Studies examine cancer-related malnutrition and nutrition management
in pre-term babies, as well as the use of hemostats in specific
pancreatic and spinal surgeries
BARCELONA, Spain--(BUSINESS WIRE)--
Baxter International Inc. (NYSE:BAX), a leading global medical products
company, is presenting four health economics and outcomes research
(HEOR) analyses this week at the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2018 meeting. The
studies evaluated potential clinical and economic impacts of various
products and practices associated with malnutrition and surgical
procedures.
“Advancing the science and understanding of issues facing patients and
hospitals worldwide is a priority for Baxter,” said Dheerendra Kommala,
M.D., vice president of Medical Affairs at Baxter. “The findings shared
this week provide real-world evidence for how clinicians may help
improve clinical outcomes while increasing hospital efficiency.”
Malnutrition in Cancer Patients
Malnutrition occurs in roughly 40 to 60 percent of cancer patients
worldwide1,2 and is a frequent complication that negatively
impacts outcomes for patients3 -- including possible loss of
skeletal muscle and increased risk of physical impairment, surgical
complications, treatment toxicity and shorter survival.3 In
fact, it’s estimated that one out of four cancer patients die from
malnutrition rather than tumor progression.1 An analysis of
real-world data from three retrospective, observational studies of
administrative healthcare databases in France, Germany and Italy
suggests that early screening, diagnosis and treatment of malnutrition
is associated with improvement in cancer patients’ clinical outcomes as
well as reduction of healthcare resources use and hospital costs.4
(PCN327,
November 2018, ISPOR Europe 2018, Barcelona, Spain)
Parenteral Nutrition in Preterm Infants
Globally, approximately 15 million babies (or 1 in 10 births) are born
preterm every year.5 Prematurity is the leading cause of
death among newborns,6 and low birth weight puts surviving
preterm infants at risk for serious complications.7
Researchers performed a cost-consequence analysis that used a
deterministic model with inputs from an existing budget impact model.
The findings suggest using a standardized, triple-chamber bag (3CB)
system for parenteral nutrition -- that includes protein, carbohydrates,
lipids and electrolytes -- to treat the majority of preterm babies would
substantially reduce the risk of blood stream infections, compounding
errors, and resource burden.8 When looking at cases across
Germany, France and Italy, the model concluded that a 10 percent
increase in the use of a 3CB system could result in a two percent
reduction in blood stream infections, a 10 percent reduction in
compounding errors and a combined 9.6 million euros of hospital budget
impact across all three countries.8 (PIH24,
November 2018, ISPOR Europe 2018, Barcelona, Spain)
Hemopatch in Pancreatic Surgeries
A pancreaticoduodenectomy -- when the head of the pancreas, a portion of
the small intestine, the gall bladder and the bile duct are surgically
removed -- is the most common procedure to treat pancreatic cancer, with
postoperative pancreatic fistula (POPF) the most common major and
potentially life-threatening complication. A retrospective observational
analysis of 26 consecutive pancreaticoduodenectomies at a hospital in
Spain suggested hemostatic-sealant Hemopatch might be an
effective and cost-beneficial additional treatment compared to the
Standard of Care (SoC) alone. The analysis concluded that the use of Hemopatch
was associated with a reduction in complications (POPF by 23.1 percent,
biliary fistula by 7.7 percent and hemorrhages by 7.7 percent), as well
as a shorter hospital stay (a mean of 4.8 days in this study) and fewer
healthcare costs (an estimated $10,676 or 23 percent in savings per
patient).9 (PGI18,
November 2018, ISPOR Europe 2018, Barcelona, Spain)
Floseal in Spinal Surgeries
A study of retrospective data on 15,105 propensity-matched pairs of
spinal surgeries from a large U.S. hospital billing database found cases
with charges for Floseal, as the sole topical adjunctive hemostat used,
were associated with fewer blood transfusions, lower blood-related
complications, shorter hospital stays, and shorter surgical procedures
than cases with charges for Floseal and other topical hemostats
(gelatin sponges and thrombin).10 Researchers then developed
a cost consequence model to calculate the potential cost savings
associated with the improved clinical outcomes and lower resource use
observed in the first study for Floseal-only cases. The model
concluded that the decreased use of resources, including shorter
hospital stays and lower overall topical adjunctive hemostat use, could
potentially save mid-volume U.S. hospitals $2,445 per spinal procedure.11
The results were published
in September in the Journal of Medical Economics. (PMD67,
November 2018, ISPOR Europe 2018, Barcelona, Spain)
Attendees at ISPOR Europe 2018 can visit each of Baxter’s poster
sessions to learn more about the data.
About Baxter
Every day, millions of patients and caregivers rely on Baxter’s leading
portfolio of critical care, nutrition, renal, hospital and surgical
products. For more than 85 years, we’ve been operating at the critical
intersection where innovations that save and sustain lives meet the
healthcare providers that make it happen. With products, technologies
and therapies available in more than 100 countries, Baxter’s employees
worldwide are now building upon the company’s rich heritage of medical
breakthroughs to advance the next generation of transformative
healthcare innovations. To learn more, visit www.baxter.com and
follow us on Twitter, LinkedIn and Facebook.
Important Safety Information
Hemopatch is intended as a hemostatic device and surgical sealant
for procedures in which control of bleeding or leakage of other body
fluids or air by conventional surgical techniques is either ineffective
or impractical. Hemopatch may be used to close dural defects
following traumatic injury, excision, retraction or shrinkage of the
dura mater.
Important Risk Information for Hemopatch
Do not compress Hemopatch into blood vessels or use
intravascularly.
The device must not be used in patients with known hypersensitivity to
bovine proteins or brilliant blue.
Hemopatch is not intended to be used in pulsatile, severe
bleedings.
The use of Hemopatch is not recommended in the presence of an
active infection.
When used in, around, or in proximity to foramina in bone, areas of bony
confine, the spinal cord, the brain and/or cranial nerves, care should
be exercised to avoid overpacking, creating the potential for neural
damage.
Hemopatch is not intended as a substitute for meticulous surgical
technique and the proper application of ligatures or other conventional
procedures for hemostasis and sealing.
About Floseal
Important Safety Information
Floseal Matrix is indicated in surgical procedures (other than
ophthalmic) as an adjunct to hemostasis when control of bleeding by
ligature or convention procedure is ineffective or impractical.
Important Risk Information for Floseal Matrix
Do not inject or compress Floseal Matrix into blood vessels. Do
not apply Floseal Matrix in the absence of active blood flow,
e.g., while the vessel is clamped or bypassed, as extensive
intravascular clotting and even death may result.
Do not use Floseal Matrix in patients with known allergies to
materials of bovine origin. Do not use Floseal Matrix in the
closure of skin incisions because it may interfere with the healing of
the skin edges.
Floseal Matrix contains Thrombin made from human plasma. It may
carry a risk of transmitting infectious agents, e.g., viruses, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Floseal Matrix is not intended as a substitute for meticulous
surgical technique and the proper application of ligatures or other
conventional procedures for hemostasis.
Excess Floseal Matrix (material not incorporated in the
hemostatic clot) should always be removed by gentle irrigation from the
site of application. Floseal Matrix swells by approximately 10%
to 20% after product is applied. Maximum swell volume is achieved within
about 10 minutes.
The safety and effectiveness of Floseal Matrix has not been
established in children under 2 years of age and pregnant women.
Do not use air to remove residual Floseal Matrix from Applicator
tip. The Applicator tips should not be cut. Do not use Floseal
Matrix on bone surfaces where adhesives, such as methylmethacrylate or
other acrylic adhesives, will be required to attach a prosthetic device.
Rx Only. For safe and proper use of this device, refer to the
full Instructions for Use.
This release includes forward-looking statements concerning Hemopatch
and Floseal, including potential benefits associated with their
use. The statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those in the forward-looking statements:
satisfaction of regulatory and other requirements; actions of regulatory
bodies and other governmental authorities; product quality,
manufacturing or supply, or patient safety issues; changes in law and
regulations; and other risks identified in Baxter's most recent filing
on Form 10-K and other SEC filings, all of which are available on
Baxter's website. Baxter does not undertake to update its
forward-looking statements.
Baxter, Hemopatch and Floseal are registered trademarks of
Baxter International Inc.
1 Hébuterne, X. et.al 2014. Prevalence of MN and current use
of nutrition support in patients with cancer. Journal of Parenteral and
Enteral Nutrition, 38(2), 196-204
2 Arends, J. et.al
2017. ESPEN expert group recommendations for action against
cancer-related MN. CN, 36(5), 1187-1196
3 Virizuela, J.
A. et.al 2018. Nutritional support and parenteral nutrition in cancer
patients: an expert consensus report. Clinical & Translational Oncology,
20(5), 619-629
4 Challenges and opportunities in
clinical nutrition in oncology: available evidence, real-word practices,
and the way forward. Goldwasser F, Piaggio T, Lucas J, Zalcman G,
Tilleul P, Schiefke I, Marschal O, Pedrazzoli P, Caccialanza R. https://tools.ispor.org/ScientificPresentationsDatabase/Presentation/84243?pdfid=58699
5
Althabe F, Howson CP, Kinney M, Lawn J, World Health Organization. Born
too soon: the global action report on preterm birth. 2012. Available
from: www.who.int/pmnch/media/news/2012/201204_borntoosoon-report.pdf
6
March of Dimes, PMNCH, Save the Children, WHO. Born Too Soon: The Global
Action Report on Preterm Birth. Eds CPHowson, MV Kinney, JE Lawn. World
Health Organization. Geneva, 2012
7 GBD 2015 Child
Mortality Collaborators, and others. Global, regional, national, and
selected subnational levels of stillbirths, neonatal, infant, and
under-5 mortality, 1980–2015: a systematic analysis for the Global
Burden of Disease Study 2015. 2016. The Lancet, 388 (10053): 1725–1774
8
Modelled effects of a pediatric triple-chamber-bag (3CB) system on payer
costs and clinical outcomes in pre-term neonates across France, Germany
and Italy. Alexander Kriz, Alberto Migliore, Antony Wright, Tomaso
Piaggio. https://tools.ispor.org/ScientificPresentationsDatabase/Presentation/87975?pdfid=56247
9
Use of peg-coated collagen hemostatic sealant (HS) in
pancreatoduodenectomy (PD) surgery: incidence of postoperative
pancreatic fistula (POPF) and cost-benefit analysis in a retrospective
study. Ramirez MG, Serradilla Mario, Ramirez Manuel A. https://tools.ispor.org/ScientificPresentationsDatabase/Presentation/85079?pdfid=57401
10
Manuel G. Ramirez, Harel Deutsch, Nitin Khanna, Donald Cheatem, Dongyan
Yang & Erik Kuntze (2018) Floseal only versus in combination in spine
surgery: a comparative, retrospective hospital database evaluation of
clinical and healthcare resource outcomes, Hospital Practice, DOI:
10.1080/21548331.2018.1498279
226840511 Cost–consequence
analysis of a hemostatic matrix alone or in combination for spine
surgery patients. Manuel G. Ramirez, Xiaoli Niu, Josh Epstein & Dongyan
Yang. Received 10 Jul 2017, Accepted 13 Aug 2018, Accepted author
version posted online: 16 Aug 2018, Published online: 30 Aug 2018. https://doi.org/10.1080/13696998.2018.1513261
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Baxter International Inc.
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Source: Baxter International Inc.