ABSTRACT
Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.
ABSTRACT
Prevention of late cardiovascular complications after radiation therapy (RT) for treatment of a malignant tumor is challenging. We report the case of a young male patient with Hodgkin's lymphoma treated with RT, who developed ischemic heart disease during follow-up, although he had no cardiovascular risk factors. We conclude that patients undergoing RT who experience chest pain should be fully investigated for coronary artery disease.
Subject(s)
Coronary Artery Disease/etiology , Coronary Vessels/radiation effects , Hodgkin Disease/radiotherapy , Radiation Injuries/complications , Coronary Artery Disease/surgery , Humans , Male , Radiation Injuries/surgery , Young AdultABSTRACT
A prevenção de complicações cardiovasculares tardias após radioterapia (RT) para tratamento de um tumor maligno é um desafio. Relatamos o caso de um jovem paciente com linfoma de Hodgkin submetido a tratamento com RT que desenvolveu doença cardíaca isquêmica no seguimento, embora não apresentasse fatores de risco cardiovasculares. Concluímos que pacientes submetidos a RT que apresentam dor torácica deveriam ser criteriosamente avaliados em relação à doença arterial coronariana.
Prevention of late cardiovascular complications after radiation therapy (RT) for treatment of a malignant tumor is challenging. We report the case of a young male patient with Hodgkin's lymphoma treated with RT, who developed ischemic heart disease during follow-up, although he had no cardiovascular risk factors. We conclude that patients undergoing RT who experience chest pain should be fully investigated for coronary artery disease.
Subject(s)
Humans , Male , Young Adult , Coronary Artery Disease/etiology , Coronary Vessels/radiation effects , Hodgkin Disease/radiotherapy , Radiation Injuries/complications , Coronary Artery Disease/surgery , Radiation Injuries/surgeryABSTRACT
A 29-year-old white woman with typical angina pectoris presented diastolic dysfunction and was suggestive of isolated non-compaction of the ventricular myocardium (INCM) by echocardiography. Cardiac catheterization disclosed normal coronary arteries. Cardiovascular magnetic resonance (CMR) depicted prominent left ventricular INCM areas with non-compaction/compaction ratio of 3.7, and dipyridamole CMR demonstrated global perfusion defect at stress and normal perfusion at rest. Adenosine-induced vasodilation showed subnormal coronary velocity flow reserve in the right, left circumflex, and left anterior descending coronary arteries. The evidence of our case indicates that patients with INCM may present angina pectoris and, probably, relative chronic myocardial ischaemia related to an impaired microvascular function is responsible for this symptom as demonstrated invasively here. It is a possible mechanism for progressive myocardial dysfunction seen in these patients.
