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The Family Practice Newsletter
of apixaban, which can be expected to
remain for about 24 hours after the
patient takes the last dose.
Additionally, as this medication has just
been approved and is only brand name,
it is unlikely to be covered by most
insurance plans.
February 2013
Inside this Issue

New Anticoagulant Hits
the Market (Eliquis®)

Myrbetriq®
(mirabegron)
Stay tuned for more information
regarding new FDA approvals for
apixaban in the future.
New Anticoagulant
Hits the Market
Bradley Janko, PharmD Candidate
Giant Eagle is no
longer offering FREE
diabetes meds!
Free Metformin IR
now available at
Meijer!
Newsletter Contact Information:
Megan Keller, PharmD
[email protected]
Doctors Hospital Family Practice
2030 Stringtown Road, Suite 300
Grove City, Ohio 43123
1
On December 28, 2012, the FDA
approved a new anticoagulant apixaban
(Eliquis®) for the prevention of stroke
and systolic embolism in patients with
non-valvular atrial fibrillation. This
long-awaited drug’s approval was
largely based on the findings of the
ARISTOTLE trial, which compared the
safety and efficacy of apixaban against
warfarin in the prevention of stroke or
systemic embolism in patients with nonvalvular atrial fibrillation. The trial
concluded that apixaban was in fact not
only safe but superior to warfarin in this
regard.
Apixaban is an oral, reversible, and
selective inhibitor of factor Xa, and the
recommended dose for most patients is
5mg by mouth twice a day. The dosing
for apixaban does not need to be
adjusted for renal impairment, although
there is no data available for patients
with CrCl <15mL/min. Apixaban is not
recommended in patients with severe
hepatic disease. Unlike warfarin, this
drug does not require routine laboratory
monitoring for anticoagulation.
Unfortunately, even though apixaban
has some advantages over warfarin, it
has its drawbacks as well. Like other
direct factor Xa inhibitors (i.e.
rivaroxaban), there is still no known
way to reverse the anticoagulant effect
Myrbetriq®
(mirabegron)
Alyssa McLaughlin, PharmD Candidate
In June 2012, the FDA approved
Myrbetriq™ (mirabegron) for the
treatment of patients with overactive
bladder (OAB). It is indicated for
symptoms of OAB including urge
urinary incontinence, urgency, and
urinary frequency. Mirabegron is a β3adrenergic receptor agonist, which is a
novel mechanism being used to treat
OAB. Action on the β3 receptor causes
the detrusor smooth muscle of the
urinary bladder to relax during the
storage phase of the fill-void cycle to
increase bladder capacity.
Other agents available for the treatment
for OAB include Detrol® (tolterodine),
Enablex® (darifenacin), and VESIcare®
(solifenacin). These agents antagonize
muscarinic receptors in the bladder to
inhibit bladder contraction, decrease
detrusor pressure, and cause an
. . . . . . . . . . . . . . . . . . . . . .
The Family Practice Newsletter – February 2013
incomplete bladder emptying. Since
these drugs are not specific for the
muscarinic receptors in the bladder,
they result in other unwanted
anticholinergic effects, such as dry
mouth, constipation, vision
disturbances, and CNS impairment.
Common adverse effects of mirabegron
are nausea headache, hypertension,
diarrhea, constipation, dizziness, and
sinus tachycardia. In clinical trials, this
medication was better tolerated than the
other pharmacological treatments, due
to their anticholinergic side effects.
Since mirabegron acts on β receptors,
with the possibility to agonize β1
receptors at higher doses, it should not
be used in patients with uncontrolled
hypertension.
Mirabegron can be administered
without regard to food, at a dose of
25mg per day. Efficacy should be seen
within 8 weeks. If not, the dose can be
increased to 50mg per day. Dosing
adjustments are required in moderate
renal and hepatic impairment, and use is
not recommended in sever hepatic and
renal disease.
Monitoring parameters for this drug
include changes in urinary urgency and
frequency and blood pressure.
flecainide, digoxin, MAOIs, and
thioridazine. Mirabegron can increase
the levels of digoxin, flecainide, and
thioridazine. Administration with
MAOIs may increase the risk of
hypertensive crisis due to the adrenergic
action of both drugs.
Mirabegron is a pregnancy category C.
Studies have not been conducted in
pregnant women, but animal studies
show that there is a low potential for
causing adverse developmental
outcomes. Animal studies also show
that mirabegron crosses into breast
milk.
Major drug interactions with
mirabegron include concurrent use of
References:
New Anticoagulant Hits Market
1. Walsh, Sandy. “FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation.” FDA, 12/28/2012. Available
from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333634.htm. Accessed on January 17, 2013.
2. Granger CB, Alexander JH, McMurray JJV et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med August 28, 2011
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1107039 (ARISTOTLE)
3. Apixaban package insert, approved 2012, accessed 1/17/13.
Myrbetriq (mirabegron)
1. Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized Double-blind, Active-controlled Phase 3 Study to Assess 12-Month Safety and Efficacy of
Mirabegron, a β3-Adrenoceptor Agonist, in Overactive Bladder. European Urology 2013; 63(2):296-305.
2. Khullar V, Amarenco G, Angulo JC, et al. Efficacy and Tolerability of Mirabegron, a β3-Adrenoceptor Agonist, in Patients with Overactive Bladder: Results
from a Randomised European–Australian Phase 3 Trial. European Urology 2013; 63(2):283-295.
3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2013. URL: http://0-www.clinicalpharmacologyip.com.polar.onu.edu/default.aspx. Updated July 2012.
4. ¨Lexi-Comp OnlineTM , Lexi Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; January 12, 2013.
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