What do we need to tell our patients about preventing the risk for death?
Certainly this year one of the more important outcomes from current studies for 2016 has to be the new indication for the SGLT-2 drug empagliflozin. Also, the results from the LEADER study showed liraglutide reduced CV death. Since most diabetes patients don’t die from diabetes, but from strokes and heart attacks, and we now have a drug that can help prevent death from cardiovascular disease, is it our responsibility to let our patients know?
In 2015, the EMPA-REG study showed that an SGLT2 inhibitor was able to reduce CV death in patients with diabetes who had established cardiovascular disease.
In September 2016, the SUSTAIN study showed that the once-weekly GLP-1 agonist semaglutide was associated with reduced risk for stroke in patients with diabetes.3
These studies are significant because, up to this point, we were not able to reduce CV death with glucose control. Glucose agents are well known to be beneficial in microvascular disease. The concept being that glucose attaches to proteins in the cells of small blood vessels. This process of glycosylation is one of the ways that hyperglycemia causes retinopathy and nephropathy. Hence, reduction of glucose helps to reduce this microvascular disease process.
On the other hand, improvement in outcomes of macrovascular diseases such as stroke and myocardial infarction has been difficult to achieve with glucose-lowering agents. Macrovascular benefits associated with these agents could only be seen in the extensions of these trials 10 or 15 years later. It is with this in mind that these new studies have earned their right to be story of the year.
EMPA-REG: Median follow-up 3.1 years – CV death reduced 38% with NNT 45
LEADER: Median follow-up 3.8 years – CV death reduced 22% with NNT 77
SUSTAIN-6: Median follow-up 2.1 years – Stroke reduced 39% with NNT 90
FDA approves new indication for Jardiance made by Eli Lilly and Boehringer Ingelheim for reducing the overall risk of having a heart attack or stroke, or of dying from cardiovascular causes, by 14 percent. Looking only at cardiovascular deaths, the reduction was 38 percent.
So, for over 2 decades, glucose-lowering agents could only barely show CV benefits. Yet, now, with these three studies, we can see benefits within a short amount time. Last year on December 2, 2016, the FDA expanded the approved use of the oral diabetes medication Jardiance (empagliflozin) to include reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. Cardiovascular disease is the leading cause of death in people with diabetes, who are at least twice as likely as those without diabetes to have heart disease or a stroke.
We will continue to argue as to why the effects are there just like we used to debate about how ACE inhibitors were vascularly protective. The debates on SGLT2 inhibitors and GLP-1 agonists will continue, but the good news is that now we have more agents that can reduce CV events and death in our patients with diabetes.
Last year, 2016, was the year that the first baby boomer turned 70 years of age, and for the next 20 years, there will be a large number of patients in this age category marching through the system. Patients in this age category have diabetes rates estimated to be as high as 25% to 30%. That is a lot of patients with diabetes coming through the system.
That is why it is crucial that we have good treatments that reduce all of the complications of diabetes. These agents will not only control glucose and reduce microvascular disease, but now they can also affect macrovascular disease and, more specifically, CV death. Truly good news for our patients with diabetes.
This medicine should not be used in people with type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or severe kidney problems.
The most commonly reported side effects of Jardiance include urinary tract infections and female genital infections.
To learn about another diabetes drug that is indicated for the reduction of postprandial blood glucose, but while doing that also reduces the risk for CVD by 53% while taking metformin, check out the article “Study Indicates that Diabetes Medication Reduced CVD Hazard Rate 53% in Type 2 Diabetes Subjects Taking Metformin”
- The FDA approved the first drug with the indication to prevent the risk for heart attacks and strokes.
- It is our responsibility to let our patients know that there is a treatment available that can reduce their risk for CV disease and death.
- Providing the information that this new drug can reduce their risk for cardiovascular death by 38%