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Semaglutide vs Endoscopic Sleeve Gastroplasty for Weight Loss

Author/s: 
Haseeb, M., Chhatwal, J., Xiao, J., Jirapinyo, P., Thompson, C.C.

Importance: Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making.

Objective: To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity.

Design, setting, and participants: This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life.

Interventions: Strategies included treatment with semaglutide and ESG.

Main outcomes and measures: Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed.

Results: The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591.

Conclusions and relevance: This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.

Keywords 
weight loss obesity obesity surgery gastroplasty

Recommendations on screening for primary prevention of fragility fractures

Author/s: 
Thériault, G., Limburg, H., Klarenbach, S., Reynolds, D. L., Riva, J. J., Thombs, B. D., Tessier, L. A., Grad, R., Wilson, B. J., Canadian Task Force on Preventive Health Care

Background: Fragility fractures are a major health concern for older adults and can result in disability, admission to hospital and long-term care, and reduced quality of life. This Canadian Task Force on Preventive Health Care (task force) guideline provides evidence-based recommendations on screening to prevent fragility fractures in community-dwelling individuals aged 40 years and older who are not currently on preventive pharmacotherapy.

Methods: We commissioned systematic reviews on benefits and harms of screening, predictive accuracy of risk assessment tools, patient acceptability and benefits of treatment. We analyzed treatment harms via a rapid overview of reviews. We further examined patient values and preferences via focus groups and engaged stakeholders at key points throughout the project. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to determine the certainty of evidence for each outcome and strength of recommendations, and adhered to Appraisal of Guidelines for Research and Evaluation (AGREE), Guidelines International Network and Guidance for Reporting Involvement of Patients and the Public (GRIPP-2) reporting guidance.

Recommendations: We recommend "risk assessment-first" screening for prevention of fragility fractures in females aged 65 years and older, with initial application of the Canadian clinical Fracture Risk Assessment Tool (FRAX) without bone mineral density (BMD). The FRAX result should be used to facilitate shared decision-making about the possible benefits and harms of preventive pharmacotherapy. After this discussion, if preventive pharmacotherapy is being considered, clinicians should request BMD measurement using dual-energy x-ray absorptiometry (DXA) of the femoral neck, and re-estimate fracture risk by adding the BMD T-score into FRAX (conditional recommendation, low-certainty evidence). We recommend against screening females aged 40-64 years and males aged 40 years and older (strong recommendation, very low-certainty evidence). These recommendations apply to community-dwelling individuals who are not currently on pharmacotherapy to prevent fragility fractures.

Interpretation: Risk assessment-first screening for females aged 65 years and older facilitates shared decision-making and allows patients to consider preventive pharmacotherapy within their individual risk context (before BMD). Recommendations against screening males and younger females emphasize the importance of good clinical practice, where clinicians are alert to changes in health that may indicate the patient has experienced or is at higher risk of fragility fracture.

Keywords 
fractures fragility fractures aged risk assessment Canada

Heart Failure With Preserved Ejection Fraction

Author/s: 
Redfield, Margaret, Borlaug, Barry

Importance Heart failure with preserved ejection fraction (HFpEF), defined as HF with an EF of 50% or higher at diagnosis, affects approximately 3 million people in the US and up to 32 million people worldwide. Patients with HFpEF are hospitalized approximately 1.4 times per year and have an annual mortality rate of approximately 15%.

Observations Risk factors for HFpEF include older age, hypertension, diabetes, dyslipidemia, and obesity. Approximately 65% of patients with HFpEF present with dyspnea and physical examination, chest radiographic, echocardiographic, or invasive hemodynamic evidence of HF with overt congestion (volume overload) at rest. Approximately 35% of patients with HFpEF present with “unexplained” dyspnea on exertion, meaning they do not have clear physical, radiographic, or echocardiographic signs of HF. These patients have elevated atrial pressures with exercise as measured with invasive hemodynamic stress testing or estimated with Doppler echocardiography stress testing. In unselected patients presenting with unexplained dyspnea, the H2FPEF score incorporating clinical (age, hypertension, obesity, atrial fibrillation status) and resting Doppler echocardiographic (estimated pulmonary artery systolic pressure or left atrial pressure) variables can assist with diagnosis (H2FPEF score range, 0-9; score >5 indicates more than 95% probability of HFpEF). Specific causes of the clinical syndrome of HF with normal EF other than HFpEF should be identified and treated, such as valvular, infiltrative, or pericardial disease. First-line pharmacologic therapy consists of sodium-glucose cotransporter type 2 inhibitors, such as dapagliflozin or empagliflozin, which reduced HF hospitalization or cardiovascular death by approximately 20% compared with placebo in randomized clinical trials. Compared with usual care, exercise training and diet-induced weight loss produced clinically meaningful increases in functional capacity and quality of life in randomized clinical trials. Diuretics (typically loop diuretics, such as furosemide or torsemide) should be prescribed to patients with overt congestion to improve symptoms. Education in HF self-care (eg, adherence to medications and dietary restrictions, monitoring of symptoms and vital signs) can help avoid HF decompensation.

Conclusions and Relevance Approximately 3 million people in the US have HFpEF. First-line therapy consists of sodium-glucose cotransporter type 2 inhibitors, exercise, HF self-care, loop diuretics as needed to maintain euvolemia, and weight loss for patients with obesity and HFpEF.

Keywords 
heart failure glucose Stroke Volume physical exertion hospitalization

Diagnosis and management of endometriosis

Author/s: 
Allaire, Catherine, Bedaiwy, Mohamed, Yong, Paul

Endometriosis is a chronic condition defined by the presence of endometrial-like tissue outside of the uterus, which can lead to estrogen-driven inflammation. The extent of disease can be highly variable, ranging from minimal peritoneal deposits to deep disease that can invade into the bowel, bladder and ureter and, more rarely, spread to extrapelvic (e.g., cutaneous, thoracic) sites. Endometriosis is a complex disease that has considerable impact on the quality of life of those affected and that has no cure. It remains poorly understood. We review the epidemiology, pathophysiology, diagnosis and management of endometriosis, based on the best available evidence and clinical guidelines

Keywords 
female Endometriosis ureter Inflammation

Cost-effectiveness of management strategies in recurrent acute otitis media

Author/s: 
Noorbakhsh, K. A., Liu, H., Kurs-Lasky, M., Smith, K. J., Hoberman, A., Shakh, N.

Objective: To evaluate the cost-effectiveness of tympanostomy tube placement vs. nonsurgical medical management, with the option of tympanostomy tube placement in the event of treatment failure, in children with recurrent acute otitis media (AOM).

Study design: A Markov decision model compared management strategies in children ages 6 to 35 months, using patient-level data from a recently completed, multicenter, randomized clinical trial of tympanostomy tube placement vs. medical management. The model ran over a two-year time horizon using a societal perspective. Probabilities, including risk of AOM symptoms, were derived from prospectively collected patient diaries. Costs and quality-of-life measures were derived from the literature. We performed one-way and probabilistic sensitivity analyses, and secondary analyses in predetermined low- and high-risk subgroups. The primary outcome was incremental cost per quality-adjusted life-year gained.

Results: Tympanostomy tubes cost $989 more per child than medical management. Children managed with tympanostomy tubes gained 0.69 more quality-adjusted life-days than children managed medically, corresponding to $520,855 per quality-adjusted life-year gained. Results were sensitive to the costs of oral antibiotics, missed work, special childcare, the societal cost of antibiotic resistance, and the quality of life associated with AOM. In probabilistic sensitivity analyses, medical management was favored in 66% of model iterations at a willingness-to-pay threshold of $100,000/quality-adjusted life-year. Medical management was preferred in secondary analyses of low- and high-risk subgroups.

Conclusions: For young children with recurrent AOM, the additional cost associated with tympanostomy tube placement outweighs the small improvement in quality of life. Medical management for these children is an economically reasonable strategy.

Keywords: acute otitis media; economic analysis; tympanostomy tubes.

Keywords 
Recurrent acute otitis media ear infections Tympanostomy tube placement nonsurgical medical management acute otitis media

Individualized antidepressant therapy in patients with major depressive disorder: Novel evidence-informed decision support tool

Author/s: 
Chin, T., Huyghebaert, T., Svrcek, C., Oluboka, O.

Objective: To introduce a visual clinical decision support tool to assist with individualizing first-line antidepressant pharmacotherapy for adults with major depressive disorder (MDD) in a Canadian context.

Sources of information: A literature review was conducted with Google Scholar, PubMed, the Cochrane Database of Systematic Reviews, and Trip Pro using the MeSH headings depression, antidepressive agents, primary care, practice patterns, medication adherence, and decision making, shared.

Main message: Major depressive disorder affects about 4.7% of Canadians annually and is a prevalent condition encountered and diagnosed in primary care. Untreated depression is associated with decreased quality of life, increased risk of suicide, and worsening physical health outcomes when depression co-occurs with other chronic medical conditions. In a network meta-analysis, antidepressant medications (such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, bupropion, and vortioxetine) reduced depressive symptoms by 50% or more when compared with placebo in acute treatment of adults with moderate to severe MDD. Poor treatment adherence and high discontinuation rates limit MDD treatment success. Factors such as strong therapeutic alliances between patients and prescribers, collaborative care, patient education, and supportive self-management have been shown to enhance treatment adherence. The most recent Canadian Network for Mood and Anxiety Treatments depression treatment guidelines (published in 2016) suggest 15 different first-line antidepressant medication options for the treatment of MDD. There is a need for evidence-informed decision support aids to individualize antidepressant therapy to treat patients diagnosed with MDD.

Conclusion: Recent studies on antidepressants have indicated no single antidepressant is superior to others in treating patients with MDD. This suggests there may be opportunities to enhance treatment adherence and success by tailoring antidepressant therapy to align with each patient's preferences. The Antidepressant Decision Support Tool was developed to help prescribers and adult patients engage in shared decision making to select an individualized and optimal first-line antidepressant for the treatment of acute MDD.

Keywords 
Systematic Reviews as Topic antidepressive agents Serotonin Uptake Inhibitors Major Depressive Disorder SSRI

Comparison of Amitriptyline and US Food and Drug Administration–Approved Treatments for Fibromyalgia A Systematic Review and Network Meta-analysis

Author/s: 
Farag, H. M., Yunusa, I., Goswami, H., Sultan, I., Doucette, J. A., Eguale, T.

Importance: Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological agents approved by the US Food and Drug Administration (FDA) to treat fibromyalgia.

Objective: To investigate the comparative effectiveness and acceptability associated with pharmacological treatment options for fibromyalgia.

Data sources: Searches of PubMed/MEDLINE, Cochrane Library, Embase, and Clinicaltrials.gov were conducted on November 20, 2018, and updated on July 29, 2020.

Study selection: Randomized clinical trials (RCTs) comparing amitriptyline or any FDA-approved doses of investigated drugs.

Data extraction and synthesis: This study follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Four independent reviewers extracted data using a standardized data extraction sheet and assessed quality of RCTs. A random-effects bayesian network meta-analysis (NMA) was conducted. Data were analyzed from August 2020 to January 2021.

Main outcomes and measures: Comparative effectiveness and acceptability (defined as discontinuation of treatment owing to adverse drug reactions) associated with amitriptyline (off-label), pregabalin, duloxetine, and milnacipran (on-label) in reducing fibromyalgia symptoms. The following doses were compared: 60-mg and 120-mg duloxetine; 150-mg, 300-mg, 450-mg, and 600-mg pregabalin; 100-mg and 200-mg milnacipran; and amitriptyline. Effect sizes are reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% credible intervals (95% CrIs). Findings were considered statistically significant when the 95% CrI did not include the null value (0 for SMD and 1 for OR). Relative treatment ranking using the surface under the cumulative ranking curve (SUCRA) was also evaluated.

Results: A total of 36 studies (11 930 patients) were included. The mean (SD) age of patients was 48.4 (10.4) years, and 11 261 patients (94.4%) were women. Compared with placebo, amitriptyline was associated with reduced sleep disturbances (SMD, -0.97; 95% CrI, -1.10 to -0.83), fatigue (SMD, -0.64; 95% CrI, -0.75 to -0.53), and improved quality of life (SMD, -0.80; 95% CrI, -0.94 to -0.65). Duloxetine 120 mg was associated with the highest improvement in pain (SMD, -0.33; 95% CrI, -0.36 to -0.30) and depression (SMD, -0.25; 95% CrI, -0.32 to -0.17) vs placebo. All treatments were associated with inferior acceptability (higher dropout rate) than placebo, except amitriptyline (OR, 0.78; 95% CrI, 0.31 to 1.66). According to the SUCRA-based relative ranking of treatments, duloxetine 120 mg was associated with higher efficacy for treating pain and depression, while amitriptyline was associated with higher efficacy for improving sleep, fatigue, and overall quality of life.

Conclusions and relevance: These findings suggest that clinicians should consider how treatments could be tailored to individual symptoms, weighing the benefits and acceptability, when prescribing medications to patients with fibromyalgia.

Keywords 
amitriptyline FDA treatment Fibromyalgia systematic review

Olfactory Loss and Beyond: A Practical Review of Chemosensory Dysfunction

Author/s: 
Claus, L. E., Leland, E. M., Tai, K. Y., Schlosser, R. J., Kamath, V., Lane, A. P., Rowan, N. R.

Background: Our ability to smell and taste is dictated by 3 chemosensory systems with distinct physiologic mechanisms - olfaction, gustation, and chemesthesis. Although often overlooked, dysfunction of these special senses may have broad implications on multiple facets of patients' lives -including safety, nutritional status, quality of life, mental health, and even cognitive function. As "loss of smell or taste" emerged as a common symptom of coronavirus disease 2019 (COVID-19), the importance of intact chemosensory function has been thrust into the spotlight. Despite the growing recognition of chemosensory dysfunction, this already highly prevalent condition will increasingly impact a larger and more diverse population, highlighting the need for improved awareness and care of these patients.

Methods: Comtemporary review of chemosensory function and assessments.

Conclusions: Although patient-reported chemosensory function measures highlight the ease of screening of chemosensory dysfunction, self-reported measures underestimate both the prevalence and degree of chemosensory dysfunction and do not adequately distinguish between olfaction, gustation, and chemesthesis. Meanwhile, psychophysical assessment tools provide opportunities for more accurate, thorough assessment of the chemosenses when appropriate. Primary care providers are uniquely situated to identify patients burdened by chemosensory dysfunction and raise patient and provider awareness about the importance of chemosensory dysfunction. Identification of chemosensory dysfunction, particularly olfactory dysfunction, may raise suspicion for many underlying medical conditions, including early detection of neurodegenerative conditions. Furthermore, identification and awareness of patients with chemosensory dysfunction may help primary care providers to identify those who may benefit from additional therapeutic and safety interventions, or consultations with specialists for more detailed evaluations and management.

Keywords 
aging Anosmia dementia Geriatrics Olfaction Disorders

Diagnosis and management of postural orthostatic tachycardia syndrome

Author/s: 
Raj, S. R., Fedorowski, A., Sheldon, R. S.

Postural orthostatic tachycardia syndrome (POTS) is a chronic multisystem disorder; the cardinal feature is orthostatic tachycardia.

Patients with POTS have symptoms of orthostatic intolerance that improve with recumbence.

Girls and women are more commonly affected with POTS, beginning in puberty and through early adulthood.

Postural orthostatic tachycardia syndrome can lead to marked functional disability, often limiting work or schooling.

Treatments for POTS can improve symptoms and function, and can be initiated in primary care.

The main characteristic of postural orthostatic tachycardia syndrome (POTS) is tachycardia when standing, without a drop in blood pressure. Patients describe lightheadedness and palpitations when upright, particularly when standing, which sometimes leads to syncope. Patients may experience impaired quality of life and functional disability, which can be economically devastating.1–3 The syndrome is more common in girls and young women and has been associated with other disorders, like migraine and Ehlers–Danlos syndrome.4 We discuss the diagnosis of POTS, conditions to consider in the differential diagnosis, associated disorders and the pharmacologic and nonpharmacologic management of patients with POTS, based on original research, narrative reviews and consensus statements

Keywords 
POTS diagnosis management Postural Orthostatic Tachycardia Syndrome

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Essentials of Diagnosis and Management

Author/s: 
Bateman, L., Bested, A., Bonilla, H., Chheda, B., Chu, L,, Curtin, J. M., Dempsey, T. T., Dimmock, M. E., Dowell, T. G., Felsenstein, D., Kaufman, D. L., Klimas, N. G., Komaroff, A. L., Lapp, C. W., Levine, S. M., Montoya, J. G., Natelson, B. H., Peterson, D. L., Podell, R. N., Rey, I. R., Ruhoy, I. S., Vera-Nunez, M. A., Yellman, B. P.

Despite myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful. Consequently, up to 91% of patients in the United States remain undiagnosed, and those diagnosed often receive inappropriate treatment. These problems are of increasing importance because after acute COVID-19, a significant percentage of people remain ill for many months with an illness similar to ME/CFS. In 2015, the US National Academy of Medicine published new evidence-based clinical diagnostic criteria that have been adopted by the US Centers for Disease Control and Prevention. Furthermore, the United States and other governments as well as major health care organizations have recently withdrawn graded exercise and cognitive-behavioral therapy as the treatment of choice for patients with ME/CFS. Recently, 21 clinicians specializing in ME/CFS convened to discuss best clinical practices for adults affected by ME/CFS. This article summarizes their top recommendations for generalist and specialist health care providers based on recent scientific progress and decades of clinical experience. There are many steps that clinicians can take to improve the health, function, and quality of life of those with ME/CFS, including those in whom ME/CFS develops after COVID-19. Patients with a lingering illness that follows acute COVID-19 who do not fully meet criteria for ME/CFS may also benefit from these approaches.

Keywords 
Myalgic Encephalomyelitis Chronic Fatigue Syndrome diagnosis management
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