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Statins Don't Save Lives. Pharmaceutical companies report misleading risk reduction percentages
$tatins don't save lives
Statins supposedly prevent cardiovascular disease (CVD). Statin
drugs, such as Pfizer's Lipitor® (Atorvastatin calcium), Merk's
Zocor® (Simvastatin), AstraZeneca's Crestor® (Rosuvastatin calcium),
Pravachol® and Mevacor® are now taken by about 43 million (2019) adults
in the U.S. for the purpose of lowering blood cholesterol levels (by inhibiting
an enzyme required for a rate-limiting step in the liver's cholesterol production).
They are taken as an attempt to prevent "cardiac events",
such as heart attack or stroke, associated with problems seen in
ischaemic cardiovascular disease (CVD) ,
such as coronary heart disease, arrythmia, high blood pressure.
Pharmaceutical companies report misleading RELATIVE, not ABSOLUTE
(REAL) risk reduction percentages
For example: Based on a specific trial involving
over 10,000 people, Lipitor™ (atorvastatin) manufacturers claim
a 36% RELATIVE risk reduction in heart attacks for people with risk factors for
heart disease . However, this 36% figure does not take into account the
number of people in the trial . . . 2% of people taking atorvastatin had heart attacks compared to 3.1%
not taking atorvastatin. The manufacturer "take home" from these
figures is that if you take their drug, you will have a
RELATIVE risk reduction of ~36% (calculated as: (3.1-2.0) / 3.1 x 100 = 35.4%).
However, the REAL risk reduction
is only ~1% (3.1% compared to 2% ) -
i.e. 1 out of a 100 people taking
atorvastatin will be spared a heart attack - - - not so much of an
attentiongrabber is it? ! For more on this chacanery and to see some "real"
risk reductions of taking statins:
Pharmaceutical companies report misleading RELATIVE, not ABSOLUTE (REAL) risk reduction
percentages
Statins DO significantly reduce cholesterol
However, it doesn't follow that lowering cholesterol significantly decreases
the risk of heart attacks or strokes :
• Multiple studies
show that the cholesterol /heart disease connection is a myth.
E.g. the large and ongoing Framington, Massachusetts population study
found virtually no connection in CHD events with cholesterol levels in the 205-294
mg/dl range. Even extremely high (up to ~1200mg/dl) levels demonstrated trivial
differences in CHD events. (Castelli, 1992; Smith &
Pickney, 1991)
• 80% of
people who develop CVD have the same blood cholesterol values as those who do not
develop CVD or incur a heart attack.
High cholesterol
does NOT cause ischaemic CVD, such as heart attacks and strokes
Statins have an anti-inflammatory effect.
Statins minimally protect people from heart attacks /stroke regardless of
whether or not they have high levels of blood cholesterol or any other risk factors
for that matter. i.e. the statins
are having effects other than lowering cholesterol --- in particular:
• Statins increase
inflammation-controlling
nitric oxide (NO)
production in the vessel wall. Free
radicals uncontrolled by sufficient
antioxidants can diminish
NO production, leading to atherosclerosis.
Decreasing inflammation lowers the risk of heart attack and stroke.
But . . . there are much better, natural ways than taking statin drugs
to lower inflammation, without the multitude of undesirable side-effects.
Serious side-effects
of statin drugs
How to treat chronic inflammation
For most people - Statins do NOT
much reduce risk of heart attacks, strokes or mortality
The effect of taking statins depends on who is taking them
. . .
taking statins can benefit those with familial hypercholesterolemia
(FH)
Individuals born with familial hypercholesterolemia
(FH) , a genetic disorder, are less responsive to the body's usual measures
of normalizing cholesterol. This group represents a minute fraction of those
taking statins.
statins as a SECONDARY prevention reduce risk of a major coronary
event (e.g. heart attack or stroke), but minimally
reduce risk of death
Statin drugs were originally prescribed for secondary
prevention. i.e. for those who already had established heart disease.
Real risk reductions of taking statins after either or
both of angina or heart attack (Scandinavian 4S study, 1994.
4444 patients, median follow-up 1.9 years) :
Major coronary events reduced by
9%. 622 out of 2223 patients (28%) in the placebo group and 431
out of 2221 (19%) in the simvastatin group had one or more major coronary events.
A REAL risk reduction of 9%.
Life expectation minimally increased.
Coronary deaths: 189 out of 2223 (8.5%) in the placebo group and 111 out
of 2221 (5%) in the simvastatin group a REAL risk reduction of 3.5%; while
non cardiovascular causes accounted for 49 out
of 2223 (2.2%) and 46 out of 2221 (2.1%) deaths --- a REAL risk reduction of 0.1%.
(i.e. it saved one person out of a 1000 dying from other than cardiovascular causes).
Study reported the 6-year probabilities of survival
in the placebo and simvastatin groups at 87.6% and 91.3%, respectively. Again,
not much between them!
LDL cholesterol reduced.
Patients taking Simvastatin had a 50% reduction in LDL cholesterol.
Real risk reductions of taking statins after either a
ischemic stroke or TIA (brief episode of neurological function caused by
loss of blood flow in the brain, spinal cord or retina, without tissue death).
Meta-analysis examined 9 trials and 10741 patients with median follow-up period
2.5 years. (Tramacere et al, 2019)
Ischemic stroke reduced 1.6%
Ischemic stroke or TIA reduced
4.2%
Cardiovascular event reduced 5.4%.
A cardiovascular event defined as any sudden death, fatal or non-fatal acute
coronary syndrome, stroke, intracranial hemorrhage, or pulmonary embolism; and rhabdomyolysis,
myalgia, or rise in creatine kinase (CK).
All-cause mortality not affected
statins As a PRIMARY prevention
do not significantly reduce the risk of a heart attack /stroke
or extend life
This chart shows the results of a meta-analysis of
eight large worldwide trials (24,647 subjects
WITHOUT established cardiovascular disease,
average 73 years old, typically with a few risk factors for heart disease,
such as high LDL, smoker, obesity, high blood pressure) comparing control
groups to those of treatment groups lowering their cholesterol using statins (Savarese G et al, 2013)
• Lowering cholesterol
minimally reduced cardiac "events" and did not reduce risk of death.
The people lowering their total cholesterol (particularly LDL cholesterol)
levels, showed an average 39.4% RELATIVE risk reduction in number of heart attacks
and 24.8% in strokes compared to the control groups.
Sounds positive doesn't it? ---until you realize
that:
(a) MI occurred in 2.7% of subjects allocated to statins
compared with 3.9% of those taking placebo during a mean follow-up of 3.5 years.
i.e. the REAL risk reduction was a mere 1.2%. i.e. Of 1000 people treated,
only 12 would NOT have a heart attack.
(b) Stroke was reported in 2.1% subjects randomized
to statins compared with 2.8% in placebo during a mean follow-up of 3.5 years. i.e.
the REAL risk reduction was a mere 0.7%. i.e. Of 1000 people treated,
only 7 would NOT have a stroke.
(c) The risk of all-cause
death and CV death were NOT significantly reduced.
• 65-75%
of patients who lower their LDL cholesterol with a cholesterol-lowering therapy
continue to have cardiovascular events.
Flawed "JUPITER Study" is the major supporting
study in the push for statin use as PRIMARY prevention against heart
attack / stroke
(JUPITER: Justification for the Use of Statins
in Prevention: an Intervention Trial Evaluating Rosuvastatin)
Headline: "Rosuvastatin can slash risk of
heart attack by 54% and stroke by 48%"
"Rosuvastatin to
prevent vascular events in men and women with elevated C-reactive protein".
This 2006 studypublished in the New England J. of Medicine in 2008
(Ridker et al. 2008), supposedly
determined that statin drugs could lower heart attack risk 54%, risk
of stroke by 48%, and risk of needing angioplasty or bypass surgery
by 46%, and the risk of death from all causes by 20%. It was taken
at face value, despite the fact that funding for this study came from
Astra-Zeneca, the maker of Crestor®.
The JUPITER trial promoted
statin use as preventive medicine against a FIRST time heart attack
or stroke (i.e. primary prevention)
adding
to its original prescription for the prevention of a SECOND (i.e.
secondary prevention), and so expanding the
market to those with an inflammatory risk (elevated
C-Reactive protein ) for CVD.
The study claimed that statins could significantly prevent people
with elevated C-Reactive protein, but otherwise healthy without a history
of cardiovascular disease (CVD) or high levels of low density lipoprotein
(LDL) cholesterol)
Lies, Damn Lies, Statistics
and the JUPITER study:
In the JUPITER study there were 68 heart attacks in the placebo group
and 31 heart attacks in the statin drug treatment group.
A RELATIVE relative risk reduction of 48%.
Sounds good, doesn't it? However, here is the reality:
In a drug treatment group of 8,901 participants, the heart attack
risk was reduced from a very low 0.76% to 0.35% and the risk of stroke
from 0.72% to 0.37%. In effect, if you treat 300 people with expensive
and dangerous drugs you might save one life. Under the best possible
scenario, the real risk reduction
was under 0.5%.
In perspective, consuming
a handful of raw mixed nuts has a much higher real risk reduction!
Pharmaceutical
companies report misleading RELATIVE, not ABSOLUTE (REAL) risk reduction
percentages
Three articles were published in the Archives
of Internal Medicine in June 2010, refuting the industry-funded JUPITER
study claims
(1) An independent assessment
of the same statistics in 2010 entitled "Cholesterol Lowering,
Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy. A
Critical Reappraisal " found
that "the JUPITER Study" was severely flawed. This
recent analysis did a careful and independent review of both results
and methods used in the Jupiter Study and reported that the "trial
was flawed". In an unprecedented attack on the study they stated
that "The possibility that bias entered the trial is particularly
concerning because of the strong commercial interest in the study."And
concluded:
"The
results of the trial do not support the use of statin treatment for
primary prevention of cardiovascular diseases and raise troubling questions
concerning the role of commercial sponsors."
(de Lorgeril et al, 2010)
(2)
Meta-analysis of 11 randomized controlled trials
(Ray KK et al, 2010). involving
a combined total of 65,229 participants with a high-risk for heart disease
and followed for approximately 244,000 person-years.
No evidence was found to back up the JUPITER trial claim that
statins can statistically reduce your risk of death when used as
primar y prevention against heart disease i.e. they don't
save lives even if you do have elevated risk factors.
(Ray, K.K. et al, 2010).
(3) Cholesterol-lowering therapy
for primary prevention: still much we don't know.
Dr. Lee Green of U. of Michigan Medical school points out
that billions of revenue dollars were at stake for the study sponsor
in the JUPITER trial, as well as potentially millions of dollars in
royalties for the principal investigator.
(Green LA, 2010)
$tatins are "pushed" mainly to make mega-profits
for the drug companies
In 2008, Pfizer made $12.4 billion
in sales of Lipitor® - the
top-selling branded pharmaceutical in the world
Recommendations are an "Inside
Job". A panel of "experts" (8 out of
9 on the payroll of statin drug manufacturers) recommended lowering blood cholesterol
of high-risk heart disease patients to levels so low, they are only attainable by
using their employers' statin drugs.
How many more studies do we need to show that statins don't
work?
Studies by the Medical Research Council dating back to
the late 1980s.
• Researchers found that of 1,000
men ranging in age from 35 to 64 who received treatment for mild hypertension over
five years, there were six fewer strokes and two fewer cardiovascular events than
would be expected. The REAL reduction was 0.9%.
(Medical Research Council Working Party, 1985;
Miall & Greenberg, 1987).
• 5 year study with 1000 middle-aged men
having high cholesterol but no previous history of heart attack touted a 22% drop
(relative risk, not real risk) in mortality. It resulted in 7 fewer
deaths from cardiovascular causes, and 2 fewer deaths from other causes than would
be expected. The real risk reduction was therefore a mere 0.9%. (9 out of a 1000
men ) The research was sponsored by Bristol-Myers Squibb Pharmaceutical (West of
Scotland Coronary Prevention Study). (Shepherd
et al, 1996).
T he Heart Protection
Study in the United Kingdom.
20,000+ participants aged 40 to 80 years with high risk of cardiovascular
disease but average-to-low levels of total cholesterol and LDL cholesterol were
treated with 40mg daily of simvastatin (Zocor®). 577 out of 10,269 people on
statins and 701 out of 10,267 not treated died from a heart attack --- a 25% relative
risk reduction over five years, but a REAL risk reduction of only 1.7%.
( Heart Protection
Study Collaborative Group, 2002).
A study of 90,056 participants combining 14 randomised
trials looked at the best outcome for people who had pre-existing conditions:
47% had pre-existing chronic heart disease, 21% had a history of diabetes and 55%
a history of hypertension. The death rate was 8.5% among the statin group compared
to 9.7% in the control group. This is a 1.2% REAL risk reduction.
(Baigent C et al, 2005)
A 2008 study reported in the British Medical Journal
- a meta-analysis of 10 randomized clinical trials of about 70,000 people followed
for an average of four years. In these trials,
people with risk factors for cardiovascular disease but no history of existing disease
were randomized to receive statins or no treatment.
The relative risk reduction was 12% for total mortality, 30% for coronary event
and 19% for a cerebrovascular event (stroke). However, the real risk reduction was
0.6%, 1.3% and 0.4% respectively. The actual number needed to treat to save
one life was 167. Despite this insignificant outcome, the authors of the study concluded, "In
patients without established cardiovascular disease but with cardiovascular risk
factors, statin use was associated with significantly improved survival and large
reductions in the risk of major cardiovascular events." The authors
had significant associations with the drug companies.
(Capewell, 2008).
References
Baigent C et al (2005 Oct 8) Efficacy and safety of cholesterol-lowering
treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised
trials of statins. Lancet. 366(9493):1267-78. Epub 2005 Sep 27.
LInk
Capewell, S. (2008). "Will screening individuals at
high risk of cardiovascular events deliver large benefits? No." British Medical
Journal 337: a1395.
Castelli, William (July 1992), "Concerning the Possibility
of a Nat. . ." Archives of Internal Medicine, 152: (7): 1371-1372
de Lorgeril M et al (2010), Cholesterol lowering, cardiovascular
diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal, Laboratoire
Coeur and Nutrition, Faculty of Medicine, Université Joseph Fourier and Centre National
de Recherche Scientifique, Grenoble, France, Arch Intern Med. 2010 Jun 28;170(12):1032-6
Link
Green LA (2010 Jun 28) Cholesterol-lowering therapy for
primary prevention: still much we don't know, Arch Intern Med;170(12):1007-8;
Link
Heart Protection Study Collaborative Group (2002). "MRC/BHF
Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk
individuals: A randomised placebo-controlled trial." Lancet 360: 7-22.
Medical Research Council Working Party (1985). "MRC
trial of treatment of mild hypertension: principal results." British Medical
Journal 291: 97-104.
Miall, W.E. and G. Greenberg (1987). Mild Hypertension:
Is There Pressure to Treat? An account of the MRC trial. New York, Cambridge University
Press.
Ray KK, et al (2010) Statins and all-cause mortality in
high-risk primary prevention: a meta-analysis of 11 randomized controlled trials
involving 65,229 participants, Department of Public Health and Primary Care, University
of Cambridge, Cambridge, England, Arch Intern Med. 2010 Jun 28;170(12):1024-31
Link
Ridker, P.M., E. Danielson, et al. (2008). "Rosuvastatin
to prevent vascular events in men and women with elevated C-reactive protein."
New England Journal of Medicine 359(21): 2195-2207.
Link to the JUPITER
trial
Ridker PM; Jupiter Study, Group (Nov. 2003). "Rosuvastatin
in the primary prevention of cardiovascular disease among patients with low levels
of low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive
protein: rationale and design of the JUPITER trial "
Circulation. 108 (19): 2292-7
Link
Savarese G et al (2013 Dec 3) Benefits of statins in elderly
subjects without established cardiovascular disease: a meta-analysis. J Am Coll
Cardiol;62(22):2090-9. doi: 10.1016/j.jacc.2013.07.069. Epub 2013 Aug 28.
Link
Scandinavian 4S study (1994 Nov 19) Randomised trial of
cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian
Simvastatin Survival Study (4S) Lancet. 344(8934):1383-9.
Link
Shepherd J et al. (1996). "Prevention of coronary
heart disease with Pravastatin in men with hypercholesterolemia." New England
Journal of Medicine 333: 1301-1307.
Smith, R. and E.R. Pickney (1991) Diet, Blood, Cholesterol
and Coronary Heart Disease: A Critical Review of the Literature, Vol 2, Vector Enterprises,
Sherman Oaks, CA
Tramacere, I et al (2019) Comparison of statins for
secondary prevention in patients with ischemic stroke or transient ischemic attack:
a systematic review and network meta-analysis, BMCMedicine 17, Article number:67
Link
