Influencia del género en la biodisponibilidad de pantoprazol administrado con alimentos

Pantoprazol es un fármaco perteneciente al grupo de los inhibidores de la bomba de protones que está indicado en el tratamiento de las enfermedades producidas por ácido. Pantoprazol tiene una cinética lineal en el rango de dosis de 10 mg a 80 mg, su biodisponibilidad es relativamente alta, 77%, y de acuerdo a la mayoría de los datos publicados y de la información del producto la ingesta concomitante de alimentos no influye en su área bajo la curva (AUC) ni en la concentración sérica máxima y por lo tanto no altera su biodisponibilidad Estudios de bioequivalencia La biodisponibilidad oral de un fármaco es la fracción de la dosis que alcanza la circulación sistémica en forma inalterada. La biodisponibilidad de un fármaco depende de factores fisiológicos, de factores relacionados con las características del principio activo y de factores relacionados con la formulación. El concepto de bioequivalencia se utiliza para establecer la equivalencia terapéutica de dos medicamentos mediante la comparación de su biodisponibilidad. Para asegurar que las conclusiones del estudio dependen solo de las características de los productos administrados, las condiciones del ensayo en todos los periodos del mismo deben ser similares..

Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial

Vitamin D plays a major role in bone health and probably also in multiple extraskeletal acute and chronic diseases. Although supplementation with calcifediol, a vitamin D metabolite, has demonstrated efficacy and safety in short-term clinical trials, its effects after long-term monthly administration have been studied less extensively. This report describes the results of a 1-year, phase III-IV, double-blind, randomized, controlled, parallel, multicenter superiority clinical trial to assess the efficacy and safety of monthly calcifediol 0.266 mg versus cholecalciferol 25,000 IU (0.625 mg) in postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL). A total of 303 women were randomized and 298 evaluated. Patients were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months (Group A1), calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months (Group A2), and cholecalciferol 25,000 IU/month (0.625 mg/month) for 12 months (Group B). By month 4, stable 25(OH)D levels were documented with both calcifediol and cholecalciferol (intention-to-treat population): 26.8 ± 8.5 ng/mL (Group A1) and 23.1 ± 5.4 ng/mL (Group B). By month 12, 25(OH)D levels were 23.9 ± 8.0 ng/mL (Group A1) and 22.4 ± 5.5 ng/mL (Group B). When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 ± 8.7 ng/mL at month 4 versus 14.4 ± 6.0 ng/mL at month 12). No relevant treatment-related safety issues were reported in any of the groups. The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns.This study was funded by Faes Farma, S.A. and Bruno Farmaceutici S.p.A. The authors wish to thank the study participants, research staff, the secondary investigators of the Osteoferol study group, the home nursing staff (Emibet), and Faes Farma clinical research team: Paula Arranz Gutiérrez, Lorena Elgezabal González, Mariana Frau Usoz, and Iñigo Saez Riesco. Medical writing support was provided by Francisco López de Saro (Trialance SCCL), funded by Faes Farma, S.A

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial

Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency

Diverse Large HIV-1 Non-subtype B Clusters Are Spreading Among Men Who Have Sex With Men in Spain

In Western Europe, the HIV-1 epidemic among men who have sex with men (MSM) is dominated by subtype B. However, recently, other genetic forms have been reported to circulate in this population, as evidenced by their grouping in clusters predominantly comprising European individuals. Here we describe four large HIV-1 non-subtype B clusters spreading among MSM in Spain. Samples were collected in 9 regions. A pol fragment was amplified from plasma RNA or blood-extracted DNA. Phylogenetic analyses were performed via maximum likelihood, including database sequences of the same genetic forms as the identified clusters. Times and locations of the most recent common ancestors (MRCA) of clusters were estimated with a Bayesian method. Five large non-subtype B clusters associated with MSM were identified. The largest one, of F1 subtype, was reported previously. The other four were of CRF02_AG (CRF02_1; n = 115) and subtypes A1 (A1_1; n = 66), F1 (F1_3; n = 36), and C (C_7; n = 17). Most individuals belonging to them had been diagnosed of HIV-1 infection in the last 10 years. Each cluster comprised viruses from 3 to 8 Spanish regions and also comprised or was related to viruses from other countries: CRF02_1 comprised a Japanese subcluster and viruses from 8 other countries from Western Europe, Asia, and South America; A1_1 comprised viruses from Portugal, United Kingom, and United States, and was related to the A1 strain circulating in Greece, Albania and Cyprus; F1_3 was related to viruses from Romania; and C_7 comprised viruses from Portugal and was related to a virus from Mozambique. A subcluster within CRF02_1 was associated with heterosexual transmission. Near full-length genomes of each cluster were of uniform genetic form. Times of MRCAs of CRF02_1, A1_1, F1_3, and C_7 were estimated around 1986, 1989, 2013, and 1983, respectively. MRCA locations for CRF02_1 and A1_1 were uncertain (however initial expansions in Spain in Madrid and Vigo, respectively, were estimated) and were most probable in Bilbao, Spain, for F1_3 and Portugal for C_7. These results show that the HIV-1 epidemic among MSM in Spain is becoming increasingly diverse through the expansion of diverse non-subtype B clusters, comprising or related to viruses circulating in other countries

Efficacy and safety of long-term treatment with monthly calcifediol soft capsules in vitamin D deficient patients

Background Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions (such as immunomodulation). In this sense, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, its optimal dosing and treatment duration, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. Objectives To assess the efficacy and safety of long-term treatment with calcifediol soft capsules compared to cholecalciferol (vitamin D3) in vitamin D deficiency. Methods This was a Phase III-IV, double blind, randomised, controlled, multicentre clinical trial. Postmenopausal women with baseline levels of 25(OH)D < 20 ng/ml were randomised 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25 000 IU/month for 12 months. Results 303 patients were enrolled, and 298 were included in the ITT population. There were no significant differences in terms of demographic variables, and the mean basal 25(OH)D levels were 13.2 ± 3.7 ng/ml. After 4 months of treatment, 25(OH)D levels over 30 ng/ml were reached by 4.3 times more patients in calcifediol group than in cholecalciferol group. The superiority of calcifediol over cholecalciferol in terms of increasing 25(OH)D levels was shown throughout the 12 months. However, the biggest difference was observed after the first month of treatment (mean change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in both calcifediol groups combined and in cholecalciferol group, respectively). After month 4, the increase in 25(OH)D levels remained fairly stable during the next 8 months of treatment. However, those patients in the group of calcifediol + placebo, despite having mean 25(OH)D levels of 28.5 ng/ml at month 4, went back to basal levels after withdrawal of treatment (16.1 ± 6.0 ng/ml at month 8 and 14.4 ± 6.0 ng/ml at month 12). Regarding safety, no patient reached 25(OH)D toxic levels (> 100 ng/ml), with 64.4 ng/ml being the highest concentration reported during the study. No relevant treatment-related safety issues were reported in any of the groups studied. Conclusion Calcifediol is efficient, faster and more potent than cholecalciferol in raising 25(OH)D levels. After 4 months of treatment, calcifediol 0.266 mg/month reaches its maximum efficacy within safe 25(OH)D levels, remaining fairly stable when treatment continues. Discontinuation of calcifediol supplementation lowers 25(OH)D levels back to baseline, suggesting that long-term treatment is safe and necessary.Sin financiaciónNo data 2020UE

Study of the antimicrobial activity of cationic carbosilane dendrimers against clinical strains of multidrug-resistant bacteria and their biofilms

IntroductionAntimicrobial Resistance is a serious public health problem, which is aggravated by the ability of the microorganisms to form biofilms. Therefore, new therapeutic strategies need to be found, one of them being the use of cationic dendritic systems (dendrimers and dendrons).MethodsThe aim of this study is to analyze the in vitro antimicrobial efficacy of six cationic carbosilane (CBS) dendrimers and one dendron with peripheral ammonium groups against multidrug-resistant bacteria, some of them isolated hospital strains, and their biofilms. For this purpose, minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC) and minimum eradication biofilm concentration (MBEC) studies were carried out. In addition, the cytotoxicity on Hela cells of those compounds that proved to be the most effective was analyzed.ResultsAll the tested compounds showed in vitro activity against the planktonic forms of methicillin-resistant Staphylococcus aureus and only the dendrimers BDSQ017, BDAC-001 and BDLS-001 and the dendron BDEF-130 against their biofilms. On the other hand, only the dendrimers BDAC 001, BDLS-001 and BDJS-049 and the dendron BDEF-130 were antibacterial in vitro against the planktonic forms of multidrug-resistant Pseudomonas aeruginosa, but they lacked activity against their preformed biofilms. In addition, the dendrimers BDAC-001, BDLS-001 and BDSQ-017 and the dendron BDEF-130 exhibited a good profile of cytotoxicity in vitro.DiscussionOur study demonstrates the possibility of using the four compounds mentioned above as possible topical antimicrobials against the clinical and reference strains of multidrug-resistant bacteria

Active learning based on the resolution of radiological cases of pathology of the locomotor system.

Las estrategias de enseñanza on-line basadas en Tecnologías de la Información y la Comunicación (TIC) se han utilizado con éxito para acercar la práctica clínica de Radiología a los estudiantes de Grado de Medicina durante el curso académico 2020-21. Los alumnos trabajaron por equipos con el método de Aprendizaje Basado en la Resolución de Problemas (ABRP). De esta manera, se aseguró la consecución de los objetivos formativos y se dio a conocer la forma de trabajo del médico radiólogo, el proceso de razonamiento diagnóstico, los sistemas de información de los hospitales y en particular del Picture Archiving and Communication System (PACS).Depto. de Radiología, Rehabilitación y FisioterapiaFac. de MedicinaFALSEsubmitte