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Premise 2: Elderly patients are unlikely
to benefit as much as younger patients
in terms of relative and absolute risk
In the 4S study, all cause and coronary
heart disease (CHD) baseline mortality
rates were twice as high in the elderly
(>65 years) vs younger (<65 years)
placebo group. As a result the ARR in
patients > 65 years of age was more than
twice that in patients < 65 years of age for
both total (6% v 2.4%) and CHD mortality
(5.9% vs 2.6%).
This trend was also observed in the CARE
study where the RRR for elderly patients
was greater that for younger patients
(32% vs 19%).
SPARCL and MIRACL did not match this
trend. SPARCL displayed a lower RRR for
stroke in patients > 65years compared
to those < 65 years (10% vs 26%).
This corresponded to an ARR of 1.5%
inpatients > 65 years of age and 2.6% in
patients < 65 years of age.
In MIRACL there was a 14% RRR in patients
≥65 years and a 22% RRR in patients
<65 years old. However due to a greater
baseline absolute risk in patients > 65
years, the ARR were slightly greater in older
(2.9%) versus younger (2.5%) patients.
With the exception of SPACRL (which was
a trial designed to prevent stroke only
in patients without heart disease) most
on the trials in this area fail to support
the premise that elderly patients do not
benefit as much as younger patients with
regards to the use of statins.
Premise 3: Elderly patients need to
live for 5 years to see any benefit from
statins, and thus those with uncertain life
expectancies are unlikely to benefit from
Although the CARE study continued for
five years, event rates tended to diverge
between the placebo group and the
pravastatin group from year two onward.
The MIRACL study demonstrated an effect
of early treatment with statins that was
evident at 16 weeks.
10 This trend has been
seen in many of the other statin trials and
is thought to be due to the pleiotropic
effects of statins.
Premise 4: That there is no point using
statins as all they do is extend life in
these patients, and they do not prevent
In 2010 the Cholesterol Treatment
Trialists (CTT) Collaboration published
a meta-analysis of data from 170,000
participants in 26 randomised controlled
This meta-analysis displayed a
15% RRR in any stroke, and showed that
more potent statins are more effective
than less potent statins in reducing any
stroke (26% RRR). There was a trend
towards a greater relative risk reduction
in those greater than 75 years of age
compared to those less than 65 years of
age (22% vs 16%). Non-Fatal strokes were
significantly reduced in both age cohorts.
MIRACL showed a greater reduction
in nonfatal strokes in patients greater
than 65 years of age (ARR 1.4%), than in
patients less than 65 years of age (ARR
1.4% vs 0.3%). This difference was driven
the higher baseline risk of stroke in the
In those who have a stroke, about a third
die due to the stroke, a third make a
good recovery, and a third have ongoing
disability or morbidity due to their
stroke. So, statins do more than extend
life; they prevent nonfatal strokes which
are significant causes of morbidity in
Much of the data presented here did
not reach statistical significance and
thus should be considered trends rather
than proof. Inclusion and exclusion
criteria for these trials have not been
discussed. In many of these trials John
may not fit the inclusion criteria, or even
if he did he would be older than the trial
cohort recruited. However despite these
limitations, these trials remain the best
evidence we have to answer the clinical
question of statin use in patients like John.
This article does not consider the case
of statin de-prescribing in primary
prevention or in patients with adverse
drug reactions due to their statins.
The above four premises proposing
elderly patients (and in particular elderly
patients with CHD like John) do not
benefit from statins are not supported
by the available evidence. Statins for
secondary prevention should not be
routinely de-prescribed in elderly
patients with known CHD who are
not suffering adverse drug reactions,
and have a high level of function/
A balanced approach is required when
de-prescribing in the elderly ensuring
secondary prevention measures
continue to remain relevant to elderly
patients whilst minimising medication
burden in an effort to reduce potentially
inappropriate prescribing and adverse
1. Couteur D et al. Aust Prescr 2011;34:182–5.
2. Scott I, Anderson K, Freeman C R, Stowasser D A. Med J Aust
2014; 201(7):390–2 .
3. Sacks F.M, Pfeffer M.A, Moye L.A, et al The effect of
pravastatin on coronary events after myocardial infarction
in patients with average cholesterol levels. N Eng J Med
4. Heart Protection Study Collaborative Group. MRC/BHF
Heart Protection Study of cholesterol lowering with
simvastatin in 20,536 high-risk individuals: a randomised
placebo-controlled trial. Lancet 2002;360(9326):7–22 .
5. The Scandinavian Simvastatin Survival Study Group.
Randomized trial of cholesterol lowering in 4,444 patients
with coronary heart disease: the Scandinavian Simvastatin
Survival Study (4S). Lancet 1994;344:1383–9 .
6. Shepherd J, Blauw GJ, Murphy MB, et al, on behalf of the
PROSPER study group. Pravastatin in elderly individuals at
risk of vascular disease (PROSPER): a randomized controlled
trial. Lancet. 2002;360:1623–30 .
7. The Stroke Prevention by Aggressive Reduction in
Cholesterol Levels (SPARCL) Investigators. NEJM 2006;355:
8. SPARCL Investigators. Effect of atorvastatin in elderly
patients with a recent stroke or transient ischemic attack.
9. Deedwania et al. Effects of Intensive Versus Moderate Lipid-
Lowering Therapy on Myocardial Ischemia in Older Patients
With Coronary Heart Disease: Results of the Study Assessing
Goals in the Elderly (SAGE). Circulation. 2007;115:700–07.
10. Myocardial Ischemia Reduction with Aggressive
Cholesterol Lowering (MIRACL) Study Investigators. Effects
of atorvastatin on early recurrent ischemic events in acute
coronary syndromes: the MIRACL study: a randomized
controlled trial. JAMA 2001;285(13):1711–18).
11. Bijesh P. Maroo, Carl J. Lavie and Richard V. Milani.
Secondary Prevention of Coronary Heart Disease in
Elderly Patients Following Myocardial Infarction Are All
HMG-CoA Reductase Inhibitors Alike? Drugs and Ageing
12. Huisa B, Stemer A, Zivin J. Atorvastatin in stroke: a review
of SPARCL and subgroup analysis. Vascular Health and Risk
Management 2010;6:229–36 .
13. Cholesterol Treatment Trialists (CTT ) Collaboration. Efficacy
and safety of more intensive lowering of LDL cholesterol:
a meta-analysis of data from 170,000 participants in 26
randomised trials. Lancet 2010;376:1670–81.
14. Bangalore S. Clinical Outcomes with B-Blockers for
Myocardial Infarction: A Meta-analysis of Randomised Trials.
Am J med 2014;127:939–53.
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