A tweet from Ethan Weiss, MD, on the increasing availability of obesity-targeting medications.

Cardiology Business

Wegovy Approved in Teens with Obesity

The FDA recently approved the GLP-1 agonist semaglutide 2.4mg (Wegovy) for obesity in adolescents. When the FDA approved Wegovy in 2021 for use in adults with obesity, physicians and patients alike hailed the medication as “miraculous” and “a game-changer.”

This class of drug has gained a lot of media attention recently as the celebrity weight loss hack of choice, causing demand to outpace supply. But that’s a story for another day. 

Childhood obesity can directly increase life-time cardiovascular disease risk, as underscored in this recent NEJM study that drives home the importance of early intervention and management.  So the FDA’s recent Wegovy approval for obesity in teenagers is all the more timely. 

The new approval comes after Wegovy basically crushed it in the STEP TEENS phase 3 trial, funded by its manufacturer Novo Nordisk, which was published in December in NEJM.  

In the trial, researchers randomized 200 teenagers with obesity to receive either Wegovy (via a weekly 2.4 mg semaglutide injection) or placebo for 68 weeks plus lifestyle interventions. The Wegovy group experienced: 

• Greater BMI reductions (16% vs. 0.6%)
• Dramatically better weight changes (-33.7 lbs vs. +5.3 lbs)
• But more adverse gastrointestinal events (62% vs. 42%) and
• Greater rates of cholelithiasis (4% vs. 0%)

The Takeaway

Wegovy’s recent approval for adolescents is an exciting development with the potential to reduce long-term health risks associated with childhood obesity. While there is still much work to be done to address the underlying causes of obesity, the early efficacy of Wegovy seems to be a step in the right direction.

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The Wire

• Public Interest in CPR Spikes: The on-field collapse of NFL player Damar Hamlin drove a spike in public interest in CPR education resources. The American Heart Association has seen a 620% increase in pageviews on its hands-only CPR webpages since the incident. Roughly 90% of people who suffer cardiac arrests outside of a hospital die. CPR, especially if performed immediately, can double or triple a cardiac arrest victim’s chance of survival.  

• Comparing Healthy Soul Food Diets: A randomized clinical trial comparing two different “healthy soul food” diets among Black American adults found that both cuisines improved body weight and CVD risk factors. The intervention included regular nutrition classes emphasizing either a vegan or a low-fat omnivorous diet. The vegan and omni diets improved 12-month weight changes (-2.39 vs. -2.03 kg), total cholesterol (-1.05 vs. 1.66 mg/dL), and LDL cholesterol (-2.56 vs. -0.79) to similar degrees. Both diets emphasized traditional Southern soul food cuisine. 

• Overlooked AI Bias: An editorial in STAT News took aim at one of the publication’s favorite topics: medical AI bias. The analysis of 518 FDA-approved AI products found that very few submissions provided data on key sources of bias (devices, patient cohorts, clinical sites, annotators), then urged the FDA to require far more transparency into AI models’ training data and performance with different patient groups, as well as to strengthen its oversight of already-cleared AI models.

• Rocket Expands Cardiac Gene Therapy Portfolio: The late stage biotech company Rocket Pharmaceuticals has added a new therapeutic, RP-A601, to its cardiac gene therapy lineup. RP-A601 is specifically designed to treat arrhythmogenic cardiomyopathy due to plakophilin 2 pathogenic variants (PKP2-ACM), a rare disorder in children that has yet to be treated effectively. This is familiar territory for Rocket, which already has robust gene therapy programs for rare childhood hematologic and cardiovascular diseases. 

• Certain Antihypertensives Combat Dementia: A study of over 57k random Medicare beneficiaries suggests that blood pressure medications that stimulate–rather than inhibit–type 2 and 4 angiotensin II receptors may lower the risk of Alzheimer’s and related dementia (ADRD). These stimulating antihypertensives were linked to a 16% lower risk for ADRD and an 18% lower risk for vascular dementia, compared to antihypertensives that inhibit the receptors. 

• Penumbra’s Thrombectomy System Clearance: The FDA has granted clearance to Penumbra’s new mechanical thrombectomy system Lightning Flash. Designed to address venous and pulmonary thrombus, the system leverages Penumbra’s Lightning Intelligent Aspiration technology and the Penumbra ENGINE, aided by dual clot detection algorithms. This is the latest addition to the startup’s Lightning portfolio, which are “the only computer-aided mechanical thrombectomy systems available in the US.”

• Mediterranean Diet Benefits Pregnant Women: Data from the nuMoM2b study suggests that maintaining a Mediterranean diet during conception and pregnancy could reduce the odds of diabetes, preeclampsia, and any adverse pregnancy outcomes. The prospective study followed dietary and pregnancy data of 7.8k women who had never given birth before– or “nulliparous” women. Those who closely followed a Mediterranean diet were less likely to experience adverse pregnancy outcomes (21%), preeclampsia or eclampsia (28%), and gestational diabetes (37%). 

• December Jobs Report: The December Jobs Report revealed that the healthcare sector added 55k jobs last month, with ambulatory services, hospitals, and residential care facilities leading the job gains (30k,16k, 9k). The healthcare industry’s been surprisingly quick to make up the job losses from the beginning of the pandemic, adding an average of 49k jobs per month in 2022 (vs. 9k per month in 2021), although it’s unclear if the momentum will continue now that the COVID job recovery is in the rear view mirror.

• Early & Rapid HF Therapy Initiation: A Canadian registry study revealed that many acute heart failure patients are not getting the guideline-directed therapy they need. About 72% of HFrEF patients were eligible for all four drug classes strongly recommended in international guidelines. Yet prescription rates for each therapy were 6.6% for ARNIs, 44.0% for MRAs, and 81.0% for beta-blockers (SGLT2 inhibitors had not yet been approved for HF). The authors emphasized the importance of “early and rapid” initiation for comprehensive HF therapy.

• Rock Health’s 2022 Recap: Rock Health’s final 2022 digital health funding analysis confirmed that last year was indeed a “downhill ride,” as a drastic decline in late-stage rounds reduced total US digital health funding to $15.3B (vs. 2021’s $29.1B). Cardiology was well represented in 2022’s funding, as cardiac CT AI company Cleerly scored one of the largest rounds ($223M), and “cardiovascular” was the second most-funded clinical indication in 2022–right behind “mental health.” Check out our full writeup in Digital Health Wire.

• Echo AI AS Detection: A Tufts Medical Center and iCardio.ai study showed that echo AI could support fully-automated aortic stenosis (AS) detection, and potentially allow AS screening. After training, validation, and testing using 577 patients’ annotated limited 2D echo images, the AI network accurately performed fully automated AS screening (AUROC: 0.96), and was able to differentiate “no significant AS” and “early AS” from “significant AS” (AUROCs: 0.86 & 0.75). The echo AI also performed well screening for AS in using 8.5k TTEs from an external dataset (AUROC: 0.91).

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