Adults with obstructive sleep apnea had a greater reduction in events per hour at 1 year with tirzepatide vs. placebo.
Tirzepatide reduced OSA symptoms for adults using and not using positive airway pressure.
Adults with moderate to severe obstructive sleep apnea and obesity had reductions in sleep apnea severity at 1 year with 10 mg or 15 mg of tirzepatide, according to topline results from two phase 3 trials.
As Healio previously reported, tirzepatide (Zepbound, Eli Lilly) was approved by the FDA for chronic weight management among adults with obesity in November 2023. Topline results from the SURMOUNT-OSA trials showed tirzepatide may have benefit beyond body weight reductions, as participants receiving the agent had greater reductions in apnea-hypopnea index (AHI) than placebo. AHI is a measure of the number of times a person with OSA has a restricted or complete block of airflow per hour of sleep.
Tirzepatide reduced sleep apnea severity and lowered body weight among adults with moderate-to-severe OSA and obesity. Image: Adobe Stock
The first SURMOUNT-OSA study enrolled adults with moderate to severe OSA and obesity who were not using positive airway pressure therapy. Participants were randomly assigned to once-weekly 10 mg or 15 mg tirzepatide or placebo for 1 year.
At 1 year, adults receiving tirzepatide had a mean AHI reduction of 27.4 events per hour from baseline compared with a mean AHI reduction of 4.8 events per hour for the placebo group according to the efficacy estimand. The tirzepatide group reduced their AHI from baseline by 55% compared with 5% for the placebo group. Adults receiving tirzepatide lost a mean 18.1% of their body weight from baseline to 1 year vs. a 1.3% reduction with placebo.
The second SURMOUNT-OSA study included adults with moderate to severe OSA plus obesity who continued positive airway pressure therapy during the study. In the efficacy estimand, adults receiving tirzepatide had a mean AHI reduction of 30.4 events per hour from baseline to 1 year compared with a mean reduction of 6 events per hour for the placebo group. The mean AHI reduction was 62.8% for the tirzepatide group vs. 6.4% for the placebo group. Those receiving tirzepatide lost a mean 20.1% of body weight from baseline to 1 year compared with a mean 2.3% weight loss with placebo.
The safety profile of tirzepatide in SURMOUNT-OSA was similar to what was previously reported in the SURMOUNT and SURPASS trials. The most common adverse events were gastrointestinal-related and were generally mild to moderate in severity. The most common adverse events in the first SURMOUNT-OSA study were diarrhea, nausea and vomiting, and the most common adverse events in the second study were diarrhea, nausea and constipation.
“Obstructive sleep apnea impacts 80 million adults in the U.S., with more than 20 million living with moderate to severe obstructive sleep apnea,” Jeff Emmick, MD, PhD, senior vice president of product development for Lilly, said in a press release. “However, 85% of obstructive sleep apnea cases go undiagnosed and therefore untreated. Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease.”
Results from the SURMOUNT-OSA trial will be presented at the American Diabetes Association Scientific Sessions on June 21 at 3:45 p.m. EDT. Based on the results, Lilly said it plans to submit an application for approval with the FDA and other global regulatory agencies beginning mid-2024.
Certain groups saw a significant decrease in numbers.
Weight loss drug tirzepatide is linked with a drop in blood pressure in a new study.
Researchers found a substantial reduction within 36 weeks on the medication.
Doctors say this could be linked to weight loss or something else entirely.
Medications like semaglutide and tirzepatide have made headlines for months for their role in helping people with obesity lose a significant amount of weight. But research is consistently finding additional benefits of going on these medications. Now, there’s a new one to add to the list: They may help lower blood pressure.
That’s the major finding from a new study published in the American Heart Association’s journal, Hypertension. For the study, researchers analyzed data from 600 people who participated in the SURMOUNT-1 weight loss study to see if there was an impact on blood pressure in people who took tirzepatide, which was approved by the U.S. Food and Drug Administration (FDA) for weight loss in November under the name, Zepbound.
Study participants either received a placebo or a tirzepatide dose of 5 milligrams, 10 milligrams, or 15 milligrams. About 1/3 of study participants had high blood pressure (a.k.a. hypertension) at the start of the study and were taking one or more medications for it.
After 36 weeks, researchers found that study participants in all of the tirzepatide groups had lowered blood pressure by the end, with the biggest reduction in systolic blood pressure (the top number in a reading) being 10.6 mmHg in the 10 milligram group.
The researchers also found that people on tirzepatide had lowered blood pressure when they did measurements during the day and at night. Here’s what doctors want you to know about the findings. (Note: Prevention no longer uses the Body Mass Index (BMI) as a measurement of health.)
Why might weight loss drugs help lower blood pressure?
Doctors agree that a lot of this is likely due to weight loss. “Typically, the greater the degree of weight loss, the greater the degree of blood pressure decrease,” says Colleen Tewksbury, Ph.D., M.P.H., R.D., a registered dietitian and associate professor at Penn Medicine. “It may not be the medication by itself.”
In this particular study, patients who took tirzepatide lost up to 20.9% of their body weight compared to those who took a placebo.
“The findings are impressive, although not unexpected given the critical role that weight gain plays in causing hypertension in the first place,” says Christoph Buettner, M.D., Ph.D., chief of the division of endocrinology at Rutgers Robert Wood Johnson Medical School. Since high blood pressure is often linked to having obesity or overweight, lowering a person’s body fat should reduce their blood pressure, he says.
In fact, weight loss can be so effective for lowering blood pressure, that patients on blood pressure medicines should check in with their doctor regularly if they’re losing weight, says Mir Ali, M.D., a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA. “Their blood pressure medications will likely need to be adjusted,” he says.
But it’s also possible that tirzepatide itself impacts blood pressure, says Sahil Parikh, M.D., director of endovascular services at NewYork-Presbyterian/Columbia University Irving Medical Center. “It remains unclear if the blood pressure reduction is benefitting from the drug having a direct effect on blood pressure, as opposed to the indirect impact on blood pressure through weight loss alone,” he says.
The study focused on tirzepatide, but Dr. Buettner says that fellow weight loss drug semaglutide “has similar effects” when it comes to impact on blood pressure.
While high blood pressure is linked to serious health conditions like heart attack, stroke, and heart failure, “we will need long-term trial results” to see if weight-loss medications can reduce those risks, too, says Laxmi Mehta, M.D., a non-invasive cardiologist at The Ohio State University Wexner Medical Center.
How tirzepatide works
Tirzepatide is a medication that’s used to help manage type 2 diabetes (under the name Mounjaro) and for weight loss (under the name Zepbound). It’s an injectable medication that’s taken once a week to help with weight loss in people who have obesity or overweight.
The medication specifically targets glucagon-like peptide 1 (GLP-1) agonists, which encourage the body to produce more insulin (a hormone that escorts blood sugar to cells, where they’re used for energy) when blood sugars start to rise, along with something called glucose-dependent insulinotropic polypeptide (GIP) receptors, Dr. Ali explains.
Zepbound can also make you feel fuller longer, as well as reduce cravings, causing people to feel less hungry than usual on the medication.
Natural ways to lower blood pressure
If you’re concerned about your blood pressure, doctors say there are a few things you can do:
Be active. “Exercise is critical to heart health, and it is one of the best ways that you can lower your blood pressure naturally,” says Nicole Weinberg, M.D., a cardiologist at Providence Saint John’s Health Center in Santa Monica, CA.
Ask your doctor if you should try to lose weight. “For every 10 pounds of weight loss, you can expect a significant blood pressure drop,” Dr. Weinberg says.
Rethink your diet. Dr. Buettner recommends following a heart-healthy diet rich in fruits, vegetables, whole grains, lean proteins, and low-fat dairy.
Limit alcohol. “If you drink alcohol, do so in moderation,” Dr. Buettner says.
Try to manage your stress levels. That can include doing things like deep breathing, meditation, yoga, or things that relax you, Dr. Buettner says.
It’s also important to stay on top of your blood pressure, even if you do everything else right, Dr. Parikh says. “As we age, there is a tendency for blood pressure to go up, and in time, medication may be critical,” he says.
As of right now, there’s nothing to suggest that weight loss drugs will lower your blood pressure if you don’t have overweight or obesity, Tewksbury says. But if you’re concerned about your blood pressure levels, check in with your doctor. They should be able to offer personalized advice.
As Zepbound dominates headlines as a new obesity-fighting drug, experts warn that weight loss shouldn’t be the only goal.
Zepbound is the newest addition to the weight loss drug arena. In November 2023, it joined the list of obesity-fighting drugs – administered as an injection – to be approved by the U.S. Food and Drug Administration.
The key to Zepbound’s weight loss potential is its active ingredient, tirzepatide. This is the same active ingredient found in the drug Mounjaro, which is approved to treat Type 2 diabetes.
The relationship between Zepbound and Mounjaro is similar to two other popular drugs making headlines, Wegovy and Ozempic. Both Wegovy and Ozempic contain the active ingredient semaglutide, with Ozempic approved for the treatment of Type 2 diabetes and Wegovy approved for the treatment of obesity.
Tirzepatide and semaglutide both mimic the digestive hormone GLP-1, which is released by the intestines when we eat to stimulate insulin production and help regulate blood sugar. GLP-1 also suppresses appetite while promoting a sensation of fullness.
Weight loss medications are intended to be used in conjunction with lifestyle changes, such as exercise and a healthy diet. But too often, people view them as a silver bullet for weight loss. And the high price tag and variable insurance coverage for these popular weight loss drugs create a barrier for many people.
Obesity is not just an American issue, nor is it going away. The World Obesity Federation estimates that by 2030, 1 in 5 women and 1 in 7 men will be living with obesity worldwide.
However, long-term weight management depends on a number of complex factors. Meal timing and types of foods eaten can affect energy levels, satisfaction and hunger levels. A person’s typical schedule, culture and preferences, activity level and health history must be taken into consideration as well. No single “best strategy” for weight management has been identified, and research indicates that strategies for weight loss and maintenance need to be individualized.
In addition, it is critical to note that research on the long-term effects of these newer weight loss drugs is limited. The available research has focused specifically on weight loss, heart health and metabolism and has found that ongoing use of these new medications is necessary to maintain improvements in weight and related health benefits.
Common side effects and the emotional toll experienced by those who regain weight once they stop taking the drugs are trade-offs that need to be considered. More research is needed to better understand the long-term impact of both direct and indirect health consequences of taking drugs for weight loss.
It’s not just what you see on the scale
Throughout my years working as a registered dietitian, I have counseled numerous people about their weight loss goals. I often see a hyperfocus on weight loss, with much less attention being placed on the right nutrients to eat.
Societal standards and weight stigma in the health care setting can negatively affect patients’ health and can lead them to obsess about the number on a scale rather than on the health outcome.
Weight loss may be necessary to reduce risks and promote health. But weight loss alone should not be the end goal: Rather, the focus should be on overall health. Tactics to reduce intake and suppress appetite require intention to ensure that the body receives the nutrients it needs to support health.
Additionally, I remind people that long-term results require attention to diet and lifestyle. When a person stops taking a medication, the condition it’s meant to treat can often return. If you stop taking your high blood pressure pills without altering your diet and lifestyle, your blood pressure goes back up. The same effects can happen with medications used to treat cholesterol and obesity.
Nourish your body with nutrients
Despite the prevalence of obesity and the emergence of newer drugs to treat it, 95% of the world’s population doesn’t get enough of at least one nutrient. According to one study, nearly one-third of Americans have been found to be at risk of at least one nutrient deficiency. Additional research indicates that those actively trying to lose weight are more prone to nutrient deficiencies and inadequate intake.
For instance, a decline in iron intake can lead to iron deficiency anemia, which can cause fatigue as well as an increased risk of many conditions. Adequate intake of calcium and Vitamin D reduce the risk of bone fractures, yet many people get less than the recommended amounts of these nutrients.
It is true that a healthy body weight is associated with reduced health risks and conditions. But if a person loses weight in a manner that does not provide their body with adequate nourishment, then they may develop new health concerns. For example, when a person follows a diet that severely restricts carbohydrates, such as the ketogenic diet, intake of many vitamins, minerals, phytochemicals – or biologically active compounds found in plants – and fiber are reduced. This can increase risk of nutrient deficiencies and impair the health of bacteria in our gut that are important for nutrient absorption and immune function.
Nutrition recommendations set by the Food and Nutrition Board of the National Academies of Sciences, Engineering, and Medicine and the Dietary Guidelines for Americans provide guidance and resources to help meet nutrient needs to promote health and prevent disease, regardless of the strategy used to lose weight.
Optimizing health
There is no doubt that striving for a healthy body weight can reduce certain health risks and prevent chronic disease. Whether a person strives to maintain a healthy body weight through diet alone or with medications to treat obesity, the following tips can help optimize health while attempting to lose weight.
Adopt an individualized approach to healthy behaviors that promote weight loss while considering personal preferences, environmental challenges, health conditions and nutrient needs.
Focus on nutrient-dense foods to ensure the body is getting required nutrients for disease prevention and optimal function. If medications reduce your appetite, it is crucial to maximize the amount of nutrients in the foods you do consume.
Seek professional help. If you are uncertain about how to adopt an individualized approach while ensuring adequate intake of essential nutrients, talk to a registered dietitian. They can learn about your individual needs based on preferences, health conditions and goals to make dietary recommendations that support health.
The American Medical Association officially recognized obesity as a disease in June 2013 after decades-long controversy.1 Although lifestyle interventions are promoted as a first-line obesity treatment, the resultant short-term weight loss often fails to improve long-term outcomes.2 In the search for other solutions, glucagon-like peptide-1 (GLP-1) receptor agonists such as tirzepatide (Mounjaro™) and semaglutide (Wegovy® or Ozempic®) have greatly increased in popularity throughout the past year.
However, the media frenzy surrounding tirzepatide and semaglutide has raised concerns about this latest obesity treatment. Originally developed for diabetes, tirzepatide and semaglutide faced widespread drug shortages as celebrities such as Elon Musk and Chelsea Handler accredited the drugs for their weight loss. Resultant backlash attributed the anti-obesity medication boom to fatphobia.3
Still, the myriad of obesity’s biological and psychosocial obstacles can feel insurmountable after lifelong efforts to lose weight. But are GLP-1 receptor agonists the right solution for patients struggling to climb uphill to a “healthy weight”? Or do these injectables amplify disordered eating, weight stigma, and reliance on expensive pharmaceuticals?
Perhaps it depends on who you ask.
For an insider’s view on this timely topic, we spoke with board-certified bariatric physician Kevin Huffman, DO and leading psychiatrist Michael Olla, MD, both of whom have decades of experience treating obesity and navigating its social implications.
Can BMI Justify Anti-Obesity Injections?
Although obesity is associated with higher risks for type 2 diabetes, certain cancers, mobility issues, and heart disease,1 some experts feel that anthropometric measures such as body mass index (BMI) fail to reflect true health status.
A veteran in his field, Dr. Huffman has treated more than 10,000 patients with obesity and trained and mentored hundreds of physicians and allied healthcare providers. He is also the CEO and founder of AmBari Nutrition and the founder and president of The American Bariatric Consultants.
Dr. Huffman admits that BMI does not tell the whole story about whether anti-obesity medication makes sense for an individual patient.
“BMI, a useful initial screening tool, necessitates more nuanced considerations when prescribing injectable weight loss medications,” he explains. “We acknowledge the uniqueness of each patient; body composition, fat distribution, metabolic health, and underlying medical conditions significantly influence our decision-making process.”
He continues, “For instance, certain patients may present with central obesity despite having a lower BMI — this suggests an escalated risk for obesity-related complications. Diabetes or hypertension, obesity-related health issues, may still qualify individuals for intervention despite a slightly lower BMI than the conventional threshold.”
Providing Quality Care in a “Fatphobic” Environment
Medical professionals are far from immune to stigmatizing patients with obesity. Research findings show that over 50% of healthcare professionals attribute obesity to a lack of willpower.4
In addition, more than half of adults with overweight in Western countries report experiencing weight stigma. As a result of this stigma, patients with obesity and overweight are more likely to avoid healthcare.2
According to Dr. Huffman, “Navigating through this deeply ingrained prejudice is crucial when prescribing injectable anti-obesity medications: potent tools in aiding patients on their weight loss journey. Unfortunately, many barriers arise due to the fear and stigma surrounding obesity — these factors tragically deter numerous individuals from pursuing these potentially life-altering treatments.”
He urges prescribers to approach these conversations with empathy, understanding, and a non-judgmental attitude to foster support and empower patients to access necessary, deserved care for a better quality of life.
Dr. Olla is the medical director at Valley Spring Recovery Center. He is a leading authority figure in the field of psychiatric medicine who focuses on holistic healing, patient well-being, and evidence-based practices.
“Believe it or not, fatphobia or weight bias is a common issue in plenty of medical professionals,” Dr. Olla explains. “Heavier patients tend to encounter lots of medical professionals with weight stigma. In these cases, doctors tend to focus so much on their weight that they ignore other symptoms these patients primarily come in for. This doesn’t just affect patients but also doctors who mean well.”
To address these biases, Dr. Olla encourages medical professionals to have honest conversations with patients before prescribing anti-obesity medications. He suggests openly discussing fatphobia’s potential influence on the decision-making process and explaining the medication’s benefits and risks without pressuring patients to use medication unless medically justified.
According to Dr. Olla, reviewing other treatment options respects a patient’s autonomy and right to make their own treatment decisions.
“The key is to focus on how the drug can help reverse or at least slow down the effects of obesity on the body,” he explains. “This can help the patient understand that their doctor is concerned about their overall health, rather than their weight.”
Weighing the Costs and Benefits of Anti-Obesity Medications
Prescribing anti-obesity medications in today’s cultural climate is no simple task. Physicians must carefully weigh the pros and cons to lead patients to the most appropriate and beneficial treatment path.
“As a doctor myself, I am 50/50 on prescribing weight loss medications,” Dr. Olla shares. “Obviously, you wouldn’t want your patients to develop metabolic or cardiovascular diseases caused by excess weight. However, at the same time, I don’t want to encourage a medication that can only cause more health problems to the patient. In my opinion, there should be more research on how anti-psychotics and weight loss medications could go hand in hand without putting an individual in further danger.”
A multidisciplinary approach is the key to ensuring that patients receive not just comprehensive care, but also unwavering support throughout their weight loss efforts.
According to research findings published in Endocrine Practice, over 70% of healthcare providers believe that anti-obesity medicine as an adjunct to lifestyle counseling is an appropriate therapy that can kick-start weight loss and give patients a greater sense of control over their weight.5
However, clinicans remain hesitant to prescribe anti-obesity medications, with some seeing anti-obesity medication as a short-term solution and others being concerned about safety, efficacy, and cost of staying on these medications. These barriers lead to low prescribing rates, which perpetuates a cycle of low perceived demand and lack of coverage by insurance carriers.6
Dr. Olla also explains how psychiatric comorbidities can complicate obesity treatment. He notes that anti-psychotics and antidepressants can raise hunger levels and cause unwanted weight gain.
“Some patients press for medications that can counteract the side effects,” he says.
He feels that it is not safe to prescribe anti-obesity medication to those with psychiatric conditions, particularly eating disorders. Doing so may increase body weight focus, promote disordered eating habits, increase anorexia risk, and lead to a psychological dependency on weight loss medication.
Aside from psychiatric comorbidities, clinicians must also consider whether a patient has diabetes or other physical conditions. As a bariatric physician, Dr. Huffman explains the counseling differences between those prescribed injectables for weight loss vs type 2 diabetes.
“In managing type 2 diabetes, the counseling provides specific guidance such as carbohydrate counting instructions, recommendations for blood glucose monitoring methods, advice on medication adherence — emphasizing its critical role in the effective management of this condition — and underlining consistency as key when maintaining stable blood sugar levels.”
Dr. Huffman emphasizes that, before prescribing injectables, clinicians should (1) take a holistic approach, (2) assess a patient’s motivation to implement lifestyle changes, and (3) monitor patient adherence to anti-obesity medication regimens. According to him, motivational interviewing and a tailored approach empowers patients to make lasting change.
Leveraging Collaboration to Ensure the Best Treatment
According to Dr. Olla, clinians should remember that they do not need to navigate the complexities of obesity treatment alone. For instance, psychiatrists may work with endocrinologists before prescribing weight loss medications to patients with mental health conditions.
“The expertise of an endocrinologist is needed because anti-psychotic drugs can cause significant weight gain, and careful health monitoring is required,” Dr. Olla explains.
In Dr. Huffman’s practice, prescribing obesity medication is far from the final step in a comprehensive approach to weight management.
“Prescribing patients with injectable weight loss medications necessitates crucial care elements: ongoing support, referrals, and follow-ups,” Dr. Huffman says. “Primarily, I guarantee comprehensive counseling and educational resources for the patients.”
Dr. Huffman encourages prescribers to refer to registered dietitians for individualized meal plans and exercise specialists or physical therapists for safe and effective exercise programs. Mental health providers, behavioral therapists, and support groups can also play a pivotal role in a patient’s success.
“A multidisciplinary approach is the key to ensuring that patients receive not just comprehensive care, but also unwavering support throughout their weight loss efforts,” he says.
It remains to be seen whether anti-obesity medications will help or hurt in the fight against obesity and weight stigma. However, clinicians can build an army of specialists to not only optimize patient care but also help share the responsibility of treating this weighty issue.
In the SURMOUNT-3 trial, researchers assessed tirzepatide efficacy following intensive lifestyle intervention among participants with obesity and overweight.
Tirzepatide is an effective obesity treatment following intensive lifestyle intervention.
Tirzepatide yields additional weight loss, cardiometabolic, and physical function benefits among individuals who achieved a weight reduction of at least 5% with an intensive lifestyle intervention, according to study findings published in Nature Medicine.
Intensive lifestyle interventions comprise a calorie-reduced diet, physical activity, and behavioral counseling. However, only less than 20% of patients lose at least 15% of baseline weight from intensive lifestyle interventions, whereas many regain one-third of their lost weight during the year after treatment. Although previous research supports the use of anti-obesity medications such as tirzepatide to prevent weight regain, the effects of these medications on weight reduction after lifestyle interventions remain understudied.
To evaluate the efficacy of tirzepatide among adults who were overweight or obese and lost at least 5% of their baseline weight after 12 weeks of an intensive lifestyle intervention, researchers conducted the double-blind, placebo-controlled SURMOUNT-3 (ClinicalTrials.gov; Identifier: NCT04657016) trial. Participants who achieved adequate weight loss following lifestyle intervention were randomized to receive either the maximum tolerated dose of tirzepatide or placebo once weekly for 72 weeks.
The primary outcomes were average percentage reduction in body weight from randomization to week 72 and the rate of at least 5% body weight reduction achievement. Secondary outcomes included changes in body mass index (BMI), cardiometabolic risk factors, and patient-reported physical function outcomes.
The researchers assessed treatment efficacy with treatment regimen and efficacy estimands, which evaluated outcomes regardless of and according to treatment adherence, respectively.
The study included a total of 579 participants (mean age, 45.6 years [SD, 12.2]), of whom 287 were assigned to receive tirzepatide and 292 were assigned to receive placebo, 62.9% were women, 86.0% were White, 64.4% were recruited in the United States, and 33.9% had no weight-related complications.
According to the treatment regimen estimand, the 72-week mean percentage reductions in body weight were -18.4% (SE, 0.7; tirzepatide) and 2.5% (SE, 1.0; placebo). Compared with placebo, tirzepatide was associated with a greater reduction in body weight (estimated treatment difference [ETD], -20.8%; 95% CI, -23.2% to -18.5%; P <.001) and a greater likelihood of achieving at least 5% weight loss (odds ratio [OR], 34.6; 95% CI, 19.2-62.6; P <.001).
The efficacy estimand showed similar outcomes, with 72-week mean percentage reductions in body weight of -21.1% (SE, 0.6; tirzepatide) and 3.3% (SE, 0.6; placebo). Compared with placebo, the tirzepatide group also had a superior reduction in body weight (ETD, -24.5%; 95% CI, -26.1 to -22.8; P <.001) and a greater rate of at least 5% weight loss achievement (OR, 130.4; 95% CI, 70.0-242.8; P <.001).
The researchers noted superior outcomes in blood pressure, fasting lipid levels, glycemic control, and fasting insulin levels among the tirzepatide group compared with the placebo group. Additionally, more tirzepatide than placebo recipients reported decreasing the intensity of their antihypertensive and lipid-lowering medications.
Compared with placebo, the tirzepatide recipients also showed greater improvements in physical functioning (ETD, 3.9; 95% CI, 2.8-4.9) and impact of weight on quality of life (ETD, 12.8; 95% CI, 9.7-16.0) scores.
At least 1 adverse event occurred among 87.1% of tirzepatide recipients compared with 76.7% of placebo recipients. The most common adverse events in the tirzepatide group included nausea, diarrhea, constipation, and COVID-19. A total of 10.5% of tirzepatide recipients discontinued use due to adverse events of nausea, vomiting, diarrhea, dyspepsia, or constipation.
Study limitations include the lack of generalizability due to a predominantly White study population and the exclusion of individuals who failed to lose at least 5% of their body weight from the initial lifestyle intervention.
The researchers concluded, “[T]irzepatide demonstrated clinically meaningful additional body weight reductions in adults with overweight or obesity following initial weight loss with intensive lifestyle intervention.”
Atherosclerosis. Computer artwork of a narrowed artery, due to a cholesterol plaque.
Tirzepatide was linked to improved risk for atherosclerosis among patients with obesity.
Tirzepatide treatment is associated with a significant reduction in 10-year risk for atherosclerosis among individuals with obesity or overweight and without diabetes, according to study findings published in Diabetes, Obesity and Metabolism.
Findings from the phase 3, randomized clinical SURMOUNT-1 (ClinicalTrials.gov; Identifier: NCT04184622) trial supported the use of tripeptide for chronic weight management among patients with obesity. However, the effect of tirzepatide on long-term risk for atherosclerosis remains unknown.
To assess the relationship between tirzepatide and obesity-related cardiovascular complications, researchers conducted post-hoc analysis of the SURMOUNT-1 clinical trial using participant data from baseline up to week 72. Participants were randomized to receive either 5, 10, or 15 mg tirzepatide or placebo weekly as an adjunct to lifestyle intervention.
Inclusion criteria were adults with obesity or overweight without diabetes. The researchers excluded patients with a history of cardiovascular disease for this analysis.
Primary outcomes were changes in antihypertensive and antihyperlipidemic therapy, waist circumference, blood pressure, glycated hemoglobin, and fasting glucose. The researchers calculated the change in 10-year atherosclerosis risk using the American College of Cardiology and American Heart Association risk engine, which stratified risk scores according to:
Low-risk (<5%);
Borderline-risk (5-7.5%);
Intermediate-risk (7.5-20%); and,
High-risk (≥20%).
The study population included 2461 participants, of whom 622, 614, 616, and 609 were assigned to the placebo and tirzepatide 5 mg, 10 mg, and 15 mg groups, respectively. The mean age was 44.5 years (SD, 12.3) and the mean body mass index was 38.0 kg/m2. Among the study population, 68.4% were women and 70.3% were White.
At baseline, the proportions of participants with low-risk, borderline-risk, intermediate-risk, and high-risk atherosclerosis risk scores were 80.4%, 8.6%, 10.0%, and 1.0%, respectively. Baseline median 10-year risk scores ranged between 1.5% and 1.6% and did not vary between treatment groups.
The researchers noted significantly greater reductions in atherosclerosis risk among the treatment groups compared with placebo. At week 72, the relative changes in predicted 10-year atherosclerosis risk were -16.4% (tirzepatide 5 mg), -23.5% (tirzepatide 10 mg) and -22.4% (tirzepatide 15 mg) compared with 12.7% (placebo; P <.001).
Among the subset of participants with baseline intermediate- and high-risk scores, the relative changes in atherosclerosis risk scores at week 72 were -10.3% (tirzepatide 5 mg), -20.6% (tirzepatide 10 mg), and -16.1% (tirzepatide 15 mg) compared with 6.4% (placebo; P <.05).
Compared with placebo, participants treated with tirzepatide had significantly improved odds of achieving reduced atherosclerosis risk at week 24 (odds ratio [OR], 2.2; 95% CI, 1.6-3.0; P <.001) and week 72 (OR, 2.4; 95% CI, 1.7-3.5; P <.001). Similarly, tirzepatide-treated participants with intermediate- and high-risk scores at baseline had significantly increased odds of achieving reduced atherosclerosis risk at week 24 (OR, 2.8; 95% CI, 1.4-5.6; P =.003) and week 72 (OR, 2.9; 95% CI, 1.3-6.2; P =.008).
Study limitations include the fact that the atherosclerosis risk engine was not developed or validated among populations of patients with obesity or overweight exclusively.
“[T]reatment with tirzepatide significantly reduced the 10-year predicted risk of [atherosclerosis] compared with placebo in people with obesity or overweight but without diabetes,” the researchers wrote. “The absolute reduction in risk was greater for participants with higher [atherosclerosis] risk at baseline.”
Question Does once-weekly subcutaneous tirzepatide with diet and physical activity affect maintenance of body weight reduction in individuals with obesity or overweight?
Findings After 36 weeks of open-label maximum tolerated dose of tirzepatide (10 or 15 mg), adults (n = 670) with obesity or overweight (without diabetes) experienced a mean weight reduction of 20.9%. From randomization (at week 36), those switched to placebo experienced a 14% weight regain and those continuing tirzepatide experienced an additional 5.5% weight reduction during the 52-week double-blind period.
Meaning In participants with obesity/overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Abstract
Importance The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown.
Objective To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction.
Design, Setting, and Participants This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes.
Interventions Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks.
Main Outcomes and Measures The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period.
Results Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was −5.5% with tirzepatide vs 14.0% with placebo (difference, −19.4% [95% CI, −21.2% to −17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo.
Conclusions and Relevance In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Discussion
The SURMOUNT-4 trial results emphasize the need to continue pharmacotherapy to prevent weight regain and ensure the maintenance of weight reduction and its associated cardiometabolic benefits.22 At least 5 trials (including the present study) across various classes of medications, including potent antiobesity medications such as semaglutide, have demonstrated that weight is substantially regained after cessation of pharmacotherapy.5,6,23,24
The consistency of these data across therapeutic classes spanning more than 2 decades suggests that obesity is a chronic metabolic condition similar to type 2 diabetes and hypertension requiring long-term therapy in most patients.
A notable finding in the SURMOUNT-4 trial is that after switching to placebo for 1 year, participants ended the study with substantial body weight reduction (9.9%). However, much of their initial improvement in cardiometabolic risk factors had been reversed. Further studies are needed to understand the potential long-term benefits and risks (ie, legacy effects) of such short-term therapy.
The health benefits seen with continued treatment with the maximum tolerated dose of tirzepatide during this study were achieved with a safety profile consistent with that previously reported in SURMOUNT and SURPASS trials and in studies of incretin-based therapies approved for the treatment of obesity and overweight.18,25–32
The strengths of this study include its large sample size and the randomized withdrawal design. The duration of the open-label lead-in period allowed the study to assess the maintenance of body weight reduction. Dose escalation protocols during the open-label lead-in period helped to maximize tolerability and reflect dose adjustment strategies that may be helpful to future prescribers.
Conclusions
After achieving clinically meaningful weight reduction during a 36-week tirzepatide lead-in treatment period, adults with obesity or overweight who continued treatment with maximum tolerated dose tirzepatide for an additional 52 weeks demonstrated superior weight maintenance and continued weight reduction compared to those who switched to placebo.
Question Does once-weekly subcutaneous tirzepatide with diet and physical activity affect maintenance of body weight reduction in individuals with obesity or overweight?
Findings After 36 weeks of open-label maximum tolerated dose of tirzepatide (10 or 15 mg), adults (n = 670) with obesity or overweight (without diabetes) experienced a mean weight reduction of 20.9%. From randomization (at week 36), those switched to placebo experienced a 14% weight regain and those continuing tirzepatide experienced an additional 5.5% weight reduction during the 52-week double-blind period.
Meaning In participants with obesity/overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Abstract
Importance The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown.
Objective To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction.
Design, Setting, and Participants This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes.
Interventions Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks.
Main Outcomes and Measures The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period.
Results Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was −5.5% with tirzepatide vs 14.0% with placebo (difference, −19.4% [95% CI, −21.2% to −17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo.
Conclusions and Relevance In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Introduction
Obesity is a serious chronic, progressive, and relapsing disease.1 Lifestyle interventions are a cornerstone of obesity management; however, sustaining weight reduction achieved through lifestyle-based caloric restriction is challenging.
Therefore, current guidelines recommend adjunctive antiobesity medications to promote weight reduction, facilitate weight maintenance, and improve health outcomes in people with obesity.2–4 Randomized withdrawal studies of antiobesity medications to date have consistently demonstrated clinically significant body weight regain with cessation of therapy.5,6 There is also evidence that antiobesity medications, including long-acting glucagon-like peptide-1 (GLP-1) receptor agonists, naltrexone/bupropion, phentermine/topiramate, and orlistat, may help maintenance of achieved weight reduction.5,7–12
Tirzepatide is a single molecule that combines glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonism13 resulting in synergistic effects on appetite, food intake, and metabolic function.14–16 Tirzepatide is approved in many countries, including the US, EU, and Japan, as a once-weekly subcutaneous injectable for type 2 diabetes and for the treatment of obesity in the US and UK.16–18 In a placebo-controlled trial of participants with obesity or overweight without diabetes, tirzepatide led to mean reductions in body weight up to 20.9% after 72 weeks of treatment.17,18
The aim of the SURMOUNT-4 trial was to investigate the effect of continued treatment with the maximum tolerated dose (ie, 10 or 15 mg) of once-weekly tirzepatide, compared with placebo, on the maintenance of weight reduction following an initial open-label lead-in treatment period in participants with obesity or overweight.
Discussion
The SURMOUNT-4 trial results emphasize the need to continue pharmacotherapy to prevent weight regain and ensure the maintenance of weight reduction and its associated cardiometabolic benefits.22 At least 5 trials (including the present study) across various classes of medications, including potent antiobesity medications such as semaglutide, have demonstrated that weight is substantially regained after cessation of pharmacotherapy.5,6,23,24
The consistency of these data across therapeutic classes spanning more than 2 decades suggests that obesity is a chronic metabolic condition similar to type 2 diabetes and hypertension requiring long-term therapy in most patients.
A notable finding in the SURMOUNT-4 trial is that after switching to placebo for 1 year, participants ended the study with substantial body weight reduction (9.9%). However, much of their initial improvement in cardiometabolic risk factors had been reversed. Further studies are needed to understand the potential long-term benefits and risks (ie, legacy effects) of such short-term therapy.
The health benefits seen with continued treatment with the maximum tolerated dose of tirzepatide during this study were achieved with a safety profile consistent with that previously reported in SURMOUNT and SURPASS trials and in studies of incretin-based therapies approved for the treatment of obesity and overweight.18,25–32
The strengths of this study include its large sample size and the randomized withdrawal design. The duration of the open-label lead-in period allowed the study to assess the maintenance of body weight reduction. Dose escalation protocols during the open-label lead-in period helped to maximize tolerability and reflect dose adjustment strategies that may be helpful to future prescribers.
Limitations
This study has limitations. First, the design of this study did not allow dose adjustments after randomization and did not evaluate the effects of intensive behavioral therapy on the maintenance of body weight reduction. Second, those who tolerated initial treatment with 10-mg or 15-mg tirzepatide may represent a subgroup of the general population.
Conclusions
After achieving clinically meaningful weight reduction during a 36-week tirzepatide lead-in treatment period, adults with obesity or overweight who continued treatment with maximum tolerated dose tirzepatide for an additional 52 weeks demonstrated superior weight maintenance and continued weight reduction compared to those who switched to placebo.
A brand new drug has been approved for patients with type 2 diabetes, and it’s now available. It may prove to be the most effective type 2 diabetes drug ever developed.
The drug is tirzepatide (Mounjaro), and it is the innovation of the pharmaceutical giant Eli Lilly and Company.
In Trials, Mounjaro’s Benefits Are Unprecedented
Mounjaro is a highly effective glucose-lowering injection that also leads to impressive and apparently effortless weight loss.
As earlier reported by our friends at diaTribe, tirzepatide (Mounjaro) has been tested in multiple large clinical trials, all of which showed that the medication leads to extraordinary blood sugar improvements for patients with type 2 diabetes.
I’ll review just one such trial in detail: the SURPASS-1 Trial, which tested the new pharmaceutical for 40 weeks in nearly 500 patients with type 2 diabetes.
A1C. The patients, who began the trial with an average A1C of 7.9%, enjoyed A1C reductions of 1.9 to 2.1%. At the end of the trial, a strong majority of patients (81-86%) saw their A1C fall to below 6.5%, outside of the diabetic range. About 50% who used the highest dosage saw their A1C fall to less than 5.7%, completely out of the pre-diabetes range.
Fasting Blood Sugar. The average fasting blood sugar of patients declined by 44-49 mg/dL!
Weight loss. Participants lost an average of 15 pounds (at the 5mg dosage) to 21 pounds (at the 15mg dosage).
Cholesterol. Triglycerides and LDL cholesterol both went significantly down; HDL (“good cholesterol”) went significantly up.
Other trials had similar results in slightly different populations: astounding blood sugar improvements and weight loss, and other health benefits to boot.
These numbers easily surpass the results observed in other diabetes medications already on the market.
Mounjaro even outperformed daily injections of insulin, widely considered the most powerful glucose-lowering treatment, in twotrials. Not only did Mounjaro users enjoy superior blood sugar improvements than insulin users, they also had a significantly reduced risk of hypoglycemia. (Mounjaro also works well when used with insulin.)
Mounjaro and Weight Loss
And then there’s the matter of the miraculous weight loss. Every one of the trials mentioned above showed that Mounjaro patients lost a massive amount of body weight.
At its highest dosage, tirzepatide helped overweight patients lose 22.5% of their body weight in 72 weeks, a completely jaw-dropping result on par with the massive benefits from bariatric surgery. Even at its lowest dosage, 5mg, patients lost an average of 35lb.
To put it simply, this appears to be the most promising weight loss drug ever invented. Although it has not yet been approved as a weight-loss drug, patients that use it for diabetes will be the first to enjoy these benefits.
Assuming it is eventually approved as a weight-loss medication, tirzepatide may be marketed separately for weight loss under a different name than “Mounjaro.”
How Does Mounjaro Work?
Mounjaro is related to the class of drugs known as GLP-1 receptor agonists. These medicines work for patients with type 2 diabetes by mimicking the effects of the hormone glucagon-like peptide 1 (GLP-1), which is usually released by the intestine during meals. GLP-1 does a variety of things: It tells the liver to release less glucose, it slows digestion, and it provokes the feeling of fullness or satiety. Put it all together, and when patients with diabetes take the drug it reduces blood glucose levels while also helping them eat less.
There are several GLP-1 receptor agonists already available for patients with diabetes. In the United States, they’re sold under the following brand names:
exenatide (Byetta, Bydureon)
liraglutide (Victoza)
lixisenatide (Adylixin)
dulaglitide (Trulicity)
semaglutide (Ozempic, Rybelsus)
GLP-1 receptor agonists work for patients with type 2 diabetes by mimicking the effects of the hormone GLP-1, which is released by the intestine during meals. GLP-1 does a variety of things: It tells the liver to release less glucose, it slows digestion, and it provokes the feeling of fullness or satiety. Put it all together, and when patients with diabetes take the drug it reduces blood glucose levels while also helping them eat less.
Mounjaro has all of those positive effects, but it additionally mimics another hormone, glucose-dependent insulinotropic polypeptide (GIP). The combination appears to be even more effective.
Cost and Availability
Mounjaro, unsurprisingly, is quite pricey. As of this update, filed in November 2022, the sticker price is about $1,000 per month. The cost is likely to remain high for the foreseeable future, although we can hope that insurers become increasingly eager to cover that cost, given the impressive benefits.
There’s no word yet on availability in other countries. Competitor Wegovy has been so popular in the United States that its maker has temporarily hit the brakes on advertising its new miracle drug.
A Few Details
Mounjaro is not intended to replace the most important therapies for type 2 diabetes: diet and exercise.
Mounjaro is not a pill; it is self-administered by injection once a week. It will come in the form of an auto-injector pen, similar to an insulin pen, that does not require patients to draw up the medicine themselves. Lilly will market six different dosages, from 2.5mg up to 15mg. New patients are recommended to begin with a starter dose of 2.5mg and gradually work up to larger amounts over a period of months.
Some side effects (particularly gastrointestinal distress) and contraindications have been announced. Because Mounjaro has been found to cause tumors in the thyroids of rats, regulators are recommending that people with a family history of thyroid cancer or multiple endocrine neoplasia syndrome type 2 do not use it. It may be inappropriate for patients with pancreatitis.
Mounjaro is not intended for patients with type 1 diabetes, but there is some hope that it could help the condition. GLP-1 receptor agonists appear to be effective for patients with T1D (when used in addition to insulin), and some doctors prescribe them off-label. It may be years before Lilly receives full approval for that use, if indeed it ever happens.
Mounjaro has not yet been thoroughly evaluated in teenagers or children.
In 2023, the FDA will likely approve Eli Lilly’s diabetes drug tirzepatide for weight loss — but there’s little indication insurers will widely cover the medication.
A new class of injectable weight loss drugs called GLP-1 inhibitors has been found to highly effective, but insurance often doesn’t cover the treatments.NBC News
An Eli Lilly drug if approved for weight loss could become the best-selling drug of all time, but concerns are mounting about who will actually be able to afford it.
Experts are confident that the drug, called tirzepatide, will be granted approval by the Food and Drug Administration sometime next year. If that’s the case, it would join two other popular — and expensive — recently approved weight loss drugs on the market, Wegovy and Saxenda, both from the drugmaker Novo Nordisk.
Annual sales of tirzepatide could hit a record $48 billion, according to an estimate from Bank of America analyst Geoff Meacham. Another Wall Street analyst, Colin Bristow at UBS, estimated the drug would reach $25 billion in annual sales — a figure that would still surpass the record $20.7 billion set by AbbVie’s rheumatoid arthritis drug Humira in 2021.
Kelly Smith, a spokesperson for Eli Lilly, declined to comment on what tirzepatide will cost. Outside experts said it is possible the drugmaker could price it similarly to Wegovy, which carries a list price of around $1,500 for a month’s supply, and Saxenda, which costs about $1,350 for a month’s supply.
If the FDA confirms the drug’s effectiveness, a “fair” price for tirzepatide could be around $13,000 annually, or around $1,100 a month, said Dr. David Rind, the chief medical officer for the Institute for Clinical and Economic Review, a research group that helps determine fair prices for drugs.
The drugs have been shown in clinical trials to be highly effective for weight loss. All three drugs — which are given as injections — work in a similar way: They’re a class of drugs called GLP-1 agonists, which mimic a hormone that helps reduce food intake and appetite.
However, Eli Lilly’s tirzepatide also imitates a second hormone, called GIP, which along with reducing appetite, may also improve how the body breaks down sugar and fat.
A phase 3 clinical trial found a high dose of tirzepatide helped patients lose 22.5% of their body weight on average, or about 52 pounds, better than any medication currently on the market. Most patients in the trial had a body mass index, or BMI, of 30 or higher. In trials, Wegovy and Saxenda reduced body weight by around 15% and around 5%, respectively.
Are weight loss drugs covered by insurance?
At lower doses, all three of the drugs are already approved to treat diabetes.
Tirzepatide is sold under the name Mounjaro for diabetes.
Semaglutide, when marketed for weight loss, is sold at a higher dose and called Wegovy; at a lower dose, it’s marketed for diabetes and sold as Ozempic.
Similarly, a higher dose of the drug liraglutide is sold under the name Saxenda for weight loss, and at a lower dose, it’s sold as Victoza, for diabetes.
With the exception of Mounjaro, which was approved earlier this year, the versions of the drugs used to treat diabetes are covered by most insurance.
That’s not always the case when they are prescribed for obesity.
Obesity carries a unique stigma, said Dr. W. Scott Butsch, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. Many physicians, he said, still see it as a behavioral problem rather than a medical one.
That belief — in addition to older anti-obesity medications not being very effective — has made insurers reluctant to cover many of the new therapies, he said.
“You have a bias,” Butsch said, adding that insurance companies ask for more proof of the benefits of anti-obesity drugs than they normally would for other kinds of medications.
Some insurers may select one of the weight loss drugs and offer coverage, he said, but they often restrict access only to patients who meet a certain threshold, such as a BMI greater than 30.
What’s more, Butsch said, not everyone responds the same way to any given weight loss drug. If the drug covered by insurance isn’t effective for that patient, there are usually no other drug options left, he said.
Dr. Holly Lofton, the director of the weight management program at NYU Langone Health, regularly prescribes the new drugs to her patients but many, she says, are denied coverage by their insurance. “Patients tell me that it appears to them as if insurance companies want to wait until they get so sick that they have more of a necessity for a medication,” she said.
Lofton said that some of her patients will end up spending thousands of dollars out of pocket for the medication for a few months as they negotiate with their insurer to get coverage. Patients usually aren’t reimbursed by their insurance plan for the money they’ve already spent on the drugs, she added.
Dr. Fatima Stanford, an obesity medicine specialist and the equity director of the endocrine division at Massachusetts General Hospital in Boston, said that private insurance coverage for anti-obesity medications is spotty, with treatments often restricted to the most expensive plans.
Medicare does not cover them. Anti-obesity drugs are not a mandatory Medicaid benefit, though some states have opted to include them, she said.
Obesity is considered a chronic illness, and like any other chronic illnesses, most patients are expected to take the medication for their entire lives — a great financial burden if they are forced to pay out of pocket, Stanford said.
The only people who will likely be able to afford a drug like tirzepatide on their own, she said, will be the “very rich.”
Despite the barriers to access, UBS analyst Bristow said he still expects tirzepatide to be a blockbuster drug for obesity, noting that the U.S. is already seeing supply shortages for the drug as a diabetes injection.
“It’s pretty clear how strong the demand is,” he said.
What needs to change?
Lofton, of NYU Langone Health, said insurance coverage of anti-obesity drugs may not improve until more people in the medical field change how they view obesity. It’s not something that diet, exercise or sheer willpower can fix — instead, it’s a dysregulation of fat cells in the body, she said.
Bias and stigma about obesity run rampant throughout the medical community.
It’s “evident across all health professionals, including physicians, nurses, dietitians and others,” said Lisa Howley, an educational psychologist and the Association of American Medical Colleges’ senior director of strategic initiatives and partnerships.
A review published last year in the research journal Obesity found that health care professionals hold implicit and/or explicit weight-biased attitudes toward people with obesity.
But shifting the opinion of the medical community — and with it, insurance companies — is extremely difficult. Requiring anti-obesity drugs to be covered by insurance may require legislative action, Stanford said.
In 2021, lawmakers in the House of Representatives introduced The Treat and Reduce Obesity Act, which would have allowed the federal government to expand Medicare Part D coverage to include anti-obesity medications. The legislation had 154 bipartisan co-sponsors, according to Congress.gov, but did not receive a vote on the House floor before the term ended.
America’s Health Insurance Plans, or AHIP, a trade group that represents insurance companies declined to say whether it would support coverage of tirzepatide should the drug win FDA approval next year or other anti-obesity drugs.
“Health insurance providers routinely review the evidence for medications and surgical treatments for obesity, and they offer many options to patients — ranging from lifestyle changes and nutrition counseling to surgical interventions to prescription drugs,” said David Allen, a spokesman for AHIP.
Butsch, of the Cleveland Clinic, said he is hopeful insurance companies will cover tirzepatide.
“We’re seeing really for the first time highly effective anti-obesity medications,” he said. “The benefit is real.”
Tirzepatide is an effective obesity treatment following intensive lifestyle intervention.
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