Saturday, September 11

Wegovy is the new treatment for obesity

The FDA announced the long-awaited approval of Wegovy, a once-weekly injectable medication for weight reduction, on June 4, 2021.

In the months leading up to approval, Wegovy received a lot of media attention, with a New York Times story calling it a "game-changer," MedPage Today reporting "extraordinary outcomes," and the BBC claiming it may usher in a "new era" in obesity treatment. Wegovy's effectiveness has been lauded in the media as being superior to any other weight-loss drug now on the market. Such dramatic headlines are prevalent in the media, therefore we must examine if all of the media attention is actually justified.

What exactly is Wegovy and how does it function?

Wegovy is the brand name for semaglutide, a high-dose injectable peptide hormone molecule that was previously authorized by the FDA for the treatment of type 2 diabetes under the trade name Rybelsus (oral) and Ozempic (lower-dose injection). The higher-dose Wegovy allows for the better crossing of the blood-brain barrier, which increases its weight-loss efficacy. Injectable semaglutide eliminates the strict guidelines for ingesting on an empty stomach required by oral semaglutide, while the higher-dose Wegovy allows for the better crossing of the blood-brain barrier, which increases its weight-loss efficacy.

Semaglutide belongs to the glucagon-like peptide-1 receptor agonists or GLP-1 RAs, class of drugs. GLP-1 is a hormone that is produced spontaneously in the gastrointestinal system in response to food consumption. It has a number of effects, including boosting pancreatic insulin release, delaying stomach emptying, and reducing hunger via targeting brain receptors. This causes a feeling of satiety, or fullness, that lasts far longer than natural GLP-1 hormone levels.

Who can take Wegovy?

Wegovy, like all other prescription obesity medicines, is authorized for use in those with a BMI of 30 kg/m2 or above, or those with a BMI of 27 kg/m2 with a weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

What are the disadvantages and advantages of Wegovy?

The STEP (Semaglutide Treatment Effect in People with Obesity) studies, Wegovy's phase 3 clinical trials, were undertaken in a number of clinical situations, each with small differences in the study population and research design. The STEP 1 study, whose findings were published in the New England Journal of Medicine, found that individuals allocated to the pharmaceutical group lost an average of 14.9 per cent of their body weight after 68 weeks of therapy, compared to only 2.4 per cent for those assigned to the placebo group. The average weight reduction seen with present anti-obesity medicines is generally about 5% to 9%, while individuals engaged in lifestyle lose an average of 3% to 5%.

Nausea, diarrhoea, vomiting, and constipation are the most frequent adverse effects of Wegovy. The medicine also comes with a warning about the danger of a particular thyroid tumour, so it's not advised for anyone who has a personal or family history of medullary thyroid cancer or types 2 multiple endocrine neoplasias (a genetic condition associated with endocrine tumours). It's worth noting that tumours were only seen in animal studies and not in human trials.

How long can you take Wegovy?

Wegovy is one of six obesity medications presently authorized by the FDA for long-term use. As a result, it can be used indefinitely as long as it is effective for weight reduction and/or maintenance and does not cause unacceptable adverse effects. Exenatide was the first GLP-1 RA drug to get FDA approval in 2005; since then, numerous GLP-1 RAs have been authorized and have undertaken long-term studies proving either non-inferiority or superiority compared to placebo for severe adverse cardiovascular events including heart attacks and stroke. The SELECT study is a long-term cardiovascular outcomes trial for Wegovy, with the goal of determining the drug's impact on heart health.

Management of anti-obesity medications is changing.

Wegovy is the latest in a long series of medicines approved by the FDA for the treatment of obesity, beginning with phentermine in 1959. In the United States, phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, phentermine/topiramate ER (Qsymia), bupropion/naltrexone (Contrave), liraglutide (Saxenda), setmelanotide (Imcivree), and recently semaglutide have all been authorized by the FDA (Wegovy). Setmelanotide, it should be noted, is only licensed for the treatment of obesity caused by uncommon hereditary disorders. Metformin, zonisamide, and other GLP-1 RAs are commonly used for treating diabetes.

Many cases of therapeutics failing to demonstrate sufficient safety data to warrant FDA approval, such as rimonabant (Acomplia), or adverse effects necessitating market withdrawal, such as lorcaserin (Belviq), sibutramine (Meridia), dexfenfluramine (Redux), fenfluramine (Pondimin), and the infamous combination medication Fen-phenUnfortunately, the rocky anti-obesity drug landscape causes physicians to be hesitant to use the numerous safe and effective tools available today to treat obesity.

The cost of anti-obesity drugs

The high expense of some of the newer therapies, as well as the reluctance of many private and public insurance to pay for anti-obesity drugs, provide obstacles for those who do prescribe anti-obesity pharmacotherapy. Patients and their supporters may be successful in persuading their employers to include obesity management in their insurance coverage. Anti-obesity medicines, on the other hand, are now uninsured for individuals on Medicare or Medicaid.

Patients without insurance have three options: pay out of pocket for a lower-cost generic anti-obesity medication; take a medication designed to treat other medical conditions such as diabetes or seizures that may also help with weight loss; or, if their BMI and health status are severe enough to satisfy insurance requirements, opt for bariatric surgery, a much more expensive option.

The Treat and Reduce Obesity Act was originally presented in Congress in 2012 and was reintroduced in 2021 with the objective of modifying the Medicare Social Security Act to allow insurance coverage of obesity counselling services and FDA-approved anti-obesity medicines. The most difficult challenge in the obesity treatment landscape is persuading government agencies, employers, and insurers that drugs treating the most common chronic condition in the United States are truly worth paying for.

Wegovy is the new treatment for obesity
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