% each) characteristic of postoperative inflammation. CONCLUSIONS: Our experience shows that day case oral surgery can be safely performed in pediatric patients, provided the required means and health care personnel resources are available.