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FDA APPROVES FIRST TREATMENT TO REDUCE RISK OF HEART PROBLEMS IN ADULTS WHO ARE OVERWEIGHT

The medication semaglutide-brand name Ozempic- was first approved by the FDA as a diabetes medication. Subsequently, when doctors observed that it helped their diabetic patients lose weight, it was studied for its effectiveness as a weight loss drug. Semaglutide was then approved as a weight loss medication under the brand name Wegovy in 2021. More recently, with there being increasing evidence that those who used Wegovy as a weight loss medication reduced their risk of having serious heart problems, this medication was evaluated by the FDA for its effectiveness as a heart disease preventive medication. Wegovy was then granted what is termed a “priority review”  meant to evaluate whether the FDA would expand the indication for the medication to another use. Wegovy received Priority Review designation for this indication, and then on March 8,2024 the U.S. Food and Drug Administration approved a new indication for the use of Wegovy “to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.” Semaglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist whose effects include decreased appetite and cravings for food, and an enhanced sense of satiety after eating a relatively smaller amount of food.

In the FDA’s press release announcing its new indication they indicated that  Wegovy should be used in addition to a proper weight reduction diet, along with exercise.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or

John Sharretts, M.D.,is the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. In the FDA’s press release he states, “Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight. 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.” 

Explaining the public’s need for this medication, the FDA points to the statistic that approximately 70% of American adults are considered overweight. Being overweight or obese is known to be associated with many health problems including heart attack and stroke. And the rate of premature death by a wide variety of illnesses has also been documented.

Wegovy’s efficacy and safety for this new indication was studied in a multi-centered placebo-controlled double-blind trial with over 17,600 study subjects. Study participants  received the usual standard-of-care medical treatments during the study as well as  healthy diet and lifestyle counseling. Wegovy significantly reduced the risk of major adverse cardiovascular events, (death, heart attack and stroke), for those  participants who received Wegovy compared to those who received placebo.

Their is growing evidence that other  health problems may be helped or avoided by losing weight with Wegovy:

WEIGHT LOSS MEDICATIONS REDUCE COLON CANCER RISK

Research published in the scientific journal JAMA Oncology showed that diabetics who took GLP-1 agonist medications had a lower risk of Colorectal cancer compared to other type 2 diabetics. Having diabetes has long been known to increase the risk of colorectal cancer. In this study participants were found to have a 25% lower risk utilizing the GLP-1 agonist medications, compared to patients who took the commonly prescribed diabetes medication Metformin.

REDUCED RISK OF OTHER CANCERS

Obesity is a risk factor for a wide variety of cancers including breast, uterine, kidney, gallbladder, liver and pancreatic cancers as well as colorectal cancer.

Approximately 4-8% of all cancers are obesity related. The NIH (National Institutes of Health) states ,”Weight-reducing strategies in obesity-associated cancers are important interventions as a key component of cancer care ” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9857053/#:~:text=Obesity%20has%20been%20linked%20to,cancers%20are%20attrib

   SEMAGLUTIDE MAY LOWER DEMENTIA /ALZHEIMER’S RISK

This is being studied by the  Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases at The University of Texas Health Science Center at San Antonio

Cardiovascular problems are known to contribute to the development of Alzheimer’s disease. Sudha Seshadri, MD, a neurologist and founding director of the Biggs Institute. explains that heart disease and diabetes are associated with vascular brain abnormalities. “Vascular brain injury, even if it doesn’t cause Alzheimer’s, reduces the brain’s resistance to developing Alzheimer’s and other pathology.”

Wegovy helps with Addiction to alcohol and other substances

Semaglutide’s great success for weight loss is due to its action in reducing the desire for food.  But another striking effect that has emerged is that it also decreases the desire for alcohol, nicotine and opioids! With more widespread use GLP-1 agonsit medication this anti-addictive property is being increasingly appreciated and being applied by doctors and clinics.

Weight Loss Drugs May Help Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome (PCOS) is a  condition of hormonal imbalance characterized by menstrual cycle irregularity, weight gain, and fertility problems. It it also associated with the metabolic factors insulin resistance and prediabetes. Thus, it is only logical to further investigate the utility of GLP-1agonist medications for their possible benefits in this condition.

GLP-1 agonist medications originally approved for diabetes, and then for weight loss are increasingly being seen as beneficial to a wide variety of important medical concerns. More research will surely follow.

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