Annals of Internal Medicine最新文献

Background: The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain.

Objective: To estimate the efficacy of 4 individual hemoglobin thresholds (<10 g/dL [<100 g/L], <9 g/dL [<90 g/L], <8 g/dL [<80 g/L], and <7 g/dL [<70 g/L]) to guide transfusion in patients with acute MI and anemia.

Design: Prespecified secondary analysis of the MINT (Myocardial Ischemia and Transfusion) trial using target trial emulation methods. (ClinicalTrials.gov: NCT02981407).

Setting: 144 clinical sites in 6 countries.

Participants: 3492 MINT trial participants with acute MI and a hemoglobin level below 10 g/dL.

Intervention: Four transfusion strategies to maintain patients' hemoglobin concentrations at or above thresholds of 10, 9, 8, or 7 g/dL. Protocol exceptions were permitted for specified adverse clinical events.

Measurements: Data from the MINT trial were leveraged to emulate 4 transfusion strategies and estimate per protocol effects on the composite outcome of 30-day death or recurrent MI (death/MI) and 30-day death using inverse probability weighting.

Results: The 30-day risk for death/MI was 14.8% (95% CI, 11.8% to 18.4%) for a <10-g/dL strategy, 15.1% (CI, 11.7% to 18.2%) for a <9-g/dL strategy, 15.9% (CI, 12.4% to 19.0%) for a <8-g/dL strategy, and 18.3% (CI, 14.6% to 22.0%) for a <7-g/dL strategy. Absolute risk differences and risk ratios relative to the <10-g/dL strategy for 30-day death/MI increased as thresholds decreased, although 95% CIs were wide. Findings were similar and imprecise for 30-day death.

Limitation: Unmeasured confounding may have persisted despite adjustment.

Conclusion: The 30-day risks for death/MI and death among patients with acute MI and anemia seem to increase progressively with lower hemoglobin concentration thresholds for transfusion. However, the imprecision around estimates from this target trial analysis precludes definitive conclusions about individual hemoglobin thresholds.

Primary funding source: National Heart, Lung, and Blood Institute.

Background: Native Hawaiian and Pacific Islander (NHPI) adults have historically been grouped with Asian adults in U.S. mortality surveillance. Starting in 2018, the 1997 race and ethnicity standards from the U.S. Office of Management and Budget were adopted by all states on death certificates, enabling national-level estimates of cardiovascular disease (CVD) mortality for NHPI adults independent of Asian adults.

Objective: To describe CVD mortality among NHPI adults.

Design: Race-stratified age-standardized mortality rates (ASMRs) and rate ratios were calculated using final mortality data from the National Vital Statistics System for 2018 to 2022.

Setting: Fifty states and the District of Columbia.

Participants: Adults aged 35 years or older at the time of death.

Measurements: CVD deaths were identified from International Classification of Diseases, 10th Revision codes indicating CVD (I00 to I99) as the underlying cause of death.

Results: From 2018 to 2022, 10 870 CVD deaths (72.6% from heart disease; 19.0% from cerebrovascular disease) occurred among NHPI adults. The CVD ASMR for NHPI adults (369.6 deaths per 100 000 persons [95% CI, 362.4 to 376.7]) was 1.5 times higher than for Asian adults (243.9 deaths per 100 000 persons [CI, 242.6 to 245.2]). The CVD ASMR for NHPI adults was the third highest in the country, after Black adults (558.8 deaths per 100 000 persons [CI, 557.4 to 560.3]) and White adults (423.6 deaths per 100 000 persons [CI, 423.2 to 424.1]).

Limitation: Potential misclassification of underlying cause of death or race group.

Conclusion: NHPI adults have a high rate of CVD mortality, which was previously masked by aggregation of the NHPI population with the Asian population. The results of this study support the need for continued disaggregation of the NHPI population in public health research and surveillance to identify opportunities for intervention.

Primary funding source: National Institute of General Medical Sciences, National Institutes of Health.

Source citation: Turgeon AF, Fergusson DA, Clayton L, et al; HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium. Liberal or restrictive transfusion strategy in patients with traumatic brain injury. N Engl J Med. 2024;391:722-735. 38869931.

Background: REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population.

Objective: To determine the contribution of known DM risk factors to excess risk for DM with pitavastatin in REPRIEVE.

Design: Phase 3, primary ASCVD prevention trial over a median of 5.6 years of follow-up. (ClinicalTrials.gov: NCT02344290).

Setting: Global, multicenter trial.

Participants: 7731 PWH aged 40 to 75 years with low to moderate ASCVD risk (by the pooled cohort equations from the American College of Cardiology and American Heart Association) without DM at study entry.

Intervention: Random 1:1 assignment to pitavastatin, 4 mg daily, or placebo.

Measurements: New-onset DM was determined at each visit by clinical diagnosis requiring initiation of medication treatment for DM. The incidence of new-onset DM was assessed in relation to predefined demographic and metabolic risk factors, stratified by treatment group. Treatment effects of pitavastatin on progression to new DM in key subgroups were determined.

Results: Participants with at least 3 DM risk factors (vs. no risk factors) had increased risk for DM in each treatment group (incidence rate, 3.24 per 100 person-years [PY] vs. 0.34 per 100 PY [pitavastatin] and 2.66 per 100 PY vs. 0.27 per 100 PY [placebo]). The incidence of DM was highest in South Asia. In adjusted analyses, high body mass index, prediabetes, and metabolic syndrome components were strongly associated with new-onset DM (all P < 0.005).

Limitation: Pitavastatin was the only statin assessed; DM was assessed clinically.

Conclusion: Metabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH.

Primary funding source: National Heart, Lung, and Blood Institute of the National Institutes of Health.

Source citation: Ie K, Hirose M, Sakai T, et al. Medication optimization protocol efficacy for geriatric inpatients: a randomized clinical trial. JAMA Netw Open. 2024;7:e2423544. 39078632.

Source citation: Lingvay I, Deanfield J, Kahn SE, et al; SELECT Trial Investigators. Semaglutide and cardiovascular outcomes by baseline HbA_1c and change in HbA_1c in people with overweight or obesity but without diabetes in SELECT. Diabetes Care. 2024;47:1360-1369. 38907684.

Description: In March 2020, the White House Coronavirus Task Force determined that clinicians in the United States needed expert treatment guidelines to optimally manage patients with COVID-19, a potentially life-threatening disease caused by a new pathogen for which no specific treatments were known to be effective.

Methods: The U.S. Department of Health and Human Services requested that the National Institutes of Health (NIH) take the lead in expeditiously convening a panel of experts to create "living" guidelines that would be widely accessible and capable of frequent updating as important new information became available.

Recommendations: The purpose of this article is to expand on the experiences of the NIH COVID-19 Treatment Guidelines Panel (the Panel) over the past 4 years, summarize the Panel's final recommendations for COVID-19, highlight some challenges and unanswered questions about COVID-19 management, and inform future responses to public health emergencies. The Panel was formed in March 2020, and the first iteration of the guidelines was released in April 2020. Now that the public health emergency has ended, the NIH COVID-19 Treatment Guidelines have sunsetted. This role will now fall to professional societies and organizations, such as the American College of Physicians, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the World Health Organization, all of which have been active in this area.