Document No. : FDA/SMC/CTD/GL-CCT/2013/01
This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field
application rates of new molluscicide products for control of schistosomiasis.
Patients with diabetes are at increased risk of developing cardiovascular disease (CVD) with its manifestations of coronary artery disease (CAD), heart failure (HF), atrial fibrillation (AF), and stroke, as well as aortic and peripheral artery diseases. In addition, diabetes is a major risk factor f...or developing chronic kidney disease (CKD), which in itself is associated with developing CVD. The combination of diabetes with these cardio-renal comorbidities enhances the risk not only for cardiovascular (CV) events but also for CV and all-cause mortality. The current European Society of Cardiology (ESC) Guidelines on the management of cardiovascular disease in patients with diabetes are designed to guide prevention and management of the manifestations of CVD in patients with diabetes based on data published until end of January 2023. Over the last decade, the results of various large cardiovascular outcome trials (CVOTs) in patients with diabetes at high CV risk with novel glucose- lowering agents, such as sodium–glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), but also novel non-steroidal mineralocorticoid receptor antagonists (MRAs), such as finerenone have substantially expanded available therapeutic op-
tions, leading to numerous evidence-based recommendations for the management of this patient population.
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Diabetes mellitus (DM) is a global epidemic with significant morbidity. Diabetic
retinopathy (DR) is the specific microvascular complication of DM and affects 1 in 3 persons with DM. DR remains a leading cause of vision loss in working adult populations. Patients with severe levels of DR are report...ed to have poorer quality of life and reduced levels of physical, emotional, and social well-being, and they utilize more health care resources.
Epidemiological studies and clinical trials have shown that optimal control of blood glucose, blood pressure, and blood lipids can reduce the risk of developing retinopathy and slow its progression. Timely treatment with laser photocoagulation, and increasingly, the appropriate use of intraocular administration of vascular endothelial growth factor (VEGF) inhibitors can prevent visual loss in vision- threatening retinopathy, particularly diabetic macular edema (DME). Since visual loss may not be present in the earlier stages of retinopathy, regular screening of persons with diabetes is essential to enable early intervention.
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BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE...COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
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Interim guidance 2 march 2021
Current use of drugs to prevent COVID-19 is variable, reflecting large-scale uncertainty. Numerous randomized trials of many different drugs are underway to inform practice. This first version of the Drugs to prevent COVID-19: A WHO living guideline contains new inform...ation and a recommendation on hydroxychloroquine. It follows the publication of six trials synthesized in a living network meta-analysis (NMA).
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Each year, ≈795 000 individuals in the United States experience a stroke, of which 87% (690 000) are ischemic and 185 000 are recurrent.1 Approximately 240 000 individuals experience a transient ischemic attack (TIA) each year.2 The risk of recurrent stroke or TIA is high but can be mitiga...ted with appropriate secondary stroke prevention. In fact, cohort studies have shown a reduction in recurrent stroke and TIA rates in recent years as secondary stroke prevention strategies have improved.3,4 A meta-analysis of randomized controlled trials (RCTs) of secondary stroke prevention therapies published from 1960 to 2009 showed a reduction in annual stroke recurrence from 8.7% in the 1960s to 5.0% in the 2000s, with the reduction driven largely by improved blood pressure (BP) control and use of antiplatelet therapy.5 The changes may have been influenced by changes in diagnostic criteria and differing sensitivities of diagnostic tests over the years.
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WHO has updated its guidelines for COVID-19 therapeutics, with revised recommendations for patients with non-severe COVID-19. This is the 13th update to these guidelines.
Updated risk rates for hospital admission in patients with non-severe COVID-19
The guidance includes updated risk rates for... hospital admission in patients with non-severe COVID-19.
The current COVID-19 virus variants tend to cause less severe disease while immunity levels are higher due to vaccination, leading to lower risks of severe illness and death for most patients.
This update includes new baseline risk estimates for hospital admission in patients with non-severe COVID-19. The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease. The updated risk estimates will assist healthcare professionals to identify individuals at high, moderate or low risk of hospital admission, and to tailor treatment according to WHO guidelines:
**High: **People who are immunosuppressed remain at higher risk if they contract COVID-19, with an estimated hospitalization rate of 6%.
**Moderate: **People over 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.
Low: Those who are not in the high or moderate risk categories are at low risk of hospitalization (0.5%). Most people are low risk.
Review of COVID-19 treatments for people with non-severe COVID-19
WHO continues to strongly recommend nirmatrelvir-ritonavir (also known by its brand name ‘Paxlovid’) for people at high-risk and moderate risk of hospitalization. The recommendations state that nirmatrelvir-ritonavir is considered the best choice for most eligible patients, given its therapeutic benefits, ease of administration and fewer concerns about potential harms. Nirmatrelvir-ritonavir was first recommended by WHO in April 2022.
If nirmatrelvir-ritonavir is not available to patients at high-risk of hospitalization, WHO suggests the use of molnupiravir or remdesivir instead.
WHO suggests against the use of molnupiravir and remdesivir for patients at moderate risk, judging the potential harms to outweigh the limited benefits in patients at moderate risk of hospital admission.
For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol.
WHO also recommends against use of a new antiviral (VV116) for patients, except in clinical trials.
The update also includes a strong recommendation against the use of ivermectin for patients with non-severe COVID-19. WHO continues to advise that in patients with severe or critical COVID-19, ivermectin should only be used in clinical trials.
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Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This s...tudy aimed to test both interventions in low-income and middle-income countries.
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Clinical management standard operating procedures.
Ebola virus disease (EVD) is a life-threatening multisystem illness associated with fever and gastrointestinal (GI) symptoms that frequently leads to hypovolaemia, metabolic acidosis, hypoglycaemia, and multi-organ failure. The prolonged 2013–201...6 EVD outbreak in West Africa allowed for an evolution of care such that by outbreak end many patients received individualized and optimized supportive care (oSoC), including volume resuscitation, symptom control, laboratory and bedside monitoring of glucose, electrolyte levels and organ dysfunction, as well as rapid detection and treatment of co-infections, potentially contributing to the downward trend in the case fatality rate (CFR).
This guidance should serve as a foundation for oSoC that should be followed to ensure both the best possible chance for survival and allow for reliable comparison of investigational therapeutic interventions as part of a randomized controlled trial. This guideline provides recommendations for the management of adults and children.
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The article from the African Journal of Thoracic and Critical Care Medicine provides updated guidelines on endoscopic lung volume reduction (ELVR) for treating advanced emphysema, a severe form of chronic obstructive pulmonary disease (COPD), which is prevalent in South Africa and other low- and mid...dle-income countries. The guidelines focus on identifying suitable patients based on specific criteria, such as age, lung function, and the presence of hyperinflation, while ruling out contraindications like pulmonary hypertension and recent smoking.
ELVR aims to reduce lung volume in the most damaged areas, improving breathing mechanics and quality of life. Various devices, including endobronchial valves, intrabronchial valves, and coils, are reviewed with evidence from clinical trials supporting their use. The guidelines emphasize careful patient selection and recommend only performing ELVR in specialized centers due to its high cost and risk of complications, such as pneumothorax.
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The Asthma Control Questionnaire (ACQ)1 was developed and validated to measure the primary clinical goal of asthma management as identified by international guidelines. They indicate that to achieve good control, treatment should minimise day and night time symptoms, activity limitation, airway narr...owing and rescue bronchodilator use and thus reduce the risk of life-threatening exacerbations and long-term morbidity. The importance of including all aspects of control in the assessment of individual patients was emphasised by a recent factor analysis which showed that clinical asthma is composed of distinct components which are not closely correlated with each other.6 However, in some studies it may not be possible to collect airway calibre or short-acting β2-agonists data. Previous analysis of non-clinical trial data suggested that when ACQ scores are analysed as group data, the heterogeneity of the way in which individual patients present with inadequate control is lost in the estimation of the mean and the need to measure each individual component of asthma control may become unnecessary. In this analysis, ACQ data from a clinical trial was used to evaluate the measurement properties (reliability, responsiveness, validity and interpretability), of three shortened versions of the ACQ. In addition, we have examined whether the precision and accuracy of estimating the effect of the intervention on asthma control was maintained when the two questions concerning airway calibre and short-acting β2-agonists use were omitted from the trial analysis.
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The cardiovascular disease continuum begins with risk factors such as diabetes mellitus (DM), progresses to vasculopathy and myocardial dysfunction, and finally ends with cardiovascular death. Diabetes is associated with a 2- to 4-fold increased risk for heart failure (HF). Moreover, HF patients wit...h DM have a worse prognosis than those without DM. Diabetes can cause myocardial ischemia via micro- and macrovasculopathy and can directly exert deleterious effects on the myocardium. Hyperglycemia, hyperinsulinemia, and insulin resistance can cause alterations in vascular homeostasis. Then, reduced nitric oxide and increased reactive oxygen species levels favor inflammation leading to atherothrombotic progression and myocardial dysfunction. The classification, diagnosis, and treatment of HF for a patient with and without DM remain the same. Until now, drugs targeting neurohumoral and metabolic pathways improved mortality and morbidity in HF with reduced ejection fraction (HFrEF). Therefore, all HFrEF patients should receive guideline-directed medical therapy. By contrast, drugs modulating neurohumoral activity did not improve survival in HF with preserved ejection fraction (HFpEF) patients. Trials investigating whether sodium-glucose cotransporter-2 inhibitors are effective in HFpEF are on-going. This review will summarize the epidemiology, pathophysiology, and treatment of HF in diabetes.
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