| Statins
- Are the Risks Worth the Benefits?
By
Thomas A. Kruzel, ND
Statin medications are presently one of the
most prescribed drugs in the United States because
of their ability to lower cholesterol levels
and presumed effects for the prevention of heart
disease. Millions of prescriptions are written
every year with little attention paid to possible
side effects, a problem encountered with any
drug. It is widely assumed in allopathic medicine
that patients who are on statin medications
will need to continue on them for indefinite
periods in order to “control” cholesterol
levels.
Statin
medications such as Lipitor, Mevacor, Pravacol
and Zocor inhibit the enzyme 3-hyroxy-3-methyl-glutaryl-coenzyme
A (HMG-CoA) reductase, the enzyme that catalyzes
the conversion of HMG-CoA to mevalonate, the
rate-limiting enzyme in the synthesis of cholesterol.
Cholesterol is normally produced by the liver
but is also derived from dietary sources.
Some
studies have shown that the use of statin medications
reduces the risk of recurrent heart attack and
stroke as well as hospitalization for unstable
angina. A regression of atherosclerotic plaque
already established does not benefit from the
use of statins however, but it is thought that
there may be a benefit derived from stabilization
of lipid levels reducing further increases.
Benefits
in the reduction of thrombic episodes associated
with atherosclerosis such as myocardial infarction
or unstable angina are few as other therapies
are needed as well. Additionally, according
to Beatrice Golomb, MD, PhD in the October 2008
issue of Pulse of Health Freedom, there is little
or no evidence to suggest that statin drugs
are of benefit for women. A study published
in the Journal of Empirical Legal Studies found
that ads for Lipitor (atorvastatin) falsely
stated the drugs’ potential benefits for
women. The ads failed to make clear that research
to date has proven only that statin drugs help
prevent heart-related deaths among women with
existing heart disease.
At
the outset, after their introduction, the use
of statin medications showed a decrease in cardiac
mortality by about 2% for every 1% decrease
in cholesterol levels. This was initially hailed
as a major victory over heart disease and death
from heart attack. However, due to the side
effects of prolonged use of the medications,
deaths due to suicide, homicide and accidents
in patients who took these drugs were 3 times
the rates seen in patients who were not on statins.
While
there has been somewhat of a decrease in deaths
attributed to myocardial infarction, much of
this can be attributed to changes in diet and
the addition of fish oils and antioxidants.
There has been no correlation between the use
of statins in decreasing the incidence of first
time heart attack.
What
has occurred however is the increasing number
of episodes of congestive heart failure (CHF)
since the introduction of statin medications.
This is thought to be due to their propensity
to deplete Coenzyme Q 10 levels, an essential
nutrient for the production of energy in muscle
and other tissues. Lowering of CoQ10 levels
translates to muscle weakness and eventually
wasting which is thought to be one of the factors
in the formation of CHF.
Cholesterol
is an essential nutrient in the formation of
Vitamin D, cortisol, and production of hormones
such as estrogen and testosterone. High concentrations
of cholesterol are found in brain and nerve
tissue as it is an essential component to nervous
system function. This is because cholesterol
is generally insoluble in water and acts as
a protective barrier in addition to being a
vital component of the cell wall. Soluble forms
of cholesterol are lipoproteins such as Low
Density Cholesterol (LDL), Very Low Density
Cholesterol (VLDL), and High Density Cholesterol
(HDL). The solubility properties of these forms
of cholesterol make them much more mobile so
they can be transported to areas where needed
and removed from areas where they aren’t.
Cholesterol,
as previously mentioned, is dependent upon the
production of ubiquinone and dilochol. Ubiquinone
or Co-Enzyme Q10 is also a critical cellular
nutrient produced in the mitochondria where
it plays a role in ATP production in the cells
and functions as an electron carrier to cytochrome
oxidase, our main respiratory enzyme. Because
of its high energy requirements, the heart requires
higher levels of Co-Q10 to be produced. Additionally,
another form of Co-Q10 is found in all cell
membranes where it plays a role in maintaining
membrane integrity and active transport of nutrients.
Co-Q10 is also vital to the formation of elastin
and collagen, components in higher amounts in
cardiac and skeletal muscle. Side effects of
Co-Q10 deficiency include muscle wasting, leading
to congestive heart failure and the most commonly
reported side effect of statin drug use, muscle
soreness and weakness.
The
body’s synthesis of cholesterol occurs
mainly at night by the liver and in Chinese
medicine, there is a correlation with an increase
in liver activity between the hours of 1 to
3 AM. This is also when the liver is doing much
of its cleansing of toxins from the blood, and
patients who awake during this time of night
often are found to be liver deficient. In other
words, the liver is not able to adequately process
cholesterol or clear toxins.
An
association between blood type and higher cholesterol
levels and an increased susceptibility to develop
coronary artery disease (CAD) and atherosclerosis
has been made. There is a higher propensity
to develop these conditions in people who are
blood types A and AB than types O and B. A person’s
secretor status also plays a role with respect
to inflammation and the ability to modulate
it once it has occurred. In the past ten years
there has been an explosion of knowledge about
inflammation and CAD. The most direct test of
inflammation in cardiovascular lab testing is
Cardiac C-reactive protein (C-CRP). Knowing
C-CRP levels allows the physician to develop
treatments to head off inflammation to decrease
the deposition of plaque.
Naturopathic
medicine views lipids such as cholesterol and
its various components as being essential to
the normal development and maintenance of cellular
function in support of homeostasis. In support
of this vital need, we have developed the ability
to not only manufacture cholesterol, but to
absorb it from dietary sources as well.
Each
of the components of cholesterol, such as LDL,
VLDL, and HDL play a role in maintaining healthy
cellar growth and function as well as being
precursors in the formation of hormones, cortisol
and mineral corticoids. To this end, the human
organism has developed numerous mechanisms to
regulate the intake and elimination of fats
and cholesterol so that a balance is maintained.
Where this becomes problematic is when excesses
of cholesterol and fats are derived from dietary
sources and the body’s ability to process
them becomes skewed. Add to this inflammation,
and the ability of the body to clear cholesterol
and fats is impaired, allowing for deposition
of the excess in the walls of arteries and veins.
Under
normal conditions, in addition to previously
mentioned roles for cholesterol, cholesterol
is seen as a reparative substance for disruption
of the glycoseaminoglycan (GAG) layer of damaged
arteries. When there is an excess, and in the
presence of inflammation causing the formation
of free radicals, oxidants, immune complexes
and inflammatory mediators, excess plaque is
laid down leading to a narrowing and weakening
of the artery affected. The development of plaque
occurs because of oxidation of cholesterol and
lipids that disrupts the normal balance, allowing
for them to be deposited in excess. This leads
to coronary artery disease and arteriosclerosis,
the predisposing factors to heart attack and
stroke. Couple this with a genetic disposition
to develop arteriosclerosis such as is seen
in certain blood groups, and the availability
of cholesterol laden fast foods, it is no wonder
that there is a rise in the number of cases
of heart disease.
Naturopathic
medicine views heart disease as being primarily
a disease due to lipid oxidation and not necessarily
because a persons cholesterol level is elevated.
Cholesterol levels elevate after ingestion of
a meal, as do triglycerides. How the body processes
them leads to the formation of plaque and deposition
of fat in various areas around the body. Conversely,
too low of levels of cholesterol, either through
the use of statins, or from a lack of dietary
intake, or due to liver disease, can be problematic
as well.
Natural
treatments to lower cholesterol and triglyceride
levels and reduce the risk of CAD include changes
in diet, monitoring of dietary fat intake, addition
of antioxidants to counter free radical formation,
and lowering inflammation. A typical program
to combat high cholesterol levels may also include
lipotrophic factors to aid the ability of the
liver to not only clear excess cholesterol,
but to produce the proper combination of bile
acids in order to eliminate excesses and reduce
the incidence of gallbladder disease. Lipotrophic
factors are made up of a combination of herbal
medicines and nutrients specific for the regulation
and normalization of liver function. An extract
from Red Rice Yeast has been shown to provide
the same benefits as statin drugs but without
the side effects. A number of natural products
combine them with niacin, phosphatidyl choline,
fatty acids such as EPA and DHA, garlic and
other known cholesterol and lipid lowering substances
in order to enhance their effectiveness.
Generally,
a combination of treatments act to bring high
cholesterol and lipid levels under control after
which, normal levels can be maintained by diet
alone. In patients with genetic predispositions
for higher lipid levels, an on-going program
can be followed based upon individual needs
and requirements.
Adverse effects of Statin medications.
Skeletal
muscle – associated with myalgia,
myopathy (muscle pain, tenderness, weakness,
and an elevation in CPK), and rhabdomyolysis,
a destruction of muscle tissue. Acute renal
failure may occur with severe rhabdomyolysis
and an associated increase in myoglobin. An
increased incidence of myopathy occurs in patient’s
age 65 or older.
Endocrine
– because statins interfere with the synthesis
of cholesterol, they also affect hormone production
as cholesterol is the main building block for
their development. Patients who have endocrine
system imbalances or difficulty generating needed
levels of cortisol, testosterone or estrogen,
may experience difficulties.
Central
Nervous System – CNS vascular
lesions such as hemorrhage, edema, mononuclear
cell infiltration of perivascular spaces were
observed in animal studies. Long term effects
on CNS lesions in humans is unknown. Anxiety,
dysfunction of certain cranial nerves related
to taste, occulomotor (eye) function, and facial
paresis have been observed. Additionally, emotional
liability, depression, memory loss, migraines,
peripheral nerve palsy/impairment, poor sleep,
tremor and vertigo have also been reported.
Renal
function – impaired renal function
will affect plasma concentrations and the half-life
of statins. This can result in interactions
with other drugs, a common problem in patients
on multiple medications.
Liver
function – as the liver is directly
affected by the use of statins, any impairment
of function will be exacerbated by their use.
Liver enzyme increases have been demonstrated
and can become severe. Depending upon the type
of statin used, the incidence and amount of
damage will vary. Liver function testing is
recommended for any patient on statins for any
length of time.
Carcinogenesis
– a significant increase in uterine
polyps, hepatocellular adenoma and carcinoma
were observed in mice. Thyroid and lung adenoma
and carcinoma increases were also seen. There
was a variance noted between the different statins,
but all produced some sort of change in normal
cellular development.
Pregnancy
– their use is contraindicated in pregnancy
as congenital anomalies and/ or musculoskeletal
malformations have been observed in test animals.
Because statins inhibit the formation of cholesterol,
fetal growth may be restricted as well.
Fertility
– statins have been shown to
inhibit the formation and viability of sperm
and can lead to testicular atrophy.
Cardiovascular
– adverse effects have been reported to
be angina, arrythmia, palpitations, phlebitis,
postural hypotension, syncope, vasodilation.
Congestive heart failure was generally not seen
in short-term studies but is being observed
with prolonged use.
Dermatologic
– acne, sensitivity to the development
of contact dermatitis, eczema, urticaria, and
various skin changes in nails, hair and mucous
membranes have been noted.
Gastrointestinal
– a variety of gastrointestinal
symptoms have been reported such as anorexia,
gallbladder pain, jaundice, fatty changes in
the liver, fulminant hepatic necrosis, hepatitis,
gastritis, melena (bloody stools), pancreatitis,
stomach ulcer, rectal ulcers, stomatitis, and
abdominal pains.
Genital/Urinary
– abnormal ejaulation, albuminuria,
breast enlargement, cystitis, erectile dysfunction,
inflammation of the epididymis, fibrocystic
breast, decreased libido, metrorrhagia, urinary
frequency and incontinence, renal failure, vaginal
or uterine hemorrhage have all been reported.
Hematologic
– anemia, bruising, lymphadenopathy,
and thrombocytopenia.
Metabolic/Nutritional
– diabetes, gout, hypo &
hyperglycemia, weight gain.
Ophthalamic
– ambylopia, dry eyes, hemorrhage, glaucoma,
ophthalmoplegia, cataract progression.
Respiratory
– asthma, shortness of breath, nosebleeds,
pneumonia.
References:
Drugs
Facts and Comparisons 2007 Wolters Kluwer
St Louis, MO
Harrison’s
Principals of Internal Medicine 15th Edition
Brunwald, Fauci, Kasper, Hauser, Longo, Jameson
Editors Mc Graw-Hill 2001
Textbook
of Natural Medicine 3rd Edition Pizzorno, Murray
Churchill Livingstone Elsiver 2006
Statins
and Women: An Update Golomb, B MD, PhD Pulse
of Health Freedom Oct 21, 2008
Eat
Right 4 Your Type Complete Blood Type Encyclopedia
D’Adamo, P, Whitney, C Riverhead Books,
New York 2002
Medical
Nutrition From Marz 2nd Edition Marz, R Omni
Press Portland, OR 1997
Drug
Pocket Clinical Reference Guide Russ, A 4th
Edition BÖrm Bruckmeier Publishing 2005
|
