In
the
rapidly
evolving
pharmaceutical
industry,
Lifecycle
Management
(LCM)
strategies
are
critical
for
maximizing
profitability
and
extending
market
life
of
drugs.
This
study
investigates
strategic
importance
expanding
indications
sodium-glucose
cotransporter
2
(SGLT2)
inhibitors
before
expiration
their
foundational
patents.
By
analyzing
these
pre-expiration
strategies,
balance
between
genuine
innovation
evergreening
is
addressed.
The
analysis
covers
legal,
regulatory,
clinical
dimensions
indication
expansions
across
US,
EU,
Japan,
contrasting
with
traditional
focus
on
LCM
post-patent
expiration.
PLoS ONE,
Journal Year:
2025,
Volume and Issue:
20(1), P. e0310568 - e0310568
Published: Jan. 31, 2025
People
with
severe
mental
illness
(SMI)
are
more
likely
to
develop
long-term
physical
health
conditions,
including
type
2
diabetes
and
cardiovascular
disease,
compared
people
without
SMI.
This
contributes
an
inequality
in
life
expectancy
known
as
the
'mortality
gap'.
Chronic
kidney
disease
(CKD)
is
a
growing
global
concern
set
be
5th
leading
cause
of
life-years
lost
by
2040.
However,
there
limited
research
exploring
relationship
between
CKD
systematic
review
will
aim
examine
prevalence
incidence
among
We
search
Medline,
Embase,
PsycINFO,
CINAHL,
Scopus
Web
Science
for
primary
epidemiological
reporting
or
SMI
any
setting.
Retrieved
records
managed
Covidence
screened
two
independent
reviewers.
Data
extracted
from
included
studies
using
piloted
data
extraction
form,
quality
evaluated
appropriate
JBI
Critical
Appraisal
Checklist.
The
certainty
evidence
assessed
Grading
Recommendations,
Assessment,
Development,
Evaluations
(GRADE)
approach.
narratively
synthesised.
Meta-analyses
conducted
random
effects
models
There
SMI,
this
proposed
first
highlight
extent
problem
provide
foundation
future
improve
outcomes
Current Opinion in Cardiology,
Journal Year:
2025,
Volume and Issue:
unknown
Published: Feb. 11, 2025
Hypertension
and
chronic
kidney
diseases
(CKDs)
are
known
risk
factors
for
the
development
or
worsening
of
heart
failure.
In
last
years,
several
new
therapeutic
approaches
management
people
with
diabetic
nondiabetic
CKD
hypertension
have
been
investigated.
this
brief
review,
most
recent
findings
regarding
ability
SGLT-2
inhibitors
nonsteroidal
mineralocorticoid
receptor
antagonists
(nsMRA)
GLP-1
agonists
to
prevent
failure
in
patients
will
be
discussed.
3
large
clinical
trials
involving
very
numbers
published
showing
that
these
significantly
reduce
events
hospitalizations
nephropathies
as
well
without
nephropathy.
Moreover,
drugs
retard
progression
towards
end-stage
disease.
These
observations
already
a
major
impact
on
CKD.
now
recommended
first-line
therapy
diabetes,
The
use
nsMRA
is
increasing
could
replace
spironolactone
over
time
early
stages.
Diabetes Obesity and Metabolism,
Journal Year:
2025,
Volume and Issue:
unknown
Published: Feb. 25, 2025
Abstract
Aims
Ketogenic
diets
are
used
by
individuals
with
obesity
and
type
2
diabetes
for
improved
glycaemic
control,
reduced
appetite
weight
loss.
However,
the
risks
associated
higher
ketone
levels,
including
diabetic
ketoacidosis
(DKA),
in
without
not
well‐documented.
Materials
Methods
We
analysed
real
world
data
from
a
single‐centre
telemedicine
clinic
specializing
very
low
carbohydrate
ketogenic
diet
(VLCKD)
as
lifestyle
intervention.
Illnesses
ketosis
(IAK)
were
defined
beta‐hydroxybutyrate
(BHB)
levels
≥3
mmol/L
when
patients
sought
in‐person
care.
estimated
IAK
DKA
incidence
rate
diabetes.
Results
In
72
751
patient‐years
of
follow‐up,
86
people
had
(incidence
1.18
per
1000
person‐years).
22
347
follow‐up
diabetes,
was
0.04
person‐years
no
cases.
50
404
(PWD),
rates
1.69
1.01
person‐years,
respectively.
12
763
PWD
using
SGLT2‐inhibitors,
2.90
patient‐years.
Conclusions
Very
generally
safe
IAK,
DKA,
The
on
VLCKD
who
also
SGLT2‐inhibitors
may
be
manageable
through
at‐home
monitoring
BHB
levels.
BMJ Open,
Journal Year:
2025,
Volume and Issue:
15(3), P. e094554 - e094554
Published: March 1, 2025
Chronic
kidney
disease
(CKD)
causes
significant
morbidity
and
mortality.
Medical
therapies
can
reduce
the
progression
of
by
up
to
50%.
CKD
is
undiagnosed
in
majority
people
who
have
it,
resulting
undertreatment.
Stewardship
(CKD-S)
aims
identify
hospital
inpatients
with
mid-stage
late-stage
goal
facilitating
diagnosis
initiating
guideline-based
therapies.
This
prospective,
multicentre,
cohort
study
compares
two
models
care,
CKD-S
standard
for
identification
management
CKD,
across
six
public
hospitals
metropolitan
Sydney,
Australia.
entails
active
case
finding
using
electronic
medical
record,
nephrologist
outreach
admitting
teams
nurse
provided
patient
education.
Adult
an
admission
estimated
glomerular
filtration
rate
(eGFR)<45
mL/min/1.73
m2
not
known
a
will
be
eligible,
excluding
those
short
life
expectancy
or
advanced
age
(>80
years).
Participants
enrolled
between
1
March
2024
2025.
Baseline
demographic
data
collected
after
discharge
from
hospital.
followed
12
months
Pharmaceutical
Benefits
Schedule
data,
linked
via
Australian
Institute
Health
Welfare
Hub.
We
report
proportion
all
adults
admitted
are
already
nephrologist,
which
stage
3b-5
recognised
intervention
team,
compared
care.
then
compare
each
eGFR
urine
albumin:creatinine
ratio
measured,
referred
prescribed
guideline-directed
over
following
The
has
ethics
approval
Sydney
Local
District's
Ethics
Committee
(Concord
Hospital
Zone).
results
published
peer-reviewed
journals
presented
at
academic
conferences.
ACTRN12624000452594.
medRxiv (Cold Spring Harbor Laboratory),
Journal Year:
2024,
Volume and Issue:
unknown
Published: Sept. 5, 2024
Abstract
Background
People
with
severe
mental
illness
(SMI)
are
more
likely
to
develop
long-term
physical
health
conditions,
including
type
2
diabetes
and
cardiovascular
disease,
compared
people
without
SMI.
This
contributes
an
inequality
in
life
expectancy
known
as
the
‘mortality
gap’.
Chronic
kidney
disease
(CKD)
is
a
growing
global
concern
set
be
5th
leading
cause
of
life-years
lost
by
2040.
However,
there
limited
research
exploring
relationship
between
CKD
systematic
review
will
aim
examine
prevalence
incidence
among
Methods
We
search
Medline,
Embase,
PsycINFO,
CINAHL,
Scopus
Web
Science
for
primary
epidemiological
reporting
or
SMI
any
setting.
Retrieved
records
managed
Covidence
screened
two
independent
reviewers.
Data
extracted
from
included
studies
using
piloted
data
extraction
form,
quality
evaluated
appropriate
JBI
Critical
Appraisal
Checklist.
The
certainty
evidence
assessed
Grading
Recommendations,
Assessment,
Development,
Evaluations
(GRADE)
approach.
narratively
synthesised.
Meta-analyses
conducted
random
effects
models
Discussion
There
SMI,
this
proposed
first
highlight
extent
problem
provide
foundation
future
improve
outcomes
The Lancet Regional Health - Western Pacific,
Journal Year:
2024,
Volume and Issue:
43, P. 101004 - 101004
Published: Jan. 15, 2024
Chronic
kidney
disease
(CKD)
is
projected
to
become
the
fifth
leading
cause
of
death
worldwide
by
2030.1Foreman
K.J.
Marquez
N.
Dolgert
A.
et
al.Forecasting
life
expectancy,
years
lost,
and
all-cause
cause-specific
mortality
for
250
causes
death:
reference
alternative
scenarios
2016-40
195
countries
territories.Lancet.
2018;
392:
2052-2090Summary
Full
Text
PDF
PubMed
Scopus
(1102)
Google
Scholar
Considering
its
severe
health
consequences,
including
renal
cardiovascular
complications,
it
imperative
adopt
measures
that
mitigate
these
risks
from
both
clinical
public
perspectives.
The
advent
SGLT2
inhibitors
marks
a
significant
advancement
in
therapeutic
options
prevent
cardiorenal
consequences
CKD.
With
robust
evidence
supporting
their
efficacy,
time
now
intensify
implementation
efforts
ensure
life-saving
drugs
reach
patients
who
need
them
most.
As
class,
have
consistently
demonstrated
protective
effects.
Meta-analyses
randomized
trials
involving
with
CKD
shown
reductions
progression,
end-stage
disease,
acute
injury,
heart
failure
hospitalizations,
mortality.2Nuffield
Department
Population
Health
Renal
Studies
GroupSGLT2
inhibitor
Meta-Analysis
Cardio-Renal
Trialists'
ConsortiumImpact
diabetes
on
effects
sodium
glucose
co-transporter-2
outcomes:
collaborative
meta-analysis
large
placebo-controlled
trials.Lancet.
2022;
400:
1788-1801Summary
(182)
These
been
observed
across
spectrum
are
evident
irrespective
presence
diabetes.
However,
despite
compelling
protection,
data
potential
impact
medications
broader
population
still
relatively
scarce.
In
Lancet
Regional
Health—Western
Pacific,3Neuen
B.L.
Jun
M.
Wick
J.
al.Estimating
population-level
impacts
improved
uptake
chronic
disease:
cross-sectional
observational
study
using
routinely
collected
Australian
primary
care
data.Lancet
Reg
Western
Pac.
2024;
43100988https://doi.org/10.1016/j.lanwpc.2023.100988Summary
Neuen
colleagues
report
comprehensive
analysis
conducted
MedicineInsight,
nationally
representative
individual-level
dataset
encompassing
392
practices
Australia.
aimed
quantify
absolute
number
cardio-renal
events
potentially
preventable
through
optimal
usage–
defined
as
75%
among
adult
population.
authors
utilized
MedicineInsight
identify
an
eGFR
<
60
ml/min/1.73
m2
and/or
urinary
albumin
creatinine
ratio
>3.4
mg/mmol.
individuals
were
then
matched
inclusion
criteria
three
pivotal
CKD:
CREDENCE,
DAPA-CKD,
EMPA-KIDNEY.
Subsequently,
they
extrapolated
age-
sex-stratified
prevalence
(using
different
UACR
definitions)
national
census
data.
This
allowed
estimate
Australia,
drawing
effectiveness
trials.
Overall,
during
2020–2021,
147,119
(12.1%)
adults
found
>
3.5
Nearly
half
(44%)
met
EMPA-KIDNEY,
17%
7%
CREDENCE.4Perkovic
V.
Jardine
M.J.
Neal
B.
al.Canagliflozin
outcomes
type
2
nephropathy.N
Engl
J
Med.
2019;
380:
2295-2306Crossref
(3459)
Scholar,
5Heerspink
H.J.L.
Stefánsson
B.V.
Correa-Rotter
R.
al.Dapagliflozin
disease.N
2020;
383:
1436-1446Crossref
(2191)
6Herrington
W.G.
Staplin
Wanner
C.
al.The
EMPA-KIDNEY
Collaborative
Group.
Empagliflozin
2023;
388:
117-127Crossref
(0)
Compared
trials,
was
older,
had
higher
eGFR,
less
likely
established
disease.
Notably,
renin
angiotensin
system
(RAS)
blockade
usage
substantially
lower
compared
where
virtually
all
participants
background
RAS
inhibition.
Baseline
use
very
low
ranging
4.1%
eligible
14.4%
CREDENCE
patients.
Using
strict
(eGFR
3.4
mgl/L
at
least
occasions,
90
days
apart),
yielded
numbers
needed
treat
(NNT)
one
event
14
25,
15
27
avert
over
years.
estimates
translated
into
more
than
3500
1000
could
be
prevented
annually
this
therapy.
findings
remained
various
definitions,
thresholds
"optimal
use,"
or
absence
provides
valuable
glimpse
tangible
real-world
setting.
It
underscores
key
points:
portion
benefit
inhibitors;
current
disappointingly
low,
only
15%
high-risk
(eligible
CREDENCE)
treatment;
and,
implementations
yield
benefits,
far
outweighing
adverse
study's
limitation
reliance
rather
directly
inhibitors,
trial
Discrepancies
often
exist
between
demographic
characteristics
Additionally,
medication
adherence
real
world
may
not
levels
reducing
expected
benefits.
Therefore,
future
studies
should
measure
adherence,
side
effects,
discontinuation
rates
accurately
assess
general
Despite
benefits
society,
remains
strikingly
low.
Structural
barriers
care,
such
inadequate
testing
albuminuria
treatment
paradox
those
albuminuria—and
consequently
risk—are
receive
preventive
treatments,7Chu
C.D.
Xia
F.
Du
Y.
al.Estimated
US
risk
disease.JAMA
Netw
Open.
6e2326230Crossref
(1)
Scholar,8Lamprea-Montealegre
J.A.
Madden
E.
Tummalapalli
S.L.
al.Prescription
patterns
cardiovascular-
kidney-protective
therapies
disease.Diabetes
Care.
45:
2900-2906Crossref
exacerbated
SGLT2-specific
challenges.
include
high
costs,
racial
ethnic
disparities
prescriptions,
lack
knowledge
about
indications,
effects.9Tummalapalli
Montealegre
J.L.
Warnock
Green
Ibrahim
S.A.
Estrella
M.M.
Coverage,
formulary
restrictions,
affordability
sodium-glucose
cotransporter
insurance
plan
types.JAMA
Forum.
2021;
2e214205Crossref
(9)
Scholar,10Lamprea-Montealegre
al.Association
race
ethnicity
prescription
GLP1
receptor
agonists
veterans
administration
system.JAMA.
328:
861-871Crossref
(20)
To
address
barriers,
coordinate
multi-disciplinary
critically
needed.
substantial
advantages
can
realized
proper
warrant
immediate
concerted
action.
JALM
supported
funding
National
Heart,
Lung,
Blood
Institute
(1K99HL157721-01A1)
related
topic.
Estimating
dataImproved
Australia
has
experiencing
progression
dying
due
Identifying
strategies
increase
critical
realising
drug
class.
Full-Text
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Access