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Displaying 21 - 30 of 104 in Policy Library
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Displaying 21 - 30 of 1949 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 142 in Annals of Internal Medicine: Clinical Cases
Renal Subcapsular Hematoma: A Rare Potentially Reversible Cause of Acute Graft Dysfunction With Immediate Intervention | Annals of Internal Medicine: Clinical Cases
Subcapsular hematoma of the kidney allograft is an often underrecognized but reversible cause of acute graft dysfunction, which occurs most commonly after percutaneous biopsy. We retrospectively reviewed 4 cases diagnosed with subcapsular hematoma between 2020 and 2023. All patients developed acute kidney injury, hypertension, and graft pain following kidney biopsy. Only 1 recovered fully after prompt surgical evacuation; delayed presentation and intervention in the others resulted in permanent graft loss. These findings emphasize the need for high index of suspicion in post-biopsy patients with acute graft dysfunction, as early diagnosis and timely intervention are essential for preserving graft function.
Fulminant Vibrio vulnificus Infection Following Dog Scratch in a Transplant Recipient Who Is Immunosuppressed: A Case Report | Annals of Internal Medicine: Clinical Cases
A 58-year-old man who is immunosuppressed presented with severe left leg pain 1 day after sustaining a scratch from his dog, which had been swimming in warm coastal water. He quickly developed necrotizing bullae secondary to Vibrio vulnificus bacteremia, progressing to septic shock and multiorgan failure. Management included prompt surgical intervention, targeted antibiotics, and immunosuppressant de-escalation. Despite his grave prognosis, he recovered after 23 days. This case highlights an unconventional V vulnificus transmission route, underscoring the need for rapid diagnosis and treatment in high-risk patients with compatible symptoms, regardless of direct water exposure.
Infectious Aortitis Secondary to Gastrointestinal Pathogens: A Case Series and Syndromic Review | Annals of Internal Medicine: Clinical Cases
Aortitis is a rare but serious complication of infection that results in high morbidity and mortality. The most common location is in preexisting aneurysmal disease in a patient with multiple chronic comorbidities. The pathogens often reflect gastrointestinal bacteria, the classic example being Salmonella spp., but also include other enteric flora, Staphylococcus aureus, Streptococcus spp., and more. Herein, we describe 2 cases of aortitis caused by gastrointestinal bacteria and review management of this complex syndrome.
Tremors and Memory Loss From Hypomagnesemia and Hypocalcemia Secondary to Long-Term Proton Pump Inhibitor Use | Annals of Internal Medicine: Clinical Cases
Proton pump inhibitors (PPIs) are commonly prescribed for short-term use but are often taken chronically, including through over-the-counter (OTC) access. Long-term use has been linked to hypomagnesemia and hypocalcemia, which may cause serious complications. A 47-year-old man on PPIs for 5 years presented with cramps, spasms, tremors, disorientation, and amnesia. Tests showed low magnesium and calcium, with other causes excluded. Proton pump inhibitor treatment was discontinued and supplementation initiated, leading to marked recovery. Chronic PPI use should be considered in unexplained electrolyte abnormalities, even in patients not at high risk, highlighting the need for cautious prescribing, periodic monitoring, and reassessment of OTC availability.
Nocturnal Enuresis in an Adult With Obesity | Annals of Internal Medicine: Clinical Cases
We present a case of nocturnal enuresis (NE) in an adult with obesity that resolved with treatment of obstructive sleep apnea (OSA). The patient reported daytime somnolence and enuresis with no daytime urinary incontinence. A home sleep study diagnosed OSA. The patient received continuous positive airway pressure (CPAP) treatment with immediate resolution of enuresis. This case highlights the importance of recognizing enuresis as a potential symptom of sleep apnea.
Progressive Internal Carotid Artery Occlusion in IgG4-Related Disease: A Case Report and Literature Review | Annals of Internal Medicine: Clinical Cases
Immunoglobulin G4–related disease (IgG4-RD) is a systemic fibroinflammatory disorder capable of multiorgan involvement, though its association with cerebral vasculitis and large-vessel occlusion remains rare and poorly characterized. We report a novel case of cryptogenic ischemic stroke secondary to progressive internal carotid artery (ICA) stenosis and occlusion, ultimately attributed to IgG4-RD. The patient exhibited multifocal hypermetabolic lesions on positron emission tomography–computed tomography, correlating with arterial wall thickening and subsequent pathologic confirmation of IgG4-positive plasma cell infiltration. This case highlights IgG4-RD as an underrecognized cause of progressive ICA stenosis and occlusion, offering critical insights into the diagnostic work-up of cryptogenic stroke and expanding the spectrum of vascular manifestations in IgG4-RD.
Beyond Preeclampsia: Steroid-Refractory Minimal Change Disease Presenting as Hypertension and Proteinuria in Pregnancy | Annals of Internal Medicine: Clinical Cases
We present a case of a 35-year-old pregnant woman (second pregnancy, 0 term or preterm births, 1 abortion/miscarriage, and 0 living children) with new-onset hypertension, lower extremity edema, and proteinuria in the third trimester who was initially diagnosed with preeclampsia. After delivery, her edema and proteinuria continued to increase, prompting consideration of alternative diagnoses. Her evaluation included a kidney biopsy that revealed minimal change disease/focal segmental glomerulosclerosis. Treatment with prednisone resulted in a rapid, but only partial, response. She was later treated with tacrolimus, with steady improvement. This case highlights the importance of looking beyond preeclampsia when a pregnant or postpartum patient has persistent hypertension and nephrotic-range proteinuria.
Postmenopausal Occult Ovarian Disease With Hirsutism – A 6-Year Follow-up Course | Annals of Internal Medicine: Clinical Cases
A postmenopausal woman presented with long-standing androgenic alopecia and progressive hirsutism. Despite normal imaging, markedly elevated testosterone levels (18.58 nmol/L) prompted surgical exploration. Bilateral salpingo-oophorectomy revealed a Leydig cell tumor, confirmed histologically by Reinke crystals. Postoperative hormonal normalization and clinical improvement affirmed the ovarian origin. This case underscores the diagnostic challenge of occult androgen-secreting tumors in postmenopausal women, especially when imaging is inconclusive. It highlights the need for high clinical suspicion and thorough evaluation in cases of virilization, emphasizing that Leydig cell tumors, though rare, remain a critical differential in postmenopausal hyperandrogenism.
Familial Metastatic Bladder Paraganglioma With Multisystem Complications | Annals of Internal Medicine: Clinical Cases
Bladder paragangliomas represent less than 0.05% of bladder tumors, with familial metastatic cases being exceptionally rare. This case outlines a relatively healthy 44-year-old woman presenting with classic symptoms of paraganglioma that initially manifested as cardiac dysrhythmia, new-onset heart failure with reduced ejection fraction, and hypercoagulability. Subsequent questioning and genetic testing identified a family history of paragangliomas and a pathogenic SDHB pR46 mutation. This case highlights the importance of early recognition of signs and symptoms associated with catecholamine-secreting tumors, indications for diagnostic testing, and appropriate genetic testing to prevent devastating complications associated with multisystem failure.
Adult Diagnosis of Cystic Fibrosis: A Cause of Recurrent Pneumonia | Annals of Internal Medicine: Clinical Cases
We describe a patient presenting for evaluation of nearly annual pneumonias since the age of 9 years, eventually requiring multiple hospitalizations. Genetic testing revealed compound heterozygous mutations for 2184insA and L206W, indicative of cystic fibrosis. The patient received Trikafta (combination of ivacaftor, tezacaftor, and elexacaftor), a cystic fibrosis transmembrane regulator modulator with subsequent improvement of her symptoms. This case highlights the importance of maintaining a broad differential diagnosis for recurrent pulmonary infections, including diagnoses not typical for a patient's population or age group. Initiation of therapies such as Trikafta has been associated with improvement in lung function in a life-limiting disease.