Re: Statins and side effects......Statin Memory Loss & Amnesia


"listener" <listener@xxxxxxxxxx> wrote in message
news:Xns976227371282some1outthere@xxxxxxxxxxxxxxxxxx
You're a chronic cherry picker

Which of these studies do you consider to be cherries?

MEMORY LOSS & STATINS
Frequently Asked Question: What medical research studies have been done on
Statins and Memory Loss, or other mental problems that I can bring to my
doctor's attention?


(Statins: Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol, aka
atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and
simvastatin; Nerve Damage: Neuropathy, peripheral neuropathy,
polyneuropathy; See separate FAQ for memory loss, cognitive damage, amnesia
and aphasia, i.e., central nervous system (CNS) damage)





Am J Med. 2004 Dec 1;117(11):823-9.

Randomized trial of the effects of simvastatin on cognitive functioning in
hypercholesterolemic adults.

Muldoon MF, Ryan CM, Sereika SM, Flory JD, Manuck SB.

Center for Clinical Pharmacology, University of Pittsburgh, Pennsylvania
15260, USA. mfm10@xxxxxxxx

"This study provides partial support for minor decrements in cognitive
functioning with statins. Whether such effects have any long-term sequelae
or occur with other cholesterol-lowering interventions is not known." This
is the second of two studies by Muldoon, both showing measurable cognitive
decline in statin groups after only 6 months, using Neuropsych testing.
Further, the cognitive deficits appear consistently in specific areas.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15589485



Golomb BA, Yang E, Denenberg J, Criqui M (2003),

Statin-associated adverse events. P95. Presented at the 43rd Annual
Conference on Cardiovascular Disease Epidemiology and Prevention. Miami;
March 5-8.





Muldoon MF, Ryan CM, Flory JD, Manuck SB (2002),

Effects of simvastatin on cognitive functioning.

Presented at the American Heart Association Scientific

Sessions. Chicago; Nov. 17-20.



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



Cognitive impairment associated with atorvastatin and simvastatin.

King DS, Wilburn AJ, Wofford MR, Harrell TK, Lindley BJ, Jones DW.

Department of Medicine, University of Mississippi Medical Center, Jackson,
Mississippi 39216, USA. dking@xxxxxxxxxxxxxxxxxxx

Pharmacotherapy. 2003 Dec;23(12):1663-7.

"we report two women who experienced significant cognitive impairment
temporally related to statin therapy. One woman took atorvastatin, and the
other first took atorvastatin, then was rechallenged with simvastatin.
Clinicians should be aware of cognitive impairment and dementia as potential
adverse effects associated with statin therapy." PMID: 14695047

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14695047



Cognitive impairment associated with atorvastatin.

King DS, Jones DW, Wofford MR et al. (2001), Presented at the American
College of Clinical Pharmacy Spring Practice and Research Forum. Salt Lake
City; April 22-25.





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.

www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf



Statin-associated memory loss: analysis of 60 case reports and review of the
literature.

Wagstaff LR, Mitton MW, Arvik BM, Doraiswamy PM.

Drug Information Service, Duke University Medical Center, Durham, North
Carolina 27710, USA. Pharmacotherapy. 2003 Jul;23(7):871-80.



This study searched the MedWatch drug surveillance system of the Food and
Drug Administration (FDA) from November 1997-February 2002 for reports of
statin-associated memory loss. They also reviewed the published literature.
References from the study are good for follow-up research.

Abstract:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12885101&dopt=Abstract



Full Study Text free on Medscape:

http://www.medscape.com/viewarticle/458867





The Role of Lipid-Lowering Drugs in Cognitive Function: A Meta-Analysis of
Observational Studies

from Pharmacotherapy

Posted 06/30/2003

Mahyar Etminan, Pharm.D., Sudeep Gill, M.D., FRCPC, Ali Samii, M.D., FRCPC



Although this study does bring the cognitive issues to light, it is a very
poor study. The authors left out the pivotal study by Dr. Muldoon, that
showed nearly 100% of statin users had a measurable loss of cognitive
ability after 6 months, while 100% of the placebo group improved their
scores.

Abstract:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12820814&dopt=Abstract

Full Study Text free on Medscape:

http://www.medscape.com/viewarticle/456866





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
analysis 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.

Q. But when it came time to human beings, that just wasn't something that
happened to human beings?

A. And I think today no one pays much attention to it.





AMNESIA & STATINS
Frequently Asked Question: Amnesia is one of the Lipitor side effects
reported by Pfizer on the Physician's Information, where can I find out more
about people who have had amnesia episodes while taking the drug?


Lipitor, Thief of Memory, by Duane Graveline M.D.
Dr. Graveline, retired family MD, USAF Flight Surgeon, researcher in space
medicine and US Astronaut, who suffered adverse effects from Lipitor,
maintains several websites and is working on a second book about statin
adverse effects, including statin-related memory loss and amnesia at:

www.spacedoc.net (you can start here and read about his life and his books)

http://www.spacedoc.net/lipitor_thief_of_memory.html

http://www.spacedoc.net/lipitor.htm

http://www.spacedoc.net/statin_dialogues.htm



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.

www.health.gov.au/tga/docs/pdf/aadrbltn/aadr9808.pdf






.

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