Hematology (all articles)
Cohort Study: Higher serious bleeding rates linked to diltiazem in elderly atrial fibrillation patients on anticoagulation
26 Apr, 2024 | 12:35h | UTCStudy Design and Population:
This retrospective cohort study analyzed data from 204,155 Medicare beneficiaries aged 65 years or older diagnosed with atrial fibrillation. The study focused on new users of the anticoagulants apixaban or rivaroxaban who commenced treatment with either diltiazem or metoprolol between January 2012 and November 2020, with follow-up extending up to 365 days.
Main Findings:
Patients treated with diltiazem exhibited a significantly increased risk of serious bleeding, including bleeding-related hospitalization and death, compared to those treated with metoprolol. The hazard ratio (HR) for serious bleeding events was 1.21, with a rate difference (RD) of 10.6 per 1000 person-years. Notably, the risk escalated with diltiazem doses exceeding 120 mg/day, indicating a dose-response relationship. Secondary outcomes, such as ischemic stroke or systemic embolism, did not show significant differences between the treatment groups.
Implications for Practice:
The findings suggest that in older adults with atrial fibrillation treated with apixaban or rivaroxaban, diltiazem increases the risk of serious bleeding, especially at higher doses. These results underscore the importance of cautious medication management and might influence clinical decisions regarding the choice of ventricular rate control in this population.
Reference (link to abstract – $ for full-text):
High efficacy of exagamglogene autotemcel in achieving transfusion independence in β-Thalassemia
25 Apr, 2024 | 23:29h | UTCStudy Design and Population:
This open-label, single-group, phase 3 trial investigated the efficacy of exagamglogene autotemcel (exa-cel), a nonviral CRISPR-Cas9 gene-edited cell therapy, in patients aged 12 to 35 with transfusion-dependent β-thalassemia. Various genotypes were included, and participants underwent myeloablative conditioning followed by exa-cel infusion. The primary endpoint was to achieve and maintain transfusion independence.
Main Findings:
Of the 52 patients treated, 35 with sufficient follow-up showed that 32 (91%) achieved transfusion independence for at least 12 months, significantly surpassing the study’s efficacy threshold. The average total hemoglobin during this period was 13.1 g/dL, with fetal hemoglobin averaging 11.9 g/dL and widely distributed across red cells. The treatment’s safety profile was compatible with the expected outcomes of myeloablative conditioning and autologous hematopoietic stem cell transplantation, with no reported deaths or cancer developments.
Implications for Practice:
The successful achievement of transfusion independence in a high percentage of patients suggests that exa-cel is a promising treatment option for transfusion-dependent β-thalassemia. This study supports the potential for gene-edited cell therapies to significantly improve outcomes in genetic blood disorders. Continued monitoring and further research are recommended to fully understand the long-term implications and safety of such treatments.
Reference:
CRISPR-Cas9 gene editing in sickle cell disease shows high efficacy in preventing vaso-occlusive crises
25 Apr, 2024 | 23:21h | UTCStudy Design and Population: This phase 3, single-group, open-label randomized clinical trial investigated the efficacy of exagamglogene autotemcel (exa-cel), a nonviral CRISPR-Cas9 gene-edited therapy, in patients aged 12 to 35 years with severe sickle cell disease. The study included patients who experienced at least two severe vaso-occlusive crises annually in the two years prior to screening. The therapeutic intervention involved editing CD34+ hematopoietic stem and progenitor cells (HSPCs) and administering a myeloablative conditioning regimen with busulfan.
Main Findings: Of the 44 participants treated, 30 with sufficient follow-up demonstrated a significant response. Ninety-seven percent (29 of 30) remained free from severe vaso-occlusive crises for at least 12 consecutive months, and 100% (30 of 30) avoided hospitalization for these crises over the same period. The intervention showed a high safety profile, consistent with myeloablative busulfan conditioning and autologous HSPC transplantation, with no cancers reported during the follow-up.
Implications for Practice: The results suggest that exa-cel can effectively eliminate severe vaso-occlusive crises in patients with sickle cell disease, marking a substantial advance in treatment options. These findings may pave the way for broader application of gene-editing therapies in hematologic diseases, pending further research on long-term outcomes and safety.
Nested Case-Control Study: Increased risk of major bleeding in atrial fibrillation patients with concomitant SSRI and oral anticoagulant use
23 Mar, 2024 | 20:48h | UTCStudy Design and Population
This nested case-control study investigated the association between the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and oral anticoagulants (OACs) on the risk of major bleeding among patients with atrial fibrillation. Conducted within the UK’s Clinical Practice Research Datalink, the study included 42,190 cases of major bleeding matched to 1,156,641 controls based on age, sex, cohort entry date, and follow-up duration. Patients initiating OACs between January 2, 1998, and March 29, 2021, were included, with risk-set sampling utilized for control selection.
Main Findings
The study found that concomitant use of SSRIs and OACs was associated with a 33% increased risk of major bleeding compared to OAC use alone, with the highest risk observed within the first 30 days of concurrent use. The increased risk was consistent across different ages, sexes, and patient histories, including those with chronic kidney disease or previous bleeding events. Notably, the elevated risk of bleeding extended up to 6 months of concomitant use but did not vary significantly with the potency of SSRIs or the type of OAC used (direct OACs or vitamin K antagonists).
Implications for Practice
These findings underscore the need for healthcare professionals to closely monitor patients with atrial fibrillation who are prescribed SSRIs in addition to OACs, particularly during the initial months of treatment. This study highlights the importance of managing bleeding risk factors and suggests reconsidering the necessity and duration of concomitant SSRI and OAC use. Future research should focus on strategies to mitigate this bleeding risk and explore alternative treatments for managing depression in patients requiring anticoagulation.
Reference
Phase 2 RCT: Low-dose aspirin significantly reduces hepatic fat in MASLD patients without cirrhosis
20 Mar, 2024 | 17:48h | UTCStudy Design and Population: This phase 2, randomized, double-blind, placebo-controlled clinical trial was carried out over six months at a single hospital in Boston, Massachusetts. The study included 80 participants aged 18 to 70 years diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD) but without cirrhosis. Participants were randomly assigned to receive either 81 mg of daily aspirin (n=40) or placebo (n=40).
Main Findings: The trial revealed that aspirin significantly reduced the mean absolute change in hepatic fat content by -10.2% compared with placebo, as measured by proton magnetic resonance spectroscopy (MRS), with a statistically significant difference (P=0.009). Furthermore, aspirin treatment notably decreased relative hepatic fat content, increased the proportion of patients achieving a 30% or greater reduction in hepatic fat, and reduced both absolute and relative hepatic fat content as assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Adverse events were mostly minor, with upper respiratory infections and arthralgias being the most common.
Implications for Practice: These findings suggest that low-dose aspirin may be an effective intervention for reducing liver fat in adults with MASLD without cirrhosis, potentially offering a simple, accessible treatment option. However, the results are preliminary and call for further confirmation in larger, more diverse populations. The study underscores the importance of considering low-dose aspirin as part of management strategies for MASLD, pending further research.
Reference
Simon TG et al. (2024). Randomized Clinical Trial: Low-Dose Aspirin Significantly Reduces Hepatic Fat in MASLD Patients Without Cirrhosis. JAMA, 331(11), 920-929. DOI: 10.1001/jama.2024.1215. Access the study here: [Link]
RCT | Restrictive vs. liberal red blood cell transfusion strategy for critically injured patients
11 Aug, 2023 | 15:08h | UTC
NICE Updated Guideline | Venous thromboembolic diseases
7 Aug, 2023 | 15:05h | UTC
Global prevalence, years lived with disability, and trends in anemia burden by severity and cause, 1990–2021
3 Aug, 2023 | 13:43h | UTC
Commentary on Twitter
NEW #GBD study by @IHME_UW on the #anaemia burden by severity and cause, 1990–2021?https://t.co/NbiEDSkbGI
Despite a decrease in prevalence, the number of people with anaemia increased globally
In every region females had a higher #anemia YLDs than males pic.twitter.com/oFx4vHRhs1
— The Lancet Haematology (@TheLancetHaem) August 1, 2023
RCT | Ferric derisomaltose plus tranexamic acid may reduce blood transfusion risk by 50% in hip surgery
3 Aug, 2023 | 13:18h | UTCFerric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial – The Lancet Haematology (link to abstract – $ for full-text)
RCT | Early oral antibiotic switch in low-risk neutropenic sepsis shows mixed results
3 Aug, 2023 | 13:15h | UTC
BSH guideline for anticoagulant management of pregnant individuals with mechanical heart valves
2 Aug, 2023 | 14:01h | UTC
Phase 1 Trial | NI006 shows potential for cardiac amyloid depletion in transthyretin amyloid cardiomyopathy
1 Aug, 2023 | 14:17h | UTCPhase 1 Trial of Antibody NI006 for Depletion of Cardiac Transthyretin Amyloid – New England Journal of Medicine (link to abstract – $ for full-text)
Commentaries:
Amyloid Removal Looks Possible in ATTR Cardiomyopathy Imaging Trial – TCTMD
Antibody NI006 for Depletion of Cardiac Transthyretin Amyloid – American College of cardiology
Review | Perioperative iron deficiency anemia
31 Jul, 2023 | 14:02h | UTCPerioperative iron deficiency anaemia – BJA Education
Systematic Review | Monocyte distribution width as a diagnostic marker for infection
26 Jul, 2023 | 13:26h | UTCMonocyte Distribution Width as a Diagnostic Marker for Infection – CHEST
Commentary on Twitter
What is the diagnostic performance of monocyte distribution width across multiple infectious disease outcomes and care settings? Read the full original research in the July issue to learn more: https://t.co/iJxzNwdlgq#JournalCHEST #MedEd #CHESTCritCare pic.twitter.com/epYYOJA9wt
— CHEST® Journal (@journal_CHEST) July 7, 2023
Cohort Study | The role of antiphospholipid syndrome and specific antibodies in predicting SLE pregnancy complications
25 Jul, 2023 | 13:44h | UTCPregnancy outcomes in 1869 pregnancies in a large cohort from the Spanish Society of Rheumatology Lupus Register (RELESSER) – Seminars in Arthritis and Rheumatism (link to abstract – $ for full-text)
Commentary: SLE and Pregnancy Outcomes – RheumNow
Consensus Paper | De-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and PCI
24 Jul, 2023 | 13:08h | UTCDe-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention: a Consensus Statement from an international expert panel on coronary thrombosis – Nature Reviews Cardiology (if the link is paywalled, try this one)
Guideline Synopsis | Diagnosis and management of priapism
21 Jul, 2023 | 13:47h | UTCDiagnosis and Management of Priapism – JAMA (free for a limited period)
Original Guideline: The Diagnosis and Management of Recurrent Ischemic Priapism, Priapism in Sickle Cell Patients, and Non-Ischemic Priapism: An AUA/SMSNA Guideline – Journal of Urology
Phase 1–2 study | Liso-cel shows effectiveness against resistant CLL/SLL post BTK inhibitor, venetoclax treatment
20 Jul, 2023 | 10:58h | UTCLisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1–2 study – The Lancet (link to abstract – $ for full-text)
News Release: Immunotherapy Improves Remission for Relapsed, Refractory Leukemia – Northwestern Medicine
RCT | No definitive benefit of enoxaparin over placebo in preventing VTE in hospitalized older adults
17 Jul, 2023 | 13:57h | UTC
Review | Guiding the use of invasive cardiac interventions in patients with advanced malignancies
17 Jul, 2023 | 13:23h | UTC
M-A | P2Y12 inhibitors show superior efficacy over aspirin for secondary prevention in CAD
11 Jul, 2023 | 14:06h | UTCP2Y12 Inhibitor or Aspirin Monotherapy for Secondary Prevention of Coronary Events – Journal of the American College of Cardiology (link to abstract – $ for full-text)
Related:
Monotherapy with a P2Y12 inhibitor or aspirin for secondary prevention in patients with established atherosclerosis: a systematic review and meta-analysis – The Lancet (link to abstract – $ for full-text)
Commentary on Twitter
Given superior efficacy & similar overall safety, #P2Y12 inhibitor monotherapy might be preferred over #aspirin monotherapy for long-term secondary prevention in pts w/ established #cvCAD. https://t.co/EehIEuWqOt#JACC #P2Y12i #CardioTwitter @FeliceGragnano @vlgmrc @Drroxmehran pic.twitter.com/betLycXGs5
— JACC Journals (@JACCJournals) July 5, 2023
Clinical Trial Update | 5-year follow-up validates efficacy of sorafenib maintenance in FLT3-ITD AML
11 Jul, 2023 | 13:37h | UTCSorafenib maintenance after allogeneic haemopoietic stem-cell transplantation in patients with FLT3-ITD acute myeloid leukaemia: long-term follow-up of an open-label, multicentre, randomised, phase 3 trial – The Lancet Haematology (link to abstract – $ for full-text)
Commentary on Twitter
NEW: with over 5 years of follow-up, sorafenib maintenance is associated with improved outcomes compared w/ non-maintenance in patients w/ FLT3-ITD AML undergoing allogeneic HSCT in a multicentre, randomised, ph 3 trial #leusm #bmtsm https://t.co/JK190vS0Ql pic.twitter.com/SBP887hgEu
— The Lancet Haematology (@TheLancetHaem) July 5, 2023
Single-arm study | Pirtobrutinib exhibits efficacy in CLL patients after failure of covalent BTK inhibitor treatment
7 Jul, 2023 | 16:14h | UTCPirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia – New England Journal of Medicine (link to abstract – $ for full-text)
News release from the manufacturer: New England Journal of Medicine Publishes BRUIN Phase 1/2 Trial Data for Pirtobrutinib in BTK Inhibitor Pre-Treated Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma – Lilly
Review | Hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA): two sides of the same coin
7 Jul, 2023 | 16:01h | UTCHES and EGPA: Two Sides of the Same Coin – Mayo Clinic Proceedings
Myelodysplastic syndromes: 2023 update on diagnosis, risk-stratification, and management
5 Jul, 2023 | 01:00h | UTC