New Retrospective Studies of Hospital Readmission Rates for
Subsequent Heart Attack and Initial Hospitalization Costs in
ACS-PCI Patients Treated with Effient® (Prasugrel) or Plavix®
(Clopidogrel) Presented at TCT
MIAMI, Oct. 23, 2012 /PRNewswire/ -- Daiichi
Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY) today announced
new results of two retrospective, observational, comparative
effectiveness studies of U.S. hospital data comparing rates of
readmission for subsequent heart attack and initial hospitalization
costs among patients with acute coronary syndromes (ACS) treated
with a percutaneous coronary intervention (PCI) and antiplatelet
therapy, including Effient® (prasugrel) or
Plavix®(clopidogrel). The findings were presented
at the 24th annual Transcatheter Cardiovascular
Therapeutics (TCT) scientific symposium. Sponsored by the
Cardiovascular Research Foundation (CRF), TCT is the world's
premier educational meeting specializing in interventional
cardiovascular medicine.
The first study evaluated the rate of rehospitalization for
acute myocardial infarction (AMI) and bleeding at both 30- and
90-days after discharge for ACS-PCI patients treated with Effient
compared to Plavix.[1] Based on a cohort of 83,567 ACS-PCI patients
in the PREMIER database, Effient-treated patients (n=9,404) had a
significantly lower adjusted rate of rehospitalization for AMI than
Plavix-treated patients (n=74,163) at 30 days (Odds Ratio [OR]:
0.89; p=0.047) and 90 days (OR: 0.90; p= 0.037) following ACS-PCI
discharge. The adjusted rates of bleeding-related rehospitalization
were not different between Effient- and Plavix-treated patients at
30 days (OR: 1.04; p=0.82) or 90 days (OR: 0.92; p=0.51)
post-discharge. In the pivotal randomized control trial,
TRITON-TIMI 38, the risk of serious bleeding was significantly
higher with Effient versus Plavix (2.2 percent versus 1.7 percent,
respectively).[2]
The second study evaluated use of healthcare resources by
Effient-treated ACS-PCI patients compared to Plavix-treated
patients during index hospitalization (hospitalization that
qualified the patients for entry into the study), as measured by
hospital costs.[3] Based on a cohort of 84,695 ACS-PCI patients in
the PREMIER database, adjusted estimates of average hospitalization
costs for patients receiving Plavix (n=75,224) or Effient (n=9,471)
were $17,519 (+ or - $2,548) and $17,139
(+ or - $2,560) respectively – a cost
savings of $380 (p<0.05) for
Effient-treated patients during the index hospital stay.
Results were consistent across subgroups by subtype of ACS (STEMI,
NSTEMI, and unstable angina).
"In the current healthcare environment, it is important to
understand the comparative effectiveness of antiplatelet therapies
on rehospitalization rates for subsequent events, such as heart
attacks, and index hospitalization costs associated with their use
in the real-world setting," said lead study investigator
Jay P. Bae, Ph.D., health economist,
Health Outcomes Research, Global Health Outcomes, Eli Lilly and
Company. "The findings of these studies expand on data from
clinical studies and previous health outcomes research."
The studies were conducted using the PREMIER Perspective
Database, a large U.S. database of drug utilization and other
aggregate hospital data on more than 45 million inpatient
discharges and 210 million hospital outpatient visits from U.S.
acute care facilities, ambulatory surgery centers and clinics.[4]
The PREMIER Perspective Database has been selected by the Centers
for Medicare & Medicaid Services for measurement of hospital
quality and is commonly used for outcomes research including
studies published in top medical journals. The data presented
at TCT evaluated non-randomized ACS-PCI patients hospitalized
between July 2009 and June 2011. The study endpoints were pre-specified
and the analyses were blinded and conducted by the PREMIER research
team. The studies included ACS-PCI patients treated with Effient
who were on label or Plavix-treated patients who would have been
eligible for Effient treatment per the U.S. prescribing information
(i.e., patients who fit the description of the indication in the
U.S. FDA-approved Effient label).[1]
"The results from the PREMIER studies provide physicians with
real-world insights into the use and effectiveness of Effient in
ACS-PCI patients in the United
States," said Xin Ye, Ph.D.,
Director, Health Economics & Outcomes Research, Daiichi Sankyo,
Inc.
This study was adjusted for potential selection bias, including
the following variables: patient age, sex, race, type of ACS
diagnosis, comorbidities and details of intervention.
The studies were conducted by researchers at Lilly and the
Premier Healthcare Alliance.
Assessment of Observed Rates of 30- and 90-Day
Rehospitalization for AMI and Bleeding in Patients with ACS-PCI:
Comparison of Effient and Plavix
The observed rates of 30- and 90-day rehospitalization due to
AMI and 30- and 90-day bleeding-related rehospitalization rates
among ACS-PCI patients treated with Effient or Plavix in a
real-world U.S. hospital setting were also presented at TCT.
At 30-days, the unadjusted AMI-related rehospitalization rates were
significantly lower for Effient as compared to Plavix (3.9 percent
and 4.7 percent, respectively; p<0.05). At 90-days, the
unadjusted AMI-related rehospitalization rates were significantly
lower for Effient as compared to Plavix (5.1 percent and 6.3
percent, respectively; p<0.05).
The unadjusted bleeding-related rehospitalization rate was 0.5
percent in Effient-treated patients compared to 0.8 percent in
Plavix-treated patients at 30-days (p<0.05) and 0.8 percent in
Effient-treated patients compared to 1.4 percent in Plavix-treated
patients at 90-days (p<0.05) post-discharge.
Observed Mean Length of Stay, Hospitalization Costs and
Bleeding Rates of ACS-PCI: Comparison of Effient and Plavix
The goal of this analysis was to compare observed mean length of
stay, total costs and bleeding rates associated with the index
hospitalization – hospitalization that qualified the patients for
entry into the study – for ACS-PCI patients treated with Effient or
Plavix. Across the entire study population, the unadjusted
mean length of stay was 2.9 + or - 2.4 days for Effient-treated
patients as compared to 3.5 + or - 4.4 days for Plavix-treated
patients (p<0.05). The actual observed mean
hospitalization costs for Effient-treated patients were
$16,199 + or - $10,054 compared to $17,647 + or - $16,696 for Plavix-treated patients
(p<0.05).
In the study, unadjusted rates of bleeding (defined as the
presence of bleeding ICD-9 codes) were 2.2 percent and 3.3 percent
in Effient- and Plavix-treated patients, respectively
(p<0.05).
Unadjusted rates of transfusion were 1.2 percent and 3.1 percent
in Effient- and Plavix-treated patients, respectively (p<0.05).
Unadjusted rates of bleeding or transfusion were 3.2 percent and
5.7 percent in Effient- and Plavix-treated patients, respectively
(p<0.05).
In the pivotal randomized control trial, TRITON-TIMI 38, the
risk of serious bleeding was significantly higher with Effient
versus Plavix (2.2 percent versus 1.7 percent,
respectively).[2]
Limitations of the PREMIER Database Studies
Although significant demographic, clinical, treatment- and
intervention-related data were used to adjust for potential bias in
these studies, other unrecognized sources of bias may still exist
in any non-randomized database study. For example, the
PREMIER database did not include data on patient characteristics,
such as blood pressure, height and weight. The lack of weight data
is important, since weight is a predictor of risk for bleeding. The
researchers plan to conduct additional quantitative analysis on
potential sources of bias in the database.
About Acute Coronary Syndrome
ACS, which includes heart attack and a type of chest pain called
unstable angina (UA), affects more than one million people in
the United States annually.[5] The
annual incidence of new heart attacks is estimated to be
approximately 610,000 and about 325,000 people will have a
recurrent attack. There are two main types of heart attack:
non-ST-segment elevation, or NSTEMI, and ST-segment elevation, or
STEMI. STEMI heart attacks are often considered more severe as the
artery is often fully blocked, preventing blood flow to the
heart.
Each year, approximately 596,000 people undergo PCI, which
typically includes the implantation of a stent that restores blood
flow to blocked arteries in the heart. The number of UA or NSTEMI
ACS patients worldwide who are managed without acute coronary
interventions, such as PCI, has ranged from 32 percent to almost 60
percent over the last few years.[6],[7] In many cases, these ACS
patients may have complex coronary anatomy, comorbidities or other
high-risk factors that prevent surgical
intervention.
ACS may result in heart attack, stroke and death, costing
Americans more than $150 billion each
year.[8] Nearly 60 percent of the U.S healthcare costs of ACS are
due to re-hospitalization. Strategies to prevent recurrent heart
attacks and re-hospitalization are important to improve patient
outcomes and reduce the cost burden of ACS.
About Effient
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and
Company (NYSE: LLY) co-developed Effient, an oral antiplatelet
agent discovered by Daiichi Sankyo and its Japanese research
partner, Ube Industries, Ltd. Effient helps keep blood platelets
from clumping together and developing a blockage in an artery.
Effient is indicated to reduce the rate of thrombotic CV events
(including stent thrombosis) in patients with ACS who are to be
managed with an artery-opening procedure called PCI as follows: [1]
patients with UA or NSTEMI; [2] patients with ST-elevation
myocardial infarction (STEMI) when managed with primary or delayed
PCI. The loading dose of Effient is 60 mg and the maintenance
dose is 10 mg once daily. Effient is available in 5-mg and 10-mg
tablets.
Important Safety Information
What is the most important information patients should
know about Effient?
|
Effient® (prasugrel) can cause bleeding.
If patients have unexplained or excessive bleeding while on
Effient, they should contact their doctor right away as some
bleeding can be serious, and sometimes fatal. Patients should not
take Effient if they currently have abnormal bleeding, such as
stomach or intestinal bleeding, bleeding in their head, or have a
history of stroke, or "mini-stroke" (also known as transient
ischemic attack or TIA), or are allergic to prasugrel or any of the
ingredients in Effient.
|
|
Patients
should get medical help right away if they suddenly have slurring
of speech, weakness or numbness in one part of their body, blurry
vision, and/or severe headache. These may be symptoms of a stroke
or TIA. If patients have a stroke or TIA while taking Effient,
their doctor will probably stop Effient.
|
|
|
Before
having any surgery, patients should talk to their doctor about
stopping Effient. If possible, patients should stop taking Effient
at least 1 week (7 days) before any surgery, as instructed by their
doctor who prescribed Effient.
|
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Patients
may also have a higher risk of bleeding if they take Effient and
they: a) are age 75 or older, b) weigh less than 132 pounds, c) are
taking anticoagulants (eg, warfarin) or regular daily use of
NSAIDs, d) have had recent trauma, such as an accident or surgery,
e) have severe liver problems, or f) have a stomach
ulcer.
|
|
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Patients
should not stop taking Effient without talking to the doctor who
prescribes it for them. People who are treated with angioplasty and
have a stent, and stop taking Effient too soon, have a higher risk
of a blood clot in the stent, having a heart attack, or
dying.
|
What should patients tell their doctor before taking
Effient?
Patients should tell their doctor about all of their medical
conditions, allergies, and medicines they are taking.
What are the possible side effects of Effient?
Bleeding is the most common side effect of Effient.
TTP, a rare but life-threatening condition, has been reported
with Effient, sometimes after a short time (less than 2 weeks).
Patients should get medical attention right away if they develop
the following unexpected symptoms of TTP: fever, weakness,
yellowing of the skin or eyes, or if skin becomes very pale or
dotted with purple spots.
Serious allergic reactions can happen with Effient, or if the
patient has had a serious allergic reaction to the medicines
Plavix® (clopidogrel) or ticlopidine. Patients should
get medical help right away if they get any of these symptoms of a
severe allergic reaction: swelling or hives of their face, lips, in
or around their mouth, or throat, trouble breathing or swallowing,
chest pain or pressure, dizziness or fainting.
Other side effects may occur.
For more information about Effient, please see the Prescribing
Information at http://pi.lilly.com/us/effient.pdf, including Boxed
Warning regarding bleeding risk, and Medication Guide at
http://pi.lilly.com/us/effient-ppi.pdf. You may also learn
more about Effient at www.Effient.com.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging
markets. While maintaining its portfolio of marketed
pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments
for thrombotic disorders and focused on the discovery of novel
oncology and cardiovascular-metabolic therapies. Furthermore, the
Daiichi Sankyo Group has created a "Hybrid Business Model," which
will respond to market and customer diversity and optimize growth
opportunities across the value chain. For more information, please
visit www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in
Parsippany, New Jersey, is a
member of the Daiichi Sankyo Group. For more information on Daiichi
Sankyo, Inc., please visit www.dsi.com.
About Eli Lilly and Company
Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers –
through medicines and information – for some of the world's most
urgent medical needs. Additional information about Lilly is
available at www.lilly.com.
This press release contains certain forward-looking
statements about Effient for the reduction of thrombotic
cardiovascular events (including stent thrombosis) in patients with
acute coronary syndromes who are managed with percutaneous coronary
intervention and reflects Daiichi Sankyo's and Lilly's current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. There is no guarantee that future
study results and patient experience will be consistent with study
findings to date or that the product will be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filing with the United States Securities
and Exchange Commission and Daiichi Sankyo's filings with the Tokyo
Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to
update forward-looking statements.
Effient® is a registered trademark of Eli Lilly and
Company.
Plavix® is a registered trademark of Sanofi-Aventis
Corp.
P-LLY
[1] Bae JP, Faries DE, Ernest FR et al. Assessment of 30-Day
Rehospitalization for Acute Myocardial Infarction in Patients with
Acute Coronary Syndrome Who Received Percutaneous Coronary
Intervention: A Comparative Effectiveness Study of Clopidogrel and
Prasugrel. Abstract TCT-53. 2012 Transcatheter Cardiovascular
Therapeutics Annual Meeting, Miami,
FL.
[2] Effient Prescribing Information (U.S.).
[3] Bae JP, Ernst FR, Lipkin C, et al. Hospitalization Costs of
Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary
Intervention: A Comparison Between Clopidogrel and Prasugrel
Patients in a US Hospital Database. Abstract 730. 2012
Transcatheter Cardiovascular Therapeutics Annual Meeting,
Miami, FL.
[4] Premier Research Services®.
https://www.premierinc.com/prs/index.jsp.
[5] Roger VL, Go AS, Lloyd-Jones DM, et al. for the American Heart
Association Statistics Committee and Stroke Statistics
Subcommittee. Heart disease and stroke statistics – 2012 update.
Circulation.
2012;125:e2-e220.
[6] Fox KAA, Steg PG, Eagle KA, et al. Decline in rates of death
and heart failure in acute coronary syndromes, 1999-2006. J Am
Med Assoc. 2007;297:1892-1900.
[7] Chan MY, Mahaffey KW, Sun LJ, et al. Prevalence, predictors,
and impact of conservative medical management for patients with
non-ST-segment elevation acute coronary syndromes who have
angiographically documented significant coronary disease. J Am
Coll Cardiol. 2008;1:369-378.
[8] Kolansky DM. Acute coronary syndromes: Morbidity, mortality and
pharmacoeconomic burden. Am J Manag Care.
2009;15:S36-S41.
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SOURCE Eli Lilly and Company