Home' Australian Pharmacist : Australian Pharmacist January 2016 Contents Australian Pharmacist January 2016 I ©Pharmaceutical Society of Australia Ltd.
follow-up period was 3.2 years.
The primary endpoint was a composite
of coronary death, non-fatal myocardial
infarction, and fatal or non-fatal stroke.
Pravastatin reduced the incidence of the
primary endpoint by 15% (95% confidence
interval: 3-26%; p = 0.01). Coronary death
and non-fatal myocardial infarction risk
was also reduced by 19%, and mortality
from coronary disease fell by 24%.
Total all-cause mortality and risk of stroke,
however, were unaffected, whereas the
incidence of transient ischaemic attacks
was reduced by 25% (p = 0.05).
Pravastatin had no effect on cognitive
functions or incapacity, which may also
reflect the short follow-up period of the
study. Coronary heart disease death and
myocardial infarction risk reduction in
elderly patients by pravastatin in the
PROSPER study was similar to the benefit
of statins in middle-aged populations in
A sub-study of the Justification for the Use
of Statins in Prevention: an Intervention
Trial Evaluating Rosuvastatin (JUPITER)
analysed the effect of rosuvastatin
(20 mg/day) or placebo in an
asymptomatic population of 5,695
subjects over the age of 70 years.
The rate of the primary end point
of a first cardiovascular event
(myocardial infarction, stroke, arterial
for unstable angina, or death from
cardiovascular causes) was reduced
by 39% (P< 0.001) with statin therapy.
All-cause mortality was reduced by 20%
(P = 0.09). The trial also demonstrated
a relatively short time to achieve this
benefit, with a median follow-up period
of less than two years.
Current evidence is that in elderly
individuals with elevated cardiovascular
risk without established CVD,
statins significantly reduce the incidence
of MI and perhaps stroke, but do not
significantly prolong survival.
In older patients, however, prevention
of disability from heart disease, stroke or
peripheral vascular diseases may be as
important a goal as an overall beneficial
effect on mortality.
The issue of statin use as primary
prevention of CVD is particularly
controversial in the very elderly
(e.g. over 85), as recently illustrated:
“There is no convincing evidence that
statins are beneficial in this age group,
particularly with respect to all-cause
mortality, whereas there is considerable
potential for clinically significant adverse
effects leading to poorer quality of life.
Therefore, currently available data strongly
support the view that, when it comes to
prescribing statins in individuals aged
85 and older, less is definitely more.”
“In summary, there are important reasons
to recommend statin therapy in individuals
aged 85 and older who have established
CVD. The high benefit-to-risk ratio that
RCTs have found in individuals just a
few years younger does not necessarily
extinguish once one turns 85. In addition,
in individuals who are at high risk but
have not had a heart attack or stroke,
such as those with diabetes mellitus or
chronic renal failure, in whom benefit in
younger individuals significantly exceeds
risks, statins can be considered, but
polypharmacy, non-adherence, drug-drug
interactions, and individual preference are
strong reasons for shared decision-making
with each individual. The decision to treat
or not treat should always start with a
careful review of likely benefits and the
potential for safety risks.”
In the United States, the rate of statin
use among octogenarians for primary
CVD prevention increased four times
from 1999 to 2012.
Given the relatively
high cost of therapy with statins
(consuming around one-fifth of the total
Pharmaceutical Benefits Scheme budget
in Australia) and the obvious limit to
society’s health care resources, it is critical
that the outcomes of lipid-lowering drug
therapy are maximised.
Elevated cholesterol levels remain a
significant risk factor for CVD in the
elderly. Although the relative risk of CVD
tends to diminish with increasing age, this
reduction is accompanied by an increase
in absolute risk (i.e. the number of events)
as the frequency of the illness increases
markedly with age.
Whether this means
that the elderly should be aggressively
treated with lipid-lowering drug therapy
or whether the elderly benefit as much as
younger patients from pharmacological
therapies directed at preventing coronary
events has been long debated. The major
problem has been the lack of research
into reducing the risk of CVD in the
elderly, so that therapeutic decisions
must be typically made on a case-by-case
basis. As frequently noted, the elderly
population is extremely heterogeneous,
ranging from incapacitated nursing
home residents to marathon runners;
this heterogeneity must be taken into
account when preventive therapies
for chronic diseases are considered.
Furthermore, elderly patients often have
multiple co-morbidities that require a
high number of concurrent medications;
this may increase the risk for drug-drug
interactions, thereby reducing the
potential benefits of statin therapy.2
The high prevalence of polypharmacy
among older adults, coupled with
age-associated physiological changes
and comorbidities, provides major
challenges in adherence and avoidance
of drug-related adverse events.
Statins are generally well-tolerated. This is
critically relevant as the willingness of
older individuals to take medication for
primary prevention of CVD is largely
influenced by their perception of the risk
of side effects, rather than the potential
benefits of the therapy.
the major adverse reaction of concern,
although it is uncommon and generally
resolves rapidly when treatment is
Increasing age per se does not
appear to increase the risk of myopathy.
Age older than 75 to 80 years is often
listed as a risk factor for adverse effects
such as myopathy, but actual evidence
for this is inconsistent and possibly
confounded in part because of the
typically less physically active lifestyle
of older people.
However, the risk
of myopathy with statin treatment
increases with co-administration of
drugs that inhibit statin metabolism.
In fact, when muscle damage does
occur with statins, it is commonly the
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