ZEPBOUND : THE NEW WEIGHT LOSS MEDICATION
The FDA has just published a news release regarding its approval of Zepbound (Tirzepatide) for weight management. Zepbound which contains the same medication as the previously released Mounjaro, is a weekly injectable medication for chronic weight management in adults with obesity, (body mass index of 30 or greater), or overweight with at least one weight related condition (high blood pressure, diabetes or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. The medication Mounjaro is approved for Diabetes management and Zepbound is simply another brand name of the same substance (Tirzepatide) with the FDA approval for weight management.
John Sharrets,MD is the director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research. In regard to the need for the approval of Zepbound for weight management he explains, ” Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes. In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need”.
The prevalence of obesity and overweight in the United States is approximately 70% of the population. There are many health problems associated with being overweight that can be greatly reduced if a patient loses weight in a healthy manner. There has been great success, and therefore great demand for the medication Mounjaro, which although FDA approved only for diabetes, has been used “off-label” by many doctors and their patients across the country to lose weight . Now with an actual approval of Tirzepatide for weight loss as the medication Zepbound, there will likely be continued increased demand. And FDA approval may help in getting insurance companies to cover the drug. Without insurance coverage most people find the mediation too expensive to access it.
The FDA news release explains the science of Zepbound this way:
“Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) to reduce appetite and food intake. Zepbound is administered by injection under the skin once weekly…”
The Starting dose for Zepbound is set at 2.5mg and the dose is increased gradually in order to have a greater effect on the appetite suppression the patient is looking for. As the dose is increased, however, side effects- most commonly nausea, vomiting, diarrhea or constipation, may also be increased.
The FDA news release reviewed the scientific studies justifying its approval: “Zepbounds’ effectiveness for chronic weight management (weight reduction and maintenance) in combination with a reduced-calorie diet and increased physical activity was established in two randomized, double blind, placebo-controlled trials of adults with obesity or overweight with at least one weight related condition. These studies measured weight reduction after 72 weeks in a total of 2,519 patients who received either 5mg, 10mg or 15mg of Zepbound once weekly, and a total of 958 patients who received once weekly placebo injections.” The FDA explained that in both studies Zepbound was successful in achieving a statistically significant weight loss compared to those receiving the placebo injection. In the larger of the two studies, with subjects who did not have diabetes, those receiving the highest dose of 15mg had an 18% reduction of the body weight compared to placebo. In the other study whose research subjects did have diabetes, those patients lost an average of 12% of their body weight compared to placebo.
As a practical matter people utilizing Zepbound or any of the related medications discussed here, should follow a healthy diet with the emphasis on lowering carbohydrate intake below that which occurs in the average American diet. Simple sugars such as those found in candies, cakes, and sodas should be entirely or at least mostly eliminated. Other carbohydrates in breads, pasta, rice, and potatoes should be reduced- particularly in those who eat them daily, especially when they are a part of most of the persons meals every day.
Side effects that were seen included nausea, vomiting, diarrhea, constipation, allergic reactions-such as fever and rash, burping, hair loss and gastroesophageal reflux. Included in warnings issued by the FDA is the information that thyroid tumors were seen in rat studies. Although it is unknown as to whether this would occur in humans, the FDA advises that the medication not be taken by people who have a history of medullary thyroid cancer. And it cautions that those who have a family history of medullary thyroid cancer or multiple Endocrine Neoplasia Syndrome type should not use Zepbound. Zepbound also contains warnings for inflammation of the pancrease (pancreatitis) or severe gastrointestinal disease including severe gastroparesis,gallbladder problems, hypoglycemia and kidney injury, diabetic retinopathy in diabetis patients, and suicidal behavior or thinking.
The FDA advises that patients should discuss with their doctor any symptoms of gallbladder disease or pancreatitis. And for patients that are already taking diabetes medication to control blood sugar, the addition of Zepbound requires the physician’s attention to possible medication dosage adjustments to reduce the incidence of hypoglycemia. They caution doctors to monitor patients with kidney disease, diabetic neuropathy or depression while using Zepbound.
Zepbound should not be used in combination with Mounjaro or a GLP-1 receptor agonist. The FDA stated that this drug approval review was granted Fast-track status and Priority Review. These designations are granted when a drug company applying for approval of a new medication demonstrates that there is an important public need. With the very high incidence of overweight and obesity, and the resulting health problems associated with obesity it would seem obvious that this new medication meets an important public need.
This FDA approval follows a period of time during which the diabetes medication Ozempic (Semaglutide) became very widely used – off label – for weight control. It produced so much success and achieved so much popularity and created so much demand for the drug, that a shortage of the drug resulted. Ozempic’s competitor the diabetes medication Mounjaro (Trizepatide) started to see the same phenomenon occur because of its success and that lead to the drug maker of Mounjaro, Eli Lily to seek approval for Tirzepatide from the FDA for weight loss which has now become a reality with the approval of tirzepatide under the new brand name Zepbound. The public will now be awaiting its availability in pharmacies nationwide.