2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group.

The 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group was coordinated and supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. It is designed to improve patient care and support informed decision making about asthma management in the clinical setting. This update addresses six priority topic areas as determined by the state of the science at the time of a needs assessment, and input from multiple stakeholders:A rigorous process was undertaken to develop these evidence-based guidelines. The Agency for Healthcare Research and Quality's (AHRQ) Evidence-Based Practice Centers conducted systematic reviews on these topics, which were used by the Expert Panel Working Group as a basis for developing recommendations and guidance. The Expert Panel used GRADE (Grading of Recommendations, Assessment, Development and Evaluation), an internationally accepted framework, in consultation with an experienced methodology team for determining the certainty of evidence and the direction and strength of recommendations based on the evidence. Practical implementation guidance for each recommendation incorporates findings from NHLBI-led patient, caregiver, and clinician focus groups. To assist clincians in implementing these recommendations into patient care, the new recommendations have been integrated into the existing Expert Panel Report-3 (EPR-3) asthma management step diagram format.

Cardiometabolic risk factors efficacy of semaglutide in the STEP program.

People with overweight or obesity often suffer from associated cardiometabolic diseases and comorbidities. Current therapies for obesity include lifestyle intervention, bariatric surgery, and pharmacotherapy. The magnitude of weight loss achieved with these therapies can determine the level of improvement in various comorbidities. Once-weekly subcutaneous semaglutide 2.4 mg is a glucagon-like peptide-1 receptor agonist recently approved by the US Food and Drug Administration for the treatment of obesity. This article reviews data from the global phase 3 Semaglutide Treatment Effect in People with obesity (STEP) program, comparing the efficacy of once-weekly subcutaneous semaglutide 2.4 mg versus placebo for weight loss and improvements in cardiometabolic parameters across the STEP 1 to 5 trials. In STEP 1 to 3 and STEP 5, semaglutide led to greater reductions from baseline versus placebo in body weight, waist circumference, body mass index, systolic blood pressure (SBP), and diastolic blood pressure, as well as positive changes in glycated hemoglobin (HbA1c), C-reactive protein, and lipid levels. In STEP 4, all participants had a 20-week run-in period on semaglutide before either continuing on semaglutide or switching to placebo at week 20 in a 2:1 ratio for 48 weeks. At week 68, continued semaglutide led to further reductions from week 20 in HbA1c, improvements in lipid profile, and stabilization of SBP. Overall, across the STEP trials, treatment with semaglutide 2.4 mg versus placebo improved cardiometabolic risk factors associated with obesity, illustrating an effective treatment option for people with overweight (and associated comorbidities) or obesity.

Integrating semaglutide into obesity management - a primary care perspective.

This final article in the supplement aims to summarize a clinical approach for weight management geared toward primary care practitioners, offering practical advice about how to integrate weight management into day-to-day practice. To achieve long-term successful weight loss, a comprehensive multimodal approach is recommended, focusing on both lifestyle modification and appropriate use of therapy. Once-weekly subcutaneous semaglutide 2.4 mg is a novel treatment that can be used as an adjunct to lifestyle modification for the management of overweight and obesity. Key considerations are presented to support its optimal administration in conjunction with lifestyle modification, with a focus on assessing suitability and the importance of dose escalation and monitoring.

Importance of Early Screening and Diagnosis of Chronic Kidney Disease in Patients with Type 2 Diabetes.

It is estimated that one in ten people in the USA have diabetes. Approximately 40% of those with diabetes also develop chronic kidney disease (CKD), which in turn increases their risk of developing cardiovascular disease. Evidence-based recommendations for the treatment of patients with type 2 diabetes (T2D) and concomitant CKD are provided by several medical societies, including the American Diabetes Association (ADA), but in real life are only carried out in fewer than 50% of individuals for whom they are recommended. Screening for CKD is recommended using the spot urine albumin-to-creatinine ratio and estimated glomerular filtration rate in all patients with T2D at the time of diagnosis, and at least annually thereafter. Screening enables early CKD diagnosis, counseling, pharmacologic intervention and, when appropriate, referral to a nephrologist. The ADA guidelines recommend good glycemic and blood pressure control and the use of medications that are kidney protective. Medications shown to slow progression of CKD include renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, glucagon-like peptide 1 receptor agonists and, more recently, non-steroidal mineralocorticoid receptor antagonists. Novel agents with different mechanisms of action are also in development that have the potential to further slow or prevent disease progression when used with currently recommended therapies.

Current evidence for COPD management with dual long-acting muscarinic antagonist/long-acting ß2-agonist bronchodilators.

Long-acting inhaled bronchodilator medications are recommended as initial maintenance therapy for many patients with COPD. These medications include long-acting muscarinic antagonists (LAMA) and long-acting ß2-agonists (LABA). Combinations of long-acting bronchodilator agents (LAMA/LABA) and inhaled corticosteroids combined with LABA (ICS/LABA) are also used as initial or follow-up therapy in patients with more severe symptoms or at risk of COPD exacerbations. This review summarizes the position of LAMA/LABA combinations in treatment recommendations, and the evidence supporting their placement relative to LAMA monotherapy and ICS/LABA combination therapy, as well as differences within the LAMA/LABA class. Most studies show that LAMA/LABA treatment leads to greater improvements in lung function and symptoms than LAMA monotherapy or ICS/LABA treatment. There are fewer studies comparing the impact of different medication classes on patients' risk of exacerbations; however, the available evidence suggests that LAMA/LABA treatment and LAMA monotherapy lead to a similar reduction in exacerbation risk, while the effect of LAMA/LABA compared with ICS/LABA remains unclear. The incidence of adverse events is similar with LAMA/LABA and LAMA alone. There is a lower risk of pneumonia with LAMA/LABA compared with ICS/LABA. This evidence supports the use of LAMA/LABA combinations as an initial maintenance therapy option for symptomatic patients with low exacerbation risk and severe breathlessness or patients with severe symptoms who are at risk of exacerbations, and as follow-up treatment in patients with uncontrolled symptoms or exacerbations on bronchodilator monotherapy.

Primary care of asthma: new options for severe eosinophilic asthma.

Objective: Asthma is a common heterogeneous disease characterized by airway inflammation and bronchoconstriction. Current treatment guidelines provide recommendations for categorizing disease severity, asthma control and management. This paper reviews asthma assessment in primary care and describes the pathophysiology, clinical characteristics and new targeted treatments available for patients with severe eosinophilic asthma. Methods: A non-systematic PubMed literature search was conducted and articles, primarily from the last 5 years, were selected based on relevance to primary care practice, asthma pathophysiology and biologic therapies. Results: Despite optimal therapy including high-dose inhaled corticosteroids (ICS), long-acting ß2-agonists and tiotropium, ∼4-10% of all patients with severe asthma continue to have poor asthma control. These patients have impaired quality of life, frequent exacerbations and are exposed to the side effects of repeated courses of oral steroids. Approximately 50% of patients with severe uncontrolled asthma have eosinophilic asthma, with increased airway expression of type 2 cytokines IL-4, IL-5 and IL-13. Eosinophilic asthma is identified in primary care by having eosinophils ≥150-300 cells/µL on a complete blood count with differential. Conclusions: A new class of agents is available for patients with moderate to severe eosinophilic asthma. Four biologic therapies - mepolizumab, reslizumab, benralizumab and dupilumab - that interfere with the regulation and activity of eosinophils have been approved by the FDA for patients with moderate to severe asthma with an eosinophilic phenotype. Primary care physicians should be familiar with these medications to explain part of the rationale for referral to specialist care and manage patient expectations for treatment.

Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician.

Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the "gold standard" for evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.Funding: Sanofi US, Inc.

Hot Topics in Primary Care: Individualizing Dual Therapy for Type 2 Diabetes Mellitus.

While many advances in the management of patients with type 2 diabetes mellitus (T2DM) have occurred over the past decade, nearly half of patients with diabetes still have a glycated hemoglobin (HbA1c) above the target of 7.0%.

Answers to Clinical Questions in the Primary Care Management of People with Obesity: Lifestyle Management.

Lifestyle modification is not a short-term endeavor, and maintaining a healthy weight requires sustained changes in dietary and physical activity. Intensive behavioral intervention can help modify deep-rooted behaviors and provide the support required to both initiate and maintain the behavioral changes that are needed to achieve weight loss goals.

Pathophysiology, epidemiology, and assessment of obesity in adults.

Obesity is a multifactorial disease that results from a combination of both physiological, genetic, and environmental inputs. Obesity is associated with adverse health consequences, including T2DM, cardiovascular disease, musculoskeletal disorders, obstructive sleep apnea, and many types of cancer. The probability of developing adverse health outcomes can be decreased with maintained weight loss of 5% to 10% of current body weight. Body mass index and waist circumference are 2 key measures of body fat. A wide variety of tools are available to assess obesity-related risk factors and guide management.