[June 08, 2016] |
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AstraZeneca to Highlight Scientific Advancements Across Its Diabetes Portfolio at the American Diabetes Association 76th Scientific Sessions
AstraZeneca and its global biologics research and development arm,
MedImmune, today announced that more than 60 abstracts reporting results
of the company's research and development in diabetes have been accepted
at the 76th Scientific Sessions of the American Diabetes
Association (ADA) in New Orleans, June 10-14, 2016.
Presentations include data evaluating FARXIGA® (dapagliflozin),
BYDUREON® (exenatide extended-release), ONGLYZA®
(saxagliptin) and BYETTA® (exenatide). Late-breaking data
will also be presented, including investigational data on the effect of
MEDI0382, a novel dual-agonist of the glucagon-like peptide 1 (GLP-1)
and glucagon receptors on glycemic control and weight, and effect of
MEDI4166, a novel fusion molecule of an anti-proprotein convertase
subtilisin/kexin type 9 (PCSK9) monoclonal antibody and a GLP-1 analog
on glucose control and cholesterol.
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, AstraZeneca, said: "The breadth
of our scientific data at ADA illustrates our 'whole patient' approach
to diabetes research, where the ultimate goal is to achieve patient
outcomes beyond glycemic control with a strong focus on delaying
cardiovascular and chronic kidney disease complications."
The studies to be presented evaluate the management of multiple risk
factors associated with type 2 diabetes, therapeutic durability and
suboptimal glycemic control, early-stage research and development,
safety and efficacy of combination therapies, and advances in diabetes
care and global treatment patterns.
Robert Henry, MD, Chief, VA Endocrinology & Metabolism, Professor of
Medicine, UC San Diego School of Medicine, said: "AstraZeneca's strong
global collaborations with health experts, patient advocates and
policymakers have established it as a leader in transforming the
management and treatment of diabetes. At ADA, the company will present a
wealth of scientific knowledge generated with these partners that
examines the interrelated nature of diabetes and its comorbidities, and
explore novel, early approaches to treatment."
Notable clinical and pre-clinical data being presented across areas of
focus for AstraZeneca and MedImmune include:
Data evaluating the effect of dapagliflozin and exenatide on risk
factors in patients with type 2 diabetes
-
Effects of Dapagliflozin on Cardiovascular Risk Factors at Varying
Degrees of Renal Function (Poster 1095-P, Saturday June 11, 12:30 pm
CDT (News - Alert))1
-
Safety and Efficacy of Dapagliflozin in Combination with
Potassium-Sparing Agents (Poster 1094-P, Saturday June 11, 12:30 pm
CDT)2
-
Baseline Characteristics of Patients Enrolled in the Exenatide Study
of Cardiovascular Event Lowering (EXSCEL) (Poster 1039-P, Saturday
June 11, 11:30 am CDT)3
Studies assessing the long-term effect and durability of
AstraZeneca diabetes treatments on glycemic control
-
Effects of Dapagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor,
on 24-hour Glycemic Control in Patients with Type 2 Diabetes (Poster
1185-P, Sunday June 12, 12:00 pm CDT)4
-
Effect of Exenatide Once-Weekly on Glycemic Fluctuations in Patients
with Type 2 Diabetes (Poster 1014-P, Sunday June 12, 12:00 pm CDT)5
-
DURATION-1 Extension in Patients with Type 2 Diabetes: Efficacy and
Tolerability of Exenatide Once-Weekly Over 7 Years (Poster 1041-P,
Saturday June 11, 11:30 am CDT)6
-
Time to Treatment Intensification and its Association with Subsequent
Glycemic Control Among Patients with Type 2 Diabetes (Poster 1218-P,
Saturday June 11, 12:30 pm CDT)7
Early-stage research and development evaluating novel approaches
to diabetes and associated metabolic conditions
-
MEDI4166 A PCSK9 Ab-GLP-1 Fusion Molecule: Impact on Antidiabetic and
Antihyperlipidemic Effects in Rodents and Non-human Primates
(Late-Breaker LB-35, Sunday June 12, 12:00 pm CDT)8
-
Effect of a Dual GLP-1/Glucagon Receptor Agonist on Steatosis and
Indices of Non-Alcoholic Steatosis (NASH) Compared to GLP-1 Receptor
and FXR Agonists in a Mouse Model of NASH (Oral 71-OR, Saturday June
11, 8:30 am CDT)9
-
MEDI0382, Effects of a GLP-1/Glucagon Dual Agonist on
Safety/Tolerability Endpoints in a Single Dose Healthy Volunteer Study
(Late-Breaker LB-107, Sunday June 12, 12:00 pm CDT)10
-
Acute metabolic effects of MEDI0382, a GLP-1/Glucagon Dual Agonist, in
Wild Type and GLP-1 Receptor Knock-Out (GLP-1RKO) Mice (Oral 134-OR,
Saturday June 11, 1:45 pm CDT)11
Real-world evidence to help drive insights into treatment patterns
globally
-
Advances in Diabetes Care 1996 to 2012: A Great Investment (Oral
350-OR, Monday June 13, 4:30 pm CDT)12
-
Real-World Clinical Outcomes Among Exenatide Once-Weekly Initiators
Compared to Matched Initiators of Basal Insulin (Poster-1056-P,
Saturday June 11, 11:30 am CDT)13
-
Suboptimal Glycemic control in Patients with Type 2 Diabetes:
Retrospective Data from 22,272 Individuals (Poster 1558-P, Sunday June
12, 12:00 pm CDT)14
The complete list of AstraZeneca data 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.
FARXIGA is not indicated for weight loss or the treatment of
cardiovascular risk factors.
Important Safety Information For FARXIGA
Contraindications
-
History of a serious hypersensitivity reaction to FARXIGA
-
Severe renal impairment, end stage renal disease, or patients on
dialysis
Warnings and Precautions
-
Hypotension: FARXIGA causes intravascular volume contraction.
Symptomatic hypotension can occur after initiating FARXIGA,
particularly in patients with impaired renal function (eGFR <60
mL/min/1.73 m2), elderly patients, or patients on loop
diuretics. Before initiating FARXIGA in patients with one or more of
these characteristics, assess and correct volume status. After
initiating therapy, monitor for signs and symptoms of hypotension.
-
Ketoacidosis has been reported in patients with type 1 and type
2 diabetes receiving SGLT2 inhibitors, including FARXIGA. 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 of therapy in
clinical situations known to predispose to ketoacidosis.
-
Impairment in Renal Function: FARXIGA increases serum
creatinine and decreases eGFR. Elderly patients and patients with
impaired renal function may be more susceptible to these changes.
Adverse reactions related to renal function can occur after initiating
FARXIGA. Before initiating FARXIGA, evaluate renal function and
monitor periodically thereafter. Discontinue FARXIGA when eGFR is
persistently <60 mL/min/1.73 m2.
-
Urosepsis and Pyelonephritis: Serious urinary tract infections
have been reported with SGLT2 inhibitors, including FARXIGA. SGLT2
inhibitors increase the risk for urinary tract infections. Evaluate
for signs and symptoms of urinary tract infections and treat promptly.
-
Hypoglycemia with Concomitant Use with Insulin and Insulin
Secretagogues: Insulin and insulin secretagogues are known to
cause hypoglycemia. FARXIGA can increase the risk of hypoglycemia when
combined with these agents. Consider a lower dose of insulin or the
insulin secretagogue to reduce the risk of hypoglycemia when used in
combination with FARXIGA.
-
Genital Mycotic Infections: FARXIGA increases the risk of
genital mycotic infections. Patients with a history of genital mycotic
infections were more likely to develop genital mycotic infections.
Monitor and treat appropriately.
-
Increases in Low-Density Lipoprotein Cholesterol (LDL-C) occur
with FARXIGA. After initiating FARXIGA, monitor LDL-C and treat per
standard of care.
-
Bladder cancer: Across 22 clinical studies, newly diagnosed
cases of bladder cancer were reported in 0.17% of FARXIGA-treated
patients and 0.03% of placebo/comparator-treated patients. After
excluding patients in whom exposure to study drug was <1 year at the
time of diagnosis of bladder cancer, there were 4 cases with FARXIGA
and no cases with placebo/comparator. Bladder cancer risk factors and
hematuria (a potential indicator of pre-existing tumors) were balanced
between treatment arms at baseline. There were too few cases to
determine whether the emergence of these events is related to FARXIGA.
There are insufficient data to determine whether FARXIGA has an effect
on pre-existing bladder tumors. FARXIGA should not be used in patients
with active bladder cancer. Use with caution in patients with a prior
history of bladder cancer.
-
Macrovascular Outcomes: There have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with
FARXIGA or any other antidiabetic drug.
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.
-
Nursing Mothers: It is not known whether FARXIGA is excreted in
human milk. Because of the potential for serious adverse reactions in
nursing infants from FARXIGA, discontinue nursing or discontinue
FARXIGA.
-
Geriatric Use: A higher proportion of patients =65 years
treated with FARXIGA had adverse reactions related to volume depletion
and renal impairment or failure compared to patients treated with
placebo. No FARXIGA dose change is recommended based on age.
Please click here
for US Full Prescribing Information and Medication Guide for FARXIGA.
Indication and Important 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.
-
BYDUREON is not recommended as first-line therapy for patients who
have inadequate glycemic control on diet and exercise because of the
uncertain relevance of the rat thyroid C-cell tumor findings to
humans. Prescribe only to patients for whom potential benefits are
considered to outweigh potential risk.
-
Not a substitute for insulin, should not be used in patients with type
1 diabetes or diabetic ketoacidosis, and cannot be recommended for use
with insulin.
-
BYDUREON and BYETTA® (exenatide) injection both contain the
same active ingredient, exenatide, and should not be used together.
-
Exenatide has been associated with acute pancreatitis, including fatal
and non-fatal hemorrhagic or necrotizing pancreatitis, based on
postmarketing data. It is unknown whether patients with a history of
pancreatitis are at increased risk for pancreatitis while using
BYDUREON; consider other antidiabetic therapies for these patients.
-
BYDUREON is not indicated for weight loss.
Important Safety Information for BYDUREON
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 hmans, 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 and in patients with Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2). Counsel patients regarding the potential risk
for 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
-
Patients with a personal or family history of MTC and in patients with
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
-
Patients with prior serious hypersensitivity reactions to exenatide or
to any of the product components.
Warnings and Precautions
-
Pancreatitis: Based on postmarketing data, exenatide has been
associated with acute pancreatitis, including fatal and non-fatal
hemorrhagic or necrotizing pancreatitis. After initiation of BYDUREON,
observe patients carefully for pancreatitis (persistent severe
abdominal pain, sometimes radiating to the back, with or without
vomiting). If pancreatitis is suspected, BYDUREON should be
discontinued promptly and should not be restarted if pancreatitis is
confirmed.
-
Increased Risk of Hypoglycemia with Concomitant Use of Insulin
Secretagogues or Insulin: Consider reducing the insulin
secretagogues (e.g., sulfonylureas) or insulin dose to reduce the risk
of hypoglycemia.
-
Renal Impairment: Should not be used in patients with severe
renal impairment or end-stage renal disease. Use with caution in
patients with renal transplantation or moderate renal failure.
Postmarketing reports of altered renal function with exenatide,
including increased serum creatinine, renal impairment, worsened
chronic renal failure, and acute renal failure, sometimes requiring
hemodialysis and kidney transplantation.
-
Gastrointestinal Disease: Because exenatide is commonly
associated with gastrointestinal adverse reactions, BYDUREON is 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: Postmarketing reports of serious
hypersensitivity reactions (eg, anaphylaxis and angioedema). If this
occurs, patients should discontinue BYDUREON and other suspect
medications and promptly seek medical advice.
-
Injection-Site Reactions: Postmarketing reports of serious
injection-site reactions (eg, abscess, cellulitis, and necrosis), with
or without subcutaneous nodules, with the use of BYDUREON.
-
Macrovascular Outcomes: No clinical studies establishing
conclusive evidence of macrovascular risk reduction with BYDUREON or
any other antidiabetic drug.
Adverse Reactions
-
The most common (=5%) adverse reactions reported in BYDUREON-treated
patients and occurring more frequently than comparator in clinical
trials were 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 (News - Alert)
-
Oral Medications: BYDUREON slows gastric emptying and can
reduce the rate of absorption of orally administered drugs. Use with
caution with oral medications.
-
Warfarin: Postmarketing reports with exenatide of increased
international normalized ratio (INR) sometimes associated with
bleeding with concomitant use of warfarin. Monitor INR frequently
until stable upon initiation or alteration of BYDUREON.
Use in Specific Populations
-
Pregnant and Nursing Women: Based on animal data, BYDUREON may
cause fetal harm and should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. To report
drug exposure during pregnancy call 1-800-633-9081. When administered
to a nursing woman, a decision should be made whether to discontinue
nursing or to discontinue BYDUREON.
-
Pediatric Patients: Use in pediatric patients is not
recommended as safety and effectiveness have not been established.
Please click
here for Full Prescribing Information and click
here for Medication Guide for BYDUREON 2 mg, including Boxed
WARNING regarding risk of thyroid C-cell tumors.
Indication and Limitations of Use for ONGLYZA® (saxagliptin)
ONGLYZA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus.
ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus
or diabetic ketoacidosis.
Important Safety Information for ONGLYZA
Contraindications
-
History of a serious hypersensitivity reaction to ONGLYZA (eg,
anaphylaxis, angioedema, or exfoliative skin conditions)
Warnings and Precautions
-
Pancreatitis: There have been postmarketing reports of acute
pancreatitis in patients taking ONGLYZA, and in the SAVOR
cardiovascular outcomes trial after initiating ONGLYZA. After
initiating ONGLYZA, observe patients carefully for signs and symptoms
of pancreatitis. If pancreatitis is suspected, promptly discontinue
ONGLYZA and initiate appropriate management. It is unknown whether
patients with a history of pancreatitis are at increased risk of
developing pancreatitis while using ONGLYZA
-
Heart Failure: In SAVOR, a cardiovascular outcomes trial
enrolling participants with established or multiple risk factors for
atherosclerotic cardiovascular disease (ASCVD), more patients treated
with ONGLYZA were hospitalized for heart failure compared to placebo.
Patients with a prior history of heart failure or renal impairment had
a higher risk for hospitalization for heart failure. Consider the
risks and benefits of ONGLYZA in patients who have known risk factors
for heart failure. Monitor for signs and symptoms. If heart failure
develops, initiate appropriate management and consider discontinuation
of ONGLYZA
-
Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin:
When ONGLYZA was used in combination with a sulfonylurea or with
insulin, medications known to cause hypoglycemia, the incidence of
confirmed hypoglycemia was increased over that of placebo used in
combination with a sulfonylurea or with insulin. Therefore, a lower
dose of the insulin secretagogue or insulin may be required to
minimize the risk of hypoglycemia when used in combination with ONGLYZA
-
Hypersensitivity Reactions: There have been postmarketing
reports of serious hypersensitivity reactions in patients treated with
ONGLYZA, including anaphylaxis, angioedema, and exfoliative skin
conditions. Onset (News - Alert)of these reactions occurred within the first 3
months after initiation of treatment with ONGLYZA, with some reports
occurring after the first dose. If a serious hypersensitivity reaction
is suspected, discontinue ONGLYZA, assess for other potential causes
for the event, and institute alternative treatment for diabetes. Use
caution in patients with a history of angioedema to another DPP-4
inhibitor as it is unknown whether they will be predisposed to
angioedema with ONGLYZA
-
Severe and Disabling Arthralgia: There have been postmarketing
reports of severe and disabling arthralgia in patients taking DPP-4
inhibitors. The time to onset of symptoms following initiation of drug
therapy varied from one day to years. Patients experienced relief of
symptoms upon discontinuation of the medication. A subset of patients
experienced a recurrence of symptoms when restarting the same drug or
a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible
cause for severe joint pain and discontinue drug if appropriate
-
Macrovascular Outcomes: There have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with
ONGLYZA or any other antidiabetic drug
Most Common Adverse Reactions
-
Most common adverse reactions reported in =5% of patients treated with
ONGLYZA and more commonly than in patients treated with control were
upper respiratory tract infection (7.7%, 7.6%), urinary tract
infection (6.8%, 6.1%), and headache (6.5%, 5.9%)
-
When used as add-on combination therapy with a thiazolidinedione, the
incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo
was 3.1%, 8.1% and 4.3%, respectively
-
Confirmed hypoglycemia was reported more commonly in patients treated
with ONGLYZA 2.5 mg and ONGLYZA 5 mg compared to placebo in the add-on
to glyburide trial (2.4%, 0.8% and 0.7%, respectively), with ONGLYZA 5
mg compared to placebo in the add-on to insulin (with or without
metformin) trial (5.3% and 3.3%, respectively), with ONGLYZA 2.5 mg
compared to placebo in the renal impairment trial (4.7% and 3.5%,
respectively), and with ONGLYZA 5 mg compared to placebo in the add-on
to metformin plus sulfonylurea trial (1.6% and 0.0%, respectively)
Drug Interactions
-
Because ketoconazole, a strong CYP3A4/5 inhibitor, increased
saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg
when coadministered with a strong CYP3A4/5 inhibitor (eg, atazanavir,
clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone,
nelfinavir, ritonavir, saquinavir, and telithromycin)
Use in Specific Populations
-
Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg
once daily for patients with moderate or severe renal impairment, or
with end-stage renal disease requiring hemodialysis (creatinine
clearance [CrCl] =50 mL/min). ONGLYZA should be administered following
hemodialysis. ONGLYZA has not been studied in patients undergoing
peritoneal dialysis. Assessment of renal function is recommended prior
to initiation of ONGLYZA and periodically thereafter
-
Pregnant and Nursing Women: There are no adequate and
well-controlled studies in pregnant women. ONGLYZA, like other
antidiabetic medications, should be used during pregnancy only if
clearly needed. It is not known whether saxagliptin is secreted in
human milk. Because many drugs are secreted in human milk, caution
should be exercised when ONGLYZA is administered to a nursing woman
-
Pediatric Patients: Safety and effectiveness of ONGLYZA in
pediatric patients have not been established
Please see US Full Prescribing
Information and Medication
Guide for ONGLYZA.
Indication and Important Limitations of Use for BYETTA®
(exenatide) injection
BYETTA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus.
-
Not a substitute for insulin and should not be used in patients with
type 1 diabetes or diabetic ketoacidosis.
-
Concurrent use with prandial insulin has not been studied and cannot
be recommended.
-
BYETTA has been associated with acute pancreatitis, including fatal
and non-fatal hemorrhagic or necrotizing pancreatitis, based on
postmarketing data. It is unknown whether patients with a history of
pancreatitis are at increased risk for pancreatitis while using
BYETTA; consider other antidiabetic therapies for these patients.
Important Safety Information for BYETTA
Contraindications
-
BYETTA is contraindicated in patients with prior severe
hypersensitivity reactions to exenatide or to any of the
product components.
Warnings and Precautions
-
Never Share a BYETTA Pen Between Patients: Pen-sharing poses a
risk for transmission of blood-borne pathogens, even if the needle is
changed.
-
Pancreatitis: Based on postmarketing data BYETTA has been
associated with acute pancreatitis, including fatal and non-fatal
hemorrhagic or necrotizing pancreatitis. After initiation and dose
increases of BYETTA, observe patients carefully for pancreatitis
(including persistent severe abdominal pain, sometimes radiating to
the back, with or without vomiting). If pancreatitis is suspected,
BYETTA should be discontinued promptly and should not be restarted if
pancreatitis is confirmed.
-
Hypoglycemia: Increased risk of hypoglycemia when used in
combination with a sulfonylurea (SU) or when used with a
glucose-independent insulin secretagogues (eg, meglitinides).
Clinicians may consider reducing the SU dose in patients receiving
BYETTA to reduce the risk of hypoglycemia. When used with insulin,
evaluate and consider reducing the insulin dose in patients at
increased risk of hypoglycemia.
-
Renal Impairment: Should not be used in patients with severe
renal impairment or end-stage renal disease. Use with caution in
patients with renal transplantation or when initiating or escalating
the dose in patients with moderate renal failure. Postmarketing
reports of altered renal function, including increased serum
creatinine, renal impairment, worsened chronic renal failure, and
acute renal failure, sometimes requiring hemodialysis and kidney
transplantation.
-
Gastrointestinal Disease: Because exenatide is commonly
associated with gastrointestinal adverse reactions, BYETTA is not
recommended in patients with severe gastrointestinal disease (eg,
gastroparesis).
-
Immunogenicity: Patients may develop antibodies to exenatide.
In 3 registration trials, antibody levels were measured in 90% of
patients, with up to 4% of patients having high-titer antibodies and
attenuated glycemic response. If worsening of or failure to achieve
adequate glycemic control occurs, consider alternative antidiabetic
therapy.
-
Hypersensitivity: Postmarketing reports of serious
hypersensitivity reactions (eg, anaphylaxis and angioedema). If this
occurs, patients should discontinue BYETTA and other suspect
medications and promptly seek medical advice.
-
Macrovascular Outcomes: No clinical studies establishing
conclusive evidence of macrovascular risk reduction with BYETTA or any
other antidiabetic drug.
Most Common Adverse Reactions (=5%)
-
24-week monotherapy trial vs placebo (PBO): nausea (8% vs 0%).
-
Three 30-week combination trials of BYETTA added to metformin (MET)
and/or SU vs PBO: nausea (44% vs 18%), vomiting (13% vs 4%), and
diarrhea (13% vs 6%), feeling jittery (9% vs 4%), dizziness (9% vs
6%), headache (9% vs 6%), dyspepsia (6% vs 3%).
-
16-week trial of BYETTA added to thiazolidinedione (TZD) ± MET vs PBO:
nausea (40% vs 15%), vomiting (13% vs 1%), dyspepsia (7% vs 1%),
diarrhea (6% vs 3%).
-
30-week trial of BYETTA added to insulin glargine ± MET and/or TZD vs
PBO: nausea (41% vs 8%), vomiting (18% vs 4%), diarrhea (18% vs 8%),
headache (14% vs 4%), constipation (10% vs 2%), dyspepsia (7% vs 2%),
asthenia (5% vs 1%).
-
Hypoglycemia: BYETTA as monotherapy vs PBO, 3.8% (10 mcg) and 5.2%
(5 mcg) vs 1.3%; BYETTA vs PBO, with metformin (MET): 5.3% (10
mcg) and 4.5%
(5 mcg) vs 5.3%; with SU, 35.7% (10 mcg) and 14.4% (5 mcg) vs 3.3%; with
MET + SU, 27.8% (10 mcg) and 19.2% (5 mcg) vs 12.6%; with TZD, 10.7% (10
mcg) vs 7.1%; with insulin glargine, 24.8% (10 mcg) vs 29.5%.
-
Withdrawals: monotherapy trial: 2 of 155 BYETTA patients
withdrew due to headache and nausea vs 0 PBO-treated patients. Three
30-week combination trials of BYETTA added to MET and/or SU vs PBO:
nausea (3% vs <1%), vomiting (1% vs 0). 16-week trial of BYETTA added
to TZD ± MET vs PBO: nausea (9%) and vomiting (5%), with <1% PBO
patients withdrawing due to nausea. 30-week trial of BYETTA added to
insulin glargine ± MET and/or TZD vs PBO: nausea (5.1% vs 0), vomiting
(2.9% vs 0).
Drug Interactions
-
Oral Medications: BYETTA slows gastric emptying and can reduce
the extent and rate of absorption of orally administered drugs. Use
with caution with medications that have a narrow therapeutic index or
require rapid gastrointestinal absorption. Oral medications dependent
on threshold concentrations for efficacy, such as contraceptives or
antibiotics, should be taken at least 1 hour before BYETTA.
-
Warfarin: Postmarketing reports of increased international
normalized ratio (INR) sometimes associated with bleeding with
concomitant use of warfarin. Monitor INR frequently until stable upon
initiation or alteration of BYETTA.
Use in Specific Populations
-
Pregnant and Nursing Women: Based on animal data, BYETTA may
cause fetal harm and should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. To report
drug exposure during pregnancy call
1-800-633-9081. When administered to a nursing woman, a decision should
be made whether to discontinue nursing or discontinue BYETTA.
-
Pediatric Patients: Use in pediatric patients is not
recommended as safety and effectiveness have not been established.
Please click here
for US Full Prescribing Information and Medication
Guide for BYETTA.
NOTES TO EDITORS
About Type 2 Diabetes
Diabetes is estimated to affect 29.1 million people in the US15
and 415 million people worldwide.16 Type 2 diabetes accounts
for approximately 90-95 percent of adults diagnosed with diabetes in the
US.15 The prevalence of diabetes is projected to reach more
than 642 million people worldwide by 2040.16 Type 2 diabetes
is a chronic and progressive disease characterized by multiple
pathophysiologic defects leading to elevated glucose levels.16,17
Significant unmet needs still exist, as many patients remain
inadequately controlled on their current glucose-lowering regimen.18
It is estimated that nearly half of people living with type 2 diabetes
are not achieving recommended A1C goals based on guidelines established
by professional societies and advocacy organizations for diabetes
management.18,19
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of
developing life-changing medicines that aim to reduce the global burden
and complications of diabetes. Our current portfolio consists of the
three newest classes of non-insulin, anti-diabetic treatments that
support individualized treatment approaches: SGLT-2 inhibitors, GLP-1
receptor agonists and DPP-4 inhibitors.
As a strategic therapy area for the company, we are focusing our
research and development efforts on diverse populations and patients
with significant co-morbidities, such as cardiovascular disease,
obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney
disease.
Our commitment to diabetes is exemplified by the depth and breadth of
our global clinical research program. This commitment is advancing
understanding of the treatment effects of our diabetes medicines in
broad patient populations, as well as exploring combination treatment
approaches to help more patients achieve treatment success earlier in
their disease progression. Our ambition is to reduce the long-term
impact of diabetes.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in three
main therapy areas - respiratory, inflammation, autoimmune disease
(RIA), cardiovascular and metabolic disease (CVMD) and oncology - as
well as in infection and neuroscience. 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.
About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialization of small
molecule and biologic prescription medicines. MedImmune is pioneering
innovative research and exploring novel pathways across key therapeutic
areas, including respiratory, inflammation and autoimmunity;
cardiovascular and metabolic disease; oncology; neuroscience; and
infection and vaccines. The MedImmune headquarters is located in
Gaithersburg, MD, one of AstraZeneca's three global R&D centers, with
additional sites in Cambridge, UK and Mountain View, CA (News - Alert). For more
information, please visit www.medimmune.com.
References
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