Updated safety data on risk-benefit profile of
Farxiga (dapagliflozin), three new analyses from the landmark
CVD-REAL study, including Farxiga vs DPP-4 inhibitors, and a
late-breaking oral presentation reveal further CV evidence across a
broad population of patients with type-2 diabetes
Data from DURATION-7 and DURATION-8 evaluating
efficacy and safety of Bydureon (exenatide extended-release) in
combination with basal insulin and Farxiga, respectively
More than 50 abstracts demonstrate commitment
to Cardiovascular and Metabolic Diseases
AstraZeneca and its global biologics research and development
arm, MedImmune, will present the latest research from the Company’s
Cardiovascular and Metabolic Diseases (CVMD) therapy area,
including for Farxiga (dapagliflozin) and Bydureon (exenatide
extended-release) for injectable suspension, with more than 50
abstracts at the American Diabetes Association’s (ADA) 77th
Scientific Sessions in San Diego, USA 9-13 June 2017.
Ludovic Helfgott, Vice President, CVMD, said: “Science points to
the need to move beyond lowering blood sugar to treat patients with
type-2 diabetes holistically and earlier in their disease
progression. Through investment in rigorous clinical and real-world
evidence studies in large and diverse patient populations, we are
committed to advancing scientific understanding of the connections
between these highly-prevalent cardiovascular and metabolic
diseases and helping to enhance clinical practice to improve the
lives of patients.”
Highlights include a comprehensive updated safety analysis of
dapagliflozin and three additional analyses from the landmark
CVD-REAL real-world evidence study, including CV data for
dapagliflozin, evaluating the risk of hospitalization for kidney
disease and heart failure (HF), as well as all-cause mortality,
compared to DPP-4 inhibitors, a commonly-used treatment for type-2
diabetes (T2D). Additionally, a late-breaking oral presentation
will explore the rates of HF and death in patients with T2D, both
with and without cardiovascular disease, receiving treatment with
SGLT-2 inhibitors (SGLT-2i) versus other T2D medicines.
Also presented will be the baseline characteristics and trial
design of DECLARE will be presented, the largest cardiovascular
outcomes trial in the SGLT-2i class. Both CVD-REAL and DECLARE are
part of the extensive DapaCare programme for dapagliflozin, which
involves patients with and without T2D to generate data across
established CV disease, CV risk factors and varying stages of renal
disease, providing healthcare providers with evidence needed to
improve patient care.
AstraZeneca will also present analyses from DURATION-8,
evaluating the investigational use of exenatide extended-release in
combination with dapagliflozin, as well as primary data from
DURATION-7, examining the investigational use of exenatide
extended-release in combination with basal insulin.
Notable data being presented by AstraZeneca include:
Real-World Evidence Evaluating CV Outcomes Treatment with
SGLT-2 inhibitors
- Evaluation of SGLT2i on Risk of
Mortality and Heart Failure Compared to Other Glucose Lowering
Drugs: A Three-country Analysis (Poster 1205-P, Sunday June 11,
12:00 p.m. PDT)
- Hospitalization for Heart Failure and
Death in New Users of SGLT2 Inhibitors in patients With and Without
Cardiovascular Disease – CVD-REAL Study (Oral 377-OR, Tuesday June
13, 10:45 a.m. PDT)
- Evaluation of dapagliflozin on Risk of
Hospitalization for Kidney Disease, Heart Failure and All-Cause
Death Compared to DPP-4i: CVD-REAL Nordic (Late-Breaker 165-LB,
Sunday June 11, 12:00 p.m. PDT)
Comprehensive New Safety Analysis of Dapagliflozin
- Safety Update on dapagliflozin (DAPA)
Across the Phase 2b/3 Clinical Trial Program (Poster 1263-P, Sunday
June 11, 12:00 p.m. PDT)
DECLARE Trial Design and Baseline Characteristics
- DECLARE-TIMI 58: Design and Baseline
Characteristics (Poster 1245-P, Sunday June 11, 12:00 p.m.
PDT)
Data Assessing GLP-1 Receptor Agonists with Other
Antidiabetic Agents
- Efficacy and Safety of exenatide QW
Versus Placebo Added to Insulin Glargine in Uncontrolled
Basal-Insulin Treated type-2 Diabetes: DURATION-7 Trial (Oral
132-OR, Saturday June 10, 4:45 p.m. PDT)
- DURATION-8 Randomized Controlled Trial
1-Year Results: Efficacy and Safety of Once-Weekly Exenatide (ExQW)
Plus Once-Daily Dapagliflozin (DAPA) Versus ExQW or DAPA Alone
(Late-Breaker Poster 141-LB, Sunday June 11, 12:00 p.m. PDT)
- Effects of exenatide Once Weekly Plus
dapagliflozin, exenatide Once Weekly, or dapagliflozin Added to
metformin Monotherapy on Cardiovascular Risk Markers in Patients
with type-2 diabetes in the DURATION-8 trial (Poster 1152-P, Sunday
June 11, 12:00 p.m. PDT)
- DURATION-8: Mechanisms of Glycemic
Control for exenatide Plus dapagliflozin Versus Each Drug Alone
(Poster 1074-P, Sunday June 11, 12:00 p.m. PDT)
- Exenatide Once Weekly (QW) Plus
dapagliflozin, exenatide QW, or dapagliflozin Added to metformin
Monotherapy in Subgroups of Patients with type-2 Diabetes in the
DURATION-8 Study (Poster 1115-P, Sunday June 11, 12:00 p.m.
PDT)
The full list of AstraZeneca scientific presentations can be
accessed on the ADA website here.
Indication and Limitations of Use for FARXIGA®
(dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes
mellitus or for the treatment of diabetic ketoacidosis.
Important Safety Information for FARXIGA®
(dapagliflozin)
Contraindications
- Prior serious hypersensitivity reaction
to FARXIGA
- Severe renal impairment (eGFR <30
mL/min/1.73 m2), end-stage renal disease, or patients on
dialysis
Warnings and Precautions
- Hypotension: FARXIGA causes
intravascular volume contraction, and symptomatic hypotension can
occur. Assess and correct volume status before initiating FARXIGA
in patients with impaired renal function, elderly patients, or
patients on loop diuretics. Monitor for hypotension
- Ketoacidosis has been reported
in patients with type 1 and type 2 diabetes receiving FARXIGA. Some
cases were fatal. Assess patients who present with signs and
symptoms of metabolic acidosis for ketoacidosis, regardless of
blood glucose level. If suspected, discontinue FARXIGA, evaluate
and treat promptly. Before initiating FARXIGA, consider risk
factors for ketoacidosis. Patients on FARXIGA may require
monitoring and temporary discontinuation in situations known to
predispose to ketoacidosis
- Acute Kidney Injury and Impairment
in Renal Function: FARXIGA causes intravascular volume
contraction and renal impairment, with reports of acute kidney
injury requiring hospitalization and dialysis. Consider temporarily
discontinuing in settings of reduced oral intake or fluid losses.
If acute kidney injury occurs, discontinue and promptly
treat.FARXIGA increases serum creatinine and decreases eGFR.
Elderly patients and patients with impaired renal function may be
more susceptible to these changes. Before initiating FARXIGA,
evaluate renal function and monitor periodically. FARXIGA is not
recommended in patients with an eGFR persistently between 30 and
<60 mL/min/1.73 m2
- Urosepsis and Pyelonephritis:
SGLT2 inhibitors increase the risk for urinary tract infections
[UTIs] and serious UTIs have been reported with FARXIGA. Evaluate
for signs and symptoms of UTIs and treat promptly
- Hypoglycemia: FARXIGA can
increase the risk of hypoglycemia when coadministered with insulin
and insulin secretagogues. Consider lowering the dose of these
agents when coadministered with FARXIGA
- Genital Mycotic Infections:
FARXIGA increases the risk of genital mycotic infections,
particularly in patients with prior genital mycotic infections.
Monitor and treat appropriately
- Increases in Low-Density Lipoprotein
Cholesterol (LDL-C) occur with FARXIGA. Monitor LDL-C and treat
per standard of care
- Bladder cancer: An imbalance in
bladder cancers was observed in clinical trials. There were too few
cases to determine whether the emergence of these events is related
to FARXIGA, and insufficient data to determine whether FARXIGA has
an effect on preexisting bladder tumors. FARXIGA should not be used
in patients with active bladder cancer. Use with caution in
patients with a history of bladder cancer
- Macrovascular Outcomes: There
have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with FARXIGA
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common
adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and
placebo respectively were female genital mycotic infections (8.4%
vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and
urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Specific Populations
- Pregnant Women: There are no
adequate and well-controlled studies of FARXIGA in pregnant women.
Consider appropriate alternative therapies, especially during the
second and third trimesters. Use during pregnancy only if the
potential benefit justifies the potential risk to the fetus
- Nursing Mothers: Discontinue
FARXIGA or discontinue nursing
Please see accompanying US Full Prescribing
Information and Medication Guide for
FARXIGA.
Indication And Limitations Of Use for BYDUREON® (exenatide
extended-release) for injectable suspension
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 in patients with type 1 diabetes or diabetic
ketoacidosis
- Not recommended for use with
insulin
- BYDUREON and BYETTA® (exenatide)
injection contain the same active ingredient, exenatide. Do not
coadminister with BYETTA
- Not studied in patients with a history
of pancreatitis. Consider other antidiabetic therapies in patients
with a history of pancreatitis
Important Safety Information for BYDUREON® (exenatide
extended-release) for injectable suspension
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
(e.g., 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
- Patients with prior serious
hypersensitivity reactions to exenatide or to any of the product
components
WARNINGS AND PRECAUTIONS
- Pancreatitis Exenatide has been
associated with acute pancreatitis, including fatal and non-fatal
hemorrhagic or necrotizing pancreatitis. 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 BYDUREON
increased the risk of hypoglycemia when coadministered with insulin
and insulin secretagogues. Consider lowering the dose of these
agents when coadministered with BYDUREON
- Renal Impairment Altered
renal function, including increased serum creatinine, renal
impairment, worsened chronic renal failure, and acute renal
failure, sometimes requiring hemodialysis and kidney
transplantation has 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 failure
- Severe 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. In 5 registration trials,
attenuated glycemic response was associated in 6% of
BYDUREON-treated patients with antibody formation. 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 BYDUREON or any other antidiabetic drug
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
PREGNANT AND NURSING WOMEN
- Pregnant Women Based on
animal data, may cause fetal harm. Use during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
- Nursing Women Discontinue
BYDUREON or discontinue nursing
Please click here for Full Prescribing Information
and click here for Medication Guide for BYDUREON 2 mg,
including Boxed WARNING.
NOTES TO EDITORS
About the DapaCare Clinical Program
AstraZeneca is taking a holistic, patient-centric approach to
disease management by focusing on the underlying morbidity,
mortality and organ damage associated with cardiovascular (CV),
metabolic and renal diseases. Due to the interconnectivity of these
diseases, AstraZeneca has developed the DapaCare clinical programme
to explore the CV and renal profile of dapagliflozin in people with
and without type-2 diabetes. The clinical programme will enroll
nearly 30,000 patients in randomized clinical trials and is
supported by a multinational real-world evidence study. DapaCare
will generate data across a spectrum of people with established CV
disease, CV risk factors and varying stages of renal disease, both
with and without type-2 diabetes, providing healthcare providers
with evidence needed to potentially improve patient outcomes.
DapaCare underscores our commitment to following the science by
pursuing a holistic patient approach to address the multiple risk
factors associated with CV, metabolic and renal diseases.
Dapagliflozin is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes.
Dapagliflozin is not indicated for the treatment of other metabolic
diseases, to reduce the risk of cardiovascular disease or renal
disease.
About AstraZeneca in Cardiovascular & Metabolic Diseases
(CVMD)
Cardiovascular, renal and metabolic diseases are key areas of
focus for AstraZeneca as part of the company’s strategy for
achieving scientific leadership and returning to growth. By
collaborating across therapeutic disciplines within the CVMD
therapy area, we are addressing the underlying disorders that drive
CVMD risk, with the goal of reducing morbidity, mortality and organ
damage through innovative therapies. Recognizing the growing unmet
needs and challenges faced by the millions of people worldwide
living with these interrelated diseases, we are determined to
understand how they interact and impact one another – and how they
can be treated together to save more patients’ lives.
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.
US- 10527 Last Updated 5/17
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