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Supplements Utilizing Advances in Diabetes and Targeting Medication Adherence to Enhance Clinical Outcomes and M
Economic Impact of and Treatment Options for Type 2 Diabetes
Jan D. Hirsch, BSPharm, PhD, and Candis M. Morello, PharmD, CDE
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Overview of the Cardiovascular Benefit With Diabetic Agents and Novel Combination Products for Type 2 Diabetes
Candis M. Morello, PharmD, CDE
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Overview of the Cardiovascular Benefit With Diabetic Agents and Novel Combination Products for Type 2 Diabetes

Candis M. Morello, PharmD, CDE
Cardiovascular (CV) disease is commonly observed in individuals with type 2 diabetes (T2D) and is associated with significant morbidity and mortality. Diabetes medications can have substantial negative or beneficial CV effects in these patients. Thus far, specific glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors have been shown to have beneficial CV effects in persons with T2D. Clinical trials are ongoing to evaluate the CV effects of investigational and recently approved diabetes medications. Additional advances through novel combination products have been shown to improve medication adherence and patient convenience. Future studies will evaluate the long-term effects of these combination products in patients with T2D.
Am J Manag Care. 2017;23:-S0
Cardiovascular (CV) disease is a common comorbidity of type 2 diabetes (T2D) and is associated with significant morbidity and mortality in this patient population.1 Since 2008, the FDA requires all new diabetes medications to be evaluated for unacceptable increases in CV risk. Among other expectations, drug sponsors must provide an independent CV endpoints committee to prospectively, and in a blinded fashion, adjudicate CV events during phase 2 and phase 3 trials. CV events include mortality due to CV disease, myocardial infarction (MI), and stroke, and can include hospitalization for acute coronary syndrome and urgent revascularization procedures, as well as other related endpoints.

Several randomized trials suggest that liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), and empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, lower CV risk when added to standard care in patients with T2D with established CV disease.2 Semaglutide, another promising GLP-1 RA under study in the SUSTAIN 6 trial, has demonstrated CV benefit and is being evaluated for FDA approval.3 In the CANVAS trial, canagliflozin (compared with placebo) was associated with a lower risk of CV events but a greater risk of amputation.4 The mechanism by which these medications exert these effects is unclear and is unlikely attributable to their modest glucose-lowering effects. However, these medications are costly and the numbers needed to treat (NNT) to benefit 1 patient are fairly large. The current American Diabetes Association and American Association of Clinical Endocrinologists/American College of Endocrinology treatment guidelines recommend considering liraglutide or empagliflozin for patients with established CV disease to reduce the risk of mortality.1 Other incretin-based drugs, such as lixisenatide, have not demonstrated these beneficial effects, or, as in the case of some dipeptidyl peptidase-4 (DPP-4) inhibitors, have revealed an association with the development of heart failure (HF).5 The mechanisms of the observed CV differences between DPP-4 inhibitors and GLP-1 RAs and among individual DPP-4 inhibitors and GLP-1 RAs need further delineation and research.
Novel combination products take advantage of complementary mechanisms of action to maximize efficacy and reduce adverse effects (AEs). These products offer patient convenience and can increase medication adherence. One novel combination product was recently FDA approved and several are under investigation.



 
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