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There were several news reports recently about potential problems with using PPI acid reducing drugs for prolonged time due to the effects they have on calcium absorption.
We also wrote about how aspirin could lower risk of colon cancer and cardiac surgery complications.
Today we have some more interesting news about effects of Omeprazole (this drug is part of Proton-Pump Inhibitors group which includes Prilosec, Nexium, Protonix and many others) when it is taken together with blood-thinning drugs – more specifically Clopidogrel which is commonly known as Plavix.
Recent study published in The New England Journal of Medicine shows that Omeprazole does not increase chances of cardiovascular complications in patients taking Clopidogrel and Aspirin. Clopidogrel and Aspirin are very important blood thinning drugs which are prescribed to patients with increased risks of heart attack and stroke. They significantly decrease chances of heart problems but have one negative health effect. They cause multiple stomach problems (here is a full list of problems from the article: composite of overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation). To mitigate these side effects doctors often prescribe Proton-Pump Inhibitors (PPIs). But until this study it was unclear what effects PPIs have on patients with heart problems.
Study involved 3761 patients. 2.9% of patients had stomach events when taking placebo instead of Omeprazole while only 1.1% of patients who took real Omeprazole had problems with stomach. So Omeprazole helped decrease stomach events by more than 60% in the Omeprazole control group. During the study 109 patients had cardiovascular event with event rates of 4.9% with Omeprazole and 5.7% with placebo. No difference in severity and distribution of cardiac events were found in Omeprazole group in comparison with placebo group. The only issue in Omeprazole group was slightly increased chance of diarrhea which is a common side effect of PPIs.
As article states in the conclusion: “There was no apparent cardiovascular interaction between clopidogrel and omeprazole, but our results do not rule out a clinically meaningful difference in cardiovascular events due to use of a PPI.”
It is great to hear that Omeprazole still proves itself as safe drug with minimal interactions with other medications. But still make sure to always consult with your doctor before starting long term regimen of PPIs.
Research study was led by Dr. Deepak Bhatt of the Veterans Affairs Boston Healthcare System.
If you’re interested in more details about this article please visit page of “Clopidogrel with or without Omeprazole in Coronary Artery Disease” article on The New England Journal of Medicine website.
Two recent studies suggest two positive effects aspirin may have on colon cancer and cardiac surgery complications.
According to a 20 year follow up study of low dose aspirin it reduces risk of colon cancer by 24% and and risk of dying from colon cancer by 35%. It is quite interesting to see this since Aspirin even in low doses could cause stomach irritation, heartburn, pain, nausea, vomiting and over time even more serious consequences like holes in stomach or intestines. So I wouldn’t run to the drug store for the aspirin just because of this report.
Lots of the side effects of the aspirin could be reduced by taking it with meals, with an antacid, glass of milk or by taking time-release or enteric-coated aspirin. It is also not recommended to take aspirin together with alcohol or coffee.
But according to the research aspirin has positive effects on specific types of cancers which occur in proximal colon. These types of cancers usually could be detected with colonoscopy only and are not detectable by sigmoidoscopy. The findings of the study could be very important if they’re confirmed and new guidelins for doctors could be created based on this. But at this moment more research needed to confirm these results.
Another recent study reports that those who take low dose aspirin before the cardiac surgery had less chances of complications after the surgery. Many Americans diagnosed with cardiovascular diseases are taking low dose aspirin to reduce risk of strokes, bl0od clots and heart attacks. But American Heart Association and the American College of Cardiology recommend to discontinue Aspirin regimen before major surgery since Aspirin may increase risk of excessive bleeding and the need of blood transfusions. But based on the study this recommendation may need to be changed in case its results are confirmed.
More studies need to performed to confirm positive effects of aspirin both for colon cancer and cardiac surgery complications. Until then no changes are planned in treatment routines.
Perrigo (NYSE:PRGO) announced on Friday that it has filled an ANDA (Abbreviated New Drug Application) for over-the-counter (OTC) version of the omeprazole 20mg/sodium bicarbonate 1100mg drug. If approved it will join Prilosec and Zegerid OTC drugs already available over-the-counter.
New Perrigo product is a generic version of Zegerid OTC produced by Schering-Plough Healthcare Products Inc. Zegerid OTC was approved by FDA in 2009 for over-the-counter heartburn treatment. To prevent Perrigo from entering competitive PPI market Schering-Plough filed a patent infringement lawsuit against Perrigo in U.S. District Court for the District of New Jersey on September 20th, 2010. This lawsuit touches the same patents which were already part of the previous lawsuit against Perrigo in U.S. District Court for the District of Delaware. At that time court ruled that these patents were invalid due to their obviousness.
Prescription market size for proton pump inhibitors was estimated to be $13.4 billion in 2006. We don’t have exact information about the size of OTC PPI market but it should be significant since many people use OTC PPIs on “as needed” basis. Generic OTC version of Zegerid from Perrigo will add pressure on competitors and push prices down which will benefit people looking for quick heartburn relief.
Note that Perrigo is only working on omeprazole 20mg version of the drug. 40mg version is still available in prescription drug only and according to Zegerid most of its sales still come from 40mg prescription Zegerid. The probable reason for it is that 40mg version is prescribed for chronic heartburn when people have to take drug on daily basis.
It is unknown how recent news about effects of PPI drugs on calcium absorption and increased risk of bone fractures will affect PPI industry. According to recent research some doctors changed their PPI prescription tactics and are not prescribing PPIs in all heartburn related cases but trying to find alternative ways of treatment if possible. But still PPIs drugs is the best option available on the market for chronic heartburn treatment and there are no indications about possible decrease of PPI market size.
Following a study which proved that PPIs cause calcium malabsorption many doctors reduced number of prescriptions for PPIs they give to patients. According to recent studies people who take PPIs for a long period of time have increased risk of fractures. This is caused by the fact that PPI drugs significantly decrease level of acid in this stomach which in its turn decrease levels of calcium absorption. Before these studies PPIs were generally considered by doctors as completely safe drugs without significant side effects and were prescribed pretty much in most acid reflux related cases.
Following prescription drugs are part of PPI family: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. OTC brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR.
Recent studies covering patients 50 years or older found that those who took PPIs for periods longer than 1 year have increased risk of hip, wrist, spine and other osteoporotics fractures. Before the studies doctors thought that fractures were caused by different reasons like age and postmenopausal osteoporosis. But based on the results this is not the case.
Thus be cautious when taking PPI drugs – don’t use them for prolonged period of time especially if there is no real need for it. Try to replace it with wedge pillow and diet. This combination may significantly reduce need for PPIs.
Endogastric Solutions based in Redwood City, CA reported today that it raised $30m in Series F financing from Canaan Partners and Radius Ventures together with Advanced Technology Ventures, MPM Capital, Foundation Medical Partners, Chicago Growth Partners, and De Novo Ventures.
Endogastric Solutions develops and markets devices for NOS (Natural Orifice Surgery) which is the next step in evolution of minimally invasive surgery. Key procedure performed with NOS is EsophyX – which fixes GERD and Hiatal Hernia through incisionless surgery. It uses an EsophyX device which is inserted through patient mouth and under visual guidance of endoscope creates a barrier to reflux and restores function of gastroesophageal junction.
This procedure was already performed on more than a thousand patients worldwide and results are very promision. Two year follow up shows that 85% patients are still heartburn free and 79% stay off daily PPIs.
There is a significant market for this procedure since 20-40% of 30 million Americans diagnosed with GERD are not satisfied with PPI therapy. Also according to recent studies long term PPI therapy could lead to osteomalacia (inadequate absorption of calcium and other minerals into the bones).
Another procedure developed by Endogastric Solutions is StomaphyX which is used for transoral tissue approximation, ligation and full-thickness plication in the GI tract.
We hope that EsophyX will pass the test of time and will become safe solution for patients who want to get away from pharmaceutical treatment. At this moment procedure is already FDA approved and could be performed by qualified doctors in your area.
Somewhat good news for those with Barret’s esophagus.
Nebraska Medical Center, offers the BARRX Medical HALO ablation technology, which removes the diseased layer of cells from the esophagus and offers treatment of the disease before it has the chance to progress to cancer.
Ablation is a physical process where material is removed from the surface with vaporization, chipping or other erosive process. Specifically in HALO ablation effect is achieved by delivering heat energy to treatment area. The goal of the ablation is to remove cells modified by Barret’s esophagus process and reduce chance of esophageal cancer complication.
Ablation is performed in an outpatient setting and no incisions are required. According to clinical studies this procedure takes about 28 minutes but requires preparation before the procedure and there is some time afterwards where patients should be monitored.
For more details look at http://app1.unmc.edu/publicaffairs/todaysite/sitefiles/today_full.cfm?match=5503
This looks like a very good progress in prevention of esophageal cancer. Hopefully this procedure will prove to be successfull long term.
If you’d like to see where this procedure is performed talk to your doctor of nurse practitioner.
Based on my conversation with a friend who is a doctor I compiled a simple strategy on how to manage nighttime heartburn symptoms occurring every day for prolonged period of time.
Option 1: Use PPIs – if it works you’re done. Most people stay with this option until it stops working (I have no idea why – but I heard from lots of people that PPIs stop for them working after several years). Just make sure to read recent safety reports about PPIs – there were some changes in it in 2010.
Option 2: Use plan below to get rid of constant nighttime heartburn.
1) Find all food triggers for your heartburn and remove them from your diet. This included but is not limited to alcholol, chocolate, caffeine, acidic food (if you have doubts about any food acidity just exclude it – you can also use acidity database on this site). It is better to exclude all foods that you have doubts in rather than suffer nighttime heartburn.
2) Make your last meal very simple and plain. I use steamed rice with butter in this case. Simple meal will make your stomach produce only tiny amount of acid before the night and reduce irritation.
3) Last meal should be at least 3 hours before going to sleep.
4) Make sure you’re not hungry through the day and especially before going to sleep. This doesn’t mean you need to eat right before going to bed. It means that you have to eat through the day to get all the calories you need. Since your last meal is going to be simple you will need to consume more food during the day. Just eat some snacks to compensate loss of calories.
5) As a bonus you should get anti heartburn propup pillow. It will help you a lot in your efforts.
Plan above works like a clock to me. It just takes willpower to stick to it.
You can also learn how to stop heartburn at stopheartburnguide.com.
Good luck!
If you had any doubts about whether eating early helps reducing nighttime heartburn look at this link with scientific article from Centre Hospitalier Universitaire Vaudois, Gastroentérologie, Lausanne, Switzerland.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1434162
Abstract: “This study examines whether eating food at different times has differential effects on intragastric pH. Experiments were done in 23 healthy volunteers (12 men). Intragastric acidity was monitored by ambulatory 22 hour pH-metry. Composition of meals was standardised: breakfast and lunch at 7 am and 12 noon respectively, and dinner at 6 or 9 pm, in random order. The time of going to bed and getting up was also standardised. With early dinner nocturnal pH was higher, than with late dinner (pH median: 1.67 and 1.39, p less than 0.001). During the remaining time periods, pH values were similar. Thus early dinner may be helpful in conditions where low intragastric acidity is desirable.”
It clearly proves that if you go to bed at 11pm and have later dinner at 9pm your pH will be 1.39. If you have early dinner at 6pm than your pH will be 1.69 or 20% lower.
Please note that the higher the pH the lower the acidity. Thus pH of 1 is very acid while pH of 5 is very alcaline.
Conclusion: moving your dinner 3 hours early will reduce your nighttime heartburn 20%… Of course your mileage may vary but trend is quite obvious.
Moving dinner even earlier won’t help much since you’ll get hungry by the time you need to get to sleep.
This study is also confirmed by many advices I get from the books and internet. Heartburn and eating late has a very close connection. Just dealing with late food cravings could make a significant difference in how heartburn affects your lifestyle.
If you had any doubts about whether eating early helps reducing nighttime heartburn look at this link with scientific article from Centre Hospitalier Universitaire Vaudois, Gastroentérologie, Lausanne, Switzerland.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1434162
Abstract: “This study examines whether eating food at different times has differential effects on intragastric pH. Experiments were done in 23 healthy volunteers (12 men). Intragastric acidity was monitored by ambulatory 22 hour pH-metry. Composition of meals was standardised: breakfast and lunch at 7 am and 12 noon respectively, and dinner at 6 or 9 pm, in random order. The time of going to bed and getting up was also standardised. With early dinner nocturnal pH was higher, than with late dinner (pH median: 1.67 and 1.39, p less than 0.001). During the remaining time periods, pH values were similar. Thus early dinner may be helpful in conditions where low intragastric acidity is desirable.”
It clearly proves that if you go to bed at 11pm and have later dinner at 9pm your pH will be 1.39. If you have early dinner at 6pm than your pH will be 1.69 or 20% lower.
Please note that the higher the pH the lower the acidity. Thus pH of 1 is very acid while pH of 5 is very alcaline.
Conclusion: moving your dinner 3 hours early will reduce your nighttime heartburn 20%… Of course your mileage may vary but trend is quite obvious.
Moving dinner even earlier won’t help much since you’ll get hungry by the time you need to get to sleep.
This study is also confirmed by many advices I get from the books and internet. Heartburn and eating late has a very close connection. Just dealing with late food cravings could make a significant difference in how heartburn affects your lifestyle.
If you ask people who take PPIs about its safety the answer you most probably will hear: it is totally safe.
Well it looks like it is safe unless you combine it with Plavix. Recent research study found that in patients who suffered heart attack and were prescribed PPIs (in case of study it was Prilosec) together with blood thinner Plavix risk of repeat heart attack doubled in comparison with patients who were prescribed just Plavix. So Plavix+Prilosec equal to double risk of getting repeat heart attack.
It would be nice to get some study to figure out if Plavix+Prilosec are doubling chances of first heart attack. If it is so then it should be taken very seriously and every patient prescribed with PPIs should know what risk they may be taking.
Anyway looks like there are some hidden edges in PPI drugs. It doesn’t mean that we should stop taking them when heartburn is really bad but be careful and if you can find alternatives it maybe time to consider them.
Here you can find more details on this study http://www.healthfinder.gov/News/newsstory.aspx?docid=624675.
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