Barry A. Borlaug, MD is a cardiologist in Rochester, Minnesota, affiliated with the Mayo Clinic.

Barry A. Borlaug, MD: Impact of Tirzepatide on Cardiorenal End-Organ Damage in HFpEF 

Tirzepatide lowered circulatory pressure-volume overload and reduced end-organ damage in the kidney and heart in patients with 

heart failure with preserved ejection fraction (HFpEF)

, according to data from the SUMMIT trial.

American Heart Association (AHA) Scientific Sessions 2024

, these data build upon the known benefit of tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist (GLP-1 RA), for the treatment of obesity-related HFpEF.

“I think it ties together a lot of the pathophysiologic components that we think are very important in obesity-related HFpEF, and tirzepatide seems to be working through many of these different pathways, some of them hemodynamic and volume-loading and [others] related to inflammation,” presenting investigator Barry A. Borlaug, MD, Mayo Clinic, told 

The double-blind SUMMIT trial randomized 731 individuals with NYHA Class II-IV heart failure, an EF of ≥50%, and body mass index (BMI) ≥30 kg/m2 to tirzepatide (n = 364) or placebo (n = 367). Tirzepatide was titrated to a maximum weekly tolerated dose of up to 15 mg subcutaneously.

For the analysis, Borlaug and colleagues collected data on blood pressure, anthropometrics, estimated plasma volume, and blood samples at baseline and 52 weeks, to determine biomarkers of cardiorenal function in all patients. Primary results from SUMMIT showed tirzepatide lowered the risk of cardiovascular death or worsening heart failure (hazard ratio [HR], 0.62; 95% CI, 0.41–0.95; 

Trial participants exhibited borderline hypertension (systolic blood pressure [SBP], ~128 mmHg), volume expansion (estimated plasma volume, ~3.3 L), chronic kidney disease (urine albumin/creatinine ratio [UACR], ~2.8 g/mol), and subclinical myocardial injury (troponin T, ~11 ng/L).

Compared with placebo, tirzepatide treatment reduced SBP by ~6 mmHg (95% CI, –8 to –4; 

<.001) at 24 weeks and by –5 mmHg (95% CI, –7 to –3; 

 <.001) at 52 weeks, respectively. Tirzepatide also decreased the estimated plasma volume by ~0.32 L (95% CI, –0.36 to –0.27; 

At the same time, tirzepatide achieved an increase in eGFR at 52 weeks (~1.85 ml/min/1.73 m2; 95% CI, 0.19–3.51; 

 = .029), decreases in microalbuminuria at 24 weeks (–25.0%; 95% CI, –36 to –13; 

 <.001) and 52 weeks (–15%; 95% CI, –28 to 0.1; 

 = .051), and a reduction in troponin T at 24 weeks (–9.8%; 95% CI, –16.0 to –3.3; 

 = .004) and 52 weeks (–10.4%; 95% CI, –16.7 to –3.6; 

“I think we need to be looking to use these drugs, these incretin-based drugs, more frequently, including tirzepatide, for the treatment of people with obesity-related HFpEF,” Borlaug told 

Disclosures: Borlaug reports relevant disclosures with Amgen, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and others.

Borlaug BA. Effects of Tirzepatide on Cardiorenal End-Organ Damage in Heart Failure and Preserved Ejection Fraction: Insights from the SUMMIT trial. Presented at the American Heart Association (AHA) Scientific Sessions 2024. Chicago, Illinois. November 16-18, 2024.

Tirzepatide, a GLP-1 RA, demonstrated significant benefits in reducing circulatory pressure-volume overload and end-organ damage in patients with HFpEF and obesity, as shown in the SUMMIT trial. The trial, presented at the AHA Scientific Sessions 2024, involved 731 participants and revealed that tirzepatide lowered cardiovascular death risk and improved cardiorenal biomarkers. Notable improvements included reductions in systolic blood pressure, plasma volume, microalbuminuria, and troponin T levels, alongside an increase in eGFR. These findings suggest tirzepatide's potential in managing obesity-related HFpEF.

Barry A. Borlaug, MD describes the beneficial effect of tirzepatide on circulatory pressure-volume overload and end-organ damage in patients with HFpEF and obesity.

Barry A. Borlaug, MD

Associate Professor, Jane Anne Nohl Division of Hematology, Keck School of Medicine, University of Southern California

Piatek shared the latest data update from the phase 3 ALPHA study at the ASH 2024.

Caroline Piatek, MD: Improving Patient-Reported Outcomes in PNH With Danicopan Add-on Therapy

Long-term danicopan add-on therapy to ravulizumab or eculizumab in people with paroxysmal nocturnal hemoglobinuria (PNH) and clinically significant extravascular hemolysis (csEVH) resulted in sustained improvements in patient-reported fatigue, QoL and physical function.

These findings are from long-term follow-up data for up to 72 weeks in the phase 3 ALPHA study and were presented at the

 66th American Society of Hematology (ASH) Annual Meeting and Exposition

, held December 7-10, 2024, in San Diego, California, by Caroline Piatek, MD, Associate Professor, Jane Anne Nohl Division of Hematology, Keck School of Medicine, University of Southern California.

“One of the issues with PNH is that patients report a lot of fatigue, and so having medications that can improve that symptom for the patients is clinically meaningful,” Piatek told 

The ALPHA study is a double-blind, placebo-controlled clinical trial that randomized adult patients with PNH, csEVH, and at least 6 months’ treatment with ravulizumab or eculizumab to danicopan (n = 57) or placebo (n = 29). Of all participants, 54 and 26, respectively, completed the study up to week 24; and 46 and 24 patients, respectively, completed the long-term extension.

Piatek and colleagues found that at week 12, change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score was significantly greater for patients receiving danicopan compared with those receiving placebo in the double-blinded phase (least-squares mean, 8.13 [95% CI, 6.30-9.96] vs 2.53 [95% CI, −0.22-4.91], respectively; 

= .0004). European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) fatigue subscale scores in the danicopan arm improved from a mean 43.3 (standard deviation [SD], 27.2) at baseline to 27.4 (SD, 20.3), 25.4 (SD, 23.6), and 27.8 (SD, 22.2) at weeks 12, 24, and 72, comparable with the general population norm (29.5); whereas in the placebo–danicopan arm scores improved from 49.0 (SD, 25.8) at baseline to 47.1 (SD, 28.6), 37.5 (SD. 27.8), and 44.9 (SD, 24.2), respectively.Mean EQ-5D-3L scores largely remained stable.

Piatek C, Lee JW, Griffin N, et al. Danicopan As Add-on Therapy to Ravulizumab or Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Long-Term Patient-Reported Outcomes from the Phase 3 ALPHA Trial. Presented at: Presented at: ASH Annual meeting; December 7-10; San Diego, California. Abstract 2692.

Caroline Piatek, MD

A panel of expert cardiologists share their clinical pearls for managing patients with hyperlipidemia.

Clinical Pearls on Lipid Management

Keith C. Ferdinand, MD, FACC, FAHA, FNLA:

 I’m going to give each of you about a minute or so to give what we call a take-home message: a clinical pearl for the physicians, nurse practitioners, physician assistants, [and] pharmacists who may be listening, something that will motivate them to do better. We’ve heard from the Family Heart Foundation that we’re not recognizing these patients early enough and that those patients at high risk are not getting high-intensity statin. We heard from Dr Michos that there is a whole world of alternatives. Christie, you suggested [that] we combine these agents [to] reach lower [lipid] levels vs pushing [the dose of] a drug to toxicity level. Dr Kohli, you’ve been very persistent that education, culturally appropriate [and] literacy-appropriate education, is one of the linchpins to success.

 We’ve talked about education, but it starts with [this]: “You can prevent heart attacks and strokes.” Patients need to know their numbers; that’s an education process. We help them get there. We’re their guides to get there. One thing that is a frustration, a practical point in terms of when you use some of the nonstatin therapies, [is] the approval process. It turns out—we have fellows coming [in] every year—if you say this patient has a family history of very high cholesterol [level] and premature heart disease, [you’re] denied. You [have] to say heterozygous familial hypercholesterolemia [FH]. There’s an 

International Classification of Diseases, Tenth Revision

] code for that. Put those words in there. If you say [the patient] “has heart disease or ASCVD [atherosclerotic cardiovascular disease] with MI [myocardial infarction]”…put the right information. Have a lipid measurement within a month, [provide] the LDL [low-density lipoprotein] cholesterol [level], [and state], “It was unacceptably high; therefore, [I’m] using this agent.” Some pragmatic steps will reduce the frustration for both [patient and provider], because if the patient doesn’t get it and you don’t get it, it’s frustrating. But you can do it. It’s easier.

 Dr McGowan, thank you for your great work with the Family Heart Foundation. Can you give us some clinical pearls to help our clinicians out there do better?

 When you screen patients, and hopefully you’ll screen all your patients, [but] when you screen patients with a lipid profile, if it’s an adult person and you see an LDL [level] greater than 190 mg/dL, you want to think familial hypercholesterolemia. With that in mind, you want to have a conversation with the patient [that] this is unlikely to be chance. This is your genetics, and, therefore, your children need to be screened, your siblings need to be screened, and it’s important. People who hear that it might [affect] their children are more likely to take action. So take action. The other big thing, [because] I’m coming from the Family Heart Foundation, [is] don’t forget to measure lipoprotein(a) [Lp(a)] [level]. Don’t think it’s unactionable. I’m going to tell you one quick story about a patient of ours who’s an advocate for Lp(a). This young woman was 44 years old [with a] completely normal lipid profile. [She] did have a history of cardiac disease [and] attributed her father’s early cardiac disease to his type A behavior. She waited 18 hours with chest pain before going in and finding that she was having a cardiovascular event: a myocardial infarction. What she said to us was, “If I had known I had such a high Lp(a) [level], I would have gone in earlier.” That was important information to me. So even if you feel like there aren’t agents currently [available], as everybody else has said, you can reduce other risk factors. Measure that Lp(a) [level] and then take action. And educate your patients about it.

 There’s so much burnout in medicine. It is so hard, what we do on a day-to-day basis. But the thing that keeps me most engaged is knowing that I made an impact on somebody’s life. If you could take 2 or 3 minutes at the end of every visit, no matter what it’s for (eg, knee pain, urinary tract infection, back pain), to look at those lipid [levels and] focus on prevention, [then] you are going to have a tremendous impact on [a] number of lives out there that you won’t even realize. That will give you the highest degree of engagement: knowing their numbers, not just knowing your numbers, but knowing your patients’ numbers and phenotyping at every visit so [that] you’re delivering a personalized care plan. You’re not lumping every secondary prevention to less than 70 mg/dL or less than 55 mg/dL. You’re using your risk modifiers to reclassify that risk in an iterative fashion at every visit for your primary and secondary prevention. So if Mrs Jones had a stroke since the last time you saw her, her risk just changed. You bump her down to the next level, δ LDL of 50%, and get [her level] below those thresholds. If you can work it into your busy practice, just spend 2 minutes at the end of each visit looking at those lipid [levels] and making a little plan. It’ll be tremendous how many lives you’ve changed and how many trajectories of atherosclerosis you’ve modified.

 That’s a wonderful message. Dr Michos, you have the last take-home [message].

 I want to circle back to something that Dr Kohli said at the beginning about cholesterol years. This is something that might resonate with patients and other clinicians when they’re familiar with pack-years of smoking. It’s not only the magnitude of elevation; it’s the duration [that] one’s [had] that value. There’s been some modeling thinking that the theoretical onset of clinical ASCVD may be around 5000 mg/dL-years. Individuals who have had high cholesterol [level] since birth—our patients with FH—if left untreated, they’ll cross that threshold of clinical ASCVD very young in life. Whereas individuals who have favorable genetics, healthy lifestyle, or early treatment may never cross that threshold for clinical ASCVD. [And] don’t forget about those with mild to moderate hyperlipidemia. The LDL [level] is [in the] 130s mg/dL [or] 160s mg/dL. A lot of these patients are ignored. But [if] left untreated for a sufficient number of years, those individuals will have earlier onset ASCVD than their counterparts who have had lifelong low LDL [levels]. The message is [that] we want to get LDL [levels] lower for longer and get there faster.

 Wonderful message. Thanks to you all for this rich and informative discussion. And thank you for watching this 

. If you enjoyed this content, please subscribe to our e-newsletters to receive upcoming 

 [videos] and other great content right in your inbox.

Christie Ballantyne, MD

Experts discuss emerging gene therapies for age-related macular degeneration (AMD) or diabetic macular edema (DME) and key end points considerations. 

Emerging Gene Therapies for Retinal Diseases

Jonathan Jonisch, MD

 What can we do with our patients to bridge the gap until we have a more solid cure? I think I can start off, and then Linda can jump in, or anybody. Are these hybrid closed-loop systems? We have 4 different ones on the market. I think you all would agree with automatic insulin delivery, modulating basal rate, alerts, and alarms that you could set individually that, for adults with type 1, my clinic has gotten so boring. Patients come in, their [hemoglobin A1C (HbA1C)] is good, time below range is really low, glycemic variability—and it’s not like you slapped [it] on, they have perfect control. You do some adjustments, a patient gets engaged in their care.

 We are still struggling on the pediatric side with some of the closed-loop technologies. We have some families that plug it in, go chug, and then we’re just tweaking little things, but kids’ insulin continues to change throughout childhood because of adolescent behaviors that lead to that. We had that nice type 1 diabetes exchange graph with peak [HbA1C] in there with 9.2%, same as before [the] DCCT [trial] across the population. So at least in our clinics, I’m still having kids [on Control-IQs walk in with HbA1Cs] of 10. And then, I got to go back, and it’s usually bolus, bolus, bolus, but don’t bolus after you’ve eaten because the system has already given you insulin; that’s why you’re going low. Avoiding the next bolus is not going to help you here. On the flip side, when we can manage them or when they manage well themselves—having just come off diabetes camp earlier this month, I have never seen so many blood sugars of 120, 130 in the morning. Still, the days are a little bit unpredictable. I don’t think we did much ketone testing at all in the morning. I’ve been doing camp for 25 years. It never looked that way before.

 I was up more of the night with the alerts and alarms from the CGMs [continuous glucose monitors] with the staff trying to figure out what to do with them. I think it’s [promising], and access is important. We know that underrepresented populations are still much less likely to be using those devices. We’re doing well in kids right now with CGM incorporation across our clinics, but we need people to be insured, [and for] the underinsured to get them and to have access. As pediatric endocrinologists, getting that stuff down to the little kids is also going to be important, and there have been huge advances there.

 I’m going to take that as your final point. Egils, do you want to end our program with some final thoughts?

 Well, we just celebrated the centenary of the discovery of insulin. I have a [Toronto, Ontario, Canada] newspaper that says, “Diabetes cured” that I show my patients; so, 101 years later and even though overnights are great with AID [automatic insulin delivery], insulin is still a pretty poor hormone replacement. I look forward to the day that we’re using teplizumab to prevent progression of diabetes.

 Well said. I think you emphasized, Linda, that although we do have these hybrid closed-loop, automatic insulin delivery systems, we have a long way to go, even for people who have access to them. Justin, my good friend, any final thoughts before we end the program officially?

 I just feel so fortunate to get to work in a field where we can have these discussions. About just a few years ago, we [had] been trying immunotherapy right and left. We’ve been doing antigen therapy right and left and disappointment after disappointment. Now we’re talking about how to implement immunotherapy in the way that we treat type 1 diabetes. I think of it as we’re at the dawn of the immunotherapy era. As endocrinologists, we don’t usually use immunotherapy drugs, unlike some of our other subspecialist colleagues. It’s an exciting era, but we’ve talked a lot about some of the challenges that we’re just starting to get our arms around as we enter that era. I look forward to getting to do it with people like you.

 Well, thank you for that. Very exciting time as well. Schafer, you get the final word on that.

 Well, I would just say I learned a lot today. Thank you for all that expert knowledge, that was fantastic. I’m going to echo a little bit what was just said to some degree that it does feel sort of a dawn of a new era. Thank God for insulin, but it has been limited, and despite all these great technologies and CGM and closed-loop, the picture is not quite as rosy as Steve painted it in his clinic, where everything’s great. We see people come into the hospital, wearing their pump, but they’re in full-blown DKA [diabetic ketoacidosis]. There are a lot of problems still that we haven’t been able to solve even with great insulin therapies, new and faster insulins, and longer-acting insulins. There are still issues with increased cardiovascular disease, with the majority of patients not meeting glycemic goals, and issues with DKA. There’s a lot of work to do, but it’s such an exciting time to have some therapies, that we’re not just trying to play catch-up and treat by giving more insulin and figuring out different ways to use insulin, but to actually be able to get ahead of the curve a little bit is just very exciting and optimistic.

 Well, thank you, Schafer, Linda, Justin, and Egils, I learned a lot myself. It’s been a pleasure working with all of you, and I wanted to thank everyone for viewing and watching this 

program. Don’t forget, they have an e-newsletter, where you can look at prior programs and future programs on different topics. Thank you very much for watching.

Expert endocrinologists provide final thoughts on addressing unmet needs and improving the management of T1D.

Bridging the Gap for T1D Management

Justin M. Gregory, MD, MSC

This article was originally published in ContagionLive.

China has officially passed the 1 billion dose mark for 

 vaccinations administered, becoming 1 of the world’s fastest inoculation efforts.

Despite the high number of doses given out, the country is still remaining very strict with its elimination efforts.

The borders are still mostly closed off to international travel, and social distancing measures are still being strongly enforced in some areas.

China has also been offering millions of its vaccines to other countries, but many places, like Brazil, are refusing the shot in hopes of getting Pfizer or Moderna’s vaccine.

In Cuba, officials are reporting that their homegrown COVID-19 vaccine, Soberana 2, is showing promising results.

On Saturday, results from a late-phase trial were reported, showing the vaccine to be 62% effective with 2 out of its 3 recommended doses.

The country has shunned foreign-made vaccines, putting all of their hopes in their own. Cuba has partnered with Iran, which has also boycotted foreign made vaccines.

The Philippines has recently agreed to purchase 40 million doses of the Pfizer-BioNTech vaccine, which will provide a significant boost to the country which has been struggling with infections.

The order is set to be delivered through the third and fourth quarter of 2020.

Since the start of the pandemic, the Philippines has seen over 1.35 millions COVID-19 infections, with 23,500 deaths.

Data Table per Our World in Data (June 20, 2021, 12 AM EST)

In the United States, Rochelle Walensky, the director of the US Centers for Disease Control and Prevention, warned on Friday that the Delta variant is soon likely to become the dominant strain in the country. The more transmissible variant is likely to spread throughout the unvaccinated population.

Data Table per CDC COVID-19 Tracker (June 20, 2021, 6 AM EST)

For more information on COVID-19 vaccination research, distribution, and assessment, check out some of these recent Contagion stories:

Emergency Use Authorization vs. Full Approval: What are the Implications?

Update on CureVac COVID-19 Vaccine Phase 2b/3 Trial

What Role Will Novavax’s Vaccine Play in the Global COVID-19 Effort?

Africa sees third wave as only 1% of the population is fully vaccinated.

China Hits 1 Billion COVID-19 Vaccines Administered 

Killian Meara

As one of the most common diseases in the United States, diabetes impacts more than 37 million Americans with 90-95% having type 2 diabetes.

 Type 2 diabetes symptoms can develop slowly over time, and may lead to serious complications including cardiovascular disease, retinopathy, nephropathy, and neuropathy.

 However, it is possible to manage the disease, and clinicians like yourself can play an important role in helping people living with type 2 diabetes achieve their health goals.

We know it is challenging for many people living with type 2 diabetes to manage the disease. In fact, a recent cross-sectional analysis of the U.S.-based National Health and Nutrition Examination Survey (NHANES) data found that the U.S. is trending in the wrong direction. After more than a decade of progress in the early 2000s, glycemic and blood-pressure control have declined in the adult population.

 This is particularly concerning given, today, more than ever before, the efficacy of new therapies, evidence-based treatment guidance for earlier and tighter management of both blood glucose and excess weight, and what patients are looking for in terms of their disease management line up well.

We are in a new era of care – or at least we 

Consistency Across Medical Capability, Guidelines and Patient Aspirations

After decades of science, research, and advancement, we have reached a time in type 2 diabetes care where medical capabilities align with what professional organizations and patients have been demanding — treatments that help control their A1C and reduce excess weight.

On the medical capability front, we have seen new, more innovative treatment options become available for patients over the last few years. These new treatments, including incretin-based therapies, are demonstrating efficacy in improving both A1C and body weight to greater extents than previously seen, while also potentially addressing other underlying issues patients may have. And many companies have even more treatments in the pipeline that offer various mechanisms of action and modes of administration, catering to an array of patient preferences.

From a science and guidelines perspective, there is also alignment. The science around type 2 diabetes care has demonstrated promise around early glucose control and weight management for the long-term health of patients.

 About 90% of people with type 2 diabetes also have obesity or overweight, demonstrating the importance of addressing excessive weight when treating these patients.

 And the American Diabetes Association (ADA) agrees. In its 2023 Standards of Care in Diabetes, ADA recommends early and consistent glucose and weight management since effective management of both can help reduce the risk of diabetes-related complications.

And importantly, the innovation in treatment and care guidelines reflect what patients are looking for when it comes to managing their type 2 diabetes.

 When looking at treatment-related attributes that encouraged patients with type 2 diabetes to initiate and stay on their medications, treatment efficacy in managing A1C and losing weight, or at least not gaining weight, were the two most important factors.

 For likely the first time in type 2 diabetes care, patients can access treatments that match their wishes after decades of insulin and other treatments that resulted in weight gain instead of weight loss.

More Needs To be Done to Improve Type 2 Diabetes Care and Clinicians Play an Important Role

Unfortunately, despite the new era of care we are in, many people living with type 2 diabetes are not reaching care goals. In fact, it is estimated that only 45-60% of adults with type 2 diabetes have achieved the ADA-recommended A1C target of <7%.

Clinicians may hesitate to incorporate new treatments into their practice for several reasons, including patient-related factors (education, engagement with treatment and therapy preferences), costs of the new medicine and reimbursement, among others.

However, this new era of type 2 diabetes care only benefits patients if health systems and clinicians incorporate the latest research, care guidelines and medications where appropriate to help patients manage their type 2 diabetes. To start, clinicians can refer to the evidence-based treatment guidelines, tackle the issue of therapeutic inertia, and leverage patient desire for better glucose control and weight reduction through patient-centric care.

The ADA recommends that a person-centered approach be taken when choosing a treatment for people with diabetes, which may include the treatment of other risk factors to help improve patient outcomes across the board.

 Once those risk factors have been identified, clinicians and their patients can determine together which treatment options work best for them, while considering individual preferences.

Even though type 2 diabetes care has changed immensely over the years, and we’ve discovered new treatments that meet patient expectations, it will continue to evolve. Embracing this constant change and innovation will benefit patients and help them get back to the life they want to live with their disease more effectively managed.

Type 2 diabetes. Centers for Disease Control and Prevention. April 18, 2023. Accessed August 2023. https://www.cdc.gov/diabetes/basics/type2.html#:~:text=More%20than%2037%20million%20Americans,adults%20are%20also%20developing%20it.

Type 2 diabetes. Mayo Clinic. March 14, 2023. Accessed August 2023. https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/symptoms-causes/syc-20351193.

Fang M, Wang D, Coresh J, Selvin E. Trends in diabetes treatment and control in U.S. adults, 1999–2018. June 10, 2021. Accessed August 2023. https://www.nejm.org/doi/full/10.1056/NEJMsa2032271.

 Ko JH, Kim TN. Type 2 Diabetes Remission with Significant Weight Loss: Definition and Evidence-Based Interventions. J Obes Metab Syndr. 2022;31(2):123-133. doi:10.7570/jomes22001.

Laiteerapong N, Ham SA, Gao Y, et al. The Legacy Effect in Type 2 Diabetes: Impact of Early Glycemic Control on Future Complications (The Diabetes & Aging Study). Diabetes Care. 2019;42(3):416-426. doi:10.2337/dc17-1144.

Type 2 diabetes and metabolic surgery: ASMBS. American Society for Metabolic and Bariatric Surgery. September 24, 2020. Accessed August 2023. https://asmbs.org/resources/type-2-diabetes-and-metabolic-surgery-fact-sheet.

ElSayed NA, Aleppo G, Aroda VR, et al. Glycemic Targets: Standards of Care in Diabetes—2023. American Diabetes Association. December 12, 2022. Accessed August 2023. https://diabetesjournals.org/care/article/46/Supplement_1/S97/148053/6-Glycemic-Targets-Standards-of-Care-in-Diabetes.

ElSayed NA, Aleppo G, Aroda VR, et al. Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes: Standards of Care in Diabetes—2023. American Diabetes Association. December 12, 2022. Accessed September 8, 2023. https://diabetesjournals.org/care/article/46/Supplement_1/S128/148043/8-Obesity-and-Weight-Management-for-the-Prevention.

Sims TJ, Boye KS, Robinson S, Kennedy-Martin T. Treatment-Related Attributes of Diabetes Therapies and How People with Type 2 Diabetes Report Their Impact on Indicators of Medication-Taking Behaviors. Patient Preference and Adherence. August 4, 2022. Accessed August 2023. https://www.dovepress.com/treatment-related-attributes-of-diabetes-therapies-and-how-people-with-peer-reviewed-fulltext-article-PPA.

Avramidis I, Apsemidou A, Lalia AZ, et al. Lessons From a Diabetes Clinic: Achieving Glycemic Goals and Clinical Use of Antidiabetic Agents in Patients With Type 2 Diabetes. Clin Diabetes. 2020;38(3):248-255. doi:10.2337/cd19-0090.

Avramidis I, Apsemidou A, Lalia AZ, et al. Lessons From a Diabetes Clinic: Achieving Glycemic Goals and Clinical Use of Antidiabetic Agents in Patients With Type 2 Diabetes . American Diabetes Association. July 1, 2020. Accessed August 2023. https://diabetesjournals.org/clinical/article/38/3/248/32205/Lessons-From-a-Diabetes-Clinic-Achieving-Glycemic.

Medlinskiene K, Tomlinson J, Marques I, Richardson S, Stirling K, Petty D. Barriers and facilitators to the uptake of new medicines into clinical practice: A systematic review - BMC health services research. BioMed Central. November 5, 2021. Accessed August 2023. https://doi.org/10.1186/s12913-021-07196-4.

ElSayed NA, Aleppo G, Aroda VR, et al. 4. Comprehensive Medical Evaluation and assessment of comorbidities: Standards of care in Diabetes-2023. American Diabetes Association. December 12, 2022. Accessed August 2023. https://diabetesjournals.org/care/article/46/Supplement_1/s49/148058/4-Comprehensive-Medical-Evaluation-and-Assessment.

Embracing change in the new era of type 2 diabetes care 

Kristina Boye, Associate Vice President, Value, Evidence, and Outcomes, Eli Lilly and Company

Matthew J. Budoff, MD: Examining the Interplay of Coronary Artery Calcium and Osteoporosis

22nd Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC)

, Matthew Budoff, MD, a professor of medicine at the David Geffen School of Medicine at UCLA and an investigator at The Lundquist Institute, discussed the intersection of 

 and osteoporosis, emphasizing how these conditions share overlapping pathophysiology as diseases of aging.

Budoff highlighted findings from studies, including the Multi-Ethnic Study of Atherosclerosis, showing that elevated CAC scores not only predicted cardiovascular events but also correlated with lower bone density and increased fracture risk. Importantly, this relationship is bidirectional—osteoporosis independently increases the risk of atherosclerosis, myocardial infarction, stroke, and cardiovascular mortality. Leveraging advanced imaging techniques, clinicians have developed algorithms to measure bone density from coronary calcium scans or routine CT imaging, allowing simultaneous diagnosis of atherosclerosis and osteoporosis. Budoff indicated this approach could bridge the diagnostic gap, as only 8% of Medicare beneficiaries currently receive bone density testing despite the high osteoporosis prevalence.

The conversation also addressed high-risk populations, including older adults, smokers, Caucasians, and those undergoing significant weight loss due to obesity medications, which exacerbate osteoporosis risk. Budoff urged clinicians to prioritize bone density screening for postmenopausal women and men over 65, using existing CT imaging when DEXA scans are unavailable. By recognizing the dual risk of cardiovascular disease and osteoporosis, Budoff suggested healthcare providers can implement earlier interventions to improve patient outcomes.

Relevant disclosures for Budoff include AstraZeneca, Amarin, Merck, Novo Nordisk, Regeneron, and others.

Budoff MJ. CAC in ASCVD Relation to Bone Density & Osteoporosis. Presented at the 22nd Annual World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC). Los Angeles, California. December 12-14, 2024.

Matthew J. Budoff, MD describes bridging the gap between atherosclerosis and osteoporosis through advanced Imaging techniques.

Matthew J. Budoff, MD: Examining the Interplay of Coronary Calcium and Osteoporosis

Matthew J. Budoff, MD

This article was originally published on 


A new drug is here to make waves in the menopause symptom treatment landscape with the FDA approval of fezolinetant (Veozah; Astellas Pharma) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

This approval makes fezolinetant the first neurokinin 3 receptor antagonist approved by the agency to treat VMS in menopause, according to the FDA.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, MD, MHS, director of the Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research.

 “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

The approval is backed by positive data from the BRIGHT SKY program. This clinical trial program consisted of 3 phase 3 studies that enrolled more than 3,000 individuals from the United States, Canada, and Europe. In 

 (NCT04003155) and SKYLIGHT 2 (NCT04003142), results emphasized the safety and efficacy of the nonhormonal treatment for VMS associated with menopause. Meanwhile, 

 (NCT04003389) demonstrated the long-term safety of fezolinetant.2

"[The] approval of fezolinetant is a significant and, I believe, long-awaited milestone for individuals in the [United States] who experience moderate to severe vasomotor symptoms during the menopausal transition," said Genevieve Neal-Perry, MD, PhD, chair, University of North Carolina School of Medicine Department of Obstetrics and Gynecology.

 "This therapy is based on our understanding of the biology behind hot flashes. I'm excited to know that patients will have the option to choose this nonhormonal treatment."

Patients taking fezolinetant are instructed to take 1, 45 mg pill orally, once per day, with or without food. Additionally, the medication should be taken at the same time every day.

According to the FDA and the prescribing information, the medication includes a warning for elevated hepatic transaminase (liver injury). Prior to using fezolinetant, patients should have blood work completed to test for liver damage. Additionally, while taking fezolinetant, patients should undergo routine bloodwork every 3 months for the first 9 months of usage. If patients experience symptoms such as nausea, vomiting, or yellowing of the skin and eyes, they should contact their physician.

The FDA also notes that fezolinetant cannot be used with CYP1A2 inhibitors, and individuals with cirrhosis, severe renal damage, or end-stage renal disease should avoid taking the medication.

Per the prescribing information, the most common side effects of fezolinetant include abdominal pain, insomnia, back pain, hot flush, diarrhea, and elevated hepatic transaminases.

FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. FDA. May 12, 2023. Accessed May 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause

Astellas’ Veozah (fezolinetant) approved by US FDA for treatment of vasomotor symptoms due to menopause. PR Newswire. May 12, 2023. Accessed May 12, 2023. https://www.prnewswire.com/news-releases/astellas-veozah-fezolinetant-approved-by-us-fda-for-treatment-of-vasomotor-symptoms-due-to-menopause-301823639.html

Announced on May 12, 2023, the FDA's approval of fezolinetant (Veozah) marks their first approval for an NK3 receptor antagonist for the treatment of vasomotor symptoms of menopause.

FDA Approves Fezolinetant for Moderate to Severe Hot Flashes in Menopause

Morgan Petronelli

Patient Education Tips for CSU and Final Thoughts

Video content above is prompted by the following:

Can you describe the importance of patient education and shared decision-making when selecting an appropriate therapy?

What are the unmet needs in CSU management? How is the field evolving?

What advice do you have for allergists for managing CSU based on your experience and the data available?

Patient education and shared decision-making are crucial in selecting appropriate therapies, as they empower patients and ensure treatment plans align with their values and preferences. In chronic spontaneous urticaria (CSU) management, unmet needs include more effective treatments and better understanding of disease mechanisms. The field is evolving with advancements in biologics and personalized medicine approaches. Allergists should stay informed about emerging therapies, engage patients in discussions about treatment options, and tailor management strategies to individual patient needs and responses, leveraging the latest data and clinical experience.

Panelists discuss the importance of patient education and shared decision-making in selecting appropriate therapies for chronic spontaneous urticaria (CSU), addressing unmet needs in CSU management and the evolving nature of the field, while also offering practical advice for allergists based on their experiences and available data.

Authors