Intended Audience Managed care pharmacists.
Release date: August 15, 2018
Expiration date: August 15, 2019
Estimated time to complete activity: 3.0 hours
Type of activity: Application
Medium: Print with Internet-based posttest, evaluation, and request for credit
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The Burden of Cardiovascular Disease in Patients With Diabetes
Adults with type 2 diabetes (T2D) have a 2-to-4–fold higher risk for cardiovascular morbidity and mortality than adults without diabetes, according to the American Heart Association (AHA). Furthermore, the AHA deems diabetes to be “1 of the 7 major controllable risk factors for cardiovascular disease (CVD).” Lack of glycemic control may lead to nerve and cardiac conduction impairments and CVD. However, glycemic control is not the only risk factor. Additional risk factors for CVD in T2D include hypertension, dyslipidemia, obesity, lack of physical activity, and smoking. Patients with T2D are also more likely to have risk factors that increase atherosclerotic cardiovascular disease (ASCVD) risk, including hypertension, dyslipidemia, and obesity. Control of these risk factors, as well as understanding the link between hyperglycemia and cardiovascular risk, is essential for the optimal management of T2D.
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Antihyperglycemic Medications for Cardiovascular Disease Risk Reduction
In recognition of the substantial prevalence of cardiovascular disease related comorbidities among patients with diabetes and the potential for some agents to increase this risk, evaluation of cardiovascular outcomes is now a standard component of late-stage clinical trials involving antihyperglycemic agents. While most agents are evaluated in noninferiority trials to establish a lack of cardiovascular-related harm, a few agents have shown significant reductions in cardiovascular-related outcomes, including mortality.
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Economic Implications With Newer Agents to Reduce Cardiovascular Risk in Diabetes
Cardiovascular disease (CVD) plays a significant role in the morbidity and mortality in type 2 diabetes (T2D). In addition to the negative impact on the health of patients, people with T2D and CVD encounter higher total healthcare costs compared with patients with T2D and without CVD. The FDA guidance of 2008 recommending cardiovascular outcomes trials (CVOTs) for T2D drug candidates prompted pharmaceutical companies to conduct such studies. Some of those drug candidates appear to have beneficial physiologic effects on cardiovascular outcomes. Pharmacoeconomic analysis can correlate observed improvements to cardiovascular outcomes to savings in healthcare spending and assist health plans in assessing the value of diabetes medications. To date, most pharmacoeconomic studies for antihyperglycemic drugs have been conducted using surrogate markers of CVD risk (eg, glycated hemoglobin, systolic blood pressure, body mass index, plasma lipid levels) and have established the economic benefit and value of diabetes drugs based on reduction in cardiovascular events. A few analyses have been conducted based on CVOT efficacy data and similarly demonstrate value in patients at high CVD risk. Combined, the pharmacoeconomic data reinforce that newer agents with CVOT benefit represent good value in general, as well as for patients with high CVD risk, and support managed care decisions regarding treatment coverage and recommendations for newer diabetes agents.
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