Dr Graveline Article and Info for a New Statin Study

[Guest guest]

Hello Group,

I just received this article from Dr Graveline (with permission to

post). At the end of the article is the description of a " cholesterol

lowering drug study " conducted by " Guthrie Biochemical Genetics

Laboratory at the Buffalo General Hospital, Kaleida Health, and the

University at Buffalo (,NY) " . There is contact info for anyone that is

interested in participating in this study.

Homepage for the study facility: http://www.rgbgl.org/

Fran

Note: Posted to both SOS & Taking Lipitor & Hate it Groups

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Genetic Susceptibility to Statin Drugs

" Taking a new medicine is the start of a new experiment. " Nowhere is

this truer than with the statin class of drugs.

Although the majority of statin users appear to do well, the

collateral damage of this class of drug is such that diverse symptoms,

reflecting multiple metabolic pathways, can be expected. Glial cell

inhibition of cholesterol synthesis appears to be the cause for such

cognitive manifestations as amnesia, confusion, disorientation and

forgetfulness. Dolichol inhibition is directly tied to altered

neuropeptide synthesis and our many behavioral side effects such as

aggressiveness, depression and irritability. CoQ10 inhibition seems

directly tied to our statin associated myopathies, neuropathies and

rhabdomyolyses.

Now we suspect that some patients may have a genetic susceptibility to

statin–induced problems. Special genetic susceptibility may explain

not only much of our statin associated rhabdomyolysis but also the

curious pattern of persistent myopathy, often following only a short

course of statins. Since susceptibility testing of this type is not

yet available, there is no way to identify these susceptibles until

the damage is done.

Such concerns document the validity of our opening statement. Every

statin user is the start of an experiment. One can hardly justify this

class of drugs for wide-scale use as in primary prevention and over

the counter distribution (as in England) when the completely

unpredictable end-point may be rhabdomyolysis death or permanent

disabling neuromyopathy.

Georgirene Vladutiu PhD, of the Guthrie Biochemical Genetics

Laboratory, informs me that a study is underway at the University at

Buffalo to pursue the possible role genetic factors may play in

increasing susceptibility to statin myopathies. There is preliminary

evidence that certain underlying muscle disorders may play a role in

conferring increased susceptibility to statin-induced myopathies.

Please see the attached flyer and understand that you will be fully

reimbursed for all expenses associated with blood drawing and mailing

of the sample. However, you are personally responsible for making

these local arrangements via hospital, doctor's office, etc and

obtaining your vouchers. That will be your only personal involvement

with participation in this NIH funded study designed to help establish

the relationship between statin drugs and the damage they cause.

Finally, your doctor (and lawyer) will have much needed proof of

causality and I will truly have helped you.

Duane Graveline MD MPH

VOLUNTEERS TAKING CHOLESTEROL-LOWERING DRUGS

NEEDED FOR RESEARCH STUDY

The Guthrie Biochemical Genetics Laboratory at the Buffalo

General Hospital, Kaleida Health, and the University at Buffalo is

currently looking for individuals who have been taking

cholesterol-lowering drugs (statins) for at least 6 months. Those

invited to participate will fall into three categories as described below:

(1) Normal Control Individuals would be those individuals that have

had no muscle pain or weakness while taking statins.

(2) Severely Affected Individuals would be those who suffer

incapacitating muscle pain, cramps or weakness that leads to

disability temporarily while taking statin drugs, or persistently

after drug therapy has been discontinued. In addition, any

participant who has had any of the following abnormal test results (if

known):

* The observation of " coca-cola " colored urine

* Abnormal elevation of a blood substance called " creatine kinase " or

CK or CPK

* Abnormal EMG (electromyogram). This test is performed by a

neurologist who places a needle in various muscles and electrically

stimulates the muscles. You may already have had muscle biopsy

studies performed.

(3) Mildly Affected Individuals are those who have noted mild muscle

pain, cramps or weakness that is bearable without discontinuing statin

therapy.

There is no cost or payment to you for participation in this study.

The benefits to you will be the possible provision of risk factor

information about side effects from these medications that may help

with your future medical care.

*Please note that participants will be responsible for the collection

and shipment of a blood sample to our laboratory, as well as the

completion of consent forms and a medical questionnaire. Costs related

to blood collection and shipping will be reimbursed to you.*

If you would like to participate in the Statin Study, please call

Kern at 716-829-2695 on Tuesday through Friday or leave a

message for a call back.

The study protocol has been approved by the Health Sciences

Institutional Review Board of The University at Buffalo