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    Huge Study Documents Higher Rates of Enteropathy for Olmesartan Users


    Jefferson Adams


    • For the first time, a comprehensive multi‐database study documents a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, though absolute rates were low for both groups.


    Image Caption: Image: CC--Ed Uthman

    Celiac.com 06/13/2018 - There have been numerous reports that olmesartan, aka Benicar, seems to trigger sprue‐like enteropathy in many patients, but so far, studies have produced mixed results, and there really hasn’t been a rigorous study of the issue. A team of researchers recently set out to assess whether olmesartan is associated with a higher rate of enteropathy compared with other angiotensin II receptor blockers (ARBs).


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    The research team included Y.‐H. Dong; Y. Jin; TN Tsacogianis; M He; PH Hsieh; and JJ Gagne. They are variously affiliated with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School in Boston, MA, USA; the Faculty of Pharmacy, School of Pharmaceutical Science at National Yang‐Ming University in Taipei, Taiwan; and the Department of Hepato‐Gastroenterology, Chi Mei Medical Center in Tainan, Taiwan.

    To get solid data on the issue, the team conducted a cohort study among ARB initiators in 5 US claims databases covering numerous health insurers. They used Cox regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy. In all, they found nearly two million eligible patients. 

    They then assessed those patients and compared the results for olmesartan initiators to initiators of other ARBs after propensity score (PS) matching. They found unadjusted incidence rates of 0.82, 1.41, 1.66 and 29.20 per 1,000 person‐years for celiac disease, malabsorption, concomitant diagnoses of diarrhea and weight loss, and non‐infectious enteropathy respectively. 

    After PS matching comparing olmesartan to other ARBs, hazard ratios were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. Patients aged 65 years and older showed greater hazard ratios for celiac disease, as did patients receiving treatment for more than 1 year, and patients receiving higher cumulative olmesartan doses.

    This is the first comprehensive multi‐database study to document a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, though absolute rates were low for both groups.

    Source:

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  • About Me

    Jefferson Adams is a freelance writer living in San Francisco. He has covered Health News for Examiner.com, and provided health and medical content for Sharecare.com. His work has appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate, among others.

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  • Related Articles

    Jefferson Adams
    Celiac.com 09/15/2016 - Some doctors and clinicians have reported cases of severe sprue-like enteropathy associated with olmesartan, but, until now, no clear demonstration of an increased risk has been documented by epidemiological studies.
    Now, a French nationwide observational cohort study has shown a connection between severe intestinal malabsorption and the drug olmesartan, according to results presented by a team of researchers. Olmesartan is an angiotensin II receptor antagonist which has been used for the treatment of high blood pressure. Olmesartan is also sold commercially under the name Benicar.
    The research team included Mickael Basson, Myriam Mezzarobba, Alain Weill, Philippe Ricordeau, Hubert Allemand, Francois Alla, and Franck Carbonnel. They are variously affiliated with the French National Health Insurance Fund, Paris, France, and the Université Paris-Sud, Assistance Publique-Hôpitaux de Paris and Gastroenterology unit, Hôpitaux Universitaires Paris Sud, Le Kremlin Bicêtre, France.
    The team set out to assess, in a nationwide patient cohort, the risk of hospitalization for intestinal malabsorption associated with olmesartan compared with other angiotensin receptor blockers (ARB) and ACE inhibitors (ACEIs). From the French National Health Insurance claim database, they included all adult patients initiating ARB or ACEI between 1 January 2007 and 31 December 2012, with no prior hospitalization for intestinal malabsorption, no serology testing for celiac disease, and no prescription for a gluten-free diet product. Their main endpoint was incidence of hospitalization with a discharge diagnosis of intestinal malabsorption.
    The team included 4,546,680 patients, for a total of 9,010,303 person-years, and observed 218 events. Compared with ACEI, the adjusted rate ratio of hospitalization with a discharge diagnosis of intestinal malabsorption was 2.49 (95% CI 1.73 to 3.57, p
    Average length of hospital stay for intestinal malabsorption was longer in the olmesartan group than in the other groups (p=0.02).
    Compared with ACEI, the adjusted rate ratio of hospitalization for celiac disease was 4.39 (95% CI 2.77 to 6.96, p<0.0001).
    These results show that olmesartan is assoc qiated with higher rates of hospitalization for intestinal malabsorption and celiac disease.
    Source:
    Gut. doi:10.1136/gutjnl-2015-309690

    Jefferson Adams
    Celiac.com 11/15/2016 - The YouTube video that helped to spark litigation against blood pressure drug Olmesartan, also marketed as Benicar, was made by celiac disease expert Dr. Joseph Murray, a gastroenterologist and a professor of medicine at the Mayo Clinic in Rochester, New York, who is very familiar with the drug's side effects.
    In July 2013, the U.S. Food and Drug Administration (FDA) issued a warning to patients and doctors that the popular blood pressure medication Benicar had been linked to a severe side effect called sprue-like enteropathy. The side effect was easily confused with celiac disease or a gluten sensitivity, and caused serious problems in many patients, including cases of irreparable gut damage.
    A week after the FDA's warning, Dr. Joseph Murray took to YouTube to notify patients about the drug's risks. In the video, Dr. Murray advises anyone who is taking Benicar, and who has also been diagnosed with celiac disease, to consult a doctor about the FDA warning.
    Many Benicar patients learned the hard way the drug can cause debilitating side effects, but Dr. Murray's video no doubt helped spread awareness to patients who suffer from sprue-like enteropathy. Many patients feel Benicar's manufacturer, Daiichi Sankyo, failed to warn consumers of the risks associated with the drug and are now trying to hold the company responsible through legal action. There are more than 1,700 lawsuits currently pending against the company.
    Plaintiffs have called into question the validity of the clinical trial leading to Benicar's approval with the FDA. Managing high blood pressure is a long-term proposition, but the clinical trial testing Benicar's safety and efficacy only lasted three months.
    Plaintiffs believe the short clinical trial caused the makers to overlook the risk of sprue-like enteropathy, but plaintiffs are also pointing to the fact that drug maker Daiichi Sankyo spent $1 billion on Benicar advertising between 2002 and 2008. The plaintiffs say that company advertising focused more on the benefits of Benicar, while downplaying potential risks.
    The suit has been slate for court docket in 2017. Stay tuned for developments on this and related matters.


    Jefferson Adams
    Celiac.com 08/25/2017 - Japanese drug maker Daiichi Sankyo will pay $300 million to settle thousands of federal and state court lawsuits over its top-selling blood pressure drugs, Benicar, Benicar HCT, Azor and Tribenzor, according to the lead Plaintiffs' lawyers.
    The settlement was reached in the federal multi-district litigation (MDL) case titled In re: Benicar (Olmesartan) Products Liability Litigation, MDL 2606, pending in the U.S. District Court for the District of New Jersey, Camden Division.
    Overseeing the federal MDL litigation are the Honorable Judge Robert Kugler and the Honorable Magistrate Judge Joel Schneider, who handled the settlement negotiations.
    The agreement covers about 2,500 claims by individuals who claim severe and sometimes life-threatening gastrointestinal injuries after using medications containing the active ingredient olmesartan medoxomil (Benicar, Benicar HCT, Azor and Tribenzor).
    Numerous reports have tied Olmesartan to sprue-like enteropathy and changes in the intestinal tract that mimic those seen in celiac disease, and inhibit a person's ability to absorb nutrients.
    The parties reached the resolution as they maneuvered ahead of pre-trial hearings, and an expected trial in federal court. Christopher L. Coffin and Adam M. Slater, Co-Lead Counsel for the Plaintiffs, praised the settlement as an excellent outcome for the Plaintiffs.
    In a statement, Coffin said that they were "very pleased with the outcome of this hard-fought litigation. This is a gratifying resolution for thousands of patients who suffered severe gastrointestinal injuries while using these blood pressure medications."
    Under the settlement, former olmesartan users who have claims, and who meet certain criteria will be eligible for compensation.
    For more information go to OlmesartanProductLitigationSettlement.com.

    Jefferson Adams
    Celiac.com 01/23/2018 - Benicar (olmesartan medoxomil) is a hypertension drug used for high blood pressure, and which is known to cause numerous side-effects in patients, including dangerous celiac sprue-like enteropathy, and is the subject of numerous lawsuits, and a $300 million settlement.
    Now the respected consumer advocacy group Public Citizen is calling for the FDA to ban the sale Benicar, due to the potential for side effects to which Public Citizen refers as "life-threatening." According to Public Citizen, originally founded by consumer advocate Ralph Nader, olmesartans risks outweigh any benefits.
    In a November 15 press release following their 20-page petition to the FDA, the organization warned that "Keeping the medication on the market would continue to put hypertension patients' lives at risk for the sake of corporate profits."
    While the FDA has formally acknowledged receiving the petition, there is no indication that any action is forthcoming any time soon. The agency can sometimes take years to act.
    Numerous drug experts note the availability of comparable hypertension drugs that are equally effective in lowering blood pressure without such dire side effects as the sprue-like enteropathy that "leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss…that often lands a patient in the hospital," noted the petition.
    Sometimes this sprue-like enteropathy is misdiagnosed as a celiac disorder, when in reality it is due to olmesarten use.
    Benicar, together with Azor, Benicar HCT, and Tribenzor, are unique in their association with sprue-like enteropathy. It is why so many plaintiffs reference Benicar defective products in their allegations, and why Public Citizen wants them off the market.
    Source:
    lawyersandsettlements.com

  • Recent Articles

    Jefferson Adams
    Celiac.com 07/21/2018 - These easy-to-make tortilla wraps make a great addition to your lunchtime menu. Simply grab your favorite gluten-free tortillas, a bit of cream cheese, some charred fresh sweet corn, creamy avocado and ripe summer tomato. Add a bit of sliced roast beef and some mayonnaise and hot sauce, and you’re in business. And it's all ready in about half an hour. If you cook the corn the night before, they can be ready in just a few minutes.
    Ingredients:
    12 ounces thinly sliced cooked beef, sliced 6 burrito-sized gluten-free tortillas 1 ripe medium avocado, diced 1 large tomato, diced ½ medium red onion, thinly sliced ¼ cup mayonnaise 2 ears sweet corn, husks and silk removed 1 teaspoon olive oil ¾ cup soft cream cheese spread 1-2 teaspoons gluten-free hot sauce of choice Sprouted pea greens, as desired fresh salsa, as desired Directions:
    Heat grill to medium-hot. 
    Brush corn with olive oil. 
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    Cool slightly; cut kernels from cobs.
    Spread 2 tablespoons cream cheese on one side of each tortilla to within ½-inch of edge; arrange beef slices to cover.
    Spread beef with mayonnaise hot sauce mixture as desired.
    Place a bit of grilled corn kernels, avocado, tomato and red onion in a 3-inch strip along one edge of each tortilla. 
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    Christina Kantzavelos
    Celiac.com 07/20/2018 - During my Vipassana retreat, I wasn’t left with much to eat during breakfast, at least in terms of gluten free options. Even with gluten free bread, the toasters weren’t separated to prevent cross contamination. All of my other options were full of sugar (cereals, fruits), which I try to avoid, especially for breakfast. I had to come up with something that did not have sugar, was tasty, salty, and gave me some form of protein. After about four days of mixing and matching, I was finally able to come up with the strangest concoction, that may not look the prettiest, but sure tastes delicious. Actually, if you squint your eyes just enough, it tastes like buttery popcorn. I now can’t stop eating it as a snack at home, and would like to share it with others who are looking for a yummy nutritious snack. 
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    Jefferson Adams
    Celiac.com 07/19/2018 - Maintaining a gluten-free diet can be an on-going challenge, especially when you factor in all the hidden or obscure gluten that can trip you up. In many cases, foods that are naturally gluten-free end up contain added gluten. Sometimes this can slip by us, and that when the suffering begins. To avoid suffering needlessly, be sure to keep a sharp eye on labels, and beware of added or hidden gluten, even in food labeled gluten-free.  Use Celiac.com's SAFE Gluten-Free Food List and UNSAFE Gluten-free Food List as a guide.
    Also, beware of these common mistakes that can ruin your gluten-free diet. Watch out for:
    Watch out for naturally gluten-free foods like rice and soy, that use gluten-based ingredients in processing. For example, many rice and soy beverages are made using barley enzymes, which can cause immune reactions in people with celiac disease. Be careful of bad advice from food store employees, who may be misinformed themselves. For example, many folks mistakenly believe that wheat-based grains like spelt or kamut are safe for celiacs. Be careful when taking advice. Beware of cross-contamination between food store bins selling raw flours and grains, often via the food scoops. Be careful to avoid wheat-bread crumbs in butter, jams, toaster, counter surface, etc. Watch out for hidden gluten in prescription drugs. Ask your pharmacist for help about anything you’re not sure about, or suspect might contain unwanted gluten. Watch out for hidden gluten in lotions, conditioners, shampoos, deodorants, creams and cosmetics, (primarily for those with dermatitis herpetaformis). Be mindful of stamps, envelopes or other gummed labels, as these can often contain wheat paste. Use a sponge to moisten such surfaces. Be careful about hidden gluten in toothpaste and mouthwash. Be careful about common cereal ingredients, such as malt flavoring, or other non-gluten-free ingredient. Be extra careful when considering packaged mixes and sauces, including soy sauce, fish sauce, catsup, mustard, mayonnaise, etc., as many of these can contain wheat or wheat by-product in their manufacture. Be especially careful about gravy mixes, packets & canned soups. Even some brands of rice paper can contain gluten, so be careful. Lastly, watch out for foods like ice cream and yogurt, which are often gluten-free, but can also often contain added ingredients that can make them unsuitable for anyone on a gluten-free diet. Eating Out? If you eat out, consider that many restaurants use a shared grill or shared cooking oil for regular and gluten-free foods, so be careful. Also, watch for flour in otherwise gluten-free spices, as per above. Ask questions, and stay vigilant.

    Jefferson Adams
    Celiac.com 07/18/2018 - Despite many studies on immune development in children, there still isn’t much good data on how a mother’s diet during pregnancy and infancy influences a child’s immune development.  A team of researchers recently set out to assess whether changes in maternal or infant diet might influence the risk of allergies or autoimmune disease.
    The team included Vanessa Garcia-Larsen, Despo Ierodiakonou, Katharine Jarrold, Sergio Cunha,  Jennifer Chivinge, Zoe Robinson, Natalie Geoghegan, Alisha Ruparelia, Pooja Devani, Marialena Trivella, Jo Leonardi-Bee, and Robert J. Boyle.
    They are variously associated with the Department of Undiagnosed Celiac Disease More Common in Women and Girls International Health, Johns Hopkins School of Public Health, Baltimore, Maryland, United States of America; the Respiratory Epidemiology, Occupational Medicine and Public Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom; the Section of Paediatrics, Department of Medicine, Imperial College London, London, United Kingdom; the Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; the Division of Epidemiology and Public Health, University of Nottingham, Nottingham, United Kingdom; the Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom; and Stanford University in the USA.
    Team members searched MEDLINE, Excerpta Medica dataBASE (EMBASE), Web of Science, Central Register of Controlled Trials (CENTRAL), and Literatura Latino Americana em Ciências da Saúde (LILACS) for observational studies conducted between January 1946 and July 2013, and interventional studies conducted through December 2017, that evaluated the relationship between diet during pregnancy, lactation, or the first year of life, and future risk of allergic or autoimmune disease. 
    They then selected studies, extracted data, and assessed bias risk. They evaluated data using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). They found 260 original studies, covering 964,143 participants, of milk feeding, including 1 intervention trial of breastfeeding promotion, and 173 original studies, covering 542,672 participants, of other maternal or infant dietary exposures, including 80 trials of 26 maternal, 32 infant, or 22 combined interventions. 
    They found a high bias risk in nearly half of the more than 250 milk feeding studies and in about one-quarter of studies of other dietary exposures. Evidence from 19 intervention trials suggests that oral supplementation with probiotics during late pregnancy and lactation may reduce risk of eczema. 44 cases per 1,000; 95% CI 20–64), and 6 trials, suggest that fish oil supplementation during pregnancy and lactation may reduce risk of allergic sensitization to egg. GRADE certainty of these findings was moderate. 
    The team found less evidence, and low GRADE certainty, for claims that breastfeeding reduces eczema risk during infancy, that longer exclusive breastfeeding is associated with reduced type 1 diabetes mellitus, and that probiotics reduce risk of infants developing allergies to cow’s milk. 
    They found no evidence that dietary exposure to other factors, including prebiotic supplements, maternal allergenic food avoidance, and vitamin, mineral, fruit, and vegetable intake, influence risk of allergic or autoimmune disease. 
    Overall, the team’s findings support a connection between the mother’s diet and risk of immune-mediated diseases in the child. Maternal probiotic and fish oil supplementation may reduce risk of eczema and allergic sensitization to food, respectively.
    Stay tuned for more on diet during pregnancy and its role in celiac disease.
    Source:
    PLoS Med. 2018 Feb; 15(2): e1002507. doi:  10.1371/journal.pmed.1002507

    Jefferson Adams
    Celiac.com 07/17/2018 - What can fat soluble vitamin levels in newly diagnosed children tell us about celiac disease? A team of researchers recently assessed fat soluble vitamin levels in children diagnosed with newly celiac disease to determine whether vitamin levels needed to be assessed routinely in these patients during diagnosis.
    The researchers evaluated the symptoms of celiac patients in a newly diagnosed pediatric group and evaluated their fat soluble vitamin levels and intestinal biopsies, and then compared their vitamin levels with those of a healthy control group.
    The research team included Yavuz Tokgöz, Semiha Terlemez and Aslıhan Karul. They are variously affiliated with the Department of Pediatric Gastroenterology, Hepatology and Nutrition, the Department of Pediatrics, and the Department of Biochemistry at Adnan Menderes University Medical Faculty in Aydın, Turkey.
    The team evaluated 27 female, 25 male celiac patients, and an evenly divided group of 50 healthy control subjects. Patients averaged 9 years, and weighed 16.2 kg. The most common symptom in celiac patients was growth retardation, which was seen in 61.5%, with  abdominal pain next at 51.9%, and diarrhea, seen in 11.5%. Histological examination showed nearly half of the patients at grade Marsh 3B. 
    Vitamin A and vitamin D levels for celiac patients were significantly lower than the control group. Vitamin A and vitamin D deficiencies were significantly more common compared to healthy subjects. Nearly all of the celiac patients showed vitamin D insufficiency, while nearly 62% showed vitamin D deficiency. Nearly 33% of celiac patients showed vitamin A deficiency. 
    The team saw no deficiencies in vitamin E or vitamin K1 among celiac patients. In the healthy control group, vitamin D deficiency was seen in 2 (4%) patients, vitamin D insufficiency was determined in 9 (18%) patients. The team found normal levels of all other vitamins in the healthy group.
    Children with newly diagnosed celiac disease showed significantly reduced levels of vitamin D and A. The team recommends screening of vitamin A and D levels during diagnosis of these patients.
    Source:
    BMC Pediatrics