In Reply In response to the insightful questions by Dr Hsu and colleagues, the ALLIUM phase 3 study was completed prior to the change in the CLSI piperacillin/tazobactam breakpoints in 2022 and the EUCAST breakpoints in 2021. However, a post hoc outcomes analysis was performed on the primary analysis set, which excluded patients with baseline urinary pathogens with a piperacillin/tazobactam MIC of greater than 16 μg/mL and/or if the pathogen encoded an extended-spectrum β-lactamase. In this analysis, improved outcomes in patients receiving cefepime/enmetazobactam compared with piperacillin/tazobactam were still observed. Although not presented in our article, we performed another post hoc analysis that excluded patients with a baseline pathogen piperacillin/tazobactam MIC of greater than 8 μg/mL, accounting for the new piperacillin/tazobactam breakpoints (susceptible, ≤8 μg/mL). In this analysis, improved outcomes in the cefepime/enmetazobactam group (79.1% [250/316]) compared with the piperacillin/tazobactam group (60.3% [182/302]) were again observed (treatment difference, 18.8% [95% CI, 11.6%-25.7%]; P
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Cefepime/Enmetazobactam vs Piperacillin/Tazobactam and Complicated Urinary Tract Infection or Acute Pyelonephritis
To the Editor A recent trial comparing the effect of cefepime/enmetazobactam vs piperacillin/tazobactam on complicated urinary tract infection or acute pyelonephritis found that patients receiving cefepime/enmetazobactam had a better primary outcome. We have some concerns about this study.
Roflumilast Cream vs Vehicle Cream and Chronic Plaque Psoriasis
To the Editor A recent study evaluating the safety and efficacy of roflumilast cream, 0.3%, for chronic plaque psoriasis involving 2% to 20% of body surface area concluded that daily use of roflumilast cream for 8 weeks was more effective than vehicle cream. We would like to point out some limitations of this study that decrease its generalizability.
Roflumilast Cream vs Vehicle Cream and Chronic Plaque Psoriasis—Reply
In Reply In response to the Letter by Mr Smith and colleagues, we agree that studies of representative patient populations are important, but we challenge the notion that our results cannot be applied to a general population of individuals with psoriasis because only 36.3% of patients were female. The consideration when assessing the applicability of the results should be whether the sample size is sufficient to make precise determinations of efficacy and safety rather than if the percentage of females in the trials match the general psoriasis population, although the latter is also important. Our study included a sizable representation of 320 female patients with psoriasis (36.3%). Indeed, the corresponding author of the Letter to which we are responding was coauthor of a recent large psoriasis study in which only 31% to 32% of patients were female. Additionally, in the study cited by Smith and colleagues that assessed sex differences in severity of psoriasis, 40% of the patients were female, and the severity of psoriasis in females as assessed by the Psoriasis Area and Severity Index (PASI) scores was lower than males. This study also reported that a lower percentage of female patients sought specialist care for their psoriasis. In a pooled analysis of the female subgroup of patients in DERMIS-1 and DERMIS-2, Investigator Global Assessment success at week 8 was achieved in 38.0% of females treated with 0.3% roflumilast cream vs 5.2% in the vehicle group (P
Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children
This randomized placebo-controlled trial examines the efficacy of low-concentration atropine eyedrops (0.05% and 0.01% concentration) for delaying the onset of myopia in children vs placebo.
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In adults with active dermatomyositis, IV immune globulin improved treatment response at 16 wk vs. placebo
Annals of Internal Medicine, Ahead of Print.
In complicated UTI or pyelonephritis, cefepime–enmetazobactam increased success vs. piperacillin–tazobactam at 14 d
Annals of Internal Medicine, Ahead of Print.
In adults, a single colonoscopy screening invitation vs. no invitation reduced CRC incidence at 10 y
Annals of Internal Medicine, Ahead of Print.
In hypertension, evening vs. morning dosing of antihypertensive drugs did not differ for major CV outcomes at 5.2 y
Annals of Internal Medicine, Ahead of Print.
In nonalcoholic fatty liver disease, a diet of freshwater fish vs. freshwater fish plus red meat reduced liver fat
Annals of Internal Medicine, Ahead of Print.
SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents
To the Editor We have several comments about the recent study that concluded that nasal swabs collected by children and adolescents have similar diagnostic performance to those collected by health care professionals.
SARS-CoV-2 Results in Self-collected Nasal Swabs vs Swabs Collected by Health Care Workers in Children and Adolescents—Reply
In Reply We appreciate the letter from Drs Hong and Sung about our study, which demonstrated the ability of children and adolescents to self-collect samples for respiratory virus testing and independently participate in their medical care.
Abstract WP1: Tenecteplase Vs Alteplase For Large Vessel Occlusion Stroke: A Systematic Review And Meta-analysis
Stroke, Volume 54, Issue Suppl_1, Page AWP1-AWP1, February 1, 2023. Introduction:Patients with large vessel occlusion stroke (LVO) benefit from thrombolysis before thrombectomy. Previous meta-analysis suggested superiority of tenecteplase over alteplase in achieving good clinical outcome at 3 months.Aim:We aimed to compare clinical outcomes after tenecteplase 0.25 mg/kg versus alteplase in patients with LVO.Methods:An experienced librarian searched PubMed and Scopus databases through July 13, 2022 for randomized controlled trials comparing tenecteplase with alteplase in patients with LVO. We included trials using 0.25 mg/kg tenecteplase dose, reporting blindly assessed pre-specified clinical outcomes at 3-4 months among patients with LVO. Two authors independently reviewed eligibility and extracted the data. We used RevMan 5.4 and random effect models with inverse variance weights to calculate odds ratios (OR) and 95% confidence intervals (CI). This systematic review is registered (CRD42022349414).Results:From 585 retrieved abstracts, 3 trials and 1 pooled secondary analysis involving 704 unique patients met the inclusion criteria. Among patients with LVO, tenecteplase 0.25mg/kg is not superior to alteplase in achieving good clinical outcome (defined as modified Rankin Scale [mRS] 0-2, OR 1.82 (95% CI 0.91-3.65, panel A); nor all-cause mortality, OR 0.75 (95% CI 0.49-1.13, panel B); while tenecteplase increases the odds of excellent outcome (mRS 0-1), OR 1.52 (95% CI 1.11-2.09, panel C), and odds of functional improvement (defined as a shift on the ordinal mRS), OR 1.54 (95% CI 1.07-2.20, panel D). High heterogeneity was present (I2 =70%) for the good clinical outcome.Conclusion:Tenecteplase is not superior over alteplase in achieving good clinical outcome. Tenecteplase, as compared to alteplase, increases the odds of functional improvement and excellent outcome. These findings support bridging tenecteplase in patients with LVO.
Abstract 23: Effect Of Intravenous Tirofiban Vs Placebo On First-pass Effect In Endovascular Stroke Thrombectomy: Insights From The Rescue Bt Randomized Clinical Trial
Stroke, Volume 54, Issue Suppl_1, Page A23-A23, February 1, 2023. Background:First-pass effect (FPE) defined as a complete or near-complete reperfusion achieved after a single thrombectomy pass is predictive of favorable outcome in acute ischemic stroke (AIS) patients with large vessel occlusion. It remains uncertain whether intravenous tirofiban is effective to improve the rate of FPE in anterior circulation strokes.Methods:RESCUE-BT (A randomized controlled trial of intravenous tirofiban or placebo prior to endovascular thrombectomy for large vessel occlusion stroke) enrolled 948 patients with proximal intracranial large vessel occlusion presenting within 24 hours of time last known well to receive intravenous either tirofiban or placebo before endovascular thrombectomy. Patients who did not treated with endovascular thrombectomy were excluded from this cohort. The endpoint was FPE, which defined by extended thrombolysis in cerebral infarction (eTICI) scale 2b, 2c or 3 after the first pass. A modified Poisson regression analysis was performed to assess the association between intravenous tirofiban treatment and FPE.Results:Twenty-two patients were excluded for not treating with endovascular thrombectomy. The remaining 926 patients were included (mean age, 66 years; 380 [41.0%] women), with 450 in the tirofiban and 476 in the placebo group, respectively. Among them, an FPE was achieved in 141 patients (31.3%) of the tirofiban group vs 114 patients (23.9%) of the placebo group. The adjusted risk ratio for FPE with tirofiban vs placebo was 1.24 (95%CI, 1.02-1.52).Conclusions:Treatment with intravenous tirofiban before endovascular thrombectomy significantly increased the incidence of FPE in acute ischemic stroke patients with large vessel occlusion presenting within 24 hours of time last known well.
Abstract TP44: No Differences In Outcomes For Stroke Patients Presenting To A Comprehensive Stroke Center And Treated Using Telestroke Vs. In-person Assessments During The Covid-19 Pandemic.
Stroke, Volume 54, Issue Suppl_1, Page ATP44-ATP44, February 1, 2023. Introduction:Telestroke is the use of videoconferencing technology by a stroke specialist to assess and treat acute ischemic stroke patients who present elsewhere. It has been well-studied previously in a “Hub-and-Spoke” model. In 2021, Telestroke was used to assess and treat acute ischemic stroke patients who presented primarily after-hours to our comprehensive stroke center because we were concerned the COVID-19 pandemic could affect the timeliness of in-person code stroke assessments. After implementation, we determined the efficacy and safety outcomes for patients treated with Telestroke versus in-person assessments.Hypothesis:We hypothesized that there will be no difference in the efficacy or safety outcomes between patients treated using Telestroke vs. in-person assessments.Methods:A retrospective chart review identified acute ischemic stroke patients who presented to our center in 2021, who were assessed and treated using either Telestroke or an in-person assessment. The primary outcomes for efficacy were door-to-needle (DTN) time for alteplase administration and door to puncture (DTP) time for endovascular thrombectomy. The primary safety outcomes were 3-month mortality and symptomatic intracranial hemorrhage rates (sICH).Results:We treated 302 acute stroke patients in 2021, with 18.2% (n=55/302) of patients treated using Telestroke. There were no differences in clinical outcomes between patients treated using Telestroke vs. in-person assessments: median DTN (35.5min (n=42) vs. 33min (n=182), p