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Injectable drugs that treat diabetes and obesity may increase the risk of a rare but serious side effect: stomach upset, according to new data. Drug use in the real world.
At least three new studies based on large patient records show that the risk of being diagnosed with stomach paralysis or gastroparesisIt is higher than those taking GLP-1 agonists.
The studies have not been reviewed by outside experts or published in medical journals, so the information is considered preliminary. The two presented at the Digestive Disease Week 2024 medical conference in Washington on Saturday. The third is to be presented on Monday.
Injectable drugs called GLP-1 agonists are in high demand because they have been shown to be very effective in weight loss. In clinical trials, some strong drugs like Wegovy and Zepbound have been found to help people lose weight At least 10% of their initial weight. Studies have also suggested that they are good for your heart and waistline. Drugmaker Novo Nordisk 25,000 people are starting Wegov. Every week in the US Alone.
The drugs prevent hunger by delaying food in the stomach. They also help the body release more insulin and send signals to the brain that reduce appetite.
In some people, however, these drugs can cause unpleasant-to-severe symptoms Vomiting that may require medical attention. In addition, medical tests show a disease called gastroparesis because they can slow down the stomach.
Doctors often say that gastroparesis improves after stopping the drug. But Some people say Months after coming off the drug, their condition did not improve, with life-changing results.
In the new studies, the risk of gastroparesis appears to be low, but consistent. Compared to similar people who did not take GLP-1 drugs, those who took them were 50% more likely to develop the disease.
A study led by researchers at the University of Cleveland Hospitals used data collected through the TriNetX database, which includes millions of patient records from 80 contributing healthcare organizations. The analysis focused on adults who were obese, had a body mass index greater than 30, had not been diagnosed with diabetes, and had not been diagnosed with gastroenteritis or pancreatitis at least 6 months before starting GLP-1 therapy. More than 286,000 patient records were included in the study.
Diabetes itself increases the risk of gastroparesis, especially if a person's blood sugar is not well controlled for a long time.
Among people prescribed GLP-1 drugs for weight loss — such as semaglutide (brand names Ozympic and Wegovy), exenatide (Baita) and liraglutide (Victoza) — 10 out of 10,000 people, or 0.1%, have been diagnosed with gastric cancer. At least six months later. In comparison, 4 out of 10,000 people, or 0.04%, who were matched for age, sex, ethnicity and other factors in the database but did not take GLP-1 drugs developed the disease.
The difference, statistically, increases the chance of being diagnosed with gastric paralysis by 52%. on GLP-1 medication.
A second study led by researchers at the University of Kansas also used records from the TriNetX research network database. It included patients who were prescribed GLP-1 for diabetes or obesity between December 2021 and November 2022, and compared it with people who had diabetes or obesity and were seen by a doctor during the same period but not prescribed it. GLP-1 drug. About 300,000 patient records were included in the study.
Compared to those who did not take GLP-1 drugs, those who took them were 66% more likely to develop gastroparesis. This study found that 0.53% of patients taking GLP-1 drugs developed gastroparesis, or about 1 in 200 people taking the drug.
People taking GLP-1 medications are also more likely to experience nausea and vomiting or gastroesophageal reflux disease (GERD) and to be prescribed proton pump inhibitors. They are more likely to have their gallbladders removed and develop medication-induced pancreatitis.
Although these medications work and should be used for the right reason, we want to warn everyone to be prepared for a 30 percent chance of GI side effects if you decide to start them. According to study author Dr. Prateek Sharma, a professor of medicine at the University of Kansas, the drug may be discontinued. Medical school.
Some of the side effects of the drugs may also decrease over time as people get used to their dosages. This is one reason why doctors start with low doses and work up to higher doses over time.
Sharma explained that in both groups of people with diabetes who were taking GLP-1 drugs and in a comparison group, they found that stomach paralysis occurred in those who were still taking the drug, suggesting that diabetes is not the only driver. The increased risk.
“The only thing between these two groups was the drug,” he said.
“And we show that all GI side effects or symptoms, nausea, vomiting and gastroparesis, are significantly higher in GLP-1 recipients compared to controls,” said Sharma, president-elect of the American Gastroenterological Association. Endoscopy.
Although these drugs have been widely studied, Sharma thinks that gastroparesis is rare enough because clinical trials of the drugs did not include enough patients.
“You need hundreds of thousands of patients to reach these conclusions, but that's why I think these database studies are so important out there,” Sharma said.
Another reason it may have been missed in clinical trials is the way researchers often diagnose it, said Dr. Michael Camilleri, a gastroenterologist and Mayo Clinic researcher who studied gastroparesis with GLP-1 liraglutide.
From the stomach “It's very important, if you want to study the problem with the gastric glands, you have to see the solid stomach contents, not the liquid from the stomach,” Camilleri said. Liquids pass through the stomach faster than solids.
“Pharmaceutical companies, when evaluating the effects of drugs of this class on gastric glands, often use a method that evaluates the emptying of fluids from the stomach,” he said.
It is called Acetaminophen absorption testAnd it is often used because it is faster and cheaper than a gastric emptying study on scintigraphy to determine how much solid food remains in the stomach hours after eating.
Acetaminophen is absorbed through the stomach and enters the bloodstream through fluids. Measuring how quickly acetaminophen appears in the blood can give an idea of how quickly liquids, but not solids, pass through the stomach. Camilleri and other professionals They say that acetaminophen absorption is not an adequate test for gastroparesis on GLP-1 drugs.
Camilleri was a co-author on a third study presented Monday in Digestive Diseases Week on GLP-1 drugs in gastric cancer.
That study included the records of nearly 80,000 patients who were prescribed the GLP-1 drug by doctors at the Mayo Clinic Health System. The researchers focused on 839 people who had symptoms of gastroparesis and underwent the gold standard test for the disease, a procedure called gastric emptying scintigraphy.
A third of the group of 241 people had food in their stomachs four hours after eating the test meal, which means they have gastroparesis.
However, the study did not calculate the difference in gastric ulcer risk between those who used the drug and those who did not.
Camilleri said the risk of gastric ulcers in these studies may have been low because not all people with symptoms eventually received the necessary tests to be diagnosed.
In a Mayo Clinic study, women and people who reported constipation on GLP-1 drugs were more likely to be diagnosed with gastric paresis.
Camilleri said that constipation may be one clue that people with GLP-1 drugs have problems with gastric paresis, but there are still many questions to be answered.
“It's very difficult for people who have this complication,” he said.