12.11.2017 19:29:46
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Press Release: New Novartis Entresto(R) real world evidence data shows beneficial impact on quality of life in people living with heart failure
Novartis International AG / New Novartis Entresto(R) real world evidence
data shows beneficial impact on quality of life in people living with
heart failure. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
-- Entresto reversed trend of worsening New York Heart Association
(NYHA) class - a key measure of the severity of a patient's heart failure
symptoms - improving common physical activity such as exercise and other
daily activities at 90 and 180 days after treatment initiation in a
retrospective database study in patients with heart failure with reduced
ejection fraction (HFrEF) in Germany[1]
-- Entresto significantly reduced levels of NT-proBNP, a key blood marker
associated with cardiovascular risk in patients with heart failure; the
magnitude of the decrease was similar to that observed in the PARADIGM-HF
study[1]
-- Results are consistent with other real world data published in 2017 which
showed Entresto improves NYHA class[2] as well as exercise capacity[2]
-- Majority of patients in this cohort started and stayed on the lowest dose
of Entresto, highlighting the potential to further improve patient
outcomes by increasing treatment to recommended target maintenance dose
-- Data were shared today at the American Heart Association's Scientific
Sessions 2017, building on existing evidence that Entresto has beneficial
effects on the quality of life in addition to reducing cardiovascular
death and heart failure hospitalization
Basel, November 12, 2017 - Novartis today announced new results from a
real-world database study of patients in Germany prescribed Entresto(R)
(sacubitril/valsartan) for heart failure with reduced ejection fraction
(HFrEF). The findings further substantiate the beneficial effect of
Entresto on heart failure symptoms and patients' quality of life
observed in the PARADIGM-HF study and in other real-world cohorts.
Results were presented today as a poster at the American Heart
Association's Scientific Sessions 2017.
"People living with heart failure experience symptoms that severely
limit their physical activities and quality of life," said Shreeram
Aradhye, Chief Medical Officer and Global Head, Medical Affairs,
Novartis Pharmaceuticals. "We are excited to see the growing body of
evidence showing that Entresto has a beneficial effect on the quality of
life in heart failure, in addition to reducing cardiovascular death and
heart failure hospitalization."
The non-interventional, retrospective database study examined changes in
clinical characteristics of 1,643 patients in Germany on Entresto in the
12 months after their first dose. All patients with available data were
analyzed and the results included:
-- The majority of patients had a stable New York Heart Association (NYHA)
class over time. Before Entresto more patients had a trend of worsening
NYHA class. The trend of worsening NYHA was reversed after switching to
Entresto at Day 90 (n=121) and 180 (n=81)[1]. NYHA classification is used
to grade the severity of a patient's heart failure symptoms, with
physicians determining class based on specific criteria (e.g., the level
of discomfort associated with physical activity)
-- There was an approximately 30% mean decrease (-503pg/mg; p<0.001; n=119)
in NT-proBNP, a blood marker used to diagnose heart failure and to
determine prognosis[1]. Levels of NT-proBNP are typically higher in
patients with worse outcomes[3]
-- The majority of patients had a documented first dose of Entresto at the
lowest level (24/26mg twice daily). Of these patients, 36% from the
primary care practices and 41% from the cardiology practices had their
dose up-titrated during follow-up; however, <11% received the target dose
(97/103mg twice daily) at the last recorded prescription
These results are consistent with other real world data published in
2017, which show that Entresto has a beneficial impact on quality of
life:
-- Canada (n=276): 45% of patients switched to Entresto report feeling
better after four weeks, 56% after 12 weeks[4]
-- France (n=200): in patients treated with Entresto improvement in NYHA
class and exercise capacity was observed[2]
These data results were also consistent with post-hoc analyses of the
landmark PARADIGM-HF clinical trial published between 2015 and 2017,
which show that:
-- In surviving patients, treatment with Entresto improved patients' quality
of life, including heart failure symptoms and physical limitations as
compared with enalapril, as measured by KCCQ[5]; this effect is sustained
over 36 months
-- Entresto improved seven out of 10 activities when compared with enalapril,
with the most significant changes in household chores and intimate/sexual
relationships[6]
-- Among patients who had been hospitalized for heart failure, Entresto has
been shown to slow the further decline in health-related quality of life
in approximately half of patients compared to enalapril, as measured by
KCCQ[7]
-- Patients were less likely to have NYHA functional class deterioration on
Entresto compared with enalapril[8]
KCCQ is a self-administered health-related quality of life (HRQL)
measure for HF patients, with higher scores indicating fewer symptoms
and physical limitations associated with HF[5]. The questionnaire
quantifies physical function, symptoms (recent change, frequency and
burden), social function, self-efficacy and knowledge, and quality of
life. Scores are transformed to a range of 0-100, in which higher scores
reflect better health status.
About the German Disease Analyzer Study
This non-interventional, retrospective database study, 'Dosing patterns
and evolution of clinical parameters in patients prescribed
sacubitril/valsartan in Germany,' was initiated to assess dosing
patterns and the evolution of clinical parameters in patients who were
prescribed Entresto(R) (sacubitril/valsartan) in the primary care or
cardiology setting in Germany. Patients aged 18 and above were
identified via electronic medical records from the German IMS(R) Disease
Analyzer database, which contained data from 1,095 primary care
practices and 43 cardiology practices at the time of the study. The
study period was January 1, 2016 to December 31, 2016, with a maximum
look-back period to January 1, 2015.
The study population included 1,643 patients with a subset of patients
having available data for analysis (n=119 evaluated for impact on
NT-proBNP and n=121 evaluated for impact on NYHA classification trend).
About the PARASAIL study
The PARASAIL study, 'Patient reported outcomes from the Canadian real
world experience use of sacubitril/valsartan in patients with heart
failure and reduced ejection fraction (HFrEF),' is an ongoing,
multi-center, open-label, prospective, post-approval (Phase IV) study
being conducted in 302 patients with HFrEF at 32 study sites across
Canada. It aims to characterize the tolerability, safety and therapeutic
effectiveness of Entresto(R) (sacubitril/valsartan) 97/103mg twice daily
in Canadian patients with HFrEF.
In addition to primary and secondary efficacy and safety endpoints, the
study included pre-specified exploratory endpoints to evaluate heart
failure symptoms and quality of life (QoL): changes in Patient Global
Assessment (PGA - a seven-point patient self-evaluation scale that
determines how a patient feels at subsequent visits compared with
baseline), Minnesota Living with Heart Failure Questionnaire (MLHFQ - a
validated questionnaire representative on how heart failure is impacting
key dimensions of QoL) and EuroQoL questionnaire (EQ-5D - an instrument
consisting of five domains [morbidity, self-care, usual activity, pain,
and anxiety and depression among patients] and a visual analogue scale
to assess the current health status of patients) from baseline to weeks
four, 12 and 24.
The interim analysis of this study evaluated these pre-specified
exploratory endpoints in the first 276 patients who completed their
initial 12 weeks of Entresto treatment. Results showed early signs of
improvement in two of the three validated QoL questionnaires: nearly
half of the patients reported feeling better (using PGA questionnaire)
and there was a significant improvement in MLHFQ scores. No changes were
detected based on the EQ-5D score.
These results were published in the September 2017 supplement of the
European Journal of Heart Failure. 2017;19: p34.
About the France Study
The study 'Results of a single center experience on 200 consecutive
patients treated with Entresto(R) (sacubitril/valsartan),' evaluates
results from a monocentric cohort of 200 consecutive heart failure with
reduced ejection fraction (HFrEF) patients treated with Entresto.
Between October 2015 and September 2016, 200 patients received Entresto;
180 were evaluated one month after introduction, 157 three months after,
and 99 after six months of follow up.
Entresto was initiated at half dosage or less depending on the fragility
of the patient (78% at 49mg/51 mg twice daily and 22% at 24/26mg twice
daily). Patients attended a first follow-up appointment after one month
of treatment, and if tolerance was good, the dosage was increased. At
three months, 82% of patients received the target dose of 97/103mg.
After one month of treatment, functional class improved significantly
with 4.5% New York Heart Association (NYHA) 1, 81% NYHA 2, and 14.5%
NYHA 3 (p= <0.001), as the 6-minute walk distance (511 vs 461m, p
<0.0001). These improvements occurred from the first month of treatment
with the half dosage of Entresto and were still significantly present
after six months of follow up.
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