AstraZeneca Shares Scientific Updates from Its Extensive Cardiovascular, Renal & Metabolic Diseases (CVMD) Portfolio at AHA 2...
November 08 2017 - 7:00AM
Business Wire
AstraZeneca and MedImmune, its global biologics research and
development arm, will be underlining its scientific focus on
cardiovascular, renal and metabolic diseases (CVMD) with 28
presentations, including two late-breaking trials, at the American
Heart Association (AHA) Scientific Sessions, November 11-15, 2017
in Anaheim, California.
Ludovic Helfgott, Vice President, Cardiovascular and Metabolic
Diseases, said: “With the breadth of our scientific updates at AHA
2017, we are at the forefront of the clinical debate, exploring the
often unseen but vital connections between cardiovascular, renal
and metabolic diseases. This approach embodies our commitment to
improving outcomes for patients while reducing long-term morbidity
and mortality.”
Key among the data being presented are two late-breaking
presentations selected by the AHA: the China-based DACAB study
(Efficacy of Different Antiplatelet Therapy Strategy after Coronary
Artery Bypass Grafting); and the EXSCEL (EXenatide Study of
Cardiovascular Event Lowering) trial, plus data for potential new
CVMD medicines.
- The DACAB study compares the use of
ticagrelor plus aspirin versus aspirin alone, and ticagrelor alone
following elective coronary artery bypass graft surgery (CABG), to
assess patency of the grafts. Ticagrelor is not approved in
elective CABG and cannot be used as monotherapy. (Session
LBS.01).
- A new analysis of the EXSCEL clinical
trial, the largest and most inclusive CV outcomes trial of any
glucagon-like peptide-1 receptor agonist (GLP-1 RA), with more
than 14,500 patients at 687 trial sites across 35 countries,
aims to further demonstrate the effect of exenatide once-weekly on
CV morbidity and mortality in patients with type-2 diabetes. This
new analysis adds to results presented at the recent annual meeting
of the European Association for the Study of Diabetes (EASD), and
published simultaneously in the New England Journal of Medicine.
Exenatide is not indicated to reduce the risk of CV outcomes.
(Session LBS.04).
- Presentations at AHA also include early
stage data for potential new medicines, as monotherapy and in
combinations, in areas including cardiac regeneration, chronic
kidney disease, acute coronary syndromes, and chronic heart
failure. These include phase IIa data of MEDI6012, a recombinant
human lecithin-cholesterol acyltransferase (LCAT) being evaluated
for the treatment of coronary artery disease (Session LB.APS.06 –
S2107) and chronic heart failure (CHF), as well as data from
AZD5718 our 5-lipoxygenase activating protein (FLAP), a potential
treatment for ACS (Session IN.APS.02 – S4093).
IMPORTANT SAFETY INFORMATION FOR
BRILINTA® (ticagrelor) 60-MG AND 90-MG
TABLETS
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA
EFFECTIVENESS
A. BLEEDING RISK
- BRILINTA, like other antiplatelet
agents, can cause significant, sometimes fatal bleeding
- Do not use BRILINTA in patients with
active pathological bleeding or a history of intracranial
hemorrhage
- Do not start BRILINTA in patients
undergoing urgent coronary artery bypass graft surgery
- If possible, manage bleeding without
discontinuing BRILINTA. Stopping BRILINTA increases the risk of
subsequent cardiovascular events
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
- Maintenance doses of aspirin above
100 mg reduce the effectiveness of BRILINTA and should be
avoided
CONTRAINDICATIONS
- BRILINTA is contraindicated in patients
with a history of intracranial hemorrhage or active pathological
bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA
is also contraindicated in patients with hypersensitivity (eg,
angioedema) to ticagrelor or any component of the product
WARNINGS AND PRECAUTIONS
- Dyspnea was reported in about 14% of
patients treated with BRILINTA, more frequently than in patients
treated with control agents. Dyspnea resulting from BRILINTA is
often self-limiting
- Discontinuation of BRILINTA will
increase the risk of MI, stroke, and death. When possible,
interrupt therapy with BRILINTA for 5 days prior to surgery that
has a major risk of bleeding. If BRILINTA must be temporarily
discontinued, restart as soon as possible
- Ticagrelor can cause ventricular
pauses. Bradyarrhythmias including AV block have been reported in
the post-marketing setting. PLATO and PEGASUS excluded patients at
increased risk of bradyarrhythmias not protected by a pacemaker,
and they may be at increased risk of developing bradyarrhythmias
with ticagrelor
- Avoid use of BRILINTA in patients with
severe hepatic impairment. Severe hepatic impairment is likely to
increase serum concentration of ticagrelor and there are no studies
of BRILINTA in these patients
ADVERSE REACTIONS
- The most common adverse reactions
associated with the use of BRILINTA included bleeding and dyspnea:
In PLATO, for BRILINTA vs clopidogrel, non-CABG PLATO-defined major
bleeding (3.9% vs 3.3%) and dyspnea (14% vs 8%); in PEGASUS,
BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs 0.8%)
and dyspnea (14% vs 6%)
DRUG INTERACTIONS
- Avoid use with strong CYP3A inhibitors
and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5.
Strong inhibitors substantially increase ticagrelor exposure and so
increase the risk of adverse events. Strong inducers substantially
reduce ticagrelor exposure and so decrease the efficacy of
ticagrelor
- Patients receiving more than 40 mg per
day of simvastatin or lovastatin may be at increased risk of
statin-related adverse events
- Monitor digoxin levels with initiation
of, or change in, BRILINTA therapy
INDICATIONS
BRILINTA (ticagrelor) tablets is indicated to reduce the rate of
cardiovascular death, myocardial infarction (MI), and stroke in
patients with acute coronary syndrome (ACS) or a history of
myocardial infarction. For at least the first 12 months following
ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients
who have been stented for treatment of ACS.
DOSING
In the management of ACS, initiate BRILINTA treatment with a
180-mg loading dose. Administer 90 mg twice daily during the first
year after an ACS event. After one year administer 60 mg twice
daily. Use BRILINTA with a daily maintenance dose of aspirin of
75-100 mg.
Please read Medication
Guide and Prescribing
Information, including Boxed WARNINGS, for
BRILINTA.
IMPORTANT SAFETY INFORMATION FOR BYDUREON (exenatide
extended-release) for injectable suspension, 2 mg
WARNING: RISK OF THYROID C-CELL TUMORS
- Exenatide extended-release causes an
increased incidence in thyroid C-cell tumors at clinically relevant
exposures in rats compared to controls. It is unknown whether
BYDUREON causes thyroid C-cell tumors, including medullary thyroid
carcinoma (MTC), in humans, as the human relevance of exenatide
extended-release-induced rodent thyroid C-cell tumors has not been
determined
- BYDUREON is contraindicated in
patients with a personal or family history of MTC or in patients
with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel
patients regarding the potential risk of MTC with the use of
BYDUREON and inform them of symptoms of thyroid tumors (eg, mass in
the neck, dysphagia, dyspnea, persistent hoarseness). Routine
monitoring of serum calcitonin or using thyroid ultrasound is of
uncertain value for detection of MTC in patients treated with
BYDUREON
CONTRAINDICATIONS
- Personal or family history of MTC,
patients with MEN 2
- Prior serious hypersensitivity
reactions to exenatide or product components
WARNINGS AND PRECAUTIONS
- Acute Pancreatitis including
fatal and non-fatal hemorrhagic or necrotizing pancreatitis has
been reported. After initiation, observe patients carefully for
symptoms of pancreatitis. If suspected, discontinue promptly and do
not restart if confirmed. Consider other antidiabetic therapies in
patients with a history of pancreatitis
- Hypoglycemia Risk of
hypoglycemia is increased when exenatide is coadministered with
insulin or insulin secretagogues. Consider lowering the dose of
these agents when coadministered with BYDUREON
- Acute Kidney Injury and Impairment
of Renal Function Altered renal function, including increased
serum creatinine, renal impairment, worsened chronic renal failure,
and acute renal failure, sometimes requiring hemodialysis and
kidney transplantation have been reported. Not recommended in
patients with severe renal impairment or end-stage renal disease.
Use caution in patients with renal transplantation or moderate
renal impairment
- Gastrointestinal Disease Because
exenatide is commonly associated with gastrointestinal adverse
reactions, not recommended in patients with severe gastrointestinal
disease (eg, gastroparesis)
- Immunogenicity Patients may
develop antibodies to exenatide. Patients with higher titer
antibodies may have an attenuated HbA1c response. In clinical
trials, attenuated glycemic response was associated with
BYDUREON-treated patients. If worsening of or failure to achieve
adequate glycemic control occurs, consider alternative antidiabetic
therapy
- Hypersensitivity Reports of
serious hypersensitivity reactions (eg, anaphylaxis and
angioedema). If this occurs, patients should discontinue BYDUREON
and promptly seek medical advice
- Injection-Site Reactions Serious
reactions (eg, abscess, cellulitis, and necrosis), with or without
subcutaneous nodules, have been reported
- Macrovascular Outcomes No
clinical studies establishing conclusive evidence of macrovascular
risk reduction with exenatide
ADVERSE REACTIONS
Most common (≥5%) and occurring more frequently than comparator
in clinical trials: nausea (16.9%), diarrhea (12.7%), headache
(8.0%), vomiting (6.8%), constipation (5.9%), injection-site
pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia
(5.1%).
DRUG INTERACTIONS
- Oral Medications BYDUREON slows
gastric emptying and may reduce the rate of absorption of orally
administered drugs
- Warfarin Increased international
normalized ratio (INR) sometimes associated with bleeding has been
reported with concomitant use of exenatide with warfarin. Monitor
INR frequently until stable upon initiation of BYDUREON
PREGNANCY
Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
INDICATION AND LIMITATIONS OF USE
BYDUREON is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes
mellitus
- Not recommended as first-line therapy
for patients inadequately controlled on diet and exercise
- Not a substitute for insulin. Should
not be used to treat type 1 diabetes mellitus or diabetic
ketoacidosis
- Not recommended for use with
insulin
- Do not coadminister with other
exenatide-containing products
- Not studied in patients with a history
of pancreatitis. Consider other antidiabetic therapies in patients
with a history of pancreatitis
Please see full Prescribing Information
and Medication Guide, including Boxed WARNINGS, for
BYDUREON.
NOTES TO EDITORS
For the full listing of AstraZeneca/MedImmune Presentations at
AHA 2017, please visit
http://www.abstractsonline.com/pp8/#!/4412/
About AstraZeneca in Cardiovascular, Renal & Metabolic
Diseases (CVMD)
Cardiovascular, renal and metabolic diseases together form one
of AstraZeneca’s main therapy areas and platforms for future
growth. By following the science to understand more clearly the
underlying links between the heart, kidney and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. Our ambition is to
modify or halt the natural course of CVMDs and even regenerate
organs and restore function, by continuing to deliver
transformative science that improves treatment practices and CVMD
health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
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