Investigational drug effective as adjunct to PPIs in refractory GERD

Approximately 20% of the adult U.S. population reports GERD-related symptoms, including heartburn and regurgitation each week and about seven per cent experience daily symptoms. 

Proton pump inhibitors are "mainstay" treatment for GERD but approximately 30% of patients continue to have symptoms. Refractory gastroesophageal reflux disease (GERD) reduces the quality of life and creates a significant financial burden on the healthcare system. The researchers performed a trial to evaluate the efficacy and safety of new drug IW-3718, a bile acid sequestrant, as an adjunct to PPI therapy.

They found that the investigational drug that binds bile acids in the stomach can reduce the severity of heartburn symptoms in patients with treatment-resistant gastroesophageal reflux disease (GERD) when combined with a proton pump inhibitor (PPI. 

The study has been published in the journal Gastroenterology. 

"As a physician, it is very challenging to have nothing new to offer patients for whom standard treatments don't work," Vaezi said. "But the reality is many of our patients continue to struggle with frequent heartburn and regurgitation despite taking their PPIs.

"These data provide strong evidence that bile acid plays a key role in refractory GERD and that IW-3718 may have the potential to make a meaningful difference for patients," he added. 

Vaezi is professor of Medicine and clinical director of the Division of Gastroenterology, Hepatology and Nutrition in the Department of Medicine, Vanderbilt University School of Medicine. PPIs such as Prilosec and Nexium reduce the production of stomach acid. 

IW-3718, which was developed by Ironwood Pharmaceuticals, combines an established drug that binds bile acids in the stomach with a technology that controls the release of drugs in the gastrointestinal tract. Bile acids have been shown to injure the lining of the oesophagus as well as stomach and colon. 

Fifty-two centres in the United States, including VUMC, participated in the randomized, double-blind study from March 2016 to April 2017. A total of 280 adult patients with refractory GERD were divided into four groups, one which received an inactive placebo and the other ascending doses of IW-3718 twice a day.

 Heartburn symptoms were significantly reduced in the group receiving the highest dose, 1,500-milligrams twice daily, compared to the placebo group. Regurgitation symptoms also decreased. The drug was well tolerated. There were no drug-related serious adverse events. 

"These results suggest that IW-3718 may provide a therapeutic option for refractory-GERD patients with continued symptoms despite once-daily PPI therapy," the researchers concluded.

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BEWARE WHEN YOU TAKKE HEARTBURN MEDICINES FOR LONG

Individuals who take drugs that are commonly used to treat heartburn, ulcers and other gastrointestinal problems for a prolonged time may be at an increased risk of death, researchers warned. PPIs are most often used for heartburn and indigestion.
The findings showed that people taking these drugs called as proton pump inhibitors (PPIs) had a 50 per cent increased risk of dying over the next five years.

“People have the idea that PPIs are very safe because they are readily available, but there are real risks to taking these drugs, particularly for long periods of time,” said a researcher. Further, for every 500 people taking PPIs for a year, there was one extra death that would not have otherwise occurred.

Given the millions of people who take PPIs regularly, this could translate into thousands of excess deaths every year, he said. PPIs have also been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia, the researchers said.

For the study, the researchers examined medical records of some 275,000 users of PPIs and nearly 75,000 people who took another class of drugs — known as H2 blockers — to reduce stomach acid. Both PPIs and H2 blockers are prescribed for serious medical conditions such as upper gastrointestinal tract bleeding, gastroesophageal reflux disease and esophageal cancer.

The results revealed a 25 per cent increased risk of death in the PPI group compared with the H2 blocker group.

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Medication For Acid Reflux, Proton Pump Inhibitors, May Increase Risk For Chronic Kidney Disease

Proton pump inhibitors (PPIs) — one of the top 10 classes of prescribed medications  — may be an independent risk factor for chronic kidney disease (CKD), finds two new papers published recently. 

While PPIs are commonly prescribed to treat acid reflux, they’ve also been associated with an increased risk of both CKD and other acid-related gastrointestinal conditions like acute interstitial nephritis. The latter is frequently undiagnosed, which may then present itself as CKD. So to better understand this incidence rate, possibly even mortality, the first study followed 10,482 participants from another study also.

The ARIC study is a prospective study conducted in four communities designed to investigate the etiology and history of atherosclerosis, or the process in which arteries thicken and harden. The participants were all adults with normal kidney function from 1996 to 2011. And researchers found that PPI users were between 20 and 50 percent more likely to develop CKD than non PPI-users. These users were also more often obese, and taking antihypertensive medication.

When researchers replicated their study, this time using patient data collected from 240,000 participants during 1997 to 2014, they had the same result. Lead study author said that people who used a different prescribed class of medications to suppress stomach acid — also known as an H2 blocker — did not have a higher risk of developing CKD in both studies. He and his team concluded that "PPI use is an independent factor for CKD."

The second study arrived at similar conclusions. Led by a Dr.,  researchers analyzed data from 99,351 patients who were seen in primary care clinics from April 2001 to April 2008; 27,835 patients with baseline CKD were excluded. The data included patient's PPI use, as well as their respective ages, gender, race, and comorbidity variables, such as chronic obstructive pulmonary disease (COPD), cancer, diabetes, and hypertension.

Excluding more than 20,000 patients brought the total number of patients down to 71,516. And of this sample, 24,149 patients developed CKD — 25.7 percent were treated with PPIs. Patients being treating with PPI were also less likely to have vascular disease, COPD, cancer, and hypertension.

There's more: When researchers analyzed the original sample size for mortality outcome, 36,290 had died. These analyses showed people taking PPIs had higher odds for developing CKD and mortality compared to patients not taking PPIs. Researchers concluded that use of PPIs is associated with increased risk of developing CKD.

As Tech Times pointed out, these studies merely show a link between PPIs and CKD — they do not prove a causal relationship. Lead author of the second study  suggested these links may stem from two things: One, repeated bouts of acute interstitial nephritis damage kidneys and/or two, PPIs reduce the levels of magnesium in the blood, which may also damage kidneys.

"As a large number of patients are being treated with PPIs, health care providers need to be better educated about the potential side effects of these drugs, such as CKD," the Dr. said in a press release. "PPIs are often prescribed outside of their approved uses, and it has been estimated that up to two-thirds of all people on PPIs do not have a verified indication for the drug."


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Those pills to reduce gastric acid may silently damage your kidney

Beware! US researchers warned that taking drugs to reduce gastric acid for prolonged periods may lead to serious kidney problems, including kidney failure.Taking popular heartburn drugs for prolonged periods has been linked to serious kidney problems.Heartburn is the form of indigestion as burning sensation in the chest, caused by acid regurgitation into the esophagus.

According to researchers from Washington university in St. Louis, the sudden onset of kidney problems often serves as a red flag for doctors to discontinue their patients' use of so-called proton pump inhibitors (PPIs) that reduce the secretion of gastric (stomach) acid.The study appeared in the journal of Kidney International.

"Our results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure. Patients should be cautioned to tell their doctors if they're taking PPIs and only use the drugs when necessary," said study's senior author Ziyad Al-Aly.

The team analysed 1,25,596 new users of PPIs and 18,436 new users of other heartburn drugs referred to as H2 blockers. The latter are much less likely to cause kidney problems but often aren't as effective.Over five years of follow up study, the results indicated that more than 80 percent of PPI users did not develop acute kidney problems, which often are reversible and are characterised by too little urine leaving the body, fatigue and swelling in the legs and ankles.

More than half of the cases of chronic kidney damage and end-stage renal disease associated with PPI use occurred in people without acute kidney problems."Doctors must pay careful attention to kidney function in their patients who use PPIs, even when there are no signs of problems," cautioned Al-Aly.

"In general, we always advise clinicians to evaluate whether PPI use is medically necessary in the first place because the drugs carry significant risks, including a deterioration of kidney function," Al-Aly concluded.

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Common heartburn drugs may damage your kidney

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 Increased use of certain medications commonly used to treat heartburn and acid reflux may have damaging effects on the kidneys, say researchers.

The researchers looked at the effects of the drugs called proton pump inhibitors (PPIs) on chronic kidney disease (CKD).

In one study, Pradeep Arora from State University of New York and his team found that among 24,149 patients who developed CKD between 2001 and 2008 (out of a total of 71,516 patients), 25.7 per cent were treated with PPIs.

PPI use was linked with a 10 per cent increased risk of CKD and a 76 per cent increased risk of dying prematurely.

"As a large number of patients are being treated with PPIs, health care providers need to be better educated about the potential side effects of these drugs, such as CKD," Arora pointed out.

In another study, Benjamin Lazarus from Johns Hopkins University and his colleagues followed 10,482 adults with normal kidney function from 1996 to 2011.

They found that PPI users were between 20 per cent and 50 per cent more likely to develop CKD than non-PPI users, even after accounting for baseline differences between users and non-users.

This discovery was replicated in a second study, in which over 240,000 patients were followed from 1997 to 2014.

"In both studies, people who used a different class of medications to suppress stomach acid, known as H2-blockers, did not have a higher risk of developing kidney disease," Lazarus pointed out.

"If we know the potential adverse effects of PPI medications we can design better interventions to reduce overuse," Lazarus noted.

The findings will be presented at ASN (American Society of Nephrology) Kidney Week 2015 to be held at San Diego Convention Centre from November 3-8.