WINNIPEG, MB, Nov. 4, 2021 /CNW/ - Medicure Inc. ("Medicure" or
the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular
pharmaceutical company, is pleased to announce the results from the
SAVI-PCI clinical trial demonstrating that the use of short
infusion AGGRASTAT® (tirofiban hydrochloride) injection
was non-inferior to label-dosing INTEGRILIN®
(eptifibatide) or long-infusion AGGRASTAT® in a primary
endpoint of combined efficacy and major bleeding.
SAVI-PCI was a randomized, multicenter, open-label study
enrolling 535 patients at 13 sites in the United States comparing a bolus plus short (1
– 2 hour) infusion AGGRASTAT® to label-dosing
(double-bolus plus 12 – 18 hour infusion) INTEGRILIN®. A
third arm of bolus plus long (12 – 18 hour) infusion
AGGRASTAT® was later added to the study. The primary
endpoint was the non-inferiority (margin 19.1%) of a composite of
death, periprocedural myonecrosis (PPM), urgent target vessel
revascularization (uTVR) or in-hospital, non-CABG related REPLACE-2
defined major bleeding within 48 hours following PCI or hospital
discharge, whichever came first (NCT01522417). This study was
sponsored by Medicure.
The study showed that short infusion AGGRASTAT® was
non-inferior to both label-dosing INTEGRILIN® (34.2% vs
30.9%, Risk Difference = 0.0323, 95% CI [-0.0599 – 0.1245]) and
long-infusion AGGRASTAT® (34.2% vs 39.0%, Risk
Difference = -0.0487, 95% CI [-0.1569 – 0.0595]) with respect to
the primary endpoint. The primary endpoint was driven by the
occurrence of PPM, defined as a troponin value ≥ 3 times the upper
limit of normal when compared to baseline. There was only a single
death in the study (INTEGRILIN® arm) and 2 uTVR events
(1 in each of the short and long AGGRASTAT® arms,
respectively). There was no significant difference in REPLACE-2
major bleeding events between the short infusion
AGGRASTAT® or label-dosing INTEGRILIN® arms
(0 vs 0.5%, p = 0.2457); however, there was a significant reduction
when compared to the long AGGRASTAT® arm (0 vs 3.2%, p =
0.0093).
"We are very pleased to announce that the SAVI-PCI study met its
primary endpoint, demonstrating the non-inferiority of a bolus plus
short-infusion of AGGRASTAT® when compared to longer
infusion regimens. We believe that these results reflect the
contemporary use of AGGRASTAT® in the United States and are pleased to provide
clinical evidence for its use", said Albert
Friesen, PhD, CEO of Medicure. When asked for comment on
behalf of the executive steering committee, Dr. Jorge Saucedo, lead author of the manuscript and
Division Chief of Cardiovascular Medicine at the Medical College of Wisconsin, stated that "We're
pleased that SAVI-PCI has reached its final completion. This data
represents the first randomized clinical trial comparing tirofiban
with long infusion glycoprotein IIb/IIIa inhibitors and
demonstrates that a short infusion strategy may mitigate some of
the bleeding risks associated with longer infusions, while still
providing a high level of ischemic protection."
The key results were shared today at the Transcatheter
Cardiovascular Therapeutics (TCT) Annual Meeting. Additionally, the
manuscript has been submitted for publication and is currently
under scientific peer review.
AGGRASTAT® (tirofiban hydrochloride) injection is a
non-peptide antagonist of the platelet glycoprotein (GP) IIb/IIIa
receptor and inhibits the final common pathway in platelet
aggregation. AGGRASTAT® is indicated to reduce the rate
of thrombotic cardiovascular events (combined endpoint of death,
myocardial infarction, or refractory ischemia/repeat cardiac
procedure) in patients with non-ST elevation acute coronary
syndrome (NSTE-ACS).1
About Aggrastat
Aggrastat is an IV antiplatelet
medication indicated to reduce the rate of thrombotic
cardiovascular events (combined endpoint of death, myocardial
infarction, or refractory ischemia/repeat cardiac procedure) in
patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Aggrastat is currently the most widely used GP IIb/IIIa inhibitor
in the U.S. and has several administration benefits including room
temperature storage, a 3-year shelf life and is available in
pre-mixed formats. Please refer to the IMPORTANT SAFETY INFORMATION
below.
About Medicure Inc.
Medicure is a pharmaceutical
company focused on the development and commercialization of
therapies for the U.S. cardiovascular market. The present focus of
the Company is the marketing and distribution of
AGGRASTAT® (tirofiban hydrochloride) injection and
ZYPITAMAG® (pitavastatin) tablets in the United States, where they are sold through
the Company's U.S. subsidiary, Medicure Pharma Inc. Medicure also
operates Marley Drug, Inc. ("Marley"), a pharmacy located in
North Carolina that offers an
Extended Supply mail order drug program serving all 50 US states,
Washington D.C. and Puerto Rico. Marley Drug™ is committed to
improving the health status of its patients and the communities
they serve while reducing overall health care costs for employers
and other health care consumers. For more information visit
www.marleydrug.com. To learn more about The Extended Supply Generic
Drug Program call 800.286.6781 or email
info@marleydrug.com. For more information on Medicure please
visit www.medicure.com. For additional information about
AGGRASTAT®, refer to the full Prescribing Information.
For additional information about ZYPITAMAG®, refer to
the full Prescribing Information.
Medicure is a pharmaceutical company focused on the development
and commercialization of therapies for the U.S. cardiovascular
market. The present focus of the Company is the marketing and
distribution of AGGRASTAT® (tirofiban hydrochloride)
injection and ZYPITAMAG® (pitavastatin) tablets in
the United States, where they are
sold through the Company's U.S. subsidiary, Medicure Pharma Inc.
For more information on Medicure please visit www.medicure.com.
Important Safety Information for AGGRASTAT®
(tirofiban hydrochloride)
Indications and Usage
AGGRASTAT is indicated to reduce
the rate of thrombotic cardiovascular events (combined endpoint of
death, myocardial infarction, or refractory ischemia/repeat cardiac
procedure) in patients with non-ST elevation acute coronary
syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25
mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18
hours. In patients with creatinine clearance ≤60 mL/min, give 25
mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
Contraindications
Known hypersensitivity to any
component of AGGRASTAT, history of thrombocytopenia with prior
exposure to Aggrastat, active internal bleeding, or history of
bleeding diathesis, major surgical procedure or severe physical
trauma within previous month.
Warnings and Precautions
AGGRASTAT can cause serious
bleeding. Most bleeding associated with AGGRASTAT occurs at the
arterial access site for cardiac catheterization. Minimize the use
of traumatic or potentially traumatic procedures such as arterial
and venous punctures, intramuscular injections, nasotracheal
intubation, etc. Concomitant use of fibrinolytics, anticoagulants
and antiplatelet drugs increases the risk of bleeding. If bleeding
cannot be controlled, discontinue AGGRASTAT.
Thrombocytopenia: Discontinue AGGRASTAT and heparin.
Adverse Reactions
Bleeding is the most commonly
reported adverse reaction.
For more information on AGGRASTAT, please refer to Full
Prescribing Information available at www.aggrastatHDB.com.
To be added to Medicure's e-mail list, please visit:
medicure.mediaroom.com/alerts
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Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Forward Looking Information: Statements contained in this press
release that are not statements of historical fact, including,
without limitation, statements containing the words "believes",
"may", "plans", "will", "estimates", "continues", "anticipates",
"intends", "expects" and similar expressions, may constitute
"forward-looking information" within the meaning of applicable
Canadian and U.S. federal securities laws (such forward-looking
information and forward-looking statements are hereinafter
collectively referred to as "forward-looking statements").
Forward-looking statements, include estimates, analysis and
opinions of management of the Company made in light of its
experience and its perception of trends, current conditions and
expected developments, as well as other factors which the Company
believes to be relevant and reasonable in the circumstances.
Inherent in forward-looking statements are known and unknown risks,
uncertainties and other factors beyond the Company's ability to
predict or control that may cause the actual results, events or
developments to be materially different from any future results,
events or developments expressed or implied by such forward-looking
statements, and as such, readers are cautioned not to place undue
reliance on forward-looking statements. Such risk factors include,
among others, the Company's future product revenues, stage of
development, additional capital requirements, risks associated with
the completion and timing of clinical trials and obtaining
regulatory approval to market the Company's products, the ability
to protect its intellectual property, dependence upon collaborative
partners, changes in government regulation or regulatory approval
processes, and rapid technological change in the industry. Such
statements are based on a number of assumptions which may prove to
be incorrect, including, but not limited to, assumptions about:
general business and economic conditions; the impact of changes in
Canadian-US dollar and other foreign exchange rates on the
Company's revenues, costs and results; the timing of the receipt of
regulatory and governmental approvals for the Company's research
and development projects; the availability of financing for the
Company's commercial operations and/or research and development
projects, or the availability of financing on reasonable terms;
results of current and future clinical trials; the uncertainties
associated with the acceptance and demand for new products and
market competition. The foregoing list of important factors and
assumptions is not exhaustive. The Company undertakes no obligation
to update publicly or otherwise revise any forward-looking
statements or the foregoing list of factors, other than as may be
required by applicable legislation. Additional discussion regarding
the risks and uncertainties relating to the Company and its
business can be found in the Company's other filings with the
applicable Canadian securities regulatory authorities or the US
Securities and Exchange Commission, and in the "Risk Factors"
section of its Form 20F for the year ended December 31, 2018.
AGGRASTAT® (tirofiban hydrochloride) is a registered
trademark of Medicure International Inc.
References
1AGGRASTAT® (tirofiban hydrochloride)
injection prescribing information:
www.accessdata.fda.gov/drugsatfda_docs/label/2013/020912s019s020lbl.pdf
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SOURCE Medicure Inc.