Annals of Pharmacotherapy最新文献

Background: Off-label tenecteplase use for acute ischemic stroke (AIS) has increased due to ease of administration and comparable efficacy and safety to alteplase.

Objective: This study aimed to evaluate time to thrombolysis before and after transition from alteplase to tenecteplase for treatment of AIS at 2 institutions.

Methods: This retrospective cohort study included adult patients receiving thrombolysis for AIS before and after transition from alteplase to tenecteplase at 2 academic medical centers from January 1, 2020 to January 31, 2024. The primary endpoint was door-to-needle (DTN) time, defined as minutes from hospital arrival to thrombolysis administration. Notable secondary endpoints included time from last known well (LKW) to thrombolysis, time from brain imaging to thrombolysis, hospital length of stay (LOS), and incidence of symptomatic intracranial hemorrhage (sICH).

Results: A total of 328 patients (168 tenecteplase and 160 alteplase) were included. Patients were 51.5% female with a median (interquartile range [IQR]) age of 70 [58-80] years and initial National Institutes of Health Stroke Scale (NIHSS) score of 8 [5-14]. There was no statistically significant difference in DTN time (60 vs 56 minutes), time from LKW to thrombolysis (134 vs 147.5 minutes), or time from brain imaging to thrombolysis (32 vs 31 minutes) between tenecteplase and alteplase. Hospital LOS (5.7 vs 4.9 days) and the rates of sICH (3% vs 3.8%) were similar between groups.

Conclusion and relevance: Tenecteplase and alteplase had comparable DTN times for treatment of AIS and similar safety endpoints. Further studies are warranted to identify opportunities to streamline DTN times with tenecteplase.

Background: Implementation of evidence-based guidelines in patient care is inefficient. Only 14% of new research are routinely adopted into clinical practice. The atrial fibrillation (AF) practice guidelines recommend anticoagulation in men with a CHA₂DS₂-VASc score greater than or equal to 2 and in women with a CHA₂DS₂-VASc score greater than or equal to 3. Despite these recommendations, oral anticoagulation prescribing rates were found to be as low as 51%. Existing frameworks, such as the Theoretical Domain Framework (TDF), are used in implementation science to identify behavior changes to overcome barriers to guideline adoption.

Objective: In this project, we explored behavioral themes and barriers that prevented clinician adherence to evidence-based recommendations for patients with non-valvular atrial fibrillation (NVAF) and developed interventions to overcome those barriers.

Methods: Nine focused interviews were conducted with stakeholders across multiple disciplines involved with NVAF care. Interview questions were based on the TDF and designed to determine behavior changes necessary to increase appropriate anticoagulation prescribing and decrease unnecessary NVAF hospital admissions. The interviews were transcribed and coded using NVivo 12 qualitative data analysis software (released 2018). Themes were documented, and interventions were then developed to address the barriers.

Results: TDF interviews yielded 4 main barrier themes regarding appropriate NVAF management in 2 theoretical domains. These themes were lack of knowledge, cost of anticoagulation, patient refusal to take anticoagulation, and social determinants of health. The theoretical domains were knowledge and environmental context and resources.

Conclusion and relevance: Based on our limited interviews, the TDF framework informed potential barriers contributing to the underutilization of appropriate anticoagulation in patients with NVAF. Techniques for behavior change interventions may be applied to overcome the identified barriers.

Background: Rates of in-hospital venous thromboembolism (VTE) in the intracranial hemorrhage (ICH) population post oral anticoagulation (AC) reversal are as high as 10%. Guidelines recommend the initiation of prophylactic AC 24 to 48 hours post ICH; however, there is no guidance regarding optimal VTE prophylaxis post-reversal.

Objective: This study aimed to identify the incidence of thromboembolism post oral AC reversal in patients presenting with ICH and describe VTE prophylaxis timing and agent selection.

Methods: This was a retrospective, descriptive study conducted within a single health system. Patients on AC who received reversal agents 4-factor prothrombin complex concentrate (4F-PCC) with or without vitamin K, andexanet alfa, and/or idarucizumab for AC-associated ICH were included. The primary endpoint was incidence of in-hospital VTE post-reversal. Secondary endpoints included AC utilization specifications, length of stay, and in-hospital mortality.

Results: There were 118 patients (57%) who received 4F-PCC and 89 patients (43%) who received andexanet alfa for reversal post-ICH. Overall, 195 patients (94.2%) achieved hemostasis. Eight patients had incidence of VTE (3.9%), and of those, 6 patients (75%) were reinitiated on AC, all of which utilized prophylactic heparin. The median time from reversal to VTE was 55.9 days (interquartile range [IQR] = 21.2-72.4). For all patients on AC, the median time to initiation from reversal was 3.98 days (IQR = 2.5-6.01), and for those with incidence of thrombosis, the median time to AC initiation was 6.4 days (IQR = 2.6-13.1). Mortality occurred in 13 patients (6.3%).

Conclusion and relevance: This patient population is complex in that the need to achieve hemostasis with AC reversal must be balanced with the risk of VTE. Further studies are needed to determine the ideal timing and agent selection for VTE prophylaxis initiation post ICH reversal.

Current clinical practice is based on the principles of evidence-based medicine (EBM) with clinical practice guidelines (CPGs) often serving as a source of information for the medical decision-making process. There are philosophical and ethical tenets underlying this process including those pertaining to patient values and preferences. Despite their importance, these tenets may receive less attention than the empirically derived recommendations in CPGs based on the principles of EBM. The purpose of this article is to provide an overview of the philosophical and ethical underpinnings of the medical decision-making process with a focus on patient values and preferences so pharmacists and other clinicians can appreciate the interplay between science, philosophy and ethics when providing patient- or person-centered care. Appreciation of these discussions should help practitioners to recognize the limitations and challenges when attempting to incorporate population-based evidence into a patient-specific medical decision-making process that often necessitates reconciliation and negotiation between the clinician and patient when striving to provide optimal care.

Background: The 2022 AHA-ACC HFSA Guideline for Management of Heart Failure recommend initiating an angiotensin receptor/neprilysin inhibitor (ARNI) in patients with heart failure with reduced ejection fraction (HFrEF) who can tolerate an angiotensin-converting enzyme inhibitor (ACEi). The manufacturer recommends initiating a 36-hour washout period when switching from ACEi to ARNI due to an increased risk of adverse effects, including angioedema. This study investigated the adherence to the washout period when transitioning from ACEi to ARNI at a community hospital.

Objectives: The primary objective was to assess the rate of adherence to the 36-hour washout when transitioning patients from ACEi to ARNI. Secondary outcomes included heart failure exacerbation readmission rates within 90 days and the rate of adverse effects (angioedema, hypotension, acute kidney injury, and hyperkalemia).

Methods: This was a retrospective cohort study including patients with HFrEF who were transitioned from ACEi to ARNI during their hospital stay between March 1, 2016 and December 31, 2022. Patients were excluded if they did not receive an ACEi or ARNI during their admission or if they had an ejection fraction >40%. Pearson chi-square was used to analyze categorical data.

Results: Of 33 patients included in this study, 67% received the full 36-hour washout period when transitioning from ACEi to ARNI. There were no significant differences between the rates of hospital readmissions or adverse effects between the groups. No patients experienced hyperkalemia or angioedema.

Conclusion and relevance: This is the first study to our knowledge to describe real-world prescribing practices when transitioning patients from ACEi to ARNI for the treatment of HFrEF. Larger, multicenter studies are needed to provide more data on prescribing practices outside this single center. Future research should also include pharmacist's role in adhering to the recommended washout.

The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections.