Studies reveal individuals taking common drugs for weight loss and diabetes have higher chances of developing stomach paralysis.
According to recent research from three different studies utilizing large patient record collections, it appears that the likelihood of developing stomach paralysis, or gastroparesis, is higher for individuals who consume GLP-1 agonists compared to those who do not.
These findings have not been fully reviewed by outside experts or published in medical publications, hence they are considered preliminary. Two of the studies were presented during the Digestive Disease Week 2024 conference in Washington, while the third will be presented on Monday.
GLP-1 agonists, which can be injected, are extremely popular due to their effectiveness in aiding weight loss. Studies have shown that powerful medications like Wegovy and Zepbound help individuals lose at least 10% of their initial weight. Furthermore, these drugs have been found to have positive effects on the heart as well as one's waistline. Novo Nordisk, a pharmaceutical firm, claims that 25,000 people in the United States alone begin using Wegovy each week.
These medications cut down on hunger by slowing down the rate at which food moves through the stomach. They also aid in the body's release of more insulin and in transmitting signals to the brain that reduce cravings.
However, these medications can also cause undesirable to severe bouts of vomiting, which may necessitate medical attention, and they can slow the stomach to the point that medical exams show a condition known as gastroparesis.
For the most part, doctors say that largely gastroparesis will improve soon after discontinuing the drug. However, some patients report that their condition did not improve even months after discontinuing the medication, with potentially life-altering consequences.
Determining the Risk of Gastroparesis
In these new studies, the risk of gastroparesis appears to be uncommon but consistent. In comparison to people who did not take GLP-1 medications, those who did had approximately a 50% greater chance of being diagnosed with such a condition.
One study led by researchers from University Hospitals in Cleveland used the TriNetX database, which includes millions of patient records from 80 healthcare organizations. The analysis focused on obese adults (those with a body mass index higher than 30) who did not have diabetes or a prior diagnosis of gastroparesis or pancreatitis for at least six months prior to starting a GLP-1 medication. Over 286,000 patients were included in the study.
Diabetes can also increase the likelihood of contracting gastroparesis, especially when a person's blood sugar levels have not been well-controlled for a long time.
Out of the individuals who were given a GLP-1 medication for weight loss, such as semaglutide (Ozempic and Wegovy), exenatide (Byetta), and liraglutide (Victoza), 10 out of every 10,000, or 0.1%, developed gastroparesis at least six months later. Conversely, 4 out of 10,000 people, or 0.04%, who were matched in the database based on their age, sex, ethnicity, and other factors but did not take a GLP-1 medication were diagnosed with the condition.
The difference was statistically significant and represented a 52% increased risk of being diagnosed with stomach paralysis whilst on a GLP-1 medication.
A second study, led by researchers from the University of Kansas, also relied on records from the TriNetX research network database. It encompassed patients who received GLP-1 medications for diabetes or obesity from December 2021 to November 2022 and compared them with individuals who had diabetes or obesity and had seen a doctor during that same period but had not been given a GLP-1 medication. Nearly 300,000 patients were included in the study.
Patients who took GLP-1 medications were 66% more likely to be diagnosed with gastroparesis. In this study, 0.53% of patients on GLP-1 medications were diagnosed with gastroparesis - or about one case of gastroparesis for every 200 people taking the drugs.
Those taking GLP-1 medications were also more likely to experience nausea and vomiting, as well as gastroesophageal reflux disease (GERD) and to be prescribed a proton pump inhibitor. Additionally, they were more prone to gallbladder removal and drug-induced pancreatitis.
"Although these drugs work and should be utilized for the appropriate reasons, we simply want to caution everyone that if you choose to initiate their use, be prepared that you have a 30% chance that you may experience GI side effects, which may necessitate the discontinuation of the drug," stated study author Dr. Prateek Sharma, a professor of medicine at the University of Kansas School of Medicine.
Some side effects from these medications may diminish over time as individuals become accustomed to their doses. This is one reason doctors start with a low dose of the drug and increase it gradually over time.
"The medication was the only distinct factor between these two sets of individuals," stated a doctor.
He added, "Our findings indicate that adverse gastrointestinal side effects, including nausea, vomiting, and gastroparesis, were considerably higher among those using GLP-1 drugs in comparison to the non-user group."
Sharma, who is also the president-elect of the American Society of Gastrointestinal Endoscopy, mentioned that although these drugs have undergone extensive research, it's plausible that gastroparesis might have been overlooked during the clinical trials due to the relatively small number of participants.
"To reach these conclusions, you'd need a significantly larger pool of patients; however, that's why I believe these database studies are of significant importance," Sharma shared.
Another probable reason for this missing adverse event during clinical trials was the way the researchers tested for gastroparesis. This was outlined by Dr. Michael Camilleri, a gastroenterologist and researcher at the Mayo Clinic who has studied gastroparesis in relation to GLP-1 drug liraglutide.
"It's crucial to scrutinize the gastric emptying of solids rather than liquids if you're trying to analyze issues with gastric emptying," remarked Camilleri. He pointed out that liquids pass through the stomach at a much quicker pace compared to solids.
When drug companies evaluated the impact of these medications on gastric emptying, they typically employed a method that assesses liquid emptying from the stomach. This method, known as the acetaminophen absorption test, is convenient and cost-efficient as it offers a faster alternative to gastric emptying studies with scintigraphy, which uses a radioactive tracer to assess the amount of solid food remaining in the stomach many hours after a meal.
Acetaminophen is absorbed into the bloodstream with the assistance of liquids. Measuring the speed at which acetaminophen is absorbed into the bloodstream can give an idea of how quickly liquids are passing through the stomach, yet it does not provide information on solids. Camilleri and other experts maintain that acetaminophen absorption isn't a satisfactory gauge for gastroparesis with GLP-1 drugs.
Camilleri was a co-author on another study being presented at Digestive Disease Week that explored gastroparesis in patients taking GLP-1 agents. The study analyzed records from nearly 80,000 patients who had been prescribed a GLP-1 medication by physicians within the Mayo Clinic's health system. Researchers zeroed in on a group of 839 people who had experienced symptoms of gastroparesis and received the standard diagnostic test: a procedure called gastric emptying scintigraphy, which involves exposing the stomach to a radioactive tracer over several hours to determine how much solid food is left in the stomach at different points in time after a meal.
About one-third of this cohort, or 241 individuals, had food in their stomachs four hours after consuming a test meal, thus qualifying as having gastroparesis. However, the study did not compute the difference in gastroparesis risk between users and non-users of these drugs.
Camilleri suggested that the risk of gastroparesis might be underestimated in these studies, as not every individual who experienced symptoms would have eventually received the required test for diagnosis.
In the Mayo Clinic study, women and those who reported experiencing constipation while using the GLP-1 medications were more likely to receive a gastroparesis diagnosis.
Camilleri mentioned that constipation could be one indication that people will experience gastroparesis while using a GLP-1 medication, but there are still many questions that need to be answered. "For those who experience this complication, it is very serious," he concluded.
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The new studies suggest that individuals who take GLP-1 agonists for weight loss or diabetes have a 50% higher risk of developing gastroparesis compared to those who do not. According to a study led by researchers from University Hospitals in Cleveland, out of 286,000 obese adults who started GLP-1 medications, 10 out of every 10,000 developed gastroparesis at least six months later, while only 4 out of 10,000 in a matched control group without the medications developed the condition.
Source: edition.cnn.com
