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Does Mounjaro Lower Your Risk of Heart Attack and Stroke?

On September 18, 2026September 18, 2026 By Dr. Scott RennieIn Weight Loss & Metabolic HealthLeave a comment

On August 28, 2026, the FDA approved a new use for Mounjaro (tirzepatide): lowering the risk of cardiovascular death, nonfatal heart attack, and nonfatal stroke in adults with type 2 diabetes who are at high risk for those events (1). That is a real change written into the drug’s FDA-approved label. The short version is this: tirzepatide matched, but did not beat, a diabetes drug that already had proven heart benefits of its own. Whether that counts as exciting news depends on what you were expecting going in.

What the Label Now Says

Mounjaro’s original approval covered blood sugar control in adults, later extended to children age 10 and up with type 2 diabetes in December 2025 (3). The new cardiovascular indication sits on top of that one. It reads, in the FDA’s language, as lowering the risk of major adverse cardiovascular events, meaning cardiovascular death, nonfatal heart attack, or nonfatal stroke, in adults with type 2 diabetes who are already at high risk for those events (1, 2). That population matters: this approval is specific to people with type 2 diabetes who already carry meaningful cardiovascular risk, largely established atherosclerotic disease.

An outcomes indication like this one is a different category of claim than glycemic control. It says the drug changed what happens to a person’s heart and vessels over years, something a lab value at three months cannot tell you on its own. That distinction is the entire reason a cardiovascular outcomes trial exists.

The Trial Behind It

The approval rests on SURPASS-CVOT, a randomized, double-blind trial that enrolled more than 13,000 adults with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries (4). Participants were assigned to tirzepatide, titrated up to 15 mg weekly or their highest tolerated dose, or dulaglutide (Trulicity) 1.5 mg weekly, followed for a median of roughly four years. Dulaglutide was not a placebo. A drug with its own proven cardiovascular track record from the REWIND trial, chosen deliberately as a harder comparator than sugar water.

The primary outcome, a composite of cardiovascular death, heart attack, or stroke known as three-point MACE, occurred in 12.2 percent of the tirzepatide group and 13.1 percent of the dulaglutide group. That is a hazard ratio of 0.92, with a 95.3 percent confidence interval of 0.83 to 1.01 (4). Tirzepatide met the prespecified bar for noninferiority (p=0.003). It did not meet the bar for superiority (p=0.09). Read plainly: tirzepatide did not fall behind a drug already known to protect the heart, and it numerically edged ahead, but the trial cannot say with statistical confidence that it beat dulaglutide on this endpoint.

Two other numbers are worth knowing even though they sit outside the approved claim. All-cause mortality was 16 percent lower with tirzepatide than with dulaglutide, hazard ratio 0.84, 95 percent confidence interval 0.75 to 0.94, per Lilly’s topline results release (5). And the weight difference was large: about 11.6 percent body weight reduction with tirzepatide against 4.5 percent with dulaglutide (4), which tracks with everything already known about how the two drugs differ on that front. Neither of those numbers was the tested primary endpoint, so treat them as suggestive rather than proven.

I do not read this trial as evidence that tirzepatide is the better heart drug. I read it as evidence that choosing tirzepatide over an active cardioprotective comparator costs you nothing on the cardiovascular side, while it still outperforms on weight and blood sugar. That is a useful thing to know, and it is a smaller claim than the headlines will make it sound.

Where This Leaves Ozempic, Wegovy, and Zepbound

Semaglutide already has cardiovascular outcomes data of its own, built from different comparators and different populations, which matters when you start comparing hazard ratios across trials. SUSTAIN-6 tested injectable Ozempic against placebo in type 2 diabetes at high cardiovascular risk and found a hazard ratio of 0.74 (6). Ozempic tablets, oral semaglutide, picked up their own cardiovascular indication in October 2025 based on the SOUL trial, hazard ratio 0.86, in a population with type 2 diabetes and atherosclerotic disease, chronic kidney disease, or both, broader than “established cardiovascular disease” alone (7). Wegovy’s SELECT trial went further still: adults with overweight or obesity and established cardiovascular disease, no diabetes required at all, hazard ratio 0.80 against placebo (8).

Four trials went into these numbers, each built around its own comparator and its own patient population. Lining the hazard ratios up side by side and picking a winner overstates what any single number can tell you. SURPASS-CVOT is the only one of the four tested against an active drug with its own proven benefit, a harder bar to clear even when the resulting number looks smaller.

Zepbound carries no such indication yet. Zepbound and Mounjaro are the same molecule, tirzepatide, at the same doses. The difference is entirely regulatory. Mounjaro is approved for type 2 diabetes, and its new cardiovascular claim comes from a trial that specifically enrolled people with diabetes. Zepbound is approved for obesity and, separately, moderate to severe obstructive sleep apnea. Its own cardiovascular outcomes trial, SURMOUNT-MMO, is still enrolling, expected to include roughly 15,000 adults with obesity who do not have diabetes, and has not reported results (9). Tirzepatide’s heart benefit currently exists on the books only under the Mounjaro name, for a population that has diabetes.

For Patients

If you have type 2 diabetes and known heart disease and you are already doing well on dulaglutide, this trial should reassure you. Superiority was not shown, so nothing in the data requires a change if your current regimen is working. If your blood sugar or weight has been harder to manage, this approval gives your clinician a documented, FDA-recognized reason to discuss tirzepatide.

Coverage is worth asking about directly. An outcomes-based indication sometimes changes how an insurer’s prior authorization process treats a drug, because it can be framed as reducing a documented risk of death rather than only managing a lab value. That is not guaranteed, and formularies vary by plan. Ask specifically whether this new indication affects your prior authorization, rather than assuming it automatically will.

Patients on my video visits do ask about switching from semaglutide to tirzepatide after news like this. I tell them to stay on semaglutide if it’s working. Superiority was not shown here, so a regimen that is already working has no data forcing a change.

The Practical Question for Prescribers

For a patient with type 2 diabetes and established cardiovascular disease, tirzepatide’s larger effect on weight and A1c, paired with a trial showing it keeps pace on cardiovascular safety against an already-protective drug, makes a reasonable case for choosing it first. That is my opinion, and it deserves the caveat the superiority test earned: the point estimate favored tirzepatide, but the confidence interval did not exclude the possibility of no difference at all.

The active-comparator design is also worth sitting with. Because there was no placebo arm, SURPASS-CVOT cannot independently quantify tirzepatide’s benefit against doing nothing. It borrows dulaglutide’s REWIND-established benefit and shows tirzepatide keeps that benefit intact. Proving a brand new benefit from scratch would have required a placebo arm, and this trial did not have one.

When type 2 diabetes is the indication, I prescribe Mounjaro.

The Bottom Line

Tirzepatide gives up nothing on heart safety when measured against a drug that already protects the heart, and it does more for weight and A1c along the way. That is the real result of SURPASS-CVOT, even though the trial stopped short of proving superiority: the noninferiority bar was met (p=0.003), the superiority bar was not (p=0.09). If you have type 2 diabetes and heart disease, ask your prescriber whether tirzepatide fits your regimen better than what you are on now, and ask whether this new indication changes what your insurer will approve. The August 28, 2026 approval gives that conversation a documented reason to happen (1).

Sources

1. FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. Eli Lilly and Company, August 28, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjaro-tirzepatide-reduce-cardiovascular

2. FDA Expands Tirzepatide Label to Reduce Cardiovascular Risk in Type 2 Diabetes. AJMC. https://www.ajmc.com/view/fda-expands-tirzepatide-label-to-reduce-cardiovascular-risk-in-t2d

3. FDA approval letter, supplement 215866/S-039 (pediatric type 2 diabetes indication, age 10 and older). U.S. Food and Drug Administration, December 19, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215866Orig1s039ltr.pdf

4. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT). New England Journal of Medicine, December 2025. PMID 41406444. https://pubmed.ncbi.nlm.nih.gov/41406444/

5. Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial. Eli Lilly and Company, July 31, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

6. Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6). N Engl J Med. 2016;375:1834-1844. https://www.nejm.org/doi/full/10.1056/NEJMoa1607141

7. McGuire DK, Marx N, Mulvagh SL, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes (SOUL). N Engl J Med. 2025. https://www.nejm.org/doi/full/10.1056/NEJMoa2501006

8. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). N Engl J Med. 2023;389:2221-2232. PMID 37952131. https://pubmed.ncbi.nlm.nih.gov/37952131/

9. Tirzepatide for Reduction of Morbidity and Mortality in Adults with Obesity (SURMOUNT-MMO). ClinicalTrials.gov, NCT05556512. https://clinicaltrials.gov/study/NCT05556512

Why Do I Eat at Night? Night Eating Syndrome Explained

On September 17, 2025September 11, 2026 By Dr. Scott RennieIn Weight Loss & Metabolic HealthLeave a comment

Night Eating Syndrome (NES) is one of those conditions that many patients, and even some clinicians, overlook. NES is a recognizable eating disorder where the timing of food intake shifts into the evening and nighttime hours, distinct from occasional snacking after dinner. Patients often feel embarrassed and dismiss it as a bad habit. It has real consequences for weight, sleep, and overall health.

The diagnosis of NES is based on established criteria. To meet the definition, at least 25 percent of daily food intake occurs after the evening meal or there are at least two episodes of nocturnal eating per week. These episodes are not explained by social or cultural norms. People with NES are aware of what they are eating at night, unlike sleep-related eating disorders where the behavior may happen without recall. The condition also needs to cause significant distress or impairment in functioning (Allison & Tarves, 2011).

In practice, this can look two different ways. Some patients skip breakfast, eat a small lunch, and end up consuming half their calories after dinner. Others wake almost every night around 1 or 2 a.m., head to the kitchen, and eat before they can fall back asleep. Over time, the pattern disrupts sleep and drives weight gain.

NES also overlaps with mood and sleep disorders. Patients often report insomnia, depression, or evening stress. Eating becomes a way to cope with anxiety or to induce sleep. That’s why treatment has to be more than calorie restriction. Cognitive behavioral therapy focused on both eating and sleep habits has shown promise, and selective serotonin reuptake inhibitors (SSRIs) have been helpful in some patients (Allison & Tarves, 2011). I prefer CBT-I, but in practice medications often end up being what gets prescribed. I don’t treat night eating syndrome myself. I screen for it before prescribing weight loss medications, then refer out.

The tie between NES and obesity is important. McCuen-Wurst and colleagues (2018) have shown that NES is associated with higher rates of metabolic problems such as type 2 diabetes and hypertension. Timing matters. Eating late into the night throws off circadian rhythms and glucose metabolism, so the impact is greater than just extra calories.

On a video visit, NES surfaces only if you ask about it directly. The question that opens it up is whether a person is eating after they have gone to bed, and whether they believe they need to eat in order to get back to sleep.

Treatment is best when it’s individualized. Weight loss alone won’t fix NES if the underlying behaviors and triggers aren’t addressed. Collaboration between primary care, psychiatry, nutrition, and sleep medicine can make a real difference. For colleagues, the key is asking when patients eat as closely as how much. For patients, understanding that this is a recognized condition with treatment options can take away some of the shame and open the door to better care.

Newly Diagnosed With Type 2 Diabetes: What You Should Know

On August 25, 2012August 30, 2026 By Dr. Scott RennieIn Weight Loss & Metabolic Health2 Comments

When a patient comes into the clinic and is diagnosed with diabetes, they usually have lots of questions. Often we discover that they are diabetic when they come in for another reason and time is often limited so I thought it would be helpful to discuss some information that I think is important for a newly diagnosed diabetic patient to understand.

Diabetes: A condition that disrupts the way your body uses blood sugar (glucose). We classify diabetes as type 1 or type 2. About 90 percent of people in the United States, Canada and Europe with diabetes have type 2.

To understand the difference between type 1 diabetes and type 2 diabetes, it’s important to understand a little about insulin. Insulin is a hormone in the body that allows all the microscopic cells inside your body to absorb and use glucose (sugar) which is one of the fuels for your body. Without enough glucose you may become tired, shaky, and not feel well. People with diabetes usually have enough sugar (digested from food) and insulin in their blood, the problem is that the cells inside the body can become resistant to insulin. Insulin is like a key that unlocks the cells inside our bodies and allows us to absorb the glucose that is present in the bloodstream. If our body cannot use our insulin effectively, the sugar in body will rise.

Type 1 diabetes is a problem where the pancreas (an organ inside your abdomen) does not make enough insulin. Remember, insulin is the key that unlocks cells/organs inside the body so that we can absorb glucose (sugar) from the blood. Without enough insulin, our blood sugar goes up and cannot be absorbed. We often treat patients with type 1 diabetes by giving them insulin because their body does not make it at all. That way the insulin will allow their body to absorb the sugar in their blood and use this “fuel” to live. Our body can also use fat as fuel instead of sugar/glucose. Some patients who have type 1 diabetes do really well by eating a low carbohydrate, high fat diet (LCHF). Many of my patients who have type 1 diabetes are able to keep their blood sugars more stable with an LCHF diet than they can with a standard high carbohydrate diet.

Type 2 diabetes is a problem where the body cannot use the insulin effectively because of an overconsumption of carbohydrates. We sometimes refer to patients who have type 2 diabetes as having insulin resistance because their bodies becomes resistant to their insulin over time. We often treat patients with type 2 diabetes by helping them lower their blood sugar naturally by taking in less carbohydrates and may also prescribe medications that help the body use insulin more effectively. Usually, patients with type 2 diabetes are overweight because of an overconsumption of carbohydrates/sugar that is stored in body fat. As body fat accumulates, our bodies become resistant to insulin and may develop type 2 diabetes.

Causes of type 2 diabetes: The most important risk factor for developing type 2 diabetes is the overconsumption of carbohydrates (carbs). Food nutrients come in the form of carbohydrates, protein and fat. When we consume carbohydrates, our insulin levels rise to help us use and store the sugar energy that comes from these carbs. Most of the storage is in the form of body fat because the insulin that is released by the body to help us process these carbs is the “storage hormone.” As fat stores in the body get filled up, the body naturally becomes more and more resistant to insulin – the body doesn’t want to store anymore fat. The end result is that the body has to produce increasing amounts of insulin to overcome this insulin resistance and keep the blood sugars under control. Our body can compensate for the overconsumption of carbohydrates for awhile (months or years), but eventually the body may fail to produce enough insulin to keep the blood sugar low enough and then type 2 diabetes can be diagnosed.

The likelihood of developing diabetes is higher in certain ethnic groups such as people of Hispanic, African and Asian descent. Environmental factors such as what you eat and how active you are the most important risk factors for developing type 2 diabetes.

Fat, an alternative fuel source for the body instead of sugar:

There is good news when it comes to diabetes and also losing weight. We can use fat as a source of energy to fuel the body instead of carbohydrates. By consuming a low carbohydrate/high fat diet our body will use body fat as an energy source by breaking it down into ketone bodies. As we eat less carbohydrates, we allow our insulin levels to remain low and therefore as a natural consequence, we breakdown stored body fat instead of becoming more overweight. Losing weight helps us become less resistant to insulin and improve our blood sugar naturally. In my opinion, this diet is one of the best ways to treat diabetes.

Pregnancy: About 3-5% of patients who are pregnant develop “gestational diabetes” or diabetes in pregnancy. Diabetes during pregnancy usually resolves after the delivery of the baby however these women are at increased risk of developing type 2 diabetes later in life.

Symptoms of diabetes: Some people develop symptoms and many people who have diabetes don’t have symptoms. Possible symptoms include:

1) Feeling thirsty

2) Fatigue or feeling tired frequently

3) Needing to urinate frequently

4) Blurred vision

Testing for diabetes: There are several tests to measure blood sugar (glucose) to establish a diagnosis of diabetes:

1) Random blood sugar: If you check your sugar and at any time of day regardless of when you ate and your blood sugar is 200 mg/dl or higher, and you have symptoms – it is likely that you have diabetes.

2) Fasting blood sugar: A blood test that is performed after not eating or drinking anything except water for 8-12 hours (overnight usually). If your blood sugar is less than 100mg/dl – you probably do not have diabetes. If it’s between 100-125, you have an impaired test and are at risk of developing diabetes if lifestyle changes are not made. If the fasting glucose is greater than 125, and symptoms are present, you have diabetes.

3) Hemoglobin A1c: A blood test that measures your average blood sugar over the past 3 months. The normal value is usually 4-5.6%. This test can be done at anytime of day. A result of 5.7-6.4 indicates a high risk of developing diabetes and greater than 6.4 indicates diabetes.

4) Oral glucose tolerance test: A patient who is fasting for 8-12 hours usually comes in and then drinks a special glucose solution (usually orange or lemon flavored) and your blood sugar is tested before drinking it and again an hour and sometimes 2 hours after drinking the solution. If your blood sugar is higher than 200 two hours after the glucose tolerance test, you have diabetes.

Other medical problems: Often people who have diabetes also have high blood pressure, and/or high cholesterol as well.

Reasons to get your blood sugar under control: Many newly diagnosed diabetic patients aren’t really sure about the value of having good control of their blood sugars because many people don’t have symptoms when their blood sugar is elevated. I think it’s important to remind ourselves of the adverse consequences of poorly controlled diabetes:

1) Increased risk for heart attack/stroke – with poorly controlled blood sugars, you increase your risk of heart attack or stroke dramatically

2) Diabetic retinopathy – diabetes can cause blindness

3) Diabetic nephropathy – diabetes can cause permanent kidney damage and is a leading cause for patients to require kidney dialysis

4) Diabetic neuropathy – diabetes can cause chronic pain or numbness which usually starts in the toes and feet. This can progress and become very painful with time.

5) Poor wound healing – when blood sugars are not well controlled, wounds such as a common scrape or cut can take much longer to heal and become prone to infection.

6) Poor circulation – many patients with poorly controlled diabetes have such poor circulation into their feet or toes that then have partial amputations of limbs performed when chronic infection or death of tissue occurs because of poor circulation.

My recommendations:

1) Talk to your primary care physician.

2) Decrease the quantity of carbohydrates/sugar that you’re consuming. Avoid soda pop, fruit juices, sports drinks, energy drinks, frappiccinos, candy, pastries (doughnuts, cookies, brownies), potatoes, rice, noodles, breakfast cereals, ice cream, jams and jellies, yogurt that has lots of sugar, and processed foods. Do not add sugar to foods that you eat. Be careful with fruit because there is a lot of sugar in fruit.

3) Meet with a diabetic nurse educator to make sure you understand how to use your glucometer, check your blood sugars and take your medication.

4) Record your blood sugars every day with a glucometer. Usually, I recommend that when you first are diagnosed with diabetes that you check more frequently including first thing in the morning before breakfast, 2 hours after breakfast, 2 hours after lunch, and right before going to bed. Write the dates and times down in a journal or computer spreadsheet and remember to bring this with you when you come to your doctor appointment. You can also email or fax these records to your doctor if this is easier for you.

5) Record your blood pressures twice a day – first thing in the morning and also right before going to bed. Try not to check your blood pressure right after exercise or after drinking a cup of coffee, tea or other caffeinated beverage.

6) Make a list of all the medications that you take, and bring the list with you each time you go to your doctor. If your doctor changes any of your medications or dosages, have them write the change on your medication list and update the list at home at your first opportunity.

If you think that you or someone that you know has diabetes, please make sure to be seen by a medical provider.

I hope that you have found this information useful. Wishing you the best of health,

Dr. Scott Rennie

Tag: type 2 diabetes

Does Mounjaro Lower Your Risk of Heart Attack and Stroke?

What the Label Now Says

The Trial Behind It

Where This Leaves Ozempic, Wegovy, and Zepbound

For Patients

The Practical Question for Prescribers

The Bottom Line

Related Reading

Sources

Why Do I Eat at Night? Night Eating Syndrome Explained

Related Reading

Newly Diagnosed With Type 2 Diabetes: What You Should Know

Related Reading