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Displaying 41 - 50 of 104 in Policy Library
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Displaying 41 - 50 of 1949 in Annals of Internal Medicine
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First-Line Therapy for Type 2 Diabetes With Sodium–Glucose Cotransporter-2 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists: A Cost-Effectiveness Study: Annals of Internal Medicine: Vol 175, No 10
Background: Guidelines recommend sodium–glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) receptor agonists as second-line therapy for patients with type 2 diabetes. Expanding their use as first-line therapy has been proposed but the clinical benefits may not outweigh their costs. Objective: To evaluate the lifetime cost-effectiveness of a strategy of first-line SGLT2 inhibitors or GLP1 receptor agonists. Design: Individual-level Monte Carlo–based Markov model. Data Sources: Randomized trials, Centers for Disease Control and Prevention databases, RED BOOK, and the National Health and Nutrition Examination Survey. Target Population: Drug-naive U.S. patients with type 2 diabetes. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: First-line SGLT2 inhibitors or GLP1 receptor agonists. Outcome Measures: Life expectancy, lifetime costs, incremental cost-effectiveness ratios (ICERs). Results of Base-Case Analysis: First-line SGLT2 inhibitors and GLP1 receptor agonists had lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke compared with metformin. First-line SGLT2 inhibitors cost $43 000 more and added 1.8 quality-adjusted months versus first-line metformin ($478 000 per quality-adjusted life-year [QALY]). First-line injectable GLP1 receptor agonists cost more and reduced QALYs compared with metformin. Results of Sensitivity Analysis: By removing injection disutility, first-line GLP1 receptor agonists were no longer dominated (ICER, $327 000 per QALY). Oral GLP1 receptor agonists were not cost-effective (ICER, $823 000 per QALY). To be cost-effective at under $150 000 per QALY, costs for SGLT2 inhibitors would need to be under $5 per day and under $6 per day for oral GLP1 receptor agonists. Limitation: U.S. population and costs not generalizable internationally. Conclusion: As first-line agents, SGLT2 inhibitors and GLP1 receptor agonists would improve type 2 diabetes outcomes, but their costs would need to fall by at least 70% to be cost-effective. Primary Funding Source: American Diabetes Association.
Gastric Bypass Versus Sleeve Gastrectomy in Type 2 Diabetes: Effects on Hepatic Steatosis and Fibrosis: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 175, No 1
Background: Weight loss improves fatty liver disease. No randomized trial has compared the effects of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on liver fat content and fibrosis. Objective: To compare the 1-year effects of SG and RYGB on hepatic steatosis and fibrosis. Design: Single-center, randomized, controlled trial (Oseberg [ObesitySurgery in Tønsberg]). (ClinicalTrials.gov: NCT01778738) Setting: Tertiary care obesity center in Norway. Participants: 100 patients (65% female; mean age, 47.5 years; mean body mass index, 42 kg/m2) with type 2 diabetes mellitus (T2DM). Intervention: From January 2013 to February 2018, patients were randomly assigned (1:1 ratio) to SG or RYGB. Measurements: The primary outcome was remission of T2DM (previously published). Predefined secondary outcomes in the present study were hepatic steatosis and fibrosis assessed by magnetic resonance imaging (liver fat fraction), enhanced liver fibrosis (ELF) test, noninvasive indices, and liver enzymes. Results: Liver fat fraction declined similarly after SG (−19.7% [95% CI, −22.5% to −16.9%]) and RYGB (−21.5% [CI, −24.3% to −18.6%]) from surgery to 1-year follow-up, and almost all patients (SG, 94%; RYGB, 100%) had no or low-grade steatosis at 1 year. The ELF score category remained stable in 77% of patients, but 18% experienced worsening of fibrosis at 1 year, with no substantial between-group difference. Limitations: Single-center study, short follow-up time, and lack of power for secondary outcomes. Conclusion: With an almost complete clearance of liver fat 1 year after surgery, RYGB and SG were both highly effective in reducing hepatic steatosis. Bariatric surgery had less influence on degree of fibrosis in the short term, but assessment of long-term progression is warranted. Primary Funding Source: Vestfold Hospital Trust and the South-Eastern Norway Regional Health Authority.
Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure: A Randomized Trial: Annals of Internal Medicine: Vol 174, No 8
Background: In the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial, sotagliflozin, a sodium–glucose cotransporter-1 and sodium–glucose cotransporter-2 inhibitor, reduced total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo by 33%. Objective: To determine whether sotagliflozin increased the prespecified efficacy outcome of days alive and out of the hospital (DAOH) in the SOLOIST-WHF trial. Design: Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT03521934) Setting: 306 sites in 32 countries. Participants: 1222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure. Intervention: 200 mg of sotagliflozin once daily (with a possible dose increase to 400 mg) or matching placebo. Measurements: The primary analysis included hospitalizations for any reason on the basis of investigator-reported incidence and duration of admissions after randomization. Days alive and out of the hospital and its converse (days dead and days in the hospital) were analyzed using prespecified Poisson regression models. Results: Although similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%), fewer patients in the sotagliflozin group were hospitalized more than once (16.3% vs. 22.1%). There were 64 and 76 deaths in the sotagliflozin and placebo groups, respectively. The DAOH rate in the sotagliflozin group was 3% higher than in the placebo group (rate ratio [RR], 1.03 [95% CI, 1.00 to 1.06]; P = 0.027). This difference was primarily driven by a reduction in the rate of days dead (RR, 0.71 [CI, 0.52 to 0.99]; P = 0.041) rather than by a reduction in the rate of days hospitalized for any cause. For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital for 3% or 2.9 more days than those in the placebo group (91.8 vs. 88.9 days); this difference reflected a 2.6-day difference in days dead (6.3 vs. 8.9 days) and a 0.3-day difference in days in the hospital (1.9 vs. 2.2 days). Limitation: Other than heart failure, the primary reason for each hospitalization was unspecified. Conclusion: Sotagliflozin increased DAOH, a metric that may provide an additional patient-centered outcome to capture the totality of disease burden. Future studies are needed to quantify the consequences of increasing DAOH in terms of health economics and patient quality of life. Primary Funding Source: Sanofi at initiation and Lexicon Pharmaceuticals at completion.
Diabetes Screening by Race and Ethnicity in the United States: Equivalent Body Mass Index and Age Thresholds
Background: Racial/ethnic minority populations in the United States have increased rates of diabetes compared with White populations. The 2021 guidelines from the U.S. Preventive Services Task Force recommend diabetes screening for adults aged 35 to 70 years with a body mass index (BMI) of 25 kg/m2 or greater. Objective: To determine the BMI threshold for diabetes screening in major racial/ethnic minority populations with benefits and harms equivalent to those of the current diabetes screening threshold in White adults. Design: Cross-sectional study. Setting: NHANES (National Health and Nutrition Examination Survey), 2011 to 2018. Participants: Nonpregnant U.S. adults aged 18 to 70 years (n = 19 335). Measurements: A logistic regression model was used to estimate diabetes prevalence at various BMIs for White, Asian, Black, and Hispanic Americans. For each racial/ethnic minority group, the equivalent BMI threshold was defined as the BMI at which the prevalence of diabetes in 35-year-old persons in that group is equal to that in 35-year-old White adults at a BMI of 25 kg/m2. Ranges were estimated to account for the uncertainty in prevalence estimates for White and racial/ethnic minority populations. Results: Among adults aged 35 years with a BMI of 25 kg/m2, the prevalence of diabetes in Asian Americans (3.8% [95% CI, 2.8% to 5.1%]), Black Americans (3.5% [CI, 2.7% to 4.7%]), and Hispanic Americans (3.0% [CI, 2.1% to 4.2%]) was significantly higher than that in White Americans (1.4% [CI, 1.0% to 2.0%]). Compared with a BMI threshold of 25 kg/m2 in White Americans, the equivalent BMI thresholds for diabetes prevalence were 20 kg/m2 (range, <18.5 to 23 kg/m2) for Asian Americans, less than 18.5 kg/m2 (range, <18.5 to 23 kg/m2) for Black Americans, and 18.5 kg/m2 (range, <18.5 to 24 kg/m2) for Hispanic Americans. Limitation: Sample size limitations precluded assessment of heterogeneity within racial/ethnic groups. Conclusion: Among U.S. adults aged 35 years or older, offering diabetes screening to Black Americans and Hispanic Americans with a BMI of 18.5 kg/m2 or greater and Asian Americans with a BMI of 20 kg/m2 or greater would be equivalent to screening White adults with a BMI of 25 kg/m2 or greater. Using screening thresholds specific to race/ethnicity has the potential to reduce disparities in diabetes diagnosis. Primary Funding Source: Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology.
Diabetes Management in Chronic Kidney Disease: Synopsis of the 2020 KDIGO Clinical Practice Guideline
Description: The Kidney Disease: Improving Global Outcomes (KDIGO) organization developed a clinical practice guideline in 2020 for the management of patients with diabetes and chronic kidney disease (CKD). Methods: The KDIGO Work Group (WG) was tasked with developing the guideline for diabetes management in CKD. It defined the scope of the guideline, gathered evidence, determined systematic review topics, and graded evidence that had been summarized by an evidence review team. The English-language literature searches, which were initially done through October 2018, were updated in February 2020. The WG used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of the recommendations. Expert judgment was used to develop consensus practice points supplementary to the evidence-based graded recommendations. The guideline document underwent open public review. Comments from various stakeholders, subject matter experts, and industry and national organizations were considered before the document was finalized. Recommendations: The guideline includes 12 recommendations and 48 practice points for clinicians caring for patients with diabetes and CKD. This synopsis focuses on the key recommendations pertinent to the following issues: comprehensive care needs, glycemic monitoring and targets, lifestyle interventions, antihyperglycemic therapies, and educational and integrated care approaches.
Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline
Description: The American Diabetes Association (ADA) updates the Standards of Medical Care in Diabetes annually to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of diabetes. Methods: To develop the 2020 Standards, the ADA Professional Practice Committee, comprising physicians, adult and pediatric endocrinologists, diabetes educators, registered dietitians, epidemiologists, pharmacists, and public health experts, continuously searched MEDLINE (English language only) from 15 October 2018 through August–September 2019 for pertinent studies, including high-quality trials that addressed pharmacologic management of type 2 diabetes. The committee selected and reviewed the studies, developed the recommendations, and solicited feedback from the larger clinical community. Recommendations: This synopsis focuses on guidance relating to the pharmacologic treatment of adults with type 2 diabetes. Recommendations address oral and noninsulin injectable therapies, insulin treatment, and combination injectable therapies. Results of recent large trials with cardiovascular and renal outcomes are emphasized.
Uses and Limitations of the Restricted Mean Survival Time: Illustrative Examples From Cardiovascular Outcomes and Mortality Trials in Type 2 Diabetes
The restricted mean survival time (RMST) has been advocated as an alternative or a supplement to the hazard ratio for reporting the effect of an intervention in a randomized clinical trial. The RMST difference allows quantification of the postponement of an outcome during a specified (restricted) interval and corresponds to the difference between the areas under the 2 survival curves for the intervention and control groups. This article presents examples of the use of the RMST in a research and a clinical context. First, the authors demonstrate how the RMST difference can answer research questions about the efficacy of different treatments. Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality. The authors show how these measures may be used to mitigate uncertainty about the efficacy of intensive glucose control. Second, the authors demonstrate how the RMST difference may be used in the setting of a clinical consultation to guide the decision to start or discontinue a treatment. They then discuss the advantages of the RMST over the absolute risk difference, the number needed to treat, and the median survival time difference. They argue that the RMST difference is both easy to interpret and flexible in its application to different settings. Finally, they highlight the major limitations of the RMST, including difficulties in comparing studies of heterogeneous designs and in inferring the long-term effects of treatments using trials of short duration, and summarize the available statistical software for calculating the RMST.
Assessing the Risk for Gout With Sodium–Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 172, No 3
Background: Hyperuricemia is common in patients with type 2 diabetes mellitus and is known to cause gout. Sodium–glucose cotransporter-2 (SGLT2) inhibitors prevent glucose reabsorption and lower serum uric acid levels. Objective: To compare the rate of gout between adults prescribed an SGLT2 inhibitor and those prescribed a glucagon-like peptide-1 (GLP1) receptor agonist. Design: Population-based new-user cohort study. Setting: A U.S. nationwide commercial insurance database from March 2013 to December 2017. Patients: Persons with type 2 diabetes newly prescribed an SGLT2 inhibitor were 1:1 propensity score matched to patients newly prescribed a GLP1 agonist. Persons were excluded if they had a history of gout or had received gout-specific treatment previously. Measurements: The primary outcome was a new diagnosis of gout. Cox proportional hazards regression was used to estimate hazard ratios (HRs) of the primary outcome and 95% CIs. Results: The study identified 295 907 adults with type 2 diabetes mellitus who were newly prescribed an SGLT2 inhibitor or a GLP1 agonist. The gout incidence rate was lower among patients prescribed an SGLT2 inhibitor (4.9 events per 1000 person-years) than those prescribed a GLP1 agonist (7.8 events per 1000 person-years), with an HR of 0.64 (95% CI, 0.57 to 0.72) and a rate difference of −2.9 (CI, −3.6 to −2.1) per 1000 person-years. Limitation: Unmeasured confounding, missing data (namely incomplete laboratory data), and low baseline risk for gout. Conclusion: Adults with type 2 diabetes prescribed an SGLT2 inhibitor had a lower rate of gout than those prescribed a GLP1 agonist. Sodium–glucose cotransporter-2 inhibitors may reduce the risk for gout among adults with type 2 diabetes mellitus, although future studies are necessary to confirm this observation. Primary Funding Source: Brigham and Women's Hospital.
Displaying 41 - 50 of 142 in Annals of Internal Medicine: Clinical Cases
A Rare Case of Doxycycline-Induced Autoimmune Hepatitis With Organizing Pneumonia | Annals of Internal Medicine: Clinical Cases
Autoimmune hepatitis and organizing pneumonia are uncommon, yet important, manifestations of drug toxicity. We describe the case of a 67-year-old woman who presented with shortness of breath shortly after completing a course of doxycycline and was incidentally found to have a prominent hepatitis. Subsequent evaluation yielded a diagnosis of doxycycline-induced autoimmune hepatitis and organizing pneumonia. This case gives credence to including drug-induced autoimmune hepatitis and organizing pneumonia in the differential for both liver injury and respiratory failure encountered in the setting of doxycycline exposure.
Lymphoid Interstitial Pneumonia Associated With Hashimoto Thyroid Disease | Annals of Internal Medicine: Clinical Cases
Lymphoid interstitial pneumonia (LIP) refers to the diffuse infiltration and accumulation of lymphocytes within the alveolar interstitium and may be associated with multiple autoimmune diseases, most notably Sjögren syndrome. Only rare cases of LIP have been reported in patients with Hashimoto thyroiditis. In these cases, the patients also had at least 1 additional autoimmune disease. We report a case of LIP in a 70-year-old woman whose only autoimmune disease was Hashimoto thyroiditis. This case supports the hypothesis that Hashimoto thyroiditis alone may instigate the development of LIP.
Severe Azithromycin-Induced Liver Injury With Vanishing Bile Duct Syndrome Necessitating Liver Transplantation | Annals of Internal Medicine: Clinical Cases
Drug-induced liver injury is a common cause of liver damage, with antimicrobial use as the leading cause. Although most patients recover after discontinuing the offending agent, severe cases may result in progressive disease or death, requiring liver transplantation. Azithromycin is a rare cause of idiosyncratic drug-induced liver injury, usually resolving within 4 to 8 weeks of discontinuation. Vanishing bile duct syndrome may occur in severe cases, marked by progressive ductopenia and cholestasis. We describe a rare case of azithromycin-induced liver injury with acute vanishing bile duct syndrome necessitating liver transplantation.
Right Coronary Artery Ectasia Manifesting With Acute Coronary Syndrome and Atrial Fibrillation: A Case Report | Annals of Internal Medicine: Clinical Cases
The patient is a 59-year-old man who presented with substernal chest pain. Electrocardiogram showed evidence of inferior ST-segment elevation, and his troponin I level peaked at 40 µg/L. Coronary angiogram showed a severely ectatic right coronary artery with near-total acute thrombotic occlusion of the distal right coronary artery and total acute thrombotic occlusion of the distal posterior descending artery. He had a successful intravascular ultrasound-guided aspiration thrombectomy with a penumbra and intracoronary tissue plasminogen activator infusion. This case highlights an alternative way of treating acute thrombotic occlusion of ectatic arteries asides from the conventional but challenging practice of coronary revascularization with stent placement.
Thromboangiitis Obliterans Successfully Treated With Smoking-Cessation Instruction Including Passive Smoking Cessation | Annals of Internal Medicine: Clinical Cases
A 22-year-old man presented with recurrent pain and linear redness of the lower extremities for 1 year. He smoked 20 cigarettes daily for 6 years and did not report cannabis use. He was referred to the vascular department by his primary care physician. He had stopped smoking for 6 months to treat thromboangiitis obliterans, but his symptoms were recurrent. The patient was interviewed about smoking in his living environment. His family members and his colleagues were smokers. Therefore, we advised to avoid secondhand smoke as well. Consequently, his symptoms resolved within 2 weeks. He had no relapse at follow-up after 6 months.
Recurrent Myopericarditis and Fulminant Cardiogenic Shock Due to Autoimmune Polyglandular Syndrome 2 | Annals of Internal Medicine: Clinical Cases
A 34-year-old man presented with acute pericarditis and a small pericardial effusion but rapidly decompensated into cardiac tamponade and fulminant cardiogenic shock, requiring venoarterial extracorporeal membrane oxygenation cannulation. He was diagnosed with autoimmune polyglandular syndrome 2 and was treated with stress dose steroids and an interleukin-1 inhibitor, with improvement in his cardiac function.
Infectious Proctitis From Cytomegalovirus in an Immunocompetent Patient | Annals of Internal Medicine: Clinical Cases
Cytomegalovirus colitis typically causes immunocompromised patients to present with hematochezia, abdominal pain, fever, or diarrhea and rarely as perforation. Here we report an 83-year-old woman with no other traditional immunocompromising risk factors who presented with cytomegalovirus proctitis. Providers should be aware of the potential for this severity of presentation even in immunocompetent patients.
Thymic Hyperplasia in Graves’ Disease: A Case Report | Annals of Internal Medicine: Clinical Cases
Thymic hyperplasia can occur secondary to Graves’ disease, although the exact mechanism is not yet entirely understood. Thymic hyperplasia in this setting is typically benign and improves with treatment of Graves’ disease. Invasive procedures are generally not required but should be considered if suspicion for other underlying disease processes (including malignancy) is suspected and/or imaging does not show thymus regression after antithyroid therapy.
Immune-Mediated Necrotizing Myopathy Associated With Myelodysplastic Syndrome | Annals of Internal Medicine: Clinical Cases
Autoimmune diseases can often be diagnosed in patients with myelodysplastic syndrome (MDS). Here, we review the emerging literature linking MDS and rare presentations of autoimmunity, including myositis. We report a patient case that underscores the consideration of myositis as an autoimmune manifestation of MDS: initial presentation included shoulder pain and fevers, and after concurrent diagnoses of MDS and autoimmune myositis, the patient continued to present periodically with recurrent flares despite immunosuppressive treatment. Timely diagnosis of MDS-associated myositis may be challenging due to concurrent fever and hemolytic anemia. Furthermore, accurate diagnosis must exclude statin-induced myopathy, effect of toxins, or infectious etiologies.
Systemic Lupus Erythematosus: Initial Manifestation as Cardiac Tamponade? | Annals of Internal Medicine: Clinical Cases
A 49-year-old man presented with 1 hour of retrosternal chest pain and ST-segment elevation. In the ambulance, he was diagnosed with an ST-segment elevation myocardial infarction and received prompt fibrinolysis. On arrival to the percutaneous coronary intervention–capable hospital, he became hemodynamically unstable, and bedside echocardiogram demonstrated a posterior pericardial effusion with tamponade physiology. He was found be profoundly thrombocytopenic secondary to a history of immune thrombocytopenic purpura (not known at the time of prehospital fibrinolysis). Given the position of his pericardial effusion, emergent surgical drainage was performed without complication. Subsequent work-up confirmed effusive pericarditis as his presenting diagnosis secondary to systemic lupus erythematosus.