Pub Date : 2025-08-12DOI: 10.1177/87551225251363438
Erik Wasowski, Anne Harris, Taylor Elias
Background: The use of warfarin is complicated by a narrow therapeutic window, requiring close monitoring to prevent serious adverse events. Literature has shown that pharmacist-led warfarin management improves patient outcomes and decreases hospitalization length of stay. This study assessed the impact of the recently implemented pharmacist-driven warfarin consult service at 3 hospitals within the Cleveland Clinic Health System. Methods: This was a retrospective, multi-centered study which included 64 adult patients admitted to Cleveland Clinic Hospitals between June 1, 2023, and July 31, 2024 who received at least 3 doses of warfarin. Exclusion criteria included an elevated international normalized ratio (INR) upon admission, argatroban use, active cancer, or warfarin ordered by both managing services. Results: The primary outcome, rate of supratherapeutic INR values, did not significantly differ between groups (P = .84). In addition, the secondary outcomes including rate of subtherapeutic INRs, INR ≥0.7 within 24 hours, therapeutic INR at discharge, and major bleeding showed no significant difference. However, pharmacists were twice as likely to order an initial starting dose of <5 mg compared to physicians (62.5% vs 31.3%). In addition, physician-managed patients were observed more frequently for the INR ≥0.7 within 24 hours (11 vs 4 events). Conclusion: Overall, there was not a significant difference found in patient outcomes when comparing pharmacist versus physician warfarin management. Future studies with a larger sample size are needed to explore the potential differences in dosing regimens and its effect on the rate of significant INR elevations.
{"title":"Evaluating the Effectiveness of a Pharmacist-Driven Warfarin Consult Service Versus Physician Management in a Tertiary Community Hospital.","authors":"Erik Wasowski, Anne Harris, Taylor Elias","doi":"10.1177/87551225251363438","DOIUrl":"10.1177/87551225251363438","url":null,"abstract":"<p><p><b>Background:</b> The use of warfarin is complicated by a narrow therapeutic window, requiring close monitoring to prevent serious adverse events. Literature has shown that pharmacist-led warfarin management improves patient outcomes and decreases hospitalization length of stay. This study assessed the impact of the recently implemented pharmacist-driven warfarin consult service at 3 hospitals within the Cleveland Clinic Health System. <b>Methods:</b> This was a retrospective, multi-centered study which included 64 adult patients admitted to Cleveland Clinic Hospitals between June 1, 2023, and July 31, 2024 who received at least 3 doses of warfarin. Exclusion criteria included an elevated international normalized ratio (INR) upon admission, argatroban use, active cancer, or warfarin ordered by both managing services. <b>Results:</b> The primary outcome, rate of supratherapeutic INR values, did not significantly differ between groups (<i>P</i> = .84). In addition, the secondary outcomes including rate of subtherapeutic INRs, INR ≥0.7 within 24 hours, therapeutic INR at discharge, and major bleeding showed no significant difference. However, pharmacists were twice as likely to order an initial starting dose of <5 mg compared to physicians (62.5% vs 31.3%). In addition, physician-managed patients were observed more frequently for the INR ≥0.7 within 24 hours (11 vs 4 events). <b>Conclusion:</b> Overall, there was not a significant difference found in patient outcomes when comparing pharmacist versus physician warfarin management. Future studies with a larger sample size are needed to explore the potential differences in dosing regimens and its effect on the rate of significant INR elevations.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251363438"},"PeriodicalIF":1.3,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12343540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-06DOI: 10.1177/87551225251359508
Surafel G Mulugeta, Shivani Kantharia, Michael P Veve, Shaina Vincent, Amy Beaulac, Nisha Patel
Introduction: Methicillin-resistant Staphylococcus aureus pneumonia (PNA) can be ruled out via methicillin-resistant Staphylococcus aureus (MRSA) culture and polymerase chain reaction (PCR) nasal screening, facilitating the de-escalation of empiric anti-MRSA agents like intravenous vancomycin. This study evaluated the impact of transitioning from culture to PCR-based MRSA nasal screening in patients with PNA. Methods: This Institutional Review Board (IRB)-approved retrospective quasi-experimental study was conducted at a 5-hospital system and included adult, nonpregnant hospitalized patients from September to December 2021 ("culture group") and September to December 2022 ("PCR group") and diagnosed with PNA. Exclusion criteria were ventilator-acquired PNA or positive MRSA respiratory culture. The primary endpoint was the number of vancomycin levels obtained. Secondary endpoints were vancomycin duration as well as acute kidney injury (AKI) and all-cause 30-day readmission rates. Results: Two-hundred patients were included: 100 in each group. Baseline characteristics were similar. There were 117 vancomycin levels obtained: 67 (67) and 50 (50) in the culture and PCR group, respectively (P = .021). Median vancomycin duration was 50% shorter in the PCR group: 2 days (1-3) versus 3 days (2-4), P < .001. After adjusting for confounders, the culture group was more likely to have vancomycin levels obtained compared to the PCR group: adjusted odd ratio (aOR) (95% confidence interval [CI])] = 1.833 (1.016-3.309). Long-term obstructive pulmonary disease was associated with reduced risk of ordering vancomycin levels: aOR [95% CI] = 0.426 (0.218-0.831). Readmission and AKI rates were comparable. Conclusion: Transitioning from culture to PCR-based MRSA nasal screening significantly reduced vancomycin levels obtained from patients and shortened vancomycin duration without negatively impacting patient outcome.
{"title":"Impact of Methicillin-Resistant <i>Staphylococcus aureus</i> Nasal PCR Versus Culture on Vancomycin Utilization in Pneumonia Management.","authors":"Surafel G Mulugeta, Shivani Kantharia, Michael P Veve, Shaina Vincent, Amy Beaulac, Nisha Patel","doi":"10.1177/87551225251359508","DOIUrl":"10.1177/87551225251359508","url":null,"abstract":"<p><p><b>Introduction:</b> Methicillin-resistant <i>Staphylococcus aureus</i> pneumonia (PNA) can be ruled out via methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) culture and polymerase chain reaction (PCR) nasal screening, facilitating the de-escalation of empiric anti-MRSA agents like intravenous vancomycin. This study evaluated the impact of transitioning from culture to PCR-based MRSA nasal screening in patients with PNA. <b>Methods:</b> This Institutional Review Board (IRB)-approved retrospective quasi-experimental study was conducted at a 5-hospital system and included adult, nonpregnant hospitalized patients from September to December 2021 (\"culture group\") and September to December 2022 (\"PCR group\") and diagnosed with PNA. Exclusion criteria were ventilator-acquired PNA or positive MRSA respiratory culture. The primary endpoint was the number of vancomycin levels obtained. Secondary endpoints were vancomycin duration as well as acute kidney injury (AKI) and all-cause 30-day readmission rates. <b>Results:</b> Two-hundred patients were included: 100 in each group. Baseline characteristics were similar. There were 117 vancomycin levels obtained: 67 (67) and 50 (50) in the culture and PCR group, respectively (<i>P</i> = .021). Median vancomycin duration was 50% shorter in the PCR group: 2 days (1-3) versus 3 days (2-4), <i>P</i> < .001. After adjusting for confounders, the culture group was more likely to have vancomycin levels obtained compared to the PCR group: adjusted odd ratio (aOR) (95% confidence interval [CI])] = 1.833 (1.016-3.309). Long-term obstructive pulmonary disease was associated with reduced risk of ordering vancomycin levels: aOR [95% CI] = 0.426 (0.218-0.831). Readmission and AKI rates were comparable. <b>Conclusion:</b> Transitioning from culture to PCR-based MRSA nasal screening significantly reduced vancomycin levels obtained from patients and shortened vancomycin duration without negatively impacting patient outcome.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251359508"},"PeriodicalIF":1.3,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12328358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144817020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: To explore whether vancomycin (VAN) plus piperacillin-tazobactam (PTZ) was associated with an increased risk of acute kidney injury (AKI) compared with VAN plus other beta-lactams (BLs) or monotherapy in critically ill patients, where the evidence remains controversial. Data sources: PubMed, Cochrane, Web of Science, and Embase were searched from inception to June 2024. Study selection: Studies comparing the risk of AKI with one group receiving VAN+PTZ, and other groups receiving VAN plus other BLs, or monotherapy in critically ill. Data synthesis: This analysis included 20 articles with 28 243 participants. The majority of included studies were retrospective (95%, 19/20) and had moderate risks of bias (80.0%, 16/20). The results indicated VAN+PTZ was associated with a significantly higher risk of AKI compared with VAN plus other BLs (OR = 1.66, 95% CI = 1.42-1.94, P < 0.001). Subgroup analyses showed that compared with adults, children were associated with a higher risk of AKI when receiving VAN+PTZ (OR = 3.16 vs 1.59). Also, VAN+PTZ was associated with a significantly higher risk of severe stage 2 to 3 AKI than VAN plus other BLs (OR = 1.63, 95% CI = 1.28-2.06, P < 0.001). No significant difference was identified in mortality, dialysis, time to AKI, and length of stay between patients receiving VAN plus PTZ and other combinations. Conclusions: In critically ill, VAN plus PTZ was associated with an increased risk of AKI and severe stage 2 to 3 AKI compared with VAN plus other BLs, especially in children. However, more high-quality multicenter, prospective cohort studies, and randomized controlled studies are needed.
目的:探讨万古霉素(VAN)联合哌哌西林-他唑巴坦(PTZ)与VAN联合其他β -内酰胺类药物(BLs)或单药治疗相比,是否与危重患者急性肾损伤(AKI)风险增加相关,目前证据仍存在争议。数据来源:PubMed, Cochrane, Web of Science, Embase从成立到2024年6月。研究选择:比较一组接受VAN+PTZ,另一组接受VAN+其他BLs或危重患者单药治疗的AKI风险的研究。数据综合:本分析包括20篇文章,28 243名参与者。纳入的大多数研究为回顾性研究(95%,19/20),偏倚风险中等(80.0%,16/20)。结果显示,与VAN+其他BLs相比,VAN+PTZ与AKI的风险显著增加(OR = 1.66, 95% CI = 1.42-1.94, P < 0.001)。亚组分析显示,与成人相比,接受VAN+PTZ治疗的儿童发生AKI的风险更高(OR = 3.16 vs 1.59)。此外,VAN+PTZ与严重2 - 3期AKI的风险显著高于VAN+其他BLs (OR = 1.63, 95% CI = 1.28-2.06, P < 0.001)。在接受VAN + PTZ和其他联合治疗的患者之间,死亡率、透析、AKI时间和住院时间没有显著差异。结论:在危重患者中,与VAN +其他BLs相比,VAN + PTZ与AKI和严重2至3期AKI的风险增加相关,尤其是在儿童中。然而,需要更多高质量的多中心、前瞻性队列研究和随机对照研究。
{"title":"Incidence of Acute Kidney Injury in Critically Ill Patients Receiving Vancomycin With Concomitant Piperacillin-Tazobactam Versus Other Beta-Lactams: A Systematic Review and Meta-Analysis.","authors":"Ranyi Li, Yanli Li, Chenqi Xu, Ziyan Shen, Xialian Xu, Xiaoqiang Ding, Xiaoyu Li, Qianzhou Lv, Kunming Pan","doi":"10.1177/87551225251350894","DOIUrl":"10.1177/87551225251350894","url":null,"abstract":"<p><p><b>Objectives</b>: To explore whether vancomycin (VAN) plus piperacillin-tazobactam (PTZ) was associated with an increased risk of acute kidney injury (AKI) compared with VAN plus other beta-lactams (BLs) or monotherapy in critically ill patients, where the evidence remains controversial. <b>Data sources:</b> PubMed, Cochrane, Web of Science, and Embase were searched from inception to June 2024. <b>Study selection:</b> Studies comparing the risk of AKI with one group receiving VAN+PTZ, and other groups receiving VAN plus other BLs, or monotherapy in critically ill. <b>Data synthesis:</b> This analysis included 20 articles with 28 243 participants. The majority of included studies were retrospective (95%, 19/20) and had moderate risks of bias (80.0%, 16/20). The results indicated VAN+PTZ was associated with a significantly higher risk of AKI compared with VAN plus other BLs (OR = 1.66, 95% CI = 1.42-1.94, <i>P</i> < 0.001). Subgroup analyses showed that compared with adults, children were associated with a higher risk of AKI when receiving VAN+PTZ (OR = 3.16 vs 1.59). Also, VAN+PTZ was associated with a significantly higher risk of severe stage 2 to 3 AKI than VAN plus other BLs (OR = 1.63, 95% CI = 1.28-2.06, <i>P</i> < 0.001). No significant difference was identified in mortality, dialysis, time to AKI, and length of stay between patients receiving VAN plus PTZ and other combinations. <b>Conclusions</b>: In critically ill, VAN plus PTZ was associated with an increased risk of AKI and severe stage 2 to 3 AKI compared with VAN plus other BLs, especially in children. However, more high-quality multicenter, prospective cohort studies, and randomized controlled studies are needed.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251350894"},"PeriodicalIF":1.3,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12301226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-30DOI: 10.1177/87551225251348830
Kristina M Burroughs, Alicia B Lichvar, Lara M Groetzinger, Edward Horn, Carlo J Iasella, Cody A Moore, Dana R Pierce, Lauren M Sacha, Ryan M Rivosecchi
Background: Patients undergoing transplantation experience higher rates of venous thromboembolism and non-valvular atrial fibrillation (NVAF) compared with the general population. Anticoagulation decisions in this patient population are complex. A national survey on direct-acting oral anticoagulant practices demonstrated significant heterogeneity, in the setting of drug-drug interactions. Objective: The aim of this study was to evaluate the anticoagulation practices of clinicians caring for solid organ transplant patients. Methods: A 15-question survey consisting of 7 demographic questions and 8 unique patient cases was distributed via email Listserv of several professional transplantation organizations. Each case question asked the participant to select an anticoagulant regimen depending on: (1) indication for anticoagulation, (2) renal function, and (3) drug-drug interactions. Participants selected one of the following options: apixaban, dabigatran, enoxaparin, rivaroxaban, warfarin, or write in an alternative option. Descriptive statistics were used to analyze survey results. Results: Fifty participants completed 4 or more (≥50%) of the case-based survey questions and were included in the analysis. Ninety-four percent of participants were pharmacists, representing 43 transplant centers. Fifty-one percent of responders preferred warfarin for the indication of NVAF. Apixaban was preferred in patients with new or previous deep vein thrombosis/pulmonary embolism (51%). Fifty-four percent of respondents preferred warfarin in questions in renal dysfunction. In scenarios involving a mild-moderate CYP3A4 inhibitor azole antifungal, 61% of respondents preferred apixaban, with 64% of those selecting a standard dose regimen (vs a reduced dose regimen). Participants preferred warfarin (57%) in scenarios with a strong CYP3A4 inhibitor. Conclusion and Relevance: The results of our survey demonstrated a high degree of variation when selecting anticoagulation strategies in complex clinical scenarios involving transplant patients.
{"title":"Evaluating the Effect of Concomitant Azoles on Anticoagulant Prescribing Practices in Transplant Patients: A National Survey of Clinicians.","authors":"Kristina M Burroughs, Alicia B Lichvar, Lara M Groetzinger, Edward Horn, Carlo J Iasella, Cody A Moore, Dana R Pierce, Lauren M Sacha, Ryan M Rivosecchi","doi":"10.1177/87551225251348830","DOIUrl":"10.1177/87551225251348830","url":null,"abstract":"<p><p><b>Background:</b> Patients undergoing transplantation experience higher rates of venous thromboembolism and non-valvular atrial fibrillation (NVAF) compared with the general population. Anticoagulation decisions in this patient population are complex. A national survey on direct-acting oral anticoagulant practices demonstrated significant heterogeneity, in the setting of drug-drug interactions. <b>Objective:</b> The aim of this study was to evaluate the anticoagulation practices of clinicians caring for solid organ transplant patients. <b>Methods:</b> A 15-question survey consisting of 7 demographic questions and 8 unique patient cases was distributed via email Listserv of several professional transplantation organizations. Each case question asked the participant to select an anticoagulant regimen depending on: (1) indication for anticoagulation, (2) renal function, and (3) drug-drug interactions. Participants selected one of the following options: apixaban, dabigatran, enoxaparin, rivaroxaban, warfarin, or write in an alternative option. Descriptive statistics were used to analyze survey results. <b>Results:</b> Fifty participants completed 4 or more (≥50%) of the case-based survey questions and were included in the analysis. Ninety-four percent of participants were pharmacists, representing 43 transplant centers. Fifty-one percent of responders preferred warfarin for the indication of NVAF. Apixaban was preferred in patients with new or previous deep vein thrombosis/pulmonary embolism (51%). Fifty-four percent of respondents preferred warfarin in questions in renal dysfunction. In scenarios involving a mild-moderate CYP3A4 inhibitor azole antifungal, 61% of respondents preferred apixaban, with 64% of those selecting a standard dose regimen (vs a reduced dose regimen). Participants preferred warfarin (57%) in scenarios with a strong CYP3A4 inhibitor. <b>Conclusion and Relevance:</b> The results of our survey demonstrated a high degree of variation when selecting anticoagulation strategies in complex clinical scenarios involving transplant patients.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251348830"},"PeriodicalIF":1.1,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12209238/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-24DOI: 10.1177/87551225251350899
Emily M Hitt, Alexa J Powell
Objective: The goals of this article are reviewing the clinical aspects of ensifentrine, results from the clinical trials that led to its approval and examining its potential impact on patient care to aid therapeutic decision-making. Data Sources: A literature search of studies took place between October 2024 and December 2024 on PubMed using the terms ensifentrine, roflumilast, Ohtuvayre™ and ensifentrine chronic obstructive pulmonary disease (COPD). Study selection/data extraction: Phase II and III randomized controlled trials were eligible for inclusion. Pertinent clinical trials included those focusing on the use of ensifentrine in the treatment of COPD. Meeting abstracts, systematic reviews and meta-analyses were excluded from this article. Data synthesis: Food and Drug Administration approval for ensifentrine is based off the phase III ENHANCE clinical trials in patients with COPD. Ensifentrine demonstrated improvement in lung function and a reduction in symptoms in clinical studies with a tolerable safety profile. Conclusion: The development and approval of ensifentrine for the maintenance of COPD demonstrates an advancement in patient care for a disease with significant morbidity and mortality. Ensifentrine could be a viable option as adjunct therapy for patients still experiencing symptoms despite treatment with currently recommended therapies.
{"title":"Ensifentrine: A Novel Option for Maintenance of Chronic Obstructive Pulmonary Disease.","authors":"Emily M Hitt, Alexa J Powell","doi":"10.1177/87551225251350899","DOIUrl":"10.1177/87551225251350899","url":null,"abstract":"<p><p><b>Objective:</b> The goals of this article are reviewing the clinical aspects of ensifentrine, results from the clinical trials that led to its approval and examining its potential impact on patient care to aid therapeutic decision-making. <b>Data Sources:</b> A literature search of studies took place between October 2024 and December 2024 on PubMed using the terms <i>ensifentrine, roflumilast, Ohtuvayre™</i> and <i>ensifentrine</i> chronic obstructive pulmonary disease (COPD). <b>Study selection/data extraction:</b> Phase II and III randomized controlled trials were eligible for inclusion. Pertinent clinical trials included those focusing on the use of ensifentrine in the treatment of COPD. Meeting abstracts, systematic reviews and meta-analyses were excluded from this article. <b>Data synthesis:</b> Food and Drug Administration approval for ensifentrine is based off the phase III ENHANCE clinical trials in patients with COPD. Ensifentrine demonstrated improvement in lung function and a reduction in symptoms in clinical studies with a tolerable safety profile. <b>Conclusion:</b> The development and approval of ensifentrine for the maintenance of COPD demonstrates an advancement in patient care for a disease with significant morbidity and mortality. Ensifentrine could be a viable option as adjunct therapy for patients still experiencing symptoms despite treatment with currently recommended therapies.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251350899"},"PeriodicalIF":1.1,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144506041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-24DOI: 10.1177/87551225251349402
Dawood Javed, Abdullah Javed, Faran Ahmed Jajja, Ahmed Jahanzeb
Objective: This meta-analysis evaluates the efficacy and safety of vamorolone, a dissociative glucocorticoid, compared with traditional glucocorticoids in treating Duchenne muscular dystrophy (DMD), aiming to assess its potential as a safer alternative with comparable therapeutic benefits. Data Sources: A systematic search was conducted in PubMed (MEDLINE), Embase, and Web of Science from inception till June 2024. Search terms included (Vamorolone) AND (Corticosteroids OR Glucocorticoids OR Prednisone) AND (Duchenne Muscular Dystrophy OR related terms). Only randomized controlled trials (RCTs) and observational studies were included, with no language restrictions. Study Selection and Data Extraction: From 276 identified reports, 135 were screened after duplicate removal, and 30 underwent full-text review. Five studies (2 RCTs, 2 observational, 1 nonrandomized trial) involving 370 patients were included. Two reviewers independently extracted data on efficacy (TTSTAND, TTRW, TTCLIMB velocities) and safety (height percentile, body mass index-z score, osteocalcin, P1NP) using Microsoft Excel, resolving discrepancies through consensus. Data Synthesis: Vamorolone significantly improved TTSTAND (MD = -0.03, 95% confidence interval [CI] = -0.06 to -0.004, P = .02), TTRW (MD = -0.11, 95% CI = -0.22 to -0.01, P = .04), and TTCLIMB velocities (MD = -0.04, 95% CI = -0.08 to -0.003, P = .03). Safety outcomes showed enhanced height percentile (MD = 16.28, 95% CI = 6.31-26.25, P = .001) and bone biomarkers (osteocalcin: MD = 15.68, P < .00001; P1NP: MD = 158.34, P < .00001), with no significant body mass index-z score difference. Conclusions: Vamorolone offers comparable efficacy with traditional glucocorticoids in DMD, with improved motor function and safer profiles in growth and bone health, suggesting its potential to transform DMD management.
目的:本荟萃分析评估了游离性糖皮质激素vamorolone与传统糖皮质激素治疗杜氏肌营养不良症(DMD)的疗效和安全性,旨在评估其作为一种更安全的替代治疗方案的潜力。数据来源:系统检索PubMed (MEDLINE)、Embase和Web of Science,从建站到2024年6月。搜索词包括(氨莫洛酮)和(皮质类固醇或糖皮质激素或强的松)和(杜氏肌营养不良症或相关术语)。仅纳入随机对照试验(rct)和观察性研究,无语言限制。研究选择和数据提取:从276份确定的报告中,135份在重复删除后进行筛选,30份进行全文审查。纳入5项研究(2项随机对照试验,2项观察性试验,1项非随机试验),涉及370例患者。两位评论者使用Microsoft Excel独立提取疗效(TTSTAND, tttrw, TTCLIMB速度)和安全性(身高百分位数,体重指数-z评分,骨钙素,P1NP)数据,通过共识解决差异。数据综合:Vamorolone显著改善TTSTAND (MD = -0.03, 95%可信区间[CI] = -0.06 ~ -0.004, P = 0.02)、TTRW (MD = -0.11, 95% CI = -0.22 ~ -0.01, P = 0.04)和TTCLIMB速度(MD = -0.04, 95% CI = -0.08 ~ -0.003, P = 0.03)。安全性结果显示身高百分位数(MD = 16.28, 95% CI = 6.31-26.25, P = 0.001)和骨骼生物标志物(骨钙素:MD = 15.68, P < 0.001;P1NP: MD = 158.34, P < 0.00001),体重指数-z评分差异无统计学意义。结论:Vamorolone治疗DMD的疗效与传统糖皮质激素相当,运动功能改善,生长和骨骼健康更安全,表明其有可能改变DMD的治疗方式。
{"title":"Vamorolone Versus Traditional Glucocorticoids in Duchenne Muscular Dystrophy: A Review and Meta-Analysis of Efficacy and Safety.","authors":"Dawood Javed, Abdullah Javed, Faran Ahmed Jajja, Ahmed Jahanzeb","doi":"10.1177/87551225251349402","DOIUrl":"10.1177/87551225251349402","url":null,"abstract":"<p><p><b>Objective:</b> This meta-analysis evaluates the efficacy and safety of vamorolone, a dissociative glucocorticoid, compared with traditional glucocorticoids in treating Duchenne muscular dystrophy (DMD), aiming to assess its potential as a safer alternative with comparable therapeutic benefits. <b>Data Sources:</b> A systematic search was conducted in PubMed (MEDLINE), Embase, and Web of Science from inception till June 2024. Search terms included (Vamorolone) AND (Corticosteroids OR Glucocorticoids OR Prednisone) AND (Duchenne Muscular Dystrophy OR related terms). Only randomized controlled trials (RCTs) and observational studies were included, with no language restrictions. <b>Study Selection and Data Extraction:</b> From 276 identified reports, 135 were screened after duplicate removal, and 30 underwent full-text review. Five studies (2 RCTs, 2 observational, 1 nonrandomized trial) involving 370 patients were included. Two reviewers independently extracted data on efficacy (TTSTAND, TTRW, TTCLIMB velocities) and safety (height percentile, body mass index-z score, osteocalcin, P1NP) using Microsoft Excel, resolving discrepancies through consensus. <b>Data Synthesis:</b> Vamorolone significantly improved TTSTAND (MD = -0.03, 95% confidence interval [CI] = -0.06 to -0.004, <i>P</i> = .02), TTRW (MD = -0.11, 95% CI = -0.22 to -0.01, <i>P</i> = .04), and TTCLIMB velocities (MD = -0.04, 95% CI = -0.08 to -0.003, <i>P</i> = .03). Safety outcomes showed enhanced height percentile (MD = 16.28, 95% CI = 6.31-26.25, <i>P</i> = .001) and bone biomarkers (osteocalcin: MD = 15.68, <i>P</i> < .00001; P1NP: MD = 158.34, <i>P</i> < .00001), with no significant body mass index-z score difference. <b>Conclusions:</b> Vamorolone offers comparable efficacy with traditional glucocorticoids in DMD, with improved motor function and safer profiles in growth and bone health, suggesting its potential to transform DMD management.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251349402"},"PeriodicalIF":1.1,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144506042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-24DOI: 10.1177/87551225251348832
Hannah DePasquale, Alexander DeLucenay, Nabila Ahmed-Sarwar
Background: Current literature is limited to describing the correlation of continuous glucose monitor (CGM) use and improved HbA1cs in patients with type 2 diabetes. There is a lack of literature correlating HbA1c and time in range (TIR). In addition, data such as time spent with low or very low blood glucose levels are not assessed in existing literature. Objective: To assess the correlation between reduction of HbA1c and increase in TIR for patients using CGMs meeting with an interdisciplinary team. Methods: This retrospective chart review includes adult patients seen in an interdisciplinary internal medicine clinic consisting of a pharmacist and nurse practitioner. Data collection included patients with diabetes using CGMs for at least 3 months, who had a visit with the team in the last 12 months. Information collected included demographics, insurance, comorbidities, diabetes medications, HbA1c and CGM data at baseline and 3-month visit, and number of pharmacist medication interventions. Fisher's exact, chi-square, and Mann-Whitney U tests were used where appropriate. Results: HbA1c decreased from 8.6% to 7.5% 3 months later (P = 0.002). The average increase in TIR was 55.5% to 65.1% (P = 0.007). The overall decrease in HbA1c and increase in TIR had a high inverse correlation at baseline and 3 months (r = -0.7 and r = -0.7, P < 0.001). Conclusion: There is a strong inverse relationship between HbA1c and TIR, reduction in glucose variability with a slightly higher incidence time in low/very low following intervention. The type and frequency of pharmacist-initiated interventions support the clinical decision-making potential for pharmacotherapy adjustments.
{"title":"Correlation of HbA1c and Continuous Glucose Monitor Time in Range.","authors":"Hannah DePasquale, Alexander DeLucenay, Nabila Ahmed-Sarwar","doi":"10.1177/87551225251348832","DOIUrl":"10.1177/87551225251348832","url":null,"abstract":"<p><p><b>Background:</b> Current literature is limited to describing the correlation of continuous glucose monitor (CGM) use and improved HbA1cs in patients with type 2 diabetes. There is a lack of literature correlating HbA1c and time in range (TIR). In addition, data such as time spent with low or very low blood glucose levels are not assessed in existing literature. <b>Objective:</b> To assess the correlation between reduction of HbA1c and increase in TIR for patients using CGMs meeting with an interdisciplinary team. <b>Methods:</b> This retrospective chart review includes adult patients seen in an interdisciplinary internal medicine clinic consisting of a pharmacist and nurse practitioner. Data collection included patients with diabetes using CGMs for at least 3 months, who had a visit with the team in the last 12 months. Information collected included demographics, insurance, comorbidities, diabetes medications, HbA1c and CGM data at baseline and 3-month visit, and number of pharmacist medication interventions. Fisher's exact, chi-square, and Mann-Whitney <i>U</i> tests were used where appropriate. <b>Results:</b> HbA1c decreased from 8.6% to 7.5% 3 months later (<i>P</i> = 0.002). The average increase in TIR was 55.5% to 65.1% (<i>P</i> = 0.007). The overall decrease in HbA1c and increase in TIR had a high inverse correlation at baseline and 3 months (<i>r</i> = -0.7 and <i>r</i> = -0.7, <i>P</i> < 0.001). <b>Conclusion:</b> There is a strong inverse relationship between HbA1c and TIR, reduction in glucose variability with a slightly higher incidence time in low/very low following intervention. The type and frequency of pharmacist-initiated interventions support the clinical decision-making potential for pharmacotherapy adjustments.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251348832"},"PeriodicalIF":1.1,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144506039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-24DOI: 10.1177/87551225251344143
Mohamed Sarg, Megan Rowcliffe, Agnes Ann Feemster, E Robert Feroli, Rosemary Duncan
Background: Emergency drug boxes (EDBs) contain essential medications and supplies for use during life-threatening emergencies. Most health system pharmacies use a manual process for stocking these boxes, relying on individuals to perform the tasks. This approach is inherently prone to human error. Objective: To assess the accuracy of the current manual stocking process for EDBs, determine the clinical severity of any errors found, and evaluate the potential for using radio frequency identification (RFID) technology to mitigate these errors. Methods: This was a 2-phase retrospective study conducted at a large academic medical center. Phase 1 involved the assessment of adult and pediatric EDBs for stocking errors. Phase 2 evaluated the clinical severity of the errors discovered. The adult and pediatric Cardiopulmonary Resuscitation Committees independently ranked each identified error on a 3-point scale (1 = unlikely harm to 3 = severe discomfort or clinical deterioration). The study calculated the percentage of errors that could be detected by the implementation of RFID technology. Results: In total, 451 EDBs were analyzed for stocking errors. 106 (24%) contained at least one error, resulting in 132 identified errors. Implementing RFID technology would detect 96 of these 132 errors (73%). Of the detectable errors, 43 (40%) were ranked 2 or 3, indicating a higher likelihood of clinical harm or deterioration. Conclusion: Manual restocking and checking of EDBs are vulnerable to human error, which can have serious consequences and jeopardize patient safety. Adopting RFID technology can greatly improve the accuracy and reliability of this essential process.
{"title":"Emergency Drug Box Accuracy: Analysis of Manual Replenishment Errors and the Use of RFID as a Preventative Strategy.","authors":"Mohamed Sarg, Megan Rowcliffe, Agnes Ann Feemster, E Robert Feroli, Rosemary Duncan","doi":"10.1177/87551225251344143","DOIUrl":"10.1177/87551225251344143","url":null,"abstract":"<p><p><b>Background:</b> Emergency drug boxes (EDBs) contain essential medications and supplies for use during life-threatening emergencies. Most health system pharmacies use a manual process for stocking these boxes, relying on individuals to perform the tasks. This approach is inherently prone to human error. <b>Objective:</b> To assess the accuracy of the current manual stocking process for EDBs, determine the clinical severity of any errors found, and evaluate the potential for using radio frequency identification (RFID) technology to mitigate these errors. <b>Methods:</b> This was a 2-phase retrospective study conducted at a large academic medical center. Phase 1 involved the assessment of adult and pediatric EDBs for stocking errors. Phase 2 evaluated the clinical severity of the errors discovered. The adult and pediatric Cardiopulmonary Resuscitation Committees independently ranked each identified error on a 3-point scale (1 = unlikely harm to 3 = severe discomfort or clinical deterioration). The study calculated the percentage of errors that could be detected by the implementation of RFID technology. <b>Results:</b> In total, 451 EDBs were analyzed for stocking errors. 106 (24%) contained at least one error, resulting in 132 identified errors. Implementing RFID technology would detect 96 of these 132 errors (73%). Of the detectable errors, 43 (40%) were ranked 2 or 3, indicating a higher likelihood of clinical harm or deterioration. <b>Conclusion:</b> Manual restocking and checking of EDBs are vulnerable to human error, which can have serious consequences and jeopardize patient safety. Adopting RFID technology can greatly improve the accuracy and reliability of this essential process.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251344143"},"PeriodicalIF":1.1,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12187701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144506040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-14DOI: 10.1177/87551225251348838
Ashwin Jagadish, Shahnawaz Notta, Stephen Bakeler, David Joseph
Introduction: Pioglitazone is a medication that can be utilized in the management of type 2 diabetes mellitus (T2DM). It can be associated with adverse effects such as edema, weight gain, and heart failure. It is not commonly associated with pleural effusions. Case Presentation: Our case involves an 81-year-old man with T2DM who presented to the emergency department due to progressively worsening lower extremity edema and exertional dyspnea. These symptoms began after the patient started to regularly take pioglitazone. He had a large pleural effusion and diffuse anasarca. Pioglitazone was discontinued and he underwent successful thoracentesis and diuresis. Discussion: The Naranjo scale yielded a score of 7 points, indicating a probable association between pioglitazone and our patient's presentation. There is limited documentation of pleural effusions associated with pioglitazone. Our case is unique as the patient had pleural effusions and anasarca associated with pioglitazone.
{"title":"Pleural Effusion and Anasarca Associated With Pioglitazone.","authors":"Ashwin Jagadish, Shahnawaz Notta, Stephen Bakeler, David Joseph","doi":"10.1177/87551225251348838","DOIUrl":"10.1177/87551225251348838","url":null,"abstract":"<p><p><b>Introduction:</b> Pioglitazone is a medication that can be utilized in the management of type 2 diabetes mellitus (T2DM). It can be associated with adverse effects such as edema, weight gain, and heart failure. It is not commonly associated with pleural effusions. <b>Case Presentation:</b> Our case involves an 81-year-old man with T2DM who presented to the emergency department due to progressively worsening lower extremity edema and exertional dyspnea. These symptoms began after the patient started to regularly take pioglitazone. He had a large pleural effusion and diffuse anasarca. Pioglitazone was discontinued and he underwent successful thoracentesis and diuresis. <b>Discussion:</b> The Naranjo scale yielded a score of 7 points, indicating a probable association between pioglitazone and our patient's presentation. There is limited documentation of pleural effusions associated with pioglitazone. Our case is unique as the patient had pleural effusions and anasarca associated with pioglitazone.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251348838"},"PeriodicalIF":1.1,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12170548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144326091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-02-03DOI: 10.1177/87551225251313707
Christine M Cheng, Cameron Rehmani, Jordan Chin
Background: Sustained-release prostaglandin intracameral implants are new targeted treatment options for open-angle glaucoma or ocular hypertension that lower intraocular pressure (IOP) and reduce or eliminate the need for topical eye drops. Objective: To summarize evidence supporting prostaglandin intracameral implants for treatment of ocular hypertension or open angle glaucoma and identify patient populations most likely to benefit from these treatments. Data sources: A PubMed search (1/1/2016 to 10/1/2024) was conducted to identify randomized, controlled clinical trials for bimatoprost 10-μg and travoprost 75-μg intracameral implants. Manufacturer prescribing information, formulary dossiers, Food and Drug Administration (FDA) clinical reviews and glaucoma clinical treatment guidelines were also reviewed. Study selection and data extraction: English-language randomized controlled trials involving bimatoprost 10-μg or travoprost 75-μg intracameral implants were included. Data synthesis: Bimatoprost and travoprost intracameral implants demonstrated noninferior IOP reduction compared to timolol eye drops in phase 3 trials, with sustained effects up to 12 and 36 months, respectively. The FDA-approved implants are limited to a single administration to the affected eye to minimize corneal risks. The travoprost implant contains a titanium reservoir and requires surgical placement, while the bimatoprost implant is biodegradable and can be placed in a clinic setting. There are no studies directly comparing the safety and efficacy of the two intracameral implants. Conclusions: Prostaglandin intracameral implants are a novel approach to reducing medication burden while delivering sustained IOP reducing effects. Pharmacists should be aware of efficacy and safety considerations of these implants relative to available topical treatments for ocular hypertension or open angle glaucoma.
{"title":"Prostaglandin Intracameral Implants for Ocular Hypertension and Open-Angle Glaucoma.","authors":"Christine M Cheng, Cameron Rehmani, Jordan Chin","doi":"10.1177/87551225251313707","DOIUrl":"10.1177/87551225251313707","url":null,"abstract":"<p><p><b>Background:</b> Sustained-release prostaglandin intracameral implants are new targeted treatment options for open-angle glaucoma or ocular hypertension that lower intraocular pressure (IOP) and reduce or eliminate the need for topical eye drops. <b>Objective:</b> To summarize evidence supporting prostaglandin intracameral implants for treatment of ocular hypertension or open angle glaucoma and identify patient populations most likely to benefit from these treatments. <b>Data sources:</b> A PubMed search (1/1/2016 to 10/1/2024) was conducted to identify randomized, controlled clinical trials for bimatoprost 10-μg and travoprost 75-μg intracameral implants. Manufacturer prescribing information, formulary dossiers, Food and Drug Administration (FDA) clinical reviews and glaucoma clinical treatment guidelines were also reviewed. <b>Study selection and data extraction:</b> English-language randomized controlled trials involving bimatoprost 10-μg or travoprost 75-μg intracameral implants were included. <b>Data synthesis:</b> Bimatoprost and travoprost intracameral implants demonstrated noninferior IOP reduction compared to timolol eye drops in phase 3 trials, with sustained effects up to 12 and 36 months, respectively. The FDA-approved implants are limited to a single administration to the affected eye to minimize corneal risks. The travoprost implant contains a titanium reservoir and requires surgical placement, while the bimatoprost implant is biodegradable and can be placed in a clinic setting. There are no studies directly comparing the safety and efficacy of the two intracameral implants. <b>Conclusions:</b> Prostaglandin intracameral implants are a novel approach to reducing medication burden while delivering sustained IOP reducing effects. Pharmacists should be aware of efficacy and safety considerations of these implants relative to available topical treatments for ocular hypertension or open angle glaucoma.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"144-150"},"PeriodicalIF":1.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}