2025 Southeastern Residency Conference

Title: Comparative Efficacy of Ertapenem in Patients with or without Hypoalbuminemia
Authors: Jakob Barton PharmD, Julia Coluccio PharmD, BCCCP, Kristin Fernandes PharmD, BCPS, Steven Parker PharmD
Background: Ertapenem, a carbapenem antimicrobial, is indicated for a wide range of bacterial infections including blood stream infections, complicated urinary tract infections, community acquired pneumonia, and complicated intra-abdominal infections. It has a broad spectrum of activity against multiple gram-positive organisms and gram-negative organisms including those that produce extended spectrum beta-lactamases (ESBL). According to the 2024 Update to the IDSA Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections, ertapenem is not the preferred carbapenem in critically ill patients or patients with hypoalbuminemia (defined as a serum albumin level of ≤2.5 g/dL). Pharmacokinetic studies have demonstrated a difference in drug concentrations among patients with normal albumin compared to those with hypoalbuminemia as ertapenem is highly protein bound. Hypoalbuminemia can lead to fewer available protein binding sites and increased free concentration of ertapenem, which may reduce the half-life of the drug and prevent it from achieving optimal minimum inhibitory concentration (MIC) targets. The purpose of this study is to evaluate if a difference is present in the rate of clinical cure with ertapenem therapy in patients with or without hypoalbuminemia.
Methodology: This was a retrospective chart review of patients admitted to Piedmont Atlanta Hospital from August 2022 to August 2024 who received ertapenem for at least 2 days and had a documented albumin level within 48 hours prior to ertapenem administration. Hypoalbuminemia was defined in this study as a serum albumin level prior to ertapenem administration of ≤2.9 g/dL. Patients were excluded if they were pregnant or if ertapenem was being used in combination with cefazolin for methicillin-susceptible Staphylococcus aureus bacteremia. The primary endpoint was the clinical cure rate within 10 days of ertapenem therapy defined as resolution of fever and leukocytosis. Secondary endpoints included 90-day readmission rates for infectious reasons, total duration of antimicrobial therapy, survival by hospital discharge and hospital length of stay. Statistical analysis was completed using an independent t-test for continuous data and Chi squared test for categorical data. In order to achieve an expected 85% cure rate it was determined that 92 patients were needed to reach 80% power with an alpha of 0.05. A p-value of <0.05 was statistically significant.
Results: A total of 154 patients were included in the study with 60 patients in the hypoalbuminemia group and 94 in the non-hypoalbuminemia group. In patients with hypoalbuminemia, 60% achieved clinical cure by day 10 compared to 70.2% of patients without hypoalbuminemia (p=0.1919). There was no difference in rates of readmission between the groups with 10% of patients in the hypoalbuminemia group being readmitted for an infectious reason compared to 21.3% in the patients without hypoalbuminemia (p=0.0685). No difference was found in rates of survival at discharge in the hypoalbuminemia group compared to the non-hypoalbuminemia group (82% vs 86%, p=0.4524) Ertapenem duration of therapy in the study was longer in the hypoalbuminemia group compared to the non-hypoalbuminemia group (8.9 days vs 6.6 days, p = 0.0109). Additionally, hospital length of stay was prolonged in the hypoalbuminemia group compared to the non-hypoalbuminemia group (35 days vs 16 days, p = 0.0002)
Conclusions: This study found no statistically significant difference in clinical cure rates at 10 days in patients with hypoalbuminemia compared to patients without hypoalbuminemia. Patients without hypoalbuminemia had significantly shorter lengths of stay in the hospital and shorter durations of therapy with ertapenem. Study limitations include retrospective design and a different of hypoalbuminemia than what is outlined in the guidance statement from IDSA. Prospective trials with a larger sample size are warranted in this population.

Title: Intravenous Thrombolytic Therapy in Acute Ischemic Stroke with Chronic Anticoagulation Therapy   
Authors: Lauren Ducote, Jessica Starr, Nathan Pinner 
Objective: Assess bleeding outcomes in patients on chronic anticoagulation therapy who are treated with an intravenous thrombolytic for acute ischemic stroke.
Self-Assessment Question: Based on recent primary literature, patients on chronic direct oral anticoagulant (DOAC) therapy who receive intravenous thrombolysis for acute ischemic stroke are at increased risk for hemorrhagic stroke. (True/False) 
Background: Guidelines for stroke management recommend against giving intravenous thrombolytic therapy for an acute ischemic stroke if the patient has received anticoagulation within the previous 48 hours unless certain labs are assessed first. Recent literature suggests that there is not an increased risk of adverse bleeding events in patients who have taken anticoagulation recently compared to those who have not.  
Methods: This is a single center, retrospective study conducted on all patients admitted with an acute ischemic stroke who received intravenous thrombolytic therapy between May 1, 2013 to September 30, 2024. Patients were included if they were 18 years or older, admitted for an acute ischemic stroke, and received intravenous thrombolytic therapy. Patients were excluded if they received thrombolytic therapy for any other indication, had a hemorrhagic stroke on presentation, or received an endovascular intervention. The primary outcome is incidence of adverse bleeding within 24 hours of thrombolytic therapy which included the composite of intracranial hemorrhage, receipt of ≥2 units of packed red blood cells, or a >2 mg/dL fall in hemoglobin. Secondary outcomes include intracranial hemorrhage, receiving ≥2 units of packed red blood cells,>2 mg/dL fall in hemoglobin, DOAC reversal, length of stay, discharge disposition, and readmission within 30 days.
Results: Of the 265 patients reviewed, 245 patients were included. There were 11 patients taking oral anticoagulation and 234 patients not taking oral anticoagulation prior to admission. There was no statistically significant difference in adverse bleeding observed between the anticoagulation and no anticoagulation groups (18% vs. 12%, P=0.62). No statistical difference was observed in any of the secondary endpoints.
Conclusion: This study determined there was insufficient evidence to determine if patients taking chronic oral anticoagulation have the same adverse bleed risk after thrombolytic administration as patients not on anticoagulation.

Title: Evaluation of Pediatric Medication Safety Mechanisms Within a Newly Implemented Electronic Health Record in the Emergency Department of an Adult Community Hospital


Authors: Anne Thomas Hooper, Anna Beth Bowles, Kevin Vanlandingham, Elizabeth Davidson


Background: Medication errors are a predominant factor in preventable patient harm. Pediatric patients are especially vulnerable due to unique medication dosing and administration principles. Electronic Health Record (EHR) systems, designed primarily for adult populations, can fail to detect errors in pediatric medication orders. The fast-paced environment, use of verbal orders, and critical nature of patients are factors that further increase risk of medication errors in the emergency department. This study aims to assess the efficacy of EHR safety mechanisms in identifying pediatric medication errors using a computerized provider order entry (CPOE) system in an adult hospital emergency setting.


Methods: The Plan-Do-Study-Act (PDSA) methodology was used to evaluate and adapt EHR safety mechanisms for quality improvement of pediatric medication safety in CPOE. A literature review was used to identify gaps in pediatric medication safety of the EHR and CPOE within high risk areas of hospital organizations. Resources such as the KIDs List, National Pediatric Readiness Program, and the Leapfrog evaluation tool provided the framework for the development of test questions. The "Do" phase involved ordering medications on test patients that were expected to trigger a safety alert. Questions to assess current medication safety alerts were based on three categories: weight-based dosing, maximum recommended dosing, and miscellaneous. Miscellaneous questions included incorrect routes, forms, and excipients. The “Study” portion involved recording results and analysis of the final endpoints. The primary endpoint is the frequency of medication order entry errors. The secondary endpoint was the detection frequency of medication errors within the categories. A “pass” was recorded if an appropriate alert populated and a fail was recorded if an alert was undetected based on the predetermined questions. During the “Act” phase, findings were assessed and changes implemented to the EHR where feasible. 


Results: In Progress


Conclusion: In Progress

Title: Safety evaluation of apixaban indicated for venous thromboembolism in patients with acute kidney injury 
 
Authors: Randall Parat, Mitchell Hutson, J. Morgan Knight, Meg Francis, Skyler Brown 
 
Background: Apixaban, a factor Xa inhibitor used in multiple thromboembolic conditions, is approximately 30% renally eliminated and may accumulate in acute kidney injury (AKI). A dose reduction is commonly utilized in patients taking apixaban for atrial fibrillation, however, no current dose reduction is accepted for the treatment of venous thromboembolism (VTE). This study aimed to compare the frequency of major bleeding events in patients with or without acute kidney injury, who are taking apixaban for the treatment of acute or chronic venous thromboembolism. 
 
Methods: This retrospective cohort study included patients admitted from January 2019 to December 2023 at a large academic medical center in Tennessee, USA. Two sets of patient encounters were gathered via chart documentation and ICD-10 codes. The control group with encounters containing documented VTE on apixaban, and the AKI group with encounters containing documented VTE on apixaban with AKI. The primary outcome evaluated was the incidence of a major bleeding event within three days of four consecutive apixaban doses. Secondary outcomes included the incidence of non-major bleeding events. 
 
Results: 195 patients were included in this study, 103 in the control group and 92 in the AKI group. The incidence of major bleeding in the control group was 5 (4.9%) vs 3 (3.3%) in the AKI group (p = 0.724). Within the sample, 145 (74.4%) patients had an acute pulmonary embolism or acute deep vein thrombosis and the median number of apixaban doses including both loading and maintenance doses was 9 (IQR: 6-15). Within the AKI group, stage 1 AKIs were the most common occurring in 42 (45.7%) patients with a total median duration of AKI being 4 days (IQR: 2-7). The median length of stay was 9 days (IQR: 5-18). 
 

Title: Proton Pump Inhibitor Use in Patients with Cirrhosis and its Association with Spontaneous Bacterial Peritonitis
 
​​​​Authors: Morgan Thomas, Cameron Lanier, Kelly Covert 
 
Objective: To determine the incidence of first episode of spontaneous bacterial peritonitis in patients with cirrhosis who are on proton pump inhibitor therapy. 
 
Self-Assessment Question: True or False. The American Association for the Study of Liver Disease recommends avoiding proton pump inhibitors (PPIs) in cirrhotic patients admitted with acute on chronic liver failure unless there is a clear indication.

Background: Liver cirrhosis is a significant source of mortality and morbidity in the United States. Advanced liver dysfunction in cirrhosis causes an alteration of the immune system and promotes bacterial translocation which increases patients’ susceptibility to infection such as spontaneous bacterial peritonitis (SBP). Risk factors for SBP include upper gastrointestinal bleeds, previous SBP episodes, low ascitic protein, and elevated MELD scores. In addition to these proven risk factors, it is hypothesized that proton pump inhibitors (PPIs) may contribute to SBP. The goal of this study is to evaluate the impact of PPIs on SBP development in patients with cirrhosis. Additionally, this study will evaluate the appropriateness of PPI medication choice, dose, duration of therapy, and documented indication for PPI therapy.
 
Methods: Eligible patients were those >18 years old with diagnosis of cirrhosis (by ICD-10 codes) admitted to a Ballad Health Facility for SBP rule out between the dates of June 1, 2022 - June 31, 2024. Patients were excluded if they were pregnant, incarcerated, or had a recent (within 2 weeks of hospitalization) or current upper gastrointestinal or variceal bleed. The primary objective of this study is to determine the incidence of first episode of spontaneous bacterial peritonitis in patients with cirrhosis who are on proton pump inhibitor therapy. Secondary outcomes included the documented indications for PPI therapy, the rate of PPI therapy usage prior to admission, in-hospital mortality rate, and the incidence of new or worsening ascites, esophageal varices, and hepatorenal syndrome.
 
Results: Eighty-one patients were included in this IRB-approved study, with 42 receiving PPI therapy prior to admission and 39 who were not. The incidence of SBP was 33.3% among patients receiving home PPI therapy, compared to 20.5% in those not on PPI therapy (χ² = 0.249, p = 0.618). Across the entire cohort, 99% experienced new or worsening ascites, 42% developed new or worsening hepatic encephalopathy, 11% had newly identified esophageal varices, and 21% developed new hepatorenal syndrome. Documentation of the clinical indication for PPI therapy was infrequent. The median hospital length of stay was 6 days (IQR 3–11). Additionally, 29.6% of patients required ICU admission, 9.9% died during hospitalization, and 4.9% underwent hemodialysis.
 
Conclusion: This retrospective chart review found no statistically significant increase in the incidence of SBP among cirrhotic patients receiving PPI therapy. Key limitations of the study include its retrospective design, limited information on the duration of PPI use prior to admission, and a relatively small sample size. Larger, prospective studies are warranted to more accurately assess the potential role of PPI therapy in the pathogenesis of SBP in patients with decompensated cirrhosis.
 
 
 

Title: Implementation of a Pharmacy-Led Medication Therapy Management Clinic in a Rural Community Hospital  

Authors: Stanislava Stancheva, Benjamin Gatlin  

Objective: To discuss the implementation of a Medication Therapy Management clinic in a rural community hospital and identify advantages of clinical pharmacy services provided.   

Background: Medication therapy management (MTM) is a strategy to deliver clinical pharmacy services to patients. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that Medicare Part D provide MTM services to select beneficiaries with chronic conditions to offer education, improve adherence, and optimize clinical outcomes while minimizing adverse drug events. This process involves collaboration with patients and providers. Under a collaborative care agreement (CCA), pharmacists can manage specified chronic conditions within the scope of practice outlined by treatment protocols. Regarding financial resources, the 340B Drug Discount Program is a federal initiative designed to provide reduced-cost prescription drugs to eligible hospitals that serve uninsured and low-income patients. In rural communities 340B MTM clinics can bridge the gap in care which medical deserts struggle with and provide valuable resources to improve cost effectiveness of care provided. 

Methods: This is a retrospective cohort study at Baptist Health Deaconess Madisonville (BHDM) hospital with prospective patient recruitment. Patients with hyperlipidemia, diabetes, and osteoporosis were included and enrolled into the 340B MTM clinic. Comprehensive treatment protocols were created and developed from the ground up, and a collaborative care agreement defined the pharmacist’s scope of practice. Pharmacists and pharmacy patient care coordinators were provided with appropriate education including creating and utilizing referrals.  The protocols and CCAs were approved by the hospital Pharmacy and Therapeutics and Medical Executive committees. As patients were enrolled and seen in the clinic, data was assessed to identify the role of the pharmacist in management of chronic conditions, prescribing and de-prescribing under protocol, as well as administration of specialty drugs approved under 340B or using manufacturer buy and bill services.  

Results: Currently, the 340B MTM clinic at BHDM has successfully expanded to 4 chronic disease states being managed under collaborative care agreements. To date, 242 patients have been included in the study with additional enrollment ongoing. Pharmacists have conducted medication reconciliation, discussed labs, ordered future labs, discussed and altered therapy regimens, and entered prescription renewals. Administration of specialty injectable medications covered through buy and bill and pharmacy benefit services was also implemented. From the start of MTM clinic on August 22 to March 31, pharmacists started new medications 71 times, increased doses 52 times, and decreased doses 5 times. Medication was discontinued on 16 occasions. 55 injections were administered by pharmacists. Immunizations, smoking cessation, and other interventions have also been incorporated into clinic visits. Further results in progress.  

Conclusions: The creation of a 340B MTM clinic at BHDM has greatly expanded the clinical services pharmacists offer. Through collaborative care agreements, pharmacists were able to intervene and prevent potential adverse events and treatment failures from occurring. The challenges of creating MTM clinics including reimbursement, referral processes, and availability of resources can be justified by significant savings which were generated through 340B eligible scripts. Further conclusions in progress. 

Title: An Evaluation of Prophylactic Enoxaparin Dosing in Patients with Obesity
 
Authors: Jeff Bruni, Elizabeth Oglesby, Hong Duong, Makayla Sborov, Catherine Childre, Will Johnson
 
Background:  Enoxaparin is routinely prescribed for patients to prevent deep vein thromboses (DVTs). While the current prophylactic dosing strategy of enoxaparin is seemingly concise for adults, the optimal dosing for patients with obesity is not well established. Standard enoxaparin (Lovenox) doses may be inadequate in this patient population, requiring weight-based adjustments for effective anticoagulation.
 
Methods: A retrospective study of inpatient adults with obesity was performed on patients admitted to the infirmary Health system with an order of enoxaparin for VTE prophylaxis. Data was randomly collected from a total of 466 patients with obesity over a period of 6 months from January 1, 2024, to June 30, 2024. Obesity was defined as BMI greater than or equal to 30 kg/m^2. Study variables collected included demographics, length of stay, medical history (including previous history of stroke or VTE), admitting diagnosis, and baseline weight in kilograms. The primary outcome was development of VTE during hospital encounter or within thirty days of discharge. Dosing strategies evaluated included: enoxaparin 30 mg, 40 mg, or 60 mg at a frequency of either daily or twice daily. Secondary outcomes included major bleeding, minor bleeding, ischemic stroke, and all-cause mortality. Patients who were pregnant, who had a serum creatinine greater than 2mg/dL, who were prescribed enoxaparin with the intent of VTE treatment, or who had documented heparin-induced thrombocytopenia prior to or during treatment were excluded.
 
Results: A total of 466 patients were prescribed enoxaparin for prophylaxis between the designated time frame. 131 of those patients met exclusion criteria. Of the 335 patients included, a total of 9 experienced a VTE within 30 days (providing an overall VTE rate of 2.7%).
 
Conclusion: The evaluated study population had a low rate of VTE irrespective of enoxaparin dosing strategy, admitting diagnosis, or BMI when compared to the national average. A superior dosing regimen for prescribing prophylactic enoxaparin in patients with obesity remains to be unclear.

Title:   
Inhaled Corticosteroid Device Delivery and Pneumonia Outcomes in a Hospitalized COPD Patient Population   
  
Authors:  
Leslie Phillips  
Luke Hentrich  
Danielle Dennis  
Hannah Suber  
Kate Wolshon  
R. Eric Heidel  
Thaddeus McGiness  
  
Objective:  
To evaluate the impact of inhaled corticosteroid (ICS) delivery type (dry powder inhaler [DPI] versus pressurized metered-dose inhaler [pMDI]) on pneumonia incidence in hospitalized patients with COPD  
  
Self Assessment Question:  

Title: Comparison of Patient-Controlled Analgesia (PCA) and non-PCA Opioid Pain Management Modalities in Sickle Cell Disease (SCD) During Vaso-Occlusive Crises (VOC)
 
Authors: Natalie Ortiz-Gratacos; Megan Durango; Nicholas Mastromarino; Irina Santamaria


Objective: To identify differences between treatment modalities for VOC in SCD. \


Self-Assessment: Based on this retrospective study, which modality had a lower morphine milliequivalent (MME) requirement?


Background: SCD causes acute pain episodes called VOC, often leading to hospitalization. The American Society of Hematology recommends intravenous (IV) opioids for VOC treatment, but the optimal administration method remains uncertain. Opioids can be given via PCA or intermittent bolus referred to as non-PCA. While some studies suggest PCAs reduce hospital stay and opioid use, others find non-PCA methods offer better pain control and shorter stays. The purpose of this study is to compare PCA versus non-PCA opioid modalities to identify the most efficient pain modality during VOC. 


Methods: Patients included in this study were 18 years or older with a preexisting SCD diagnosis, two or more admissions to AdventHealth Central Florida Division and who were treated with both modalities (PCA vs non-PCA) in separate encounters. The reason for admission had to be for pain from VOC. The primary objective is to evaluate the change in pain intensity scores for each modality. The secondary objectives are mean pain scores, length of stay (LOS), 30-day readmission rates, leaving against medical advice (AMA) rates, daily average MMEs, and life-threatening opioid side effects (naloxone use). 


Results: Sixteen patients participated in this study. A within-patient comparison was conducted between two encounters; one with PCA and one without PCA for each patient. Ten patients reported lower pain scores during the PCA encounter, while six patients reported lower pain scores during the non-PCA encounter. In terms of percentage differences in pain scores, eight patients experienced a greater reduction with PCA, five with non-PCA, and three had no difference. Although there were differences among the groups, none were found to be statistically significant. The average percent reduction between the initial and final pain scores was higher in the PCA group compared to the non-PCA group (49% vs 43%, respectively, p= 0.416). The mean pain score for the PCA encounters was not significantly lower than for non-PCA encounters (6.67±2.60 vs 6.82±2.51, p=0.717). Regarding LOS and daily average MMEs, the non-PCA group had lower values of 5.6 days and 169 MMEs compared to the PCA group of 7 days and 210 MMEs, (p= 0.23 and 0.599, respectively). However, 30-day readmission rates were lower in the PCA group (7 patients) than in the non-PCA group (9 patients); p=0.687. AMA rates were the same between the groups (p= 1). No naloxone was used in the non-PCA group, while one patient in the PCA group required naloxone (p=1). 


Conclusion: The treatment of VOC in SCD patients using a PCA may be associated with greater pain reduction at discharge and readmission rates compared to non-PCA modalities. However, the PCA group also exhibited higher MME amounts and one incidence of naloxone use. From the within patient comparison, it was concluded the majority of patients had better pain control with PCA use. Further studies are needed to support these findings.

Title: Rivaroxaban vs enoxaparin in post-operative bariatric patients for thromboprophylaxis


Authors: Tulsiben Patel; Jessica Sterchi; Erika McDonald; Elizabeth Egawa; Stephanie Grimes; Crystal Laudermilk; Kellie Gaby; James Ray


Objective: The purpose of this study is to compare the safety and efficacy of rivaroxaban to weight-based enoxaparin for thromboprophylaxis in post-operative bariatric patients at Blount Memorial Hospital (BMH).


Background: 
Venous thromboembolism (VTE) is linked to considerable morbidity and mortality following bariatric surgery, with over 70% of cases occurring within the first 30 days post-discharge.¹ Patients undergoing bariatric surgery are regarded as being at least at moderate risk for VTE due to severe obesity, associated comorbidities, laparoscopic surgery, and reduced mobility during the perioperative period.² Currently, low molecular weight heparin i.e. enoxaparin is the preferred pharmacologic agent for VTE prevention in non-orthopedic surgical patients. Oral agents such as warfarin, aspirin, dabigatran and factor Xa inhibitors (apixaban, rivaroxaban) have not been largely studied in non-orthopedic surgical patients. Kroll et al. compared the effectiveness of rivaroxaban 10 mg daily for 7 vs 28 days in postoperative thromboprophylaxis after bariatric surgery.³ More adverse bleeding events were seen in the 28-day group with no difference in thrombotic events between groups within the first month in this study. 
Historically, Blount Memorial Physicians Group (BMPG) surgeons prescribed weight-based enoxaparin for 14 days based on the BMI for thromboprophylaxis after a bariatric surgery. 

• BMI 30-39 kg/m2 - 30 mg q12h or 40 mg daily or 0.5 mg/kg q12h or daily
• BMI ≥40 kg/m2 - 30 mg q12h or 40 mg q12h or 0.5 mg/kg q12h or daily
• High VTE-risk bariatric surgery with BMI ≤50 kg/m2 - 40 mg q12h
• BMI ≥50 kg/m2 - 60 mg q12h 

Recently, our BMPG bariatric group has also adopted the use of rivaroxaban 10 mg daily for 7 days as a thromboprophylaxis option due to the ease of administration and fixed dosing regimens. The purpose of this study is to compare the safety and efficacy of rivaroxaban to weight-based enoxaparin for thromboprophylaxis in post-operative bariatric patients at Blount Memorial Hospital (BMH).


Methods:
This is an IRB-approved, retrospective cohort analysis to determine safety and efficacy differences between rivaroxaban and weight-based enoxaparin as thromboprophylaxis post bariatric surgery. Electronic Health Record (EHR) reports have been generated to identify the bariatric patients being discharged on either enoxaparin or rivaroxaban after the surgery. NextGen EHR has been utilized to assess for any thrombotic or bleeding events at the post-op follow up visits. The primary objective is to compare major thrombotic events with rivaroxaban versus weight-based enoxaparin at 14 days or 28 days. The secondary objectives are to compare major and minor bleeding events and minor thrombotic events with rivaroxaban versus weight-based enoxaparin at 14 days or 28 days.


Results:
Of the 170 patients screened, 80 patients in enoxaparin group and 56 patients in rivaroxaban group met the inclusion criteria. Thrombotic events were not reported in either group. Major and minor bleeding events were observed in four total patients (two major and two minor bleeds) in enoxaparin group and two total patients (one major and one minor bleed) in rivaroxaban group. 


Conclusion:
In this retrospective cohort analysis, rivaroxaban was equally effective compared to enoxaparin group secondary to absence of thrombotic events. Moreover, it resulted in less bleeding events compared to enoxaparin.  


References:

1. Winegar D, Sherif B, Pate V, DeMaria EJ. Venous thromboembolism after bariatric surgery performed by Bariatric Surgery Center of Excellence Participants: analysis of the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis. 2011;7(2):181-188. 
2. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2)(suppl):e227S-e277S. 
3. Kröll D, Nett PC, Rommers N, et al. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(5):e2315241. 

Author names: Emily Brackett, Emily Rudisell, Carrie Ellison, DeVon Suber, Ismaeel Yunusa 
 
Background: Pain-related hospital admissions are prevalent in the United States, and in 2016, the CDC released guidelines to assist clinicians with opioid prescribing at discharge. Patients aged ≥ 65 years are particularly vulnerable to inadequate pain control and adverse effects, including dizziness, drowsiness, and constipation. The presence of non-opioid alternatives on the BEERs list further complicates pain management. The CDC recommends the lowest effective opioid dose, with reassessment for doses >50 morphine milliequivalents per day. Prisma Health lacks a discharge opioid protocol, prompting this study to evaluate prescribing patterns in opioid-naïve geriatric patients. 
 
Methods: This retrospective cohort study included patients aged ≥65 years admitted to Prisma Health Richland between January 1, 2024, and August 1, 2024. Eligibility required inpatient admission and an inpatient order for at least 1 opioid for ≥24 hours. The primary objective was to quantify morphine milliequivalents (MMEs) prescribed at discharge. Secondary objectives included comparing inpatient opioid use with discharge regimens, identifying overdose risk factors based on high-risk medications and conditions, evaluating prescribing patterns by provider group, assessing length of therapy, 30-day readmission for opioid adverse reactions, as well as the impact of discharge disposition on MMEs. Statistical analysis will involve one-sample t-tests, Wilcoxon signed-rank tests, paired t-tests, chi-square, and Fisher’s exact tests. 
 
Results: In progress 
 
Conclusion: In progress  

Title: Evaluation of Electronic Beta-Lactam Allergy Alert Suppression on Carbapenem Prescribing Practices 


Authors: J. Morgan Knight, PharmD, MHIIM; Brandon Hawkins, PharmD, BCIDP, AAHIVP; Erin Anderson, PharmD, BCPS; Skyler Brown, PharmD, BCPS; Brooke Brown, PharmD, BCPS; John R. Yates, PharmD, BCPS; Jason Tuttle, PharmD Candidate; Samantha Walker, PharmD, BCPS 


Objective: The purpose of this study is to determine if the selective suppression of beta-lactam allergy alerts leads to decreased prescribing of carbapenems.


Self Assessment Question: True/False. Selectively alert suppressing allergies based on R1 side chains significantly impacted the volume of carbapenem prescribing


Background: Beta-lactam antibiotics are commonly prescribed in the United States due to their effectiveness and tolerability. Carbapenems are frequently prescribed in the setting of a penicillin allergy due to the low probability of cross-reactivity. Reducing carbapenem prescribing is essential to decrease resistance rates. Clinical decision support assisted alert suppression of beta-lactams with dissimilar side chains may promote increased prescribing of non-carbapenems. 


Methods: This retrospective quasi-experimental study was approved by the institutional review board at a 710-bed academic medical center.  A total of 819 patients were screened between the months of August 2020-October 2024. Patients were assigned to one of two groups: pre- or post-beta-lactam allergy alert suppression implementation. Group 1 included patients pre-alert suppression from August 1st, 2020, to September 25th, 2022. Group 2 included patients post-alert suppression from September 26th, 2022, to October 1st, 2024. Adult patients with a documented beta-lactam allergy who received at least one dose of an antibiotic were included. Exclusion criteria included allergy alerts that were unable to be suppressed due to Cerner coding limitations (e.g., drug classes listed as “penicillins,” or “cephalosporins”) and patients who only received a one-time dose pre-operatively for surgical prophylaxis. The primary outcome is the percentage of patients prescribed any carbapenem for empiric antimicrobial therapy. Secondary outcomes include percentage of patients empirically prescribed a cephalosporin, fluoroquinolone, and aztreonam, and documentation of a new beta-lactam allergy during current admission. A total of 266 patients were required to detect a 15% difference with a power of 90%.


Results: The percentage of patients prescribed any carbapenem in the pre-alert group and post-alert group were 8.04% and 5.17% (p=0.28), respectively. The percentage of patients empirically prescribed a cephalosporin in the pre-alert group versus the post-alert group was 66.7% and 75.9% (p=0.03), fluoroquinolone 4.60% and 6.32% (p=0.78), and aztreonam 6.90% and 4.02% (p=0.24), respectively. Documentation of a new beta-lactam allergy between pre-and post-groups were 2.30% and 2.87%, respectively.


Conclusion: Allergy alert suppression of beta-lactams did not result in a statistically significant difference in prescribing behavior in our study population, but carbapenem prescribing in the post-suppression cohort was numerically lower. To our knowledge, this is a unique approach to investigating allergy alert suppressions based on side chains alone without consideration of reaction type.

Title: Real world analysis of safety and efficacy outcomes in lymphoma patients receiving CAR T-cell therapy with prophylactic dexamethasone

Authors: Alleah Al-Amery, Karin Abernathy, Darby Siler, Laura Beth Parsons, and Chelsea Mitchell

Background: Axicabtagene ciloleucel (axi-cel) and brexucabtagene autoleucel (brexu-cel) are CD19-directed chimeric antigen receptor T-cell (CAR-T) therapies used to treat certain B-cell malignancies. Administration of CAR-T requires monitoring and management of potential adverse events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Prior studies have demonstrated a reduced incidence of CRS and ICANS with prophylactic dexamethasone in axi-cel recipients without compromising efficacy. Though brexu-cel shares a similar structure to axi-cel, there are no studies assessing effect of corticosteroid prophylaxis in this population. This study seeks to bridge the gap in the literature and assess institutional practice regarding prophylactic dexamethasone in both axi-cel and brexu-cel recipients.

Methods: This was a retrospective study at a tertiary medical center, including patients who received axi-cel or brexu-cel for a lymphoma diagnosis between June 1, 2020 and July 31, 2024. Patients were excluded if they did not receive prophylactic dexamethasone on days 0, +1, and +2, were enrolled in a clinical trial, received CAR-T as an inpatient, were under 18 years old, or were treated on the pediatric oncology service. The primary endpoint was incidence of all-grade CRS and ICANS, compared to a historical control. Secondary endpoints included time to onset, severity, duration, and resolution of CRS and ICANS, as well as hospitalization rates, disease response at Day 30, and survival at Day 30.
 
Results: Of the 32 patients screened, 27 (axi-cel: N=17 ; brexu-cel: N=10) were included. Baseline demographics were similar between both axi-cel and brexu-cel groups and the respective historical controls. The axi-cel group had similar rates of CRS compared with historical controls that also received prophylactic dexamethasone (88% vs. 80%; p=0.70). Overall incidence of ICANS was lower (35% vs 53%, p=0.16) than historical comparator. Similarly, Grade 3+ ICANS was lower than comparator group (5.8% vs. 12.5%, p=1.00). The brexu-cel group had a lower rate of CRS compared with historical controls that did not receive prophylactic dexamethasone (80% vs. 91%, p=0.27). Though not statistically significant, the brexu-cel group had lower incidence of Grade 3+ CRS compared with historical controls (0% vs. 15% p = 0.60). Incidence of ICANS was similar across brexu-cel groups (60% vs. 63%, p=1.00). However, Grade 3+ ICANS was lower in the brexu-cel group compared with historical controls (10% vs. 31%, p=0.66). Median days to onset of CRS and ICANS were delayed with the addition of prophylactic dexamethasone prior to brexu-cel (CRS: 7 vs. 2, p =0.06; ICANS: 10 vs. 7, p=0.70).
 
Conclusion: This real-world assessment of prophylactic dexamethasone with axi-cel showed comparable results to the historical studies. Prophylactic corticosteroids with brexu-cel appears to decrease severity of both CRS and ICANS while also delaying onset. These results could increase feasibility of outpatient administration of brexu-cel. These results also mirror outcomes with dexamethasone prophylaxis with axi-cel.

Disclosure: This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities. 

Title: Determining the Therapeutic Dosage of Enoxaparin Anticoagulation Among Morbidly Obese Patients After the Implementation of an Automatic Clinical Pharmacy Anti-Xa Monitoring Service Using Enoxaparin Dosing Protocol
Authors: Kelsey Green, Michael Ezebuenyi, Jennifer Jones, Danielle Ricks, and Gregg Davis
Objective: The purpose of this study is to determine the required dose of enoxaparin in mg/kg to attain therapeutic anti-Xa levels in morbidly obese patients. 
Background: Enoxaparin is a low-molecular weight heparin (LMWH) used for prophylaxis and treatment of venous thromboembolism (VTE), acute coronary syndromes (ACS) and stroke prevention in atrial fibrillation. Most patients receiving LMWH do not need laboratory monitoring. However, monitoring anti-Xa levels in patients with morbid obesity is recommended due to variations in pharmacokinetic parameters which affect drug concentrations. Currently, there is no standardized dosing regimen for the morbidly obese patient population. 
Methods: This study is a single-center retrospective electronic chart review conducted from August 2021 to August 2024. This study has been approved by the Institutional Review Board at Our Lady of the Lake Regional Medical Center (OLORMC). The electronic medical record was used to identify eligible patients, which include adults with a BMI greater than or equal to 35 kilograms per square meter or total body weight greater than or equal to 150 kilograms who are initiated on treatment dosing of enoxaparin. OLOLRMC employs an automatic consult for a clinical pharmacist-driven anti-Xa protocol, which was implemented in 2019, for monitoring and adjusting enoxaparin doses for morbidly obese patients. Data was collected on the initial enoxaparin dose, initial anti-Xa levels, enoxaparin dose at goal anti-Xa level, the time (in days) to reach therapeutic anti-Xa level, length of hospitalization and the occurrence of adverse bleeding events. Descriptive statistics along with other relevant statistical tests, such as regression and correlation, will be utilized in the analysis of collected data. The primary outcome of the study is the required enoxaparin dose in mg/kg to attain two therapeutic anti-Xa levels. Subgroup analyses are planned to compare the doses of enoxaparin across BMI ranges, renal function, and different indications. 
Results: Overall, the enoxaparin dose at time of second consecutive therapeutic anti-Xa level was found to be 0.77 mg/kg (IQR 0.60, 0.84). The median time to attain two consecutive therapeutic anti-Xa levels was 154 hours (IQR 76, 221). Out of the patients weighing greater than or equal to 155 kg who had initial doses capped at 150 mg, had lower rates of supratherapeutic levels and improved time to two consecutive anti-Xa levels. In addition, one limitation of our study was 20% of anti-Xa levels were unable to be assessed due to being drawn outside of the peak window. 
Conclusion: In conclusion, lower initial enoxaparin doses of ~0.75 mg/kg and appropriate drawing times of anti-Xa levels would improve the ability and time to reach therapeutic anti-Xa levels in morbidly obese patients. 

Title: Evaluation of an Automated Dispensing Cabinet Patient Medication Management Software’s Impact on Medication Dispense Rates 


Authors: Trey Carter, Claire Johns 


Background: As healthcare technology advances, many inpatient institutions have moved to utilizing automated dispensing cabinets (ADC) to store and dispense medications. Less utilized medications may be stored in the institution’s central pharmacy and dispensed to non-automated patient-specific bins. Automating the medication storage and distribution process allows the ADC to store patients’ medications in patient-specific bins via medication management software and ensures a regulated, monitored process to reduce potential for error. This study is designed to evaluate medication dispensing rates from the central distribution pharmacy pre- and post-patient medication management software implementation at our institution.  


Methods: This study is an IRB-approved; pre-post analysis of medication re-dispense rates from a central distribution pharmacy. Patient medication management software was implemented at Baptist Health Lexington in August 2024.  A retrospective chart review was conducted on patients who received a medication dispensed from our institution’s central distribution pharmacy between January 1st, 2024 and June 30th, 2024 to identify the rates at which medications were re-dispensed. For bulk items, the length of time between consecutive dispenses of the same medication was also assessed. Additionally, post-patient medication management software implementation medication re-dispense data were collected from September 1st, 2024 to February 28th, 2025. The primary endpoint of this study is the difference in the medication re-dispense rate from our central distribution pharmacy pre- and post- patient medication management software implementation. The secondary endpoint is the difference in length of time between consecutive dispenses of bulk items. 


Results: In Progress


Conclusion: In Progress

Title: COMPARISON OF HIGH-DOSE VERSUS LOW-DOSE SYSTEMIC CORTICOSTEROIDS FOR ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE IN  NON-CRITICALLY ILL PATIENTS
Authors: Hanna Condrey, Alexis Chlada, Sharon Jordan
Practice Site: Grand Strand Medical Center – Myrtle Beach, SC
Background/Purpose: This study aims to compare the outcomes of non-critically ill patients receiving high-dose versus low-dose systemic steroids for acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Methodology: This retrospective cohort study included 2,277 patients aged ≥ 18 years, who were admitted for acute COPD exacerbation and received at least 2 days of any dose of glucocorticoids. Patients were categorized into two groups based on their daily steroid dose: high-dose (> 40 mg prednisone equivalents per day) or low-dose (≤ 40 mg prednisone equivalents per day). The primary outcome was length of stay (LOS). Secondary outcomes included 30-day and 90-day readmission rates, as well as the incidence of hyperglycemia and hypertension during hospitalization.
Results: In-Progress
Conclusions: In-Progress
Disclaimers: This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.

Title: Evaluation of Outpatient Parenteral Antimicrobial Therapy (OPAT) in a Community Healthcare System
 
Authors: Giovanna Brannon, Chris Whitman, Rachel L. Foster, Kelly Huff, Nichole Moore, Charles Hartley
 
Objective: Describe the pharmacist's role in OPAT management, such as review of antimicrobial selection and adverse event monitoring, to optimize patient safety and reduce hospital readmissions
 
Self Assessment Question: What are potential risk factors associated with unplanned healthcare events that pharmacists can identify in patients receiving OPAT?
 
Background: Outpatient parenteral antimicrobial therapy (OPAT) enables patients to complete extended courses of antimicrobial treatment for serious infections at home or in a step-down facility following hospital discharge. OPAT discharges require a multidisciplinary and well-coordinated approach. The Infectious Diseases Society of America OPAT guidelines recommend all patients should have infectious diseases (ID) experts review prior to initiation of OPAT. Prior studies have shown improved patient safety, improved patient outcomes, and reduction in healthcare costs when ID-trained pharmacists are involved. No formal OPAT program exists at this hospital system. The purpose of this study is to evaluate the OPAT prescribing and management practices across the Infirmary Health system (IHS) in order to understand factors associated with hospital readmissions and improve patient safety and efficiency through streamlining and standardizing the OPAT discharge process.

Methods: In this retrospective epidemiological cohort study, data was collected on patients at least 19 years of age who were discharged with orders to receive parenteral antimicrobials between May 1, 2023 and April 30, 2024. Patients meeting any of these three criteria were screened for inclusion: 1) Discharge order for an intravenous antimicrobial, 2) Order for vascular access for intention of OPAT, or 3) Case management order containing specific OPAT orders. Patients were excluded if they completed the entire planned OPAT course prior to hospital discharge. The primary outcome is the rate of unplanned healthcare events within 30 days of completing OPAT therapy. The secondary outcomes include qualitatively describing the OPAT patient population, hospital length of stay, and 30-day mortality. A sub-group analysis was conducted to evaluate risk factors associated with unplanned healthcare events.

Results: There were 1244 patients who received OPAT during the study period; 101 patients were included in the final analysis after randomization. The median age of patients included was approximately 63 years old (IQR 52-73). The most common infectious diagnoses were osteoarticular (30%), skin and skin structure (18%), endovascular (16%), urologic (16%), and complicated intra-abdominal (14%). Ceftriaxone and vancomycin were the most commonly prescribed antimicrobials. Of the 101 patients evaluated, 42 experienced a 30-day unplanned healthcare event. Of these 42 patients, 25 (60%) of the unplanned healthcare events were OPAT or infection related.  

Conclusion: OPAT patients experienced a high rate of 30-day unplanned healthcare events. Opportunities exist within our healthcare system to improve the OPAT workflow and to enhance safety and efficiency. The results of this study demonstrate the opportunity for our healthcare system to implement a formal multidisciplinary OPAT inpatient review program. This would include ID-trained pharmacists who will review OPAT orders and provide treatment recommendations regarding OPAT modality, antimicrobial selection, outpatient safety and efficacy monitoring, and patient counseling.  

Title: Evaluation of Pharmacist-Initiated Dose Adjustment of Prophylactic Enoxaparin in Low Body Weight Patients 
 
Authors: 

• Cody Seward
• Breanne Wofford
• Kimberly Keller
• Brooke Brown
• Kaylee Behal
• Shaun Rowe
• Sarah Crowell
• Miller Hadley
• Ava Mosadegh

 
Objective: Compare the impact of a Pharmacy & Therapeutics (P&T) committee-approved protocol for pharmacist-driven adjustment of prophylactic enoxaparin dosing among low body weight patients pre- and post-protocol.  
 


Background:

• Enoxaparin is commonly used for venous thromboembolism (VTE) prevention in acutely ill patients; however, low body weight may increase the risk of bleeding with standard dosing (40 mg daily). Low-dose enoxaparin (30 mg daily) has shown similar VTE prevention with lower bleeding rates. This study evaluates the impact of a pharmacist-initiated Pharmacy & Therapeutics (P&T) protocol on enoxaparin dosing adjustments in low body weight patients. 

Methods:

• This quasi-experimental study, approved by the institutional review board, included 205 patients from September 1, 2022, to September 1, 2024. The P&Tprotocol allowing pharmacists to reduce enoxaparin doses for low body weight patients was implemented on October 31, 2023. Inclusion criteria were patients aged ≥ 18 years, receiving either enoxaparin 30 mg twice daily or 40 mg daily, with a BMI ≤18 or body weight ≤45 kg. Exclusion criteria included Creatinine Clearance <30 mL/minute at the time of enoxaparin initiation (Cockroft-Gault using adjusted body weight), therapeutic anticoagulation indication, acute thrombus on admission, active bleeding on admission, pregnant or peripartum, admitted or transferred to any ICU service, platelets < 50,000 cells/microliter, and patients with neuraxial catheters.Patients were required to receive at least two doses of enoxaparin to be included. Pre- and post-protocol groups were compared in accordance with when the P&T protocol was implemented. The primary outcome was whether or not the enoxaparin dose was appropriately adjusted to the reduced dose. Secondary outcomes included the title of the person initiating dose changes, time until adjustment, and bleeding incidence (defined by ISTH criteria). 

Results:

• The analysis included 115 pre-protocol and 90 post-protocol encounters. The post-protocol group had significantly more appropriate enoxaparin dose adjustments to 30 mg daily (40 [33.0%] vs 75 [77.9%], p < 0.0001). Of those that received dose adjustments, pharmacists were the providers more commonly making dose adjustments (70 [77.9%] vs 4 [4.4%], p < 0.0001). The length of hospital stay was similar in both groups (4.9 days vs 5.2 days, p = 0.2582). There were no significant differences in the time to appropriate dosing (0 [0,0] days vs 0 [0,1] days, p = 0.0676). Additionally, there were no major differences ineither major (0% in pre-protocol vs 0% in post-protocol) or minor bleeding incidence (0% in pre-protocol vs 1.1% in post-protocol, p = 0.439) between the groups. 

Conclusions:

• A pharmacist-initiated P&T-approved dose-adjustment protocol resulted insignificantly more appropriate dose adjustments of enoxaparin by pharmacists, with no difference in bleeding events. The lack of bleeding events in either group may be a result of the low number of patients included in this study compared to other similar studies. The relatively short length of stay may also have contributed to the lack of bleeding events, as the follow-up period lasted only until hospital discharge; patients who experienced bleeding events after hospital discharge would not have had the event recorded in this study. Further study is needed with a larger sample size to fully understand the safety benefits of a pharmacist-initiated dose adjustment protocol of enoxaparin and whether such a protocol should be considered for broader implementation to enhance clinical outcomes in low body weight hospitalized patients at risk for VTE.

 

TITLE:    Oral Vancomycin vs Fidaxomicin for Treatment of Initial Clostridioides Difficile Infection   
Olivia Hill, Marcus Mize, Serina Tart
BACKGROUND: The 2021 Society for Healthcare Epidemiology of America/Infectious Diseases Society of America (SHEA/IDSA) Update to the Clinical Practice Guidelines for the Management of Clostridioides difficile infection (CDI) in Adults recommends oral (PO) fidaxomicin 200 milligrams (mg) twice daily for 10 days as the preferred therapy for an initial severe or non-severe CDI episode due to lower rates of recurrence.  Cost is a substantial barrier to fidaxomicin use and often leads to the utilization of PO vancomycin as the alternative initial treatment agent in practice. This research project aimed to evaluate the differences in treatment failure, rate of recurrence, and treatment cost between vancomycin and fidaxomicin for the treatment of initial CDI to provide additional information to help guide the choice between the two agents. 
METHODS: This multicenter, retrospective, observational cohort study examined patients with confirmed first occurrence of mild to severe CDI who were admitted to hospitals within the Cape Fear Valley Health System (CFVHS) from January 1, 2023, to December 31, 2023. Included patients were 18 years or older and had a confirmed CDI defined as positive antigen/toxin or PCR test. Patients were excluded if they had a fulminant or recurrent CDI, were actively being treated for other infections, or had received bezlotoxumab. The primary outcome assessed the differences in composite endpoint of treatment failure and/or 30-day recurrence rates in patients with documented first occurrence of CDI treated with vancomycin versus fidaxomicin. Secondary outcomes included differences in the rate of treatment failure and rate of 30-day recurrence between groups as well as differences in mean treatment cost between intensive care unit (ICU) setting versus medical/surgical floors.
RESULTS: Sixty-seven patients met inclusion criteria with 7 patients in the fidaxomicin group and 60 in the PO vancomycin group. The most common reason for exclusion was treatment for concurrent infections. Of patients included, 47.8% had community acquired CDI, 94.0% of patients had non-severe CDI, and 97.0% were admitted to a medical/surgical floor at the time of diagnosis. The average length of stay from time of diagnosis was 6.48 days. For the primary outcome, 7 (11.7%) patients in the vancomycin group experienced treatment failure or 30-day recurrence compared to 3 (42.9%) patients in the fidaxomicin group (p=0.0284). Treatment failure was experienced by 5 (8.3%) patients in the PO vancomycin group compared to 3 (42.9%) patients in the fidaxomicin group (p=0.0077). Recurrence at 30 days was experienced by 2 (3.3%) patients in the PO vancomycin group compared to 1 (14.3%) patient in the fidaxomicin group (p=0.1849). All fidaxomicin patients were located on a medical/surgical floor. The mean treatment cost for those in the PO vancomycin group was $8,752.05 (± $10,067.92) versus $7,148.09 (± $3239.33) in the fidaxomicin group, with a cost difference of $1603.96 (95% CI –2081.1 to 5289.0, p=0.7506). 
CONCLUSION: A limitation of this study was the lack of an adequate sample size in the fidaxomicin group which led to wide intergroup variability, making it difficult to draw conclusions. Within the PO vancomycin group, there were lower rates of treatment failure, 30-day recurrence, and 1-year recurrence compared to fidaxomicin. Although the results of this study are hypothesis-generating, it supports the idea that PO vancomycin could be utilized as a first-line option for initial CDI without increasing the risk of recurrence or treatment failure. More studies should be conducted to further analyze the potential for vancomycin’s place as a first-line agent for initial CDI.

Title:
Evaluation of SGLT2 Inhibitor Effects on Glycemic Management in Hospitalized Non-Critically Ill Patients 
 
Authors: 
EJ Marineau, PharmD
Dennis Dubovetsky, PharmD
 
Background:
The American Association of Clinical Endocrinology (AACE) and American Diabetes Association (ADA) guidelines recommend the use of sodium-glucose co-transporter-2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM) who either have established or are high-risk for atherosclerotic cardiovascular disease, heart failure (HF), or chronic kidney disease. ADA endorses use of SGLT2i in T2DM patients hospitalized with HF, while AACE and Endocrine society guidelines provide no guidance on SGLT2i role in hospitalized patient population. Only a handful of studies focused on evaluation and reported glycemic management outcomes and safety in hospitalized patients with T2DM receiving SGLT2i. Due to this increased inpatient use, additional data on safety and efficacy for glycemic management is warranted. The objective of this study was to assess the safety and efficacy of SGLT2i in the management of T2DM in non-critically ill hospitalized patients.
 
Methods:
This was a single-center, retrospective chart review conducted at AdventHealth Orlando. Patients were enrolled if they were at least 18 years of age and had an established history of T2DM.  Intervention group consisted of patients who received a SGLT2i plus multimodal insulin and compared to patients who received multimodal insulin alone. Primary objective evaluated difference in median blood glucoses.  Secondary objectives evaluated difference: percentage of blood glucose readings within target range (100 to 180 mg/dl), total insulin dose (units), 90-day all-cause readmission rate, inpatient mortality, rate of acute kidney injury, length of stay (days), percentage of patients with hypoglycemic events (less than 70 mg/dl), and rate of new onset ketoacidosis.
 
Results: 
A total of 150 patients met the inclusion criteria and were evenly distributed into each arm. There was a significant difference in the primary outcome of median blood glucose in favor of the SGLT2i arm (165 mg/dL) compared to the insulin alone arm (180 mg/dL, p<0.001). Patients in the SGLT2i arm received lower median total daily dose of insulin (15 versus 16 units, p=0.006). SGLT2i arm was associated with lower median number of 90-day readmissions (28 versus 48 p=0.005). There was no difference between the groups with respect to remaining safety secondary outcomes of inpatient mortality, length of stay, acute kidney injury, rates of hypoglycemic events and ketoacidosis (p=NS).

Conclusions:
In acutely ill hospitalized patients with T2DM treatment with SGLT2i in addition to standard care (multimodal insulin) was associated with overall lower blood glucose values, lower insulin requirements, and a lower rate of 90-day readmissions when compared to insulin only strategy. SGLT2i exposure was not associated with significant difference in other safety outcomes. Further studies are warranted to characterize safety and efficacy profile of SGLT2i as an option for inpatient glycemic management.