Ro Prescribes Compounded Semaglutide; Tirzetapide for Fatty Liver; Obesity Center of Excellence; No-Zempic; AMG133 and Survodutide.

AT A GLANCE

  • STAT reports on Eli Lilly drug trial of tirzetapide as a treatment for the liver disease MASH.
  • Business Insider reporter Shelby Livingston notes ‘…startup Ro just started prescribing “compounded” semaglutide, an alternative to Ozempic.’
  • Milliman, an international actuarial and consulting firm based in Seattle, Washington, explores the concept of an obesity center of excellence.
  • No-zempic is leaving lots of people behind, from Yasmin Tayag at The Atlantic.
  • Nature Medicine publishes on AMG 133 results, with almost 15% of total body weight by the third dose, at three months.
  • Prof Carel Le Roux publishes in The Lancet on survodutide for 46 weeks; the highest dose led to almost 15% total body weight loss.
  • The Journal of the American College of Cardiology publishes a clinical trial on patients with obesity and hypertension, undergoing bariatric surgery.

NEWS

    • STAT reports on Eli Lilly drug trial of tirzetapide as a treatment for the liver disease MASH, with ‘…74% of adults in the trial taking the drug were free of MASH after 52 weeks.’
      • This impact beyond weight loss per se, is important to further define the role of anti-obesity medications to treat clinically significant disease, from fatty liver disease to diabetes to hypertension.
      • There is a hope ‘…that insurers will be swayed by evidence these medications provide other health benefits…’ moving away from weight loss as a cosmetic treatment.
    • CNBC reports on Eli Lilly sales of Zepbound, which won approval from U.S. regulators in early November, at $175.8 million for the fourth quarter of 2023.
      • Eli Lilly is the largest pharmaceutical company based in the U.S. with a market cap of roughly $673 billion, and total fourth quarter revenue of $9.35 billion.
      • The forecasted 2024 revenue was stated to be between $40.4 billion to $41.6 billion, supported by increasing demand for tirzetapide.
      • In addition, Mounjaro booked $2.21 billion in sales for the fourth quarter, up from just $279.2 million in the same period a year ago.
      • The only way is up…

OPINION

    • Business Insider reporter Shelby Livingston notes ‘…startup Ro just started prescribing “compounded” semaglutide, an alternative to Ozempic.’
      • Ro ‘…started prescribing the compounded drug about two months ago to ensure that its patients can stay on medication when brand-name drugs are hard to find…’ as a backup, spurred on by supply shortages.
        • Whilst there are multiple webistes, medspas and telehealth clinics prescribing compounded weight loss drugs, Ro has taken a stance to ‘…effectively endorse compounded semaglutide by prescribing it.’
        • Compounded drugs may be of poor quality and just not work, or potentially harmful if contaminated with other ingredients; the drugs are not tested or approved by the US Food and Drug Administration.
        • There have been 165 reports to the FDA of adverse events related to compounded semaglutide from August 2021 through January 23, 2024; this is very small number, even though it is unknown how many Americans are taking the compounded drug.
        • Novo Nordisk and Eli Lilly have taken legal action against compounding pharmacies, and medspas that are prescribing such drugs too.
        • In counter, ‘…Weight Watchers, Noom, and Found, are steering clear of compounded GLP-1s.’
        • Ro says ‘…patients can trust that it’s done the legwork to ensure its compounded semaglutide is safe and works…’ with ‘…extensive quality checks by third-party labs that Ro hired.’
    • Dani Blum at The New York Times looks ‘…for ways to counteract the muscle loss that can happen…’ on weight loss drugs.
      • Gyms offering strength-training programs, nutritionists focused upon protein-rich meal plans, and pharmaceutical companies are exploring drugs to regulate muscle mass.
      • Noom now has ‘…a Muscle Defense program that includes fitness videos and a protein tracker.’
    • Milliman, an international actuarial and consulting firm based in Seattle, Washington, explores the concept of an obesity center of excellence.
      • Austin Barrington and colleagues outline a white paper, commissioned by Eli Lilly, to develop a ‘…targeted obesity care model combined with a risk-sharing financial component may align provider and employer incentives for treatment of obesity.’
      • Employee wellness programs, obesity telehealth programs, and traditional clinical services inclusive of anti-obesity medications and bariatric surgery are considered.
      • The financial implications of obesity to an employer are significant, with ‘…each one-unit BMI increase is associated with an additional cost of $253 per person per year…’ and additional impact on absenteeism and presenteeism.
      • Centers of excellence have ‘…been implemented to improve value in multiple conditions and medical episodes from cancer to knee replacement…’ to provide best-in- class care through a specific provider network.
      • A center of excellence provides comprehensive and effective obesity care, with a personalized treatment plan, comprising lifestyle support, medication, and surgical therapies.
      • Scope of services, patient eligibility, the provider network, and a technology platform are essential components, supplanted by financial structures and contracting.
      • welcome and support the Milliman approach, to be fully aligned with twenty30 health, to deliver whole-person, longitudinal, multimodal care for over one hundred million Americans managing with obesity and related diseases.
      • Thank you.
    • No-zempic is leaving lots of people behind, from Yasmin Tayag at The Atlantic.
      • Anita from Arizona and Tina from Florida simply did not lose any weight on the drug; they respond weakly or did not respond.
      • Somewhere between one in six to one in three people are non-responders, due to genetics, metabolism, and other unknown effects.
      • It may be that one drug works better for them than another – think of it like chemotherapy; it does not work the same for everyone, with the same tumor type.
      • Indeed, patients like Anita and Tina may be great candidates for bariatric surgery – which again though, does not yield the same result for everybody.
      • Newer and better drugs will help, but the human body is amazing in its diversity; indeed the ‘…disease is simply too complex, with too many drivers, for a single type of medication to treat it.’

DATA

    • A fascinating publication in Nature Medicine this week, focuses upon AMG 133, known as maridebart cafraglutide, or Maritide, an antibody developed by Amgen that impacts GLP-1 and its lesser known cousin, GIP, or glucose-dependent insulinotropic polypeptide.
      • The drug has been shown to reduce body weight in laboratory mice and monkeys, as well as impact blood glucose, insulin, and cholesterol levels.
      • An additional study recruited 49 obese human subjects – some of whom were injected with the drug just once; those on the highest 840mg single dose maintained a total weight loss of 8.2% at up to five months – let me say that again… this was just based on a single shot.
      • An additional group received three shots of 420mg over two months – they lost almost 15% of total body weight by the third dose, and without any further medications, maintained this to an 11% weight loss at seven months, which was five months since their last dose.
      • Having a drug that is taken monthly is a competitive edge; the additional durability out to five months since the last injection has game-changing potential – data from Zepbound and Wegovy trials show a weight rebound much sooner after stopping the drug.
    • Past colleague and friend Prof Carel Le Roux publishes in The Lancet on almost 400 subjects enrolled to receive varying doses of survodutide for 46 weeks; the highest dose led to almost 15% total body weight loss.
      • Survodutide, developed by Boehringer Ingelheim works on GLP-1 and glucagon hormones, in that it reduces appetite with the novel impact to also increase liver energy expenditure.
    • 600 patient study in the journal Hypertension evaluated the role of tirzetapide in 24h blood pressure reduction by about 10 points.
      • In addition, nighttime systolic BP, which is a stronger predictor for cardiovascular death and  all-cause  death than daytime and 24-hour systolic  BP, was also significantly reduced by tirzepatide.
      • Once again, we are seeing the role of GLP-1 medications beyond weight loss; exactly how we need to think of treatment for people with obesity and related metabolic disease.
    • The Journal of the American College of Cardiology publishes a clinical trial on patients with obesity and hypertension, undergoing bariatric surgery.
      • From 100 subjects enrolled, almost half those who had undergone gastric bypass were in remission, or cured, of their high blood pressure.
        • The total number of medications taken were reduced from 3 per day, to less than 1 per day, whilst maintaining a normal blood pressure.
        • Indeed, bariatric surgery ‘…represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity…’ with a concomitant reduction in medical expenditures too.

DR.RAJESH TWENTLY 30 HEALTH


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