Daily Archives: April 26, 2024
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):
Cohort Study: Increased fracture risk linked with initiation of antihypertensive medication in older veterans
26 Apr, 2024 | 12:29h | UTCStudy Design and Population:
This retrospective cohort study evaluated the association between antihypertensive medication initiation and fracture risk among older long-term care nursing home residents within the Veterans Health Administration. Conducted from 2006 to 2019 with data analysis spanning 2021 to 2023, the study utilized target trial emulation techniques and included 29,648 residents. A 1:4 propensity score-matched method was employed to compare medication initiators with non-initiators.
Main Findings:
Out of the matched cohort of 64,710 residents, those who initiated antihypertensive medication showed a higher incidence of fractures (5.4 per 100 person-years) compared to controls (2.2 per 100 person-years). The adjusted hazard ratio for fractures was 2.42. Notably, higher risks were observed in subgroups with dementia or elevated blood pressure thresholds (systolic ≥140 mm Hg or diastolic ≥80 mm Hg). Risks for severe falls and syncope were also elevated in the medication-initiating group.
Implications for Practice:
The study indicates a significant association between the initiation of antihypertensive medications and increased fracture risks among older, frail nursing home residents. Given these findings, clinicians should exercise caution and consider enhanced monitoring and preventive strategies when prescribing these medications to this vulnerable population.
Reference (link to abstract – $ for full-text):
Dave, C. V. et al. (2024). Antihypertensive Medication and Fracture Risk in Older Veterans Health Administration Nursing Home Residents. JAMA Intern Med, Published online April 22, 2024. DOI:10.1001/jamainternmed.2024.0507.
M-A: Reduced risk of infective endocarditis following dental procedures with antibiotic prophylaxis in high-risk individuals
26 Apr, 2024 | 12:07h | UTCStudy Design and Population:
This systematic review and meta-analysis evaluated the impact of antibiotic prophylaxis on the incidence of infective endocarditis following invasive dental procedures. Researchers analyzed data from 1,152,345 cases sourced from PubMed, Cochrane-CENTRAL, Scopus, and other databases up to May 2023. The study included various research designs, such as case-control, cohort, and time-trend studies, assessing the effectiveness of antibiotic prophylaxis across different risk groups.
Main Findings:
The meta-analysis revealed that antibiotic prophylaxis significantly lowers the risk of infective endocarditis among individuals at high risk (pooled relative risk, 0.41; 95% CI, 0.29-0.57), with consistent findings across studies of good quality. However, the effectiveness of prophylaxis in individuals at moderate or low/unknown risk remains unsupported by sufficient evidence. Time-trend studies provided mixed results, with some indicating no change or an increase in infective endocarditis incidence post-guideline changes in 2007.
Implications for Practice:
The findings support the continued use of antibiotic prophylaxis for high-risk individuals undergoing invasive dental procedures, aligning with current guidelines from the American Heart Association and European Society of Cardiology. The lack of clear benefits in moderate and low-risk groups suggests a need for further research to optimize prophylaxis guidelines and ensure effective risk stratification in clinical practice.
Reference (link to abstract – $ for full-text):
RCT: Lack of significant effect of Paxlovid (nirmatrelvir–ritonavir) on symptom alleviation in Covid-19
26 Apr, 2024 | 11:49h | UTCStudy Design and Population:
This phase 2–3 randomized clinical trial investigated the efficacy of nirmatrelvir in combination with ritonavir for treating mild-to-moderate Covid-19 in adults. Participants, both vaccinated and unvaccinated, were enrolled based on their risk factors for severe Covid-19. The study included 1296 adults who had confirmed Covid-19 with symptom onset within the past 5 days. They were randomly assigned to receive either nirmatrelvir–ritonavir or placebo every 12 hours for 5 days.
Main Findings:
The primary endpoint was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Results showed that the median time to alleviation was 12 days for the treatment group and 13 days for the placebo group, a difference that was not statistically significant (P=0.60). Hospitalizations and deaths were slightly lower in the treatment group (0.8%) compared to the placebo group (1.6%), but this difference was also not statistically significant. Adverse events were similar across both groups, with dysgeusia and diarrhea being the most common in the treatment group.
Implications for Practice:
The findings indicate that nirmatrelvir–ritonavir treatment does not significantly reduce the time to symptom alleviation for Covid-19 compared to placebo among vaccinated or unvaccinated adults. These results suggest that further research is needed to explore the potential benefits of this treatment in specific subpopulations or in combination with other interventions.
Reference (free full-text):
FDA approves antibiotic Zevtera (ceftobiprole medocaril sodium) for three indications
26 Apr, 2024 | 11:39h | UTCThe FDA has granted approval for Zevtera (ceftobiprole medocaril sodium), an antibiotic formulated for injection, targeting three key bacterial infections. This includes treatment for adults with Staphylococcus aureus bloodstream infections (SAB) with or without right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in both adults and pediatric patients aged three months to under 18 years.
The approval follows rigorous clinical trials demonstrating Zevtera’s efficacy. In a multicenter study for SAB, Zevtera achieved a 69.8% success rate, slightly outperforming the comparator drug. For ABSSSI, Zevtera showed a 91.3% early clinical response, and for CABP, it had a clinical cure rate of 76.4% in adults. Pediatric efficacy for CABP was extrapolated from adult data and supported by a smaller pediatric trial.
Common side effects include anemia, nausea, and increased liver enzyme levels, with specific reactions varying by infection treated. Contraindications include severe hypersensitivity to ceftobiprole or other cephalosporins. Zevtera also carries warnings about potential hypersensitivity reactions, central nervous system effects, and Clostridioides difficile-associated diarrhea.
This approval, supported by Priority Review and Fast Track designations, offers a new treatment option for clinicians managing these serious infections.
Source: FDA NEWS RELEASE: FDA Approves New Antibiotic for Three Different Uses
Cohort Study: Inappropriate pneumonia diagnoses and associated risks in 17,290 hospitalized adults
26 Apr, 2024 | 11:25h | UTCStudy Design and Population:
This prospective cohort study analyzed medical records and patient interactions from July 2017 to March 2020 across 48 Michigan hospitals. A total of 17,290 adults admitted for general care were retrospectively assessed for community-acquired pneumonia (CAP) treatment, focusing on those who received antibiotics within the first two days of hospitalization.
Main Findings:
The study identified that 12.0% of the patients were inappropriately diagnosed with CAP. Key risk factors for misdiagnosis included older age, presence of dementia, and altered mental status at presentation. Among those misdiagnosed, 87.6% underwent a full course of antibiotics, which did not significantly change the 30-day risk of mortality, readmission, emergency visits, or Clostridioides difficile infections compared to brief treatment but was associated with higher antibiotic-related adverse events.
Implications for Practice:
The findings underscore the prevalence of inappropriate pneumonia diagnosis among hospitalized adults, especially in older patients with specific geriatric conditions. This study highlights the potential harms of unnecessary antibiotic use, suggesting a need for improved diagnostic accuracy and treatment decision-making in hospital settings to mitigate adverse outcomes.