New drugs/drug news december 2003

DRUG NEWS
NEW DRUGS
Fosamprenavir Calcium
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 Combination Option
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
DRUG NEWS
Name: Dermagraft®
Manufacturer: Advanced Tissue
received fluconazole (Diflucan®, Pfizer), Approval Date: July 7, 2003
rhinitis, and nasal polyps. Both types of Use Classification: Skin, skin sub-
reactions have the potential to be fatal.
that most often led to discontinuation in Description: 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 Purpose: The dressing covers and
ber 2003; www.tap.com; www.prevacid.
Name: Multi-Link Vision™ RX and
Manufacturer: Guidant Corporation,
NEW INDICATION
Voriconazole for
Approval Date: July 16, 2003
losa defect, a group of rare inherited skin Esophageal Candidiasis
Use Classification: Angioplasty,
Pfizer, Inc., has received FDA approval to Description: The Multi-Link Vision™
Precautions: 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- Name: FX miniRail™ RX Percuta-
infections caused by the pathogen Scedo- sporium apiospermum and Fusarium thin, flexible wire-like tube) with a small Manufacturer: Guidant Corporation,
Candida organisms are normally found Purpose: The stents are used to help
unclog the fatty deposits (cholesterol) in Approval date: June 11, 2003
Use Classification: Catheter for
genated blood and adequate blood flow.
Description: 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 Precautions: 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
DRUG NEWS
Purpose: The catheter is used to open
(Source: Ann Pharmacother 2003;37: ularly useful for treating coronary artery Precautions: 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 Precautions: The catheter should not
be used if the narrowing is situated in an DRUG NEWS
Abacavir and Hypersensitivity
work as a result of their depression.
of treatment are significant. Ninety-four Name: Computer-Aided Diagnosis
(e.g., psychotherapy and/or medication).
Manufacturer: Cytyc Corporation,
Approval date: June 6, 2003
Use Classification: Imaging with an
icolaou (Pap test) slides for cervical can- Description: The computer-aided
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
Purpose: The device is designed to
sensitivity, as are hepatic disorders.
Drug-Coated Stents
Vol. 28 No. 12 • December 2003 • P&T® 767
DRUG NEWS
www. fda.gov/cdrh/safety/cypher.html.
tion of the device. A thin polymer coating recent clinical trial was a small study.
slowly released into the patient’s arteries (Sources: JAMA 2003;290(17):2292– Synthetic Cholesterol
Removes Plaque
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
NEW DRUGS
DRUG NEWS
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 Pharmacy 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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