GLP-1 for Kidney Disease; FDA approves Wegovy for Cardiovascular Disease; Eli Lilly’s new Ad Campaign ahead of the Oscars; Obesity is South Africa’s New HIV Epidemic.
Novo Nordisk’s FLOW trial of Ozempic demonstrates a ‘…24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease.’
From over 3,500 people with type 2 diabetes and chronic kidney disease, there was reduction ‘…in kidney disease progression as well as cardiovascular and kidney death of 24% for people treated with semaglutide 1.0 mg compared to placebo.’
Martin Holst Lange, executive vice president for development at Novo Nordisk was ‘…excited about the results from FLOW…’ noting that ‘…Approximately 40% of people with type 2 diabetes have chronic kidney disease.’
The onward charge to go beyond weight loss as a metric of success, to truly conquering obesity-related chronic diseases is unstoppable.
Regulatory FDA approval is likely to be followed by calls for GLP-1 drugs to become the standard of care for those with obesity and related metabolic diseases – to currently impact over 110 millions Americans!
STAT reports on Novo Nordisk’s phase 1 trial of experimental oral medicine amycretin, with an average of 13.1% weight loss after 12 weeks.
The weight loss is fast and large, in comparison to about 6% at the same time point for injectable medication Wegovy.
Amycretin targets well-known GLP-1 as well as amylin – a hormone from the pancreas that reduces food intake by delayed stomach emptying, and well as decreasing blood glucose levels.
A Phase II trial of the drug will commence in the second half of 2024, with results due in early 2026.
Reuters informs on Novo Nordisk market cap of $556 billion and had surpassed that of Tesla, in an 8% surge following results of the phase 1 amycretin trial.
Novo Nordisk is now the 12th most valuable company worldwide, from 14 previously, with a more than three-fold increase in share price since June 2021.
Eli Lilly has ‘…found bacteria and high levels of impurities in products claiming to be compounded versions of tirzepatide…’ from Reuters.
The drugmaker has ‘…sued several medical spas, weight-loss clinics and compounding pharmacies to stop them from selling products purporting to contain tirzepatide.’
The company has further stated that in ‘…at least one instance, the product was nothing more than sugar alcohol.’
The FDA approved ‘…a new indication for use for Wegovy injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.’
The drug is to be used in addition to a reduced calorie diet and increased physical activity.
John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research said ‘…This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.’
The approval is based on the SELECT cardiovascular outcomes trial of over 17,000 patients, which demonstrated that Wegovy statistically significantly reduced the risk of major adverse cardiovascular events by 20% compared to placebo when added to standard of care.
Martin Holst Lange, executive vice president and head of Development at Novo Nordisk said ‘…We are very pleased that Wegovy is now approved in the US as the first therapy to help people manage their weight and reduce cardiovascular risks.’
Great stuff – let’s advance the ball to treat many more patients in a multi-modal manner.
This is an inevitable boost to demand and insurance coverage.
OPINION
TIME profiles Jennifer Witherspoon, a former dental office manager with zero medical training, is now a TikTok influencer treating Ozempic side effects.
A Mounjaro user, she ‘…figured out ways to minimize her own side effects, absent guidance from the doctor who prescribed her the drug…’ also known as ‘…the side effect girl.’
Sadly, more people are getting GLP-1 drugs from sources that offer little or no follow-up care, beyond the prescriptions they dole out.
Robert Kushner, an obesity specialist at Northwestern Medicine rightly states ‘…There’s a lot of hand-holding that goes into prescribing GLP-1 drugs.’
‘Jen is like my doctor…’ said Ashley Hamilton, who started taking Ozempic to lose weight last May.
This is a real trend, and with the increasing number of patients on GLP-1 medications, likely to continue; my concern is when the advice provided by non-medical individuals on a widely available social media platform is wrong, harmful, or both.
I am not against social media at all – there are many bariatric surgeon colleagues of mine that utilize the platform to inform, acquire and maintain relationships with their patients, to name Dr. Betsy Dovec, and Dr. Eric Smith as high quality examples.
The insurer will ‘…limit spending to up to 15% annually – well below the 40%–50% spending some plans are spending on weight loss and diabetes drugs.’
This will be achieved through unique agreements with drugmakers Novo Nordisk and Eli Lilly, via its health services company Evernorth.
CNN reports on Eli Lilly’s new ad campaign kicking off with Big Night.
The opening states ‘…Some people have been using medicine never meant for them… for the smaller dress or tux, for a big night, for vanity.’
The voiceover continues ‘…People whose health is affected by obesity are the reason we work on these medications. It matters who gets them.’
Eli Lilly CEO David Ricks bluntly tells CNN ‘…These medicines were invented for people with a serious health condition; they were not invented just to have someone who’s famous look a little bit better.’
There is a second new ad from Lilly, twice as long as Big Night, called Shame; a result of years his team spent with people with obesity, and its goal is to engender more empathy for them, particularly within the health-care system.
The campaign is scheduled to go out this weekend, in concert with the Oscar ceremony; remember when Jimmy Kimmel joked at last year’s ceremony ‘…Is Ozempic right for me?’
Past colleague of mine, Professor Carel le Roux writes ‘…Obesity is South Africa’s new HIV epidemic…’ in the South African Medical Journal.
Weight-related diseases have eclipsed tuberculosis (TB) and HIV as leading causes of morbidity and mortality in South Africa.
As with HIV in the early 2000s, tools to prevent and treat obesity are available, but too often are being ignored or obfuscated through government inaction, industry interests, and societal inertia.
The medical establishment serves to further perpetuate shame and stigma for those with the disease.
The country must apply the lessons from the HIV epidemic to reduce obesity-related stigma and facilitate widespread access to novel anti-obesity therapies using a public health approach.
Much as combination therapy was a game changer for the HIV response, modern obesity medicine has demonstrated that novel medications and/or surgery are critical elements to achieve sustained weight loss and improved health outcomes.
DATA
JAMA Surgery publishes on 124 patients undergoing surgery who were on a GLP-1 drug, such that over half, 56% had residual stomach contents, compared with 19% of those not on the drug, following the pre-procedure fasting guidelines.
The authors from University of Texas Health Science Center suggest ‘…preprocedural fasting duration suggested by current guidelines may be inadequate in this group of patients at increased risk of aspiration under anesthesia.’
This is important, as aspiration, or vomiting during anesthesia, can lead to serious and sometimes life-threatening pneumonia.
