Pruritus after discontinuation of cetirizine

Background: Intense pruritus or itching emerging after discontinuation of cetirizine has been the subject of postmarketing reports submitted to the U.S. Food and Drug Administration (FDA), published in the medical literature, and discussed on the internet. To better understand and further investigate this adverse event, we analyzed cases of pruritus occurring after discontinuation of cetirizine in the FDA Adverse Event Reporting System (FAERS) database and medical literature. Methods: We conducted a retrospective study to identify and describe cases of pruritus occurring after discontinuation of cetirizine in the FAERS database and medical literature through April 24, 2017. Data collected from the reports included demographic information, reason for use, serious outcome, report source, duration of cetirizine use, time to onset of pruritus after cetirizine discontinuation, presence of associated urticaria, treatment for pruritus, concomitant comorbidities and medications associated with pruritus, rechallenge information, and patient outcome information. Results: We identified 146 cases of pruritus after discontinuation of cetirizine. Reporting frequency increased starting in 2008. The median patient age was 38 years ( n = 141), ranging from 6 to 71 years, and cases were predominantly reported in females ( n = 110). Most cases ( n = 115) were submitted directly to the FDA from consumers or healthcare providers. The median duration of use of cetirizine prior to discontinuation was 24 months ( n = 130), ranging from 0.3 to 172.2 months. The median time to onset of pruritus from discontinuation was 2 days ( n = 91), ranging from 0.5 to 5 days. Of the 55 cases that reported discontinuation of cetirizine again after restarting, 54 reported pruritus recurrence. Conclusions: Our case series provided evidence of an association between the discontinuation of cetirizine and the development of pruritus. The mechanism by which cetirizine causes pruritus upon discontinuation is unknown. Patients and prescribers should have knowledge of this adverse event, given the widespread use and availability of cetirizine, and potential impact on patient quality of life. </jats:sec

Istaroxime, a first in class new chemical entity exhibiting SERCA-2 activation and Na-K-ATPase inhibition: a new promising treatment for acute heart failure syndromes?

Acute heart failure syndromes (AHFS) are associated with the rapid onset of heart failure (HF) signs and symptoms. Hospitalizations for AHFS continue to rise and are associated with significant mortality and morbidity. Several pharmacological agents are currently approved for the treatment of AHFS, but their use is associated with an increase in short-term mortality. There is a need for new agents that can be given in the acute setting with increased efficacy and safety. Istaroxime is a unique agent with both inotropic and lusitropic properties which is currently being studied for the treatment of AHFS. Istaroxime inhibits the sodium-potassium adenosine triphosphatase (ATPase) and stimulates the sarcoplasmic reticulum calcium ATPase isoform 2 (SERCA-2) thereby improving contractility and diastolic relaxation. Early data from human studies reveal that istaroxime decreases pulmonary capillary wedge pressure (PCWP) and possibly improves diastolic function without causing a significant change in heart rate (HR), blood pressure, ischemic or arrhythmic events. Most commonly reported side effects were related to gastrointestinal intolerance and were dose related. In conclusion, istaroxime is a novel agent being investigated for the treatment of AHFS whose mechanism of action and cellular targets make it a promising therapy. Further studies with longer infusion times in patients with hypotension are required to confirm its efficacy and safety

Abstract 262: Preferences for Primary versus Specialty Palliative Care Among Patients With Heart Failure

Background: More than 5 million people in the USA suffer from heart failure (HF). Palliative care (PC) is both a clinical subspecialty and overall approach to care that focuses on promoting seriously ill patients and their family’s quality of life. PC takes several forms, including consultation by a PC specialist, or attention to palliative domains by a non-PC specialist (aka “primary” PC). Despite guidelines calling for the integration of PC in HF, specialty PC remains underutilized. Patient preferences regarding primary vs specialty PC are unknown. Objective: To identify patient knowledge and perceptions regarding how primary and specialty PC could complement usual HF management, as well as barriers preventing PC utilization. Methods: We recruited individuals with NYHA class II-IV HF from general medicine wards and an outpatient advanced HF clinic, both at an academic quaternary care hospital. We conducted semi-structured interviews addressing: (1) patient-perceived physical, emotional, social, and decision-making needs; (2) perception, knowledge, and preferences regarding PC; (3) barriers and facilitators to PC. To understand patient preferences regarding primary vs specialty PC, in the interview guide, we conceptualized PC into 5 domains: physical, emotional, spiritual and social aspects of care, and advance care planning. For each domain, participants discussed unmet needs, and preferences about whether the needs would be best met by their existing cardiology team or a PC specialist. Two investigators independently analyzed data using template analysis, an inductive/deductive qualitative technique. Results: We interviewed 28 patients; 82% were white, 61% were &gt;60 years, and 64% were male. 43% of participants had ejection fractions &lt;30%, and 64% were of NYHA classes III or IV. Symptom burden was high and a source of dissatisfaction; yet, few believed that their disease management was suboptimal, often citing a sense of resignation that symptoms are inevitable in HF. We heard mixed and often incorrect understandings of PC (and its distinction from hospice). Once misperceptions of PC were corrected, respondents expressed variable preferences for specialty vs. primary PC. Proponents of primary PC cited trust and rapport in their existing clinicians, HF-specific expertise, convenience, and cost. Alternatively, participants preferring specialty PC involvement cited expertise in symptom management, addressing caregiver concerns, reduced time constraints, and a comprehensive non-HF-exclusive approach to care. Conclusion: We frequently identified limited and often incorrect understanding of PC. Though once corrected, patients articulated variable preferences for primary vs. specialty PC integration into their existing HF care. Research is needed to identify means of increasing primary and specialty PC delivery in HF in a manner that reflects patient preferences. </jats:p

Why would I choose death?: A qualitative study of patient understanding of the role and limitations of cardiac devices

Background: Although cardiology organizations recommend early introduction of palliative care for patients with heart failure (HF), integration has remained challenging, particularly in patients with cardiac devices such as cardiac implantable electronic devices and left ventricular assist devices. Study authors suggest that patients often have limited and erroneous understanding of these devices and their implications for future care. Objective: The aim of this study was to assess perceptions of cardiac devices in patients with HF and how these perceptions impacted advance care planning and future expectations. Methods: This study used qualitative semistructured interviews with 18 community-dwelling patients with New York Heart Association stage II to IV HF. Results: We interviewed 18 patients (mean ejection fraction, 38%; mean age, 64 years; 33% female; 83% white; 39% New York Heart Association class II, 39% class III, and 22% class IV). All had a cardiac implantable electronic device (6% permanent pacemaker, 56% implantable cardioverter-defibrillator, 28% biventricular implantable cardioverter-defibrillator); 11% had left ventricular assist devices. Patients with devices frequently misunderstood the impact of their device on cardiac function. A majority expressed the belief that the device would forestall further deterioration, regardless of whether this was the case. This anticipation of stability was often accompanied by the expectation that emerging technologies would continue to preempt decline. Citing this faith in technology, these patients frequently saw limited value in advance care planning. Conclusions: In our sample, patients with cardiac devices overestimated the impact of their devices on preventing disease progression and death and deprioritized advance care planning as a result