Sek Kathiresan MD on the expected popularity of Lilly’s new weight loss drug.

Pharmaceuticals

Lilly’s Zepbound (aka tirzepatide) Lands FDA Approval for Weight Loss

The US obesity management arena gained a major new competitor last week with the FDA approval of Eli Lilly’s Zepbound, giving obese and overweight patients in the US a second (on-label) option beyond Novo Nordisk’s Wegovy.

• Zepbound is Lilly’s new obesity-targeted brand for tirzepatide, which has been available to US diabetic patients under its Mounjaro brand since May 2022
• Although often referred to as a GLP-1, tirzepatide uniquely activates both GIP (affects adipose tissue regulation and storage) and GLP-1 (increases feeling of fullness and decreases gastric emptying) hormone receptors

Zepbound already has significant momentum, given the massive popularity of GLP-1s, the fact that many people were already using Mounjaro as an off-label weight loss treatment, and tirzepatide’s impressive weight loss achievements in recent studies:

• Lilly’s SURMOUNT-3 and SURMOUNT-4 trials showed that tirzepatide allows overweight people who don’t have type 2 diabetes to shed a massive 26% of their weight
• Before that, tirzepatide drove 13.4% to 15.7% weight reductions among people with T2D in the SURMOUNT-2 trial, and 15% to 20.9% reductions in non-diabetic adults in SURMOUNT-1
• Like all GLP-1s (so far), tirzepatide also comes with a risk of adverse GI events

Those weight loss results should make Zepbound a formidable opponent to Novo Nordisk’s Wegovy, which might have a first-to-market advantage, but only achieved 10.9% to 14.9% weight reductions in previous trials.

Zepbound’s launch could also improve patient access to GLP-1s, potentially alleviating shortages, and creating more price flexibility.

• Lilly executives were sure to point out that Zepbound’s $1,059 monthly price is 20% lower than their “lowest competitor,” and highlighted new programs that can reduce Zepbound to between $25 and $550 per month with commercial coverage 
• Time will tell if increased competition drives down prices further, or increased adoption drives expanded payor coverage

Particularly notable to CW readers, tirzepatide has also been shown to positively impact key cardiovascular metrics, including cholesterol and blood pressure. 

• However, its cardiovascular impact might prove to be much greater in the future, given that it’s currently being evaluated in a range of cardiovascular-related studies (MACE, CKD, and HFpEF).
• One more reason for cardiovascular optimism: Novo Nordisk’s semaglutide was recently shown to reduce major cardiovascular events by a whopping 20% over five years.

The Takeaway

There’s arguably no pharma segment with stronger patient demand than GLP-1s, and Zepbound’s weight loss and cost advantages just made that segment even hotter.

Register now: Durability & TAVR: Critical Appraisal of the evidence after TCT.

Join Medtronic’s expert faculty for a live, case-based discussion on November 14 at 7:00 p.m. ET. Over the course of 90 minutes, they will discuss durability and TAVR and evidence review designed to expand your TAVR expertise. Register now!

Better Cardiovascular Care, With a Better Bottom Line

Twenty million chest CTs are acquired in the U.S. each year, but CAC is typically unreported. See how you can leverage Bunkerhill Health’s Incidental CAC algorithm to screen for incidental coronary calcium on routine chest CTs in real-time, improving care and your bottom line.

The Wire

• Ross Procedure’s Excellent Outcomes: In a post-hoc analysis of a randomized trial of 108 adults who underwent the Ross procedure, which involves the replacement of a diseased aortic valve with a patient’s own pulmonary valve, 83% survived 25 years after surgery. That’s roughly in line with 25-year survival in the general population (83.7%). The investigators described these results as “excellent,” and as evidence supporting renewed interest in the procedure.

• Inappropriate Anticoagulants: A new registry study highlighted the tendency to prescribe less or more than the recommended dose of direct oral anticoagulants for AFib. In the study of 22.5k patients discharged from the hospital with anticoagulants, the rates of under- and over-dosing were 8.9% and 2.3%. Under-dosing was more common in people who were older or on dialysis while over-dosing was an issue with patients who were female and who weighed more.

• AccurKardia & Lucem’s ECG Alliance: AccurKardia launched a partnership with Lucem Health that will make AccurKardia’s AI-based ECG interpretation software, AccurECG, available within the Lucem Health Reveal family of clinical AI solutions. The alliance adds cardiovascular disease detection to the Lucem Health Reveal portfolio, which previously focused on pre-diabetes, diabetes, and lower GI disorders. AccurKardia’s AccurECG is a cloud-based, device-agnostic, and automated ECG interpretation platform that can detect up to 13 arrhythmias. 

• BWI QDot Micro’s Positive Data: New analysis highlights Biosense Webster’s QDot Micro radiofrequency ablation catheter’s ability to improve AFib symptoms and quality-of-life. In the study of 166 patients ablated with the catheter, self-reported control of AFib and relief of AFib symptoms improved by 99% and 93.1% at 12 months, while 87.9% reported a meaningful improvement in QoL, and the need for anti-arrhythmic drugs declined by 79.9%.

• Elucid Adds $80M: Cardiovascular AI continues to be one of the hottest corners of the imaging AI market, following Elucid’s $80M Series C round (total funding now $121M). Elucid will use the new capital to drive its commercialization efforts and expand its suite of AI-powered cardiovascular risk solutions, which currently focuses on a unique histological-based approach to CTA AI atherosclerosis assessments and could add FFRCT in the future. Elucid joins Cleerly and HeartFlow among the cardiovascular imaging AI startups who’ve raised over $100M.

• As Kidney Function Dips, Dapagliflozin Still Protects: A recent analysis from the DAPA-HF and DELIVER trials suggests that dapagliflozin (AstraZeneca’s Farxiga) may benefit HF patients even as kidney function declines. Pooling data from over 11k participants, researchers found that 3.2% of patients experienced a significant decline in kidney function, and this deterioration was tied to a heightened risk of adverse CV events. Interestingly, dapagliflozin seemed to offer protection against these events, significantly reducing the risk of worsening HF or CV death compared to placebo (HR: 0.78).

• Ultromics’ Outpatient Reimbursement: Echo AI solutions company Ultromics announced that CMS assigned a $284 reimbursement for each outpatient use of echo AI tools for HFpEF detection (HCPCS code: APC 5743), such as the company’s EchoGo Heart Failure product. The new 2024 echo AI HFpEF reimbursement comes just a few months after CMS issued an NTAP reimbursement for inpatient use, and continues a strong trend towards cardiovascular imaging AI reimbursements following payments for FFR-CT analysis and CT AI plaque assessments.

• Biodegradable SES Stents Superior: The BIOSTEMI ES study revealed that biodegradable polymer sirolimus-eluting stents (BPSES) have superior long-term outcomes compared to durable polymer everolimus-eluting stents (DPES) after PCI. Researchers randomized 1,300 STEMI patients to receive either BPSES or DPES, finding lower target lesion failure rates in BPSES patients after five years (difference of -3%, risk ratio: 0.70).

• Kento Health’s Cardiac Rehab Funding: Cardiac rehabilitation startup Kento Health wrapped up a $3M pre-seed funding round that it will use to drive its expansion from Canada into the US. Kento’s platform combines coaching with personalized content delivery, adaptive learning, remote monitoring, and natural language processing to provide patients with custom education and exercise recommendations.

• Brilinta Holds Its Own Post-PCI: A new meta-analysis revealed a dramatic safety benefit from switching post-PCI ACS patients from DAPT with aspirin and ticagrelor (AstraZeneca’s Brilinta) to taking ticagrelor monotherapy. In the analysis of TWILIGHT and TICO trial data (N=7,529), rates of BARC type 3 or 5 bleeding were reduced by 63% for patients who switched to ticagrelor monotherapy. Rates of all-cause death, MI, or stroke were similar (2.4% and 2.7%).

• SGLT2is & HF Comorbidities: A post hoc analysis of the DELIVER study examining the SGLT2 inhibitor dapagliflozin (AstraZeneca’s Farxiga) showed that patients with HF often have cardio-renal-metabolic comorbidities (e.g. ASCD, CKD, type 2 diabetes). Out of 6,263 HF patients, 31%, 36% and 20% had one, two, or three additional comorbid conditions, putting them at increased risk of death or worsening HF. However, dapagliflozin was effective regardless of comorbidities, highlighting the benefit of SGLT2is.

Accurately Measuring Heart Rate Variability

Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.

HeartFlow’s FFRCT’s Nationwide Improvements

What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains.

The Resource Wire

• The ESC has updated its heart failure guidelines, for the first time including a guideline-directed medical therapy for heart failure with preserved ejection fraction (HFpEF). See how cardiologists are trusting echo AI to find these cases earlier in this video from Us2.ai. 

• Check out this Change Healthcare report detailing the benefits of cardiovascular structured reporting, and how to drive structured reporting adoption in your own organization.

• Heart disease is the leading cause of death, so it might be time to change how we think about heart attack prevention. Read Cleerly’s manifesto on why our current approach is unsustainable, how Cleerly’s AI-based platform can transform care, and what it will take to change today’s unacceptable heart disease statistics.

• Ready to enhance your cardiovascular CT services with automated CT-FFR integration? Tune-in to Keya Medical and Precision Image Analysis’s SCCT webinar and learn from industry experts how to solve the challenges of scaling CT-FFR services and overcome the complexity of CT-FFR implementation.