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April
2001
Hormonal
Therapy Recommended for All Hormone-Receptor-Positive Breast
Cancers
In a statement issued late last year, the National Institutes of
Health recommended that all women who have hormone-receptor-positive
breast cancer receive hormonal therapy in addition to their primary
treatment (surgery alone or surgery plus chemotherapy). This recommendation
holds regardless of a woman's age, menopausal status, tumor size,
or whether the cancer has spread to the lymph nodes.
Hormone-receptor-positive cancers grow in response to the hormone
estrogen, which is produced by the ovaries. Tamoxifen (Nolvadex,
Tamoplex), the most widely used hormonal therapy, works by blocking
estrogen receptors on breast cancer cells. It is used to halt, slow,
or prevent tumor growth. Studies have shown that women who take tamoxifen
for five years reduce their annual risk of a recurrence of breast
cancer by 40%. Taking the drug for more than five years offers no
additional advantage, and it increases the risk of toxic effects.
Premenopausal breast cancer patients under the age of 50 reap a significant
benefit from adjuvant tamoxifen therapy. Results from a small study
show that women under 50 who received tamoxifen in addition to chemotherapy
had a 40% reduction in recurrence and a 39% reduction in death compared
with women who had chemotherapy alone. These results are not conclusive,
however, because of the small trial size. A study currently underway
in Canada may provide more reliable results.
Postmenopausal women with very small, low-grade tumors, however,
may experience only a small overall benefit from tamoxifen. After
menopause, women have lower levels of estrogen in their bodies. Studies
have shown that women in this group who undergo chemotherapy but
do not take tamoxifen may live as long as women of the same age with
no history of breast cancer. Because tamoxifen can cause rare, serious
side effects such as blood clotting and endometrial cancer, postmenopausal
women and their physicians should weigh the benefits of taking the
drug against the risks.
May
2001 Update
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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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