WASHINGTON, Feb. 15 (UPI) -- The number of potential side effects from the use of proton-pump inhibiting drugs to control heartburn continues to grow, with new research in Germany linking them to the development of dementia. 
 
 A new study links the widely used PPIs -- which include Nexium, Prevacid and Prilosec -- to an increased risk for cognitive decline, though researchers caution the study has limitations, and does not show a definite cause. 
 
 PPIs have recently been linked to kidney disease, heart disease, and deficiencies of B12 and other vitamins. While patients have reported side effects of the drugs, not taking them often results in stomach pains and worse heartburn as the drug leaves their systems. 
 
 "It does not tell us anything that should change medical practice right now," Keith Fargo, director of scientific programs and outreach for the Alzheimer's Association, told CBS News. "I don't think there's going to be an uprising among doctors telling patients not to take their PPIs. This doesn't rise anywhere near the level of evidence you would need for that." 
 
 For the study, published in JAMA Neurology, researchers analyzed patient data collected from 2004 to 2011 by the German health insurer Allgemeine Ortskrankenkassen for 73,679 of its customers. 
 
 The patients, who were 75 years or older and did not have dementia, on PPI drugs showed a 44 percent increased risk of dementia compared with those who did not use them. Researchers said in the study the data is supported by recent studies with mice that found rodents on PPIs had increased levels of amyloid plaques in their brains, the buildup of which contributed to dementia. 
 
 Researchers and doctors note that these studies have not accounted for lifestyle or diet, both of which affect the risk for dementia, or other diseases for which PPIs may increase risk. 
 
 "The teaching for many years was that these drugs were quite safe," John Clarke, a gastroenterologist at Johns Hopkins Hospital, told NPR. "But there is data that's emerging that suggests PPIs may not be as safe as we think they are." ||||| A popular class of heartburn medications might raise a senior's risk of dementia, a new study suggests. 
 
 Called proton pump inhibitors (PPIs), this group of drugs includes Prilosec, Nexium and Prevacid. They work by lowering the amount of acid produced by the stomach. 
 
 But German researchers found that people 75 or older who regularly take the medications had a 44 percent increased risk of dementia, compared with seniors not using the drugs. The study only found an association, however, and not a cause-and-effect link. 
 
 "To evaluate cause-and-effect relationships between long-term PPI use and possible effects on cognition in the elderly, randomized, prospective clinical trials are needed," said corresponding author Britta Haenisch, from the German Center for Neurodegenerative Diseases in Bonn. 
 
 In the meantime, "Clinicians should follow guidelines for PPI prescription, to avoid overprescribing PPIs and inappropriate use," Haenisch said. 
 
 The report was published Feb. 15 in the journal JAMA Neurology. 
 
 The results are surprising enough that at least one leading expert on aging, Dr. Malaz Boustani, plans to share the findings with older patients who are using PPIs. 
 
 Boustani said earlier studies have linked another type of antacid, H2 blockers, with an increased risk of dementia. Up to now, he's recommended that patients use PPIs to treat acid reflux and steer clear of H2 blockers like Tagamet, Pepcid and Zantac. 
 
 "I'm going to disclose the finding to my patients and then let them decide whether they will take the risk or not," said Boustani, a professor of medicine with the Indiana University Center for Aging Research and a spokesman for the American Federation for Aging Research. "On Monday I have clinic, and if I have patients taking a PPI or an H2 blocker I will tell them exactly what I'm telling you, and then they can decide." 
 
 More than 15 million Americans used prescription PPIs in 2013, at a total cost of more than $10 billion, according to a report by the IMS Institute for Healthcare Informatics. Several popular PPIs -- Prilosec, Prevacid and Zegerid -- also are available over-the counter, further boosting their use. 
 
 Concern has been increasing that Americans might be overusing PPIs to treat minor cases of heartburn or acid reflux. 
 
 As many as 70 percent of PPI prescriptions in the United States have been inappropriately handed out by doctors, and 25 percent of long-term users could stop taking the medication without suffering increased heartburn or acid reflux, according to a study published in January in the journal JAMA Internal Medicine. 
 
 Overuse of PPIs could have drastic effects on health, that study found. For example, the medications have been linked to a 20 percent to 50 percent higher risk of chronic kidney disease. 
 
 And now the German researchers report there also is some evidence that PPI use might affect a person's ability to reason. 
 
 PPIs appear to effect levels of amyloid beta and tau, which are proteins associated with Alzheimer's disease, the German authors said. PPI use can also lead to vitamin B12 deficiency, which has been associated with cognitive decline. 
 
 To test the possible association between PPIs and dementia, the German researchers collected data from a large German health insurance firm on almost 74,000 seniors aged 75 or older. The data ran from 2004 to 2011, and included diagnoses and drug prescriptions. 
 
 About 2,950 patients regularly used PPIs, which for this study was defined as at least one PPI prescription in each quarter of an 18-month interval. 
 
 Regular users of PPIs had a 44 percent increased risk of dementia compared with those not receiving PPI medications. 
 
 However, the study doesn't make clear whether PPIs are also available over the counter in Germany, as they are in the United States, said Dr. Arun Swaminath, director of the inflammatory bowel disease program at Lenox Hill Hospital in New York City. 
 
 If over-the-counter PPIs are available, then more people might have been taking them and the dementia risk described in this paper could be overestimated, Swaminath said. 
 
 "However, I think the point here is that for some patients, weaning off PPIs is reasonable and they should make this decision with their doctors," he said. 
 
 People who want to ease off PPIs can take a number of steps to reduce excess acid or prevent acid reflux, Boustani said. They can eat smaller meals, lay off chocolate and caffeine, and stay upright for a few hours following each meal. 
 
 Boustani added that his group has received federal funding to design clinical trials in which people would be weaned off PPIs, to see how it affects their ability to remember and think. 
 
 Dr. Gisele Wolf-Klein, director of geriatric education at North Shore-LIJ Health System in New Hyde Park, N.Y., added that even the researchers aren't sure why PPIs would affect the aging brain. 
 
 "We don't know what is causing the brain to deteriorate. Until we know this, there's no reason for people who are taking PPIs to be too concerned about that and stop taking those agents if they are needed," Wolf-Klein said. 
 
 Another expert agreed. 
 
 While the study is intriguing, it's not enough for doctors to warn patients off PPI use, said Keith Fargo, director of scientific programs and outreach for the Alzheimer's Association. 
 
 "It does not tell us anything that should change medical practice right now," Fargo said. "I don't think there's going to be an uprising among doctors telling patients not to take their PPIs. This doesn't rise anywhere near the level of evidence you would need for that." 
 
 One of the paper's main flaws is that researchers could not control for diet and body weight as risk factors, Fargo said. 
 
 "Both of those things, we know, are risk factors for developing cognitive decline and dementia in later life, and both of those are reasons why a person might need to take a proton pump inhibitor," Fargo explained. ||||| Millions of Americans take proton pump inhibitors to treat acid reflux and heartburn. Known as PPIs, they are among the most prescribed drugs in the United States and are widely available over the counter. 
 
 But according to preliminary research presented today at an American Heart Association conference in New Orleans, these medications may also increase the risk of ischemic stroke 
 
 Ischemic strokes are the most common type of stroke, according to the Centers for Disease Control and Prevention . They occur when a blood clot cuts off blood flow to the brain. 
 
 "PPIs have been associated with unhealthy vascular function, including heart attacks, kidney disease and dementia," said Dr. Thomas Sehested, the study's lead author and a researcher at the Danish Heart Foundation . "We wanted to see if PPIs also posed a risk for ischemic stroke, especially given their increasing use in the general population." 
 
 Most serious warning yet 
 
 Protonix, The research was conducted in Denmark among a quarter-million patients who suffered from stomach pain and indigestion, and were taking one of four PPIs: Prilosec Prevacid or Nexium 
 
 Overall stroke risk increased 21% among patients who were taking a PPI, according to the study. At the lowest doses, the authors found either no or minimal increased risk of stroke. At the highest doses, they found that stroke risk increased 33% for Prilosec and Prevacid patients, 50% for Nexium patients and 79% for Protonix patients. 
 
 In an email to CNN, P&G, the company that makes Prilosec, said the drug is an "FDA approved, safe and effective remedy to relieve frequent heartburn symptoms. Prilosec OTC has the longest history of safe and effective consumer use of any [over the counter] PPI." 
 
 Takeda, the maker of Prevacid, said it could not comment on the results and conclusions of the study until the full data is published for review. "Patient safety is a top priority ... and we continuously monitor the safety of all our medicines and collaborate with regulatory agencies to ensure this information is reflected in the respective prescribing information," a spokesman said in an email to CNN. 
 
 AstraZeneca, the maker of Nexium, said, "Patient safety is an important priority ... and we believe all of our PPI medicines are generally safe and effective when used in accordance with the label." A spokeswoman said the company was not consulted during the research, so it could not comment on the data. 
 
 Pfizer, the maker of Protonix, did not respond to CNN's request for comment. 
 
 "At one time, PPIs were thought to be safe, without major side effects," Sehested said. "This study further questions the cardiovascular safety of these drugs." 
 
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 A pair of 2010 studies found that PPIs were associated with an increased risk of a serious bacterial infection . Stomach acid seems to play a role in killing off both good and bad bacteria in our gut. When someone is taking PPIs, their amount of stomach acid is reduced, and it creates an environment in which bacteria can flourish. 
 
 "As a culture, we tend to want a pill to deal with our problems, when a lot of people could reduce their heartburn by eating smaller meals, drinking less alcohol or not smoking," Dr. Michael Katz, who wrote an editorial accompanying the studies, told CNN in 2010 
 
 In April, another study published in the Journal of the American Society of Nephrology found that patients who took PPIs had a 96% increased risk of kidney failure and a 28% increased risk of kidney disease, compared with those who were prescribed alternative medications. 
 
 What are the alternatives? 
 
 Medical professionals estimate that the majority of people who suffer from acid reflux or heartburn could drastically or completely reduce their discomfort by making a few lifestyle changes: quit smoking, lose weight and cut back on spicy and fatty foods. 
 
 If your doctor determines that you do need pills for your problem, pharmacist NaaDede Badger-Plange suggests starting with an antacid , such as Tums, Rolaids or Maalox. 
 
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 "Antacids usually would help if you have less than one incident a week," Badger-Plange said . "So, if you have heartburn very rarely -- especially people who have heartburn associated with certain foods -- they could take antacids." 
 
 Antacids provide quick relief, but only for a short amount of time, said Badger-Plange, and consumers should pay close attention to the ingredients on the label. If you're pregnant, you should avoid sodium bicarbonate and magnesium trisilicate. Patients with kidney disease should avoid antacids that contain aluminum. 
 
 For longer-lasting relief, H2 antagonist medications (also called H2 blockers) are also an option, but they can take a few hours to kick in. 
 
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 "One thing to keep in mind is, certain products that are in the H2 receptor antagonist class have drug interactions," Badger-Plange said. "So, if you have a lot of medications, you probably want to check with your pharmacist at the counter to make sure it's OK to take those medications." 
 
 As always, you should talk to your doctor before starting or stopping any medication -- prescribed or over the counter. 
 
 For years, Katz has been worried that PPIs "reinforce the idea that the solution to behavioral health issues is to take a pill, and that's just not how we're going to get healthier," he said in 2010. "Consumers need to ask their doctors, 'Why am I taking this? Do I still need this? Do I have an alternative?' " ||||| Importance Medications that influence the risk of dementia in the elderly can be relevant for dementia prevention. Proton pump inhibitors (PPIs) are widely used for the treatment of gastrointestinal diseases but have also been shown to be potentially involved in cognitive decline. 
 
 Objective To examine the association between the use of PPIs and the risk of incident dementia in the elderly. 
 
 Design, Setting, and Participants We conducted a prospective cohort study using observational data from 2004 to 2011, derived from the largest German statutory health insurer, Allgemeine Ortskrankenkassen (AOK). Data on inpatient and outpatient diagnoses (coded by the German modification of the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision) and drug prescriptions (categorized according to the Anatomical Therapeutic Chemical Classification System) were available on a quarterly basis. Data analysis was performed from August to November 2015. 
 
 Exposures Prescription of omeprazole, pantoprazole, lansoprazole, esomeprazole, or rabeprazole. 
 
 Main Outcomes and Measures The main outcome was a diagnosis of incident dementia coded by the German modification of the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision. The association between PPI use and dementia was analyzed using time-dependent Cox regression. The model was adjusted for potential confounding factors, including age, sex, comorbidities, and polypharmacy. 
 
 Results A total of 73 679 participants 75 years of age or older and free of dementia at baseline were analyzed. The patients receiving regular PPI medication (n = 2950; mean [SD] age, 83.8 [5.4] years; 77.9% female) had a significantly increased risk of incident dementia compared with the patients not receiving PPI medication (n = 70 729; mean [SD] age, 83.0 [5.6] years; 73.6% female) (hazard ratio, 1.44 [95% CI, 1.36-1.52]; P < .001). 
 
 Conclusions and Relevance The avoidance of PPI medication may prevent the development of dementia. This finding is supported by recent pharmacoepidemiological analyses on primary data and is in line with mouse models in which the use of PPIs increased the levels of β-amyloid in the brains of mice. Randomized, prospective clinical trials are needed to examine this connection in more detail. ||||| No elevated risk linked to H2 blockers 
 
 Interestingly, another commonly prescribed heartburn drug class called H2 blockers showed no association with elevated heart-attack risk. H2 blockers, which have been around longer than PPIs, are reasonably effective against heartburn and are the second-largest-selling class of drugs used to treat it. 
 
 The study’s findings lend support to an explanation for an untoward effect of PPIs on heart-disease risk proposed by Stanford scientists a few years ago. Research done then showed that PPIs impede the production of an important substance, nitric oxide, in the endothelial cells that line all of the nearly 100,000 miles of blood vessels in an average adult’s body. 
 
 Shah has pioneered the use of data-mining techniques to capture sometimes elusive but medically important phenomena. His methodology makes it possible, for example, to scour huge numbers of electronic health records — not only their structured portions, but also free-form notes entered by attending clinicians — for hints of an association between use of a drug or drug combination and unanticipated health outcomes, whether good or bad. 
 
 This kind of work is promoted by Stanford Medicine’s Biomedical Data Science Initiative, which strives to make powerful transformations in human health and scientific discovery by fostering innovative collaborations among medical researchers, computer scientists, statisticians and physicians. 
 
 At Stanford, all clinical notes dating back to 1994 have been entered into a database known by its acronym, STRIDE. Shah and Leeper and their colleagues sifted through data on 19 million encounters between Stanford physicians and 1.8 million patients and identified more than 70,000 who were age 18 or older and had been diagnosed with heartburn. To this number, the scientists added more than 227,000 adult heartburn patients culled from another privately held health-record database containing data on 1.1 million patients. They compared subsequent heart-attack frequencies of those who either had been prescribed PPIs, or said they were using them, with those of heartburn sufferers who were not using PPIs. The researchers saw a 16-21 percent increase in the rate of heart attacks, depending on which statistical approach they used, among members of the PPI group. This higher heart-attack frequency could be seen even in otherwise healthy PPI users under age 45. 
 
 Other bad outcomes 
 
 To further validate the association, they turned to an ongoing prospective, longitudinal study of 1,500 patients with chest pain, shortness of breath or abnormal stress-test results, conducted by Stanford in collaboration with Mount Sinai Medical Center in New York City. As a routine part of this study, patients are asked whether they are using PPIs. 
 
 To ensure that they would spot adverse drug effects if there were any, Shah, Leeper and their colleagues looked for not only heart attacks but cardiac arrest, stroke and other bad outcomes. They found that in this study population, PPI use more than doubled the risk of a patient’s suffering a subsequent major adverse cardiovascular event. 
 
 Several hypotheses have been advanced to explain the increased cardiovascular risk attributable to PPI use among clopidogrel users, who in the past were often placed on PPIs because clopidogrel can increase gastric distress. But those hypotheses haven’t held up well under scrutiny. 
 
 These drugs may not be as safe as we think. 
 
 A new hypothesis was born in 2013, when a study in Circulation by John Cooke, MD, PhD, then a professor of cardiovascular medicine at Stanford, and his colleagues, including Yohannes Ghebremariam, PhD, implicated PPIs in igniting a cascade of biochemical reactions that led to diminished nitric oxide levels in endothelial tissue. (Cooke and Ghebremariam, both now at Houston Methodist Research Institute, are co-authors of the new study.) 
 
 “That study implied that PPIs’ cardiovascular-risk effect had nothing to do with clopidogrel but was, instead, a direct effect on blood vessels themselves,” Leeper said. “That could mean everybody on PPIs, not just people with coronary disease, is at increased risk from these drugs.” 
 
 Those findings inspired Shah and Leeper to undertake the new study. “We looked at cardiovascular risk for different PPI drugs,” said Shah. “And we found that the degree to which the use of any particular PPI was associated with a subsequent heart attack mirrors the degree to which the drug inhibits nitric oxide in the vasculature.” 
 
 A small pilot trial led by Leeper and recently published in Vascular Medicine showed a trend between PPI use and increases in a chemical known to impair the function of an enzyme that produces nitric oxide. But the study population of 21 subjects was too small to show a conclusive link. 
 
 “This association needs to be tested in a large, prospective, randomized trial,” said Leeper. “The truth will come out when we randomize several hundred people, give half of them PPIs and put the other half on H2 blockers, and see what happens.” 
 
 Neither Shah nor Leeper recommends that people now on PPIs simply stop taking them without first talking to their doctors about alternatives. 
 
 Meanwhile, they both said, the study results should give clinicians and patients pause when deciding whether to take these medications — particularly because they’re so often taken for far longer time periods than the label recommends. 
 
 Research scientist Paea LePendu, PhD, shares lead authorship with Shah. Other Stanford co-authors are postdoctoral scholar Anna Bauer-Mehren, PhD; research assistant Srinivasan Iyer; and medical resident Kevin Nead, MD. 
 
 The study was funded by the National Institute of General Medical Science (grant R01GM101430) and the National Human Genome Research Institute (grant U54HG004028). 
 
 Information about Stanford’s Department of Medicine, which also supported the work, is available at http:// http://medicine.stanford.edu/. ||||| HOUSTON -- ( June 4, 2015 ) - Adults who use proton pump inhibitors are between 16 and 21 percent more likely to experience a heart attack than people who don't use the commonly prescribed antacid drugs, according to a massive new study by Houston Methodist and Stanford University scientists. 
 
 An examination of 16 million clinical documents representing 2.9 million patients also showed that patients who use a different type of antacid drug called an H2 blocker have no increased heart attack risk. The findings, reported in PLOS ONE, follow a Circulation report in 2013 in which scientists showed how -- at a molecular level -- PPIs might cause long-term cardiovascular disease and increase a patient's heart attack risk. 
 
 "Our earlier work identified that the PPIs can adversely affect the endothelium, the Teflon-like lining of the blood vessels," said John Cooke, M.D., Ph.D., a senior author of the PLOS ONE report. "That observation led us to hypothesize that anyone taking PPIs may be at greater risk for heart attack. Accordingly, in two large populations of patients, we asked what happened to people that were on PPIs versus other medications for the stomach." 
 
 The PLOS ONE study's principal investigator was Stanford vascular medicine specialist Nicholas J. Leeper, M.D. 
 
 In the present study, the researchers found a clear and significant association between exposure to PPIs and the occurrences of heart attack. 
 
 "By looking at data from people who were given PPI drugs primarily for acid reflux and had no prior history of heart disease, our data-mining pipeline signals an association with a higher rate of heart attacks," said the PLOS ONE report's lead author, Nigam H. Shah, Nigam H. Shah, M.B.B.S., Ph.D., an assistant professor of biomedical informatics at Stanford, where the work was done. "Our results demonstrate that PPIs appear to be associated with elevated risk of heart attack in the general population, and H2 blockers show no such association." 
 
 The estimated increase of heart attack risk ranges from 16 to 21 percent, because of uncertainty in the estimation process, Shah said. 
 
 The FDA estimates about 1 in 14 Americans has used proton pump inhibitors. In 2009, PPIs were the third-most taken type of drug in the U.S., and are believed to account for $13 billion in annual global sales. Doctors prescribe PPIs to treat a wide range of disorders, including gastro-esophageal reflux disease, or GERD, infection by the ulcer-causing bacterium Helicobacter pylori, Zollinger-Ellison syndrome, and Barrett's esophagus. The drugs can also be purchased over the counter. PPIs come in a variety of slightly different chemical forms, always ending with the suffix "-prazole," for example, omeprazole or lansoprazole. Brand examples of PPIs are Nexium, Prilosec, and PrevAcid. 
 
 H2 blockers are another type of antacid drug. They are not believed to be associated with increased risk of heart attack or cardiovascular disease. Examples of the drug are cimetidine and ranitidine. Brand examples of H2 blockers are Zantac and Tagamet. 
 
 The researchers collected data from two repositories -- STRIDE (Stanford Translational Research Integrated Database Environment), which contains information about 1.8 million Stanford hospital and clinic patients, and a subset of information for 1.1 million patients from the Web-based electronic medical records company Practice Fusion, Inc. Both sources of patient information were anonymized before the researchers accessed the data. 
 
 The group scanned the databases for patients who were prescribed proton pump inhibitors or other drugs, such as H2 blockers, and also looked to see if a given patient had a mention of having experienced a major cardiovascular event, such as myocardial infarction (heart attack), in their medical record. 
 
 Patients who had used PPIs were found to be at 1.16-1.21-fold-increased risk of heart attack. 
 
 Scrutiny of PPIs has only increased with time. Initially it was believed PPIs only posed a risk to a very narrow subset of patients -- those with coronary artery disease who were using the anti-platelet drug clopidogrel to prevent future heart attacks. 
 
 "Investigators originally assumed this was due to a drug-drug interaction between these compounds, and the FDA went so far as to release a warning about their concomitant use," said Nicholas Leeper. 
 
 A 2013 report to Circulation by several of the present report's coauthors, including Cooke, raised the possibility that PPIs could lead to cardiovascular disease in the general population. 
 
 "This led us to use powerful 'big-data' approaches to try to determine whether PPIs might in fact be associated with risk in 'all comers,' Leeper said. "Our report raises concerns that these drugs -- which are available over the counter and are among the most commonly prescribed drugs in the world -- may not be as safe as we previously assumed." 
 
 In the future, the researchers say they hope to conduct a large, prospective, randomized trial to determine whether PPIs are harmful to a broader population of patients. 
 
 ### 
 
 Also contributing to the PLOS ONE report were co-lead author Paea LePendu, Anna Bauer-Mehren, Srinivasan V. Iyer, and Kevin T. Nead (Stanford University), Yohannes T. Ghebremariam (Houston Methodist), and Jake Marcus (Practice Fusion, Inc.). Research was funded by grants from the National Institutes of Health (U54HG004028, U54LM008748, and 1U01HL100397), the American Heart Association (11IRG5180026), Apixio, Inc., and the Stanford SPARK Translational Research Program. 
 
 To speak with Dr. John Cooke, please contact David Bricker, Houston Methodist, at 832-667-5811 or dmbricker@houstonmethodist.org. To speak with Drs. Shah and Leeper, please contact Bruce Goldman, Stanford University, at 650-725-2106 or goldmanb@stanford.edu. 
 
 "Proton pump inhibitor usage and the risk of myocardial infarction in the general population," by Nigam H. Shah et al, PLOS ONE
– Certain heartburn drugs have already been linked to heath woes including heart disease and kidney disease. Now a study in JAMA Neurology says those drugs—proton-pump inhibitors like Prilosec, Prevacid, and Nexium—may also boost the chance of dementia, UPI reports. Analyzing a German health insurer's data on nearly 74,000 customers aged 75 and up from 2004 to 2011, researchers found a 44% higher dementia risk among "PPI" users. The finding also coincides with research showing that mice on PPIs had higher amyloid plaque levels in their brains, which has been linked to dementia. So what to do, when roughly 15 million Americans use prescription PPIs and other patients take over-the-counter versions? For now, nothing. More clinical trials are needed to analyze the possible PPI-dementia link, senior study author Britta Haenisch tells CBS News. For one thing, the JAMA Neurology study didn't account for lifestyle and diet, which can influence dementia risk. But, she adds, "clinicians should follow guidelines for PPI prescription, to avoid overprescribing PPIs and inappropriate use." Up to 70% of PPI prescriptions may be needless reactions to minor cases of acid reflux or heartburn, per a recent study. Big picture: PPIs are being seen in a whole new light. "The teaching for many years was that these drugs were quite safe," a gastroenterologist tells NPR. "But there is data that's emerging that suggests PPIs may not be as safe as we think they are." (Turns out vegetable oils may cause dementia when heated.)