Background
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
Methods
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
Results
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P=1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P=1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
Conclusions
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number,
NCT04322123
.)
Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and it is associated with other medical conditions such as diabetes mellitus, metabolic syndrome, and obesity. The mechanisms of the underlying disease development and progression are not completely established and there is no consensus concerning the pharmacological treatment. In the gold standard treatment for NAFLD weight loss, dietary therapy, and physical activity are included. However, little scientific evidence is available on diet and/or physical activity and NAFLD specifically. Many dietary approaches such as Mediterranean and DASH diet are used for treatment of other cardiometabolic risk factors such as insulin resistance and type-2 diabetes mellitus (T2DM), but on the basis of its components their role in NAFLD has been discussed. In this review, the implications of current dietary and exercise approaches, including Brazilian and other guidelines, are discussed, with a focus on determining the optimal nonpharmacological treatment to prescribe for NAFLD.
Background
Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIetaCArdioprotetoraBrasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI).
Methods
DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data.
Discussion
It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br.
Trial registration
ClinicalTrials.gov Identifier NCT03728127. First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.
Cardiovascular disease (CVD) is the leading cause of mortality worldwide and hypertension is one of the main cardiovascular risk factors. A large body of evidence have demonstrated the increased risk for CVD and mortality associated with uncontrolled hypertension and also the benefits of an adequate blood pressure (BP) control. In some cases, lack of adherence to treatment found during the evaluation of a subject with poor BP control may be part of a more complex scenario, as depression. It is known that individuals with depression have a higher risk of CVD-related morbidity and mortality, and early diagnosis and treatment have beneficial effects.
Hypertension is a well established cardiovascular risk factor and its deleterious effects had already been largely studied. Although the benefits of adequate blood pressure (BP) control have already been demonstrated, the prevalence of persons who fail to achieve such control is alarming. A number of causes for uncontrolled hypertension can be listed. According to recent guidelines, obstructive sleep apnea (OSA) is an important, although neglected cause of hypertension that is resistant to optimal medical therapy. Specific treatment for OSA with continuous positive airway pressure (CPAP) can be a helpful adjunct to conventional pharmacological therapy to attain controlled BP levels.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.