|
Archives
2003
June
May
April
March
February
January
2002
December
November
October
September
August
July
June
May
April
March
February
January
|
Two
New Cancer Agents Receive Accelerated Approval
Following accelerated review by the FDA, two new cancer
agents have been approved as third-line agents. Bortezomib
(Velcade) is the first in a new drug class that blocks
the activity of enzymes known as proteasomes, which are
involved in regulating cell function and growth. Bortezomib
is indicated for treating multiple myeloma in patients
who have received two prior therapies and experienced
progression of disease on the last treatment. In this
difficult-to-treat stage of disease, bortezomib produced
a partial or complete response in 28% of patients; nearly
18% had clinical remission. Among its side effects, asthenia,
nausea, and diarrhea have each affected 50% or more of
patients. The second new drug-gefitinib (Iressa)-is approved
as third-line monotherapy for patients with locally advanced
or metastatic non-small-cell lung cancer after failure
of both platinum-based and docetaxel (Taxotere) chemotherapies.
In studies, gefitinib shrunk tumors by >50% in 10%
of patients in whom those other agents hadn't been successful.
Gefitinib blocks several tyrosine kinase enzymes that
are part of the pathway that stimulates growth in cells.
U.S.
Food and Drug Administration. "FDA approves Velcade
for multiple myeloma treatment." 2003. www.fda.gov/bbs/topics/news/2003/new00905.html
(14 May 2003). U.S. Food and Drug Administration. "FDA
approves new type of drug for lung cancer." 2003.
www.fda.gov/bbs/topics/NEWS/2003/NEW00901.html (14 May
2003).
More
At-Risk Patients Can Now Take Advantage Of Zocor
The FDA has expanded the approved uses
for simvastatin (Zocor), based on results of a study involving
20,536 patients. The trial showed that the statin not
only protected patients who were at high risk of coronary
events because they had existing coronary heart disease
(CHD), but it also protected those with diabetes, peripheral
vessel disease, and those with a history of stroke or
other cerebrovascular disease. As a result, simvastatin,
which had already been approved for reducing the risk
of cardiovascular events and death for patients with CHD,
can now be used by a broader group of patients. In the
trial, patients took simvastatin 40 mg/day and were followed
for an average of five years. Compared with placebo, the
statin significantly reduced the risk of nonfatal MI and
stroke, death from CHD, and the need for coronary and
non-coronary revascularization procedures such as bypass
surgery and angioplasty. These benefits were seen across
all subgroups regardless of age, sex, or baseline cholesterol
level. U. S. Food and Drug Administration.
"FDA
announces labeling changes on heart benefit associated
with cholesterol drug Zocor." 2003. www.fda.gov/bbs/topics/answers/2003/ans01213.html
(17 Apr. 2003). Merck &. Co. "FDA approves Zocor
40 mg as starting dose for people at high risk of coronary
events because of coronary heart disease or diabetes."
2003. www.merck.com/newsroom/press_releases/041703.html
(28 Apr. 2003).
Serevent
Study Halted Midway To Probe Risks In Subgroups
A large study to investigate whether salmeterol xinafoate
(Serevent) might cause rare serious asthma-related adverse
events was halted by GlaxoSmithKline (GSK). In an interim
analysis, researchers found a small but statistically
significant increased risk of life-threatening and fatal
asthma-related events in African-American patients (<1%),
who had more severe disease at baseline. The number of
asthma-related deaths was higher in those not taking inhaled
corticosteroids as part of their usual therapy. No conclusions
about causality have been drawn. A new study is under
discussion to evaluate these risks further. Based on the
available data, the FDA indicated that the drug's benefits
continue to outweigh the risk and reiterated that the
drug shouldn't be stopped abruptly. Labeling for salmeterol
also cautions that it shouldn't be used in patients with
significantly worsening asthma, that it's not meant for
acute attacks, and that corticosteroid therapy shouldn't
be stopped or reduced when salmeterol is started. Salmeterol
is used in two other GSK asthma products: Serevent Diskus
and Advair Diskus.
U.S.
Food and Drug Administration. "Study of asthma drug
halted." 2003. www.fda.gov/bbs/topics/answers/2003/ans01192.html
(24 Jan. 2003). GlaxoSmithKline. "GSK announces interim
US Serevent study results." 2003. www.gsk.com/press_archive/press2003/press_01232003.htm
(27 Jan. 2003).
Study
Finds 10% Rise In Bugs Resistant To Cipro
A study tracking the emergence of resistance among gram-negative
aerobic bacteria between 1994 and 2000 found an increase
in bacteria isolates resistant to ciprofloxacin HCl (Cipro).
The trend corresponds to an increased use during the same
period of fluoroquinolones, a class of drugs that includes
ciprofloxacin, levofloxacin (Levaquin) and ofloxacin (Floxin).
A total of 35,790 isolates from patients in ICUs across
the country were tested for susceptibility to antimicrobial
agents from 1994 - 2000. The activity of most agents against
the isolates showed a decrease of 6% or less. The "most
alarming trend," however, was that susceptibility
to ciprofloxacin dropped from 86% to 76% during the study
period. Researchers also noted that ciprofloxacin resistance
was tied to a cross-resistance to other broad-spectrum
antibiotics.
Neuhauser,
M. M., Weinstein, R. A., et al. (2003.) Antibiotic resistance
among gram-negative bacilli in US intensive care units.
Implications for fluoroquinolone use. JAMA, 289(7), 885.
Drug
Roundup
*Rosiglitazone maleate (Avandia) is now approved for use
in combination with insulin for treating Type 2 diabetes.
Patients will need to be monitored for edema and symptoms
of heart failure or other adverse cardiovascular events.
*Four weekly doses of an experimental agent called TNX-901
protected patients with peanut allergy. The patients'
tolerance rose from about half a peanut to nearly nine
peanuts.
*The Pharmaceutical Research and Manufacturers of America
has launched Help ingPatients.org, a "one-stop"
link to patient assistance programs. Visit the Web site
or call (800) 762-4636 for a directory of programs.
*The FDA has approved a 625 mg formulation of the HIV
treatment nelfinavir mesylate (Viracept). The new formulation
of the protease inhibitor demonstrated greater bioavailability
than the 250 mg tablets. Its approval reduces the regimen
from five to two tablets twice daily.
OTC
Talk
There's Plenty Of Help For Kicking That Habit Patients
who want to stop smoking need a good deal of encouragement-and
perhaps some prodding-to quit for good. As a nurse, you
can make them aware of drug therapies that may help. Several
OTC nicotine replacement therapies (NRTs) are available:
a nicotine lozenge (Commit Lozenge), nicotine polacrilex
gum (Nicorette Gum), and nicotine transdermal systems,
or patches (Nicoderm CQ, Nicotrol, others). These products
come in different strengths to enable patients to wean
themselves gradually from nicotine. The patches deliver
a relatively consistent amount of nicotine throughout
the day. The gum and lozenge formulations provide patients
with a bolus of nicotine, designed to mimic what they'd
get from a cigarette. As drugs, these products do have
risks, so patients should consult with their healthcare
provider before using them. Nicotine toxicity is one obvious
concern; patients shouldn't start smoking while on NRT,
and they should never combine such products unless a provider
directs them to. If the OTC products aren't helpful, there
are prescription NRTs, such as the Nicotrol Nasal Spray
and Nicotrol Inhaler. Zyban, a version of the antidepressant
bupropion HCl, is a non-nicotine aid to smoking cessation.
For a useful clinician action plan for treating tobacco
dependence, visit www.surgeongeneral.gov/tobacco/tobaqrg.htm#findings.
Centers for Disease Control and Prevention.
"Tobacco
information and prevention source (TIPS). You can quit
smoking consumer guide." 2003. www.cdc.gov/tobacco/quit/canquit.htm
(22 May 2003). THE AUTHOR JAMES M. WOOTEN, a member of
the RN editorial board, is an assistant professor of medicine
at the University of Missouri School of Medicine, in Kansas
City, Mo.
|
