8 Must-Read GI Studies for the Primary Care Physician

This transcript has been edited for clarity.

Hi. I'm Dr Vivek Kaul and I'm professor of medicine in the Division of Gastroenterology & Hepatology at the University of Rochester Medical Center. It gives me great pleasure to do this presentation in collaboration with Medscape. I have just returned from Digestive Disease Week 2022, which is the largest international GI conference, and it was held in person for the first time in 3 years due to the pandemic.

Whereas there are a lot of "Best of DDW" presentations for gastroenterologists, there are not that many for primary care providers, so I thought it would be a good idea to do this in collaboration with Medscape. What I've tried to do is to bring some information that is here now and almost imminently translatable into clinical practice, talk a little about the middle-future range where things will become available in the next few months to years; and then, of course, reflect upon concepts that might become more standard paradigms of care in the distant future.

My collection of papers is divided into the esophagus and the colon, and then finishing up with the liver. [Editor's note: Some of the abstracts that Dr Kaul refers to are available here.]

The first paper in the esophagus realm is a multicenter study called "The Association of Proton Pump Inhibitor Use and Cognitive Decline and Incident Dementia in Older Adults." The researchers looked at about 19,000 patients, 65 years and older, who were on PPI therapy and had no significant disability or prior dementia. They followed them for about 5 years and found that a total of about 566 of them developed dementia in this time frame and 235 or so had Alzheimer's. What they concluded based on that analysis was that PPI use was not associated with dementia or changes in the overall cognitive score.

This is important information. As the American Gastroenterological Association guidelines and others have recommended, those patients who do require a PPI on clinical grounds should definitely receive it, and the side-effect profiles are quite acceptable.

The second paper, "Double-Blind Randomized Trial of the Potassium-Competitive Acid Blocker Vonoprazan vs. the Proton Pump Inhibitor Lansoprazole in U.S. and European Patients with Erosive Esophagitis," is also related to GERD [gastroesophageal reflux disease] therapy but introduces a new paradigm known as potassium-competitive channel blockers. This is a new drug that has now become available, called vonoprazan.

This was a double-blinded, randomized trial of the potassium-competitive acid blocker vonoprazan in comparison with lansoprazole, which is a well-established medical agent available for the treatment of esophagitis. These are patients with erosive esophagitis in a multicenter US and European cohort of about 1000 patients who were prospectively treated. The crux of this study was to say that vonoprazan is quicker to provide healing and symptom relief, and that these results are maintained in both the initial phase, which is the treatment phase, and the maintenance phase.

So, there might be some advantages in terms of how quickly we can treat these patients and get them symptom free. I thought that study was worth mentioning because it reflects, after a long period of time, a new class of acid-suppression therapy, which we should all be familiar with, and certainly at the primary care level.

The next paper relates to Barrett's esophagus and esophageal cancer. This paper came out of the OneFlorida+ Clinical Research Network and was titled "Alarming Rise Found in Esophageal Cancer and Barrett's Esophagus in Middle-Aged Adults: Findings From a Statewide Database of Over 5 Million Patients." This paper talks about the increasing prevalence of esophageal cancer in Barrett's in middle-aged patients — those in the 45-to-64-years age group; the prevalence of esophageal cancer is rising in this cohort. So, as is shown in the first graph, the orange line is depicting the 45-64 age group patients whose esophageal cancer prevalence has gone up. And in the second graph, it's actually the gray line which looks at the Barrett's esophagus prevalence, which is also increasing. And all the other cohorts have either plateaued or are declining.

This is important information because these patients who are at risk in these age groups with these demographic profiles should be referred on for endoscopic screening to rule out Barrett's at least once in their lifetime. And most certainly a percentage of them will be found to have dysplasia and or early esophageal cancer that might be amenable to endoscopic therapy.

The next section that we'll talk about is the colon section. We have a few very good, high-quality papers with some provocative information in this realm. The first paper ["Multi-modal Blood-based Colorectal Cancer Screening Is a Viable Colorectal Cancer Screening Option — a Prospective Study"] in the colonoscopy section involves the concept of colorectal cancer screening. While we have multiple modalities available for colorectal cancer screening today, a third of eligible patients are not getting screened.

This study looks at a blood test for colorectal cancer screening. We have colonoscopy, we have stool DNA and other tests, but now we have a blood test looking at circulating tumor DNA. For this prospective, multicenter study, researchers from Madrid, Spain, enrolled about 550 patients between 45 and 84 years of age. The blood test was completed prior to the complete colonoscopy. The prevalence of colorectal cancer screening in this study was about 2%; the sensitivity ranged from about 90% to 95%, and the specificity ranged from about 100% to 88%, depending on what confidence levels you were looking at.

In this prospective study, a blood-based colorectal cancer screening test was able to perform very similar to stool-based options. Therefore, it may further increase the probability that patients might come in for screening.

The message from this paper is that there's yet another modality for colorectal cancer screening, and now we have a blood test potentially, but obviously we look forward to more data on how the test itself performs. And there probably will be other candidates in the same realm.

The second paper ["Real-World Comparative Effectiveness of Fidaxomicin Vs. Vancomycin Among Medicare Beneficiaries with Clostridioides difficile Infection"] in the colon section is also about a very important topic in clinical practice for all of us, and that is C difficile infection. As you may know, current guidelines have recommended the use of fidaxomicin over vancomycin as the initial treatment for C diff infection. This paper looked retrospectively at a cohort of patients in the real world and compared the efficacy of fidaxomicin vs vancomycin among Medicare beneficiaries with C diff infection.

The initial results of this multicenter study suggest that treatment with fidaxomicin had higher sustained response compared with vancomycin at both weeks 4 and 8, as well as decreased recurrence of C difficile.  

This retrospective study further confirms that C diff infection remains a problem and that we might have better solutions now with fidaxomicin compared with vancomycin. That's important information and is already endorsed by the guidelines.

The next paper in the colon realm, "A Randomized Controlled Trial on the Effectiveness of Cognitive-Behavioral and Mindfulness Intervention on Pain, Fatigue and Impairments at Work and Daily Activity in Patients With Crohn's Disease," is also an important paradigm that has entered our medical practice. When we are treating patients with GI symptoms, the role for cognitive-behavioral therapy and mindfulness interventions has now come of age.

This paper was a randomized controlled trial on the effectiveness of cognitive-behavioral therapy and mindfulness intervention on the aspects of pain and fatigue, as well as impairments at work and daily activity in patients with Crohn's disease.

This is a difficult population with chronic illness, and this study comes out of Israel. About 120 patients were randomized to seven 1-hour sessions of psychological training over 12 weeks. The placebo group was the control group that did not get this treatment.

These interventions reduced both fatigue as well as pain levels, and also reduced work and home impairment, and so overall led to a better quality of life.

This paper is important because it shows us in a randomized trial design fashion that a difficult clinical population with Crohn's disease, with a multitude of systemic symptoms and psychological, psychosomatic issues as well, can be positively impacted by these newer strategies related to cognitive-behavioral therapy and mindfulness interventions. We'll likely be seeing more of these types of papers coming out, not just for Crohn's and inflammatory bowel disease, but also for functional disease, which is where this started.

Our final paper on the colon section relates to an interesting concept, which is the treatment of chronic idiopathic constipation — not irritable bowel syndrome with constipation, but chronic idiopathic constipation —being managed with a novel device known as the Vibrant capsule. The Vibrant capsule is exactly that: It's a capsule that the patient ingests, and it vibrates and therefore creates a mechanical movement.

"Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation (Vibrant)" was a US multicenter study. The device is an orally ingestible, programmable vibrating capsule developed in Israel. It basically mimics the biological clock and increases the stool frequency by augmenting the circadian rhythm. This was a prospective trial of around 350 patients, and there was significant improvement in the complete spontaneous bowel movement pattern, both for one and two bowel movements per week. This significant improvement persisted at week 3, peaked at about week 6, and then remained sustained through 8 weeks.

The Vibrant capsule also was able to improve stool consistency and the overall quality of life. So this is a novel treatment intervention over and above all the medical therapies in the bowel regimens, which of course our patients find somewhat difficult, understandably. But this might be a complementary direction to go in, and we'll probably hear more of these novel interventions for chronic constipation, which is a huge problem both at the primary care level as well as in subspecialty practice.

In the final section, which is the liver section, I found one paper very interesting, which refers to the concept of lean nonalcoholic fatty liver disease (NAFLD) ["Lean NAFLD in the United States is Characterized by Increased Central and Visceral Adiposity That Is Comparable to Overweight and Obese Persons"]. NAFLD is an epidemic throughout the country, with obvious implications both for the metabolic syndrome as well as chronic liver disease. This paper from Wisconsin looks at lean NALFD in the United States, characterizes the central and visceral adiposity, and compares it with that of overweight and obese patients. Lean NAFLD occurs in about 10%-20% of patients with a normal BMI; 1800 patients were evaluated in this particular study, and they underwent cross-sectional analysis and the so-called gap score, which looks at the measurement of fat in the liver, DEXA measurements, and so forth.

What they found was that patients with lean NAFLD are more likely to have hypertension, diabetes, high triglycerides, and are more likely to smoke compared with lean patients without NAFLD, despite having similar BMIs.

A couple of additional observations from the study were that central adiposity was similar in lean NAFLD compared with the obese non-NAFLD population, and the visceral abdominal fat in patients who have lean NAFLD was slightly higher, actually, than in the obese NAFLD patients, but the P values were not significant.

The overall summary from this paper was that NAFLD should be considered in lean patients with risk factors of the metabolic syndrome. This is an important paper because it highlights the fact that we don't necessarily have to be externally obese or have a high BMI to necessarily be at risk for the metabolic syndrome. I think the importance of evaluating for the metabolic syndrome, even in those patients who have a relatively lower BMI, is underscored by this paper, which has significant implications given the larger denominator of this population in this country.

So, with that, we come to the conclusion of these top papers from Digestive Disease Week 2022. We covered the gamut of conditions, from the esophagus to the colon and to the liver. And these represent some of the best science that was presented at this very large international meeting. I hope you will find value in this information for the care of your patients, and I look forward to presenting again when the next opportunity arises. I thank Medscape for this opportunity and for this collaboration.

Vivek Kaul, MD, is Segal-Watson Professor of Medicine in the Gastroenterology & Hepatology Division at the University of Rochester Medical Center in Rochester, New York.

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