"Positive Kidney Health": Implementation and design of a pharmacist-led intervention for patients at risk for development or progression of chronic kidney disease.

Background: Patients with early chronic kidney disease (CKD) or underlying risk factors are often unaware of their kidney test results, common causes of CKD, and ways to lower risk of disease onset/progression.

Objective: To test feasibility of a pharmacist-led intervention targeting patient education and risk factors in patients with early CKD and those at risk for CKD.

Practice Description: Ambulatory care pharmacists in community-based primary care clinics delivered kidney health education, ordered labs, and recommended medication adjustments.

A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study).

Background: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings.

Association of Type 2 Diabetes Risk Perception With Interest in Diabetes Prevention Strategies Among Women With a History of Gestational Diabetes.

Objectives: The aims of this study were to identify predictors of perception of type 2 diabetes risk in women with a history of gestational diabetes mellitus (GDM) and to determine factors associated with interest in evidence-based strategies for type 2 diabetes prevention.

Research Design And Methods: We surveyed women with a history of GDM who had not progressed to type 2 diabetes from a large academic medical center. We used multivariate logistic regression to assess predictors of high levels of perception of type 2 diabetes risk.

Differences in Weight Loss by Race and Ethnicity in the PRIDE Trial: a Qualitative Analysis of Participant Perspectives.

Background: Many Diabetes Prevention Program (DPP) translation efforts have been less effective for underresourced populations. In the cluster-randomized Prediabetes Informed Decision and Education (PRIDE) trial, which evaluated a shared decision-making (SDM) intervention for diabetes prevention, Hispanic and non-Hispanic Black participants lost less weight than non-Hispanic White participants at 12-month follow-up.

Objective: To explore perspectives about weight loss from PRIDE participants of different racial and ethnic groups.

Educational Attainment, Decision-Making Preferences, and Interest in Evidence-Based Diabetes Prevention among Women with a History of Gestational Diabetes Mellitus.

The Diabetes Prevention Program (DPP) showed that lifestyle change or metformin is equally efficacious in preventing diabetes in women who have had gestational diabetes mellitus (GDM). Few studies have investigated the relationship between education and willingness to engage in either intervention and between education and preferred decision-making style. Within a large health system, we surveyed insured women 18-64 years old with a history of GDM, identified through the electronic health record.

Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects.

Remdesivir (RDV), a single diastereomeric monophosphoramidate prodrug that inhibits viral RNA polymerases, has potent in vitro antiviral activity against severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). RDV received the US Food and Drug Administration (FDA)'s emergency use authorization in the United States and approval in Japan for treatment of patients with severe coronavirus disease 2019 (COVID-19). This report describes two phase I studies that evaluated the safety and pharmacokinetics (PKs) of single escalating and multiple i.

A randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome.

Objective: The objective of this study was to determine steady-state gabapentin exposures and corresponding relief of symptoms and safety profile produced by 4 dose levels of gabapentin enacarbil (GEn) in subjects with restless legs syndrome (RLS).

Methods: Subjects with RLS (n = 217) were randomized to receive once-daily, orally administered GEn 600 (n = 48), 1200 (n = 45), 1800 (n = 38), or 2400 mg (n = 45) or placebo (n = 41) in this 12-week, double-blind, multicenter study (NCT01332305). Clinic visits were at screening, baseline, and weeks 1, 2, 3, 4, 6, 8, 10, and 12; plasma gabapentin concentrations were measured by a validated liquid chromatography-mass spectrometry/mass spectrometry method at weeks 4 and 12.

Pharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteers.

Background: Gabapentin enacarbil is an actively transported prodrug of gabapentin that provides predictable dose-proportional gabapentin exposure with high (> or =68%) oral bioavailability.

Objectives: The aims of this study were to investigate the pharmacokinetics and tolerability of gabapentin enacarbil up to supratherapeutic doses and the effects of gabapentin enacarbil on cardiac repolarization in healthy volunteers, and to provide a dose reference for a future definitive QT/corrected QT (QTc) study.

Methods: This was a randomized-sequence, double-blind, placebo-controlled, single escalating-dose, crossover study of gabapentin enacarbil 600-mg extended-release tablets administered as a single oral dose of 2400, 3600, 4800, or 6000 mg or placebo, with a 1-week washout between administrations.