Contributor: Frank Lavernia, MD
In December 2008, the U.S. Food and Drug Administration (FDA) issued guidance to the pharmaceutical industry setting new expectations for the development of anti-diabetes drugs for type 2 diabetes (T2DM). This guidance focused specifically on cardiovascular (CV) safety, largely in recognition of the excess burden of cardiovascular disease (CVD) in T2DM. The FDA was responding to prevailing concerns about the potential for increased CVD risk associated with certain anti-diabetes drugs. The completed CVOTs (Cardiovascular Outcome Trials) have provided much valuable information. It turns out that the newer agents in classes such as the oral SGLT-2 inhibitors (SGLT-2i, such as Invokana, Jardiance, Farxiga, and Steglatro) and the non-insulin injectable GLP-1 receptor agonists (GLP-1 RA, such as Byetta, Victoza, Bydureon, Trulicity, Ozempic), have all shown safety (in all) and benefit (in some) in improving on cardiac, stroke, and kidney events in people with diabetes and underlying vascular disease (history of myocardial infarction, stroke, or peripheral vascular disease).
Previously clinicians (as well as patients) have grouped people into silos. For instance, the patients have been put into groups of people with diabetes and or history of cardiovascular disease. Real patients have a multitude of different disease afflictions. But people with diabetes are twice as likely to develop heart disease. If they struggle with obesity, their risk is even higher. If their age is over 60, having T2DM and cardiovascular risk can cut their life short by an average of 12 years. The incidence of heart failure is increased 2-fold in men with diabetes and 5-fold in women. This connection between diabetes and cardiovascular risk also means high cost with medicines and provider visits. This is why the development of these newer classes of medications are so important. Not only have they shown a benefit for better cardiovascular outcomes (GLP-1 RA) but also for congestive heart failure, hypertension, and improvement of renal function with use of (SGLT-2i).
We are moving away from the glucocentric management of diabetes, when we were more concerned about getting only to A1c goals. Now, we have newer drugs in the arsenal that not only get more blood glucose readings into intended target ranges, but also lower the incidence of hypoglycemia and weight gain. These newer drugs can also lower blood pressure and improve on glucose variability (less up and downs of blood sugars throughout the day).
Unfortunately, they cost more. Or do they? It turns out that the #1 cause of ER visits and hospitalizations in the Medicare population is secondary to hypoglycemia with the culprit being sulphonylureas (Glyburide, Glimeperide, and Gliplizide) and/or insulin use at a tune of over $10,000 per hospitalization. The ADA/EASD consensus statement recently announced that the GLP-1 RA are now the first injectables that should be used (some are weekly preparations) before insulin (daily) is started.
Health care providers are moving into a patient-centered era where patients, in partnership with their health care providers, participate in decisions about the medications that they will use. This increased empowerment and active participation will result in better cardiovascular and diabetes outcomes.
Dr. Lavernia has been a practicing diabetologist in South Florida for more than 35 years. He was the founder and director of the North Broward Diabetes Center in Florida. He is an adjunct faculty member of the National Diabetes Education Initiative (NDEI), Vascular Biology Working Group (VBWG), and for the Coalition for the Advancement of Cardiovascular Health (COACH). He is also a member of the American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes, and the National Hispanic Medical Association. He is a member of the DiabetesSisters Board of Directors.