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Objective: To determine whether the formation of a multidisciplinary team, pharmacist-led therapeutic interchange, and streamlined electronic health record optimization improved biosimilar adoption throughout Mayo Clinic., Patients and Methods: The project focused on the use of reference products and biosimilars for 5 biologics-bevacizumab, epoetin alfa, filgrastim, rituximab, and trastuzumab-at all Mayo Clinic locations. Pharmaceutical wholesale purchase histories of those reference products and biosimilars were assessed from September 1, 2020, through August 31, 2021, and compared with data from September 1, 2019, through August 31, 2020. Formulary decisions were implemented across 5 biologics for most ordering pathways on September 1, 2020. Pharmaceutical purchased drug units and expenditures were tracked at 3-month intervals for conversion to formulary-preferred contracted biosimilars., Results: In the final postimplementation period, the absolute percentage increase of formulary-preferred biosimilars was 69% for bevacizumab, 63% for epoetin alfa, 80% for filgrastim, 79% for rituximab, and 72% for trastuzumab. Pharmaceutical line item savings in the 12-month postimplementation period totaled $23.1 million across all 5 biologics., Conclusion: Creation of a multidisciplinary team to implement formulary-preferred contracted biosimilars led to the adoption of biosimilars throughout Mayo Clinic with considerable pharmaceutical line item savings., (Published by Elsevier Inc.)

Objectives: This study investigated the impact of the MR antagonist (MRA) eplerenone on LVM in type 2 diabetes patients at high risk for cardiovascular disease (CVD)., Background: MRA activation is associated with cardiac fibrosis and increased left ventricular mass (LVM), which is an independent predictor of adverse CVD, including heart failure in patients with type 2 diabetes., Methods: A prespecified analysis of secondary endpoints in a randomized, double-blinded clinical trial of 140 patients with type 2 diabetes at high risk of or established CVD. Patients were randomized to receive high-dose eplerenone therapy (100 mg-200 mg) or placebo as an add-on to standard care for 26 weeks. Indexed LVM (LVMi) and T1 time were measured using cardiac magnetic resonance (CMR) imaging. Biomarkers included N-terminal pro-B-type natriuretic peptide (NT-proBNP), pro-collagen type I N-terminal propeptide (P1NP), and type III N-terminal propeptide (P3NP)., Results: Of 140 patients in the MIRAD trial, 104 patients were subject to CMR imaging (eplerenone: 54 patients; placebo: 50 patients). Mean LVMi at baseline was 74.2 ± 16 g/m 2 . The treatment effect (ie, between-group differences) was a decrease of 3.7 g/m 2 following the eplerenone treatment (95% CI: -6.7 to -0.7; P = 0.017), with a corresponding decrease in absolute LVM. Plasma NT-proBNP concentrations decreased by 22% (P = 0.017) using eplerenone compared with placebo, and P1NP decreased 3.3 ng/mL (P = 0.019). No differences in T1 times or P3NP concentrations were observed between groups., Conclusions: The addition of high-dose eplerenone in high-risk type 2 diabetes was associated with a clear reduction in LVMi and in NT-proBNP and P1NP levels, which may suggest a clinical benefit in heart failure prevention. (EU Clinical trials: Mineralocorticoid Receptor Antagonists in Type 2 Diabetes [MIRAD]; 2015-002519-14)., Competing Interests: Funding Support and Author Disclosures Supported by Danish Heart Foundation grant 15-R99-A5855; Danish Diabetes Academy; Herlev Hospital Research Foundation; Danish Medical Association Research Foundation; Gangsted Foundation grant R572-A38190; and Foundation for the Promotion of Medicine AP-Møller. The funders had no role in the design and conduct of the trial, analysis of data, or writing of the manuscript. Dr Kristorp has served on scientific advisory panels and received speaker fees from Boehringer Ingelheim, Merck Sharpe and Dome, AstraZeneca, Amgen, Novartis, Novo Nordisk, and Shire. Dr Rossignol is a consultant for Idorsia, Novartis, Relypsa, AstraZeneca, G3P(stocks), Grünenthal, Stealth Peptides, Fresenius, Sequana Medical, Vifor Fresenius Medical Care Renal Pharma, and Vifor; and is cofounder of Cardiorenal. Dr Forman has served on scientific advisory boards at Merck Sharpe and Dome, AstraZeneca, Novo Nordisk. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: As mineralocorticoid receptor antagonists (MRAs) may possess renoprotective effects in type 2 diabetes (T2D), it was decided to investigate the impact of high-dose MRA on prespecified secondary endpoints-namely, change in urinary albumin-creatinine ratio (UACR) and 24-h ambulatory blood pressure-in the MIRAD trial., Methods: This was a double-blind clinical trial in which T2D patients at high risk of or with established cardiovascular disease (CVD) were randomized to either high-dose (100-200 mg) eplerenone or a dose-matched placebo as an add-on to background antihypertensive treatment for 26 weeks. Safety was evaluated by the incidence of hyperkalaemia and kidney-related adverse events., Results: A total of 140 patients were enrolled (70 in each group). Baseline UACR was 17 mg/g (geometric mean; 95% CI: 13-22); this decreased by 34% in the eplerenone group compared with the placebo group at week 26 (95% CI: -51% to -12%; P =  0.005). There was no significant decrease in 24-h systolic blood pressure (SBP) due to treatment (-3 mmHg; 95% CI: -6 to 1; P = 0.150). However, the observed change in 24-h SBP correlated with the relative change in UACR in the eplerenone group (r = 0.568, P < 0.001). Mean baseline (± SD) estimated glomerular filtration rate (eGFR) was 85 (± 18.6) mL/min/1.73 m 2 , and 12 (± 9%) had an eGFR of 41-59 mL/min/1.73 m 2 . No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P = 0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed., Conclusion: The addition of high-dose eplerenone to T2D patients at high risk of CVD can markedly reduce UACR with an acceptable safety profile., (Copyright © 2020 Elsevier Masson SAS. All rights reserved.)

Objective: To measure long-term knowledge gain after provision of nursing education in a low-income country., Design and Sample: Global health education research has often focused on the short- term effects of providing education and direct patient care. Assessment of long-term knowledge gain is key for determining whether education knowledge transfer is sustainable., Measurements: This prospective cohort study of educational training for nurses in Haiti tested knowledge gain before, immediately after, and 6 months after education., Intervention: Quantitative assessments were obtained through multiple choice tests at 3 time points. Qualitative data were obtained through focus groups and self-assessments., Results: Knowledge gain was significant from pretest to immediate posttest, and knowledge retention was assessed at 6 months after the education. Qualitative data showed improvement in reported confidence levels and patient care activities. Short-term knowledge gain was statistically significant for improvement; however, long-term knowledge gain was statistically significant in only 4 of 19 lectures., Conclusions: Reported qualitative improvements in patient care indicated added value of providing education to the nursing staff. Hands-on learning techniques were important to long-term retention, and building trust was vital to the completion of our study., (© 2019 Wiley Periodicals, Inc.)

Aim: Natriuretic peptides (NPs) have emerged as important regulators of lipid metabolism. Reduced levels of NPs are reported in obesity and in patients with type 2 diabetes (T2D). This NP deficiency may affect their ectopic fat distribution and lead to high risk of non-alcoholic fatty liver disease (NAFLD)., Methods: In this cross-sectional study, the association between N-terminal pro-B-type natriuretic peptide (NT-proBNP) and liver fat content was quantified using 1H-magnetic resonance spectroscopy in 120 patients with T2D., Results: NAFLD (defined as liver fat content ≥ 5.6%) was found in 57 (48%) of the T2D patients, who also had significantly lower NT-proBNP (P = 0.002) levels compared with patients without NAFLD, but did not differ as regards the presence of cardiovascular disease (CVD) or in kidney function. After adjusting for potential confounders (age, gender, HbA 1c , BMI, HOMA2-IR, CVD, eGFR), the odds ratio for the presence of NAFLD was increased by 2.9 (P = 0.048) for NT-proBNP levels < 45 ng/L. In a multivariable linear regression model, the relationship with NT-proBNP was further analyzed as a continuous variable, and was independently and inversely associated with increasing liver fat content after full adjustment (P = 0.031)., Conclusion: Reduced plasma NT-proBNP levels are independently associated with high liver fat content in patients with T2D. The present study suggests that NP deficiency may play a role in the development of NAFLD in T2D., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Aim: To investigate whether the mineralocorticoid receptor antagonist eplerenone has beneficial effects on liver fat and metabolism in patients with type 2 diabetes (T2D), the mineralocorticoid receptor antagonist in type 2 diabetes (MIRAD) trial., Material and Methods: In this 26-week, double-blind, randomized, placebo-controlled trial, we enrolled 140 patients with T2D and high risk of cardiovascular disease. Patients were randomized 1:1 to either eplerenone with a target dose of 200 mg/day for patients with estimated glomerular filtration rate (eGFR) of 60 mL/min per 1.73 m 2 or more and 100 mg/day for patients with eGFR between 41 and 59 mL/min per 1.73 m 2 or placebo. The primary outcome measure was change in liver fat by proton magnetic resonance spectroscopy at week 26 from baseline; secondary outcomes were changes in metabolism, and safety by incident hyperkalaemia., Results: No changes in liver fat in the eplerenone group 0.91% (95% CI -0.57 to 2.39) or the placebo group -1.01% (-2.23 to 0.21) were found. The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049). There was no beneficial impact on supporting secondary outcome variables of metabolism as fat mass distribution, lipid metabolism or insulin resistance. Despite a high dosage of eplerenone 164 versus 175 mg in patients treated with placebo (P = 0.228), the number of patients with incident hyperkalaemia (≥5.5 mmol/L) was low, with six in the eplerenone versus two in the placebo group (P = 0.276)., Conclusion: The addition of high doses of eplerenone to background antidiabetic and antihypertensive therapy does not show beneficial effects on liver fat and metabolism in patients with T2D., (© 2019 John Wiley & Sons Ltd.)

Background: In the aftermath of the 2010 earthquake in Haiti, St. Luke Hospital was built to help manage the mass casualties and subsequent cholera epidemic. A major problem faced by the hospital system was the lack of an available and sustainable supply of medications. Long-term viability of the hospital system depended largely on developing an uninterrupted medication supply chain., Objective: We hypothesized that the implementation of a new Pharmacy Computerized Inventory Program (PCIP) would optimize medication availability and decrease medication shortages., Design: We conducted the research by examining how medications were being utilized and distributed before and after the implementation of PCIP. We measured the number of documented medication transactions in both Phase 1 and Phase 2 as well as user logins to determine if a computerized inventory system would be beneficial in providing a sustainable, long-term solution to their medication management needs., Results: The PCIP incorporated drug ordering, filling the drug requests, distribution, and dispensing of the medications in multiple settings; inventory of currently shelved medications; and graphic reporting of 'real-time' medication usage. During the PCIP initiation and establishment periods, the number of medication transactions increased from 219.6 to 359.5 (p=0.055), respectively, and the mean logins per day increased from 24.3 to 31.5, p<0.0001, respectively. The PCIP allows the hospital staff to identify and order medications with a critically low supply as well as track usage for future medication needs. The pharmacy and nursing staff found the PCIP to be efficient and a significant improvement in their medication utilization., Conclusions: An efficient, customizable, and cost-sensitive PCIP can improve drug inventory management in a simplified and sustainable manner within a resource-constrained hospital.

Following the introduction of highly active antiretroviral therapy (HAART), a number of metabolic and morphologic alterations, known as HIV-associated lipodystrophy syndrome (HALS), have been increasingly common in HIV-infected patients being treated with this therapy. The use of protease inhibitors (PI), in particular, has been associated with insulin resistance and hyperglycaemia, but only infrequently with diabetic ketoacidosis. We report a case of diabetic ketoacidosis in an HIV-infected woman after 1(1/2) years of a PI-containing regimen, demonstrating reduced beta cell function and insulin resistance.

An investigation on the effect of hypercapnia in vivo on the rat brain gangliosides is reported. In contradiction to the results reported by Lowden and Wolfe (1964) for the cat, no diminution in total brain ganglioside concentration could be demonstrated. The ganglioside pattern in test and control animals was the same.