The ACR20 response rate in the group receiving peficitinib 50 mg plus MTX was significantly different compared with the rate in patients receiving placebo, but there were no apparent dose-dependent responses, and the placebo response rate was high. Peficitinib plus MTX in patients with moderate-to-severe RA was well tolerated, with limited safety signals emerging.
A prospective, randomized, controlled, multi-centre clinical trial was performed to test the effectiveness of an antimicrobial central venous catheter (CVC) made of polyurethane integrated with silver, platinum and carbon black (Vantex). Adults expected to require a CVC for more than 60 h were eligible, and were randomized to receive the test or control catheter. All CVCs were inserted with new venipunctures using full aseptic technique. Following catheter removal, the distal tip and an intracutaneous segment were removed and cultured using semiquantitative and quantitative methods. Peripheral blood samples were obtained and cultured to confirm cases of catheter-related bloodstream infection (CRBSI). Bacterial and fungal organisms were identified by standard microbiological methods. Catheter placement was performed primarily in the intensive care unit (50%) or operating theatre (42%). Complete data could be evaluated for 539 patients (77%). The mean duration of CVC placement was 149.3h (six days). There were no significant differences in colonization or bacteraemia rates between the test and control catheters. The overall colonization rate was not particularly low (24.5%), and yet CVC-related bacteraemia occurred in only 1.4% of patients, and CRBSI occurred in only one patient from the control group (0.2%). Insertion site and dressing change frequency were significantly associated with the colonization rate. Although CVCs with antimicrobial features have been associated with a decrease in catheter-related colonization and bacteraemia, this study demonstrated that infection rates may depend more on non-catheter-related factors, such as adherence to infection control standards, selection of insertion site, duration of CVC placement, and dressing change frequency. As microbial resistance increases, clinicians should make maximal use of these processes to reduce catheter-related infections.
Objectives
This analysis from the PERSPECTIVE (a Prospective, Non‐interventional Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder) study evaluated treatment persistence with mirabegron or antimuscarinics over a 12‐month period.
Methods
Participants were adults diagnosed with overactive bladder (OAB) by their health care provider (HCP), who were initiating mirabegron or antimuscarinic treatment. The HCP made all treatment decisions, and patients were followed for 12 months with no mandatory scheduled visits. Information requests were sent to patients at baseline and months 1, 3, 6, and 12. Patients were nonpersistent if they switched, discontinued, or added OAB medications/therapies to their initial treatment. Reasons for discontinuation and switching patterns were investigated.
Results
Overall, 1514 patients were included (613 mirabegron and 901 antimuscarinic initiators). Persistence rates decreased steadily over time in both groups. A low proportion of patients added or switched medication at each time point. Unadjusted Kaplan‐Meier analysis showed similar persistence rates for both groups. When the data were adjusted for patient characteristics (age, sex, and OAB treatment status), mirabegron initiators had higher persistence rates. No significant differences were noted in unadjusted median time to end of persistence. However, end of treatment persistence by any cause was longer with mirabegron (median: 9.5 vs 6.7 months for antimuscarinics). HCPs stated that the most common reasons for nonpersistence were no symptomatic improvement and side effect aversion.
Conclusions
Treatment persistence was longer for mirabegron compared with antimuscarinic initiators after controlling for patient characteristics. End of treatment persistence by any cause was also longer with mirabegron.
A multicenter, double-blind, randomized study was conducted to assess the effect of caffeine on regadenoson stress myocardial perfusion imaging (MPI). Subjects with a high likelihood of coronary artery disease underwent a rest single-photon emission computed tomography MPI on day 1 (MPI-1) and a stress MPI with regadenoson on day 3 (MPI-2). Individuals with ≥1 segment with a reversible defect received double-blind caffeine tablets (200 or 400 mg) or placebo 90 min before a repeat regadenoson stress MPI (MPI-3) on day 5. Overall, 207 subjects completed the study (caffeine 200 mg, n = 70; caffeine 400 mg, n = 71; placebo, n = 66). The mean number of segments with reversible defects decreased from MPI-2 to MPI-3 in the caffeine 200 and 400 mg groups versus no significant change in the placebo group [mean ± standard deviation: −0.61 ± 1.097, −0.62 ± 1.367, and 0.12 ± 0.981, respectively (overall treatment effect, P < 0.001)]. The majority of subjects who received caffeine shifted to a lower ischemia size category from MPI-2 to MPI-3, with no clear pattern observed in subjects who received placebo. For caffeine exposed patients with ≥3 segments with reversible defects at MPI-2, 21/23 had fewer detected at MPI-3. Both the 200 and 400 mg doses of caffeine significantly reduced the number of segments with reversible defects detected by regadenoson stress MPI.
Background Cumulative exposure to one or more anticholinergic medications ("anticholinergic burden") is associated with an increased risk of adverse outcomes, particularly among older individuals. Mirabegron, an oral selective β3-adrenergic receptor agonist, has demonstrated efficacy in managing the symptoms of overactive bladder without contributing to anticholinergic burden. However, it is not known whether the favorable safety profile of mirabegron relative to antimuscarinics varies with increasing age among a patient population who may have a high anticholinergic burden. Objective The primary objective of this study was to indirectly compare the safety and efficacy profile of mirabegron relative to antimuscarinics in older adults with overactive bladder. Methods A systematic literature review was conducted to identify randomized controlled trials that reported safety and efficacy endpoints among patients aged ≥ 65 years. Identified randomized controlled trials were subsequently synthesized via a network meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines in designing, performing, and reporting the literature review were followed. In line with current best practices, the network meta-analysis was conducted using a Bayesian approach and according to the overall general guidance for evidence synthesis developed by the National Institute for Health and Care Excellence decision support unit. Estimates of relative safety were assessed via the odds ratio and estimates of relative efficacy were assessed via means and credible intervals. Results A total of 3078 abstracts, 300 of which underwent full-text screening, were identified using the search criteria. Twenty articles reporting on 21 randomized controlled trials were eligible for data extraction and synthesis. Following review, five safety and five efficacy endpoints were considered for inclusion in the network meta-analysis. Regarding findings typical of anticholinergic exposure in older adults, mirabegron was not associated with an increased odds of dry mouth (odds ratio 95% credible interval 0.76 [0.26-2.37]) or constipation (1.08 [0.39-3.02]) relative to placebo, whereas antimuscarinics were strongly associated with these events (odds ratio range 3.78-7.85 and 2.12-4.66, respectively). In this older population, mirabegron was associated with a similar odds of experiencing adverse event-related treatment discontinuations relative to placebo (0.99 [0.57-1.70]), while the odds of experiencing an adverse event-related treatment discontinuation for antimuscarinics had a range of 1.14-3.03 (in most cases, the association was mild). No increased odds of experiencing overall treatment-emergent adverse events was observed for mirabegron or antimuscarinics (odds ratio range 1.25-1.55), apart from fesoterodine (2.23 [1.37-3.37]). Finally, a similar treatment effect was observed across all efficacy endpoints between mirabegron and antimuscarinics in this older population. Conclusions This study indicates that the safety and effica...
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