Annals of Pharmacotherapy最新文献

{"title":"Xanomeline-Trospium: A Novel Therapeutic for the Treatment of Schizophrenia.","authors":"Olivia L Ramey, Armando Silva Almodóvar","doi":"10.1177/10600280251324642","DOIUrl":"https://doi.org/10.1177/10600280251324642","url":null,"abstract":"<p><strong>Objective: </strong>This review describes a novel combination muscarinic agonist and antagonist, xanomeline-trospium, which was recently approved by the Food and Drug Administration (FDA) for schizophrenia. Efficacy and safety evidence from phase II and III clinical trials are reviewed.</p><p><strong>Data sources: </strong>The MEDLINE and EMBASE databases were searched in 2024; terms included \"xanomeline trospium\" OR \"xanomelinetrospium\" OR \"KarXT\" OR \"Cobenfy\" AND \"schizophrenia.\" The search was repeated in January 2025.</p><p><strong>Clinicaltrials: </strong>gov was used to review ongoing or unpublished studies.</p><p><strong>Study selection and data extraction: </strong>Human subject studies of xanomeline-trospium were included.</p><p><strong>Data synthesis: </strong>In phase III trials, xanomeline-trospium was superior to placebo for acute exacerbation of schizophrenia. EMERGENT-2 and EMERGENT-3 found patients improved by 9.6 and 8.4 points on the Positive and Negative Symptom Scale (PANSS), respectively, compared with placebo (95% confidence interval -13.9 to -5.2, <i>P</i> < 0.001 and -12.4 to -4.3, <i>P</i> < 0.001). Participants in EMERGENT-4, a long-term open-label extension study, who received the intervention in the randomized phases experienced a 9-point decrease in PANSS from the last result.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Xanomeline-trospium is a novel antipsychotic that is effective for treatment of schizophrenia and may have a favorable adverse effect profile in comparison with other antipsychotics due to its lack of dopamine receptor antagonism. Efficacy for improvement in negative symptoms and cognitive function in schizophrenia is promising.</p><p><strong>Conclusions: </strong>Xanomeline-trospium shows promising results for treatment of schizophrenia. Further studies with active comparators, larger sample sizes, and more patients with prominent negative symptoms are needed to corroborate efficacy and determine place in therapy.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251324642"},"PeriodicalIF":2.3,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143717926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Error Incidence Between Single-Tablet Versus Multiple-Tablet INSTI-Based Regimens in the Inpatient Setting.","authors":"Denise Kelley, Kayla Blackmon, Brian L Nguyen, Dusten T Rose","doi":"10.1177/10600280251324337","DOIUrl":"https://doi.org/10.1177/10600280251324337","url":null,"abstract":"<p><strong>Background: </strong>Errors related to antiretroviral therapy (ART) occur in up to 86% of hospitalized patients living with human immunodeficiency virus (HIV) and may contribute to treatment failure, drug resistance, adverse effects, and toxicity. ART can be administered as a single-tablet regimen (STR) or multiple-tablet regimen (MTR), with limited data on whether the number of tablets affects inpatient error incidence.</p><p><strong>Objective: </strong>The purpose of this study was to determine the error rate of substituting dolutegravir-based STRs to an MTR while admitted.</p><p><strong>Methods: </strong>This multicenter, retrospective, observational study in adult inpatients receiving ART for HIV evaluated continuation of bictegravir-based STR versus dolutegravir-based STR given as an MTR. The primary outcome was the composite error incidence when ART was dispensed as an STR versus MTR. Secondary endpoints included number of errors per patient encounter, between-group error types, time to error correction and pharmacist involvement, and conversion back to STR at discharge.</p><p><strong>Results: </strong>Of 514 patient encounters (257 bictegravir-based STR; 257 dolutegravir-based MTR), there was a significantly lower composite incidence of errors in the STR group versus the MTR group (23% vs 31.5%; <i>P</i> = 0.029). A significantly higher incidence of dose-related errors in the MTR group occurred related to renal or hepatic dose adjustments, which was the only significantly different between-group error type identified. Approximately one error per encounter was identified in both groups, with median time to error correction slightly over 1 day. Multiple-tablet regimens were converted back to an STR at discharge in 89.9% of admissions.</p><p><strong>Conclusion and relevance: </strong>Providing INSTI-based ART as an STR while admitted may reduce ART-related medication errors and has potential to improve patient care; however, use of an STR may not address errors related to inappropriate dosing in organ dysfunction. Increased vigilance for medication errors is warranted when substituting with MTRs in inpatient settings.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251324337"},"PeriodicalIF":2.3,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time to Target Anti-Xa Level in Obese Vs Nonobese Patients Using an Adjusted Body Weight Heparin Infusion Protocol for the Treatment of Venous Thromboembolism.","authors":"Mary K Eibye, Jacqueline N Poston, Amanda G Kennedy, Michael DeSarno, Rebecca M Nashett","doi":"10.1177/10600280251321478","DOIUrl":"https://doi.org/10.1177/10600280251321478","url":null,"abstract":"<p><strong>Background: </strong>Unfractionated heparin (UFH) is a first-line option for the acute treatment of venous thromboembolism (VTE). Weight-based dosing protocols have demonstrated a decreased time to therapeutic anticoagulation, however, there are limited data on their utilization in obese patients, including the type of weight used.</p><p><strong>Objective: </strong>The purpose of this study was to determine equivalency in time to reach target antifactor-Xa (anti-Xa) for obese and nonobese patients using the same adjusted body weight (AdjBW)-based UFH infusion protocol.</p><p><strong>Methods: </strong>This was a single-center retrospective study of patients aged 18 years or older receiving an infusion of UFH for the treatment of VTE. The primary outcome was the median time to first target anti-Xa. Secondary outcomes included the percentage of first anti-Xa levels at 6 hours that were within, below, or above the target range and the median time to the second consecutive anti-Xa level within the target range. The safety outcome of evidence of major bleed was also evaluated.</p><p><strong>Results: </strong>Of the 166 patients assessed (75 obese and 91 nonobese), there was no observed difference in median time to first target anti-Xa in obese vs nonobese patients when using an AdjBW UFH protocol (12.45 vs 13.03 hours, <i>P</i> = 0.49). The percentage of patients achieving a target anti-Xa at first evaluation did not differ between obese and nonobese groups (32.0% vs 34.07%, <i>P</i> = 0.78). A total of 14 patients across groups experienced evidence of major bleed, with no observed difference between obese and nonobese groups (8.00% vs 8.89%, <i>P</i> = 0.84).</p><p><strong>Conclusions and relevance: </strong>There was no observed difference in median time to first target anti-Xa in obese vs nonobese patients when using an AdjBW heparin infusion protocol, with no observed difference in evidence of major bleed. Our findings support the use of AdjBW in weight-based UFH dosing.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251321478"},"PeriodicalIF":2.3,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Meta-Analysis Comparing Metolazone Versus Intravenous Chlorothiazide in Patients With Acute Decompensated Heart Failure.","authors":"Kazuhiko Kido, Mikiko Shimizu, Tsuyoshi Shiga, Masayuki Hashiguchi","doi":"10.1177/10600280251325250","DOIUrl":"https://doi.org/10.1177/10600280251325250","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251325250"},"PeriodicalIF":2.3,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serotonergic Antidepressant Use and Risk of Clinically Significant Bleeding in Thrombocytopenic Hematologic Malignancy Patients.","authors":"Hannah Delp, Marissa Olson, Emily Owen, Colleen McEvoy, Emily Gill","doi":"10.1177/10600280251319757","DOIUrl":"https://doi.org/10.1177/10600280251319757","url":null,"abstract":"<p><strong>Background: </strong>Serotonin reuptake inhibitor (SRI) antidepressants have known antiplatelet properties. Patients with hematologic malignancies (HMs) are at an increased risk of bleeding complications due to their malignancy and treatment-induced thrombocytopenia.</p><p><strong>Objective: </strong>The purpose of this study was to evaluate the risk of clinically significant bleeding (CSB) in patients with HM and thrombocytopenia who are prescribed SRIs.</p><p><strong>Methods: </strong>This retrospective cohort study included adult patients admitted to the hospital with HM and thrombocytopenia. Patients were stratified into SRI-exposed and SRI-unexposed groups. Patients were followed up until resolution of thrombocytopenia, hospital discharge, death, or SRI therapy interruption. The primary outcome was the incidence of CSB.</p><p><strong>Results: </strong>A total of the 324 patients were included in the study (119 SRI exposed vs 205 SRI unexposed). The median baseline platelet value was 35 × 10⁹/L and 31 × 10⁹/L, respectively. The median platelet nadir was 6 × 10⁹/L, and the median duration of study inclusion was 12 days in both groups. No difference was seen in the incidence of CSB between groups (16% vs 13%, <i>P</i> = 0.487). Hospital length of stay (LOS) (20 vs 19 days, <i>P</i> = 0.227) and intensive care unit (ICU) LOS (3.9 vs 3.9 days, <i>P</i> = 0.996) were similar between groups. On multivariable analysis, SRI exposure was not independently associated with CSB (adjusted odds ratio [aOR] = 1.46, 95% confidence interval [CI] 0.75-2.86).</p><p><strong>Conclusion and relevance: </strong>In patients with HM and thrombocytopenia, SRI exposure was not associated with an increased risk of CSB. Given the small study size, assessment of patient-specific risks versus benefits should still be considered when prescribing SRI therapy in this patient population.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251319757"},"PeriodicalIF":2.3,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seladelpar for the Treatment of Primary Biliary Cholangitis.","authors":"Adonice P Khoury, Jason Powell","doi":"10.1177/10600280251320069","DOIUrl":"https://doi.org/10.1177/10600280251320069","url":null,"abstract":"<p><strong>Objective: </strong>To review the published data including the pharmacology, efficacy, and safety of seladelpar, a peroxisome proliferator-activated receptor delta (PPARδ) agonist leading to the Food and Drug Administration (FDA) accelerated approval for the treatment of primary biliary cholangitis (PBC).</p><p><strong>Data sources: </strong>A PubMed (January 1, 1985 to January 27, 2025) literature search was performed using the terms seladelpar, MBX-8025, peroxisome proliferator-activated receptor agonist, and PBC. Other data sources included Google Scholar and the National Institutes of Health Clinical Trials Registry.</p><p><strong>Study selection and data extraction: </strong>All English-language literature evaluating the pharmacology, pharmacokinetics, safety, and efficacy of seladelpar in the treatment of PBC was reviewed.</p><p><strong>Data synthesis: </strong>Seladelpar is the first PPARδ agonist in the treatment of PBC that has shown a significant reduction across biochemical response, alkaline phosphatase (ALP) normalization, and pruritus as compared to placebo while demonstrating safety and tolerability.Relevance to patient care and clinical practice in comparison to existing drugs:While existing drug treatments for PBC are efficacious, there remains an unmet need due to an incomplete biochemical response in many patients. Patients frequently suffer from symptoms, including pruritus, impacting their quality of life. Seladelpar could have a beneficial role in PBC as add-on therapy in improving biochemical response as well as alleviating pruritus.</p><p><strong>Conclusion: </strong>Seladelpar is a safe and effective treatment for PBC and fills a significant unmet need. Seladelpar's clinical benefit predicted by improvement in surrogate endpoints may need confirmation for traditional FDA approval.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251320069"},"PeriodicalIF":2.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic Potential of GLP-1 Receptor Agonists in Metabolic Associated Steatotic Liver Disease.","authors":"Klaudia Nowak, Krzysztof Łupina, Anna Romac, Aleksandra Kalisz, Łucja Ilkiewicz, Jakub Janczura","doi":"10.1177/10600280251322002","DOIUrl":"https://doi.org/10.1177/10600280251322002","url":null,"abstract":"<p><strong>Objective: </strong>To summarize the current knowledge on the therapeutic potential of GLP-1 receptor agonists in managing metabolic associated steatotic liver disease (MASLD).</p><p><strong>Data sources: </strong>A literature review was conducted using the search terms <i>GLP-1 agonists</i>, <i>MASLD</i>, <i>NAFLD</i>, <i>nonalcoholic fatty liver disease</i>, <i>treatment</i>, and <i>therapy</i> on PubMed (from January 1, 2019, through February 1, 2025), National Institutes of Health (NIH) (from January 1, 2019, through February 1, 2025), Scopus (from January 1, 2019, through February 1, 2025), and the World Health Organization (WHO) data.</p><p><strong>Study selection and data extraction: </strong>All relevant clinical trials, review articles, package inserts, and guidelines evaluating clinically relevant evidence regarding the therapeutic potential of GLP-1 agonists in MASLD were considered for inclusion.</p><p><strong>Data synthesis: </strong>GLP-1 RAs have shown promising results in MASLD treatment. Semaglutide has demonstrated efficacy in reducing liver fat content, inflammation, and fibrosis, with clinical trials indicating improvements in hepatic biomarkers and cardiometabolic risk factors. Similarly, tirzepatide has been associated with substantial weight loss and significant reductions in liver fat and fibrosis markers. Both agents exert their effects through mechanisms involving improved insulin sensitivity, reduced lipid accumulation, and attenuation of hepatic inflammation.</p><p><strong>Relevance to patient care and clinical practice: </strong>Given the high prevalence of MASLD in patients with obesity and type 2 diabetes, tirzepatide and semaglutide could play a critical role in clinical practice by addressing multiple facets of the disease. Both agents have shown potential in reducing liver fat, improving hepatic biomarkers, and mitigating cardiometabolic risks, which are leading causes of morbidity and mortality in MASLD patients. Incorporating these therapies into MASLD treatment guidelines could significantly enhance patient outcomes by targeting both liver-related and systemic complications of the disease.</p><p><strong>Conclusions: </strong>GLP1 RAs show great potential in managing MASLD by promoting weight loss, improving glycemic control, and reducing liver inflammation.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251322002"},"PeriodicalIF":2.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Albumin-Bilirubin-Fibrosis-4 Score for Predicting Teicoplanin-Induced Abnormal Liver Enzyme Levels in Patients Undergoing Therapeutic Drug Monitoring: A Multicentral Retrospective Cohort Study.","authors":"Hayahide Ooi, Yuki Asai, Yoshihiro Kondo, Takumi Tashiro, Nobuyuki Zakoji, Maria Aoki, Yoshiki Koriyama, Takuya Iwamoto, Masaaki Takahashi","doi":"10.1177/10600280251319519","DOIUrl":"https://doi.org/10.1177/10600280251319519","url":null,"abstract":"<p><strong>Background: </strong>Although therapeutic drug monitoring (TDM) maintains serum teicoplanin (TEIC) concentration between 15 and 30 μg/mL, TEIC-induced liver injury may still occur. The albumin-bilirubin (ALBI)-fibrosis-4 (FIB-4) score may be useful for predicting TEIC-induced liver injury in patients undergoing TDM.</p><p><strong>Objective: </strong>This pilot study aimed to investigate whether the ALBI-FIB4 score can predict TEIC-induced abnormal liver enzyme levels in patients undergoing TDM.</p><p><strong>Methods: </strong>The multicenter retrospective cohort study included 140 patients undergoing TDM of TEIC at steady state. The primary outcome was TEIC-induced abnormal liver enzyme levels. Cut-off values for the alanine aminotransferase (ALT), ALBI score, FIB-4 index, and ALBI-FIB4 score were detected using receiver-operating characteristic curves. The cumulative risk of TEIC-induced abnormal liver enzyme levels was evaluated using Kaplan-Meier curves analyzed log-rank test. Subgroup analysis was performed to examine cumulative risk in patients with serum TEIC concentration of <30 μg/mL.</p><p><strong>Results: </strong>The incidence of TEIC-induced abnormal liver enzyme levels was 14.3% (20/140). Cut-off values were 24 IU/L for ALT (sensitivity: 0.800; specificity: 0.692; area under the curve [AUC]: 0.753), -1.33 for the ALBI score (sensitivity: 0.550; specificity: 0.617; AUC: 0.539), 2.73 for the FIB-4 index (sensitivity: 0.700; specificity: 0.475; AUC: 0.550), and -0.85 for the ALBI-FIB4 score (sensitivity: 0.800; specificity: 0.467; AUC: 0.572). The cumulative risk of TEIC-induced abnormal liver enzyme levels was significantly higher for patients with ALT ≥24 IU/L (<i>P</i> < 0.01) and ALBI-FIB4 score ≥-0.85 (<i>P</i> = 0.042). Patients with a serum TEIC concentration of <30 µg/mL exhibited a similar trend, with a higher cumulative risk for patients with ALBI-FIB4 score ≥-0.85 (<i>P</i> = 0.058).</p><p><strong>Conclusion and relevance: </strong>An ALBI-FIB4 score ≥-0.85 may serve as a potential predictor for TEIC-induced abnormal liver enzyme levels in patients undergoing TDM. However, evidence supporting this threshold requires further statistical validation using a larger dataset.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280251319519"},"PeriodicalIF":2.3,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of Subcutaneous Insulin Regimens in the Management of Diabetic Ketoacidosis in Adults and Pediatrics.","authors":"Francisco Ibarra, Ryan Bae, Bardya Haghighat","doi":"10.1177/10600280241263357","DOIUrl":"10.1177/10600280241263357","url":null,"abstract":"<p><strong>Objective: </strong>Summarize the studies evaluating the use of subcutaneous (SQ) insulin in the management of diabetic ketoacidosis (DKA) in adults and pediatrics.</p><p><strong>Data sources: </strong>A PubMed literature search was conducted for articles published between 2000 and the end of May 2024 which contained the following terms in their title: (1) subcutaneous, glargine, or basal and (2) ketoa*.</p><p><strong>Study selection and data extraction: </strong>Review articles, guidelines, meta-analysis, commentaries, studies not related to the acute management of DKA, studies evaluating continuous SQ insulin, animal studies, if the time to DKA resolution was not clearly defined, and studies where basal insulin was administered greater than 6 hours after the insulin infusion was started were excluded.</p><p><strong>Data synthesis: </strong>The electronic search identified 58 articles. Following the initial screening 38 articles were excluded and 3 were added after bibliography review. Of the 23 articles assessed for eligibility, 7 were excluded. Sixteen articles were included. Five studies compared SQ rapid/short-acting insulin and intravenous (IV) insulin infusions in adults, 4 compared SQ rapid/short-acting insulin and IV insulin infusions in pediatrics, 4 evaluated IV insulin infusions with or without SQ basal insulin in adults, and 3 evaluated IV insulin infusions with or without SQ basal insulin in pediatrics.</p><p><strong>Relevance to patient care and clinical practice: </strong>In comparison with IV insulin infusions, rapid/short-acting SQ insulin regimens were associated with reduced ICU admission rates, hospital length of stay, and hospitalization costs. IV insulin infusion regimens that included a single SQ basal insulin dose upon therapy initiation were associated with reduced concurrent IV insulin infusion durations.</p><p><strong>Conclusion: </strong>Studies reviewed suggest that SQ insulin regimens may be as effective and safe as IV insulin infusions in the management of DKA and are associated with the conservation of resources. Providers may refer to this review when establishing or modifying their DKA management protocols.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"277-288"},"PeriodicalIF":2.3,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141756702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium-Glucose Co-Transporter 2 Inhibitors and the Risk of Genitourinary Infections at HbA1c ≥10%: A Population Health-Based Retrospective Review.","authors":"Bryce Ashby, Marina Kawaguchi-Suzuki, Yvette Grando Holman, Jackie Harris, Rachel Chlasta, Ryan Wargo","doi":"10.1177/10600280241264585","DOIUrl":"10.1177/10600280241264585","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are first-line treatment for type 2 diabetes. Evidence has shown a 3- to 5-fold increase in the risk of genitourinary infections with their use due to inhibition of renal glucose reabsorption, resulting in glucosuria. Increased glucosuria is thought to increase the risk of genitourinary infections at a greater degree in patients with a significantly elevated HbA1c (≥10%), and initiation of SGLT2i is often delayed in these patients. While a limited body of evidence exists indicating that A1c level is not an independent risk factor for SGLT2i-induced genitourinary infection, pragmatically this concern remains a barrier to SGLT2i utilization.</p><p><strong>Objective: </strong>Evaluate the real-world genitourinary (GU) infection rate in patients receiving SGLT2i with a baseline HbA1c ≥10% compared to patients with a baseline HbA1c <10%.</p><p><strong>Methods: </strong>This retrospective cohort study evaluated data from 5542 adult patients treated between January 2013 and January 2023, who were prescribed an SGLT2i. Data collected included sex, age, race/ethnicity, renal function, date of SGLT2i start, number of SGLT2i orders, name and dose of SGLT2i, HbA1c, and a predetermined set of diagnosis codes related to bacterial and fungal genitourinary infections. The primary outcome was the overall GU infection rate after SGLT2i initiation within groups of baseline HbA1c of ≥10% and <10%, and the secondary outcome was total GU infections within these same groups.</p><p><strong>Results: </strong>The primary outcome was equivalent between those with HbA1c <10% and HbA1c ≥10% (0.0064 ± 0.0565 vs 0.0030 ± 0.0303 infection per month [mean ± standard deviation]; <i>P</i> < 0.0001 for both lower and upper bounds). There was no statistically significant difference in total GU infections between the same groups (0.027 ± 0.21 vs 0.015 ± 0.14, <i>P</i> = 0.11). Female gender and prior recurrent infection were associated with increased GU infection after SGLT2i.</p><p><strong>Conclusion and relevance: </strong>A baseline HbA1c ≥ 10% was not significantly associated with an increased risk of GU infection following the initiation of SGLT2i compared to those with a baseline HbA1c of <10%.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"238-243"},"PeriodicalIF":2.3,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}