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Clinical profile of patients treated with evolocumab in lipid/internal medicine units of Spain. Observational study (RETOSS-IMU).
Masana, L, López Miranda, J, Civeira, F, Reinares, L, Guijarro, C, Plana, N, Cuenca, R, Sánchez, D, Hernández, JL, Andrés, R, et al
Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis. 2020;(5):183-192
Abstract
OBJECTIVE To describe the clinical characteristics, the reasons for initiating therapy, and the effects of treatment in the initial phase of evolocumab availability in lipid/internal medicine units in Spain. METHODS Retrospective, observational study, based on the medical records of consecutive patients initiating treatment with evolocumab (from February 2016 to July 2017) in 20 internal medicine units in Spain. A review was made of the demographic and clinical characteristics of the patients, the lipid lowering treatment, and the evolution of the lipid profiles between 12weeks pre-initiation and 12±4weeks post-initiation of evolocumab. RESULTS A total of 136 patients were analysed, of whom 64.0% were men, and the mean age (standard deviation, SD) was 56.6 (11.5) years. The large majority (75%) had familial hypercholesterolaemia (4 homozygous), and 51.0% of them had suffered at least one cardiovascular event. Atherosclerotic cardiovascular disease (ASCVD) was present in 61% of all patients. At initiation of evolocumab, 61.0% of the patients were taking high-intensity statins, and 60.3% were receiving ezetimibe. The mean (and SD) of LDL-C levels at initiation of evolocumab was 169.1 (56.6) mg/dL. The LDL-C was greater than 160mg/dL in 46.4% of patients, and ≥190mg/dL in 26.5%. During the observation period, evolocumab produced significant reductions in LDL-C of 55.7% (P<.0001), achieving mean values of 74.3mg/dL. At week12, more than half (53.8%) of patients achieved LDL-C levels <70mg/dL, and 26.9% <50mg/dL. CONCLUSIONS In the lipid/internal medicine units, evolocumab was mainly prescribed in patients with familial hypercholesterolaemia, with or without ASCVD. The initial use of evolocumab was in accordance with the guidelines of the Spanish Society of Arteriosclerosis (SEA) of 2016, with LDL-C levels being well above the recommended thresholds for treatment initiation. Evolocumab treatment in clinical practice reduced LDL-C levels by about 55%, a similar reduction to that reported in clinical trials. Most patients achieved LDL-C goals.
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"Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study".
Entrenas Castillo, M, Entrenas Costa, LM, Vaquero Barrios, JM, Alcalá Díaz, JF, López Miranda, J, Bouillon, R, Quesada Gomez, JM
The Journal of steroid biochemistry and molecular biology. 2020;:105751
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Abstract
OBJECTIVE The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19. DESIGN Parallel pilot randomized open label, double-masked clinical trial. SETTING University hospital setting (Reina Sofia University Hospital, Córdoba Spain.) PARTICIPANTS 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1). PROCEDURES All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 h on the first day, and 200 mg every 12 h for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths. RESULTS Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50 %) p value X2 Fischer test p < 0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95 %CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95 %CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged. CONCLUSION Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.
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[Role of the stevia and L-carnitine of a nutritional supplement on glycemic impact in adults].
Angarita Dávila, L, Durán Agüero, S, Apaicio, D, Parra, K, Uzcátegui, M, Céspedes, V, Reina Villasmil, N, López Miranda, J
Nutricion hospitalaria. 2017;(5):1455-1462
Abstract
Currently the food industry has generated interest in non-nutritive sweeteners, for example Stevia and in special components such as L-carnitine, used in formulations of nutritional supplements for glycemic control specific for diabetics. The present study evaluated the effect of stevia and L-carnitine on the glycemic index (GI) and glycemic load (CG) of a nutritional supplement in 19 healthy subjects (9 men and 10 women), who randomly completed 3 consumption tests, 1 for the supplement and 1 for each reference product: Glucose solution (SG) and white bread (PB), obtaining blood samples at the 0, 15, 30, 45, 60, 90 and 120 min times; for measurement of blood glucose, basal and postprandial insulin. The increase area under the glucose curve (IAUC) was lower for supplement 11,778.73 than for reference products (SG) 13,724.06; (PB) 13,153.56 α= p 0.005. IG = (62) and CG = (16) were intermediate and lower than white bread IG = (69) and CG = (18), with no difference in postprandial insulin. This demonstrates that this nutritional supplement formulated with stevia and L-carnitine is able to prolong the glycemic response without increasing the insulin requirements in healthy subjects. Specific studies are required in diabetics to validate whether the glycemic impact is lower than the standard product. The presence of other nutrients in the formula, influential in these indicators, does not allow to infer that the results are due only to the type of sweetener used and the L-carnitine.
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[Glycemic index, glycemic load and insulin response of two formulas of isoglucose with different sweeteners and dietary fiber in healthy adults and type-2 diabetes].
Angarita Dávila, L, López Miranda, J, Aparicio Camargo, D, Parra Zuleta, K, Uzcátegui González, M, Céspedes Nava, V, Durán Agüero, S, Reyna Villasmil, N
Nutricion hospitalaria. 2017;(3):532-539
Abstract
Objective: The aim of this study is to compare the glycemic index (GI) and glycemic load (GL) of two formulas with the same glucose content with different sweeteners and dietary fiber for diabetics in healthy adults and in patients with type-2 diabetes (DM2). Methodology: In this randomized, double-blind crossover research, eleven healthy people and six with DM2 consumed two enteral formulas, Glucerna SR®, Laboratorios Abbott C.A. (GF) and Enterex Diabetic®, Victus C.A. (EF), sweetened with fructose y sucralose, with 1.2 and 1.3 g/100 ml of fiber source respectively (four times). Additionally, they consumed glucose solution once, obtaining blood samples at 0, 15, 30, 45, 60, 90 and 120 min for controls; in the diabetics, minutes 150 and 180 were added for measuring blood glucose, basal and postprandial insulin after two and three hours. Results: The incremental area under the curve (IAUC) was lower for the formulas rather than for SG. In the healthy controls was 12,857 ± 422 for EF and 11,601 ± 272 for GF (p < 0.014). In diabetics, this curve reduced for GF (28,656 ± 123) compared to EF (29,855 ± 496) (p < 0.01). The IG resulted in 58.07 ± 8.4 and 60.7 ± 2 for GF and EF, respectively, in the controls, and 65.16 ± 0.2 and 68.06 ± 1 in diabetics, without significant differences, as well as in post-prandial insulin. Conclusions: The GI and the GL of the two formulas resulted in an intermediate value in both groups, with a glycemic profile inferior to SG. No significant differences were observed regarding insulin behavior, showing that the absorption rate of carbohydrates in these formulas is slower, with a lower glycemic impact than the pattern product; thus, making its indication acceptable for the diabetic patient.