DRUG

NEWS

HYPONATREMIA
Treating dangerous
sodium imbalances
Administered I.V., conivaptan HCl
injection (Vaprisol) is FDA-approved
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It’s contraindicated in patients with
hypovolemic hyponatremia and in
those who are hypersensitive to any
of its components. It’s not indicated
to treat patients with heart failure.
Baseline lung function tests are
recommended at the beginning of
treatment and every 6 to 12 months
afterward. The manufacturer, Pfizer,
Inc., will conduct postmarketing
studies to evaluate the drug’s long-

to treat euvolemic hyponatremia in term safety and effectiveness.

hospitalized patients. The FDA has DIABETES
also issued an approvable letter for Inhaled insulin earns
Vaprisol as a treatment for hyper- ANTIDEPRESSANTS
volemic hyponatremia. Known as FDA approval
SSRIs take time to work
dilutional hyponatremia, both of An inhaled powder form of recombi-
these electrolyte imbalances occur nant human insulin, Exubera was In a major study, about half of pa-
when retained body water dilutes approved by the FDA in late January tients with major depression re-
serum sodium content. Hyponatremia for treatment of adults with type 1 sponded to treatment with citalo-
is the most common electrolyte im- or type 2 diabetes. Patients with type pram (Celexa), a selective
balance in hospitalized patients. 1 diabetes may add Exubera to their serotonin reuptake inhibitor
Vaprisol works by blocking the regimen in place of short-acting in- (SSRI), but many of them required
activity of arginine vasopressin jected insulin taken with meals. (Ex- at least 8 weeks of treatment with
(AVP), a hormone that helps regulate ubera doesn’t replace longer-acting periodic dose increases.
water and sodium balance in the insulin, which must still be in- The study included 2,876 people
body. Blocking AVP activity increases jected.) Those with type 2 diabetes with a major nonpsychotic depres-
urine output without loss of elec- may take it alone, or in combination sive disorder who were seeking treat-
trolytes. Researchers say Vaprisol will with oral antihyperglycemic medica- ment in primary care or psychiatric
help clinicians manage hyponatremia tions or longer-acting insulin. outpatient clinics. The researchers
more effectively than traditional Exubera, which is delivered via a chose Celexa as a prototype SSRI.
treatments, such as administering specially designed inhaler, is con- Clinicians started patients at a
diuretics and saline solutions or traindicated in patients who smoke dosage of 20 mg/day. Using the
restricting fluid intake. and isn’t recommended for those with 16-item Quick Inventory of Depres-
Vaprisol’s most common adverse asthma, bronchitis, or emphysema. sive Symptomatology self-report to
effects are infusion-site reactions, Potential adverse reactions include rate symptoms and adverse reactions,
hypokalemia, headache, thirst, and hypoglycemia, cough, shortness of clinicians could increase doses to
vomiting; these are generally mild. breath, sore throat, and dry mouth. 40 mg/day by week four and to
60 mg/day by week six.
Of those who responded to treat-
KIDNEY CANCER ment, 56% responded only after
First new drug treatment in a decade 8 weeks or more of treatment.
Treatment was more likely to work in
The FDA has approved an oral tablet, sorafenib tosylate (Nexavar), to slow the those with less severe depression at
spread of advanced renal cell carcinoma. A multikinase inhibitor, Nexavar the study’s start and in those who
decreases tumor growth and angiogenesis. In one clinical trial, patients taking it
were white, female, better educated,
lived twice as long (a median of 6 months) without cancer progression or death
relatively healthy, earning a good
compared with those taking a placebo. The recommended dosage is 400 mg
(two tablets) twice a day, to be taken without food.
income, and living with someone.
In trials, most patients tolerated Nexavar well. About 3% developed cardiac Researchers conclude that clini-
ischemia or infarction. Other adverse reactions included hypertension and a rash cians may need to prescribe longer
and blisters on the palms of the hands or soles of the feet. treatment durations and higher
Kidney cancer, which accounts for 3% of all adult cancers, usually strikes peo- dosages of SSRIs to achieve remissions
ple ages 50 to 70. Nexavar is the first new treatment option for advanced kidney in patients with major depression.
cancer in more than 10 years. Studies are under way to determine if it’s effective
Source: Evaluation of outcomes with Citalopram for depres-
against other cancer types. sion using measurement-based care in STAR*D: Implications
for clinical practice, American Journal of Psychiatry,
MH Trivedi, et al., January 2006.

30 Nursing2006, Volume 36, Number 3 www.nursing2006.com

LUPUS ERYTHEMATOSUS
Immunosuppressant for lupus nephritis
An immunosuppressant drug that helps prevent organ
rejection may also help patients with lupus nephritis, a
severe complication of lupus erythematosus. If approved
for this indication, mycophenolate mofetil (CellCept)
will be the first new lupus drug in almost 40 years.
The 24-week study involved 140 patients with lupus
erythematosus who were randomly assigned to receive
either CellCept or I.V. cyclophosphamide (Cytoxan), the
standard drug for lupus nephritis. Almost 23% of
patients who took CellCept had a complete remission,
compared with 6% of those who took Cytoxan. Thirty
percent of those in the CellCept group had partial remis-
sions, compared with 25% in the Cytoxan group.
People who took CellCept had fewer severe infections
and hospitalizations, but more diarrhea. CellCept comes
in pill form, so it’s easier to take than Cytoxan.
The FDA has called for two more studies of CellCept’s
effects in patients with lupus before it grants approval.
Source: Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis, The
New England Journal of Medicine, EM Ginzler, et al., November 24, 2005.

THROMBOCYTOPENIA
Is low-molecular-weight heparin
really safer?
Contrary to a common assumption, administering low-
molecular-weight heparin (LMWH) instead of unfrac-
tionated heparin (UFH) may not lower the risk of
heparin-induced thrombocytopenia (HIT), according to a
recent study. Italian researchers studied the incidence of
HIT and overt thromboembolic events in 1,754 patients
receiving LMWH for thromboembolic treatment or pro-
phylaxis. Within 2 weeks of treatment, 14 patients devel-
oped HIT, defined as a platelet drop of at least 50%, no
other explanation for thrombocytopenia, and the pres-
ence of immunoglobulin G antibodies. Researchers say
this is consistent with the rate at which HIT develops in
patients taking UFH. Previous exposure to either LMWH
or UFH significantly raised the risk of HIT.
Because their findings indicate that heparin triggers
HIT at a similar rate regardless of molecular weight,
researchers urge clinicians to monitor any patient receiv-
ing heparin closely for problems, regardless of heparin
type—especially if he’s received heparin in the past.‹›

Source: The incidence of heparin-induced thrombocytopenia in medical patients treated

with low-molecular-weight heparin: A prospective cohort study, Blood, P Prandoni, et al.,
November 1, 2005.

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