Daily Archives: March 23, 2024
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
RCT: Clarithromycin improves early clinical and inflammatory responses in hospitalized community-acquired pneumonia patients
23 Mar, 2024 | 20:25h | UTCStudy Design and Population: The ACCESS trial was a phase 3, prospective, double-blind, randomized controlled trial conducted in 18 Greek hospitals, involving adults hospitalized with community-acquired pneumonia who displayed systemic inflammatory response syndrome, had a Sequential Organ Failure Assessment (SOFA) score of 2 or more, and procalcitonin levels of 0.25 ng/mL or more. Participants were randomly assigned to receive either standard of care with intravenous cephalosporins or β-lactam/β-lactamase inhibitor combinations plus oral clarithromycin (500 mg twice daily for 7 days) or placebo. The trial aimed to evaluate the impact of clarithromycin on early clinical and inflammatory responses.
Main Findings: Among 278 participants allocated to clarithromycin (n=139) or placebo (n=139), the primary composite endpoint—indicating early clinical response and inflammatory burden reduction within 72 hours—was met by 68% of patients in the clarithromycin group compared to 38% in the placebo group, showcasing a significant difference (29.6%, odds ratio 3.40, p<0.0001). Serious treatment-emergent adverse events were slightly lower in the clarithromycin group than in the placebo group, although not statistically significant.
Implications for Practice: The addition of clarithromycin to the standard of care for hospitalized patients with community-acquired pneumonia significantly improves early clinical response and reduces inflammatory burden, potentially through modulation of the immune response. These results support the use of clarithromycin alongside β-lactam antibiotics in the treatment of community-acquired pneumonia, highlighting its role in enhancing patient outcomes by targeting early clinical and inflammatory indicators.
Reference
Prof Evangelos J Giamarellos-Bourboulis, MD et al. (2024). Clarithromycin for early anti-inflammatory responses in community-acquired pneumonia in Greece (ACCESS): a randomised, double-blind, placebo-controlled trial. The Lancet Respiratory Medicine, Volume(Issue), Pages. DOI: https://doi.org/10.1016/S2213-2600(23)00412-5. Access the study here: Link
Observational Study: Association of antiarrhythmic drug use with increased risk of pacemaker implantation and syncope in new-onset atrial fibrillation patients
23 Mar, 2024 | 20:08h | UTCStudy Design and Population
This observational study utilized data from the Korean National Health Insurance Service to evaluate the impact of antiarrhythmic drugs (AADs) on the risk of pacemaker implantation or syncope in patients diagnosed with new-onset atrial fibrillation (AF) between 2013 and 2019. A total of 770,977 new-onset AF cases were identified, with 142,141 patients prescribed AADs within one year of diagnosis. The study compared the risk of these outcomes between AAD users and nonusers.
Main Findings
The study found that the use of AADs was associated with a significantly increased risk of pacemaker implantation or syncope, with adjusted risks being 3.5 times higher for either outcome, 2.0 times higher for syncope alone, and 5.0 times higher for pacemaker implantation. These associations were consistent across various patient subgroups, and propensity score-matched analysis supported these findings. Notably, women were found to be more susceptible to the adverse effects of AADs than men.
Implications for Practice
The findings suggest a need for careful evaluation of the risks associated with AAD use in patients with new-onset AF, particularly regarding the potential for pacemaker implantation or syncope. These results highlight the importance of individualized patient assessment before prescribing AADs to mitigate these risks effectively. Further research is needed to explore the mechanisms behind these associations and to develop strategies to minimize adverse outcomes in this patient population.