American heart journal
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American heart journal · Oct 2020
Clinical TrialRHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis.
Recurrent pericarditis (RP) occurs in 15% to 30% of patients following a first episode, despite standard treatment with nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids; many patients become dependent on corticosteroids. Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP. RHAPSODY, a double-blind, placebo-controlled, randomized-withdrawal (RW) pivotal Phase 3 trial (NCT03737110), enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C-reactive protein ≥1 mg/dL at screening. ⋯ Primary efficacy end point was time to adjudicated pericarditis recurrence during the RW period; secondary efficacy end points were proportion of patients maintaining clinical response, percentage of days with NRS ≤2, and percentage of patients with no-to-minimal pericarditis symptoms at week 16 of the RW period. Safety evaluations include adverse event monitoring, physical examinations, and laboratory tests. The RHAPSODY trial will evaluate the efficacy and safety of rilonacept in the treatment of RP to improve outcomes and patient health-related quality of life.
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American heart journal · Oct 2020
Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.
Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear. ⋯ OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.
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American heart journal · Sep 2020
Meta Analysis Comparative StudyP2Y12 inhibitor monotherapy versus aspirin monotherapy after short-term dual antiplatelet therapy for percutaneous coronary intervention: Insights from a network meta-analysis of randomized trials.
A number of trials have assessed the efficacy and safety of short-term dual antiplatelet therapy (DAPT) in patients who undergo percutaneous coronary intervention (PCI). However, whether to continue aspirin or a P2Y12 inhibitor after a short course of DAPT is actively debated. ⋯ Among patients undergoing PCI, short-term DAPT with continuation of either aspirin or P2Y12i reduced bleeding without increasing ischemic outcomes when compared with long-term DAPT. The choice of antiplatelet therapy after short-term DAPT should be evaluated in well-powered trials.
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American heart journal · Sep 2020
LetterExploring payments in the US pharmaceutical market from 2011 to 2019: Update on pharmacy benefit manager impact.
We extended an earlier analysis of the gross revenue, payments, and net revenues of pharmaceutical manufacturers to include data from 2017 through 2019. In the period of 2017 to 2019, we found that gross revenue increased by 6.8% per annum, and payments from manufacturers increased by 13.5% annually, whereas net revenues for the same manufacturers increased by only 2.9% annually. By 2019, these same firms made payments of 67.4% of net revenue, or $141.4 billion, to generate $209.9 billion in net sales. We observed that list price increases and payments have been growing disproportionally to manufacturer net income despite widespread public concern about rising outpatient prescription drug prices.
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American heart journal · Sep 2020
ReviewThe cardiac intensive care unit and the cardiac intensivist during the COVID-19 surge in New York City.
Critical care cardiology has been impacted by the coronavirus disease-2019 (COVID-19) pandemic. COVID-19 causes severe acute respiratory distress syndrome, acute kidney injury, as well as several cardiovascular complications including myocarditis, venous thromboembolic disease, cardiogenic shock, and cardiac arrest. ⋯ These include practical recommendations regarding structural and organizational changes to facilitate care of patients with COVID-19; staffing and personnel changes; and health and safety of personnel. We draw upon our own experiences at NewYork-Presbyterian Columbia University Irving Medical Center to offer insights into the unique challenges facing critical care clinicians and provide recommendations of how to address these challenges during this unprecedented time.