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2003
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New
Drug Regimen Packs Powerful One-Two Punch
In a randomized, double-blind placebo-controlled trial involving
5,187 postmenopausal women, letrozole (Femara) was found to reduce
overall breast cancer recurrence by 43% in women who had previously
been treated with tamoxifen citrate (Nolvadex; Tamofen). There was
also a 46% reduction in contralateral disease. The trial participants,
whose cancer had been diagnosed and treated at an early stage, had
completed five years of postsurgical therapy with tamoxifen. A five-year
tamoxifen regimen reduces the risk of recurrence by 47% and reduces
the risk of death by 26%. But it is not beneficial beyond five years
of treatment. The participants in the letrozole trial were set to
receive 2.5 mg of the drug or a placebo once daily for five years.
But because of the positive results, the trial was terminated after
nearly 21ž2 years so that patients taking the placebo could
be offered letrozole. Participants experienced minimal side effects.
However, there were new diagnoses of osteoporosis in 5.8% of the
women taking letrozole compared with 4.5% in the placebo group.
Because the study ended sooner than scheduled, long-term effects
of letrozole on bone metabolism are unknown. Goss, P. E., Ingle,
J. N., et al. "A randomized trial of letrozole in postmenopausal
women after five years of tamoxifen therapy for early-stage breast
cancer."
N Engl J Med. Nov. 6, 2003. http://content.nejm.org/cgi
content/abstract/NEJMoa032312v1 (10 Oct. 2003).
Hypertension
Drug Approved For CHF Patients After An MI
The FDA has approved the use of eplerenone (Inspra) tablets for
improving the survival of congestive heart failure (CHF) patients
after they've suffered a heart attack. A placebo-controlled clinical
trial involving more than 6,000 patients revealed a 15% reduction
in the risk of death when patients took eplerenone rather than placebo
in addition to standard therapy. (Standard therapy included angiotensin
converting enzyme [ACE] inhibitors and beta-blockers.) Eplerenone
works by inhibiting the effects of aldosterone, a hormone that may
contribute to the development and progression of hypertension and
CHF. The recommended starting dose is 50 mg once daily. In the trial,
side effects that occurred more frequently in patients treated with
eplerenone than with placebo were hyperkalemia (3.4% compared with
2.0%) and increased creatinine (2.4% compared with 1.5%). Hypokalemia
occurred less frequently in the eplerenone patients. The drug is
contraindicated in patients with serum potassium >5.5m Eq/L or
creatinine clearance £30 ml/min. It also shouldn't be administered
to patients taking CYP3A4 inhibitors.
U.S. Food and Drug Administration. "FDA approves
Inspra for improving survival of congestive heart failure patients
after a heart attack." 2003. www.fda.gov (8 Oct. 2004). Pfizer
Inc. "Pfizer receives approval to market Inspra for congestive
heart failure in heart attack patients." 2003. www.pfizer.com/are/news_releases/mn_2003_1008.html
(8 Oct. 2003).
New
Use For Valtrex: Prevent Herpes Spread Valacyclovir
HCl (Valtrex) caplets may now be used to do more than treat herpes
zoster and genital herpes: It can be used to reduce the risk of
heterosexual transmission of genital herpes to susceptible partners
with healthy immune systems. The FDA based its approval of this
suppressive therapy on the results of an eight-month, double- blind,
placebo-controlled clinical trial. Participants were 1,484 monogamous,
heterosexual, immunocompetent couples. When the study began, only
one member of each couple had evidence of genital herpes. Partners
with herpes were treated with Valtrex 500 mg once daily or a placebo
once daily. In addition, patients and their partners were counseled
to also use condoms during the study period. Results showed a 48%
reduction in herpes simplex virus transmission. Patients taking
the drug should use latex or polyurethane condoms during sex and
abstain from sex when they have any symptoms or outbreak of genital
herpes. The recommended dosage of Valtrex for suppressive therapy
of recurrent genital herpes is 1 gm daily in patients with normal
immune function. Patients with a history of nine or fewer recurrences
per year may take an alternative dose of 500 mg once daily. Advise
patients to tell their healthcare provider if their immune system
is compromised because of advanced HIV disease or bone marrow transplant.
They should also discuss any kidney problems they may have.
U.S. Food and Drug Administration. "FDA updates
labeling of Valtrex." 2003. www.fda.gov/bbs/topics /ANSWERS/2003/anso1250.html
(3 Sept. 2003). GlaxoSmithKlein. "Valtrex. Prescribing information."
2003. http://us.gsk.com /products/assets/us_valtrex.pdf (9 Sept.
2003).
Drug
Roundup
*A new form of clonazepam (Klonopin Wafers) dissolves on the tongue
without water. The drug is indicated for panic and seizure disorders.
*The growth hormone somatropin, rDNA origin (Humatrope) has a new
indication for the long-term treatment of children with idiopathic
short stature. Somatropin is restricted to the shortest 1.2% of
children. In clinical trials, children on the drug grew an extra
1.5 to 2.8 inches. *The first biotechnology treatment for asthma
received FDA approval. Omalizumab (Xolair) is a monoclonal antibody
for the treatment of patients 12 and older with moderate-to- severe
allergy-related asthma that's not controlled with inhaled steroids.
*The FDA has approved ciprofloxacin extended release tablets (Cipro
XR), a once-daily formulation, for the treatment of complicated
urinary tract infections (cUTIs) and acute uncomplicated pyelonephritis
(AUP), or kidney infection. Dosing is 1,000 mg once daily for cUTIs,
and 500 mg once daily for AUP.
Pain
Clinic
Relief From Back Pain: Must It Come At A Price?
Q: Your 32-year-old patient tells you she developed a muscle
spasm in her lower back while lifting her 1-year-old son recently.
She's been receiving physical therapy and taking cyclobenzaprine
HCl (Flexeril) 10 mg tid to treat the acute muscle spasms. There's
been some improvement but the drug has been making her too sleepy
to manage her daily activities. She's wondering if she has other
options. What can you tell her?
A: A recently published multicenter study suggests
that your patient may benefit from a lower dosage of cyclobenzaprine
HCl. This study found that a lower dose (5 mg tid) is as effective
in reducing acute muscle spasm as is 10 mg tid and is less likely
to cause sedation. Sedation is the most common side effect of this
drug, followed by dry mouth and dizziness. There's one drawback,
and it's a small one: The lower dose is likely to take two days
to provide meaningful relief, compared to one day for the higher
dosage. Caution patients that cyclobenzaprine cannot be used with
monoamine oxidase inhibitors (MAOIs), or by patients with arrhythmias,
heart block, conduction disturbances, congestive heart failure,
or hyperthyroidism. It also can't be used during the acute recovery
phase of myocardial infarction. This drug may also enhance the effect
of alcohol, barbiturates, and other central nervous system depressants.
Borenstein, D. G., & Korn, S. (2003). Efficacy
of a low-dose regimen of cyclobenzaprine hydrochloride in acute
skeletal muscle spasm: Results of two placebo-controlled trials.
Clin Ther, 25(4), 1056. Thomson PDR. (2003). Physician's desk reference
(57th ed.). Montvale, NJ: Author. THE AUTHOR MARY J. SCHOLZ, RN,
PhD, is a nurse clinician and behavioral medicine specialist at
Northwest Psychophysiology, an affiliate of Northwest Neuroscience
Institute in Seattle.
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