Cytokinetics Announces Presentations Related to Health Economics and Outcomes Research in Heart Failure and Hypertrophic Card...
May 16 2021 - 8:00AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new
findings from analyses of claims data and electronic health records
related to heart failure (HF) and hypertrophic cardiomyopathy (HCM)
were shared in two poster presentations at the American College of
Cardiology 70th Annual Scientific Session & Expo (ACC.21). One
poster presented data on spending for hospitalized Medicare
patients with HF underscoring the economic burden of their
healthcare, and an additional poster presented demographics and
clinical characteristics of patients with hypertrophic
cardiomyopathy.
“Together these analyses highlight the severity,
complexity and burden associated with each of heart failure and
hypertrophic cardiomyopathy as well as the high costs associated
with managing the cycle of hospitalization and readmission for
patients with heart failure,” said Robert I. Blum, President and
Chief Executive Officer of Cytokinetics. “Our collaborative
research initiatives with leading teaching institutions and health
economics experts continue to inform our understanding of the
clinical and economic burden and underscore how potential new
therapies may improve health outcomes.”
High Spending Among Medicare Patients
Hospitalized with Heart Failure and Substantial Payments for
Post-Acute Care
This analysis builds upon a previously presented
analysis conducted in collaboration with Yale University School of
Medicine examining payments spanning index hospitalization through
30-days post-discharge for Medicare beneficiaries with HF. Using
Medicare fee-for-service administrative claims data, patients
hospitalized with HF from 2016-2018 were identified with the
following primary discharge diagnoses (ICD-10 codes): systolic HF
(50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease
(HHD) with HF (I11), and HHD with HF and chronic kidney disease
(I13). The total estimated mean Medicare 30-day payments for HF
care were approximately $16.5 billion over the 3-year study period,
with little change in spending year to year.
This new analysis of the same dataset examined
90-day post-discharge spending and found that the total estimated
Medicare 90-day payments were approximately $27 billion over the
3-year study period. The index hospitalization accounted for 35% of
the total mean 90-day payments. The remaining 65% of payments
occurred in the post-acute care period (mean $11,374), driven by
payments for readmission including observation stays (36% of
post-acute care payments; mean $6,828) and skilled nursing
facilities (27% of post-acute care payments; mean $5,192). Overall,
36% of Medicare patients hospitalized with HF were readmitted
within 90 days. These results further emphasize the high cost of HF
related health care, not only for initial hospitalization but for
readmission and ongoing care.
Retrospective Observation of Patients
with Obstructive HCM Finds Increase in Cardiovascular Comorbidities
and Medication Use Over 2-Year Follow-Up
In a retrospective analysis of demographics and
clinical characteristics of adult patients with obstructive HCM
(oHCM), the first to examine a national sample using longitudinal
medical and pharmacy claims data, patients were identified using
claims data from the HealthCore Integrated Research Database
(HIRD®), a database representing over 50 million people who are
commercially insured or Medicare Advantage members in the United
States, between January 1, 2012 to January 31, 2020. Patient
characteristics and outcomes were reported for the 12-month period
before the index date (the earliest diagnosis of oHCM) and a 2-year
follow-up. Of the 1,841 patients identified with oHCM, 52% were
male and the average age was 63.2 years. Cardiovascular
comorbidities were common at the 2-year follow-up, including
hypertension (64%), coronary artery disease (31%), atrial
fibrillation (26%), HF (24%), and diabetes (21%). Between the
12-month baseline and 2-year follow up the percentage of patients
with diagnostic procedures and myocardial imaging increased, as did
the use of HCM-related medications (p < 0.01) including
β-blockers (59% vs 70%), calcium channel blockers (29% vs 33%),
anticoagulants (14% vs 22%), and antiarrhythmics (all: 6% vs 10%;
disopyramide: 1% vs 3%). At the 2-year follow-up, 144 patients (8%)
had received an implantable cardioverter-defibrillator for sudden
death prevention and 123 patients (6%) underwent septal reduction
procedures (5% myectomy; 1% alcohol septal ablation), with the mean
time from initial evaluation to procedure being 218 days and 97
days, respectively. The results from this analysis, may help
characterize the population of patients with oHCM and understand
their disease progression to better support current treatment
approaches and inform development of novel therapies to address
this unmet need.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-in-class muscle
inhibitors as potential treatments for debilitating diseases in
which muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is engaging with regulatory authorities
in preparation for a U.S. NDA submission of omecamtiv mecarbil, its
novel cardiac muscle activator, following positive results from
GALACTIC-HF, a large, international Phase 3 clinical trial in
patients with HF. Cytokinetics is conducting METEORIC-HF, a second
Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next-generation cardiac myosin inhibitor, for
the potential treatment of HCM. Cytokinetics is conducting
REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with
obstructive HCM. Cytokinetics is also developing reldesemtiv, a
fast skeletal muscle troponin activator for the potential treatment
of ALS and other neuromuscular indications following conduct of
FORTITUDE-ALS and other Phase 2 clinical trials. The company is
preparing for the potential advancement of reldesemtiv to a Phase 3
clinical trial in ALS. Cytokinetics continues its over 20-year
history of pioneering innovation in muscle biology and related
pharmacology focused to diseases of muscle dysfunction and
conditions of muscle weakness.
For additional information
about Cytokinetics, visit www.cytokinetics.com and follow
us on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cytokinetics disclaims any
intent or obligation to update these forward-looking statements and
claims the protection of the Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, the potential benefits of omecamtiv mecarbil,
including its ability to represent a novel therapeutic strategy to
increase cardiac muscle function and restore cardiac
performance; the timing and likelihood of regulatory approval
for omecamtiv mecarbil, Cytokinetics' research and
development activities; the design, timing, results, significance
and utility of preclinical and clinical results; and the properties
and potential benefits of Cytokinetics' other drug
candidates. Such statements are based on management's current
expectations, but actual results may differ materially due to
various risks and uncertainties, including, but not limited to,
potential difficulties or delays in the development, testing,
regulatory approvals for trial commencement, progression or product
sale or manufacturing, or production
of Cytokinetics' drug candidates that could slow or
prevent clinical development or product
approval; Cytokinetics' drug candidates may have adverse
side effects or inadequate therapeutic efficacy; the FDA or foreign
regulatory agencies may delay or limit Cytokinetics'
ability to conduct clinical trials; Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for
its intellectual property; the nature of Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation
of development activities for omecamtiv mecarbil; standards of
care may change, rendering Cytokinetics' drug candidates
obsolete; and competitive products or alternative therapies may be
developed by others for the treatment of
indications Cytokinetics' drug candidates and potential
drug candidates may target. For further information regarding these
and other risks related to Cytokinetics' business,
investors should consult Cytokinetics' filings with
the Securities and Exchange Commission.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
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