Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy最新文献

{"title":"Safety and efficacy of cefiderocol for off-label treatment indications: A systematic review.","authors":"Riyan Babidhan, Abigale Lewis, Cailin Atkins, Nicolas J Jozefczyk, Branden D Nemecek, Courtney A Montepara, Michael R Gionfriddo, David E Zimmerman, Jordan R Covvey, Anthony J Guarascio","doi":"10.1002/phar.2704","DOIUrl":"10.1002/phar.2704","url":null,"abstract":"<p><strong>Purpose: </strong>Cefiderocol is a siderophore cephalosporin recently approved by the United States Food and Drug Administration for the treatment of hospital- and ventilator-acquired bacterial pneumonia and complicated urinary tract infections. However, there is potential for cefiderocol utility for a variety of other infections. The purpose of this systematic review was to identify literature examining the safety and efficacy of cefiderocol for off-label indications.</p><p><strong>Methods: </strong>The PRISMA guidelines were utilized for reporting. Databases searched included PubMed, Scopus, and Embase, from inception to September 2021. Manuscripts describing cefiderocol off-label use in clinical settings were included. Exclusion criteria were studies focused on labeled indications, animal studies, pharmacodynamic/pharmacokinetic studies, in vitro or laboratory studies, and manuscripts in languages other than English or Arabic. Each stage of review utilized two independent investigators, with conflicts resolved and critical appraisal performed. Data regarding presentation, clinical course, and infection characteristics were extracted and descriptively analyzed.</p><p><strong>Results: </strong>The search identified a total of 985 records, narrowed to a final set of 27 studies. Among studies included were 18 (66.7%) case reports, 8 (29.6%) case series, and 1 (3.7%) phase 3 clinical trial. Cefiderocol was most frequently used off-label for bacteremia/sepsis with or without an identified source in 51 (67.1%) out of a total of 76 included patients. Among case series/reports with available data, 43 of 53 patients (81.1%) received combination antibiotic therapy. The most common pathogens identified included multi/extensively drug-resistant Pseudomonas aeruginosa and/or Acinetobacter baumannii. Various clinical end points were reported, while microbiological end points were reported in 18 (66.7%) studies. Cefiderocol-related side effects were uncommon and rarely use-limiting.</p><p><strong>Conclusions: </strong>This systematic review depicts relative clinical effectiveness of off-label cefiderocol, most commonly for P. aeruginosa and A. baumannii infections as combination antibiotic therapy. Further study is needed to elucidate the safety and efficacy of cefiderocol across an expanded set of patients and indications.</p>","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73885047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Poor tolerability of cystic fibrosis transmembrane conductance regulator modulator therapy in lung transplant recipients","authors":"C. Doligalski, C. McKinzie, Anita Yang, L. Lobo, R. Coakley","doi":"10.1002/phar.2710","DOIUrl":"https://doi.org/10.1002/phar.2710","url":null,"abstract":"Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a highly effective therapy for patients with cystic fibrosis (CF) with potential benefits in lung transplant recipients (LTRs) for extrapulmonary CF manifestations; however, tolerability and efficacy in this population are largely unknown. We report our experience with ELX/TEZ/IVA in LTRs for extrapulmonary complications of CF including tolerability, drug–drug interactions, and therapeutic benefit. All LTRs at a single center initiated on ELX/TEZ/IVA were reviewed. Adverse events and patient‐reported outcomes attributed to ELX/TEZ/IVA were documented. Pulmonary function, tacrolimus requirements in mg/kg/dl, body mass index (BMI), and reason for initiation were assessed at the initiation of ELX/TEZ/IVA, and at 12 months post‐initiation or at the time of discontinuation for those in whom therapy was discontinued. Thirteen LTRs were initiated on ELX/TEZ/IVA at a mean of 115 ± 92 months post‐transplant. All were initiated on ELX/TEZ/IVA for sinus or sinus and gastrointestinal CF manifestations. Five (38.4%) patients discontinued therapy due to declining pulmonary function (2/5, 40%), mood disturbances (2/5, 40%), or lack of benefit (1/5, 20%). Of the eight patients who remain on ELX/TEZ/IVA, four reported adverse effects and three LTRs temporarily held therapy. Six (46.2%) LTRs reported improvement in sinus symptoms, while four (30.7%) reported improved gastrointestinal symptoms. Weight declined in the cohort overall. Tacrolimus dose requirements decreased following initiation of ELX/TEZ/IVA therapy, with a 50% decline in dose requirements observed. In our experience, ELX/TEZ/IVA in LTRs is poorly tolerated with modest perceived extrapulmonary benefit and a significant effect on tacrolimus dose requirements. More data are needed to determine the benefits of ELX/TEZ/IVA therapy in LTRs.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85303216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reduced risk of NSAID‐Induced adverse events with concomitant use of misoprostol (MICRO study)","authors":"M. Munger, S. Nelson, C. Teng, A. Cheung, B. Sauer","doi":"10.1002/phar.2708","DOIUrl":"https://doi.org/10.1002/phar.2708","url":null,"abstract":"Non‐steroidal anti‐inflammatory drugs (NSAIDs) are one of the most frequently used medications for pain, even though they increase the risk for adverse cardiovascular events.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72976930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating adherence to concomitant diabetes, hypertension, and hyperlipidemia treatments and intermediate outcomes among elderly patients using marginal structural modeling","authors":"R. Paranjpe, Michael L. Johnson, Hua Chen, K. Birtcher, O. Serna, A. Mohan, S. Abughosh","doi":"10.1002/phar.2705","DOIUrl":"https://doi.org/10.1002/phar.2705","url":null,"abstract":"Medication adherence to concomitant oral antidiabetics, statins, and renin‐angiotensin system (RAS) antagonists (triple therapy) is vital to manage glycated hemoglobin (A1C) and low‐density lipoprotein cholesterol (LDL‐C) control among patients with comorbid diabetes, hyperlipidemia, and hypertension. The objective of the current study was to evaluate the association between adherence to concomitant triple therapy and A1C as well as LDL‐C outcomes, among elderly patients using marginal structural modeling.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77853674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between glucagon‐like peptide‐1 receptor agonists and biliary‐related diseases in patients with type 2 diabetes: A nationwide cohort study","authors":"Yaa-Hui Dong, Jo-Hsuan Wu, Chia‐Hsuin Chang, Jou-Wei Lin, Li‐Chiu Wu, S. Toh","doi":"10.1002/phar.2688","DOIUrl":"https://doi.org/10.1002/phar.2688","url":null,"abstract":"Clinical trials have suggested that glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) may be associated with a higher risk of biliary‐related diseases in patients with type 2 diabetes. Limited real‐world studies have examined the comparative biliary safety of GLP‐1RAs versus other antihyperglycemic drugs. We aimed to estimate the comparative risk of biliary‐related diseases between GLP‐1RAs and sodium glucose cotransporter 2 inhibitors (SGLT2is), which are indicated for patients with similar diabetes severity in Taiwan.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89290498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The safety of rapid infusion levetiracetam: A systematic review","authors":"Alexa Jense, Alyssa A. Douville, Ashley Weiss","doi":"10.1002/phar.2687","DOIUrl":"https://doi.org/10.1002/phar.2687","url":null,"abstract":"Epilepsy is a common diagnosis and can quickly progress to status epilepticus which requires rapid treatment. Levetiracetam is a frequent treatment choice in these situations. The approved administration of intravenous levetiracetam is an infusion over 15 min. In recent years, studies have been published on faster infusion rates of levetiracetam. The objective of this review is to discuss the safety of levetiracetam as an intravenous push at a rate quicker than recommended. A literature search using PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar resulted in 192 articles. Inclusion criteria consisted of English language, human studies, use of levetiracetam administered intravenously at a rate faster than 15 min, discussion of safety, and full‐text availability. After screening, nine articles remained for inclusion. Of the nine articles, one was a prospective, open‐label study, six were retrospective studies, and two were open‐label, randomized controlled trials. The most common rapid infusion speed was 5 min and doses ranged from 280 to 4500 mg. Some of these trials used undiluted levetiracetam and many reported that peripheral access was used for a portion or all of the administrations. There were few adverse effects, including specific adverse effects relating to medication concentration and speed of infusion, in all the studies. Administration of intravenous levetiracetam at a rate faster than recommended in the labeling information appears to be safe and tolerable and can be given via a peripheral line. Rapid infusion of levetiracetam is a beneficial method of administration in an acute care setting where patients need rapid attainment of therapeutic levels of antiepileptic medications. Additional research is needed to ensure that rapid administration of intravenous levetiracetam is as efficacious as the traditional dosing method.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84843723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Norepinephrine reuptake inhibitors and risk of antihypertensive treatment intensification and major adverse cardiovascular events in patients with stable hypertension and depression","authors":"Raj Desai, Haesuk Park, Joshua D. Brown, Raj Mohandas, Steven M. Smith","doi":"10.1002/phar.2686","DOIUrl":"https://doi.org/10.1002/phar.2686","url":null,"abstract":"To compare the risk of antihypertensive treatment intensification (TI) and major adverse cardiovascular events (MACE) with the initiation of serotonin norepinephrine reuptake inhibitors compared to selective serotonin reuptake inhibitors (SSRIs) in patients with stable hypertension and depression.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88655576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of the frequency distribution of five single‐nucleotide polymorphisms of the MTRRgene in a Chinese pediatric population with acute lymphoblastic leukemia","authors":"Miao Li, Xiao-yan Kong, Shu‐Mei Wang","doi":"10.1002/phar.2685","DOIUrl":"https://doi.org/10.1002/phar.2685","url":null,"abstract":"The objective of the present study was to examine the frequency distribution of five single‐nucleotide polymorphisms (SNPs; rs1801394 A>G, rs1532268 C>T, rs162036 A>G, rs10380 C>T, and rs9332 C>T) of the methionine synthase reductase (MTRR) gene, their effects on methotrexate (MTX) concentration, and the risk of relapse in a Chinese pediatric population with acute lymphoblastic leukemia (ALL).","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88716579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine learning to predict vasopressin responsiveness in patients with septic shock","authors":"Aileen Scheibner, K. Betthauser, A. Bewley, P. Juang, B. Lizza, S. Micek, P. Lyons","doi":"10.1002/phar.2683","DOIUrl":"https://doi.org/10.1002/phar.2683","url":null,"abstract":"The objective of this study was to develop and externally validate a model to predict adjunctive vasopressin response in patients with septic shock being treated with norepinephrine for bedside use in the intensive care unit.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87470081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of proton pump inhibitors on sustained virologic response in veterans treated with sofosbuvir/velpatasvir for chronic hepatitis C virus: A retrospective cohort study","authors":"Danielle M Rumph, C. Straley, Jenny L Kolberg, David A. Jacob","doi":"10.1002/phar.2682","DOIUrl":"https://doi.org/10.1002/phar.2682","url":null,"abstract":"The objective of this study was to determine the clinical relationship between proton pump inhibitor (PPI) use and sustained virologic response (SVR) in patients treated with sofosbuvir/velpatasvir (SOF/VEL) for chronic hepatitis C virus (HCV) infection.","PeriodicalId":19812,"journal":{"name":"Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73455176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}