What Are SGLT-2 Inhibitors and How Can They Help Your Heart?

This content originally appeared on diaTribe. Republished with permission.

By Mary Barna Bridgeman

SGLT-2 inhibitors can protect your heart! This type of medicine is recommended for people with type 2 diabetes who have heart disease or risk factors related to heart disease. Learn about the use of these medicines, including side effects, their effect on A1C, and their role in supporting heart health

Diabetes is a risk factor for heart disease: people with diabetes are twice as likely to have heart disease or a stroke compared to those without diabetes. Heart disease is often a “silent” condition, meaning that symptoms are not necessarily present until a heart attack or a stroke actually happens. It is important for people with diabetes to realize they may be at risk – click to read more about the link between diabetes and heart disease from Know Diabetes By Heart.

There are many ways to take care of your heart and to reduce the risk of heart disease while living with diabetes. New medicines, including sodium-glucose cotransport 2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) agonists, have been shown to protect the heart and reduce the risk of many specific heart-related outcomes. This article will focus on SGLT-2 medications, and our next article will focus on GLP-1 medications.

Heart diseases

Image source: diaTribe

Click to view and download diaTribe’s helpful infographic on preventing heart disease.

What are SGLT-2 inhibitors?

There are currently four medicines that are categorized as SGLT-2 inhibitors:

These medicines help people with type 2 diabetes manage their glucose levels: they work in the kidneys to lower sugar levels by increasing the amount of sugar that is passed in the urine. SGLT-2s increase time in range and reduce A1C levels while also lowering blood pressure and supporting weight loss. For people with diabetes who have had a heart attack or are at high risk of heart disease, or who have kidney disease or heart failure, these medicines could be considered regardless of A1C level. While SGLT-2 medications are expensive, some assistance programs are available to help with cost – see one of diaTribe’s most popular articles, “How to Get Diabetes Drugs For Free.”

What do you need to know about SGLT-2 inhibitors?

SGLT-2s have a low risk of causing hypoglycemia (low blood sugar levels). Because they increase sugar in the urine, side effects can include urinary tract infections and genital yeast infections in men and women. Dehydration (loss of fluid) and low blood pressure can also occur. Symptoms of dehydration or low blood pressure may include feeling faint, lightheaded, dizzy, or weak, especially upon standing.

Before starting an SGLT-2 inhibitor, here are some things to discuss with your healthcare team if you have type 2 diabetes:

  • How much water to drink each day
  • Ways to prevent dehydration and what to do if you cannot eat or you experience vomiting or diarrhea (these are conditions that may increase your risk of developing dehydration)
  • Any medicines you take to treat high blood pressure

When prescribed for people with type 2 diabetes, SGLT-2s rarely cause diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition. For people with type 1 diabetes, DKA is a well-known risk when SGLT-2s are prescribed. Call your healthcare professional if you have warning signs of DKA: high levels of ketones in your blood or urine, nausea, vomiting, lack of appetite, abdominal pain, difficulty breathing, confusion, unusual fatigue, or sleepiness. When you are sick, vomiting, have diarrhea, or cannot drink enough fluids, you should follow a sick day plan – see Dr. Fran Kaufman’s article on developing your sick day management plan. Your healthcare professional may instruct you to test your urine or blood ketones and stop taking your medication until symptoms go away.

If you have type 1 diabetes or chronic kidney disease, depending on your level of kidney function, these medicines may not be for you. Additionally, SGLT-2s are associated with increased risk of lower limb amputation.

SGLT-2 inhibitors are usually taken as a pill once a day – often in the morning before breakfast – and can be taken with or without food.

What do SGLT-2 inhibitors have to do with heart health?

Results from clinical studies suggest SGLT-2 inhibitors may play an important role in lowering heart disease risks.

Jardiance was the first SGLT-2 inhibitor to show positive effects on heart health in the EMPA-REG OUTCOME trial. In this study, more than 7,020 adults with type 2 diabetes and a history of heart disease were followed. Participants received standard treatment for reducing heart disease risk – including statin medications, blood pressure-lowering drugs, aspirin, and other medicines – and diabetes care, plus treatment with Jardiance. Over a four-year period, results from the study showed that, compared to placebo (a “nothing” pill), Jardiance led to:

  • a 14% reduction in total cardiovascular events (heart attacks, strokes, heart-related deaths)
  • a 38% reduction in risk of heart-related death
  • a 32% reduction in overall death
  • a 35% reduction in hospitalizations from heart failure

Read diaTribe’s article on the results here.

Similarly, the heart protective effects of Invokana have been shown in two clinical studies, CANVAS and CANVAS-R. These two studies enrolled more than 10,140 adults with type 2 diabetes and a high risk of heart disease, randomly assigned to receive either Invokana or placebo treatment. In the CANVAS studies, treatment with Invokana led to the following:

  • a 14% reduction in total cardiovascular events (heart attacks, strokes, heart-related deaths)
  • a 13% reduction in risk of heart-related death
  • a 13% reduction in overall death
  • a 33% reduction in hospitalizations from heart failure

Read diaTribe’s article on the results here.

Farxiga may also reduce heart disease risks. In the DECLARE-TIMI 58 study, more than 17,000 people with type 2 diabetes received Farxiga; 40% of participants had known heart disease and 60% had risk factors for heart disease. Importantly, more than half of the people included in this study did not have existing heart disease. While Farxiga was not found to significantly reduce total cardiovascular events (heart attacks, strokes, heart-related deaths) compared with placebo, its use did lead to a 17% lower rate of heart-related death or hospitalization for heart failure. Read diaTribe’s article about the results here.

More recently, the DAPA-HF study evaluated the use of Farxiga for treating heart failure or death from heart disease in people with or without type 2 diabetes. The study included more than 4,700 people with heart failure; about 42% of those enrolled had type 2 diabetes. Farxiga was shown to reduce heart-related death or worsening heart failure by 26% compared to placebo, both in people with type 2 diabetes or without diabetes. Learn more about these results here.

All of the available SGLT-2 inhibitors have evidence suggesting benefits of this class of medications for people with established heart failure. Click to read diaTribe’s article on SGLT-2 Steglatro and heart health.

Other possible benefits of SGLT-2 inhibitors

InvokanaFarxiga, and Jardiance have also been shown to reduce the progression of kidney disease. Learn more about diabetes and kidney disease here.

SGLT-2s have been studied in people with type 1 diabetes, but are not yet approved for use by the FDA – you can learn about SGLT-2s for people with type 1 diabetes here.

What’s the bottom line?

You can reduce your risk of heart disease and promote heart health while living with diabetes. You and your healthcare team should develop a personalized plan to determine what ways are best for reducing your risk of heart disease. According to the latest evidence and treatment recommendations, SGLT-2 inhibitors may be most useful for people with type 2 diabetes and heart disease or at high risk of heart disease.

About Mary

Mary Barna Bridgeman, PharmD, BCPS, BCGP is a Clinical Professor at the Ernest Mario School of Pharmacy at Rutgers University. She practices as an Internal Medicine Clinical Pharmacist at Robert Wood Johnson University Hospital in New Brunswick, New Jersey.

This article is part of a series to help people with diabetes learn how to support heart health, made possible in part by the American Heart Association and American Diabetes Association’s Know Diabetes by Heart initiative.

Source: diabetesdaily.com

Rybelsus, the First GLP-1 Pill, Approved for Type 2 Diabetes in Europe

This content originally appeared on diaTribe. Republished with permission.

By Frida Velcani

Rybelsus, a GLP-1 agonist pill already approved in the US, received positive feedback from the European Medicines Agency (EMA) in January and was just approved on Saturday!

In exciting news for the type 2 diabetes community, the first GLP-1 agonist pill for type 2 diabetes has not only been recommended for approval in Europe, it has just been approved by the European Medicines Agency (EMA)! Rybelsus (formerly known as oral semaglutide in clinical trials) is a pill version of Ozempic, a GLP-1 agonist injection for type 2 diabetes. Rybelsus was approved in the US in September 2019, and was met with incredible enthusiasm from the diabetes community, particularly due to its availability and accessibility in the US. For a Rybelsus savings card, text READY to 21848, or go to saveonr.com.

Rybelsus, a once-daily pill, can be taken alone or in combination with other treatments for type 2 diabetes. Currently, GLP-1 agonists in Europe are available only as injections (which, depending on the medication, are taken twice-daily, once-daily, or once-weekly). This approval provides more options for people interested in starting GLP-1 treatment. The EMA approval was great news for giving people more options – the once-weekly injections have also been widely embraced.

The EMA added data to the Rybelsus label confirming that it lowers blood glucose and improves heart health – although it doesn’t say “primary prevention,” the label indicates that heart attacks are prevented in people with and without established heart disease. Clinical trials show that both Rybelsus and Ozempic reduce the risk of heart attack, stroke, and heart-related death. This is important because people with type 2 diabetes are at substantially higher risk of heart disease than those without diabetes. Click here to learn more about the benefits of Rybelsus.

Novo Nordisk has not released information about pricing for Rybelsus in Europe. Our hope is that everyone who can benefit from a GLP-1 agonist will be able to access it as early as possible.

There are more social safety nets in the EU than in the US, and many parts of the EU are more focused on prevention and preparedness than the US, so we have high hopes for accessibility in the EU. The European Society of Cardiology recommends that those with type 2 diabetes begin taking GLP-1 or SGLT-2 medications directly after diagnosis. This is good news for people with type 2 diabetes, as the recommendation should enable greater awareness among healthcare professionals. It will also help the field get less caught up in what has previously been called “clinical inertia.”

If you have type 2 and would like to learn more about a pill that has the benefits of GLP-1 – heart disease prevention, weight loss, lower A1C, and less hypoglycemia (and many experts associate also associate improved time in range with GLP-1) – chat with your doctor or a member of your healthcare team. If you like the idea of a pill, mention Rybelsus, or if you like the idea of a once-weekly injection, mention BydureonOzempic, or Trulicity.

Source: diabetesdaily.com

Diabetes Isn’t “One Size Fits All”

I love the diabetes online community for everything that it offers: advice in times of need, hope in times of despair, helpful anecdotes and inspiring stories, and friendships formed across time zones and many miles.

One of the things that the diabetes online community sometimes does, though, is to try and prescribe how everyone with diabetes should live. One day, it’s the Dr. Bernstein diet, the next, it’s high-carb, low-fat. The Mastering Diabetes (mostly) fruit diet is so popular now that their book has even made the NYTimes Bestsellers list. People are jumping on diet and exercise bandwagons before they figure out what they truly need (and want!) in terms of their diabetes management, and what it should look like, day-to-day.

Parents are often left feeling guilty if they can’t “hack” their child’s insulin pump, and individuals with diabetes feel bad when they don’t (or can’t?) do CrossFit or maintain a super low-carb lifestyle. A once seemingly supportive community now raises an eyebrow if they spot you eyeing over a cookie during a meet-up group, or (god forbid) a sugar-sweetened beverage. But I’m here to say one thing: diabetes isn’t a “one size fits all” disease.

You are not a “bad diabetic” if you don’t have a DIY looping system, or if you don’t want to sit down and try to figure it out. You’re fine just the way you are if MDI or insulin pens work better for you, if you dislike skin adhesives, or feel claustrophobic always having something attached to you.

It’s okay if you spike every morning, without fail, due to dawn phenomenon, and if you don’t ever post your CGM graphs to social media. It’s okay if you don’t have a CGM (really, it’s fine). Or if you don’t take an SGLT2-inhibitor off-label. Or even want to try. There’s no perfect low snack. There’s no perfect meal.

Figure out what your body needs, and honor that. It’s okay if you don’t want to eat low-carb, high-carb, or in-between. Or if you’ve lived with type 1 for 15 years, enjoy your weekly ice cream treat, and don’t want to give it up. Figure out what you need and want, and do that. 

It’s okay if you don’t own a Myabetic bag, or can’t afford one, or think they’re ugly. It’s alright if you’ve never been to diabetes camp or don’t want to go. It’s alright if you don’t want to jump all into advocacy and chant, and rally, and cheer. It’s okay if self-care for you is sitting in a quiet room, and coming to a place of acceptance.

It’s okay if you don’t join any Facebook diabetes support groups, or seek out diabuddies in real life. It’s okay if diabetes is only a very small part of your life. It’s okay if it’s your whole life.

It’s okay if you don’t like going to the endocrinologist, or have to force yourself to see your eye doctor. It’s okay if you don’t like talking about your diabetes with others. Diabetes is not one size fits all.

It’s okay if sometimes you’re feeling overwhelmed, over-stimulated, and need to turn inwards, for yourself and rest sometimes.

There is no perfect way to (micro)manage, eat, exercise, handle stress, socialize (or not!), dose, count, or bolus. There is only the way that will work for you and your body. Find what works for you, and embrace that. 

Have you ever been pressured to manage your diabetes a certain way? Eat a certain diet? Exercise in a specific way? How did you deal with the pressure? Share this post and comment below; we would love to hear your stories!

Source: diabetesdaily.com

Advancements in Treatment: The Use of Adjunctive Therapies in Type 1 Diabetes

This content originally appeared on diaTribe. Republished with permission.

By Paresh Dandona and Megan Johnson

Read on to learn about the research around GLP-1, SGLT-2, and combination therapy use in type 1 diabetes. Dr. Paresh Dandona is a Distinguished Professor and Chief of Endocrinology at the University of Buffalo, and Megan Johnson is a fellow on his team

For people living with type 1 diabetes, new treatments are finally on the horizon. The University at Buffalo (UB) Endocrinology Research Center is helping to revolutionize the treatment of this condition. Among the most promising new therapies are two non-insulin medications currently used in type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists.

SGLT-2 inhibitors, such as Farxiga, act the kidney to help the body excrete more glucose in the urine. Meanwhile, GLP-1 receptor agonists like Victoza work in several different ways: increasing the body’s natural insulin production, decreasing the release of the glucose-raising hormone glucagon, slowing the emptying of the stomach, and curbing excess appetite. Some people with type 1 diabetes take these medications as an addition to insulin treatment as an “off-label” drug. To learn more about off-label, check out the article: Can “Off Label” Drugs and Technology Help You? Ask Your Doctor.

Why consider these medications?

In people without diabetes, the body is constantly releasing more or less insulin to match the body’s energy needs.  People with type 1 diabetes do not make enough insulin on their own and have to try to mimic this process by taking insulin replacement – but it isn’t easy.

People with type 1 diabetes often have fluctuations in their blood sugars, putting them at risk for both low blood sugars (hypoglycemia) and high blood sugars (hyperglycemia). Many individuals are unable to manage their blood sugars in a healthy glucose range with insulin alone. In fact, less than 30% of people with type 1 diabetes currently have an A1C at the target of less than 7%.

Can GLP-1 agonists be safely used in type 1 diabetes?

Over the past decade, the endocrinologists at the University at Buffalo and other research groups have been conducting studies to see whether GLP-1-receptor agonists can safely be used in type 1 diabetes.

  • The first of these was published in 2011 and showed a decrease in A1C within just four weeks of GLP-1 agonist treatment. Importantly, people given GLP-1 agonists plus insulin also had much less variation in their blood sugars, as measured by continuous glucose monitors (CGM).
  • Another study involved 72 people with type 1 diabetes who took GLP-1 agonist or placebo (a “nothing” pil) in addition to insulin for 12 weeks. The GLP-1 group had decreases in A1C, insulin requirements, blood sugar fluctuations, and body weight. People in this group did report more nausea – a common side effect of GLP-1 agonists.
  • Since then, multiple studies, some involving over 1000 people and lasting up to 52 weeks, have shown that GLP-1 treatment in people with type 1 diabetes can reduce A1C and body weight, along with insulin dosages.

Many of these studies, but not all, have suggested that GLP-1 agonists can do this without increasing the risk for hypoglycemia or diabetic ketoacidosis (DKA). There is also some evidence that GLP-1 agonists can improve quality of life in type 1 diabetes.

Who should consider GLP-1’s?

The effects of GLP-1 agonists seem to be especially strong in individuals who are still able to make some insulin on their own, although it also works in people who do not.

In one notable study, researchers gave a GLP-1 agonist to 11 people with type 1 diabetes who were still able to produce some insulin. To get an estimate of insulin production, they measured levels of a molecule called C-peptide, which is produced at the same time as insulin. In these 11 individuals, C-peptide concentrations increased after GLP-1 treatment. By the 12-week mark, they had decreased their insulin dosage by over 60%. Incredibly, five people were not requiring any insulin at all. Even though the study was very small, the results were exciting, because it was the first study to suggest that some people with type 1 diabetes had sufficient insulin reserve and thus, could – at least temporarily – be treated without insulin.

Can SGLT-2 inhibitors be used in type 1 diabetes?

SGLT-2 inhibitors like Farxiga have also shown tremendous potential. In two large studies called DEPICT-1 and DEPICT-2, adults with type 1 diabetes were randomly assigned to take either placebo or SGLT-2 inhibitor in combination with insulin. Over 700 people from 17 different countries participated in DEPICT-1, and over 800 people with type 1 diabetes participated in DEPICT-2. At the end of 24 weeks, people taking dapaglifozin had a percent A1C that was lower, on average, by 0.4 compared to people who had received placebo, and it was still lower, by over 0.3, at 52 weeks. The number of hypoglycemic events was similar in both groups.

As with GLP-1 agonists, people taking SGLT-2 inhibitors had weight loss and decreased insulin requirements. People taking SGLT-2 inhibitor, however, did have an increased risk of diabetic ketoacidosis (DKA). If individuals consider this therapy, they should be cautious about not missing meals or insulin, and not drinking large amounts of alcohol, as these behaviors can lead to increased ketone production.

Several other research groups, in trials recruiting up to 1000 individuals, have seen similar results when using this class of medications.  Researchers have been conducting additional studies to try to determine how best to minimize the risks associated with them. Farxiga (called Forxiga in Europe) has now been approved as the first oral agent as an adjunct treatment for type 1 diabetes in Europe and Japan.

Promising Combination Therapy

Now, endocrinologists are also looking at whether GLP-1 agonist and SGLT-2 inhibitor combination therapy could increase the benefits of each of these treatments. A study conducted on a small number of people showed that GLP-1 agonists can help prevent ketone production, so it is theoretically possible that this medication could reduce the risk of DKA that was seen with SGLT-2 inhibitors.

In an early study involving 30 people with type 1 diabetes who were already on GLP-agonist and insulin were randomly assigned to take SGLT-2 inhibitor or placebo, as well. People who received both drugs saw an 0.7% reduction in A1C values after 12 weeks, without any additional hypoglycemia. People on the SGLT-2 inhibitor did make more ketones, though, and two individuals in the combination group experienced DKA. Larger studies are now being conducted to expand on these results and learn more about how to give these drugs safely. The hope is that non-insulin therapies will soon be approved for type 1 diabetes. By unlocking the potential of these therapies, we can do more than manage blood glucose levels – we can improve people’s lives.

Source: diabetesdaily.com

Can Ozempic Protect the Kidneys for People with Type 2 Diabetes?

This content originally appeared on diaTribe. Republished with permission.By Divya Gopisetty A trial is enrolling over 3,000 individuals living with type 2 diabetes and chronic kidney disease Clinical Trial Identifier: NCT03819153 Trial Name: A Research Study to See How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease (FLOW) Diabetes type: Type […]
Source: diabetesdaily.com

I Thrive: Being the Architect of Your Future

While Basil’s story might not be about epic adventures of climbing mountains or sailing around the world, his story is real and unapologetically his. He’s a husband, father, uncle, son, and entrepreneur. His story deeply resonates. During the years when his body was in a pre-diabetic state, he actually wasn’t aware it existed and ultimately […]
Source: diabetesdaily.com

Diabetes Medicines That Help Your Waistline and Your Heart

This content originally appeared on TCOYD: Taking Control of Your Diabetes. Republished with permission.By Daniel Einhorn Among the dirty little secrets of the older diabetes medicines was that they usually made you gain weight, they could cause low blood sugar suddenly and unexpectedly, and they had no particular benefit to the most important consequence of […]
Source: diabetesdaily.com

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