PHILADELPHIA—Even though it is understudied and relatively expensive, the duodenal ulcer medication sucralfate continues to be prescribed commonly, often for off-label uses, according to new research presented at ACG 2024.
The agent often is used off-label as an adjunct therapy for gastric ulcers, non-ulcer dyspepsia and erosive esophagitis, despite research showing it no more effective than placebo and American College of Gastroenterology guidelines recommending against its use for treatment of reflux disease, said investigator Neha Wadhavkar, MD.
“First developed in Japan in the 1960s, [sucralfate] is thought to act through the formation of a thick, viscous, ulcer-adherent complex in which the aluminum salt binds to positive proteins in an acidic environment,” said Dr. Wadhavkar, an internal medicine resident at Brown University, in Providence, R.I. The FDA approved sucralfate in tablet form in 1981 and the oral suspension in 1993 for the short-term treatment of duodenal ulcers.
The FDA approval for duodenal ulcer was based on a double-blind, randomized controlled trial showing 10% to 20% superiority over placebo, and there is a smattering of case studies and reports supporting sucralfate for other off-label uses, such as radiation proctitis and stress ulcer prophylaxis, Dr. Wadhavkar said. But, she added, the drug appears to be no better than placebo for gastric ulcers, non-ulcer dyspepsia and erosive esophagitis.
She and her co-investigators surveyed 24 residents, fellows and attendings from Brown University and members of the American College of Gastroenterology to better understand the degree of sucralfate use.
All participants reported prescribing sucralfate within the past year, but only 30% prescribed the agent solely for the treatment of duodenal ulcers. When the investigators further analyzed the frequency of prescribing by level of training, they found that residents and fellows more commonly prescribed weekly and monthly prescriptions.
The researchers performed a cost analysis based on the ClinCalc 2021 database, the most recent U.S. pharmacology data available. Among the top 200 most prescribed medications were seven GI-specific medications, including proton pump inhibitors, histamine receptor antagonists and sucralfate. Data for ranitidine were available only through 2020 due to its recall.
While prescribing trends for other GI medications such as famotidine and omeprazole fluctuated between 2013 and 2021, prescriptions for sucralfate have remained relatively steady, rising from 1.8 million to 2.6 million over those eight years.
“We also looked at price per prescription for a 30-day supply and were surprised that, at $119, sucralfate was second most expensive behind esomeprazole, which is about $195,” Dr. Wadhavkar said.
Sucralfate had a total annual cost of $312 million, while the highly prescribed PPIs, at around $900 million, were the most expensive.
“Our team did think it would be interesting to see how these values and trends shift if PPI usage continues to decline in future years as more patients and providers turn toward alternatives,” Dr. Wadhavkar said.
Based on their findings, Dr. Wadhavkar said sucralfate has a considerable financial impact, similar to that of famotidine and lansoprazole. “Keeping all this in mind, we encourage our colleagues to question and exercise appropriate clinical judgment with an expensive and understudied medication,” she said.
Commenting on the findings, Felice Schnoll-Sussman, MD, a professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, in New York City, said it’s fascinating to watch such prescribing patterns “when there’s little to no data on efficacy.”
“My question is why do you think this is happening? You had a lot of residents and fellows in your survey,” Dr. Schnoll-Sussman said. Noting that she believes that a lot of resident and fellow prescribing “on an inpatient basis has to do with what’s available in the formulary,” she asked Dr. Wadhavkar whether the investigators saw “a pattern based on inpatient prescription versus outpatient prescription.”
Dr. Wadhavkar said the fellows and residents in her study practice in both inpatient and outpatient settings, and that sucralfate is available at their formulary. “One thing that came up was that residents, fellows and even some attendings said they’ve often turned to sucralfate when patients are still symptomatic. It’s one more thing we can rely on. Even if it’s a placebo effect, patients feel better.”
Dr. Schnoll-Sussman suggested that an interesting follow-up analysis would be to identify which medications for GI symptomatology were ordered prior to the sucralfate, asking, “Was it ordered after other medications failed rather than as a primary treatment?”
Dr. Wadhavkar agreed that “it would be an interesting future analysis to assess prescription order and indication for prescription,” because sucralfate often is used either as an adjunct or as second- or third-line therapy. She said, “additional larger and randomized trials may further elucidate the true clinical efficacy of sucralfate as either monotherapy or adjunct therapy.”
—Monica J. Smith
Dr. Wadhavkar reported no relevant financial disclosures.
This article is from the March 2025 print issue.