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New drugs/drug news december 2003
these trials, ED was associated with dia-
for HIV Infection
pills. Easily affixed to the skin, Climara
anticipated sexual activity. A higher dose
new protease inhibitor (PI) for the treat-
diol. Estradiol is the most active estrogen
with other antiretroviral medications.
necessary for patients taking other medi-
cations or having medical conditions that
tablets twice daily, as two 700-mg tablets
may decrease the body’s ability to metab-
once a day, or as one 700-mg tablet twice
used with nitrates (such as nitroglycerin
lower blood pressure and lead to fainting
for Patients with Arthritis
with PIs. Patients receiving antiretroviral
tion or accumulation of body fat, includ-
enlargement (“buffalo hump”), peripheral
Third Drug Approved
for Erectile Dysfunction
associated gastric ulcers in patients with
(Cialis®, Eli Lilly), an oral medication to
Low-Dose Hormonal Patch
treat erectile dysfunction (ED) in men.
for Menopausal Symptoms
stomach’s ability to protect itself from
for ED do. It acts by relaxing muscles in
translucent patch is the first once-weekly
syn® tablets of either 375 mg or 500 mg.
ized, placebo-controlled trials involving
Vol. 28 No. 12 • December 2003 • P&T® 765
received fluconazole (Diflucan®, Pfizer),
July 7, 2003
rhinitis, and nasal polyps. Both types of
: Skin, skin sub-
reactions have the potential to be fatal.
that most often led to discontinuation in
Dermagraft® is a der-
clinical trials were elevated liver-function
test results, rash, and visual disturbances.
living human cells known as fibroblasts.
ulceration, or perforation can occur with
NEW MEDICAL DEVICES
By Marvin M. Goldenberg, PhD, RPh, MS
The dressing covers and
ber 2003; www.tap.com; www.prevacid.
Multi-Link Vision™ RX and
July 16, 2003
losa defect, a group of rare inherited skin
Pfizer, Inc., has received FDA approval to
The Multi-Link Vision™
Dermagraft® is not
the treatment of esophageal candidiasis.
indicated for patients with an allergy to
that show signs of clinical infection.
L-605 cobalt–chromium alloy. The deliv-
FX miniRail™ RX Percuta-
infections caused by the pathogen Scedo-
thin, flexible wire-like tube) with a small
organisms are normally found
The stents are used to help
unclog the fatty deposits (cholesterol) in
June 11, 2003
genated blood and adequate blood flow.
The miniRail™ PTCA
Angioplasty and the implantation of stents
catheter is a flexible tube that contains an
are used as alternatives to medical therapy
inflatable balloon and external stainless
or to bypass surgery. The stent is designed
steel wires. The balloon is attached to a
to stay in place permanently, holding the
end is inserted into a small opening in an
The stent is not indi-
over a guide wire to the area of the block-
the mouth, resulting in pain and difficulty
is inflated, and this causes it to push the
for patients who have a lesion that might
wires into the arterial plaque. The plaque
mised patients conducted in 15 countries,
766 P&T® • December 2003 • Vol. 28 No. 12
The catheter is used to open
(Source: Ann Pharmacother
ularly useful for treating coronary artery
: Health care workers
Women and Depression
application of a coronary stent and block-
in the Workplace
ages that are expected to be resistant to
that the slides are oriented correctly. Par-
external wire. It is anticipated that the
tion, decrease chest pain, and reduce the
risk of a heart attack, stroke, and other
events often experienced by patients with
The catheter should not
be used if the narrowing is situated in an
Abacavir and Hypersensitivity
work as a result of their depression.
of treatment are significant. Ninety-four
(e.g., psychotherapy and/or medication).
: June 6, 2003
Imaging with an
icolaou (Pap test) slides for cervical can-
not cover the costs, or worries that they
microscope slide and identifies 22 fields
of view containing the cells that are most
their delay to the stigma of depression or
likely to be diagnostically relevant. Using
cells are observed, the result is consid-
ered “negative” and no further review is
the entire slide should be reviewed.
Adverse Reactions with
The device is designed to
sensitivity, as are hepatic disorders.
Vol. 28 No. 12 • December 2003 • P&T® 767
tion of the device. A thin polymer coating
recent clinical trial was a small study.
slowly released into the patient’s arteries
from Coronary Arteries
Valsartan Saves Lives
After Heart Attacks
On the basis of positive results from the
“good,” cholesterol) can remove signifi-
ring one to 30 days after the procedure.
cant amounts of plaque from the arteries.
In more than 60 of these reports, the use
ticals plans to file for a new indication for
cardiovascular agent ever shown in a rig-
orous head-to-head trial to have all of the
possible hypersensitivity reactions.
heart disease, but these people did not.
attack, or myocardial infarction (MI).
tory alterations, hives, itching, fever, and
that they had a variant in a protein known
city of Milan, where the initial laboratory
protection, tolerability, antihypertensive
hypersensitivity reactions occurring with
apy. It is estimated that valsartan might
be able to save 30,000 lives in the U.S.
sclerosis have focused on lowering levels
tinue to follow their regularly scheduled
ventricular systolic dysfunction. Patients
ground” therapy, including aspirin, cho-
safety and effectiveness of the stents and
IV infusion for a total of five weeks.
fit of captopril by reducing mortality rates
to look for rare side effects. Doctors and
768 P&T® • December 2003 • Vol. 28 No. 12
ment. This finding translates into a 25% reduction in pre-
mature death by valsartan in patients at high risk after an MI.
Pregnant women should not take valsartan, and patients with
hear t failure should not take it concomitantly with ACE
Because of the risk of hypotension, caution should be
observed for post-MI patients and patients with heart failure.
Patient evaluations should always include a renal assessment.
The most common side effects in patients with heart failure
were dizziness, hypotension, and diarrhea.
(Sources: N Engl J Med
2003; 349:1893–1906; Managed Care
2003;9:424–429; Novartis, news release, November
High-Dose Lipitor® Halts Plaque Buildup
According to findings presented at the annual meeting of the
American Heart Association, patients taking the cholesterol-
lowering medication atorvastatin calcium (Lipitor®, Pfizer)
experienced a greater reduction in the progression of athero-
sclerosis than did patients taking pravastatin (Pravachol®,
The Reversing Atherosclerosis with Aggressive Lipid Low-
ering (REVERSAL) study included 502 patients who had coro-
nar y heart disease and required cardiac catheterization.
Patients had at least one arterial vessel with 20% or more
constriction causing a buildup of plaque. The investigators
compared the effectiveness of atorvastatin (80 mg/day) and
The average low-density lipoprotein-cholesterol (LDL-C, or
“bad” cholesterol) levels of the patients at the beginning of the
study were 150 mg/dl (accepted guidelines recommend levels
below 100 mg/dl). Before enrollment, patients were not taking
any medications to treat cholesterol and they had other heart
disease risk factors, such as a histor y of diabetes, hyper-
tension, or a previous heart attack.
It was theorized that atorvastatin might have had a greater
impact on C-reactive protein (CRP), an indicator of inflammation
and an independent risk factor for cardiovascular disease.
Patients taking atorvastatin experienced a 36.4% reduction in
CRP; patients taking pravastatin experienced a 5.2% reduction.
Of the patients taking atorvastatin, 97% reached their rec-
ommended LDL-C goals; in contrast, 67% of the patients taking
pravastatin reached their target goals.
(Sources: Dow Jones Business News online at http://
biz.yahoo.com; Pfizer news release, November 12, 2003.)
782 P&T® • December 2003 • Vol. 28 No. 12
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