brad

I'm stopping Lipitor 10 mg and going on Niaspan (hdl increaser). What
scares me is the muscle problems some people get. For Niaspan info see
http://www.niaspan.com/templates/patient.asp?class=1&page=1

sharon hope

Obvious from the conclusion: Every statin study should now include pre and
post neuropsych testing. The absence of data is due to not measuring this
vital information objectively in enough trials.

In particular, the November decision by the FDA to permit statin treatment
of children screams for parents to insist - trial or not - that their
children be tested before and during the course of treatment.


of

cholesterol

statin.

cases,

certain.

sharon hope

Anna,

Do not permit your husband's doctor to ignore this symptom.

Please see the following (in addition to the full text of this study):

Australian Adverse Drug Reactions Bulletin (Australia's equivalent to the
FDA)
Volume 17, Number 3, August 1998, section 3, page 3
Simvastatn is listed under "DRUGS THAT MAKE YOU FORGET"
Recognizing the 14 reports of Amnesia under that drug, .8% of the total
adverse effects for that drug.
http://www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf

Studies & Links in chronological order, with the latest on top:

Muldoon MF, Barger SD, Ryan CM, Flory JD, Lehoczky JP, Matthews KA, Manuck
SB.
Effects of lovastatin on cognitive function and psychological well-being.
After 6 months, 100% of the patients on placeboes showed a measurable
increase in cognitive function, and 100% of the statin patients showed a
measurable decrease in cognitive function.
Am J Med. 2000 May;108(7):538-46.
PMID: 10806282 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10806282&dopt=Abstract

Simvastatin-Associated Memory Loss
Amanda Orsi, Pharm.D., Olga Sherman, Pharm.D., and Zegga Woldeselassie,
Pharm.D.,

Abstract: The statins are widely used to treat dyslipidemias. They are
generally associated with mild adverse effects, but rarely, more serious
reactions may occur. A 51-year-old man experienced delayed-onset,
progressive memory loss while receiving simvastatin for
hypercholesterolemia. His therapy was switched to pravastatin, and memory
loss resolved gradually over the next month, with no recurrence of the
adverse effect.
from Pharmacotherapy
Posted 06/01/2001
Page 1 of 3:
http://www.medscape.com/viewarticle/409738?WebLogicSession=PXke2H8h99pyNVSCajAh5clptzOAHJSZuNBobSwWmi9veWjdJ2A3%7C-1468812056489609316/184161392/6/7001/7001/7002/7002/7001/-1

full printable version: http://www.medscape.com/viewarticle/409738_print

ADR of the Month
September 2001 Vol. 6 No. 9
EDITORS
Michelle W. McCarthy, Pharm.D.
Anne E. Hendrick, Pharm.D.

University of Virginia Health System
Department of Pharmacy Services
Drug Information Center
PO Box 800674
Charlottesville, VA 22908-0674
http://hsc.virginia.edu/pharmacy-services/Newsletters/ADR%20of%20the%20Month/ADRMonth%209-01htm.html


The Tablet, a general member benefit published by the British Columbia
Pharmacy Association, September 2001, Volume 10 no 8.
Excerpt:
Do HMG-CoA reductase inhibitors impair memory? After taking simvastatin for
a year, a 51-year-old patient developed short term memory loss, to the
extent of being unable to complete his sentences because he would forget
what he was going to say. The drug was discontinued, replaced by
pravastatin, and within one month his memory returned.14 In a separate case,
a 67-year-old woman developed impaired short-term memory, altered mood,
social impairment, cognitive impairment and dementia after one year of
atorvastatin therapy. When atorvastatin was discontinued, her memory, mood
and cognition improved completely.15 Memory impairment in a patient
receiving atorvastatin has been reported to the BC Regional ADR Centre.
REFERENCES:
14. Orsi A, Sherman O, Woldeselassie Z. Simvastatin-associated memory loss.

15. King DS, Jones DW, Wofford MR et al. First report of cognitive
impairment in an elderly patient: case report. Pharmacotherapy 2001 Mar; 21:
371.

http://www.bcpharmacy.ca/publications/thetablet/pdf_version/BCPhA_Tablet-Sep2001.pdf
See page 11 of 16:

See also:

Statins and risk of polyneuropathy, A case-control study
D. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. García
Rodríguez, MD, MSc;
J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhD
http://213.4.18.135/87.pdf full text

Preclinical safety evaluation of cerivastatin, a novel HMG-CoA reductase
inhibitor.
von Keutz E, Schluter G.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9737641&dopt=Abstract
Institute of Toxicology, PH-Product Development, Bayer AG, Wuppertal,
Germany
Am J Cardiol. 1998 Aug 27;82(4B):11J-17J.
PMID: 9737641
"In dogs, the species most sensitive to statins, cerivastatin caused
erosions and hemorrhages in the gastrointestinal tract, bleeding in the
brain stem with fibroid degeneration of vessel walls in the choroid plexus,
and lens opacity."

Subchronic toxicity of atorvastatin, a hydroxymethylglutaryl-coenzyme A
reductase inhibitor, in beagle dogs.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8864188&dopt=Abstract
Walsh KM, Albassam MA, Clarke DE.
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann
Arbor, Michigan 48105, USA.
"The toxicity of atorvastatin (AT), an inhibitor of
hydroxymethylglutaryl-coenzyme A reductase (HMG), was evaluated in beagle
dogs. hemorrhage in gallbladder and brain, demyelination of optic nerve, and
skeletal muscle necrosis"

Finally, on memory loss and statins: Sworn testimony from the Baycol trial
in Corpus Christi, Texas. From the transcript of the AM Session on 03-05-03,
in the case Hollis Haltom Vs. Bayer Corporation. Testifying under oath,., in
response to the plaintiff's attorney's question, "What is your current
position at Bayer?", LAWRENCE POSNER, M.D of BAYER stated: "I'm the --
currently I'm the head of worldwide regulatory affairs for our prescription
drug business, which means I have responsibility in somewhere between 60 and
100 countries where we sell products for registrations, compliance, things
of that nature." Excerpts from the trial transcript follow, with the Q
indicating counsel's Question, and the A indicating Dr. Posner's Answer:
Q. So there are some concerns addressed here back in 1995 about testing up
to .8. And do you know what the nature of the concern was?
A. Yes. It was related to a side effect that occurred in the brain.
Q. Of what kind of animal?
A. It occurred in the brain of dogs.
Q. Okay. So there was a side effect that occurred in dogs, and then there
was a concern about whether you wanted to go forward and test at this higher
dose level in human beings, given what you had learned about the dogs,
right?
A. That's correct.
Q. Okay. Now, did you just say, well, let's forget about these concerns and
we'll go ahead and put .8 on the market anyway, or did you do some further
****ysis that was not mentioned the other day?
A. Yes. The authors of this had -- they had two concerns. One concern was
the toxicity that they found in the brain of dogs. But the other was that
they had no way to identify this and who might be at risk before it
happened. So there was no way to detect that someone was at risk for this
side effect.
[skip some testimony on other topics]
Q. Do you remember in one kind of animal there had been some studies done
that there could be a particular kind of problem with one kind of animal?
A. Oh, yeah. Yes, from the -- that's correct, from the toxicology studies.
Q. Okay. And were you able to demonstrate to your own satisfaction, to
SmithKline's satisfaction, to the FDA's satisfaction, that that particular
problem that showed up with that kind of animal is not something that
happens in human beings?
A. Yes. We did it -- we did it by explaining the toxicology data. We also
explained it on the basis of kinetic data. That actually at the higher
levels of drug, what happens is a certain amount of drug is bound to
proteins in the body that circulate; and therefore, is not -- cannot cause
side effects. And actually, a much smaller proportion of the drug is free.
And that what you corrected for that, you actually found out that the
margins of safety were in fact greater than you would predict just from the
animal data.
Q. And as you move forward then and got approval and sold Baycol from 1997
through 2001, did that problem that had shown up with that one kind of
animal ever become a problem with human beings?
A. It was actually shown with other statins as well. It wasn't unique to
cerivastatin. It was a problem -- it was identified early on with lovastatin
and some of the others. In fact, for none of the statins did it ever predict
for any clinical problem or toxicity.
Q. So these animals would have that same problem regardless of which
statin -- or at least with other statins?
A. Certainly with lovastatin it was true.


http://www.latimes.com/features/health/la-he-statin23jun23,1,1321207.story
" Dr. Beatrice A. Golomb, a researcher at UC San Diego, says that other
scientifically rigorous studies have found that, after six months,
middle-aged people who took statins scored lower on tests of thinking and
memory than did people who got a dummy pill. It is possible, Golomb said,
"that statins will have benefits to cognitive function in some people and
harm to cognitive function in others."

See also, Dr. Graveline's sites
http://www.spacedoc.net/lipitor_thief_of_memory.html
http://www.spacedoc.net/lipitor.htm
http://www.spacedoc.net/statin_dialogues.htm

sharon hope

To quote Dr. Faxon, co-author of the joint advisory on statin safety issued
by the American College of Cardiology and the American Heart Association,
shortly after Baycol was pulled. In the context of our conversation that
indicated this adverse effect was known, was thought to be rare, and that
there is no way known to screen patients to prevent the succeptible from
having their memory destroyed, and that there is no known treatment. He
said to me,

"How rare the condition is does not make any difference if, in your family, it is 100%."

sharon hope

Brad,
Lipitor has this problem, too. Please see
http://www.citizen.org/publications/release.cfm?ID=7051, Petition to the
FDA to issue strong warnings about the potential for certain
cholesterol-lowering drugs to cause potentially life-threatening muscle
damage. (HRG Publication #1588)

You will note that, while Baycol had the largest number of deaths to
rhabdomyolysis, in the period October 1997 through December 2000, there were
86 cases of rhabdomyolysis, 11 % of the rhabdo cases, in Lipitor patients.
Of those, 13 Lipitor patients died in that same time period - 18.1% of the
statin death cases.

On that same site you listed, but at
http://www.niaspan.com/templates/patient.asp?class=1&page=75 it says
(emphasis added with *s) "Rare cases of a serious muscle disorder have been
reported *****when niacin is taken in combination with other cholesterol-
correcting medications*****. You should report to your doctor any
unexplained muscle pain or weakness if you're taking other
cholesterol-correcting medications while on NIASPAN®, as this could be a
sign of a serious, but rare, side effect."

You said you were stopping Lipitor, so the combination effect should not be
an issue if you wait for the Lipitor to leave your body before starting the
other drug.

brad

Thanks, I'm going to stop Lipitor. I don't want any muscle damage. My
ratio with 10 mg Lipitor is great - 2.3 - but my LP(a) is high at 53.
I'll try Niaspan if the flushing bothers me too much I'll take nothing
and see what happens to my blood. Niaspan reduces LP9a).

don kirkman

Each of us has to do what we think reasonable and justified *in the
light of all of our individual factors*, but I'm at 80mg of lipitor,
have been on statins since my MI in 1998, am 74 (and 1/2 <G>), normally
run four 3-mile sessions per week, walk 18 holes of golf per week, and
have normal blood tests including liver enzymes. I think the odds are
on my side for continuing to do well, and my cardios all have seemed to
think the same. I'm also on 500mg niacin (has been 1000 until a few
months ago), 20mg lisipronil, aspirin 325mg, and atenolol 12.5mg, as
well as some doctor-recommended supplements.

I gave my rationale in an earlier message in this thread.

--
Don
donkirk@covad.net

sharon hope

Absolutely - ENLIGHTENED risk aversion. Do a search on the NIH pub med site
on the terms "statin" and "memory" and see how many hits you get: 1

There is no ENLIGHTENED acknowledgement of the side effect in the US, and
therefore no patient is aware they are taking the risk. Worse, their
doctors are also unaware, and therefore they don't watch for it, nor do they
consider it a reason for discontinuing the drug.

Australia's FDA-equivalent recognized memory loss is associated with statins
and published it as a known adverse effect in 1998.


Dr. Faxon was talking to me about my husband, disabled by Lipitor. A 55
year old man, twice a CEO, who after 4 years of Lipitor scores BELOW the 1
percentile in short-term memory (along with a long list of other adverse
effects, including myopathy, myositis, peripheral neuropathy, aphasia, and
multiple on-Lipitor Transient Global Amnesia events, muscle wasting, and
extreme exercise intolerance.) My husband, who like many many others, did
not recover by merely discontinuing the drug, and still is disabled 19
months off the drug.

Not Baycol, not generalities, not enlightened risk taking, my husband of 34+
years.

It is my home and my family he was referring to when he said it did not
matter how rare these KNOWN (but not well do***ented) adverse effects are,
if they happen to your family they are 100%.

The point is that people need to know to make ENLIGHTENED risk decisions.
Not addresing the problem, not developing a method of screening out patients
who are candidates for disability, not developing a treatment is not
supporting decisions of risk. It is unconscionable.

sharon hope

news:<KR7Za.71837$Vt6.24003@rwcrnsc52.ops.asp.att. net>...

I am talking about my own husband of 34+ years. In our family the incidence
rate is 100%. If you consider "rare" a 2% rate (which the article sited
considers too low), then take a look at how many people that affects. There
are over 100 million people on statins now, world-wide. At 2% that is 2
million people affected.

Do you want commercial jet pilots to be among that 2 million? How about
brain surgeons? How about the guy driving the 16-wheeler 2 feet away from
your car in the next lane?

Here is to your health and hoping you do better than most. Dr. Gaist's
study showed people over 50 on statins for 2 or more years were 26 times as
likely as the normal population to develop polyneuropathy.

Here's hoping your muscles stay intact, your memory survives, you don't get
the amnesia, and your nerves are not affected in hands, feet and elsewhere.

be

the

sharon hope

Don,
You are very fortunate, and I hope your health remains good.

At least now you know some of the adverse effects to be aware of and watch
for. How many of the ones I mentioned in this thread were brought to your
attention by your doctor?


news:<KR7Za.71837$Vt6.24003@rwcrnsc52.ops.asp.att. net>...