Download A Sneak Peek at Soon-to-Be-Released Asthma Drugs

T h o m a s J . K a l l s t r o m , r r t, f a a r c
AARC Representative, National Asthma Education and Prevention Program
Focus on
Asthma
A Sneak Peek at Soon-to-Be-Released
Asthma Drugs
F
our years ago, the National
Heart, Lung, and Blood Institute published the National
Asthma Education and
Prevention Program’s Expert
Panel Report 2: Asthma Guidelines
for the Diagnosis and Management
of Asthma.1 A significant amount
of research has been published
since. In fact, a recent
MEDLINE search revealed
more than 13,000 asthma-related
citations since 1997, a large
proportion of which was related
to changes in pharmacotherapy.
We will continue to see many
improvements in the drugs we
use to treat asthma. Below are
highlights of what 2001
promises.
A d va i r D i s ku s
Combination drugs are no
strangers to asthmatic patients
and are a logical approach that
simplifies the administration of
medications. Patient compliance
is enhanced when drugs can be
combined. Such drugs have been
used successfully and efficiently
to treat hypertension, tuberculosis, and AIDS. GlaxoSmithKline plans to release a
new combination drug this
spring: fluticasone and
salmeterol will be combined in a
dry diskus powder inhaler
named Advair Diskus.
10
A AR C Tı m e s
April 2001
In a study by Kavuru et al,2 a 12week randomized, double-blind,
multicenter study consisting of
356 patients (over age 12), found
that a combination of fluticasone
and salmeterol reduced the
symptom scores and overall need
for rescue drug (albuterol).
Additionally, nocturnal
awakenings decreased, while days
with no symptoms increased
(compared to those receiving
placebo and salmeterol).
Many new
The combination of these
two drugs causes a synergistic
response as the inhaled
corticosteroid provides a
protective effect on the betaagonist receptor. At the same
time, the long-acting agonists
prime the glucocorticoid
receptor, which in turn
intensifies the antiinflammatory action of the
glucocorticoid. Once released,
Advair will be available in 100
asthma medications
will soon be available, and RTs should
become knowledgeable about what
these drugs
have to offer.
Shapiro et al3 reached a
similar conclusion when they
noted significantly decreased
asthma symptom scores and
need for rescue drug. Patients in
this study who received fluticasone and salmeterol had a
significantly greater probability
of remaining in the study
without being withdrawn
because of deterioration of
symptoms than did patients
receiving the placebo,
salmeterol, or fluticasone.
mcg, 250 mcg, and 500 mcg
strengths.
F o rm o t e r o l a n d
omalizumab
Novartis Pharmaceuticals
plans to release two products in
2001: formoterol (sold as
Foradil Aersolizer) and
omalizumab (sold as Xolair).
Formoterol has been used since
1991 outside of the United
States in more than 60
countries. This long-acting
Focu s on Asthma
beta-2 adrenergic provides
control for up to 12 hours when
given twice daily. The onset of
action is 10 to 20 minutes.
A recently published study by
Bensch et al4 noted that
formoterol had a rapid onset
and was effective for 12 hours.
Morning and evening peak
expiratory flow rates improved,
and patients were less likely to
use a rescue medication than
those who received albuterol or
placebo. Use of formoterol also
provided significantly greater
improvements in asthma
symptom scores compared to
both albuterol and placebo.
This breath-actuated powder
drug is administered by an
aersolizer device, which delivers
the medication from a capsule.
Another interesting development on the horizon is the
Novartis and Genentech drug
omalizumab. Omalizumab is a
genetically engineered
recombinant humanized
monoclonal antibody.
Omalizumab is given to the
patient via a subcutaneous
route. Once administered, it
binds to the IgE antibody,
thereby preventing it from
binding to receptors on mast
cells and basophils. As a result,
the cross-linking of the IgE and
the degranulation of mast cells
and basophils are inhibited. It is
this sequence that stops the
allergic response. Once patients
start taking this medication,
they should observe dramatic
and prompt reductions in IgE
levels within the first few days
of initial administration.
Omalizumab has been
studied in more than 1,700
patients with allergic asthma,
and in more than 750 with
allergic rhinitis. Patients who
received the drug in a study
done by Milgrom et al5 noted a
significant improvement in
asthma symptom scores (compared to those who received
placebo) and a reduction in use
of inhaled corticosteroids.
There was also an association
with those treated with
omalizumab and an improvement in asthma-specific quality
of life. The therapy was well
tolerated; and after 20 weeks,
none of the patients who
received the drug developed
antibodies against it.
Once on the market there will
need to be significant patient
education about omalizumab.
Patients will need to understand
that unlike a rescue medication,
this drug will not provide shortacting relief. Education should
be focused on the route of
administration, dosing, and
expected clinical response to the
drug.
( c on t in ue d on p a ge 94)
A AR C Tı m e s
A pri l 20 0 1
11
A A RC Ti m e s
F oc us o n
Asthma
Ve n t i l a t i o n
fo r L i f e
(c on ti nu e d f ro m p a g e 11)
( con tin u ed fr om p ag e 2 6)
Indeed, many new drugs will
soon be available. All respiratory
therapists involved in the
management of asthma should
become knowledgeable about
what these drugs have to offer.
While not all of these drugs will be
given by the bedside respiratory
therapist, it is essential that we are
knowledgeable and able to teach
our patients about them. •
the delivery of non-acute care
ventilation. The acute care setting has
generated a group of patients
requiring an extended time to wean.
Also, there is earlier recognition of
the decidedly ventilator-dependent
patient. The diagnosis-related group
(DRG) reimbursement system and
the managed care movements have
driven the VAI from the expensive,
acute care setting. The options then
are a specialized unit for further
attempts at weaning, a skilled nursing
facility (SNF), a group home setting,
or “home.”
The important reimbursement
issue then becomes, primarily, a
caregiver issue. If the weaning unit,
SNF, group home, or home health
agency can employ caregivers,
placement can be made to that
setting. If the family can arrange
payment for caregivers or provide
care themselves, the situation is
greatly simplified and placement at
home is the preferred choice.
Reimbursement for ventilators
and caregivers is available through
government programs, but the
caregivers must be skilled and the
care must be continual and dependable. While the ventilator is usually
rented and reimbursed, the caregiver
situation is complex. For example, if
an SNF accepts a VAI, reimbursement does not often cover continual
care by an RT. Afacility can contract
for the therapist’s services; but
without continual involvement of an
RT, active weaning attempts are
often halted. Inadequate airway care,
ventilation monitoring, or ventilator
management often result in readmission to the acute care setting. If
nursing personnel provide ventilator
care, they must be skilled and comfortable with airway care, ventilator
settings, and pressure/volume alarms.
Thomas J. Kallstrom is director of
cardiopulmonary services at Fairview
Hospital in Cleveland, OH.
REFERENCES
1. U.S. Department of Health and Human
Services. (1997, July). National Asthma
Education and Prevention Program,
Expert panel report 2: Guidelines for the
diagnosis and management of asthma
(NIH Publication No. 97-4051). Bethesda,
MD: National Institutes of Health, National
Heart, Lung, and Blood Institute.
2. Kavuru, M., Melamed, J., Gross, G., et
al. (2000). Salmeterol and fluticasone
propionate combined in a new powder
inhalation device for the treatment of
asthma: A randomized, double-blind,
placebo-controlled trial. Journal of Allergy
and Clinical Immunology, 105(6), 11081116.
3. Shapiro, G., Lumry, W., Wolfe, J., et al.
(2000). Combined salmeterol 50 microg
and flutucasone propionate 250 microg in
the diskus device for the treatment of
asthma. American Journal of Respiratory
and Critical Care Medicine, 161(2), 527534.
4. Bensch, G., Lapidus, R.J., Levine, B.E.,
et al. (2001). A randomized, 12-week,
double-blind, placebo-controlled study
comparing formoterol dry powder inhaler
with albuterol metered-dose inhaler.
Annals of Allergy, Asthma & Immunology,
86(1), 19-27.
5. Milgrom, H., Fick, R.B., Su, J.Q., et al.
(1999). Treatment of allergic asthma with
monoclonal anti-IgE antibody. New
England Journal of Medicine, 341(26),
1966-1973.
94
A AR C Tı m e s
April 2001
With the current shortage of
nursing personnel — particularly
those with experience in ventilator
care — and limited reimbursement
for respiratory therapy, the VAI can
become a refugee in the health care
system dependent on finding
caregivers with experience in nonacute care ventilation. •
Alexander B. Adams is senior research
associate at Regions Hospital in St. Paul,
MN, and can be reached at Alex.b.
[email protected]. Peter
Bliss is an engineer at Valley Inspired
Products in Eden Prairie, MN, and can be
reached at [email protected].
Tak in g a
B re a t h e r
( con tin u ed fr om p a ge 9 6)
garbled, as if he were using his
forefinger to flap his lips.
“Have a little respect,” I said.
“What if you lost your teeth?”
“I’ll never lose my teeth.”
“Spoken like a true teenager,” I
said. “But suppose you did.”
He was quiet for a moment. “I’d
sneak in here and steal them back
— you know — like — take a bite
out of crime.”
I laughed. “That’s it. Wrap them
in the napkins and leave them
where you found them, next to the
Certs.”
Later that evening Shannon
called to say that a gentleman
wearing a porkpie hat had come in.
His collar was turned up, and he
took a long time browsing the
magazines. When Shannon moved
into the second aisle to dust pickle
jars, the man headed for the check
stand, snatched the messy little
wad of napkins, and escaped into
the night. •
Jean Blackmon Waszak is a columnist for
the Corrales Comment in Corrales, NM.
Her essays have been widely reprinted.
Jean Blackmon Waszak, ©2001