Trial Files: A Biologic for COPD, Feedback on ABx Prescribing, Remote Care Post-ACS
Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation (NOTUS)
Bhatt S et al. NEJM (May 2024)
Bottom line: This phase 3, double-blind, randomized trial evaluated the efficacy and safety of subcutaneous dupilumab (300 mg) versus placebo every 2 weeks in 935 patients with COPD and type 2 inflammation with elevated blood eosinophil counts equal to or greater than 300 cells per microlitre. The primary outcome was the annualized rate of moderate or severe exacerbations, which was significantly lower in the dupilumab group compared to the placebo group (0.86 and 1.30 respectively; rate ratio of 0.66, p<0.001). The secondary outcomes included changes in lung function and quality of life, which were also improved in the dupilumab group. The prebronchodilator FEV1 increased from baseline to week 12 with dupilumab (least-squares mean change, 139 ml [95% CI, 105 to 173]) as compared with placebo (least-squares mean change, 57 ml [95% CI, 23 to 91]). Adverse events were similar between the two groups. This study suggests that dupilumab may be a beneficial treatment for patients with COPD and type 2 inflammation.
Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial
Schwartz K et al. BMJ (April 2024)
Bottom Line: This pragmatic, factorial randomized controlled trial evaluated the effects of providing family physicians with feedback on their antibiotic prescribing as compared with their peers. The study included 5,046 primary care physicians in Ontario, Canada who were actively prescribing antibiotics to patients 65 years or older. The intervention group received peer comparison antibiotic prescribing feedback with or without a combination of case-mix adjustment and emphasis on harms messaging, while the control group did not receive a letter (4:1 allocation with further randomization in a 2x2 factorial trial for the intervention group). The primary outcome was the antibiotic prescribing rate per 1000 patient visits for patients 65 years or older at six months post intervention. At six months, the mean antibiotic prescribing rate was 59.4 (standard deviation 42.0) in the control group and 56.0 (39.2) in the intervention group (relative rate 0.95 (95% confidence interval 0.94 to 0.96). The results showed a significantly lower antibiotic prescribing rate in the intervention group compared to the control group, as well as lower rates of unnecessary antibiotic prescribing, prolonged duration prescriptions, and broad spectrum subscribing. No significant effect was seen for including emphasis on harms messaging. The study concluded that peer comparison audit and feedback letters are a scalable and effective intervention for reducing unnecessary antibiotic prescribing in primary care.
Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome (Tele-ACS)
Alshahrani N et al. JACC (June 2024)
Bottom Line: This randomized controlled trial compared a telemedicine-based approach to standard care in patients with at least 1 cardiovascular risk factor presenting with ACS. 337 patients were randomized 1:1 at discharge to standard care or telemonitoring, in which patients received an ECG belt, automated BP cuff, pulse oximeter, and accompanied training. The primary outcome was time to first readmission at 6 months, with secondary outcomes including ED visits, major adverse cardiovascular events, and patient-reported symptoms. The study showed a significant reduction in readmission (HR: 0.24; 95% CI: 0.13-0.44; P < 0.001), ED visits (HR: 0.59; 95% CI: 0.40-0.89), and unplanned coronary revascularizations (3% vs. 9%) in the telemedicine group. Additionally, patient-reported symptoms including chest pain, breathlessness, and dizziness were lower in the telemedicine group. This study highlights the potential benefits of telemedicine in managing high-risk cardiovascular patients post-ACS.
Trial Files Issue #2024-14
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