35 scientific data presentations and
publications, including new evidence for LOKELMA™
(sodium zirconium cyclosilicate) in hyperkalemia and
FARXIGA® (dapagliflozin) on renal endpoints in type-1
diabetes
Latest data on potential new medicine
roxadustat for anemia in chronic kidney disease and early-stage
findings from multiple investigational treatments
AstraZeneca will present new research spanning the Company’s
Cardiovascular, Renal and Metabolism (CVRM) therapy area at the
American Society of Nephrology (ASN) Kidney Week Annual Meeting in
San Diego, US, October 23-28, 2018.
ASN Kidney Week is a landmark meeting for AstraZeneca, which
will provide new and in-depth research aiming to inform clinical
practice across the renal treatment paradigm, while also advancing
science that uncovers commonalities and potential treatment targets
across cardiovascular, renal and metabolic diseases.
Danilo Verge, Vice President, Cardiovascular, Renal and
Metabolism, Global Medical Affairs at AstraZeneca said:
“The data we are presenting at ASN Kidney Week demonstrate our
ambition to advance treatment for patients with chronic
kidney disease and its associated complications. We are exploring
solutions to help address unmet medical need, including
disease modification during early-stage diagnosis to
managing potentially life-threatening complications as
patients progress to dialysis and end-stage renal disease.”
New research will include data from the Phase III HARMONIZE
Global trial to evaluate the safety and efficacy of LOKELMA™ for
the treatment of patients with hyperkalemia in Japan, Russia, Korea
and Taiwan. These findings add to the growing body of evidence for
LOKELMA and will support regulatory filings in those markets.
In the US, LOKELMA was approved by the Food and Drug
Administration (FDA) in May 2018 for the treatment of hyperkalemia
in adults.
Building awareness of clinical practice with real-world
evidence and clinical data
AstraZeneca will present and publish 11 abstracts that focus on
the treatment and management of hyperkalemia, including an analysis
of real-world dosing practices of renin-angiotensin-aldosterone
system (RAAS) inhibitors and their association with risk of adverse
clinical events in patients with chronic kidney disease (CKD).
The risk of hyperkalemia–a serious condition characterized by
abnormally high levels of potassium in the blood associated with
cardiovascular, renal and metabolic diseases–increases
significantly for patients with CKD and those on common medications
for heart failure (HF), such as RAAS inhibitors which can increase
potassium in the blood.
Key abstracts
Presentation/poster details LOKELMA Sodium zirconium
cyclosilicate for hyperkalemia: results of the randomized,
placebo-controlled, multi-dose HARMONIZE-GLOBAL study
Poster #TH-PO1158
Thursday, Oct 25, 10:00 AM to 12:00 PM
Poster session: Late-Breaking Clinical
Trials Posters [LB-PO]
Correction of serum potassium with sodium zirconium cyclosilicate
in Japanese patients with hyperkalemia: a dose-finding study
Poster #TH-PO1157
Thursday, Oct 25, 10:00 AM to 12:00 PM
Poster session: Late-Breaking Clinical
Trials Posters [LB-PO]
Real-world dosing practices of renin-angiotensin-aldosterone system
inhibitors are associated with risk of adverse clinical events in
CKD patients
Abstract #FR-OR116
Room 26A
Friday, Oct 26, 5:18 PM to 5:30 PM
Session Title: Towards Better Medication
Usage in Patients with CKD [OR1902-1]
Evaluating unmet needs in anemia management for CKD
patients
AstraZeneca will provide new data on investigational medicine
roxadustat, as well as additional research on the treatment
paradigm of anemia and CKD patients. Roxadustat is a potential
first-in-class new medicine and orally administered small molecule
currently in Phase III development for anemia associated with CKD
in dialysis-dependent (DD) and non-dialysis-dependent (NDD)
patients.
Data from large registries around the globe, including US, China
and countries in Europe, indicate a strong association between
anemia and poor quality of life, though many NDD patients with
anemia remain untreated due to concerns with the safety of the
current standard of care, erythropoiesis stimulating agents
(ESAs).1
Key abstracts
Presentation/poster details Anemia in CKD Anemia
treatment patterns in chronic kidney disease: results from three
international surveys among physicians
Poster
#TH-PO249
Thursday, Oct 25, 10:00 AM to 12:00 PM
Session Title: Anemia and Iron Metabolism:
Clinical [PO0202-1]
Associations of hemoglobin levels and quality of life in patients
with chronic kidney disease: pooled results from three
international surveys
Poster #TH-PO250
Thursday, Oct 25, 10:00 AM to 12:00 PM
Session Title: Anemia and Iron Metabolism:
Clinical [PO0202-1]
Early science and investigational combination
treatments
Delving deep into the science and molecular basis of CVRM
diseases, AstraZeneca’s Innovative Medicines and Early Development
(IMED) Biotech Unit will present eight abstracts focusing on
mechanisms of obesity, HF and renal disease.
New modalities provide an opportunity to design therapeutics for
disease mechanisms previously considered difficult to address, and
are a key part of our early science strategy. Our research, in
collaboration with Ionis Pharmaceuticals, on antisense
oligonucleotides (ASO) as a potential modality for new targets in
CKD will be an oral presentation, with an additional poster that
furthers our understanding of the science behind this new modality.
An additional key abstract investigates distinct endothelial cell
subpopulations using cutting-edge single cell RNA-sequencing
analysis.
Early scientific data on verinurad, an investigational treatment
for uric acid elimination, will be presented. Expanding on our
existing portfolio, a poster presentation will describe the
investigation of dapagliflozin on serum uric acid when given in
combination with verinurad and febuxostat. Dapagliflozin is
indicated to improve glycemic control in type 2 diabetes. It is not
indicated for type 1 diabetes, reduction in serum uric acid or
albuminuria.
Key abstracts
Presentation/poster details Dapagliflozin Effect of
adding dapagliflozin as an adjunct to insulin on urinary albumin to
creatinine ratio over 52 weeks in adults with type 1 diabetes
Poster #TH-PO1156
Thursday, Oct 25, 10:00 AM to 12:00 PM
Session Title: Late-Breaking Clinical
Trials Posters [LB-PO]
Reduction in albuminuria with dapagliflozin cannot be predicted by
baseline clinical characteristics or changes in most other risk
markers
Abstract #SA-OR081
Room 1B
Saturday, Oct 27, 5:06 PM to 5:18 PM
Session Title: New Considerations for
Renoprotection Clinical Trials [OR1902-2]
Early Science APOL1 antisense oligonucleotide treatment
ameliorates IFNγ-induced proteinuria in genomic APOL1 transgenic
mice
Abstract #FR-OR068
Room 33C
Friday, Oct 26, 4:30 PM to 4:42 PM
Session Title: Genetics and Kidney
Diseases: Beyond PKD [OR1002-1]
Single Cell RNA-Seq identifies molecular fingerprints of
endothelial cell subpopulations in kidney
Poster
#FR-PO942
Friday, Oct 26, 10:00 AM to 12:00 PM
Session Title: Development, Stem Cells,
Regenerative Medicine - II [PO0501-2]
The distribution profile of anti-sense oligonucleotides indicates
that proximal tubular targets should be prioritized in renal
disease
Poster #SA-PO631
Saturday, Oct 27, 10:00 AM to 12:00 PM
Session Title: Pharmacology [PO1700-1]
For a complete list of AstraZeneca data presentations during
Kidney Week, please access the ASN website.
INDICATION AND LIMITATION OF USE FOR LOKELMA™ (sodium
zirconium cyclosilicate) 10 g ORAL SUSPENSION
LOKELMA is indicated for the treatment of hyperkalemia in
adults.
LOKELMA should not be used as an emergency treatment for
life-threatening hyperkalemia because of its delayed onset of
action.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS:
- Gastrointestinal Adverse Events in
Patients with Motility Disorders: Avoid LOKELMA in patients
with severe constipation, bowel obstruction or impaction, including
abnormal post-operative bowel motility disorders. LOKELMA has not
been studied in patients with these conditions and it may be
ineffective and may worsen gastrointestinal conditions
- Edema: Each 5 g dose of LOKELMA
contains approximately 400 mg of sodium. In clinical trials of
LOKELMA, edema was generally mild to moderate in severity and was
more commonly seen in patients treated with 15 g once daily.
Monitor for signs of edema, particularly in patients who should
restrict their sodium intake or are prone to fluid overload (eg.,
heart failure or renal disease). Advise patients to adjust dietary
sodium, if appropriate. Increase the dose of diuretics as
needed
ADVERSE REACTIONS: The most common adverse reaction with
LOKELMA was mild to moderate edema. In placebo-controlled trials up
to 28 days, edema was reported in 4.4%, 5.9%, 16.1% of patients
treated with 5 g, 10 g and 15 g of LOKELMA once daily, respectively
vs 2.4% of patients receiving placebo.
DRUG INTERACTIONS: LOKELMA can transiently increase
gastric pH. In general, oral medications with pH-dependent
solubility should be administered at least 2 hours before or 2
hours after LOKELMA. Spacing is not needed if it has been
determined the concomitant medication does not exhibit pH-dependent
solubility.
PLEASE READ FULL PRESCRIBING INFORMATION For LOKELMA.
INDICATION AND LIMITATIONS OF USE FOR
FARXIGA® (dapagliflozin) tablets 5 mg and 10
mg
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
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 pre-existing 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
- Pregnancy: Advise females
of potential risk to a fetus especially during the second and third
trimesters.
- Lactation: FARXIGA is not
recommended when breastfeeding.
Please read US Full Prescribing
Information and Medication
Guide for FARXIGA
NOTES TO EDITORS
About Hyperkalemia
The risk of hyperkalemia is associated with common comorbidities
including chronic kidney disease, HF and diabetes, and these are
the same conditions in which RAAS inhibitors are recommended in
guidelines. To help prevent the recurrence of hyperkalemia,
important guideline-recommended RAAS inhibitor therapy is often
modified or discontinued. Hyperkalemia may affect 40% to 50% of
patients with CKD, and up to 50% of chronic heart failure (CHF)
patients on RAAS inhibitors.2,3,4
About Anemia in CKD
Anemia is a serious medical condition in which patients have
insufficient red blood cells and low levels of hemoglobin (“Hb”), a
protein in red blood cells that carries oxygen to cells throughout
the body.5,6 Anemia is associated with increased risk of
hospitalization, cardiovascular complications and death.5,6 In
addition, anemia frequently causes significant fatigue, cognitive
dysfunction, and decreased quality of life.7,8 Severe anemia is
common in patients with CKD and other serious illnesses. Even when
it accompanies prevalent and serious diseases, anemia is often not
effectively treated.
Anemia is particularly prevalent in patients with CKD, which
itself affects more than 200 million people worldwide and is
generally a progressive disease characterized by gradual loss of
kidney function that may eventually lead to kidney failure.
According to the United States Renal Data System, a majority of
dialysis-eligible CKD patients in the US are currently on dialysis.
Of the approximately 475,000 patients receiving dialysis in the US,
around 83% are being treated with ESAs for anemia. In clinical
practice, patients typically do not receive ESA treatment for their
anemia until they initiate dialysis.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca’s main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys 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 CVRM diseases and potentially
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and
cardiovascular 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, Renal &
Metabolism 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.
References
- Jackson, J., van Haalen, H., Salehi,
H., Milligan, G., Moon, R. Anemia Treatment Patterns in Chronic
Kidney Disease: Results From Three International Surveys Among
Physicians [abstract]. American Society of Nephrology; 2018 Oct 26;
San Diego; Abstract nr TH-PO249.
https://www.asn-online.org/education/kidneyweek/2018/program-abstract.aspx?controlId=3023640.
- Kosiborod M, Rasmussen HS, Lavin P, et
al. Effect of sodium zirconium cyclosilicate on potassium lowering
for 28 days among outpatients with hyperkalemia. JAMA. 2014.
doi:10.1001/jama.2014.15688.
- Kovesdy CP. Management of hyperkalemia
in chronic kidney disease. Nat Rev Nephrol. 2014.
doi:10.1038/nrneph.2014.168.
- Vardeny O, et al. Incidence,
predictors, and outcomes related to hypo- and hyperkalemia in
patients with severe heart failure treated with a mineralocorticoid
receptor antagonist. Circ Heart Fail. 2014;7: 573–579.
- National Kidney Foundation. “Managing
Anaemia When You Have Kidney Disease or Kidney Failure.” 2014.
- National Institute of Diabetes and
Digestive and Kidney Diseases. “Anaemia in Chronic Kidney Disease.”
2014.
- KDOQI Clinial Practice Guidelines and
Clinical Practice Recommendations for Anaemia in Chronic Kidney
Disease. Am J Kidney Dis. 2006 May;47(5):S1-S132
- American Heart Association.
“Life-Threatening Electrolyte Abnormalities.” 2005; Circulation.
2005;112:IV-121-IV-125.
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AstraZenecaMedia InquiriesMichele Meixell, +1
302-885-2677Abigail Bozarth, +1 302-885-2677
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