Clinical therapeutics
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Clinical therapeutics · Mar 2019
ReviewPreoperative Frailty Evaluation: A Promising Risk-stratification Tool in Older Adults Undergoing General Surgery.
General surgical procedures are among the most commonly performed operations in the United States. Despite advances in surgical and anesthetic techniques and perioperative care, complications after general surgery in older adults remain a significant cause of increased morbidity, mortality, and health care costs. Frailty, a geriatric syndrome characterized by multisystem physiologic decline and increased vulnerability to stressors and adverse clinical outcomes, has emerged as a plausible predictor of adverse outcomes after surgery in older patients. Thus, the goal of this topical review is to evaluate the evidence on the association between preoperative frailty and clinical outcomes after general surgery and whether frailty evaluation may have a role in surgical risk-stratification in vulnerable older patients. ⋯ Evidence supports the further development of preoperative frailty evaluation as a risk-stratification tool in older adults undergoing general surgery. Research is urgently needed to quantify and differentiate the predictive ability of validated frailty instruments in the context of different general surgical procedures and medical acuity and in conjunction with existing surgical risk indices widely used in clinical practice. Practical applicability of frailty instrument as well as geriatrics-centered outcomes need to be incorporated in future studies in this line of research. Furthermore, clinical care pathways that integrate frailty assessment, geriatric medicine focused perioperative and postoperative management, and patient-centered interdisciplinary care models should be investigated as a comprehensive intervention approach in older adults undergoing general surgery. Finally, early implementation of palliative care should occur at the outset of hospital encounter in frail older patients who present with indications for emergent general surgery.
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Clinical therapeutics · Feb 2019
ReviewThe Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia.
In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision making, it is important to understand how such data are developed, the limitations of these data, and how to best use RWD to improve patient care. Historically, the use of RWE has been approached with skepticism because of its often-retrospective nature compared with data from conventional randomized controlled trials (RCTs). This review discusses the role and function of RWE and RWD in clinical research. We summarize the types of RWE used in clinical research, outline the challenges and limitations involved with these data, and suggest how these types of analyses can supplement results from clinical trials to foster a more complete understanding of a drug or disease area of interest. In particular, we focus on the role of RWE in investigating chronic myeloid leukemia (CML) and tyrosine kinase inhibitor therapy for CML. ⋯ Real-world studies are different from conventional RCTs and therefore provide insight into distinct aspects of treatment and patient outcomes. Together with results from clinical trials, RWE can help to illustrate a more complete picture of the tolerability, effectiveness, and impact of a drug. The recently published guidelines indicate that the FDA expects a growing role for RWE.
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Disease management of stable coronary artery disease consists of controlling hemostasis and lipid regulation. No treatment strategies preventing plaque erosion or rupture are yet available. Cholesterol crystal-induced inflammation leading to plaque destabilization is believed to be an important factor contributing to plaque instability and might well be amenable to treatment with anti-inflammatory drugs. Colchicine has anti-inflammatory properties with the potential to address both the direct and indirect inflammatory mechanisms in the plaque. ⋯ The body and quality of evidence regarding the efficacy of colchicine for secondary prevention of stable and acute phases of coronary artery disease will be greatly expanded in the upcoming years, providing less biased and more accurate effect estimates. If colchicine's anti-inflammatory characteristics translate to improved event-free cardiovascular survival, this relatively safe, low-cost, and well-known drug may become the third pillar (next to lipid regulation and platelet inhibition) in the medical management of stable coronary artery disease.
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Clinical therapeutics · Jan 2019
Review Meta AnalysisEffects of Perioperative Dexmedetomidine on Postoperative Mortality and Morbidity: A Systematic Review and Meta-analysis.
Major postoperative complications translate into increased health care resource utilization, prolonged hospital stays, and increased mortality. We aimed to assess the effects of perioperative dexmedetomidine use on postoperative mortality and the prevalence of major complications after cardiac and noncardiac surgery. ⋯ Dexmedetomidine use may help to reduce postoperative 30-day mortality, durations of mechanical ventilation, ICU stay, and hospital stay, and the prevalences of delirium, atrial fibrillation, and cardiac arrest in patients who undergo cardiac surgery. The majority of the benefits of dexmedetomidine were not significant in patients undergoing noncardiac surgery. An increased risk for bradycardia should be taken into consideration when prescribing dexmedetomidine. International Prospective Register of Systematic Reviews identifier: CRD42017070791.
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Clinical therapeutics · Jan 2019
Review Meta AnalysisEffects of Perioperative Dexmedetomidine on Postoperative Mortality and Morbidity: A Systematic Review and Meta-analysis.
Major postoperative complications translate into increased health care resource utilization, prolonged hospital stays, and increased mortality. We aimed to assess the effects of perioperative dexmedetomidine use on postoperative mortality and the prevalence of major complications after cardiac and noncardiac surgery. ⋯ Dexmedetomidine use may help to reduce postoperative 30-day mortality, durations of mechanical ventilation, ICU stay, and hospital stay, and the prevalences of delirium, atrial fibrillation, and cardiac arrest in patients who undergo cardiac surgery. The majority of the benefits of dexmedetomidine were not significant in patients undergoing noncardiac surgery. An increased risk for bradycardia should be taken into consideration when prescribing dexmedetomidine. International Prospective Register of Systematic Reviews identifier: CRD42017070791.