Sodium-Glucose Cotransporter 2 Inhibitor Use Associated With Fournier's Gangrene: A Review of Case Reports and Spontaneous Post-Marketing Cases.

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are effective for glycemic control and have demonstrated cardiorenal benefits. The U.S. Food and Drug Administration (FDA) released a boxed warning in 2018 regarding the potential development of Fournier's gangrene (FG) with the use of SGLT2 inhibitors. FG is a serious perineal infection with a mortality rate of up to 88% in some cases. OBJECTIVES: To report spontaneous post-marketing cases from the FDA Adverse Event Reporting System (FAERS) database and case reports from the literature of FG associated with the use of SGLT2 inhibitors and to determine whether correlations exist with specific agents. METHODS: A search of the FAERS database was conducted to identify reported cases of FG associated with the use of any FDA-approved SGLT2 inhibitor between 1 March 2013 and 30 June 2020. Additionally, a literature search was conducted of PubMed, Embase, and the Cochrane library using PRISMA guidelines to identify case reports of FG with the use of SGLT2 inhibitors up to 9 October 2020. RESULTS: A total of 491 cases from the FAERS database were included for review. Descriptive analysis depicted more cases in the empagliflozin, canagliflozin, and dapagliflozin groups than in the ertugliflozin group. Nine case reports were included from the literature review; four attributed to dapagliflozin, three to empagliflozin, and two to canagliflozin. The median ages from cases reported in the FAERS database and from the literature review were 54 and 52 years, respectively. In both datasets, males had a higher incidence of FG than females. Additional data reported include clinical outcomes and concomitant antihyperglycemic medications. CONCLUSION: Consistent findings are noted in this systematic review and warrant further investigation to elucidate the association between SGLT2 inhibitor use and the development of FG. These results may drive enhanced prescribing patterns to consider patient-specific risk factors and timely monitoring, especially as more indications are approved related to these medications' cardiorenal protective properties.

Measurement of Pharmacist-Physician Collaborative Care on Therapeutic Inertia in Patients With Type 2 Diabetes.

BACKGROUND: Team-based care practice models have been shown to improve diabetes-related therapeutic inertia, yet the method and type of antidiabetic treatment intensification (TI) leading to improvements in glycemic control are not well understood. OBJECTIVE: To evaluate time to TI in a pharmacist-physician practice model (PPM) as compared with usual medical care (UMC), explore the method and type of antidiabetic TI, and evaluate achievement of hemoglobin A1C (A1C) goal among each cohort. METHODS: This was a retrospective cohort study conducted between January 1, 2017, and December 31, 2018. Median time to TI was calculated and compared between patients in the PPM and UMC groups using the log rank test. Descriptive statistics were used to evaluate the method and type of TI and A1C goal achievement. RESULTS: A total of 56 patients were included. The median (interquartile range) time to antidiabetic TI among the PPM cohort was 37.5 days (8, 216.5), as compared with 142 days (16, 465) in the UMC cohort (P = 0.19). At 1 year post-index date, 25% of patients in the PPM cohort reached their A1C goal compared with 18.8% of patients in the UMC cohort. This effect was maintained in the subgroup (n = 49) of patients receiving TI (23.1% vs 17.8%). CONCLUSION AND RELEVANCE: A shorter time to TI and improvement in A1C goal achievement was observed with pharmacist-physician care compared with UMC. These findings suggest that pharmacist-physician care may be one of several interventions necessary to overcome therapeutic inertia in diabetes care.

Continuous glucose monitoring in persons with type 2 diabetes not using insulin.

INTRODUCTION: CGM is an evidence-based intervention to improve glycemic control in persons with T1D and T2D using insulin. Use of CGM in persons with T2D not using insulin is not well studied. AREAS COVERED: Existing clinical evidence for the use of CGM in persons with T2D is reviewed with a focus on persons with T2D not using insulin. Additional perspective and consideration are provided on the role and rationale for using CGM in persons with T2D not using insulin. EXPERT OPINION: On the basis of available evidence, persons with T2D not using insulin benefit clinically through reduction in HbA1c, and improvement in time in range. Additional benefits include improvement in behavior modification, satisfaction, quality of life, empowerment, and diabetes distress. Drivers of these benefits are independent of insulin use in persons with T2D and may include an improved understanding of how diet, lifestyle, and exercise impact diabetes through CGM use. Clinical benefits from CGM independent of medication use include ability to modify health behavior and subsequently improve self-management.

Prevalence of and Characteristics Associated With Overbasalization Among Patients With Type 2 Diabetes Using Basal Insulin: A Cross-Sectional Study.

This article describes a cross-sectional analysis of 655 patients to determine the prevalence of and patient-specific characteristics associated with overbasalization in patients with type 2 diabetes. Overbasalization was defined as uncontrolled A1C (>8%) plus a basal insulin dose >0.5 units/kg/day. The period prevalence of overbasalization was found to be 38.1, 42.7, and 42% for those with an A1C >8, ≥9, and ≥10%, respectively. Those with an A1C ≥9% had the greatest likelihood of experiencing overbasalization. These results suggest that overbasalization may play a role in patients not achieving optimal glycemic control in type 2 diabetes.

Is it Time to Expand Glucagon-like Peptide-1 Receptor Agonist Use for Weight Loss in Patients Without Diabetes?

The obesity and type 2 diabetes mellitus epidemics demonstrate that simply emphasizing a healthy lifestyle is insufficient. While weight loss medications have historically been considered "cosmetic", glucagon-like peptide-1 receptor agonists (GLP1-RAs) also reduce cardiovascular risk in patients with type 2 diabetes. Therefore, we assessed whether GLP1-RAs warrant use in patients who are overweight (body mass index 27.0-29.9 kg/m2) without weight-related comorbidity. We reviewed trials of available GLP1-RAs with a natural GLP1 backbone given their trend toward cardiovascular benefit and excluded trials requiring concurrent antidiabetic agents associated with weight gain. We assessed 20 phase III trials of GLP1-RAs studied in cardiovascular outcome trials. The GLP1-RAs consistently produced weight loss. Hypoglycemia risk with GLP1-RAs was generally low without other precipitating factors, whereas gastrointestinal adverse effects were common. Dulaglutide 1.5 mg weekly did not produce sufficient weight loss to support its use specifically for weight loss, while data supporting dulaglutide 3.0 or 4.5 mg weekly were limited to a single trial. Weight loss was sufficient with liraglutide 1.8 mg daily in one trial and was consistently sufficient with liraglutide 3.0 mg daily. Oral and injectable semaglutide at both doses consistently produced weight loss, though demonstrated a potential increased risk for retinopathy. Overall, we suggest five GLP1-RAs can be used in the treatment of overweight (body mass index 27.0-29.9 kg/m2 without weight-related comorbidity) with shared decision making to address each medications' key limitation: liraglutide 1.8 mg daily (less demonstrated weight loss), liraglutide 3.0 mg daily (no cardiovascular outcome trial at this dose), and oral and injectable semaglutide at both doses (uncertain retinopathy risk and pending cardiovascular outcome trial of high-dose semaglutide). Use should be limited to patients who fail, refuse, or cannot access lifestyle interventions for weight loss, and should be accompanied by standard restrictions on and monitoring of weight loss medications. We expect additional and earlier use of weight loss therapies to help clinicians curb the obesity and type 2 diabetes epidemics.

Anticipatory guidance and systematic review of prescribing combination incretin therapy in the treatment of type 2 diabetes.

WHAT IS KNOWN AND OBJECTIVE: Few studies have evaluated the efficacy and safety of combining a glucagon-like peptide-1 receptor agonist and dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes mellitus. Clinicians may frequently encounter this drug therapy combination in practice and should be aware of clinical evidence and risks associated with its use. METHODS: A literature search was conducted in Embase (1947-April 20, 2020), Medline - Ovid (1946-April 21, 2020), Medline - PubMed (1946-April 21, 2020), Cochrane Library CENTRAL Register of Controlled Trials (1991-April 20, 2020) and Web of Science (1900-April 17, 2020). Databases were searched using keywords and subject headings to identify studies assessing efficacy and safety of combination incretin therapy. The search identified 1255 studies. Of these, 383 were excluded for duplicate citations. Articles were then excluded based on title and abstract screen. RESULTS AND DISCUSSION: Six studies were included. A small reduction in haemoglobin A1c and weight loss was found by combining incretin therapy. Adverse effects such as hypoglycaemia, gastrointestinal upset and pancreatitis were infrequent. WHAT IS NEW AND CONCLUSION: On current evidence, the small benefit in glycaemic control that may be realized by using combination incretin therapy is unlikely to be offset by the potential increased risk of pancreatitis or additional cost. Additional long-term prospectively designed studies are needed to better understand the efficacy and safety of combination incretin therapy.

Pharmacists interventions using Bluetooth technology and telehealth to improve blood pressure-A pilot study.

OBJECTIVES: To assess patients' knowledge of blood pressure (BP) and their comfort level with using technology, including a Bluetooth-enabled BP device and pharmacist telemonitoring. The secondary objective was to discover if pharmacist interventions improved BP readings. SETTING: The study took place in Pharmacy Plus and the Family Medicine Department at the University of South Florida in Tampa, FL. PRACTICE DESCRIPTION: The pharmacists within Pharmacy Plus and the Family Medicine Department are part of the interdisciplinary team providing care to patients and seeking to achieve optimal patient outcomes. Pharmacy Plus breaks away from the traditional behind-the-counter model using innovative technology to create a personalized experience for patients. PRACTICE INNOVATION: During this pilot study, the patients received a Bluetooth-enabled BP monitor and were asked to obtain their BP readings at least once daily for 6 weeks. The patients' electronic health records automatically captured the BP readings, which were reviewed by the study pharmacists. The patients had an appointment with the pharmacists once weekly via a telehealth platform through which they were counseled on their weekly average BP, BP goals, lifestyle modifications, and proper use of the devices. EVALUATION: The patients completed a prestudy survey assessing their baseline knowledge of BP, comfort level when using technology, and ease in working with pharmacists. Reliability and satisfaction in using the BP device and telehealth communication with pharmacists were also assessed poststudy. RESULTS: Twelve patients enrolled, with 9 completing the study. There was a statistically significant increase in patients' knowledge of BP and an improvement in the recommended lifestyle modifications. In addition, comfort level regarding communication with the pharmacist was statistically significantly improved. The patients responded positively to using the Bluetooth-enabled BP monitor and telehealth for receiving health care services. CONCLUSION: Using Bluetooth-enabled BP monitors that report results in real time into electronic health records, along with pharmacist interventions within a team-based care model, may result in improved BP control and patient outcomes.