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April 2001


Killing H. Pylori Helps Prevent Gastrointestinal Bleeding in Patients Taking Low-Dose Aspirin
Many people take low-dose aspirin on a daily basis to help prevent heart attacks. Others take larger doses of stronger nonsteroidal antiinflammatory drugs (NSAIDs), such as naproxen (Anaprox, Aleve, others), to relieve musculoskeletal pain such as that caused by arthritis. When taken on a regular basis, however, NSAIDs often cause ulcers and gastrointestinal (GI) bleeding. Ulcers, which are raw, crater-like breaks in the mucosal lining of the digestive tract, may also be caused by excess acid production and a bacterium known as Helicobacter pylori (H. pylori).

In a study published in the New England Journal of Medicine, researchers enrolled 400 patients with a history of GI bleeding who were taking aspirin or other NSAIDs to prevent heart disease or to control musculoskeletal pain. They set out to find whether eradicating H. pylori infection reduces the risk of recurrent GI bleeding in these patients. For six months, 250 patients were given an 80 mg "baby" aspirin once per day, while the remaining 150 patients received 500 mg of naproxen twice per day. Within each of the two groups, patients were randomly assigned to take either a daily dose of omeprazole (Prilosec), an acid-suppressing medication, or a one-week antibiotic treatment to eradicate H. pylori infection, followed by placebo for the remainder of the trial.

The researchers found that in patients taking aspirin, those who were treated for H. pylori had a 1.9% risk of GI bleeding while the risk for those taking omeprazole was 0.9%. In other words, for patients on low-dose aspirin, the treatments were almost equal.

The results were very different for patients taking naproxen. 19% of the naproxen patients who had H. pylori treatment suffered from recurrent bleeding. In contrast, only 4% of the omeprazole group did.

The study suggests that patients with a history of GI bleeding who take low-dose aspirin to prevent heart attacks should be tested for H. pylori infection and treated if the infection is found to be present. Patients taking non-aspirin NSAIDs and who have experienced GI bleeding are more likely to benefit from acid-suppressing therapy.
April 2001 Update

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Ipriflavone Not Effective for Osteoporosis
For years, estrogen replacement therapy was the drug of choice for treatment of osteoporosis in postmenopausal women. But the potential risks of HRT sent women searching for alternatives. One option was phytoestrogens — plant-based compounds that bind to estrogen receptors in the body, presumably mimicking the beneficial effects of estrogen without its potential risks. Of the phytoestrogens, the most promising was ipriflavone, a synthetic version of a naturally occurring isoflavone, a type of phytoestrogen.

But a well-designed study published in the March 21, 2001 Journal of the American Medical Association refutes the positive results of previous studies, demonstrating that ipriflavone does not prevent bone loss or reduce the risk of fracture in postmenopausal women. It also cautions that ipriflavone lowers levels of lymphocytes, an effect that could make women more vulnerable to infection.

In the JAMA study, members of the Ipriflavone Multicenter European Fracture Study Group assigned 474 postmenopausal white women with low bone mass aged 45 to 75 to either 200 mg. of ipriflavone taken three times per day or a placebo, for the three-year duration of the trial.

At the end of the trial, the researchers found no significant difference between the treatment groups in regard to bone mineral density measured at the lumbar spine, total hip, and distal radius; in biochemical markers of bone formation or bone resorption; or in the number of vertebral fractures suffered by the women.

The major difference was that women treated with ipriflavone experienced significant drops in their lymphocyte concentration. 13.2% of the ipriflavone-treated women developed lymphocytopenia, a condition defined as a total lymphocyte concentration below 500/µL. Of these women, 52% returned to normal lymphocyte values within one year of discontinuation of the drug; 81% returned to normal within two years.

In reviewing their findings, the researchers cautioned against the use of ipriflavone to treat osteoporosis.

Women throughout much of the world have used ipriflavone since 1969 to treat osteoporosis. More recently it has been sold over-the-counter in the United States as Ostovone.
April 2001 Update

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Early Cognitive Impairment Following Coronary Bypass May Predict Lasting Cognitive Impairment
More than 500,000 coronary-artery bypass grafting (CABG) surgical procedures are performed in the United States each year to bypass blood around clogged arteries and improve the flow of blood and oxygen to the heart. Advances in anesthesia, surgical procedure, and other areas have made CABG a relatively safe procedure for an expanding group of heart disease patients including older and other high-risk patients. But while the risk of death after CABG has decreased, the risk of cognitive impairment has not. Growing evidence suggests that many patients experience short-term cognitive impairment after CABG.

A recent study in the New England Journal of Medicine confirmed not only the high incidence but also the persistence of cognitive decline following the procedure. It also showed that patients who exhibit signs of cognitive decline immediately following surgery are more likely to continue to suffer from cognitive decline at up to five years after surgery.
Researchers from Duke University Medical Center tested the cognitive function of 261 patients before they underwent CABG surgery, and then again before discharge from the hospital and at six weeks, six months, and five years after the CABG procedure. 172 patients, whose average age was 61, completed all of the follow-up.

The researchers found that the incidence of cognitive decline was 53% at discharge, 36% at six weeks, 24% at six months, and 42% at five years. The pattern demonstrated improvement of cognitive functioning within the first six months, and then a decline between six months and five years after surgery.

Even after controlling for age, education level, and baseline test score, patients who experienced cognitive decline immediately following surgery were at a significantly increased risk for long-term cognitive decline and a reduced level of overall cognitive functioning.

It remains unclear why early, postsurgical cognitive decline is associated with a greater risk of long-term cognitive decline.
April 2001 Update

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Sertraline Effectively Treats Depression in Alzheimer's Patients
A large portion of the 4 million Americans with Alzheimer's disease (AD) — a progressive degenerative disease of the brain that results in memory loss, impaired thinking, and personality change — also suffer from major depression. This can make the already devastating condition even more difficult, not only for patients, but also for their caregivers. Until recently, the efficacy of antidepressants in such patients was uncertain. Now, a study from The American Journal of Psychiatry shows that sertraline (Zoloft) a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI) is more effective than placebo in reducing depression in patients with AD. This study is the first to show both the efficacy and safety of an SSRI in treating depression in patients with AD.

A team of researchers from the Johns Hopkins University School of Medicine and the Copper Ridge Institute in Maryland selected 22 patients with Alzheimer's disease who also met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for having had a major depressive episode. Over the course of the 12 week double-blind trial, the scientists gave the patients, whose average age was 77, either a placebo or up to 150 milligrams of sertraline per day. All patients and caregivers received illness education, encouragement, and emotional support every three weeks over the course of treatment.

The scientists found that AD patients who had been given sertraline experienced significantly greater improvements in mood than patients who received a placebo. In addition, the sertraline patients experienced less decline than placebo patients in the participation of daily activities.

Side effects of the drug included tremor, restlessness, and gastrointestinal complaints. But all were mild, and there was no significant difference in side effects between the sertraline group and the placebo group.
April 2001 Update

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Warfarin and Vaginal Cream Drug Interaction Warning
The Food and Drug Administration (FDA) has issued a warning stating that women taking the prescription blood thinner warfarin (Coumadin) should consult their doctor or pharmacist before using over-the-counter vaginal creams containing the antifungal drug miconazole because of an increased risk of bleeding or bruising. Miconazole is an active ingredient in many over-the-counter creams and suppositories used to treat vaginal yeast infections.

Doctors were already aware of adverse reactions between warfarin and systemically administered miconazole. This warning urges women to beware of creams and suppositories as well.

The warning was issued in response to two reports of abnormal blood clotting tests in women taking the anticoagulant warfarin who used vaginal miconazole. In addition to the abnormal blood-clotting test, one of the two women also developed bruises, bleeding gums, and a nosebleed. Two journal articles also warned of a possible interaction between warfarin and vaginal miconazole.

The FDA warning will appear on miconazole-containing product labels and consumer brochures.
April 2001 Update

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