Background The role of ivermectin in the treatment of COVID-19 is still under debate, yet the drug has been widely used in some parts of the world, as shown by impressive market data. The available body of evidence may have changed over the last months, as studies have been retracted and “standards of care” (SOC) used in control groups have changed with rapidly evolving knowledge on COVID-19. This review aims to summarize and critically appraise the evidence of randomized controlled trials (RCTs) of ivermectin, assessing clinical outcomes in COVID-19 patients. Methods RCTs evaluating the effects of ivermectin in adult patients with COVID-19 were searched through June 22, 2022, in four databases, L.OVE platform, clinical trial registries and pre-prints platforms. Primary endpoints included all-cause mortality and invasive ventilation requirement. Secondary endpoint was the occurrence of adverse events. Risk of bias was evaluated using the Cochrane Risk of Bias 2.0 tool. Meta-analysis included only studies which compared ivermectin to placebo or SOC. Random-effects were used to pool the risk ratios (RRs) of individual trials. The quality of evidence was evaluated using GRADE. The protocol was register in PROSPERO (CRD42021257471). Results Twenty-five RCTs fulfilled inclusion criteria (n = 6310). Of those, 14 compared ivermectin with placebo, in night ivermectin associated with SOC was compared to SOC and two studies compared ivermectin to an active comparator. Most RCTs had some concerns or high risk of bias, mostly due to lack of concealment of the randomization sequence and allocation, lack of blinding and high number of missing cases. Ivermectin did not show an effect in reducing mortality (RR = 0.76; 95%CI: 0.52–1.11) or mechanical ventilation (RR = 0.74; 95%CI: 0.48–1.16). This effect was consistent when comparing ivermectin vs. placebo, and ivermectin associated with SOC vs. SOC, as well as in sensitivity analysis. Additionally, there was very low quality of evidence regarding adverse effects (RR = 1.07; 95%CI: 0.84–1.35). Conclusions The evidence suggests that ivermectin does not reduce mortality risk and the risk of mechanical ventilation requirement. Although we did not observe an increase in the risk of adverse effects, the evidence is very uncertain regarding this endpoint.
Background: The role of ivermectin in the treatment of COVID-19 is still under debate, yet the drug has been widely used in some parts of the world, as shown by impressive market data and ivermectin-related adverse event reports. The available body of evidence may have changed over the last months, as studies have been retracted and "standards of care" (SOC) used in control groups have changed with rapidly evolving knowledge on COVID-19 rapidly. This review aims to summarize and critically appraise the evidence of randomized controlled trials (RCTs) of ivermectin, assessing clinical outcomes in COVID-19 patients.Methods: RCTs evaluating the effects of ivermectin in adult patients with COVID-19 were searched through December 14, 2021, in four databases, L.OVE platform, clinical trial registries and pre-prints platforms. Primary endpoints included all-cause mortality and invasive ventilation requirement. Secondary endpoint was the occurrence of adverse events. Risk of bias was evaluated using the Cochrane Risk of Bias 2.0 tool. Random-effects were used to pool the risk ratios (RRs) of individual trials. The quality of evidence was evaluated using GRADE. Subgroup and sensitivity analysis were performed. The protocol was register in PROSPERO (CRD42021257471)Results: Twenty-one RCTs fulfilled inclusion criteria (n=2592). Of those, 12 compared ivermectin with placebo and in seven ivermectin associated with SOC was compared to SOC. Most RCTs had some concerns or high risk of bias, mostly due to lack of concealment of the randomization sequence and allocation, lack of blinding and high number of missing cases. Ivermectin did not show an effect in reducing mortality (RR=0.76; 95%CI:0.44 to 1.32) or mechanical ventilation (RR=0.83; 95%CI:0.31 to 2.22) in COVID-19 patients. This effect was consistent when comparing ivermectin vs. placebo, and ivermectin associated with SOC vs. SOC, as well as in sensitivity analysis. Additionally, there was very low quality of evidence regarding adverse effects (RR=0.95; 95%CI: 0.86 to 1.04).Conclusions: The evidence suggests that ivermectin does not reduce mortality risk and the risk of mechanical ventilation requirement. Although we did not observe an increase in the risk of adverse effects, the evidence is very uncertain regarding this endpoint.Funding: Research agencies FAPEMIG and CNPq.
Introduction: During the COVID-19 pandemic, social isolation led to a reduction in the number of consultations of patients with hypertension and diabetes mellitus (DM) , which may cause serious complications. Objective: To assess the effect of the pandemic on the control of hypertension and DM in primary care. Additionally, to develop and assess usability of a digital solution to improve patient monitoring. Methods: Quasi-experimental study. Patients ≽30 years-old with diagnosis of hypertension or DM from 34 primary health care centers from 10 Brazilian municipalities were assessed from Jun/2017 to Dec/2020. Data on the number of consultations, systolic, diastolic blood pressure (SBP, DBP) and glycohemoglobin levels were collected. A decision support system (DSS) was developed, to be used by community health workers (CHW), to identify patients with uncontrolled diseases during household visits. Software usability was assessed by a panel of experts. Results: From 5,070 patients (mean age 56.0 [IQR 48.0-62.0], 66.4% women), 94.9% had hypertension and 27.0% DM. There was a significant reduction in the weekly number of consultations before vs. after social restriction, (107 [IQR 60, 153] vs (20 [IQR 7, 29]), p<0.001). Only 772 patients (15.2%) returned for consultation since the beginning of the pandemic. They had lower SBP (120.0, IQR 120.0-140.0 mmHg) and DBP (80.0, IQR 80.0-80.0 mmHg), comparing to individuals who did not return (SBP: 130.0, IQR 120.0-140.0 mmHg; DBP: 80.0, IQR 80.0-90.0 mmHg; p<0.001). There was no difference in glycohemoglobin levels. The expert panel agreed the DSS may identify patients at risk, and can be incorporated into the CHW routine. Up to March 2021, over 17,000 registries were performed using the app. Conclusion: COVID-19 pandemic caused a significant reduction in the number of consultations of patients with hypertension and DM in PHC. The DSS was considered useful, and it was well accepted by the CHW.
Background Although dementia has emerged as an important risk factor for severe SARS-CoV-2 infection, results on COVID-19-related complications and mortality are not consistent. We examined the clinical presentations and outcomes of COVID-19 in a multicentre cohort of in-hospital patients, comparing those with and without dementia. Methods This retrospective observational study comprises COVID-19 laboratory-confirmed patients aged ≥60 years admitted to 38 hospitals from 19 cities in Brazil. Data were obtained from electronic hospital records. A propensity score analysis was used to match patients with and without dementia (up to 3:1) according to age, sex, comorbidities, year and hospital of admission. Our primary outcome was in-hospital mortality. We also assessed admission to the intensive care unit (ICU), invasive mechanical ventilation (IMV), kidney replacement therapy (KRT), sepsis, nosocomial infection, and thromboembolic events. Results Among 8,947 eligible patients, 405 (4.5%) had a diagnosis of dementia and were matched with 1,151 patients without dementia. Compared to a group of similar demographics and comorbidities, patients with dementia presented a lower duration of symptoms (5.0 vs. 7.0 days; p<0.001) and frequency of dyspnoea, cough, myalgia, headache, ageusia, and anosmia. Fever and delirium were more frequent in patients with dementia than the control group. Patients with dementia also received more palliative care than the control group. Dementia was associated with lower admission (32.7% vs. 47.1%, p<0.001) and length of stay (7 vs. 9 days, p<0.026) in the ICU, frequency of sepsis (17% vs. 24%, p=0.005), KRT (6.4% vs. 13%, p<0.001), and IVM (4.6% vs. 9.8%, p=0.002). We did not find differences in hospital mortality among those with and without dementia. Conclusion Clinical manifestations of COVID-19 differ in older patients with and without dementia in the hospital, with delirium being highly prevalent among those with dementia. Our findings indicate that dementia alone might not explain higher short-term mortality after severe COVID-19. Clinicians should include other risk factors such as acute morbidity severity and baseline frailty when evaluating the prognosis of COVID-19 in the hospital.
Background Warfarin remains the most affordable oral anticoagulant in many countries. However, it may have serious side effects, and the success of the therapy depends on the patient’s understanding of the medication and their adherence to treatment. The use of short messages services (SMS) is a strategy that can be used to educate patients, but there are no studies evaluating this intervention in patients taking warfarin. Therefore, we aimed to develop, implement, and assess the feasibility of an intervention using SMS to primary care patients taking warfarin in a medium-sized Brazilian city. Methods A bank of 79 SMS was drafted and validated by an expert panel. During 6 months, three times a week, patients received messages about anticoagulation with warfarin. At baseline and after 3 months, we assessed their knowledge and adherence with validated instruments. At the end of the follow-up, participants answered a satisfaction questionnaire. Subsequently, a scale-up phase was conducted, with another round of the intervention including 82 participants (29 from the first phase and 53 newly recruited). Seven months after the end of the scale-up, we asked the patients for their insights about the long-term effects of this program. All patients signed informed consent. The study was approved by the Research and Ethics committee of the Universidade Federal de Minas Gerais. Results In the pilot, 33 (89.2%) patients completed the follow-up. Among the participants who answered the satisfaction questionnaire (n = 29), 86.2% considered that the intervention motivated a healthy lifestyle and improved their understanding of warfarin therapy. All patients were willing to continue receiving the messages. Adherence measured by the Measure of Adherence to Treatment (MAT) test was high in the pre-intervention assessment and remained high (96.7% vs. 93.3%; p = 1.0000). The proportion of patients who achieved > 75% correct answers on the Oral Anticoagulation Knowledge (OAK) test increased from 6.5% to 25.6, p = 0.0703. In the scale-up, 23 patients answered the long-term assessment questionnaire. The main long-term knowledge reported was dietary information. Nine patients received the messages but did not remember their content. Conclusion The intervention was well-accepted and had a positive impact on patient’s knowledge about oral anticoagulation therapy. The scale-up assessment reinforced the need to constantly monitor digital interventions.
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