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Displaying 21 - 30 of 105 in Policy Library
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Displaying 21 - 30 of 1988 in Annals of Internal Medicine
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Association of State Insulin Out-of-Pocket Caps With Insulin Cost-Sharing and Use Among Commercially Insured Patients With Diabetes: A Pre–Post Study With a Control Group: Annals of Internal Medicine: Vol 177, No 4
This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Twenty-five states have implemented insulin out-of-pocket (OOP) cost caps, but their effectiveness is uncertain. Objective: To examine the effect of state insulin OOP caps on insulin use and OOP costs among commercially insured persons with diabetes. Design: Pre–post study with control group. Setting: Eight states implementing insulin OOP caps of $25 to $30, $50, or $100 in January 2021, and 17 control states. Participants: Commercially insured persons with diabetes and insulin users younger than 65 years. Subgroups of particular interest included members from states with insulin OOP caps of $25 to $30, enrollees with health savings accounts (HSAs) that require high insulin OOP payments, and lower-income members. Measurements: Mean monthly 30-day insulin fills and OOP costs. Results: State insulin caps were not associated with changes in insulin use in the overall population (relative change in fills per month, 1.8% [95% CI, −3.2% to 6.9%]). Insulin users in intervention states saw a 17.3% (CI, −22.3% to −12.1%) relative reduction in insulin OOP costs, largely driven by reductions among HSA enrollees; there was no difference in OOP costs among nonaccount plan members. More generous ($25 to $30) state insulin OOP caps were associated with insulin OOP cost reductions of 33.6% (CI, −48.6% to −18.7%), again primarily driven by a larger reduction in the subgroup with HSA plans. Limitations: Single national insurer; 9-month follow-up. Conclusion: Insulin OOP caps were associated with reduced insulin OOP costs but no overall increases in insulin use. A proposed national insulin cap of $35 for commercially insured persons might lead to meaningful insulin OOP savings but have a limited effect on insulin use. Primary Funding Source: Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases.
Cost-Effectiveness of Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Systematic Review of Cost-Effectiveness Studies for the American College of Physicians
Background: In the United States, costs of antidiabetes medications exceed $327 billion. Purpose: To systematically review cost-effectiveness analyses (CEAs) of newer antidiabetes medications for type 2 diabetes. Data Sources: Bibliographic databases from 1 January 2010 through 13 July 2023, limited to English. Study Selection: Nonindustry-funded CEAs, done from a U.S. perspective that estimated cost per quality-adjusted life-year (QALY) gained for newer antidiabetic medications. Two reviewers screened the literature; disagreements were resolved with a third reviewer. Data Extraction: Cost-effectiveness analyses were reviewed for treatment comparisons, model inputs, and outcomes. Risk of bias (RoB) of the CEAs was assessed using Drummond criteria and certainty of evidence (CoE) was assessed using GRADE (Grading of Recommendations Assessment, Development, and Evaluations). Certainty of evidence was determined using cost per QALY thresholds predetermined by the American College of Physicians Clinical Guidelines Committee; low (>$150 000), intermediate ($50 to $150 000), or high (<$50 000) value per QALY compared with the alternative. Data Synthesis: Nine CEAs were eligible (2 low, 1 high, and 6 some concerns RoB), evaluating glucagon-like peptide-1 agonists (GLP1a), dipeptidyl peptidase-4 inhibitors (DPP4i), sodium–glucose cotransporter-2 inhibitors (SGLT2i), glucose-dependent insulinotropic peptide agonist (GIP/GLP1a), and insulin. Comparators were metformin, sulfonylureas, neutral protamine Hagedorn (NPH) insulin, and others. Compared with metformin, GLP1a and SGLT2i are low value as first-line therapy (high CoE) but may be of intermediate value when added to metformin or background therapy compared with adding nothing (low CoE). Insulin analogues may be similarly effective but more expensive than NPH insulin (low CoE). The GIP/GLP1a value is uncertain (insufficient CoE). Limitations: Cost-effectiveness analyses varied in methodological approach, assumptions, and drug comparisons. Risk of bias and GRADE method for CEAs are not well established. Conclusion: Glucagon-like peptide-1 agonists and SGLT2i are of low value as first-line therapy but may be of intermediate value when added to metformin or other background therapy compared with adding nothing. Other drugs and comparisons are of low or uncertain value. Results are sensitive to drug effectiveness and cost assumptions. Primary Funding Source: American College of Physicians. (PROSPERO: CRD42022382315)
Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5): A Randomized Trial: Annals of Internal Medicine: Vol 176, No 11
Background: Inadequate dose titration and poor adherence to basal insulin can lead to suboptimal glycemic control in persons with type 2 diabetes (T2D). Once-weekly insulin icodec (icodec) is a basal insulin analogue that is in development and is aimed at reducing treatment burden. Objective: To compare the effectiveness and safety of icodec titrated with a dosing guide app (icodec with app) versus once-daily basal insulin analogues (OD analogues) dosed per standard practice. Design: 52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements. (ClinicalTrials.gov: NCT04760626) Setting: 176 sites in 7 countries. Participants: 1085 insulin-naive adults with T2D. Intervention: Icodec with app or OD analogue (insulin degludec, insulin glargine U100, or insulin glargine U300). Measurements: The primary outcome was change in glycated hemoglobin (HbA1c) level from baseline to week 52. Secondary outcomes included patient-reported outcomes (Treatment Related Impact Measure for Diabetes [TRIM-D] compliance domain score and change in Diabetes Treatment Satisfaction Questionnaire [DTSQ] total treatment satisfaction score). Results: The estimated mean change in HbA1c level from baseline to week 52 was greater with icodec with app than with OD analogues, with noninferiority (P < 0.001) and superiority (P = 0.009) confirmed in prespecified hierarchical testing (estimated treatment difference [ETD], −0.38 percentage points [95% CI, −0.66 to −0.09 percentage points]). At week 52, patient-reported outcomes were more favorable with icodec with app than with OD analogues (ETDs, 3.04 [CI, 1.28 to 4.81] for TRIM-D and 0.78 [CI, 0.10 to 1.47] for DTSQ). Rates of clinically significant or severe hypoglycemia were low and similar with both treatments. Limitation: Inability to differentiate the effects of icodec and the dosing guide app. Conclusion: Compared with OD analogues, icodec with app showed superior HbA1c reduction and improved treatment satisfaction and compliance with similarly low hypoglycemia rates. Primary Funding Source: Novo Nordisk A/S.
Chronotype, Unhealthy Lifestyle, and Diabetes Risk in Middle-Aged U.S. Women: A Prospective Cohort Study: Annals of Internal Medicine: Vol 176, No 10
Background: Evening chronotype may promote adherence to an unhealthy lifestyle and increase type 2 diabetes risk. Objective: To evaluate the role of modifiable lifestyle behaviors in the association between chronotype and diabetes risk. Design: Prospective cohort study. Setting: Nurses’ Health Study II. Participants: 63 676 nurses aged 45 to 62 years with no history of cancer, cardiovascular disease, or diabetes in 2009 were prospectively followed until 2017. Measurements: Self-reported chronotype using a validated question from the Morningness-Eveningness Questionnaire. The lifestyle behaviors that were measured were diet quality, physical activity, alcohol intake, body mass index (BMI), smoking, and sleep duration. Incident diabetes cases were self-reported and confirmed using a supplementary questionnaire. Results: Participants reporting a “definite evening” chronotype were 54% (95% CI, 49% to 59%) more likely to have an unhealthy lifestyle than participants reporting a “definite morning” chronotype. A total of 1925 diabetes cases were documented over 469 120 person-years of follow-up. Compared with the “definite morning” chronotype, the adjusted hazard ratio (HR) for diabetes was 1.21 (CI, 1.09 to 1.35) for the “intermediate” chronotype and 1.72 (CI, 1.50 to 1.98) for the “definite evening” chronotype after adjustment for sociodemographic factors, shift work, and family history of diabetes. Further adjustment for BMI, physical activity, and diet quality attenuated the association comparing the “definite evening” and “definite morning” chronotypes to 1.31 (CI, 1.13 to 1.50), 1.54 (CI, 1.34 to 1.77), and 1.59 (CI, 1.38 to 1.83), respectively. Accounting for all measured lifestyle and sociodemographic factors resulted in a reduced but still positive association (HR comparing “definite evening” vs. “definite morning” chronotype, 1.19 [CI, 1.03 to 1.37]). Limitations: Chronotype assessment using a single question, self-reported data, and homogeneity of the study population. Conclusion: Middle-aged nurses with an evening chronotype were more likely to report unhealthy lifestyle behaviors and had increased diabetes risk compared with those with a morning chronotype. Accounting for BMI, physical activity, diet, and other modifiable lifestyle factors attenuated much but not all of the increased diabetes risk. Primary Funding Source: National Institutes of Health.
Achievement of Guideline-Recommended Targets in Diabetes Care in China: A Nationwide Cross-Sectional Study: Annals of Internal Medicine: Vol 176, No 8
Background: Nationwide achievement of guideline-recommended diabetes care targets has not been comprehensively assessed in China. Objective: To estimate the proportions of adults with diabetes achieving major clinical risk factor control, body mass index (BMI), lifestyle, and dietary targets specified in the Chinese diabetes guidelines. Design: Nationwide cross-sectional survey. Setting: China, 2015 to 2017. Participants: A national sample of 8401 adults with self-reported diabetes and a subset of 3531 with dietary data. Measurements: The assessed targets included 1) ABC targets (individualized hemoglobin A1c [HbA1c] target; blood pressure [BP] <130/80 mm Hg; and low-density lipoprotein cholesterol [LDL-C] level <2.6 or <1.8 mmol/L [<100 or <70 mg/dL], depending on the presence of atherosclerotic cardiovascular disease), 2) BMI below 24 kg/m2, 3) lifestyle targets (not currently smoking or drinking, guideline-recommended leisure time activity level, and sleep duration of 7 to 8 hours), and 4) dietary targets (50% to 65% of energy from carbohydrate, 15% to 20% from protein, 20% to 30% from fat, ≥14 g of fiber per 1000 kcal, and <2000 mg of sodium per day). Results: The proportion of adults with self-reported diabetes achieving each ABC target was 64.1% (95% CI, 61.4% to 66.8%) for HbA1c, 22.2% (CI, 20.2% to 24.1%) for BP, and 23.9% (CI, 21.9% to 25.9%) for LDL-C. The proportion achieving a BMI below 24 kg/m2 was 32.2% (CI, 30.3% to 34.2%). The proportion achieving each lifestyle target was 75.8% (CI, 73.9% to 77.7%) for smoking, 66.7% (CI, 64.4% to 69.1%) for drinking, 17.9% (CI, 15.8% to 20.1%) for leisure time activity, and 52.0% (CI, 49.6% to 54.3%) for sleep duration. The proportion achieving each dietary target was 39.1% (CI, 36.0% to 42.2%) for carbohydrate, 20.1% (CI, 16.9% to 23.3%) for protein, 20.5% (CI, 17.6% to 23.4%) for fat, 9.0% (CI, 7.0% to 10.9%) for sodium, and 2.5% (CI, 1.3% to 3.6%) for fiber. Only 4.4% (CI, 3.5% to 5.2%) of participants achieved all 3 ABC targets, 5.1% (CI, 4.3% to 6.0%) achieved all 4 lifestyle targets, and 4 participants achieved all 5 dietary targets. Limitations: Self-reported data and age of the data. Conclusion: Achievement of guideline-recommended diabetes care targets in Chinese adults with self-reported diabetes was exceedingly low. The findings highlight the need for immediate national health actions to improve diabetes care. Primary Funding Source: Shanghai Municipal Education Commission, National Key R&D Program of the People's Republic of China, and the National Health Commission of the People's Republic of China.
Displaying 21 - 30 of 138 in Annals of Internal Medicine: Clinical Cases
Cardiac Tamponade, Mesenteric Ischemia, and Macrophage Activation Syndrome as the Initial Manifestation of Systemic Lupus Erythematosus: A Case Report | Annals of Internal Medicine: Clinical Cases
A 36-year-old man presented with dyspnea requiring emergent pericardiocentesis for cardiac tamponade (700 mL). On hospital day 19, he developed acute mesenteric ischemia; exploratory laparotomy revealed vasculitic vessel wall thickening without retrievable thrombus on embolectomy. Postoperatively, he developed macrophage activation syndrome with ferritin >16 000 ng/mL and transaminitis >3000 U/L. Systemic lupus erythematosus was diagnosed (ACR/EULAR score 21), representing the first reported case to our knowledge of simultaneous cardiac tamponade, mesenteric vasculitis, and macrophage activation syndrome at SLE onset. Treatment with cyclophosphamide and rituximab achieved remission. The surgical finding of vasculitis rather than thrombosis proved critical in guiding immunosuppressive therapy.
Hydroxychloroquine Cardiomyopathy—A Case Series and Review of the Literature | Annals of Internal Medicine: Clinical Cases
Cardiomyopathy is a rare but serious adverse effect of long-term hydroxychloroquine therapy, manifesting as conduction abnormalities and heart failure. Its incidence is not well established. We present the largest case series, to our knowledge, of 13 patients with endomyocardial biopsy–proven hydroxychloroquine cardiomyopathy conducted over an 8-year period at one institution. Outcomes after therapy discontinuation varied, ranging from complete resolution to progressive heart failure requiring advanced therapies, including the first reported cases of left ventricle assist device as destination therapy. Early recognition and timely drug cessation may allow for partial or full recovery of cardiac function.
Sequential Drug-Induced DRESS Syndrome With Severe Rhabdomyolysis and Probable Myocarditis: A Case Report | Annals of Internal Medicine: Clinical Cases
DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) is a severe hypersensitivity syndrome with multiorgan involvement. An 81-year-old man with cardiomyopathy and stage IV chronic kidney disease developed DRESS syndrome after sequential exposure to allopurinol and vancomycin. He presented with diffuse rash, eosinophilia, transaminitis, severe rhabdomyolysis (CK 19,228 U/L), and probable myocarditis (troponin 9,712 ng/L). Corticosteroids started late, and a repeat vancomycin dose was temporally associated with rapid multiorgan deterioration and death. This case illustrates a rare presentation of DRESS syndrome with concurrent rhabdomyolysis and myocarditis, emphasizing the lethality of delayed diagnosis and sequential exposure to high-risk agents.
Salmonella Osteomyelitis of the Rib: An Extraintestinal Manifestation | Annals of Internal Medicine: Clinical Cases
Salmonella osteomyelitis is rare, accounting for <0.5% of all bacterial osteomyelitis cases, and rib involvement is exceedingly uncommon. A middle-aged immunocompetent man presented with a 6-month history of right lateral chest pain and a 1-month history of soft tissue swelling. Imaging revealed an abscess and lytic lesion of the right eighth rib. Interventional radiology–guided drainage yielded purulent material growing Salmonella species. The patient improved with intravenous ceftriaxone followed by oral ciprofloxacin. This case highlights that Salmonella can cause osteomyelitis even in immunocompetent hosts without gastrointestinal symptoms or bacteremia.
Portal, Superior Mesenteric, and Splenic Vein Thrombosis After Tirzepatide Therapy: Triple Threat in Splanchnic Circulation | Annals of Internal Medicine: Clinical Cases
Obesity is a major risk factor for venous thromboembolism, but rapid weight loss itself also has been associated with increased thrombotic risk. Tirzepatide, a dual glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor agonist, is highly effective for weight reduction, but data are limited on its potential association with thrombosis. We report the case of a 56-year-old man with a known history of class II obesity on tirzepatide who developed diffuse abdominal pain after initiation and dose escalation of tirzepatide. Computed tomography angiography revealed occlusive thrombosis of the superior mesenteric, portal, and splenic veins. History was negative for predisposing risk factors to thrombophilia, and hematologic investigation was noncontributory.
Emergomyces canadensis in an Immunocompromised New Mexican Man | Annals of Internal Medicine: Clinical Cases
Emergomyces canadensis is a rare, dimorphic fungus capable of causing fatal disseminated human disease, most frequently in immunocompromised hosts. This report discusses an older man with an indolent hematologic malignancy who was found to have disseminated emergomycosis in New Mexico. Initially found to have asymptomatic, hypermetabolic lung nodules and slowly progressive, pruritic subcutaneous nodules, biopsies ultimately revealed growth of Emergomyces canadensis, which was successfully treated with intravenous liposomal amphotericin B and posaconazole oral tablets.
Familial Transmission of Invasive Group A Streptococcus: A Case Series | Annals of Internal Medicine: Clinical Cases
This case series discusses the rare familial transmission of invasive Group A Streptococcus (GAS) infection with differing manifestations. It describes the hospital course, treatment, and outcomes of 2 related patients—one hospitalized with cellulitis and sepsis and the other with invasive streptococcal pneumonia and sepsis. The series also reviews treatment of invasive GAS, familial transmission, and chemoprophylaxis guidelines.
Retatrutide-Induced Intractable Diarrhea | Annals of Internal Medicine: Clinical Cases
Gastrointestinal symptoms accompanying the use of glucagon-like peptide-1 (GLP-1) receptor agonists and glucose-dependent insulinotropic polypeptide receptor-GLP-1 receptor co-agonists have been extensively catalogued. This case report contains a dramatic presentation of unintended consequences from the use of a novel triple-hormone receptor agonist and points toward the need for increased regulatory measures regarding the marketing of these treatments.
Insulin Autoimmune Syndrome Presenting With Recurrent Hypoglycemia and Extreme Hyperinsulinemia | Annals of Internal Medicine: Clinical Cases
Insulin autoimmune syndrome (IAS) is a rare but important cause of hypoglycemia. Herein, we describe a case of a 67-year-old White man with recurrent episodes of confusion and fatigue relieved by food intake. Biochemical evaluation revealed profound hyperinsulinemia and an elevated C-peptide level, suggesting endogenous insulin production, with no pancreatic lesion on imaging. The presence of insulin autoantibodies confirmed the diagnosis. Fluctuating beta-hydroxybutyrate levels provided an additional physiologic clue, reflecting variable insulin activity resulting from antibody binding and release. This case highlights how characteristic biochemical patterns, including variable ketone levels, can facilitate timely recognition of IAS and help avoid unnecessary diagnostic procedures.