A Review of the Safety and Efficacy of Bexagliflozin for the Management of Type 2 Diabetes.

OBJECTIVE: To review the pharmacology of bexagliflozin in addition to its safety and efficacy from available clinical trials used for its approval, as well as available clinical evidence to date. DATA SOURCES: A search of the National Institutes of Health Clinical Trials Registry (http://www.clinicaltrials.gov) and PubMed database was performed from inception through June 1, 2023. STUDY SELECTION AND DATA EXTRACTION QUANTIFICATION: The following study designs were included: meta-analyses, systematic review, clinical trial, or observational study design. Abstracts and drug monographs were also reviewed. Narrative or scoping reviews were excluded. Only articles in the English language and those evaluating the pharmacology, pharmacokinetics, safety, or efficacy of bexaglifozin in humans were included. DATA SYNTHESIS: Bexagliflozin reduces hemoglobin A1c ~0.5% with similar reductions in systolic blood pressure and body weight to other SGLT2 inhibitors. No cardiovascular outcomes trial is published, nor ongoing at this time. Adverse effects are similar to other SGLT2 inhibitors (genital mycotic and urinary tract infections, increased urination) including a warning for lower extremity amputation similar to canagliflozin. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS: Although no cost-effectiveness data are available, statements from the manufacturer suggest a competitive price point. Given limited trial data, lower cost, if chosen, may create a temporary niche for bexagliflozin pending generic availability of other SGLT2 inhibitors. However, given lack of cardiovascular and renal outcome data, empagliflozin, dapagliflozin, or canagliflozin may be preferred. CONCLUSION: Bexagliflozin appears safe and effective as monotherapy and add-on pharmacological therapy for the treatment of T2D.

Effect of Antidepressants on Glucagon-Like Peptide-1 Receptor Agonist-Related Weight Loss.

Background: Depression and obesity have a bidirectional relationship making the management of one, without the other, problematic. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a preferred medication class for diabetes and obesity treatment given their weight loss effect; however, it is not known how antidepressants impact this effect. Objective: To assess the impact of antidepressant use on GLP-1 RA-associated weight loss in patients with or without type 2 diabetes mellitus. Methods: This was a retrospective, propensity matched, cohort study conducted using TriNetX. The study identified patients initiating a GLP-1 RA being treated with citalopram/escitalopram, bupropion, or no antidepressant. Cohorts were propensity score matched to analyze the primary outcome of mean end-of-study (77-371 days) body weight. Results: An initial query identified 31 273 patients eligible for analysis (30 160 receiving no antidepressant, 311 receiving bupropion, and 802 receiving citalopram/escitalopram). After propensity score matching, the study found patients receiving citalopram/escitalopram were taking more antidiabetic therapies at baseline compared with patients not treated with an antidepressant. Patients in the antidepressant cohorts experienced less weight loss compared with their respective matched cohorts not receiving antidepressants (citalopram/escitalopram -0.73 kg versus -1.74 kg; bupropion -0.84 kg versus -3.46 kg). Only the bupropion cohort was significantly heavier at end-of-study versus the non-antidepressant cohort (108 kg versus 103 kg, P = 0.018). Conclusion and Relevance: Antidepressants may diminish the weight loss effect of GLP-1 RAs. Additional research is needed to assess whether all GLP-1 RAs are affected similarly and the optimal weight loss strategies in patients receiving antidiabetic therapy with comorbid depression.

Primary prevention aspirin use in high-risk patients: A pharmacist intervention and comparison of risk stratification tools.

OBJECTIVES: The objectives of this project are 1) to describe aspirin use for primary prevention in an underserved, minority population; 2) to determine the impact of a pharmacist-led intervention on the prevalence of aspirin use for primary prevention; and 3) to compare aspirin indications based on Framingham Risk Score (FRS) and atherosclerotic cardiovascular disease (ASCVD) risk score. METHODS: Men and women age 45-79 and 55-79 years, respectively, without ASCVD were screened for aspirin use. An FRS of 10% or greater and low risk for a serious bleed were considered indications for primary prevention aspirin on the basis of guideline-directed medical therapy recommendations. When treatment with aspirin was indicated, providers were notified with patient-specific messages. Patients' FRS and ASCVD risk score distributions were plotted and compared. Primary prevention aspirin indications were identified using both risk stratification tools. RESULTS: One hundred sixteen patients were evaluated for aspirin use in a predominantly black (80%), middle-aged (mean age, 58 years), and indigent population. Thirty-one patients (27%) had an FRS of 10% or greater and low risk for bleeding, and 10 patients (9%) were taking aspirin at baseline. Providers approved recommendations to start administering aspirin in 19 of 31 patients (61%), which significantly increased the overall proportion receiving aspirin compared to baseline (9%-25%; P < 0.01). Patients were more than twice as likely to meet the minimum risk score threshold (≥10%) for a primary prevention aspirin indication using ASCVD risk scores versus FRS (70% vs. 30%; P < 0.01). CONCLUSIONS: Baseline utilization of primary prevention aspirin was low in an indigent, minority population. A provider-focused pharmacist intervention improved the prevalence of aspirin use for primary prevention, while minimizing risk for serious bleeding events. Among our cohort, more patients had indications for primary prevention aspirin using ASCVD risk scores versus FRS.

Comparison of dietary supplement product knowledge and confidence between pharmacists and health food store employees.

OBJECTIVES: To determine pharmacists' and health food store employees' knowledge about the safety and efficacy of common, nonvitamin, nonmineral dietary supplements in a retail setting and confidence in discussing, recommending, and acquiring knowledge about complementary and alternative medicine (CAM). DESIGN: Cross-sectional survey. SETTING: Central and western New York in May and June 2012. MAIN OUTCOME MEASURES: Knowledge and confidence survey scores based on true/false and Likert scale responses. RESULTS: Pharmacists' mean knowledge score was significantly higher than that of health food store employees (8.42 vs. 6.15 items of 15 total knowledge questions). Adjusting for differences in experience, education, occupation, and confidence, knowledge scores were significantly higher for pharmacists and those with a higher total confidence score. Pharmacists were significantly less confident about the safety and efficacy of CAM comparatively (13 vs. 16 items of 20 total questions). CONCLUSION: Pharmacists scored significantly higher than health food store employees on a survey assessing knowledge of dietary supplements' safety and efficacy. Despite the significant difference, scores were unacceptably low for pharmacists, highlighting a knowledge deficit in subject matter.

Semaglutide once-weekly: improved efficacy with a new safety warning.

INTRODUCTION: Semaglutide once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection has been approved as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus (T2DM). Areas Covered: The safety and efficacy of the semaglutide once-weekly injection are reviewed using results from preliminary pharmacology studies and later-phase randomized control trials (RCTs) and meta-analyses. Semaglutide once-weekly is compared to placebo and active comparators for T2DM in the SUSTAIN clinical trial series, with outcomes of: glycemic control, weight loss, major adverse cardiovascular events, and adverse effects. Risk for diabetic retinopathy complications (DRCs) is reviewed in detail, due to significantly higher risk for DRCs seen in SUSTAIN 6. SUSTAIN 6 is the first instance of a GLP-1 RA demonstrating significantly increased risk for DRCs. Semaglutide's current regulatory approvals, practice considerations, and cost-effectiveness compared to similar therapies are also considered. Expert Commentary: Semaglutide demonstrates high glycemic efficacy and favorable safety profile, and reduces the risk for cardiovascular events. Mild to moderate gastrointestinal events and retinopathy complications were more common with semaglutide compared to placebo, though serious adverse events were similar to controls and infrequent. Improved clinical efficacy should be carefully weighed against the risk for GI and retinopathy complications.

Providing Comprehensive Medication Management in Telehealth.

The goal of this white paper is to provide direction for clinical pharmacists providing telehealth. Telehealth care is rapidly emerging to improve patient access to health care and optimize patient health outcomes. With the increasing ability to access electronic health record portals, as many as 75 million telehealth encounters are expected in North America annually. Although electronic "point of access" undoubtedly increases the use of medical and pharmacy services, the real value of telehealth lies in improved access to patients in remote areas lacking adequate medical and pharmacy services and to high-risk patients requiring frequent monitoring. This document is intended to serve as a guide for those interested in or already using telehealth to provide direct patient care. Specifically, it focuses on general concepts of telehealth and demonstrates how the delivery of comprehensive medication management (CMM) by telehealth aligns with the Standards of Practice for Clinical Pharmacists set forth by the American College of Clinical Pharmacy. Although clinical pharmacists must be appropriately credentialed and privileged to provide CMM, their process of care must also be adapted to suit the remote patient. Patient assessment, evaluation of medication therapy, development and implementation of a plan of care, follow-up, monitoring, and documentation of all processes of care are influenced by the technology available, the collaborations established, and the applicable regulations and requirements for telehealth practice.

White Paper on Natural Products.

The American College of Clinical Pharmacy (ACCP) published an initial white paper on herbal products in 2000. Since then, the global market for natural products has continued to expand, with tens of millions of consumers using such products on an annual basis in the United States alone. However, despite this expansion, natural products remain largely unregulated compared with prescription medications, have moderate- to low-level clinical evidence for efficacy, and continue to have safety concerns, including adulteration and misbranding. As comprehensive medication management experts, clinical pharmacists are uniquely qualified to navigate these concerns and advise patients appropriately. To develop and recommend a suitable care plan involving natural products, clinical pharmacists must establish a strong pharmacist-patient relationship, assess the appropriateness of therapy, educate the patient regarding key issues, and continuously monitor and follow up on the effectiveness of the care plan. This process should not only occur in an individual community or hospital setting, but also whenever a patient transitions from one care setting to another in cooperation with other clinicians.