Alirocumab and Coronary Atherosclerosis in Asymptomatic Patients with Familial Hypercholesterolemia: The ARCHITECT Study.

BACKGROUND: The effect of alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, on coronary plaque burden in patients with familial hypercholesterolemia has not been addressed. Our aim was to assess changes in coronary plaque burden and its characteristics after treatment with alirocumab by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of a noninvasive analysis of coronary computed tomographic angiography in asymptomatic subjects with familial hypercholesterolemia receiving optimized and stable treatment with maximum tolerated statin dose with or without ezetimibe. METHODS: This study is a phase IV, open-label, multicenter, single-arm clinical trial to assess changes in coronary plaque burden and its characteristics after 78 weeks of treatment with alirocumab in patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. Participants underwent an initial coronary computed tomographic angiography at baseline and another at 78 weeks. Every patient received 150 mg of alirocumab subcutaneiously every 14 days in addition to high-intensity statin therapy. The main outcome was the change on coronary plaque burden and its characteristics by quantification and characterization of atherosclerotic plaque throughout the coronary tree on the basis of analysis of coronary computed tomographic angiography. RESULTS: The study was completed by 104 patients. The median age was 53.3 (46.2-59.4) years. Of these patients, 54 were women (51.9%). Median low-density lipoprotein cholesterol was 138.9 (117.5-175.3) mg/dL at entry and 45.0 (36.0-65.0) mg/dL at follow-up (P<0.001). Coronary plaque burden changed from 34.6% (32.5%-36.8%) at entry to 30.4% (27.4%-33.4%) at follow-up (P<0.001). A significant change in the characteristics of the coronary atherosclerosis was also found: an increase in the proportion of calcified (+0.3%; P<0.001) and mainly fibrous (+6.2%; P<0.001) plaque, accompanied by a decrease in the percentage of fibro-fatty (-3.9%; P<0.001) and necrotic plaque (-0.6%; P<0.001). CONCLUSIONS: Treatment with alirocumab in addition to high-intensity statin therapy resulted in significant regression of coronary plaque burden and plaque stabilization on coronary computed tomographic angiography over 78 weeks in these groups of patients with familial hypercholesterolemia without clinical atherosclerotic cardiovascular disease. ARCHITECT (Effect of Alirocumab on Atherosclerotic Plaque Volume, Architecture and Composition) could link and explain ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) results. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05465278.

Previous Vitamin D Supplementation and Morbidity and Mortality Outcomes in People Hospitalised for COVID19: A Cross-Sectional Study.

Aim: The study aim was to assess the association of vitamin D supplementation before hospital admission and severe outcomes in subjects admitted for COVID-19. Methods: We performed a cross-sectional analysis of pseudonymised medical record data from subjects admitted to the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) for COVID-19 during March and April 2020. The composite primary study outcome was defined as death and/or invasive mechanical ventilation (IMV). Association between risk factors and study outcomes was evaluated by bivariate analysis, followed by logistic regression analysis. Results: In total, 1,267 persons were hospitalised during the observation period. Overall, 14.9% of the subjects were on active vitamin D supplementation treatment before admission. The subjects in the vitamin D group were significantly older than subjects without vitamin D supplementation. We observed higher rates of the primary outcome (death and/or IMV) among the persons with previous use of vitamin D (30.1 vs. 22.9% in those not receiving treatment). In the bivariate analysis, previous use of vitamin D was positively associated with death and/or IMV [odds ratio (OR): 1.45 95% CI: 1.03; 2.04]; however, after adjustment for other risk factors this association disappeared (OR: 1.09 95%CI: 0.65; 1.81). Conclusion: We did not find an association between vitamin D supplementation before hospital admission and death and/or IMV in subjects admitted for COVID-19. The age and the burden of age-associated comorbidities were independently associated with the in-hospital events.

Hipertensión arterial resistente sin lesión de órgano diana: un nuevo caso de síndrome de Munchausen / Resistant hypertension and no organ damage: a new case of Munchausen syndrome

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