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Threats to Cardiologist Compensation in Post-alignment Years | Advocating for Equal Treatment
CardioSource
WorldNews
vol 5, no 7 / JULY 2016
A publication of the
American College
of Cardiology
Print
EXPERT COMMENTARY
fred bove: Is AF Contributing
to Dementia?…p.7
gerard martin, md:
Pediatric Cardiac Care and the
Global Health Agenda…p.43
CLINICAL NEWS
Study Explores Prescribing
Habits for AF Patients at
Risk for Stroke…p.13
Pharmacists’ Interventions
May Cut CVD Risk…p.13
Leaders Trial Shows Benefit
of Liraglutide for Type 2
Diabetes Patients…p.15
Low-income Countries in
AMI Outcomes…p.16
Online
SAVE
YOUR
BRAIN
PCI vs. OMT for Stable IHD:
What Part of ‘Optimal Medical
Therapy’ Is Confusing?...p.19
Disturbed Sleep, Aging and
CVD…p.20
More reasons
to optimize AF
therapy
ACC.org/CSWN
BRIEF SUMMARY
The following is a brief summary of the full prescribing
information for Orenitram® (treprostinil) ExtendedRelease Tablets. Please review the full prescribing
information before prescribing Orenitram.
INDICATIONS AND USAGE
Orenitram is indicated for the treatment of pulmonary
arterial hypertension (PAH) (WHO Group 1) to
improve exercise capacity. The study that established
effectiveness included predominately patients with
WHO functional class II-III symptoms and etiologies
of idiopathic or heritable PAH (75%) or PAH associated
with connective tissue disease (19%). When used as the
sole vasodilator, the effect of Orenitram on exercise
is about 10% of the deficit, and the effect, if any, on
a background of another vasodilator is probably less
than this.
CONTRAINDICATIONS
Severe hepatic impairment (Child Pugh Class C).
WARNINGS AND PRECAUTIONS
Worsening PAH Sympt
mptoms upon Abrupt Withdrawal —
Abrupt discontinuation or sudden large reductions
in dosage of Orenitram may result in worsening of
PAH symptoms.
Risk of Blee
Bleed
ding—Orenitram
ng
inhibits platelet
aggregation and increases the risk of bleeding.
Use in Patients with Blind-end Pouches—The tablet
shell does not dissolve. In patients with diverticulosis,
Orenitram tablets can lodge in a diverticulum.
ADVERSE REACTIONS
Clinical Trials Experience—Because clinical trials are
conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical
Table 1. Adverse Reactions with Rates at Least 5% Higher on Orenitram Monotherapy than on Placebo
Treatment (%)
Reaction
Orenitram (N=151)
Placebo (N=77)
Headache
63%
19%
Diarrhea
30%
16%
Nausea
30%
18%
Flushing
15%
6%
Pain in jaw
11%
4%
Pain in extremity
14%
8%
Hypokalemia
9%
3%
Abdominal discomfort
6%
0%
The safety of Orenitram was also evaluated in an
open-label study transitioning patients from Remodulin.
The safety profile during this study was similar to that
observed in the three pivotal studies.
DRUG INTERACTIONS
Antihypertensive Agents or Other Vasodilator—
Vasodilator
Concomitant administration of Orenitram with
diuretics, antihypertensive agents or other
vasodilators increases the risk of symptomatic
hypotension.
Anticoagulants
Anticoagulants—Treprostinil
inhibits platelet
aggregation; there is increased risk of bleeding,
particularly among patients receiving anticoagulants.
—Co-administration
of Orenitram and the CYP2C8 enzyme inhibitor
exposure to treprostinil. Reduce the starting dose
of Orenitram to 0.125 mg BID and use 0.125 mg BID
increments every 3 to 4 days.
Effect of Other Drugs on Orenitram—Based
Orenitram
on
human pharmacokinetic studies, no dose adjustment
of Orenitram is recommended when coadministered
or esomeprazole.
observed in clinical practice. In a 12-week placebocontrolled monotherapy study (Study 1; WHO Group
1; functional class II-III), the most commonly reported
adverse reactions that occurred in patients receiving
Orenitram included: headache, diarrhea, nausea and
flushing. Tab