|
|
|
November
2000
Lung
Volume Reduction Surgery for Patients with Severe Emphysema
In recent years,
thousands of patients with severe emphysema have undergone lung
volume reduction surgery even though private insurers and governmental
organizations have questioned the benefits of the treatment. Physicians
believe, however, that removal of the most damaged areas of the
lung allows the rest of the lung to work more efficiently. Now,
the results of a clinical study confirm the benefits of the treatment.
The study, performed in the U.K., involved 48 patients with severe
emphysema who received either a continuation of medical treatment
or the lung volume reduction surgery. After six months, most
patients in the surgical group showed improvements in the amount
of air they were able to exhale in one second (called the forced
expiratory volume, FEV1). In contrast,
the FEV1 of patients in the standard medical
treatment group dropped. Most patients in the surgical group
also performed better on a walking test and scored higher on
a quality-of-life questionnaire than they had prior to treatment.
Patients in the medical treatment group, on the other hand, experienced
declining health, as witnessed by lower scores on both the walking
test and quality-of-life questionnaire.
Deaths occurred in both treatment groups, five among the group
receiving the surgical treatment and three in the medical-care
only group. The researchers believe this relatively high mortality
was a result of inexperience of the surgical team and severity
of the patients’ emphysema. In any case, because of the
small number of patients in the trial, investigators could not
draw any conclusions on whether surgery reduces the number of
deaths from emphysema. A larger United States study, which is
now underway may answer this question and might offer insight
into which patients benefit most from surgery.
Back
to Top
Important
Information on Lotronex
In February 2000, the Food and Drug Administration
approved Lotronex (alosetron), a new medication for women suffering
from diarrhea-predominant irritable bowel syndrome. Since the
drug’s approval, the FDA has received seven reports of severe
complications in women taking this drug. Of these patients six
required hospitalization and one required surgery. During this
same period, an additional eight patients taking the Lotronex
were stricken with ischemic colitis. Ischemic colitis is a serious
condition in which blood supply to the colon is compromised.
The colon may become damaged by severe inflammation and ulceration
of the lining of the intestine. Ischemic colitis may require
hospitalization and possibly surgery.
These reports prompted the FDA to add important safety information
to the labeling and patient inserts for Lotronex. This information
highlights the risk of serious complications and emphasizes what
patients should do if symptoms of such problems arise. If you
are considering this medication or currently take Lotronex, here
is what you should know.
Treatment with Lotronex should not be started when a woman
is constipated. Patients who have any of the following medical
issues should not take Lotronex: a history of chronic
constipation or severe complications from constipation; a history
of intestinal obstruction, stricture, toxic megacolon, gastrointestinal
perforation and/or adhesions; history of ischemic colitis; active
diverticulitis; or current (or history of) Crohn's disease or
ulcerative colitis. Women with these medical problems are at
higher risk of developing severe complications from Lotronex.
If you take Lotronex and develop constipation, call your doctor
right away. If you develop severe constipation or worsening constipation
with increasing abdominal discomfort, stop taking Lotronex until
you get to speak with your physician and do not re-start the
medication until you clear it with you doctor. Ischemic colitis
is one of the most serious adverse effects of Lotronex. Stop
taking Lotronex and call your doctor right away if you develop
any of these signs of ischemic colitis: new or worsening abdominal
pain; bloody diarrhea or bloody bowel movements. (11.03.00)
Back
to Top
Cholesterol-Lowing
Drugs for.Osteoporosis?
As we age,
our bones tend to become less dense (that is, more porous and
prone to fracture) — a
condition known as osteoporosis. Typically thought of as a problem
for post-menopausal women, men also suffer fractures due to osteoporosis.
As a result, roughly 1.5 million Americans each year will have
to endure the pain and inconvenience of a broken bone — often
the hip, the wrist, or vertebra. It is hopeful news then, that
the class of cholesterol-lowering drugs called "statins" may
also provide some protection against the weakening of bones.
By analyzing data on 6,110 women in New Jersey, most of
whom were over age 75, researchers discovered that those
patients who had used a statin were 50% less likely to
experience a hip fracture — even
when investigators adjusted for the presence of other diseases
or conditions (including diabetes, cancer, high blood pressure,
and congestive heart failure). The chances of breaking
a hip were lower still when statin use was current. Use
of non-statin drugs to lower cholesterol was not associated
with a similar protective effect on the bones. Another
study, conducted in Britain, showed that statins seem to
help the body increase bone mineral density at the hip,
which in turn lowers a person's risk for hip fracture,
and that this benefit accrues even after only a few weeks
or months of statin use.
The likely reason that statins benefit bones as well
as cholesterol levels is that these drugs act upon a
series of chemical reactions called the "mevalonate
pathway." Mevalonate is necessary for the body to
produce cholesterol, but it is also involved in bone
formation and resorption. Right now researchers think
that this discovery may lead the way to additional (and
possibly better) medications to treat or prevent osteoporosis.
While people who do not need to take medication for high
cholesterol should not rush to the doctor to ask for
a statin, those who already take these medications should
take comfort in knowing that they may be getting double
benefits from their daily dose.
Back
to Top
Benefits
of COX-2 Inhibitors for Familial Adenomatous Polyposis
Familial adenomatous polyposis (FAP) is a condition
in which an inherited mutation in the APC (adenomatous polyposis
coli) gene results in the formation of multiple polyps in
the mucous membrane of the large intestine. As early as puberty,
hundreds of polyps may be evident in people with FAP and
the presence of these growths practically ensures that these
individuals will develop colon cancer. The risk is so close
to 100% that many FAP patients have their large intestines
removed (colectomy) to protect them from this very serious
diagnosis.
The enzyme cyclooxygenase-2 appears to play a role in the growth
of polyps. It makes sense then, that researchers would be interested
in seeing whether COX-2 inhibitors — a
new class of nonsteroidal antiiflammatory medication that suppresses
cyclooxygenase-2 - might provide some protection against colon
cancer. In fact, data from a study conducted at the M.D. Anderson
Cancer Center (Houston, TX) and St. Mark's Hospital (London)
suggest that 400 mg of the COX-2 inhibitor celecoxib (Celebrex),
taken twice daily can suppress colorectal adenomas in people
with familial adenomatous polyposis.
Researchers studied 77 FAP patients between the ages of 18
and 65 years old. At the start of the trial, these volunteers
were tested for the APC gene mutation and also underwent endoscopy.
During the procedure, physicians identified areas of the rectum
and/or colon with a high density of polyps so they could compare
the degree of polyposis before and after treatment with celecoxib.
Investigators then randomly assigned the study subjects to
one of three protocols: 1) 400 mg of celecoxib twice daily,
2) 100 mg of celecoxib twice daily, or 3) placebo. The three
groups were followed for six months. Fifty-three percent of
the individuals taking 400 mg of celecoxib experienced a 25%
or more reduction of the average number of colorectal polyps.
Only 31% of patients taking the 100 mg dose (and a mere 7%
of the placebo group) showed a comparable benefit. In addition,
the 400 mg group experienced significant improvement in polyposis
throughout the large intestine (including the rectum, ascending
colon, and cecum, and in the transverse descending, and sigmoid
colon). The patients in the 100 mg group and placebo group
did not show similar improvement.
Right now it is unclear whether prolonged treatment with celecoxib,
or a medication like it, could limit the extent of polyps,
replace or delay the need for colectomy, or perhaps keep polyps
from becoming cancerous. However, this data suggest that celecoxib
could be used along with current treatments to suppress the
formation of polyps in patients who are waiting to undergo
surgical removal of the intestine and in cases where the rectum
is not removed along with the colon.
Back
to Top
New
Treatment for "Wet" Age-Related Macular Degeneration
The U.S.
Food and Drug Administration (FDA) has recently approved verteporfin
(Visudyne) for the treatment of age-related macular degeneration.
Verteporfin is used to treat the "wet" (or "classic")
form of this disease in which well-defined blood vessels proliferate
beneath the retina. These vessels leak blood and fluid, which
causes scarring and loss of vision in the center of the eye.
Peripheral vision remains unimpaired. Affected individuals experience
a sudden worsening and distortion of their central vision and
may become legally blind within a few weeks or months of the
time symptoms first appear. Only 10% of age-related macular degeneration
cases are of this type.
The new treatment is applied in two stages. First, verteporfin,
a photosensitive dye, is injected intravenously into the bloodstream
over a 10-minute period. The dye is picked up by the abnormal
blood vessels behind the retina. The physician then directs
a "cold" laser into the eye. This activitates the
dye and triggers clotting and constriction of the abnormal
blood vessels without damaging the retina. In many people,
the effects of this therapy last only a few months, but the
procedure can be repeated every three months if necessary.
In a recent clinical trial comparing treatment with verteporfin
to treatment with a sugar-water solution (placebo) and the
same phototherapy, the patients treated with verteporfin had
significantly better outcomes than those treated with placebo.
At the 12-month follow-up visit, 61% of the verteporfin group
had lost fewer than three lines of vision compared with 46%
of the placebo group. The benefit was even greater for those
with the purely "classic" form of the disease - 77%
of the verteporfin group versus 27% of the placebo group. No
benefit was seen in members of the verteporfin group who did
not have primarily "classic"
macular degeneration.
Side effects of verteporfin treatment include headache, visual
disturbances, injection site reactions, and infusion-related
low back pain. A small percentage of patients (1%-4%) experienced
severe vision loss within a week after treatment, but this
loss of vision was not always permanent. Patients who undergo
this therapy must avoid exposing their eyes and skin to direct
sunlight or bright light indoors for five days so as not to
activate any traces of verteporfin still in the bloodstream.
Back
to Top
|
