Study: Drug doesn ' T plavix undermined.

October 7, 2010

News Review From Harvard Medical School -- Study: Drug Doesn't Undermine Plavix

Taking a heartburn drug does not make the blood thinner Plavix less effective, a new study suggests. Some people take a heartburn drug to reduce their risk of stomach or intestinal bleeding from the blood thinner. Early studies suggested that adding the heartburn drug increased people's risk of heart attacks or strokes. But the new study followed a design that is considered more accurate. It included 3,873 people who took clopidogrel (Plavix). They were randomly assigned to also receive the heartburn drug omeprazole (Prilosec) or a placebo. Everyone took aspirin. In the next 6 months, 109 people died, had a heart attack or stroke, or needed a heart procedure. The rate of these events was slightly lower for people who took Prilosec than for those who got the placebo. About 1.1% of people who took Prilosec developed stomach or intestinal bleeding. The rate was 2.9% for those taking a placebo. The New England Journal of Medicine published the study. HealthDay News wrote about it October 6.

By Robert H. Shmerling, M.D.
Harvard Medical School

What Is the Doctor's Reaction?
Clopidogrel and omeprazole are among the world's most widely prescribed drugs. Clopidogrel (Plavix) is a mild blood thinner. It is the second most commonly prescribed drug worldwide. Omeprazole (Prilosec and others) is used to treat heartburn and stomach ulcers. It's the sixth most commonly prescribed generic drug.
Clopidogrel is typically prescribed along with aspirin. The two drugs together are particularly helpful after heart procedures for narrowed coronary arteries. They can help to prevent blood clots.
Omeprazole is often prescribed for gastroesophageal reflux disease (GERD). This disease is a cause of heartburn. It also can damage the esophagus.
Many people need to take the heartburn drug and the blood thinner together. Doctors often prescribe omeprazole to protect the stomach from ulcers and bleeding that clopidogrel and aspirin may cause.
But recent research has suggested that clopidogrel may not work as well for people who also take omeprazole. If that's true, this common combination could increase the risk of having a heart attack.
New research looks at the risks and benefits of taking these two drugs together. The study included nearly 4,000 people. Everyone in the study took clopidogrel and aspirin for 6 months. In addition, half took omeprazole and half took a placebo.
Here's what the researchers found:

• About 2.9% of those who took a placebo had major stomach problems, including bleeding. Only 1.1% of those taking omeprazole had these problems.
• The rate of heart and artery problems, such as heart attack, was similar for the two groups -- 5.7% of those taking placebo and 4.9% of those taking omeprazole. This suggests that adding omeprazole did not make the blood thinners less effective.
• Side effects were similar in two groups, although diarrhea was more common among those taking omeprazole.

This study did not include as many people as planned because of funding problems. As a result, the researchers could not state for certain that clopidogrel remained just as effective despite the use of omeprazole. A much larger study would be needed to be sure about that conclusion. But the results are encouraging. If confirmed, these findings suggest that taking a drug to prevent stomach bleeding does not make clopidogrel less effective.
What Changes Can I Make Now?
If you've stopped taking omeprazole because of concerns it will make clopidogrel less effective, talk to your doctor. Discuss the results of this study. It may be reasonable to resume omeprazole.
Do what you can to prevent the need for any of these medicines.
To reduce your chances of coronary artery disease:

• Don't smoke.
• Work with your doctor to maintain a normal blood sugar and blood pressure. Take your medicines as prescribed. If you have diabetes or high blood pressure, discuss treatment options with your doctor.
• Exercise regularly.
• See your doctor regularly to monitor your heart health.

To lessen your risk of stomach ulcers or heartburn:

• Limit your use of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. These drugs can be quite effective for pain or fever, but your doctor can tell you about safer alternatives. Take the lowest effective dose for the shortest time possible (as directed by your doctor).
• Wash your hands well before meals and after using the restroom. This may prevent spread of an infection (called H. pylori) involved in some stomach ulcers.
• If you have had an ulcer in the past related to H. pylori, a course of antibiotics may prevent future ulcers.
• Don't smoke.
• Drink less alcohol.

Be sure you understand the reasons for the medicines you take. It's generally obvious why someone is taking clopidogrel. But I've met many people who were taking omeprazole without really knowing why. For some, the drug was started while they were in the hospital and never stopped. For others, it was because they used to take an NSAID, which increases the risk of stomach ulcers. But when the NSAID was stopped, the omeprazole was not.
What Can I Expect Looking to the Future?
For many people, interactions between drugs are more important than the side effects of a single drug. You can expect researchers to continue to study drug interactions and to discover new ones.
But the first step is proving that a possible drug interaction is real. That's why well-designed research like this study is so important.

Young children sleep Positioners pose suffocation risk

The FDA and the Consumer Product Safety Commission (CPSC) are warning against the use of infant positioning products after two recent deaths because of suffocation.
Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD), or flat head syndrome, a deformation caused by pressure on one part of the skull.
The federal government is aware of 12 reports of infant deaths in the last 13 years attributed to the sleep positioners. The Consumer Product Safety Commission has received "dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product," the according to a statement from the FDA.
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep," says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.
FDA pediatric expert Susan Cummins, M.D., M.P.H, says, "The safest crib is a bare crib. Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC's of safe sleep--Alone on the Back in a bare Crib."
Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new information suggests the positioners pose a risk of suffocation. As a result, FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products' benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data.
Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately, agency experts say, adding there's no evidence the devices have benefits that outweigh the risk of suffocation.

Digestive disorder and ulcer treatments

By John Sherman - Kelowna Capital News
Published: September 28, 2010 6:00 PM
Updated: September 30, 2010 8:12 PM

With Thanksgiving not that far away, here are some thoughts on having a well-tuned digestive system in anticipation for that big dinner.
By preparing, I do not mean starve yourself for two weeks so that you have room to gorge out on dinner.
A well-tuned digestive system works better than starvation. Your quality of life depends on it.
Many factors may contribute to digestive disturbances that can cause conditions such as an ulcer or heartburn, sometimes referred to as gastroesophageal reflux disease.
Lifestyle choices such as stress, poor eating habits, alcohol consumption and smoking can contribute to these conditions.
There are many symptoms that indicate heartburn. The most common are “burping up,” regurgitating often during the day, a heavy feeling in the chest or abdomen or a burning feeling in the throat, chest or stomach.
Some of the symptoms that may indicate an ulcer include a burning feeling in the stomach area before, during or after a meal, usually in waves that last several minutes; painful digestion, heartburn and increased acid production indicated by “sour stomach” blackened stools and nausea.
It seems very common for people to take antacids or similar products for relief of stomach pain and upset.
This is definitely not solving any problems. In fact, that solution may actually contribute to the problem.
Other medications that are commonly prescribed for people with gastroesophageal reflux disease are Omeprazole, in a class of drugs called proton pump inhibitors (PPI), which block the production of acid by the stomach.
When stomach acid is blocked, food will sit in your digestive tract and will not digest.
Imagine after months of taking these drugs, what kind of fermenting mass of semi-digested food you would have sitting in your digestive tract. It really is quite scary.
There are other drugs in the same class as Omeprazole including lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esomeprazole (Nexium).
There are many side-effects to these drugs such as diarrhea, nausea, vomiting, headaches, rash and dizziness to name a few.
Homeopathy offers some excellent remedies that can provide relief gently, safely and with no side-effects for many digestive related problems.
If you do have a chronic ongoing complaint, it is probably best to see a homeopath for constitutional treatment.
The following list of remedies is just a sampling of some homeopathic remedies that may help for an acute digestive disturbance:
Nux Vomica: This remedy is indicated for symptoms of digestive upset that include, sour, and bitter burping. It can be accompanied by nausea and vomiting every morning. The person generally will have quite a high-stress lifestyle.
Carbo Vegetabilis: This remedy is indicated when there seems to be a sense of rawness in the stomach that rises up into the esophagus to the middle of the chest. There can be bloating and distention in the stomach.
Arsenicum: With this remedy, the key indications are burning sensations in the stomach with a sense of internal chilliness. The heartburn symptoms will almost feel like the person was just gulping up acid that burns the throat and leaves it raw.
With all the remedies above, start with a 30 CH potency every few hours for a day or two. If this does not provide relief, try the next best remedy.
Homeopathic remedies in acute situations generally work quite rapidly. Homeopaths tend to use the term “susceptibility to disease,” meaning that even though modern science has determined the cause of some diseases, it has not determined or explained how a person becomes susceptible to these conditions in the first place.
You may also want to try digestive enzymes available at your local natural health store.
John G .Sherman is
a professional classical homeopath in Kelowna .

Dr. Siegal cookie diet leads CalciOs

By Allison Cerra

VIENNA, Va. (Sept. 24) Dr. Siegal's Cookie Diet has expanded its offerings to include calcium-fortified cookies designed to treat occasional heartburn.

CalciOs cookies are vanilla-flavored cookies, each one providing 30% of the daily value of dietary calcium, Dr. Siegal's Cookie Diet said. The cookies contain calcium carbonate, designed to treat heartburn relief. CalciOs also are free of artificial colors and preservatives.

Small purple pill is under microscope

'Little purple pill' is under microscope

Heartburn drugs, while effective, might be doing more harm than good.

Dr. Marcus Thygeson once wrote his patients countless prescriptions for heartburn drugs such as Prevacid, Prilosec and Nexium -- the "little purple pills'' of TV ads.
But several months ago, when his own doctor advised him to start taking the pills, he refused. "It was all I could do to get out of the office without a prescription," he said.
The Twin Cities gastroenterologist has come to see the popular pills as a symbol of the excesses of modern medicine -- a powerful medication "handed out like water" in his words, amid mounting evidence that it may do many people more harm than good.
"It's a drug we've become very cavalier about," says Thygeson, president of the Center for Healthcare Innovation at Allina Hospitals & Clinics. "Now it's like front-line therapy if you so much as belch."
The heartburn drugs, known as proton-pump inhibitors (PPIs), are designed to reduce the body's ability to pump acid into the stomach. Today, they are among the nation's best-selling medications, with more than 119 million prescriptions written last year, in addition to over-the-counter sales. Experts have called them a godsend for ailments like acid reflux, a major cause of heartburn.
Yet there's a growing consensus that millions of people are taking the pills needlessly, or far longer than necessary, wasting billions of dollars and in some cases triggering significant side effects.
Some skeptics even dare to ask why so many Americans are taking pills, which can cost up to $200 a month, to control digestive problems that can be tied to their own bad habits, particularly at the dinner table.
"I'm not blaming patients -- it's the path of least resistance," said Dr. Greg Plotnikoff, an internist at Abbott Northwestern's Penny George Institute for Health and Healing in Minneapolis. Fixing the underlying problem, he said, may require losing weight, avoiding certain foods or other lifestyle changes. A pill can seem like an easy alternative.
In the past few years, though, scientists have raised concerns about long-term side effects, such as bone fractures and pneumonia. One study in 2009 even found that the drugs, when stopped abruptly, can cause the very symptoms they were designed to prevent.
The drug manufacturers and some leading experts have disputed those findings. But insurers and doctors alike are starting to have second thoughts.
"When you put a patient on a PPI, you're essentially setting them up to be on it for a lifetime," said Thygeson. "I think we need to back away from those drugs."

Grateful -- at first

Bernice Koniar had every reason to feel grateful when her doctor started her on heartburn medication. She had just learned she had gastroesophageal reflux disease (GERD), a cause of chronic acid indigestion and all-around misery.
And there was nothing more effective for that condition, experts said, than this new class of acid-suppressing drugs.
Actually, they were the second big breakthrough. The first, cimetidine (Tagamet), revolutionized treatment by blocking acid production for short periods.
Then Prilosec, the first proton-pump inhibitor, made its debut in 1989.
"This drug was a miracle," said Dr. Robert Ganz, a Twin Cities gastroenterologist and associate professor at the University of Minnesota. It was remarkably effective for GERD, a condition that causes stomach acid to leak into the esophagus, which in turn can cause burning sensations, nausea and even permanent damage.
In the past, he said, doctors could offer little beyond temporary relief (Tums or Mylanta) or, for severe cases, surgery. "Without this drug, you'd have 20 million people going to surgery," he said. "This drug was one of the great pharmaceutical discoveries ... of all time."
It's now a certified blockbuster, with $13.6 billion in sales last year (more, counting over-the-counter sales).

Heartburn Remedies