Assessment of Glucagon-like Peptide-1 Receptor Agonists in Veterans Taking Basal/Bolus Insulin Regimens.

Background: Clinical use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is well established as add-on therapy to oral medications and basal insulin. However, there is little published data regarding the use of GLP-1 RAs for longer than 12 months in patients taking basal/bolus insulin regimens. The primary goal of our study was to assess the long-term efficacy of GLP-1 RAs as add-on therapy to basal/bolus insulin regimens. Methods: This study was a retrospective record review of all patients on basal/bolus insulin regimens who received additional therapy with a GLP-1 RA. The primary outcome was the change in glycosylated hemoglobin A1c (HbA1c) at 3, 6, 12, 18, and 24 months after initiation of the GLP-1 RA. Secondary outcomes included change in weight and total daily dose (TDD) of insulin and incidence of hypoglycemia and other adverse effects (AEs). Results: Ninety-two patient records were reviewed. Mean glycemic control changed from baseline -1.1% (95% CI, -1.3 to -0.8; P < .001) at 3 months; -1.0% (95% CI, -1.3 to -0.7; P < .001) at 6 months; -0.9% (95% CI, 1.3 to -0.6; P < .001) at 12 months; -0.9% (95% CI, -1.4 to -0.3; P = .002) at 18 months; and -0.7 (95% CI, -1.4 to 0.1; P = .07) at 24 months. A significant decrease in weight was also observed from baseline through 18 months, and a significant decrease in TDD of insulin was identified from baseline through 12 months. Hypoglycemia was documented in 29.8% of patients at any point during GLP-1 RA therapy, and gastrointestinal AEs were documented in 18.3% of patients. Conclusions: Adding GLP-1 RAs to complex insulin regimens may help achieve glycemic control while decreasing insulin requirements and mitigating undesirable AEs, such as weight gain.

Utilization of Lean Techniques in Pharmacy Residency Training: Modifying the PGY1 Management and Leadership Experience.

Purpose: The purpose of this study was to utilize lean process improvement principles to enhance the health-system pharmacy administration learning experience within a postgraduate year 1 (PGY1) residency program. Summary: The Richard L. Roudebush VA Medical Center adopted the use of lean to improve customer service and workplace efficiency. The Residency Advisory Council, overseeing the 6 pharmacy residency programs, felt that training residents in a proven process improvement technique would benefit the service and assist in developing problem-solving skills. Yellow Belt training was incorporated into the residency programs in 2012, and the Yellow Belt project for the 2014-2015 residency class was the modification of the PGY1 Health-System Pharmacy Administration learning experience. Residents focused on a few key areas as part of their completion plan: educating residents and preceptors on the importance of leadership activities, establishing a list of consistent topic discussions to be held during the administration learning experience, confirming a topic list for the pharmacy practice management and leadership seminars, piloting collaborative precepting for the administration experience, revising the staff development program, and increasing resident involvement in the PGY1 interview process. Two portions of the project lacked effective and timely communication, and as a result, those areas were not fully implemented. The remainder of the items achieved 100% completion. Conclusion: Lean techniques were effectively utilized within a residency program to enhance the health-system pharmacy administration learning experience. Successful implementation of lean requires engagement of stakeholders within the health-system, timely communication, frequent reassessments, and accountability.

Potential new treatments for diabetic kidney disease.

Antifibrotic agents, antioxidant agents, ET-a receptor antagonists, and a few other agents with nonspecific or multifaceted mechanisms of action have been evaluated and progressed to small clinical studies in human subjects. Although there are limited data at the present time, these early evaluations have produced some favorable results that at least warrant further investigation. There is certainly not enough compelling evidence to justify the routine use of any of these products specifically for DKD at the moment; however, more well-controlled and adequately powered studies in several hundred patients will help determine which of these may have a place in the DKD treatment armamentarium of the future.

Saxagliptin: a clinical review in the treatment of type 2 diabetes mellitus.

BACKGROUND: Some conventional therapies for type 2 diabetes mellitus (T2DM) fail to address the progressive nature of the disease, and as a result, they may become ineffective in maintaining normoglycemia. Antihyperglycemic agents have been developed to target incretin hormones, specifically glucagon-like peptide (GLP)-1. Incretin analogues and agents that delay GLP-1 degradation, the dipeptidyl peptidase (DPP)-4 inhibitors, offer mechanisms of action that may improve T2DM management. Saxagliptin was approved by the US Food and Drug Administration in July 2009 and by the European Medicines Evaluation Agency in October 2009 for use as monotherapy or in combination regimens for the treatment of T2DM. OBJECTIVE: The aim of this article was to review the mechanism of action, pharmacology, clinical efficacy, and tolerability associated with the use of saxagliptin in patients with T2DM. METHODS: MEDLINE, BIOSIS, International Pharmaceutical Abstracts, and Google Scholar were searched for English-only clinical trials and therapeutic reviews published between 1966 and June 15, 2011 (search term: saxagliptin). Additional trials and reviews were identified from the reference lists of published articles. RESULTS: Findings on efficacy and tolerability were obtained from 11 completed Phase III clinical trials. In trials in saxagliptin-naive patients, changes from baseline in glycosylated hemoglobin (HbA(1c)) ranged from -0.72% to -0.90% in the saxagliptin treatment arms compared with -0.27% with placebo (all, P < 0.007). When saxagliptin was used in combination with metformin for 24 weeks, the adjusted mean reductions from baseline in HbA(1c) and the proportions of patients achieving target HbA(1c) (<7.0%) were significantly greater with saxagliptin + metformin compared with monotherapy with either drug (all, P ≤ 0.0001). When saxagliptin was used in combination with a sulfonylurea or a thiazolidinedione, the changes in HbA(1c) ranged from -0.54% to -0.64% and -0.66% to -0.94%, respectively, in a dose-dependent manner (P ≤ 0.0007 vs monotherapies). Based on changes in HbA(1c), saxagliptin + metformin was reported to be noninferior to sitagliptin + metformin (-0.52% and -0.62%, respectively; difference, 0.09% [95% CI, -0.01% to 0.20%]). Saxagliptin was reported to have been well tolerated, with the most common adverse events being upper respiratory infection, urinary tract infection, headache, and nasopharyngitis. A systematic review of cardiovascular events in pooled trial results of saxagliptin use reported no increased cardiovascular risk compared with metformin, glyburide, or placebo (relative risk, 0.24 [0.09-0.63]). CONCLUSIONS: Saxagliptin, used as monotherapy and in combination regimens, has been associated with significant reductions in HbA(1c) and significant increases in the rate of achieving target HbA(1c) in patients with T2DM. It has been reported to be well tolerated compared with other oral antihyperglycemic agents. Based on the findings from the studies in this review, the primary role of saxagliptin is expected to be in combination therapy with other antihyperglycemic agents.

Update on personal digital assistant applications for the healthcare provider.

OBJECTIVE: To review the common general drug information applications and specialty drug information applications available for personal digital assistants (PDAs). DATA SOURCES: The literature was accessed through MEDLINE (2003-June 2004). Other information was obtained through secondary sources, such as Web sites describing common PDA applications as well as actual product trials. The key search terms used were handheld, PDA, personal digital assistants, drug information, pharmacokinetics, medical information, and medical applications. STUDY SELECTION AND DATA EXTRACTION: Articles or studies that provided a review of drug information references for the PDA since 2002 were included. Data pertaining to cost and application size were obtained from product or vendor Web sites. DATA SYNTHESIS: There are numerous medical applications available for the PDA including general drug information references, specialty drug information references (eg, pediatrics, cardiology, infectious diseases, oncology, psychology, herbals), diagnostic applications, medical calculators, nursing references, and patient tracking databases. Due to the huge array of programs, as well as factors such as cost and memory requirements, the healthcare provider must be selective in the medical applications that are placed on the PDA. CONCLUSIONS: There are many excellent PDA drug information applications that provide fast and accurate drug information and other features that assist the healthcare provider.