Type 2 diabetes mellitus (T2DM) is characterized by the progressive loss of adequate insulin secretion from the pancreas and peripheral insulin resistance. It affects more than 34 million Americans, with minorities bearing a disproportionate burden of disease.1 Chronic exposure to high blood glucose levels may damage both small (microvascular) and large (macrovascular) blood vessels, and can result in complications such as blindness, chronic kidney disease (CKD), and atherosclerotic cardiovascular disease (ASCVD). Consequently, the annual costs associated with T2DM exceeded $300 billion in 2017.2 Patients with T2DM described the struggle of managing their disease, including struggles with glycemic control, losing weight, managing comorbidities and disease complications, and the expense of medications. Early, comprehensive, culturally tailored education about diabetes self-management, along with access to and affordability of medications, were identified as critical factors in the success of managing T2DM over a patient’s lifetime. A measurable short-run goal of treating T2DM is glycemic control, with a goal glycated hemoglobin (HbA1c) of <7.0% in most patients. Beyond lifestyle modifications, metformin is recommended as first-line therapy in most patients. Additional therapy is indicated if glycemic goals are not met with metformin alone. For patients with or at high risk of ASCVD, heart failure, or CKD, sodium glucagon-like peptide-1 receptor agonists (GLP-1 RA) or glucose transporter-2 (SGLT-2) inhibitors – with or without metformin - are preferred due to favorable cardiovascular and renal outcomes data. Even with current treatment options, nearly half of T2DM patients may not have adequate levels of glycemic control. Tirzepatide (Eli Lilly), a novel, once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) receptor and GLP-1 RA combination drug, has been developed to treat patients with T2DM. A biologics license application with priority review was submitted to the FDA for T2DM on October 27, 2021, with a decision expected in mid-2022. We compared the clinical and cost effectiveness of tirzepatide added on to background therapy compared with background therapy alone, or injectable semaglutide (Ozempic®, Novo Nordisk) or empagliflozin (Jardiance®, Boehringer Ingelheim and Eli Lilly) added on to background therapy. Treatment with tirzepatide 15 mg resulted in a statistically significant decrease in HbA1c of 2.5% and in weight of 10.9 kg compared with background therapy. Gastrointestinal symptoms were the most common adverse events; severe hypoglycemia was rare.
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