Efficacy and safety of biological treatment for inflammatory bowel disease in elderly patients: Results from a GETECCU cohort.

INTRODUCTION: Biological therapies used for the treatment of inflammatory bowel disease (IBD) have shown to be effective and safe, although these results were obtained from studies involving mostly a young population, who are generally included in clinical trials. The aim of our study was to determine the efficacy and safety of the different biological treatments in the elderly population. METHODS: Multicenter study was carried out in the GETECCU group. Patients diagnosed with IBD and aged over 65 years at the time of initiating biological therapy (infliximab, adalimumab, golimumab, ustekinumab or vedolizumab) were retrospectively included. Among the patients included, clinical response was assessed after drug induction (12 weeks of treatment) and at 52 weeks. Patients' colonoscopy data in week 52 were assessment, where available. Regarding complications, development of oncological events during follow-up and infectious processes occurring during biological treatment were collected (excluding bowel infection by cytomegalovirus). RESULTS: A total of 1090 patients were included. After induction, at approximately 12-14 weeks of treatment, 419 patients (39.6%) were in clinical remission, 502 patients (47.4%) had responded without remission and 137 patients (12.9%) had no response. At 52 weeks of treatment 442 patients (57.1%) had achieved clinical remission, 249 patients had responded without remission (32.2%) and 53 patients had no response to the treatment (6.8%). Before 52 weeks, 129 patients (14.8%) had discontinued treatment due to inefficacy, this being significantly higher (p<0.0001) for Golimumab - 9 patients (37.5%) - compared to the other biological treatments analyzed. With respect to tumor development, an oncological event was observed in 74 patients (6.9%): 30 patients (8%) on infliximab, 23 (7.14%) on adalimumab, 3 (11.1%) on golimumab, 10 (6.4%) on ustekinumab, and 8 (3.8%) on vedolizumab. The incidence was significantly lower (p=0.04) for the vedolizumab group compared to other treatments. As regards infections, these occurred in 160 patients during treatment (14.9%), with no differences between the different biologicals used (p=0.61): 61 patients (19.4%) on infliximab, 39 (12.5%) on adalimumab, 5 (17.8%) on golimumab, 22 (14.1%) on ustekinumab, and 34 (16.5%) on vedolizumab. CONCLUSIONS: Biological drug therapies have response rates in elderly patients similar to those described in the general population, Golimumab was the drug that was discontinued most frequently due to inefficacy. In our experience, tumor development was more frequent in patients who used anti-TNF therapies compared to other targets, although its incidence was generally low and that this is in line with younger patients based on previous literature.

ß-Endorphins are not responsible for delayed gastric emptying of digestible solids after exercise in professional cyclists. A preliminary study.

OBJECTIVE: It has been reported that professional cyclists had an accelerated solid gastric emptying which decreased by increasing the exercise intensity. That could be explained by a predominance of stress-dependent motility inhibitors such gastrointestinal hormones, neurotransmitters and or the predominance of the gastric inhibitory vagal motor circuit. The aim of this preliminary study was to evaluate the role of ß-endorphins, inhibitors of gastric motility, in these findings. METHODS: Gastric emptying of solids marked with Tc99 while resting and plasmatic levels of ß-endorphins were evaluated in 27 healthy controls and 19 professional cyclists (day 1). Besides, gastric emptying of solids was also assessed in cyclists when they reached 50% (day 1) and 75% (day 2) of the maximum oxygen consumption (low and high, respectively), during exercise on the cycle-ergometer. The third day, naloxone was administered in cyclists in order to block the ß-endorphins receptors and gastric emptying was measured when they reached 75% of the maximum oxygen consumption. RESULTS: Basal ß-endorphin levels were lower in cyclists vs controls (p<0.05) and they increased with the exercise intensity (p<0.001). There were no significant differences in gastric emptying of solids with or without naloxone when 75% of the maximum oxygen consumption was reached. CONCLUSIONS: The inhibitory effect of the exercise in the gastric emptying of solids does not seem to be secondary to the action of ß-endorphins, that leaves the gastric inhibitory vagal motor circuit a more likely predominant role.

Risk factors for functional dyspepsia, erosive and non-erosive gastroesophageal reflux disease: A cross-sectional study.

BACKGROUND: Conflicting data exists regarding risk factors associated with Gastroesophageal Reflux Disease (GERD) and Functional Dyspepsia (FD). Few studies examine anxiety/depression in relation to GERD phenotypes (Esophagitis/EE, and Non-Erosive Reflux Disease/NERD), FD, and Rome-IV syndromes. Our aim was to evaluate the association between epidemiological factors and comorbidities with GERD phenotypes, FD, and Rome-IV syndromes, as well as their relationship with anxiety/depression. METHODS: 338 subjects were selected from 357 patients referred to three tertiary-centers for endoscopic evaluation. Every subject was interviewed individually to administer three validated questionnaires: GERD-Q, Rome-IV and HADS. RESULTS: 45/338 patients were controls, 198/58.6% classified as GERD, 81/24.0% EE (49/14.5% symptomatic, and 32/9.5% asymptomatic), 117/34.6% NERD, 176/52.1% FD (43/12.7% epigastric pain syndrome, 36/10.7% postprandial distress syndrome, and 97/28.7% overlapping syndrome). 81 patients were mixed GERD-FD. Multivariate analysis found significant independent associations: age in NERD and FD; sex in EE, asymptomatic EE and FD; body mass index in NERD and FD; alcohol in EE; anxiety/depression in FD; use of calcium channel antagonists in EE; and inhalers in FD. We compared controls vs different groups/subgroups finding significantly more anxiety in NERD, FD, all Rome-IV syndromes, and mixed GERD-FD; more depression in FD, overlapping syndrome, and mixed GERD-FD; and higher levels of anxiety+depression in NERD, FD, overlapping syndrome, and mixed GERD-FD. CONCLUSIONS: NERD and FD share demographic and psychopathological risk factors which suggests that they may form part of the same pathophysiological spectrum. Regarding NERD anxiety was predominant, and in FD anxiety+depression, suggesting that both processes may require complementary psychological therapy.

Accuracy in optical diagnosis for polyps between 5 and 15 mm and its implications on surveillance. A prospective, multicenter study. (POPS study).

BACKGROUND AND AIMS: Polyps histology and diameter up to 1 cm determine whether a patient needs a colonoscopy after 3 years or less, or far ahead. Endoscopists' and pathologists' size estimations can be imprecise. Our aim was to assess endoscopist ability to correctly recommend surveillance colonoscopies for patients with polyps around the 10 mm threshold, based on its endoscopic sizing and optical diagnosis by NBI. METHODS: NBI-assisted diagnosis and endoscopist estimation of polyp size were compared with reference standard, considering this as the post resection polyp measurements by the nurse assistant and the pathologic results, in a prospective, multicenter, real life study, that recruited adults undergoing colonoscopy in five hospitals. By comparing the endoscopic and pathologist size estimation, with polyps' measurement after resection, and optical and histological diagnoses in patients with polyps between 5 and 15 mm, sensitivity was assessed at the patient level by means of two characteristics: the presence of adenoma, and the surveillance interval. Surveillance intervals were established by the endoscopist, based on optical diagnosis, and by another gastroenterologist, grounded on the pathologic report. Determinants of accuracy were explored at the polyp level. RESULTS: 532 polyps were resected in 451 patients. Size estimation was more precise for the endoscopist. Endoscopist sensitivity for the presence of adenoma or carcinoma was 98.7%. Considering the presence of high-grade dysplasia or cancer, sensitivity was 82.6% for the endoscopic optical diagnosis. Sensitivity for a correct 3-year surveillance interval was 91.5%, specificity 82.3%, with a PPV of 93.2% and NPV of 78.5% for the endoscopist. 6.51% of patients would have had their follow-up colonoscopy delayed, whereas 22 (4.8%) would have it been performed earlier, had endoscopist recommendations been followed. CONCLUSION: Our study observes that NBI optical diagnosis can be recommended in routine practice to establish surveillance intervals for polyps between 5 and 15 mm. CLINICAL TRIALS REGISTRATION NUMBER: NCT04232176.

How is the duodenal mucosa in functional dyspepsia?

Gastric mucosa has been widely studied during the pre/post-Helicobacter pylori (Hp) era. Excluding peptic ulcer disease (PUD), the duodenal mucosa has not been thoroughly analyzed, even less so in functional dyspepsia (FD). We would like to make some comments after studying 161 dyspeptic patients with samples taken from the gastric body, antrum, proximal and distal duodenum.

When the routine gets complicated: Gastric and splenic perforation by a nasogastric tube.

Every invasive procedure carries some kind of risk, however rutine it may be. We present a case of a male patient which suffers a gastric and splenic perforation by a nasogastric tube, solved by means of surgery.

Is gastroparesis that is often detected in patients with alcoholic chronic liver disease a manifestation of an autonomic dysfunction syndrome? A preliminary study.

BACKGROUND: the autonomic dysfunction defines the neuropathy of the autonomic nervous system. The prevalence of the gastric dysmotility and its relationship with the autonomic dysfunction in patients with alcohol chronic liver disease is not well known. METHODS: thirty-six patients with alcohol chronic liver disease and 25 healthy controls were evaluated, in order to detect an autonomic dysfunction through different cardiovascular reflexes and gastric emptying tests. RESULTS: ninety-four per cent of the patients showed an impaired R index (variations in heart rate during six deep inspirations-expirations per minute) and/or S/S-HR (variations in heart rate when standing from a supine position). Seventy-five per cent of the patients showed gastroparesis (T1/2: gastric half-emptying time was delayed). There was a correlation between the R index and T1/2 (r = -0.49; p < 0.01). CONCLUSIONS: we suggest that gastroparesis detected in alcoholic chronic liver disease is another clinical manifestation of the autonomic parasympathetic dysfunction.

Changes in gastric emptying of digestible solids in professional cyclists: relationship with exercise intensity.

We share the preliminary results of a study we are conducting about the relation between gastric emptying and physical activity. It is a subject not well known, and so far studied with different methodologies and with discordant results. The aim of this letter is to communicate our results, which can be very useful in future nutritional programs in athletes.

Temporomandibular joint dislocation after an upper endoscopy: a complication to consider.

After observing a case of a temporomandibular joint dislocation after an upper endoscopy, we carried out a literature review to find out how frequent it is and suggest the sedation as a possible risk factor to such complication.

A legal issue with dental prostheses and their possible complications.

After observing two cases of dental prostheses impacted in esophagus, fortunately solved by means of endoscopy, we have revised the current legislation in Spain. Knowing the present design of the prostheses and in accordance with the legislation, we consider some modifications must be performed in order to lower the risk of such complications. We want to raise an issue about this topic, often underestimated, and with a significant impact for the patients.

Vitamin D and inflammatory bowel disease: what do we know so far?

In the last years,several studies have focused on the involement of vitamin D in different physiological and pathological processes. One of the most interesting actions occurs in the Inflammatory bowel disease, where a higher prevalence of vitamin D deficiency has been observed. This study aimed to review the literature in order to explain its relationship with the disease, the risk factors, measuring the importance of sun exposure, describing how treatments are affected or observing the effect of vitamin supplementation in this type of patients.

Dyspepsia, functional dyspepsia and Rome IV criteria.

We present a number of comments about the recently published paper by Aziz et al. about the epidemiology of Functional Dyspepsia in USA, Canada and UK in comparison with previous studies in our country.

Keriorrhea (waxy diarrhea), a new sign to bear in mind.

Due to the increasing intake of raw fish, the appearance of keriorrhea in our environment has become more and more frequent. We present three clinical cases in order to aknowledge this sign and avoid unnecesary diagnostic tests.

Assessing the Risk of Hypertension in Chronic, Elderly Patients during the COVID-19 Pandemic: A Prospective Study.

BACKGROUND: This study considers care management for older chronic patients during and after the COVID-19 pandemic. AIMS: To identify groups of variables at previous time points as a basis for deriving efficient classification models during and after a pandemic situation and to quantify the effect of each variable within the model to predict levels of worsening risk in diastolic and systolic arterial hypertension (AHT). MATERIAL AND METHODS: In this prospective longitudinal study, data were collected at three time points: before, during, and after the COVID-19 pandemic period. RESULTS: The study included 148 patients with an average age of 81.6 years. During the study period, mean systolic blood pressure among this population rose by 5 mmHg to 128.8 mmHg; the number of patients with systolic blood pressure > 140 mmHg rose by 45.3%; among those with diastolic blood pressure > 90, the number rose by 41.2%; mean triglycerides levels rose to 152.6 mg/dL; cholesterol levels rose to 147 mg/dL; and LDL cholesterol rose to 112.2 mg/dL. Meanwhile, mean levels of HDL cholesterol decreased to 46.5 mg/dL. Binary-response logistic regression models were constructed to identify the most relevant variables for predicting AHT risk during and after the pandemic. The heart rate (OR = 1.79; 95% CI: 1.22-2.72) and body mass index (OR = 1.75; 95% CI: 1.08-2.94) variables were significant at the population level (p < 0.05) for diastolic and systolic AHT in the pandemic period risk models. The body mass index variable was also significant for diastolic AHT in the post-pandemic period risk model (OR = 1.97; 95% CI: 1.32-2.94), whilst the triglycerides variable was significant in the systolic AHT post-pandemic period risk model (OR = 1.49; 95% CI: 1.01-1.86). CONCLUSIONS: Bad control of arterial hypertension in older patients with chronic disease is associated with elevated levels of LDL cholesterol, total cholesterol, systolic blood pressure, heart rate and triglycerides, and lower levels of HDL cholesterol.

Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU.

Background: The usefulness of thiopurines has been poorly explored in pouchitis and other pouch disorders. Objective: To evaluate the effectiveness and safety of azathioprine as maintenance therapy in inflammatory pouch disorders. Design: This was a retrospective and multicentre study. Methods: We included patients diagnosed with inflammatory pouch disorders treated with azathioprine in monotherapy. Effectiveness was evaluated at 1 year and in the long term based on normalization of stool frequency, absence of pain, faecal urgency or fistula discharge (clinical remission), or any improvement in these symptoms (clinical response). Endoscopic response was evaluated using the Pouchitis Disease Activity Index (PDAI). Results: In all, 63 patients were included [54% males; median age, 49 (28-77) years]. The therapy was used to treat pouchitis (n = 37) or Crohn's disease of the pouch (n = 26). The rate of clinical response, remission and non-response at 12 months were 52%, 30% and 18%, respectively. After a median follow-up of 23 months (interquartile range 11-55), 19 patients (30%) were in clinical remission, and 45 (66%) stopped therapy. Endoscopic changes were evaluated in 19 cases. PDAI score decreased from 3 (range 2-4) to 1 (range 0-3). In all, 21 patients (33%) presented adverse events and 16 (25%) needed to stop therapy. Conclusion: Azathioprine may be effective in the long term for the treatment of inflammatory pouch disorders and could be included as a therapeutic option.