Publications by authors named "Mason W Freeman"

Baxdrostat is a selective small-molecule aldosterone synthase inhibitor in development for treatment of hypertension and chronic kidney disease. This phase 1, open-label, parallel-group study assessed the safety and pharmacokinetics (PK) of baxdrostat in participants with varying degrees of renal function. Participants were enrolled into control (estimated glomerular filtration rate [eGFR] ≥60 mL/min), moderate to severe renal impairment (eGFR 15-59 mL/min), or kidney failure (eGFR <15 mL/min) groups and received a single 10-mg baxdrostat dose followed by 7 days of inpatient PK blood and urine sampling.

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  • The study aimed to examine the cardiovascular risks associated with bexagliflozin in individuals with type 2 diabetes (T2D) by analyzing data from 4090 participants involved in controlled trials.
  • Results indicated that bexagliflozin did not increase the risk of major adverse cardiovascular events (MACE) compared to a placebo, satisfying safety benchmarks set by regulatory authorities.
  • The findings support FDA approval of bexagliflozin for T2D, confirming its safety concerning cardiovascular events.
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  • The study aimed to assess the safety and effectiveness of bexagliflozin when used alongside metformin for treating type 2 diabetes in 317 participants.
  • Results showed that bexagliflozin led to a significant reduction in HbA1c levels compared to the placebo, with an impressive mean change of -1.09% versus -0.56%.
  • Both systolic blood pressure, fasting plasma glucose, and weight loss also improved in the bexagliflozin group, and fewer serious adverse events were reported compared to the placebo group, indicating that bexagliflozin is a beneficial addition to metformin therapy.
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Background: Due to the high comorbidity of diabetes and hypertension, co-administration of metformin with anti-hypertensive drugs is likely. Baxdrostat is an aldosterone synthase inhibitor in development for the potential treatment of hypertension. In vitro data indicated that baxdrostat inhibits the multidrug and toxin extrusion 1 (MATE1) and MATE2-K renal transporters.

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Background: Aldosterone synthase controls the synthesis of aldosterone and has been a pharmacologic target for the treatment of hypertension for several decades. Selective inhibition of aldosterone synthase is essential but difficult to achieve because cortisol synthesis is catalyzed by another enzyme that shares 93% sequence similarity with aldosterone synthase. In preclinical and phase 1 studies, baxdrostat had 100:1 selectivity for enzyme inhibition, and baxdrostat at several dose levels reduced plasma aldosterone levels but not cortisol levels.

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Baxdrostat is a selective inhibitor of aldosterone synthase designed for the treatment of disorders associated with elevated aldosterone. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of baxdrostat in healthy volunteers. Subjects were randomized to receive oral baxdrostat (0.

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  • The study aimed to compare the effectiveness of bexagliflozin tablets (20 mg) versus glimepiride in treating adults with type 2 diabetes who weren't adequately controlled by metformin.
  • A total of 426 adults were randomized, with the primary focus on changes in glycated hemoglobin (HbA1c) levels after 60 weeks, while secondary outcomes included body mass, blood pressure, and hypoglycemia occurrences.
  • Results showed bexagliflozin was noninferior to glimepiride in reducing HbA1c, outperformed it in reducing body weight and blood pressure, and led to fewer instances of hypoglycemia, along with a positive impact on kidney function.
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The SARS-CoV-2 pandemic has affected more than 185 million people worldwide resulting in over 4 million deaths. To contain the pandemic, there is a continued need for safe vaccines that provide durable protection at low and scalable doses and can be deployed easily. Here, AAVCOVID-1, an adeno-associated viral (AAV), spike-gene-based vaccine candidate demonstrates potent immunogenicity in mouse and non-human primates following a single injection and confers complete protection from SARS-CoV-2 challenge in macaques.

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Implementation of clinically useful research discoveries in the academic environment is challenged by limited funding for early phase proof-of-concept studies and inadequate expertise in product development and commercialization. To address these limitations, the National Institutes of Health (NIH) established the National Centers for Accelerated Innovations (NCAI) program in 2013. Three centers competed successfully for awards through this mechanism.

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The SARS-CoV-2 pandemic has affected more than 70 million people worldwide and resulted in over 1.5 million deaths. A broad deployment of effective immunization campaigns to achieve population immunity at global scale will depend on the biological and logistical attributes of the vaccine.

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  • - A study was conducted to assess the safety and effectiveness of bexagliflozin, a medication for type 2 diabetes, at three different doses (5, 10, and 20 mg) over 12 weeks, comparing it to a placebo in patients who had minimal previous medication exposure.
  • - Results showed that all doses of bexagliflozin significantly reduced HbA1c levels, with the 20 mg dose showing the most substantial decrease, along with improvements in fasting plasma glucose and body mass.
  • - The medication had a similar incidence of adverse effects as the placebo, indicating it is generally safe; further research is recommended to explore its long-term effects for managing type 2 diabetes.
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  • The study aimed to assess the safety and effectiveness of bexagliflozin, a medication for type 2 diabetes, over a 96-week period compared to a placebo.
  • It involved 288 adults from the USA, Colombia, and Mexico, showing a significant reduction in HbA1c levels and beneficial changes in body mass and blood pressure for those taking bexagliflozin.
  • The results indicated that bexagliflozin was well tolerated, with fewer serious adverse events and urinary tract infections compared to the placebo group, demonstrating it provided meaningful improvements in diabetes management.
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  • The study aimed to compare the safety and effectiveness of bexagliflozin and sitagliptin when used alongside metformin for treating type 2 diabetes in adults.
  • A total of 386 participants were randomized to receive either bexagliflozin or sitagliptin, with the main goal of assessing their impact on HbA1c levels after 24 weeks.
  • Results showed that bexagliflozin was as effective as sitagliptin for reducing HbA1c and outperformed it in lowering fasting plasma glucose and body mass, with similar rates of adverse events for both medications.
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  • Hyperglycemia can worsen chronic kidney disease (CKD), and traditional diabetes treatments often don't help CKD-related problems; bexagliflozin, an SGLT2 inhibitor, was studied for its potential effectiveness in patients with diabetes and CKD.
  • A Phase 3, double-blind trial involved 312 participants with type 2 diabetes and CKD stages 3a and 3b across 54 sites in 4 countries, comparing the effects of 20mg of bexagliflozin to a placebo over 24 weeks.
  • Results showed bexagliflozin significantly reduced hemoglobin A1c levels by 0.37%, lowered body weight, systolic blood pressure, fasting
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Aims: Chronic kidney disease (CKD) in heart failure (HF) increases the risk of hyperkalaemia (HK), limiting angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB) use. Patiromer is a sodium-free, non-absorbed potassium binder approved for HK treatment. We retrospectively evaluated patiromer's long-term safety and efficacy in HF patients from AMETHYST-DN.

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Commercializing innovations in academic environments is notoriously challenging. Here, we describe the progress of the NIH Centers for Accelerated Innovations program — initiated in 2013 to address these challenges — which we believe could help set a new standard for the early-stage commercialization of biomedical innovations in academic environments.

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Patients with chronic kidney disease (CKD) have a high risk of hyperkalemia, which increases mortality and can lead to renin-angiotensin-aldosterone system inhibitor (RAASi) dose reduction or discontinuation. Patiromer, a nonabsorbed potassium binder, has been shown to normalize serum potassium in patients with CKD and hyperkalemia on RAASi. Here, patiromer's onset of action was determined in patients with CKD and hyperkalemia taking at least one RAASi.

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Importance: Hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system (RAAS) inhibitors with stage 3 or greater chronic kidney disease (CKD) who may also have diabetes, heart failure, or both.

Objectives: To select starting doses for a phase 3 study and to evaluate the long-term safety and efficacy of a potassium-binding polymer, patiromer, in outpatients with hyperkalemia.

Design, Setting, And Participants: Phase 2, multicenter, open-label, dose-ranging, randomized clinical trial (AMETHYST-DN), conducted at 48 sites in Europe from June 2011 to June 2013 evaluating patiromer in 306 outpatients with type 2 diabetes (estimated glomerular filtration rate, 15 to <60 mL/min/1.

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The field of genetics and genomics has advanced considerably with the achievement of recent milestones encompassing the identification of many loci for cardiovascular disease and variable drug responses. Despite this achievement, a gap exists in the understanding and advancement to meaningful translation that directly affects disease prevention and clinical care. The purpose of this scientific statement is to address the gap between genetic discoveries and their practical application to cardiovascular clinical care.

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Background: Individuals infected with human immunodeficiency virus (HIV) have decreased high-density lipoprotein (HDL)-cholesterol and increased cardiovascular disease (CVD). Reverse cholesterol transport from macrophages may be inhibited by HIV and contribute to increased CVD. Human studies have not investigated longitudinal effects of HIV and antiretroviral therapy (ART) on cholesterol efflux.

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