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February
2001
FDA
Approves
Weekly
Dose
of Fosamax
(alendronate)
for Osteoporosis
Treatment
and Prevention
The
FDA recently approved once-a-week doses of Fosamax (alendronate)
for the prevention and treatment of osteoporosis. The weekly
dose for prevention is 35 mg while the weekly dose for treatment
is 70 mg. Fosamax, which was already approved for once-a-day
use, works by slowing bone loss.
The main advantage of the once-a-week version is convenience.
Doctors recommend that Fosamax be taken first thing in the
morning, on an empty stomach, approximately 30 minutes before
breakfast, and that patients not lie down for at least 30 minutes
after taking the medication. Patients may find that they prefer
to adhere to this routine only once a week, rather than every
day.
FDA approval was based largely on a two-year clinical trial
that showed that for postmenopausal women, a weekly 70 mg dose
of alendronate was just as effective at increasing bone mineral
density as a 10 mg daily dose. The study included 1,258 postmenopausal
women with a mean age of 67. The once-weekly alendronate dose
was effective regardless of the women’s underlying condition,
age, bone mineral density (BMD), or pre-existing fractures.
Compared with the daily dose, 70 mg of alendronate once a week
was better tolerated and produced fewer serious upper gastrointestinal
and esophageal problems. The weekly dose also produced similar
gains in bone mineral density at the lumbar spine, total hip,
femoral neck, hip and total body sites.
February
2001 Update
Meningococcal
Disease Prevention for College Students
Meningococcal disease is an inflammation of the membranes that encase
and protect the brain and spinal cord. When caused by a bacterial
infection, meningococcal disease can be fatal. Survivors can suffer
significant lifelong impairments, including permanent brain damage
or hearing loss.
In recent years, the incidence of meningococcal disease has been
on the rise in 15- to 24-year-olds in the United States. And the
Centers for Disease Control and Prevention (CDC) has revealed that
U.S. college students living in a dormitory setting are more than
three times as likely to contract meningococcal disease than those
in the same age group who do not live in a dormitory setting. Freshmen
face the greatest risk.
Sixty percent or more of these cases could be prevented with an existing,
available vaccine. Adverse reactions to the vaccine have been shown
to be mild, and serious reactions are rare. Based on findings from
recent studies and on input from expert committees, the American
Academy of Pediatrics advises physicians to inform college-bound
patients who intend to live in a dormitory of the increased risk
for meningococcal disease and of the benefits and limitations of
the vaccine. Physicians are also advised to make the vaccine available
to those patients who then request it.
U.S. military recruits have been routinely vaccinated against meningococcal
disease since 1971, in response to a high incidence of the disease
in that population.
February 2001 Update
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to Top
Treating
Chronic Hepatitis C
An estimated 3.9 million people in the United States are infected
with the hepatitis C virus (HCV). Hepatitis C affects the liver.
In many — but
not all — cases,
hepatitis C progresses from mild to moderate inflammation (hepatitis),
to scarring (fibrosis), to severe fibrosis with loss of liver
function (cirrhosis), and finally liver failure. It is the leading
cause of chronic liver disease and liver transplantation. But
not all cases of hepatitis C progress to cirrhosis and the rate
of progression of the disease is often unpredictable.
The standard of care for treating hepatitis C is a combination
of the antiviral drugs interferon-alpha and ribavirin. However,
these drugs are not completely effective, they cause side effects,
and they are expensive. Given the drugs' limitations and the
unpredictable nature of disease progression, doctors remain in
disagreement about whether treatment should begin at the onset
of mild inflammation, or whether it should be delayed until a
moderate amount of inflammation or cirrhosis exists.
Using information from recent studies about the natural progression
of HCV, researchers created a computer model that would help
determine the optimal time to start combination antiviral drug
therapy with interferon-alpha and ribavirin. The simulation projected
that 18 percent of patients who had a liver biopsy every three
years and started treatment at the onset of moderate inflammation
would progress to cirrhosis after 20 years. This strategy avoided
the need for treatment in 50 percent of patients, and increased
life expectancy by 1.2 years. In patients who began treatment
at the onset of mild inflammation, only 16 percent would progress
to cirrhosis after 20 years, increasing life expectancy by another
0.4 years. In comparison, the computer model predicted that 27
percent of patients in the control group, which was left untreated,
would have cirrhosis after 20 years.
This study illustrated that beginning antiviral treatment at
the onset of mild inflammation is the most effective treatment
strategy. However, for patients with HCV and mild inflammation
of the liver who do not wish to receive drug treatment or hope
to delay it, biopsy management is also a reasonably effective
option that could avoid treatment altogether.
A
Promising New Drug: Peginterferon
In January 2001,
the FDA approved Peg-Intron (peginterferon) to treat hepatitis
C. Peginterferon is a form of interferon-alpha that stays active
in the immune system longer than interferon-alpha. As a result,
it can be taken once a week, as opposed to three times a week.
Two recent studies published in the New England Journal
of Medicine compared the effects of another brand of peginterferon,
called Pegasys, with interferon-alpha on patients with chronic
hepatitis C. Both studies revealed that peginterferon is significantly
more effective in managing the virus. It was also better tolerated
and had fewer side effects.
In the clinic, interferon-alpha is usually given in combination
with ribavirin, which has been shown to double the effectiveness
of interferon-alpha. Researchers regard testing a combination
of peginterferon and ribavirin the next logical step in determining
how to treat this disease more successfully.
February 2001 Update
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