AT A GLANCE
- FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products.
- Eli Lilly announced positive results from SUMMIT phase 3 clinical trial of tirzepatide injection in adults with heart failure and obesity.
- STAT on the worst for Dexcom may not be over, as ‘…shares plummeted nearly 40%…’ after lowered full-year sales guidance.
- Lisa Goldstein at Kaufman Hall asks Can One Drug Change the Hospital Industry?
- From the Alzheimer’s Association comes data that liraglutide, a GLP-1 drug appears to slow cognitive decline by protecting the brain.
NEWS
- FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products.
- Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug.
- Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports.
- Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness.
- Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug.
- In one reported case, it was difficult for the patient to obtain clarity on dosing instructions from the telemedicine provider, who prescribed the compounded semaglutide, leading the patient to conduct an online search for medical advice and resulting in the patient taking five times the intended dose.
- Eli Lilly announced positive topline results from the SUMMIT phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
- There was a statistically significant reduction of 38% in the risk of heart failure outcomes, and improvements in heart failure symptoms and physical limitations.
- This makes it the second GLP-1 drug to show positive results in the disease area after Novo Nordisk’s Wegovy.
- More data will be presented at an upcoming medical meeting, and Eli Lilly said that it plans to submit the data to the FDA and other regulatory agencies later this year.
- The American Association for Clinical Endocrinology published the AACE Journey For Patients With Obesity, billed as a guide to help manage the complex and emotional experience of living with obesity.
- More deeply, the journey is a roadmap for up-to-date information, resources, and tools to navigate the diagnosis, treatment plan, and wellness goals no matter where one is in their personal journey, based upon key stages of contemplation, initial assessment, diagnosis and staging, treatment and goals, care and continuity.
OPINION
- STAT on the worst for Dexcom may not be over, as ‘…shares plummeted nearly 40%…’ after lowered full-year sales guidance.
- Mizuho analyst Jared Holz noted ‘…it’s hard not to see Dexcom’s business being impacted by GLP-1 drugs.’
- Holz added ‘…We believe there is no doubt that the Company and industry feel pressure from the tens of millions of patients that begin to use the weight-loss therapies.’
- I am pretty surprised by this approach, akin to the past CEO at Teladoc stating that airlines will require less fuel due to less heavy passengers, and Krispy Kreme donuts will no longer be desirable.
- Drs. Richard DiMarchi and Matthias Tschop, who discovered and validated the novel drug class of dual and triple gut hormone co-agonists for the treatment of obesity and diabetes, write in Cell on Transforming obesity: The advancement of multi-receptor drugs.
- Noting worldwide obesity will continue to rise to one billion adults by 2030, the authors review the development of GLP-1R agonists, and gut-hormone multi-receptor agonists, in the treatment of T2D and obesity.
- Concluding, the ‘…progress witnessed in the last decade in the management of obesity and its related diseases has been nothing short of stunning.’
- Despite this, ‘…bariatric surgery still stands as the benchmark for weight loss, triggering weight reduction of 25%–30% within a 1- to 2-year period…’ with a multimodal approach to ‘…undoubtably change the trajectory of the relentless rise in global obesity.’
- Lisa Goldstein at Kaufman Hall asks Can One Drug Change the Hospital Industry?
- On GLP-1 drugs, ‘…it stands to reason that if one drug can change the trajectory of health outcomes, it can change how hospital care is delivered over the long-term.’
- Indeed ‘…One could imagine that GLP-1s could be as impactful as the smallpox vaccine, penicillin, or fluoridated water.’
- I do think it is right that ‘…Hospital leaders will also need to consider how these drugs may impact operations. Will certain service lines lose volume?’
DATA
- Annals of Internal Medicine publish on over two hundred thousand new users of antidiabetic medications, with almost six thousand on semaglutide; the latter group had a significantly lower risk for medical encounters for tobacco-use disorder diagnosis.
- In addition, semaglutide was associated with reduced smoking cessation medication prescriptions and counseling.
- The authors suggest the need for clinical trials to evaluate semaglutide’s potential for TUD treatment.
- Nora Volkow, Director of the NIH institute for Drug Abuse, and a co-author on this study notes ‘…The main driver of why many of us overeat relates to those reinforcing positive responses that we get from eating certain foods. And it’s the same circuit for foods as for drugs.’
- From the Alzheimer’s Association comes data that liraglutide, a GLP-1 drug appears to slow cognitive decline by protecting the brain.
- Research in animal models of Alzheimer’s disease suggests these drugs may have neuroprotective effects, reduce early forms of amyloid, normalize the brain’s processing of glucose, and improve memory and learning.
- The new research suggests liraglutide may protect the brains of people with mild Alzheimer’s disease and reduce cognitive decline by as much as 18% after one year of treatment compared to placebo.
- Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead said ‘…We are in an era of unprecedented promise, with new treatments in various stages of development that slow or may possibly prevent cognitive decline due to Alzheimer’s disease.’
- Lead researcher, Dr. Paul Edison at Imperial College London, writes ‘…The slower loss of brain volume suggests liraglutide protects the brain, much like statins protect the heart.’
- From The Lancet Diabetes & Endocrinology, STEP 10, a randomized phase 3 trial of semaglutide versus lifestyle therapy in over 200 patients with obesity and pre-diabetes, reported a superior reduction in bodyweight and reversion to normoglycaemia in the treatment group.
- The semaglutide group lost almost 14% total body weight, and 81% versus 14% achieved normal glucose levels, at one year.
- The authors support the potential use of semaglutide therapy as a treatment option for individuals with obesity and prediabetes to achieve reversion to normoglycaemia.
ADDITIONAL TOPICS