Pharmacotherapy最新文献

{"title":"The efficacy and safety of sodium-glucose cotransporter-2 inhibitors in solid organ transplant recipients: A scoping review.","authors":"Hansa Mreyoud, Krysta Walter, Elizabeth Wilpula, Jeong M Park","doi":"10.1002/phar.2928","DOIUrl":"10.1002/phar.2928","url":null,"abstract":"<p><p>Sodium glucose co-transporter 2 (SGLT2) inhibitors are used for the treatment of diabetes and for their cardiovascular and kidney benefits in patients with or without diabetes. Use in solid organ transplant recipients is controversial because transplant recipients were excluded from the major clinical trials assessing SGLT2 inhibitors. The goal of this review was to assess the available literature regarding the use of SGLT2 inhibitors in solid organ transplant recipients. A PubMed search was conducted for studies published in English through December 31, 2023. Studies were excluded if they were meta-analyses, review articles, commentaries, single case reports, or in vitro studies, or did not involve the use of SGLT2 inhibitors in solid organ transplant recipients with a diabetic, cardiovascular, or kidney outcome being assessed. In the final review, 20 studies were included: kidney (n = 15), heart (n = 4), and liver/lung/kidney (n = 1) transplant recipients. SGLT2 inhibitors had similar A1c reduction efficacy and were found to be weight neutral with possible weight reduction effects. Cardiovascular and kidney outcomes were not adequately assessed in the available studies. Adverse effects were reported to occur at a similar rate in transplant recipients compared to the general population. SGLT2 inhibitors were initiated ≥1-year post-transplant in most transplant recipients included in these studies. The overall safety and antihyperglycemic efficacy of SGLT2 inhibitors in kidney and heart transplant recipients is similar to the general population. Data assessing SGLT2 inhibitors use in solid organ transplant recipients for longer durations are needed.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increasing the bioavailability of oral esketamine by a single dose of cobicistat: A case study.","authors":"Cornelis F Vos, Wietske L Hemminga, Rob E Aarnoutse, Henricus G Ruhé","doi":"10.1002/phar.2942","DOIUrl":"10.1002/phar.2942","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141180430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy.","authors":"David B Cluck, Daniel B Chastain, Milena Murray, Spencer H Durham, Elias B Chahine, Caroline Derrick, Julie B Dumond, E Kelly Hester, Sarah B Jeter, Melissa D Johnson, Christin Kilcrease, Wesley D Kufel, Jeffrey Kwong, Amber F Ladak, Nimish Patel, Sarah E Pérez, Jonell B Poe, Charlotte Bolch, Ian Thomas, Elizabeth Asiago-Reddy, William R Short","doi":"10.1002/phar.2914","DOIUrl":"10.1002/phar.2914","url":null,"abstract":"<p><p>Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy: An executive summary.","authors":"David B Cluck, Daniel B Chastain, Milena Murray, Spencer H Durham, Elias B Chahine, Caroline Derrick, Julie B Dumond, E Kelly Hester, Sarah B Jeter, Melissa D Johnson, Christin Kilcrease, Wesley D Kufel, Jeffrey Kwong, Amber F Ladak, Nimish Patel, Sarah E Pérez, Jonell B Poe, Charlotte Bolch, Ian Thomas, Elizabeth Asiago-Reddy, William R Short","doi":"10.1002/phar.2913","DOIUrl":"10.1002/phar.2913","url":null,"abstract":"<p><p>Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed in the main document.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Andexanet alfa versus PCC products for factor Xa inhibitor bleeding: A systematic review with meta-analysis.","authors":"C Michael White, Kimberly Snow Caroti, Youssef Bessada, Adrian V Hernandez, William L Baker, Paul P Dobesh, Heleen van Haalen, Kirsty Rhodes, Craig I Coleman","doi":"10.1002/phar.2925","DOIUrl":"10.1002/phar.2925","url":null,"abstract":"<p><p>Previous meta-analyses assessed andexanet alfa (AA) or prothrombin complex concentrate (PCC) products for the treatment of Factor Xa inhibitor (FXaI)-associated major bleeding. However, they did not include recent studies or assess the impact of the risk of bias. We conducted a systematic review with meta-analysis on the effectiveness of AA versus PCC products for FXaI-associated major bleeding, inclusive of the studies' risk of bias. PubMed and Embase were searched for comparative studies assessing major bleeding in patients using FXaI who received AA or PCC. We used the Methodological Index for NOn-Randomized Studies (MINORS) checklist and one question from the Joanna Briggs Institute (JBI) Critical Appraisal of Case Series tool to assess the risk of bias. Random-effects meta-analyses were performed to provide a pooled estimate for the effect of AA versus PCC products on hemostatic efficacy, in-hospital mortality, 30-day mortality, and thrombotic events. Low-moderate risk of bias studies were meta-analyzed separately, as well as combined with high risk of bias studies. Eighteen comparative evaluations of AA versus PCC were identified. Twenty-eight percent of the studies (n = 5) had low-moderate risk and 72% (n = 13) had a high risk of bias. Studies with low-moderate risk of bias suggested improvements in hemostatic efficacy [Odds Ratio (OR) 2.72 (95% Confidence Interval (CI): 1.15-6.44); one study], lower in-hospital mortality [OR 0.48 (95% CI: 0.38-0.61); three studies], and reduced 30-day mortality [OR 0.49 (95% CI: 0.30-0.80); two studies] when AA was used versus PCC products. When studies were included regardless of the risk of bias, pooled effects showed improvements in hemostatic efficacy [OR 1.36 (95% CI: 1.01-1.84); 12 studies] and reductions in 30-day mortality [OR 0.53 (95% CI: 0.37-0.76); six studies] for AA versus PCC. The difference in thrombotic events with AA versus PCC was not statistically significant in the low-moderate, high, or combined risk of bias groups. The evidence from low-moderate quality real-world studies suggests that AA is superior to PCC in enhancing hemostatic efficacy and reducing in-hospital and 30-day mortality. When studies are assessed regardless of the risk of bias, the pooled hemostatic efficacy and 30-day mortality risk remain significantly better with AA versus PCC.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on \"Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution\".","authors":"Yongyi Zhang, Qiushun Zhang, Junchen Zhang","doi":"10.1002/phar.2918","DOIUrl":"https://doi.org/10.1002/phar.2918","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expert consensus recommendations for innovative antiretroviral drugs.","authors":"C Lindsay DeVane","doi":"10.1002/phar.2924","DOIUrl":"https://doi.org/10.1002/phar.2924","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to comment on \"Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution\".","authors":"Lily Price, Lisa Garrity, Sarah Stiehl","doi":"10.1002/phar.2919","DOIUrl":"https://doi.org/10.1002/phar.2919","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genetic polymorphisms and major bleeding risk during vitamin K antagonists treatment: The BLEEDS case‐cohort","authors":"Eleonora Camilleri, Mira Ghobreyal, Mettine H. A. Bos, Pieter H. Reitsma, Felix J. M. Van Der Meer, Jesse J. Swen, Suzanne C. Cannegieter, Nienke van Rein","doi":"10.1002/phar.2923","DOIUrl":"https://doi.org/10.1002/phar.2923","url":null,"abstract":"BackgroundMajor bleeding occurs annually in 1%–3% of patients on vitamin K antagonists (VKAs), despite close monitoring. Genetic variants in proteins involved in VKA response may affect this risk.AimTo determine the association of genetic variants (cytochrome P450 enzymes 2C9 [<jats:italic>CYP2C9</jats:italic>] and 4F2 [<jats:italic>CYP4F2</jats:italic>], gamma‐glutamyl carboxylase [<jats:italic>GGCX</jats:italic>]) with major bleeding in VKA users, separately and combined, including vitamin K epoxide reductase complex subunit‐1 (<jats:italic>VKORC1</jats:italic>).MethodsA case‐cohort study was established within the BLEEDS cohort, which includes 16,570 patients who initiated VKAs between 2012 and 2014. We selected all 326 major bleeding cases that occurred during 17,613 years of follow‐up and a random subcohort of 978 patients. We determined variants in <jats:italic>CYP2C9</jats:italic>, <jats:italic>CYP4F2</jats:italic>, <jats:italic>GGCX</jats:italic>, <jats:italic>VKORC1</jats:italic> and evaluated the interaction between variant genotypes. Hazard ratios for major bleeding with 95% confidence intervals (95% CI) were estimated by weighted Cox regression.ResultsGenotype was determined in 256 cases and 783 subcohort members. Phenprocoumon was the most prescribed VKA for both cases and the subcohort (78% and 75%, respectively). Patients with major bleeding were slightly older than subcohort patients. <jats:italic>CYP4F2</jats:italic>‐TT carriership was associated with a 1.6‐fold (95% CI 0.9–2.8) increased risk of major bleeding compared with CC‐alleles, albeit not statistically significant. For the <jats:italic>CYP2C9</jats:italic> and <jats:italic>GGCX</jats:italic> variants instead, the major bleeding risk was around unity. Carrying at least two variant genotypes in <jats:italic>CYP2C9</jats:italic> (poor metabolizer), <jats:italic>CYP4F2</jats:italic>‐TT, and <jats:italic>VKORC1</jats:italic>‐AA was associated with a 4.0‐fold (95%CI 1.4–11.4) increased risk, while carriers of both <jats:italic>CYP4F2</jats:italic>‐TT and <jats:italic>VKORC1</jats:italic>‐AA had a particularly increased major bleeding risk (hazard ratio 6.7, 95% CI 1.5–29.8) compared with carriers of CC alleles in <jats:italic>CYP4F2</jats:italic> and GG in <jats:italic>VKORC1</jats:italic>. However, the number of major bleeding cases in carriers of multiple variants was few (8 and 5 patients, respectively).Conclusions<jats:italic>CYP4F2</jats:italic> polymorphism was associated with major bleeding, especially in combination with <jats:italic>VKORC1</jats:italic> genetic variants. These variants could be considered to further personalize anticoagulant treatment.","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140827219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antiviral influenza treatments and hemorrhage-related adverse events in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.","authors":"Jyotirmoy Sarker, Emir Carkovic, Karolina Ptaszek, Todd A Lee","doi":"10.1002/phar.2920","DOIUrl":"https://doi.org/10.1002/phar.2920","url":null,"abstract":"STUDY OBJECTIVE\u0000To determine whether there is a signal for gastrointestinal (GI) or intracranial (IC) hemorrhage associated with the use of antiviral medications for influenza in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.\u0000\u0000\u0000DESIGN\u0000Disproportionality analysis.\u0000\u0000\u0000DATA SOURCE\u0000The FAERS database was searched using OpenVigil 2.1 to identify GI and IC hemorrhage events reported between 2004 and 2022.\u0000\u0000\u0000MEASUREMENTS\u0000Antiviral medications for influenza included the following: oseltamivir, zanamivir, peramivir, and baloxavir marboxil. Hemorrhage events were identified using Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries for GI and IC hemorrhages. Reporting odds ratios (RORs) were calculated to compare the occurrence of GI and IC hemorrhage events between antiviral drugs for influenza and (i) all other medications and (ii) antibiotics. RORs were also calculated for each of the individual antiviral medications.\u0000\u0000\u0000MAIN RESULTS\u0000A total of 245 cases of GI hemorrhage and 23 cases of IC hemorrhage were identified in association with four antivirals. In comparison with all other drugs, the RORs of GI hemorrhage for oseltamivir, zanamivir, peramivir, baloxavir, and all antivirals combined were 1.17, 0.62, 4.44, 2.53, and 1.22, respectively, indicating potential variations in GI hemorrhage risk among the antivirals. In contrast, in comparison with all other drugs, the RORs of IC hemorrhage for oseltamivir (0.44), zanamivir (0.16), baloxavir (0.44), and all antivirals combined (0.41) were less than 1.0 which is consistent with no elevated risk of IC hemorrhage.\u0000\u0000\u0000CONCLUSION\u0000In this study, some signals for GI hemorrhage were observed, particularly for peramivir and baloxavir marboxil. Further investigation is warranted to better understand and evaluate the potential risks of GI hemorrhage associated with antiviral treatments for influenza.","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140659532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}