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Lozenge
Can Wean Smokers From Nicotine Dependence
A new OTC nicotine replacement therapy called the Commit
Lozenge gives smokers another option in their efforts
to stop smoking. Patients select the dosage-2 mg or 4
mg-based on their "Time To First Cigarette"
(TTFC), a unique indicator that links a smoker's degree
of nicotine dependence to the time he ordinarily smokes
his first cigarette after waking. Using the lozenges to
relieve nicotine cravings, the patient weans himself off
nicotine over 12 weeks.
The
lozenges come with comprehensive instructions and an option
to enroll in a clinically proven computer-tailored behavioral
support program. Patients with heart disease or hypertension
and those taking medication for asthma or depression should
check with their doctor before taking the Commit Lozenge.
GlaxoSmithKline
Consumer Healthcare. "U.S. Food and Drug Administration
approves effective new tool to help smokers quit."
2002. http://commitlozenge.quit.com (5 Nov. 2002).
New
Cholesterol-Lowerer Complements Statins' Actions
The FDA has approved a new cholesterol-reducing agent
with a unique mechanism of action that brings additional
improvements in cholesterol levels over that of a statin
alone.
Ezetimibe
(Zetia) inhibits the intestinal absorption of cholesterol
from food and from bile. It is approved for use as monotherapy
or in combination with statins to lower elevated total
cholesterol, low-density lipoprotein (LDL) cholesterol,
and apolipoprotein B, the major protein component of LDL.
When combined with ongoing statin therapy, ezetimibe provided
a 25% additional reduction in LDL, compared to 4% with
a statin plus placebo; significant improvements in total
cholesterol, high-density lipoprotein (HDL) cholesterol,
and triglycerides were also seen.
The
ezetimibe-statin combination is contraindicated in patients
with active liver disease or unexplained elevations in
serum transaminases, and statins shouldn't be used in
pregnant or nursing women. Elevations in liver enzymes
greater than three times the upper limit of normal occurred
at a higher rate with combination therapy than with a
statin alone (1.3% vs. 0.4%). Liver function tests aren't
required when ezetimibe is used alone, but should be ordered
before and during combination therapy according to the
statin's labeling.
Merck.
"FDA approves Zetia (ezetimibe) for cholesterol reduction."
2002. www.zetia.com/ezetimibe/zetia/consumer/press_release/index.jsp
(5 Nov. 2002).
Report
May Give Moms On Meds Reason To Pause
Researchers seeking to gauge the risks to infants and
children under age 2 from drugs, biologicals, and other
products examined spontaneous reports of adverse events
(AEs) to the FDA's MedWatch between November 1997 and
December 2000.
Of
more than a half million reports, 7,111 involved infants
and children younger than age 2. Drug therapy was associated
with an average of 243 reported deaths annually over the
study period, with 41% occurring during the first month
of life and 84% during the first year. In nearly a quarter
of AE cases, exposure was to a drug the mother was taking
during pregnancy, delivery, or lactation.
The
researchers caution that an AE report doesn't necessarily
mean the drug caused the event. They call for additional
drug testing in the youngest pediatric patients and for
prescribers to carefully weigh the risks and benefits
of medication in mothers during pregnancy and breastfeeding.
Moore,
T. J., Weiss, S. R., et al. "Adverse drug events
in infants and children under 2 years of age." 2002.
www.pediatrics.org/cgi/content/full/110/5/e53 (15 Nov.
2002).
New
Type 2 Diabetes Product: Two Agents, One Pill
A newly approved product combines two existing therapies
for Type 2 diabetes into one pill. As its name suggests,
Avandamet contains rosiglitazone maleate (Avandia) and
metformin HCI (Glucophage). Rosiglitazone helps lower
insulin resistance by making cells more sensitive to the
body's insulin, while metformin reduces the amount of
glucose produced by the liver.
Avandamet
is approved for use in patients already on those two therapies
and for those in whom metformin alone isn't adequate.
Avandamet shouldn't be used with insulin.
Patients
should be monitored for lactic acidosis, which has occurred
in a small number of patients taking metformin, and for
fluid retention, which has occurred with rosiglitazone.
Avandamet should not be used in patients with renal disease
or dysfunction or in those who are being treated for congestive
heart failure. It is not recommended for people with liver
disease or those who drink alcohol excessively. Patients
should be tested for liver function before and while on
Avandamet.
GlaxoSmithKline.
"FDA approves GlaxoSmithKline's Avandamet for the
treatment of type 2 diabetes." 2002. www.gsk.com/media/pressreleases.htm
(15 Oct. 2002).
Drug
Roundup
The Clozaril brand of the antipsychotic drug clozapine
has been approved for treating recurrent suicidal behavior
in patients with schizophrenia or schizoaffective disorder.
Frequent blood monitoring is required due to the risk
of agranulocytosis. * An extended-release formulation
of ciprofloxacin (Cipro XR) received FDA approval for
treating uncomplicated urinary tract infections. The 500
mg tablets are taken once a day for three days.
*
The CDC reports that only 60% of elderly patients received
pneumococcal vaccine in 2001. Significantly lower rates
(40%) were seen in African Americans and Hispanics than
in non-Hispanic whites (64%).
*
There are now 11 reported cases of liver failure "possibly
associated" with the consumption of kava-containing
supplements, according to the CDC. Two cases occurred
in the United States. The herb is derived from Piper methysticum.
Advise patients of this risk and ask those with hepatic
injury about their use of dietary supplements.
Problem
Rx
Should This Patient Continue HRT? Q A 55-year-old woman
has been on hormone replacement therapy (HRT) for several
years for severe menopausal symptoms, including insomnia,
hot flashes, and difficulty concentrating. She doesn't
smoke, but does consume as many as three alcoholic drinks
daily. Her family physician recommends she continue on
HRT, since it appears to have improved her quality of
life. Is this good advice? A No. Over the long term, that
com bination can significantly increase her risk of developing
breast cancer. A recent analysis of data from the Nurses'
Health Study found that women who were currently on postmenopausal
hormone therapy for five years or more and who consumed
20 gm or more of alcohol daily (>1.5 drinks) doubled
their risk of developing breast cancer, compared to those
who didn't drink and never used hormones. This means,
the report says, that a hypothetical patient with a 4%
lifetime risk of breast cancer would raise her risk to
8%. The study also found that each of the two risk factors
alone was associated with about a 30% higher risk of breast
cancer. Thus, this patient should cut down on the number
of drinks and consider alternatives to HRT for her menopausal
symptoms.
Source:
Chen, W. Y., Golditz, G. A., et al. (2002). Use of postmenopausal
hormones, alcohol, and risk for invasive breast cancer.
Ann Intern Med, 137(10), 798.
THE
AUTHOR LINDA M. PORTERFIELD, RN, PhD, is a clinical pharmacologist
and director of cardiovascular research at Arrhythmia
Consultants in Memphis. She works with her husband, James
Porterfield, MD, FACC, who is a cardiologist and electrophysiologist.
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