Obesity: drug promises effect close to bariatric action – 05/02/2022 – Equilibrium

An experimental drug has allowed obese or overweight people to lose about 22.5% of their body weight, which is about 23.5 kg, the drug’s manufacturer announced on Thursday.

Eli Lilly has not yet submitted the data for publication in a peer-reviewed medical journal or presented it in a public setting, but the claims surprised medical experts.

“Wow (and a double wow!),” Dr. Sekar Kathiresan, CEO of Verve Therapeutics, a company focused on drugs for heart disease. Drugs like Eli Lilly’s “really are going to revolutionize the treatment of obesity!!!” he added. Kathiresan has no ties to Eli Lilly or the drug.

The Doctor. Lee Kaplan, an obesity specialist at Massachusetts General Hospital, said the effect of this drug “appears to be significantly better than any other obesity drug currently available in the US.” The results, he added, are “very impressive.”

Kaplan, who consults for a dozen pharmaceutical companies, including Eli Lilly, said he was not involved in the new trial or development of the drug.

Study participants weighed an average of 104.7 kg at baseline and had a BMI (body mass index) – a commonly used measure of obesity – of 38. Obesity is defined as a BMI of 30 or more.

At the end of the study, those who took the highest doses of Eli Lilly’s drug, called tirzepatide, weighed about 81.6 kg and had a BMI just under 30, on average. The results far surpass those usually seen in weight loss drug trials and are typically seen only in surgical patients.

Some study participants lost enough weight to enter the normal range, said Dr. Louis J. Aronne, director of the comprehensive weight management program at Weill Cornell Medical Center in New York, who worked with Eli Lilly as the study’s principal investigator.

Most people in the study did not qualify for bariatric surgery, which is reserved for people with a BMI over 40 or those with a BMI of 35 to 40 with sleep apnea or type 2 diabetes. The risk of developing diabetes is many times greater. for people with obesity than for people without it.

As obesity is a chronic medical condition, patients would need to take tirzepatide for life, as they do with blood pressure or cholesterol medications, for example.

Robert F. Kushner, an obesity expert at Northwestern University’s Feinberg School of Medicine in Chicago and a paid consultant to Novo Nordisk, said the new drug, along with a similar but less effective drug from this lab, could end a so-called treatment. “gap” (gap, gap).

Diet and exercise, combined with previous obesity medications, usually produce a 10% weight loss in patients. It’s enough to improve health, but not enough to make a big difference in the lives of obese people.

The only other treatment is bariatric surgery, which can result in substantial weight loss. But many people are ineligible or simply don’t want the surgery.

With Eli Lilly’s drug and Novo Nordisk’s semaglutide, which was recently approved, “we are really on the cusp of a new form of treatment,” Kushner said.

But prices can be a barrier. Insurers generally do not pay for weight loss medications. The Novo Nordisk drug, whose brand is Wegovy, has a list price of US$ 1,349.02 (about R$ 6,000) per month.

Experts fear that tirzepatide, if approved, could be priced in the same range. Many people who would most benefit from weight loss may not be able to afford these drugs.

The Eli Lilly study lasted 72 weeks and involved 2,539 participants. Many qualified as obese, while others were overweight but also had risk factors such as high blood pressure, high cholesterol levels, cardiovascular disease or obstructive sleep apnea.

They were divided into four groups. All received dietary advice to reduce calorie intake to about 500 a day.

One group was randomly assigned to take a placebo, while the other three received doses of tirzepatide ranging from 5 to 15 mg. Patients injected the drug once a week.

Those who took the highest dose lost more weight, the researchers found. Participants who took a placebo lost 2.4% of their weight, averaging 2.26 pounds, typical for a diet study.

Dr. Nadia Ahmad, senior medical director of Eli Lilly’s obesity program, said seeing the results was an emotional moment for her.

“I don’t think I ever imagined that we could achieve this degree of weight loss with a drug,” he said. “We only got this far with surgery.”

For decades, overweight or obese people have been told that solving the problem was up to them. Diet and exercise were prescriptions and it just didn’t work for many people. Most tried various diets, and only regained the lost weight.

Last year, the situation began to change when Novo Nordisk received FDA approval to market semaglutide. The drug can cause weight loss of 15% to 17% in people with obesity.

The drugs are among a new class of drugs called incretins, which are natural hormones that slow stomach emptying, regulate insulin and decrease appetite. Side effects include nausea, vomiting, and diarrhea, but most patients either tolerate or are not bothered by these effects.

Incretins raise the bar for the type of weight loss possible with drugs. But they also pose difficult questions about whether bariatric surgery is becoming a relic of the past. There are already new versions of incretins in development that could be even more powerful than Eli Lilly’s drug.

Even without them, Aronne said, the reductions seen with Eli Lilly’s drug are “almost in the range of surgical weight loss.”

Some patients who have had bariatric surgery describe mixed results. Sarah Bramblette, a board member of the Obesity Action Coalition, had bariatric surgery but regained her weight.

Now 44 years old, Bramblette weighed 226 kg when she was operated on 20 years ago, which allowed her to reach 113 kg. Over the years, however, her weight has returned to 222 kg. She needed heart surgery, but she was too heavy for the operating table. She tried dieting several times, but the regimens didn’t help.

Novo Nordisk’s semaglutide allowed her to reach 195 kg. Now, Bramblette said, she’d like to try Eli Lilly’s drug if it’s available.

“Believe me, I didn’t choose to be that big,” Bramblette said. “I need to lose weight.”

Translated by Luiz Roberto M. Gonçalves

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