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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.

    Huge Study Documents Higher Rates of Enteropathy for Olmesartan Users
    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).

    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 earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided health and medical content for Sharecare.com.

    Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book Dangerous Grains by James Braly, MD and Ron Hoggan, MA.

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    Jefferson Adams
    Severe Intestinal Malabsorption Linked with Olmesartan (Benicar)
    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
    See the Viral Video that Helped Spawn Benicar Lawsuit
    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
    Benicar Users Reach $300 Million Settlement with Drug Maker Daiichi Sankyo
    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
    Should Benicar Be Banned?
    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

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