Background The relationship between efavirenz use and suicidality is not well defined. Objective Compare time to suicidality with efavirenz-containing versus efavirenz-free antiretroviral regimens for initial treatment of HIV. Design Participant-level data were analyzed from four AIDS Clinical Trials Group (ACTG) antiretroviral-naïve studies conducted from 2001 to 2010. Within each study, participants were randomly assigned to an efavirenz-containing (n=3241) or efavirenz-free regimen (n=2091). Setting ACTG sites; 74% enrolled in the United States. Patients Antiretroviral-naïve participants. Intervention Efavirenz versus efavirenz-free regimens. Measurements Suicidality was defined as suicidal ideation, attempted or completed suicide. Groups were compared with a hazard ratio (HR) and 95% confidence interval (CI) estimated from a Cox model stratified by study. Results 73% were men, median age was 37 years; 32% had documented psychiatric history or received psychoactive medication within 30 days prior to study entry. Median follow-up was 96 weeks. Suicidality incidence per 1000 person-years was 8.08 (47 events) in the efavirenz group and 3.66 (15 events) in the efavirenz-free group, HR: 2.28 (95% CI: 1.27 to 4.10, p=0.006). Incidence of attempted or completed suicide was 2.90 (17 events) and 1.22 (5 events) in the efavirenz and efavirenz-free groups, respectively, HR: 2.58 (95% CI: 0.94 to 7.06, p=0.065). Eight suicide deaths in the efavirenz group and one in the efavirenz-free group were reported. Limitations There was not a standardized questionnaire regarding suicidal ideation or attempt. Efavirenz was open-label in three of four studies. Conclusions Initial treatment with an efavirenz-containing antiretroviral regimen was associated with a two-fold increased hazard of suicidality compared to a regimen without efavirenz.

Background: Research criteria for prodromal dementia with Lewy bodies (DLB) were published in 2020, but little is known regarding prodromal DLB in clinical settings. Methods: We identified non-demented participants without neurodegenerative disease from the National Alzheimer’s Coordinating Center Uniform Data Set who converted to DLB at a subsequent visit. Prevalence of neuropsychiatric and motor symptoms were examined up to 5 years prior to DLB diagnosis. Results: The sample included 116 participants clinically diagnosed with DLB and 348 age and sex-matched (1:3) Healthy Controls. Motor slowing was present in approximately 70% of participants 3 years prior to DLB diagnosis. In the prodromal phase, 50% of DLB participants demonstrated gait disorder, 70% had rigidity, 20% endorsed visual hallucinations, and over 50% of participants endorsed REM sleep behavior disorder. Apathy, depression, and anxiety were common prodromal neuropsychiatric symptoms. The presence of 1+ core clinical features of DLB in combination with apathy, depression, or anxiety resulted in the greatest AUC (0.815; 95% CI: 0.767, 0.865) for distinguishing HC from prodromal DLB 1 year prior to diagnosis. The presence of 2+ core clinical features was also accurate in differentiating between groups (AUC = 0.806; 95% CI: 0.756, 0.855). Conclusion: A wide range of motor, neuropsychiatric and other core clinical symptoms are common in prodromal DLB. A combination of core clinical features, neuropsychiatric symptoms and cognitive impairment can accurately differentiate DLB from normal aging prior to dementia onset.

ImportanceThe US Preventive Services Task Force (USPSTF) is updating its 2016 recommendation on the use of aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC).ObjectiveTo provide updated model-based estimates of the net balance in benefits and harms from routine use of low-dose aspirin for primary prevention.Design, Setting, and ParticipantsMicrosimulation modeling was used to estimate long-term benefits and harms for hypothetical US cohorts of men and women aged 40 to 79 years with up to 20% 10-year risk for an atherosclerotic CVD event and without prior history of CVD or elevated bleeding risks.ExposuresLow-dose (≤100 mg/d) aspirin for lifetime use, unless contraindicated by a bleeding event, and with stopping ages in 5-year intervals from age 65 to 85 years.Main Outcomes and MeasuresPrimary outcomes were lifetime net benefits measured in quality-adjusted life-years (QALYs) and life-years. Benefits included reduced nonfatal myocardial infarction and ischemic stroke. Harms included increased nonfatal major gastrointestinal bleeding and intracranial hemorrhage. Reduced CRC incidence was considered in sensitivity analysis.ResultsEstimated lifetime net QALYs were positive for both men and women at 5% or greater 10-year CVD risk when starting between ages 40 and 59 years and at 10% or greater 10-year CVD risk when starting between ages 60 and 69 years. These estimates ranged from 2.3 (95% CI, −2.7 to 7.4) to 66.2 (95% CI, 58.2 to 74.1) QALYs per 1000 persons. Lifetime net life-years were positive for men at 5% or greater and women at 10% or greater 10-year CVD risk starting aspirin at ages 40 to 49 years and for men at 7.5% or greater and women at 15% or greater 10-year CVD risk at ages 50 to 59 years. These estimates ranged from 0.4 (95% CI, −6.1 to 6.9) to 52.4 (95% CI, 43.9 to 60.9) life-years per 1000 persons. Lifetime net life-years were negative in most cases for persons starting aspirin between ages 60 and 79 years, as were lifetime net QALYs for persons aged 70 to 79 years. Stopping aspirin between ages 65 and 85 years generally showed little advantage compared with lifetime use. Sensitivity analyses showed lifetime net benefits may be higher if aspirin reduced CRC incidence or CVD mortality and lower if aspirin increased fatal major gastrointestinal bleeding or reduced quality of life with routine use.Conclusions and RelevanceThis microsimulation study suggested that several population groups may benefit from taking aspirin for the primary prevention of CVD, primarily in persons starting at younger ages with higher 10-year CVD risk.

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Background Prior studies have indicated high rates of vascular risk factors, but little is known about stroke in Hmong. Methods and Results The institutional Get With The Guidelines (GWTG) database was used to identify patients discharged with acute ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage between 2010 and 2019. Hmong patients were identified using clan names and primary language. Univariate analysis was used to compare Hmong and White patients. A subarachnoid hemorrhage comparison was not conducted because of the small sample size. We identified 128 Hmong patients and 3084 White patients. Hmong patients had more prevalent hemorrhagic stroke (31% versus 15%; P <0.0016). In the acute ischemic stroke cohort, compared with White patients, Hmong patients were younger (60±13 versus 71±15 years; P <0.0001), presented to the emergency department almost 4 hours later; and had a lower thrombolysis usage rate (6% versus 14%; P =0.03496), worse lipid profile, higher hemoglobin A 1C , similar stroke severity, and less frequent discharge to rehabilitation facilities. The most common ischemic stroke mechanism for Hmong patients was small‐vessel disease. In the intracerebral hemorrhage cohort, Hmong patients were younger (55±13 versus 70±15 years; P <0.0001), had higher blood pressure, and had a lower rate of independent ambulation on discharge (9% versus 30%; P =0.0041). Conclusions Hmong patients with stroke were younger and had poorer risk factor control compared with White patients. There was a significant delay in emergency department arrival and low use of acute therapies among the Hmong acute ischemic stroke cohort. Larger studies are needed to confirm these observations, but action is urgently needed to close gaps in primary care and stroke health literacy.