Sprue-like Enteropathy Research Articles

Diagnosis and resolution of olmesartan-associated sprue-like enteropathy confirmed by capsule endoscopy: a case report and literature review.

Herein, we describe a case of olmesartan-associated sprue-like enteropathy, in which improvement in villous atrophy was confirmed using small bowel capsule endoscopy. The patient was a 69-year-old woman who had persistent watery diarrhea (20 bowel movements/day) for 1year and experienced a weight loss of 10kg in the same period. Abdominal computed tomography revealed no abnormalities, and blood test results revealed no inflammatory reactions. Upper endoscopy and colonoscopy revealed villous atrophy in the duodenum and terminal ileum. As the patient was administered olmesartan for a long time and capsule endoscopy showed villous atrophy throughout the small bowel, she was diagnosed with olmesartan-associated sprue-like disease. Following the discontinuation of the medication, symptoms of diarrhea soon improved, and repeat capsule endoscopy indicated improvement in small intestinal villous atrophy. Olmesartan-associated sprue-like enteropathy should be considered a differential diagnosis in patients with severe chronic watery diarrhea. Our report is the first in which capsule endoscopy was performed multiple times over a long period for follow-up observation of improvements in the small intestine. In addition, our literature review regarding capsule endoscopy for olmesartan-associated enteritis might aid clinicians in the early diagnosis of the condition and the assessment of treatment efficacy.

Drug-induced mucosal alterations observed during esophagogastroduodenoscopy.

Several features of drug-induced mucosal alterations have been observed in the upper gastrointestinal tract, i.e., the esophagus, stomach, and duodenum. These include pill-induced esophagitis, desquamative esophagitis, worsening of gastroesophageal reflux, chemotherapy-induced esophagitis, proton pump inhibitor-induced gastric mucosal changes, medication-induced gastric erosions and ulcers, pseudomelanosis of the stomach, olmesartan-related gastric mucosal inflammation, lanthanum deposition in the stomach, zinc acetate hydrate tablet-induced gastric ulcer, immune-related adverse event gastritis, olmesartan-asso-ciated sprue-like enteropathy, pseudomelanosis of the duodenum, and lanthanum deposition in the duodenum. For endoscopists, acquiring accurate knowledge regarding these diverse drug-induced mucosal alterations is crucial not only for the correct diagnosis of these lesions but also for differential diag-nosis of other conditions. This minireview aims to provide essential information on drug-induced mucosal alterations observed on esophagogastroduodenoscopy, along with representative endoscopic images.

Drug-induced spruelike enteropathy

Drug-induced spruelike enteropathy

Angiotensin Receptor Blocker-Related Sprue-like Enteropathy: Review of Food and Drug Administration Adverse Event Reporting System.

Sprue-like enteropathy (SE) related to olmesartan use was first reported in 2012. In 2017, the manufacturer of Benicar paid $300 million for 2300 claims for olmesartan-related SE. A study in 2019 suggested that SE was related to olmesartan and with the possibility of angiotensin receptor blocker (ARB) class effect. To further characterize this condition, our group examined reports of ARB-related SE to Food and Drug Administration Adverse Event Reporting System (FAERS). All reports of ARB-related SE from January 2017 to December 2021 were downloaded from the FAERS database. Gastrointestinal adverse events including SE were reviewed. Reporter categories included physicians, pharmacists, other health care professionals, consumers, and attorneys. A total of 106 590 reports of ARB-related adverse effects were analyzed. Sprue-like enteropathy was identified in 4337 cases (4.1% of total reports). Of these, 4240 cases (98.0%) of ARB-related SE were reported in patients using products with olmesartan, and 97 cases of SE were reported for all other ARBs (eprosartan, losartan, telmisartan, irbesartan, valsartan, and candesartan). Reports of olmesartan-related SE increased rapidly in 2017, continued at a high rate in 2018 and 2019, and essentially stopped in 2020 and 2021. Reports to FAERS for ARB-related SE are mostly related to olmesartan. There was a steep decline in reports of olmesartan-related SE following the lawsuit with potential of lawyer interference. There are reports of SE related to ARBs other than olmesartan, with increased physician awareness and the potential to discover a class effect with future studies.

Fecal Calprotectin Elevations Associated with Food Intolerance/Malabsorption Are Significantly Reduced with Targeted Diets.

Inflammatory bowel disease (IBD) involves two clinically defined entities, namely Crohn's disease and ulcerative colitis. Fecal calprotectin (FCAL) is used as a marker to distinguish between organic IBD and functional bowel disease in disorders of the irritable bowel syndrome (IBS) spectrum. Food components may affect digestion and cause functional abdominal disorders of the IBS spectrum. In this retrospective study, we report on FCAL testing to search for IBD in 228 patients with disorders of the IBS spectrum caused by food intolerances/malabsorption. Included were patients with fructose malabsorption (FM), histamine intolerance (HIT), lactose intolerance (LIT), and H. pylori infection. We found elevated FCAL values in 39 (17.1%) of 228 IBS patients with food intolerance/malabsorption and H. pylori infection. Within these, fourteen patients were lactose intolerant, three showed fructose malabsorption, and six had histamine intolerance. The others had combinations of the above conditions: five patients had LIT and HIT, two patients had LIT and FM, and four had LIT and H. pylori. In addition, there were individual patients with other double or triple combinations. In addition to LIT, IBD was suspected in two patients due to continuously elevated FCAL, and then found via histologic evaluation of biopsies taken during colonoscopy. One patient with elevated FCAL had sprue-like enteropathy caused by the angiotensin receptor-1 antagonist candesartan. When screening for study subjects concluded, 16 (41%) of 39 patients with initially elevated FCAL agreed to voluntarily control FCAL measurements, although symptom-free and -reduced, following the diagnosis of intolerance/malabsorption and/or H. pylori infection. After the initiation of a diet individualized to the symptomatology and eradication therapy (when H. pylori was detected), FCAL values were significantly lowered or reduced to be within the normal range.

Olmesartan Associated Enteropathy, an easily overlooked etiology of bowel disturbance: report of three cases

Olmesartan medoxomil is one of eight marketed Angiotensin II Receptor Blocker for the treatment of high blood pressure. Olmesartan Associated Enteropathy has been described in several case reports, subsequently, the United states Food and Drug Administrationincluded severe sprue-like enteropathy as an adverse effect of Olmesartan. Olmesartan Associated Enteropathy mimics celiac disease clinically and pathologically. The pathologic findings are villous atrophy and increased intraepithelial lymphocytes. Clinical presentation of Olmesartan Associated Enteropathy includes nausea, bloating, diarrhea and weight loss. In contrast to celiac disease, tissue transglutaminase is not elevated, and there is no response to a gluten-free diet. Several case reports have described the effects of olmesartan on gut, giving rise to the term of Olmesartan Associated Enteropathy. Clinicians should always be aware that Olmesartan can cause an enteropathy clinically and histologically similar to celiac disease since replacing Olmesartan with an alternative antihypertensive drug can simplify the diagnostic workup and provide both clinical and histologic improvement. We report three cases of Olmesartan Associated Enteropathy in this article. Bangladesh Crit Care J September 2022; 10(2): 154-157

The histological spectrum of ARB-induced gastritis.

Olmesartan, an angiotensin receptor blocker (ARB) used for hypertension management, is known to cause a sprue-like enteropathy in a subset of patients. Rare cases of gastritis occurring with ARB use have also been reported, but the histological features of ARB-induced gastritis and the response to drug cessation have not been examined in a dedicated case-series. Cases of suspected ARB-induced gastritis were identified from the pathology archives of four institutions. Haematoxylin and eosin (H&E) slides from gastric biopsies were reviewed. Fifteen patients (14 female, one male) were identified. The most common presenting symptoms were diarrhoea (10) and weight loss (six). Gastric biopsies commonly showed a full-thickness active chronic gastritis with surface epithelial injury involving the antrum and body. Glandular atrophy, intra-epithelial lymphocytosis and/or subepithelial collagen thickening were also present in some cases. Duodenal involvement, including villous atrophy, intra-epithelial lymphocytosis and/or collagenous sprue, was identified in 11 of 13 cases with concurrent duodenal biopsies. Following drug cessation, symptomatic improvement occurred in all 11 cases for which follow-up data were available. Histological resolution occurred in five of eight cases with follow-up gastric biopsies, with improvement seen in the remaining three biopsies. ARB-induced gastritis typically presents as active chronic gastritis, frequently with associated surface epithelial injury. Glandular atrophy, intra-epithelial lymphocytosis and/or subepithelial collagen thickening may also be present. These gastric changes can be seen without associated duodenal injury in rare cases, and they should alert the pathologist to the possibility of ARB-induced injury. Drug cessation results in marked symptomatic and histological improvement.

A Rare Case of Synchronous Severe Duodenal Ulcers and Acute Colitis in Sartan-Induced Enteropathy: A Case Report and Review of Literature

Sartan induced sprue-like enteropathy (SIE) was initially reported as a side effect of chronic Olmesartan use in 2012 and is characterized by chronic diarrhoea and weight loss. The diagnosis is often difficult and requires ruling out of other causes of enteropathy including infectious gastroenteritis, autoimmune enteropathy and celiac disease. A 51 – year – old Caucasian male was admitted to our hospital because of chronic non-bloody diarrhoea associated with severe acute renal failure and electrolyte imbalances. His medical history was only positive for hypertension for which he was on Olmesartan Medoxomil and Lacidipine, both of which were discontinued due to hypotension at admittance. Stool cultures and search for C. Difficile toxin resulted negative, whilst a Colonscopy showed endoscopic and histological signs of aspecific acute colitis. After having responded to i.v. hydration with normalization of the renal function the patient was discharged home with the same medications he was on before admittance. His diarrhoea relapsed and he was readmitted shortly afterwards with acute renal failure and electrolyte imbalances; the anti-hypertensive medications were again discontinued. After having excluded all other causes of diarrohea, including celiac disease and HIV, Sartan – induced enteropathy (SIE) was suspected and then confirmed with an esophagogastroduodenoscopy which revealed a severe erosive duodenitis with multiple duodenal ulcers. The patient again responded to i.v. hydration with normalization of the renal function and Olmesartan was held also at discharge without further relapse of the symptoms. SIE is a rare cause of chronic diarrhoea, weight loss and possible severe renal failure. It could affect the whole gastrointestinal tract and in cases of unexplained non-bloody diarrhea, suspecting SIE is fundamental and should be considered in the differential diagnosis. Discontinuation of the drug is generally sufficient for symptom resolution: in suspected cases with a positive medical history for chronic angiotensin receptor blocker (ARB) use, stopping the drug ex-juvantibus should be undertaken. Further research on the immunopathological mechanisms and how to recognize patients at higher risk of developing this condition is deemed necessary.

Angiotensin Receptor Blockers Associated Enteropathy-Brief Report.

The current literature has shown equivocal results regarding the association of Olmesartan and other angiotensin receptor blockers (ARBs) use and the presence of Celiac sprue-like enteropathy (CSLE). Various factors affecting the association are- patient population under study, geographic area, and duration of use of medication. Various case reports/case series and observational studies have shown the mixed results regarding an association. We have tried to answer a question what exists in the literature regarding the angiotensin receptor blockers related sprue like enteropathy.

Severe spruelike enteropathy and collagenous colitis caused by olmesartan

BackgroundOlmesartan, which is an angiotensin II receptor blocker, reportedly causes spruelike enteropathy, with intestinal villous atrophy as its typical histopathological finding. Interestingly, collagenous and/or lymphocytic gastritis and colitis occur in some patients. We report the case of a 73-year-old Japanese man with a 2-month clinical history of severe diarrhea and weight loss. There were few reports in which spruelike enteropathy and collagenous colitis were both observed and could be followed up.Case presentationWe report a case of a 73-year-old man with a 2-month clinical history of severe diarrhea and weight loss. He had taken olmesartan for hypertension treatment for 5 years. Endoscopic examination with biopsies revealed intestinal villous atrophy and collagenous colitis. Suspecting enteropathy caused by olmesartan, which was discontinued on admission because of hypotension, we continued to stop the drug. Within 3 weeks after olmesartan discontinuation, his clinical symptoms improved. After 3 months, follow-up endoscopy showed improvement of villous atrophy but not of the thickened collagen band of the colon. However, the mucosa normalized after 6 months, histologically confirming that the preexistent pathology was finally resolved.ConclusionsThis report presents a case in which spruelike enteropathy and collagenous colitis were both observed and could be followed up. In unexplained cases of diarrhea, medication history should be reconfirmed and this disease should be considered a differential diagnosis.

An unusual cause of diarrhoea: case report and literature review of olmesartan-associated enteropathy

Olmesartan is an angiotensin II receptor blocker, approved in 2002 by the Food and Drug Administration for the treatment of hypertension. During chronic therapy with olmesartan, sprue-like enteropathy can occur, being mainly characterised by non-bloody diarrhoea, weight loss and variable degrees of duodenal mucosal damage, which resolved after withdrawal of olmesartan. We hereby report the case of a 77-year-old, poli-treated male patient with a 3-month history of diarrhoea, vomiting and weight loss, associated with severe intestinal villous atrophy and lymphocytic infiltration of gastric and colonic mucosa. After extensive investigations aimed at excluding other possible causes of chronic diarrhoea, a diagnosis of olmesartan-associated enteropathy was made, which was later confirmed by clinical improvement after the discontinuation of the drug. Repeated endoscopy 8 months later showed complete healing of duodenal mucosa with normal villous architecture. Villous atrophy and lymphocytic infiltration of duodenal mucosa are the most described pathologic finding, but several cases of gastric and colonic involvement have also been reported. We, therefore, reviewed the available literature, focussing on the extent of mucosal damage throughout the whole intestine and on its possible causative factors.

Mycophenolate-Associated Sprue-Like Intestinal Disease Evolving into Collagenous Sprue

A 43-yr old female with two prior renal transplants for renal failure associated with diabetes, retinopathy and coronary artery disease developed diarrhea. Her medications included mycophenolate mofetil, an immunosuppressive medication documented to cause sprue-like mucosal changes in the small intestine. Later studies revealed a small intestinal mucosal lesion characterized by marked crypt hyperplasia, villous atrophy and increased intra-epithelial lymphocytes. Serological studies for celiac disease were negative and repeated biopsies despite a strict gluten-free diet, revealed histopathological persistence of a severely abnormal sprue-like enteropathy. Eventually, further biopsies of her small intestine revealed superimposed changes characterized by dense sub-epithelial collagen deposits histochemically staining positive for trichrome, typical of collagenous sprue and representing an expansion of published pathological features of mycophenolate-associated small intestinal mucosal disease.

Belangrijk gewichtsverlies bij een patiënt met een hardnekkige huideruptie

Persistent skin eruption in a 52-year-old man losing weight This case report describes a 52-year-old male patient with important weight loss, fatigue, diarrhea and a skin eruption since 1 year. An olmesartan-induced enteropathy and skin vasculitis were diagnosed. There was a total resolution of the symptoms after the interruption of olmesartan. Although sprue-like enteropathy and cutaneous vasculitis are very rare, clinicians should be aware of those potential adverse events, even years after the initiation of an angiotensin II receptor blocker.

Severe cases of sprue‐like enteropathy associated with angiotensin receptor blockers other than olmesartan

Background Sprue-like enteropathy (SLE) has been reported in patients with arterial hypertension who are treated with the angiotensin receptor blocker (ARB) olmesartan. It is currently controversial whether this is a class effect or specific to olmesartan. Methods A systematic literature search was conducted in Medline/PubMed, Embase, Web of Science and Scopus without language, publication year or publication status restrictions up to October 2019 to retrieve publications on SLE related to all ARBs excluding olmesartan. Results Overall, 17 reports including a total of 21 patients describing SLE cases were identified with the following ARBs: candesartan (n = 1), eprosartan (n = 1), irbesartan (n = 4), losartan (n = 7), telmisartan (n = 4) and valsartan (n = 4). The treatment duration among these ARB-treated patients varied from 2 months to up to 13 years, while the onset of enteropathy-related symptoms ranged from 2 months to 10 years from treatment initiation. The most frequently reported SLE symptoms were as follows: chronic diarrhoea, abdominal symptoms, loss of appetite and weight loss (3-27 kg). Symptomatic treatment with antibiotics, corticosteroids and dietary modifications did not significantly improve the SLE symptoms in patients while on treatment with ARBs. However, diarrhoea resolved in all 21 patients after the withdrawal of ARBs and other gastrointestinal symptoms had resolved on follow-up in all but two patients. Conclusions SLE is observed in patients treated with ARBs other than olmesartan. This suggests a class effect in the rare event of patients treated with ARBs developing SLE.

S2793 Sprue-Like Enteropathy Secondary to Lisinopril Use

INTRODUCTION: Diarrhea is reported as a rare adverse effect of angiotensin-converting enzyme (ACE) inhibitors, but there are few reports of sprue-like enteropathy from its use. In contrast, this has been well described with the angiotensin II receptor blocker (ARB), olmesartan. We describe a case of drug-induced enteropathy secondary to lisinopril. CASE DESCRIPTION/METHODS: A 76-year-old man with hypertension and coronary artery disease presented with one year of diarrhea, abdominal discomfort and a 35-pound unintentional weight loss. His first EGD yielded duodenal biopsies with villous blunting and increased IELs. Tissue transglutaminase antibody (tTg, IgA) was 22 U/mL (negative is <20 U/mL), and the patient was advised to follow a gluten free diet. He did so for 9 months without symptom improvement and so returned to a gluten-rich diet. Despite a gluten-rich diet for 4 months, the patient’s repeat tTg, IgA and deamidated gliadin peptide (DGP) IgA and IgG were negative. In addition, he was negative for HLA-DQ2 and HLA-DQ8 genotypes, making celiac disease unlikely. All immunoglobulin levels were normal. Then on repeat EGD and colonoscopy, duodenal and terminal ileal biopsies showed villous blunting and dense infiltrate of IELs. Biopsies were negative for Congo red and periodic acid-Schiff diastase stains, sent to evaluate for amyloid and Whipple's disease. Video capsule endoscopy identified diffuse small bowel villous flattening, though no erosions, ulcerations or strictures were seen. Stool testing was negative for giardia and fecal calprotectin. Glucose hydrogen breath test was negative. The patient had a normal fasting gastrin level, and his ANA and anti-enterocyte antibody were negative. We then considered lisinopril-induced enteropathy, as the patient had been on lisinopril since symptom onset. After lisinopril was stopped, the patient's symptoms resolved within 3 months. He gained back weight and no longer had abdominal discomfort. Repeat endoscopy is planned, but was postponed during the COVID-19 pandemic. DISCUSSION: It is important to maintain a high degree of suspicion for drug-induced enteropathy. One study from Italy and Germany examined patients on olmesartan, ARBs and ACE inhibitors and found rare instances of ACE inhibitors leading to intestinal malabsorption (Malfertheiner et al. Pharmacoepidemiol Drug Saf. 2018, 581-586). Olmesartan is classically the medication associated with sprue-like enteropathy, and our case highlights that lisinopril should be considered as well.

Olmesartan-Induced Enteropathy: A Case of Recurrent Diarrhoea.

A 77-year-old man with arterial hypertension and dyslipidaemia, treated with olmesartan/hydrochlorothiazide and simvastatin, was admitted with a 3-week history of anorexia, nausea, vomiting, profuse diarrhoea and weight loss. He was dehydrated and blood tests showed acute kidney injury. The aetiological study was inconclusive. The patient had a favourable clinical evolution during hospitalization and was discharged. However, after about 10 days at home, he was re-admitted to hospital with the same clinical presentation. It was noticed that olmesartan had not been prescribed during the previous admission but had been restarted on an outpatient basis. Biopsy examination showed duodenal mucosa with villous atrophy and polymorphic inflammatory infiltrate. Antibody testing for coeliac disease was negative. Based on these facts, it was hypothesized that the patient had olmesartan-induced enteropathy, which was subsequently confirmed.LEARNING POINTSDrug-induced sprue-like enteropathy must be considered in the differential diagnosis of patients with diarrhoea, weight loss, and villous atrophy of the duodenal mucosa of unknow origin.Olmesartan has been associated with the development of enteropathy.Olmesartan-induced enteropathy can happen years after drug initiation.

Pharmacy and therapeutics committees strategy to address olmesartan safety issues at a primary care level.

Background Olmesartan, an antihypertensive drug, has been associated with a severe and potentially life-threatening sprue-like enteropathy, consisting of a serious, chronic diarrhoea and malabsorption syndrome. Treatment with this drug should be discontinued if patients develop such symptoms. Objective To retrospectively determine the reduction in olmesartan prescription following a strategy promoted by pharmacy and therapeutics committees within daily clinical practice to manage updated safety information on olmesartan. Setting Three primary healthcare centres. Method In May 2016, local pharmacy and therapeuticscommittees integrated by general practitioners, nursing staff and clinical pharmacists sent information about olmesartan safety issues to general practitioners, together with an individual list of their patients who were then being treated with olmesartan. Moreover, information about dose equivalents between angiotensin II receptor blockers and angiotensin II receptor blockers versus angiotensin-converting-enzyme inhibitors was also attached. The strategy aimed to promote individual benefit/risk assessment by general practitioners of the continuation of olmesartan treatment as a means to achieving a decrease in the risk of sprue-like enteropathy. The investigation team retrospectively reviewed the clinical records. Main outcome measure Reduction of olmesartan prescription. Results Olmesartan was discontinued in 44.4% of patients (197/444) in the year after the safety alert e-mail. In their medical records general practitioners registered that, after informing about olmesartan safety warnings, in four cases (0.9%), patients reported gastrointestinal symptoms. Conclusion A multidisciplinary strategy implemented to promote individual benefit/risk assessment regarding continuation of olmesartan treatment showed an important reduction in olmesartan prescriptions 1year later.

Olmesartan Associated Enteropathy: Usefulness of Video Capsule Endoscopy in a Case With Doubtful Upper Endoscopic/Histological Picture

Olmesartan, an antihypertensive drug, may be associated with a severe "sprue-like enteropathy". To report a case of Olmesartan enteropathy demonstrated by video capsule endoscopy distally from the second duodenum along with the whole small bowel before and after drug withdrawal. A 81-years-old man was referred for asthenia, chronic watery diarrhea and anasarca (ascites, pleural effusion and edemas of superior and inferior limb). The only comorbidity was hypertension treated with Olmesartan. All causes of infective and inflammatory chronic diarrhea were investigated and excluded. Upper endoscopy was normal; histological examination of the second portion of the duodenum showed moderate and patchy infiltration of lymphocytes at mucosal and intra-epithelial level with intermittent partial villous atrophy. The possibility of adverse drug reaction, estimated by Naranjo scale, showed a score of 7, indicating a strong probability. Olmesartan was then withdrawn. However, because of severe clinical general condition, we preferred to corroborate our diagnostic work-up by a non-invasive investigation, i.e. video capsule endoscopy, which showed jejunal and ileal mucosal alterations (mosaic pattern, diffuse hyperemia, severe edema, consequent apparent reduced lumen, diffuse thickening of intestinal folds, multiple erosions, patchy lymphangectasia). After 14 days, the resolution of anasarcatic state and hydroelectrolytic imbalances was observed. Nine months later, small-bowel video-capsule demonstrated mild mucosal hyperaemia and mosaic pattern. Our case could give new insights in the field of Olmesartan associated enteropathy by highlighting the possibility of distally main lesion location and, therefore, the usefulness of video capsule endoscopy in the presence of doubtful diagnostic features.

1174 Cases of Angiotensin Receptor Blocker (ARB) Related Sprue-Like Enteropathy (SE): A Review of the Food and Drug Administration Adverse Event Reporting System (FAERS)

INTRODUCTION: In 2002, olmesartan, an ARB, was introduced to the market as Benicar. In 2012, Rubio-Tapia et al. reported 22 cases of SE related to olmesartan. In 2013, the Food and Drug Administration (FDA) issued a safety warning about SE related to olmesartan. In August 2017, Benicar’s manufacturer paid $300 million to settle claims from about 2,300 plaintiffs in SE cases. The FAERS is a publicly available database for voluntary reporting of adverse drug events to the FDA. No study has summarized the reports of ARB-related SE to the FAERS. Our aim is to establish the timeline of FAERS reports of SE from ARBs and to further characterize reports of olmesartan and another ARB-related SE to the FAERS. METHODS: A total of 9,144,290 FAERS reports from January 2013 to December 2018 were downloaded. Data was first queried for all patients using an ARB for hypertension. All drugs were limited to those defined as “Primary Suspect”. Gastrointestinal adverse events (GIAE), including SE and control reactions were then obtained for all ARBs and searched by both generic and trade names. Information regarding the timeline of reports and demographics of reporters was collected. Reporters are categorized as physicians, pharmacists, other health care professionals, consumers, and attorneys. RESULTS: A total of 77,245 FAERS reports of people for ARBs were analyzed. SE was identified in 5,290 (6.8%) cases. With the exception of 6 cases, all were related to olmesartan. All olmesartan cases were filed under its trade name Benicar. In addition to the SE cases reported, there were 7,402 (9.6%) cases of GIAE related to ARB. These included drugs other than olmesartan. The number of reports filed by each category each year is shown in Table 1 and Figure 1. Cases of SE were followed, and their outcomes identified (Table 2). Hospitalization was reported in 52.7% and death in 0.9%. CONCLUSION: The FDA reports for olmesartan-related SE and ARB-related GIAE have increased dramatically. Unlike some high-profile cases with dramatically increased lawyer reporting, these reports originate from physicians and consumers. All reports were for Benicar, none for generics and a few reports for combinations. This can be explained by the minimum of 2 years of ARB use prior symptoms onset suggested in the literature. Other explanations include Benicar’s large market share or potential problems with the Benicar formulation.

Sprue-Like Intestinal Disease Complicated by Inclusion Body Myositis

A woman with long-standing weight loss and malabsorption demonstrated a severe sprue-like enteropathy. She insidiously developed persistent and progressive muscle weakness caused by inclusion body myositis, an uncommon muscle disorder. Treatment with a gluten-free diet, steroids, calcium, zinc and vitamin supplements, including empirical vitamin E resulted in weight gain, but failed to histologically improve her small intestinal mucosa or the muscle weakness which became profound. The myopathic process could reflect a co-existent autoimmune disorder, or, possibly a direct result of long-standing and superimposed nutrient deficits. An alternative explanation may be a hitherto unrecognized syndrome manifested as inclusion body myositis and a form of sprue-like enteropathy.