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Displaying 741 - 750 of 7456 in ACP Online
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Displaying 741 - 750 of 6915 in Annals of Internal Medicine
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Risk for Chronic Kidney Disease Progression After Acute Kidney Injury: Findings From the Chronic Renal Insufficiency Cohort Study
Background: Prior studies associating acute kidney injury (AKI) with more rapid subsequent loss of kidney function had methodological limitations, including inadequate control for differences between patients who had AKI and those who did not. Objective: To determine whether AKI is independently associated with subsequent kidney function trajectory among patients with chronic kidney disease (CKD). Design: Multicenter prospective cohort study. Setting: United States. Participants: Patients with CKD (n = 3150). Measurements: Hospitalized AKI was defined by a 50% or greater increase in inpatient serum creatinine (SCr) level from nadir to peak. Kidney function trajectory was assessed using estimated glomerular filtration rate (eGFR) based on SCr level (eGFRcr) or cystatin C level (eGFRcys) measured at annual study visits. Results: During a median follow-up of 3.9 years, 433 participants had at least 1 AKI episode. Most episodes (92%) had stage 1 or 2 severity. There were decreases in eGFRcr (−2.30 [95% CI, −3.70 to −0.86] mL/min/1.73 m2) and eGFRcys (−3.61 [CI, −6.39 to −0.82] mL/min/1.73 m2) after AKI. However, in fully adjusted models, the decreases were attenuated to −0.38 (CI, −1.35 to 0.59) mL/min/1.73 m2 for eGFRcr and −0.15 (CI, −2.16 to 1.86) mL/min/1.73 m2 for eGFRcys, and the CI bounds included the possibility of no effect. Estimates of changes in eGFR slope after AKI determined by either SCr level (0.04 [CI, −0.30 to 0.38] mL/min/1.73 m2 per year) or cystatin C level (−0.56 [CI, −1.28 to 0.17] mL/min/1.73 m2 per year) also had CI bounds that included the possibility of no effect. Limitations: Few cases of severe AKI, no adjudication of AKI cause, and lack of information about nephrotoxic exposures after hospital discharge. Conclusion: After pre-AKI eGFR, proteinuria, and other covariables were accounted for, the association between mild to moderate AKI and worsening subsequent kidney function in patients with CKD was small. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.
Drug Repurposing and Observational Studies: The Case of Antivirals for the Treatment of COVID-19
Remdesivir and molnupiravir were the only 2 repurposed antivirals that were approved for emergency use during the COVID-19 pandemic. Both drugs received their emergency use authorization on the basis of a single industry-funded phase 3 trial, which was launched after evidence of in vitro activity against SARS-CoV-2. In contrast, for tenofovir disoproxil fumarate (TDF), little in vitro evidence was generated, no randomized trials for early treatment were done, and the drug was not considered for authorization. Yet, by the summer of 2020, observational evidence suggested a substantially lower risk for severe COVID-19 in TDF users compared with nonusers. The decision-making process for the launching of randomized trials for these 3 drugs is reviewed. Observational data in favor of TDF was systematically dismissed, even though no viable alternative explanations were proposed for the lower risk for severe COVID-19 among TDF users. Lessons learned from the TDF example during the first 2 years of the COVID-19 pandemic are described, and the use of observational clinical data to guide decisions about the launch of randomized trials during the next public health emergency is proposed. The goal is that gatekeepers of randomized trials make better use of the available observational evidence for the repurposing of drugs without commercial value.
Indefinite Anticoagulant Therapy for First Unprovoked Venous Thromboembolism: A Cost-Effectiveness Study: Annals of Internal Medicine: Vol 176, No 7
Background: Clinical practice guidelines recommend indefinite anticoagulation for a first unprovoked venous thromboembolism (VTE). Objective: To estimate the benefit–harm tradeoffs of indefinite anticoagulation in patients with a first unprovoked VTE. Design: Markov modeling study. Data Sources: Systematic reviews and meta-analyses for the long-term risks and case-fatality rates of recurrent VTE and major bleeding. Published literature for costs, quality of life, and other clinical events. Target Population: Patients with a first unprovoked VTE who have completed 3 to 6 months of initial anticoagulant treatment. Time Horizon: Lifetime. Perspective: Canadian health care public payer. Intervention: Indefinite anticoagulation with direct oral anticoagulants. Outcome Measures: Recurrent VTE events, major bleeding events, costs in 2022 Canadian dollars (CAD), and quality-adjusted life-years (QALYs). Results of Base-Case Analysis: When compared with discontinuing anticoagulation after initial treatment in a hypothetical cohort of 1000 patients aged 55 years, indefinite anticoagulation prevented 368 recurrent VTE events, which included 14 fatal pulmonary emboli, but induced an additional 114 major bleeding events, which included 30 intracranial hemorrhages and 11 deaths from bleeding. Indefinite anticoagulation cost CAD $16 014 more per person and did not increase QALYs (−0.075 per person). Results of Sensitivity Analysis: Model results were most sensitive to the case-fatality rate of major bleeding and the annual risk for major bleeding during extended anticoagulation. Limitation: The model assumed that risks for recurrent VTE and major bleeding measured in clinical trials at 1 year remained constant during extended anticoagulation. Conclusion: Clinicians should use shared decision making to incorporate individual patient preferences and values when considering treatment duration for unprovoked VTE. Primary Funding Source: Canadian Institutes of Health Research.