Off label update:
Ozemipic’s new indication, what does it mean for type 1 diabetes management?
There are two massive money makers in the pharmaceutical space these days, type 2 diabetes and Cardiovascular disease. With diabetes diagnosis rates climbing year after year, and heart disease being the number one cause of death in the US, this is not surprising. This population also typically overlaps. A major complication risk for people with diabetes is an increased risk for heart disease. Heart attack and heart failure rates are 4x higher in people with diabetes than the general public. Elevated blood sugars can cause triglyceride levels to rise in the blood, which can put us at higher risks for development of blockages and plaques in blood vessels, so blood sugar management is key. However, the two most popular and effective medications that we have used to treat high blood sugars have also carried side effects of the potential to increase heart disease risk (Specifically basal insulin and sulfonylureas). Finding medications that are not only heart disease risk neutral but can reduce heart disease risk is the ideal.
What are the 2 most popular and effective medications to treat high blood sugars that increase heart disease risk?
We have had an SGLT2 medication called Empaglifolozin.
This medication has had an indication to reduce heart failure in persons with Type 2 diabetes by reducing fluid volume retained in the body which also reduces blood pressure. This medication has also been a standout in the industry for having shown a reduction in repeated incidence in hospitalizations in people with established heart disease. Studies on most diabetes medications excluded participants with existing heart disease diagnoses and measured occurrences of new disease onset or events. But the Empagliflozin included persons with preexisting heart disease in their study data, and were this allowed an indication of not only preventing, but reducing occurrences of cardiovascular events.
We have also had liraglutide approved to reduce Heart disease risks.
However, Recently Novonordisk announced an additional indication for their GLP-1 medications Ozempic to “reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.” This medication works by slowing gastric emptying which can reduce post prandial blood sugar spikes. Another helpful effect of this slowing is that we remain feeling full longer so it can help in weight management. Ozempic also stimulates insulin production to help maintain blood sugars in target range more effectively.
In 2019 we saw the FDA refuse to approve SGLT2 medications for people with type 1 diabetes due to DKA risk concerns, though this medication has been approved in the EU for years. GLP1 medications are also not indicated for use in the treatment of type 1 diabetes, however this medication can be helpful as people with Type 1 also have been shown to produce less of a hormone called incretins. This means that we often struggle with more rapid gastric emptying that can cause post meal blood sugars to rapidly climb. We also are more likely to struggle with increased appetite and reduced satiety due to these reduced incretin levels. As people with Type 1 we also may see an increased glucagon release after meals that we are not able to regulate leading to rapid post meal blood sugar spikes. GLP1 medications can offset these issues to help us keep post prandial blood sugars down.
An additional benefit for people with type 1 diabetes would be that reduced post prandial blood sugars can reduce total daily insulin use. This reduced insulin use combined with increase satiety can help us with weight management, a very complex struggle in Type 1 management.
Side effects of GLP-1 medications are primarily gastric, including nausea, diarrhea or constipation. These typically go away over a week or so at a steady dose and doses should be titrated up over months to avoid intense side effects. When starting these medications people with type 1 should expect digestion times to increase. This can be offset with using longer absorption times in Loop, using extended boluses on pumps, or splitting bolus doses with injection therapy. A reduction in bolus dose may also be needed.
Because these medications are not approved for use by persons with type 1 diabetes doctors may be hesitant to prescribe but approaching the conversation with education can help us partner with our prescribers well. Insurance companies may require a prior authorization from your prescriber.
The physiological truth is that diabetes is not black and white, type one or type 2. Most of us fall along the spectrum with type 1 with features of type 2 diabetes. So remaining open minded to the ability of medications for type 2 diabetes helping us manage type 1 can be really helpful.