posted 10-09-2003 11:08 AM            

He did eventually go to the doctor, get some reassurance and a clean bill of health, and he restarted Lipitor, and now also takes Zetia. Has not had any problems on it, and his labs have all been normal with normal liver enzymes also. No further muscle pain.

I work in a job where I read a lot of medical records and tons of people take Lipitor. Most have no problems whatsoever. Side effects seem somewhat rare.

I would suggest that your husband discuss his muscle pain with his doctor. I doubt it's anything serious, but I think it's always a good idea to discuss things like this with your physician.

posted 10-09-2003 01:59 PM            

Anyway...check the cholesterol board on this site for some assistance there. My knowledge of Lipitor is pretty much limited to what I've already posted, but I'm sure there are people on the cholesterol board who can help out. There are other cholesterol drugs, so maybe your hubby can switch if the muscle aches is particularly bothersome.

I wish him, and you, continued good heath!

posted 10-09-2003 09:15 PM            

quote:

---

Originally posted by MyOMy:
Beth, My husband did discuss it with the Dr. back in August. He said that it would'nt be the Lipitor. He more or less brushed it off as nothing to worry about. My hubby went back to work mid-July, and he does quite a bit of lifting, at first we thought it ws because he was off and needed to get used to using those muscles again, but he has been back for almost 3 months, and he still gets occasional pain in his right arm. He ad a catherization test done back in May, and all of his vessels were completely open, other then the small vessel were the attack occured. The Dr. said that other than that one area he has the heart of a normal 45 year old man. Any other ideas what it could be?

---

posted 10-10-2003 08:00 AM            

I guess what I'm saying is that it's hard to point blame at a drug unless onset is rapid after starting the drug, or you can show some pattern of pain start-stop that correlates with starting and stopping the drug.

posted 10-12-2003 03:06 PM            

-----------------------
I know this should be on the cholestrol board, but I thought you might like to see what I was talking about when I said Lipitor DOES HAVE HORRIBLE SIDE EFFECTS!!

Updated 21 June 2003:

Frequently Asked Questions about Statin Adverse Effects

What are the names of the Statin drugs?

The Cholesterol-lowering Statin Drug Names: Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol, aka atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin; This class of drugs is also known as HMG-CoA Reductase Inhibitors, short for 3-Hydroxy-3-Methyl-Glutaryl Coenzyme A Reductase.
http://www.bms.com/cgi-bin/anybin.pl?sql=select%20PPI%0A%09%09%09%09%20%20%20from%20TB_PRODUCT_PPI%20%0A%09%09%09%09%20%20%20where%20PPI_SEQ%20=%2056&key=PPI
http://www.ca.pharma.novartis.com/downloads/e/lescol_scrip_e.pdf
http://www.merck.com/product/usa/pi_circulars/m/mevacor/mevacor_pi.pdf
http://www.merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf

Where can I look to find information on research studies of statin drugs?

The National Institutes of Health has a website, http://www.ncbi.nlm.nih.gov/Entrez/ that offers a search engine that is useful in finding the latest studies that have been published in medical journals (over 11,000,000 biomedical journal citations) and other major repositories of medical research. Each study usually comes with an Abstract, or summary of the findings. In most cases, should you want to see the full text of the study, the full article can be purchased online for approximately $25 to $40, depending on the journal, which is much cheaper than a subscription.

Note that journals publish new studies every month, so revisit the site often. Also, if you find a study that is pertinent to what you are looking for, check the links to the right that will take you to similar studies on the same topic. Finally, if you don’t get a ‘hit’ on what you are looking for, try medical terminology synonyms. Search results are different when using different search terms. So, for example: “statin” or “atorvastatin” or “lipitor” or “reductase inhibitor” or “HMG-CoA”. Similarly, “cholesterol” will return different results from “Dyslipidemia.”

Why does my physician have such a difficult time believing that my physical problems might be an adverse effect of Lipitor or one of the other statins?

Statins are now the most widely prescribed of all prescription drugs, making them very big business. The Wall Street Journal Online, in a June 13, 2003 article, “As Drug Sales Teams Multiply, Doctors Start to Tune them Out; 'Arms Race' by Pfizer and Rivals Boosts Pill Prices, Ire, but No One Dares Retreat”, reported that Pfizer’s sales of Lipitor alone were $8 BILLION for the year 2002. That is just for Lipitor alone, one of FIVE statins on the market today. The article states that in 2002 the drug companies spent over $12 Billion on their sales forces. According to the article, “Last year, a few Pfizer reps brought along a guest speaker who was both a doctor and lawyer to a lunch meeting with doctors at Clinical Associates, a group practice in suburban Baltimore. He said they risked being sued if their patients didn't reach their cholesterol goals”. Doctors are the ones who are primarily targeted by the advertising blitz to make the expectations of increased sales come true. In addition, consumers are marketed with slick commercials and ads. Doctors are very busy, and they are inundated with positive statin spin. They may think that, since everyone is taking it, if there were problems they would have heard about it. They may not take the time to dig out negative information, and there are no major sponsors to fund equal time for negative reports.

Only last year, in 2002, did the Journal of the American Medical Association begin annotating publications with the author’s ties to the company studied, citing potential conflict of interest.

The British Journal of Medicine in their May 31, 2003 issue on the theme “Time to untangle doctors from drug companies”, ran no less than 6 articles saying that too many of the published drug studies are no more than industry-sponsored infomercials, and cited the selective reporting bias whereby only pro-industry studies are published. These articles were entitled: “Research sponsored by drug companies is biased”; ” Drug representatives may increase unnecessary GP prescribing”; ”Reporting of clinical trials of drugs shows bias”; “Characteristics of General Practicioners who Frequently see Drug Industry Representatives: National Cross-Sectional Study ”; “No more free lunches; Patients will benefit from doctors and drug companies disentangling”; “Information from drug companies and opinion leaders; Double standards in information for medical journals and practitioners should go” http://bmj.com/content/vol326/issue7400/

The Canadian CBC News ran a series of consumer articles on March 25, 2003, on the prevalent problem of medical ghostwriting. In this scheme, drug companies write a study favorable to their product and then “reward” a doctor who prescribes the drug by listing his name as the “author” in the publication. http://www.cbc.ca/consumers/market/files/health/ghostwriting/links.html

Your physician should look into your physical adverse effects, regardless of suspected cause. Do not permit your physician to put you off when you express a concern. Too many people are reporting long-term, perhaps permanent, damage when statin therapy is continued despite the appearance of adverse effects. In some cases, like rhabdomyolysis, death results. Oddly, people consistently report doctors who are dubious of reported problems being due to statins, even when the problem is listed by the manufacturer on the Physicians’ Information page for the drug. It may help, if you identify your problems with the findings of a published study, to print out a copy and bring it with you to the doctor’s appointment.

That is one of the purposes for this FAQ – to give people an additional tool help them to communicate with their doctors.

Note: These articles documenting or speculating on adverse effects of statins are in the vast minority. Hundreds, even thousands, of articles and research have praised statins. Certainly the people with side effects are in the minority, and the benefits are fantastic. Still, the doctors who do attempt to publish about problems associated with statins are often very bitter: they feel they are up against a tremendous political bias and going against an incredibly powerful industry. Med Journal editors tend to insist that all negative findings be couched in terms of how, overall, the statins are doing tremendous good, and the major studies finding problems with statins have been the subject of a pro-statin editorial in the same journal. Further, the popular press is extremely reluctant to cover negative research findings for the companies who are among their heaviest advertisers.

Two recent examples of bias in the presentation of pivotal findings are:

1) Dr. Gaist’s study that proves statins cause polyneuropathy http://213.4.18.135/87.pdf. If you read the entire research article, you will note the vast difference between his findings and the tone of the descriptive abstract, that tends to water down the findings. Further, the journal ran an editorial that provided further pro-statin spin as damage control.

2) The ALLHAT study, published in JAMA, was the largest to date. It ran for years and encompassed 10,000 people. Their study website http://allhat.sph.uth.tmc.edu/default.htm These folks were funded by NIH, and they have published what the drug companies do not want to hear: that statins do not prevent deaths. Again, there was a pro-statin damage control editorial in the same issue, and the news carriers did not highlight the findings. In fact, CNN buried it inside an article on the other finding: that diuretics worked better than other blood-pressure medications, where no reader looking for cholesterol drug results would find it.

OK, I understand the doctor’s need to read clinical study results, but where can I find out what other people are experiencing in plain language, and maybe share my experiences?

The Dispace statin boards are an excellent source:
Lipitor: http://forum.ditonline.com/viewboard.php?BoardID=38
Zocor: http://forum.ditonline.com/viewboard.php?BoardID=41
Lescol: http://forum.ditonline.com/viewboard.php?BoardID=37
Pravachol: http://forum.ditonline.com/viewboard.php?BoardID=40
Mevacor: http://forum.ditonline.com/viewboard.php?BoardID=39

AARP ran an article on statin drugs and asked for responses, these posts start at: http://community.aarp.org/n/mb/message.asp?webtag=rp-health&msg=743.1
(at the bottom of the page, you can click to the next post)

Another board: http://www.rxlist.com/rxboard/lipitor.pl http://www.rxlist.com/rxboard/lescol.pl http://www.rxlist.com/rxboard/mevacor.pl http://www.rxlist.com/rxboard/pravachol.pl http://www.rxlist.com/rxboard/zocor.pl

WebMD has a roundtable on Cholesterol: http://boards.webmd.com/roundtable_topic/1121

Also, there is a newsgroup (access via your email program):
sci.med.cardiology

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 has written on a book about statin-related memory loss and amnesia, Lipitor, Thief of Memory, 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

What are the Liptior warnings and side-effects listed by the manufacturer on the physicians’ information?

For a full introduction to the list, view http://www.lipitor.com/pi/default.asp . Summary of some of the items on the website includes Warnings of liver dysfunction, and skeletal muscle rhabdomyolysis for the physicians information updated as of April 2002.

What are the Lipitor Adverse Events in Placebo-Controlled Studies listed by Pfizer in the Physician’s information?

For a full introduction to the list, view http://www.lipitor.com/pi/default.asp, the information below is from the version updated as of April 2002:
Body as a whole: Infection, Headache, Accidental Injury, Flu Syndrome, Ab******l Pain, Back Pain, Allergic Reaction, Asthenia;
Digestive system: Constipation, Diarrhea, Dyspepsia, Flatulence;
Respiratory system: Sinusitis, Pharyngitis;
Skin and Appendages: Rash;
Musculoskeletal system: Arthralgia, Myalgia.

What are the Lipitor Averse Events reported in patients treated with Lipitor in clinical trials listed by Pfizer in the Physician’s information?

For a full introduction to the list, view http://www.lipitor.com/pi/default.asp, the information below is from the version updated as of April 2002:
Body as a Whole: Chest pain, face edema, fever, neck rigidity, malaise, photosensitivity reaction, generalized edema.
Digestive System: Nausea, gastroenteritis, liver function tests abnormal, colitis, vomiting, gastritis, dry mouth, rectal hemorrhage, esophagitis, eructation, glossitis, mouth ulceration, anorexia, increased appetite, stomatitis, biliary pain, cheilitis, duodenal ulcer, dysphagia, enteritis, melena, gum hemorrhage, stomach ulcer, tenesmus, ulcerative stomatitis, hepatitis, pancreatitis, cholestatic jaundice.
Respiratory System: Bronchitis, rhinitis, pneumonia, dyspnea, asthma, epistaxis.
Nervous System: Insomnia, dizziness, paresthesia, somnolence, amnesia, abnormal dreams, libido decreased, emotional lability, incoordination, peripheral neuropathy, torticollis, facial paralysis, hyperkinesia, depression, hypesthesia, hypertonia.
Musculoskeletal System: Arthritis, leg cramps, bursitis, tenosynovitis, myasthenia, tendinous contracture, myositis.
Skin and Appendages: Pruritus, contact dermatitis, alopecia, dry skin, sweating, acne, urticaria, eczema, seborrhea, skin ulcer.
Urogenital System: Urinary tract infection, urinary frequency, cystitis, hematuria, impotence, dysuria, kidney calculus, nocturia, epididymitis, fibrocystic breast, vaginal hemorrhage, albuminuria, breast enlargement, metrorrhagia, nephritis, urinary incontinence, urinary retention, urinary urgency, abnormal ejaculation, uterine hemorrhage.
Special Senses: Amblyopia, tinnitus, dry eyes, refraction disorder, eye hemorrhage, deafness, glaucoma, parosmia, taste loss, taste perversion.
Cardiovascular System: Palpitation, vasodilatation, syncope, migraine, postural hypotension, phlebitis, arrhythmia, angina pectoris, hypertension.
Metabolic and Nutritional Disorders: Peripheral edema, hyperglycemia, creatine phosphokinase increased, gout, weight gain, hypoglycemia.
Hemic and Lymphatic System: Ecchymosis, anemia, lymphadenopathy, thrombocytopenia, petechia.

What are the Lipitor Adverse events associated with Lipitor therapy reported since market introduction, that are not listed above, listed by Pfizer in the Physician’s information?

For a full introduction to the list, view http://www.lipitor.com/pi/default.asp, the information below is from the version updated as of April 2002:
anaphylaxis, angioneurotic edema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and rhabdomyolysis.

REPORTING ADVERSE EFFECTS FROM STATINS
Where should I report adverse effects from statins?
Report to the FDA, http://www.fda.gov/medwatch/how.htm

Also, it is important to report side-effects to the Statin Study, funded by the National Institutes of Health and conducted at the University of California, San Diego.
Statin Study website: http://medicine.ucsd.edu/statin/
with contact info at: http://medicine.ucsd.edu/statin/contactinfo.html
UCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (85 558-4950
Dr. Golomb, the principal investigator of the Statin Study, is an incredibly intelligent and active woman. Take a look at her Curriculum Vitae at: http://www.medicine.ucsd.edu/faculty/golomb/

NERVE DAMAGE & STATINS
Frequently Asked Question: What medical research studies have been done on Statins and Nerve Damage that I can bring to my doctor’s attention?

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

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

Are users of lipid-lowering drugs at increased risk of peripheral neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas · Søren H. Sindrup http://213.4.18.135/75.pdf full text
abstract

Are users of lipid-lowering drugs at increased risk of peripheral neuropathy?
David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas · Søren H.
Sindrup http://213.4.18.135/76.2.pdf full text http://213.4.18.135/87.pdf full text

Pharmacodynamics: Statins and peripheral neuropathy
U. Jeppesen (2), D. Gaist (1)(2), T. Smith (1), S. H. Sindrup (1)(2)
(1) Department of Neurology, Odense University Hospital, DK-5000 Odense C, Denmark Tel.: +45-6541-2474, Fax: +45-6541-3389
(2) Department of Clinical Pharmacology Odense University, Odense, Denmark
Received: 6 July 1998 / Accepted in revised form: 1 October 1998
Abstract Volume 54 Issue 11 (1999) pp 835-838 http://link.springer-ny.com/link/service/journals/00228/bibs/9054011/90540835.htm

Association of HMG-CoA reductase inhibitors with neuropathy. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12549960&dopt=Abstract
Ann Pharmacother. 2003 Feb;37(2):274-8.
Backes JM, Howard PA.
Department of Pharmacy Practice and Lipid, Atherosclerosis, Metabolic and LDL-Apheresis Clinic, University of Kansas Medical Center, Kansas City, KS 66160-7231, USA. jbackes@kumc.edu
“Epidemiologic studies and case reports suggest an increased risk of peripheral neuropathy with statin drugs… The majority of cases were at least partially reversible with drug cessation.” (emphasis added)

Statin therapy and small fibre neuropathy: a serial electrophysiological study. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12639733&dopt=Abstract
Lo YL, Leoh TH, Loh LM, Tan CE.
J Neurol Sci. 2003 Apr 15;208(1-2):105-8.
Department of Neurology, Singapore General Hospital, Outram Road, Singapore. gnrlyl@sgh.com.sg
Describes 3 patients who developed neuropathy after ONE MONTH of statin therapy. “One patient redeveloped small and large fibre neuropathy when the similar drug was readministered.”

Peripheral Neuropathy and Lipid-Lowering Therapy
Paul E. Ziajka, MD, PhD, and Tammy Wehmeier, RN, Orlando, Fla.
Abstract: We report a case of peripheral neuropathy induced and excerbated by several commonly used HMG-CoA reductase inhibitors including lovastatin, simvastatin, pravastatin, and atorvastatin, and the vitamin niacin. A review of the literature shows similar cases with individual lipid-lowering drugs, but this case shows the cross-reactivity of the neuropathic process to different HMG-CoA reductase inhibitors, and is the first reported case of a peripheral neuropathy exacerbated by the use of niacin. http://www.sma.org/smj1998/julysmj98/ziajka.pdf

Phan T, McLeod JG, Pollard JD, Peiris O, Rohan A, Halpern JP.
Peripheral neuropathy associated with simvastatin.
J Neurol Neurosurg Psychiatry. 1995 May;58(5):625-8.
PMID: 7745415 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7745415&dopt=Abstract

Ahmad S.
Lovastatin and peripheral neuropathy.
Am Heart J. 1995 Dec;130(6):1321. No abstract available.
PMID: 7484806 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7484806&dopt=Abstract

Jacobs MB.
HMG-CoA reductase inhibitor therapy and peripheral neuropathy.
Ann Intern Med. 1994 Jun 1;120(11):970. No abstract available.
PMID: 8172444 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8172444&dopt=Abstract

Medication-induced peripheral neuropathy. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12507417&dopt=Abstract
Curr Neurol Neurosci Rep. 2003 Jan;3(1):86-92. Review.
Weimer LH.
Neurological Institute of New York, 710 West 168th Street, Unit 55, New York, NY 10032, USA. Lhw1@columbia.edu
PMID: 12507417 [PubMed - indexed for MEDLINE]
“Although most cases demonstrate acute or subacute onset after exposure, recent experiences with statin drugs raise the possibility of occult toxic causes of chronic idiopathic neuropathy.”

Le Quesne PM. Neuropathy due to drugs. In: Dyck PJ, Thomas PK, Griffin JW, et al, eds. Peripheral neuropathy. 3rd ed. Philadelphia: Saunders, 1993:1571–1581.
(Book, no link)

Of interest:

MacDonald BK, Cockerell OC, Sander WAS, Shorvon SD (2000) The incidence and lifetime prevalence of neurological disorders in a prospective community-based study in the UK. Brain
123:665-676
General background medical Info from

Related, but also will appear in other FAQs:

Neuromuscular Disease Center
Washington University School of Medicine, St. Louis, MO
Home: http://www.neuro.wustl.edu/neuromuscular/index.html

Under Disorders & Syndromes:
Select:
Myopathy: http://www.neuro.wustl.edu/neuromuscular/maltbrain.html
Neuropathy: http://www.neuro.wustl.edu/neuromuscular/naltbrain.html
Neuromuscular: http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html
CNS (Central Nervous System): http://www.neuro.wustl.edu/neuromuscular/syaltbrain.html#cns

Specifics,
MYOGLOBINURIA – RHABDOMYOLYSIS http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html
Then see Lipid Lowering Agent Myopathies http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#lipid
Note that this connects to CARDIAC + MYOPATHY http://www.neuro.wustl.edu/neuromuscular/msys/cardiac.html
And to TOXIC NEUROPATHIES: http://www.neuro.wustl.edu/neuromuscular/nother/toxic.htm#statin
OR Locally supplied Search on “Statin” leads to:
TOXIC MYOPATHIES http://www.neuro.wustl.edu/neuromuscular/mother/myotox.htm

Note also tht under Mitochondrial Disorders, the list of problems associated with Coenzyme Q10 Deficiency http://www.neuro.wustl.edu/neuromuscular/msys/myoglob.html#coq10

MITOCHONDRIAL MYOPATHIES
Facts About Mitochondrial Myopathies from the Muscular Dystrophy Association http://www.mdausa.org/publications/mitochondrial_myopathies.html#whatcauses

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)

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

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
Charlottes*****, 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?

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 book about 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

CHEST PAIN & STATINS
Frequently Asked Question: Chest pain, that my cardiologist cannot explain via angiogram, stress test, EEG or EKG, is one of the side-effects I see is reported by many people. Is there any information on chest pain associated with statins?

Naturally, chest pain should be first evaluated by a cardiologist. If the usual explanations for chest pain do not apply to you, and you believe that statin adverse-effect may be the cause, here are some articles that may give you some background, or may be useful to give to your doctor. Some are specific to statins and cardiomyopathy, some are background on how statins affect CoQ10 production and how a CoQ10 deficiency affects the cells.

Most of these research articles have been found via a search of the National Institutes of Health website http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=&DB=PubMed , a repository for hundreds of medical journals. In most cases, only the abstract is available and the full article must be purchased. Many of the others can be found via a Google or other net search, or were discovered via posts on the Lipitor message boards.

See: http://www.lipitor.com/pi/default.asp Pfizer's Physician's Info for prescribing Lipitor, includes documented known adverse effects. Note "Body as a Whole: Chest pain," the italics indicate that the incidence was > 2% in original trials.

COENZYME Q10 (UBIQUINONE) DEFICIENCY CAUSED BY STATINS
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12353945&dopt=Abstract
Study report: http://www.annals.org/issues/v137n7/nts/200210010-00004.html
Dr. Phillips study mentioned in a Wall Street Journal article (This is smooth muscle, not cardiac muscle.) Conclusion "statin therapy may be associated with increased oxidation injury…mild adverse effects of statins that are difficult to assess might be much more prevalent than widely considered " http://www.impostertrial.com Is Myopathy Part Of Statin Therapy? Dr. Phillips study website, with info for Patient and Physician

Cohen & Gold, Mitochondrial Cytopathy in Adults: What we know so far http://www.ccjm.org/pdffiles/COHEN701.PDF
(See "Heart" in table page 4, and section on page 7) CoQ10 If statins cause CoQ10 deficiency, and CoQ10 deficiency causes mitochondrial disease, what are the symptoms of mitochondrial disease? Heart pain is one of them.
Oxidation Injury in Patients Receiving HMG-CoA Reductase Inhibitors: Occurrence in Patients without Enzyme Elevation or Myopathy.

US Patents: # 4,933,165 http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1&f=G&l=50&s1=4933165.WKU.&OS=PN/4933165&RS=PN/4933165

see also subsequent related patents: Do a search by patent number at: http://patft.uspto.gov/netahtml/srchnum.htm
for the following:
United States Patent 5,082,650
United States Patent 5,849,777
United States Patent 6,264,960
Merck Patent application stating that statins interfere with CoQ10 and that deficiency causes problems. They documented that they knew this about statins in 1989, 10 years before the 100+ deaths by Rhabdomyolysis!
http://sites.huji.ac.il/malaria/maps/ubiquinonemetpath.html
Malaria Parasite Metabolic Pathways Ubiquinone Metabolism
another version: http://www.stdgen.lanl.gov/stdgen/images/KEGG/00130.html
DEFINITION Ubiquinone biosynthesis - Reference pathway. Diagram of the Ubiquinone (aka CoQ10) metabolic pathway, highlighting exactly where the Statins interrupt it. All of the 17 or so steps have to happen correctly for the body to produce CoQ10, but statins interrupt (or retard) this in step #2.

Introduction to the Citizen's petition to the FDA: http://www.vaccinationnews.com/DailyNews/July2002/StatinInduced8.htm by Dr. Peter Langsjoen This is the introduction to the petition. (It is aimed at getting attention, and the wording may be more alarming than necessary.)

To the FDA: "Citizen Petition To Change The Labeling For All Statin Drugs (Mevacor, Lescol, Pravachol, Zocor, Lipitor, And Advicor) Recommending Use Of 100-200mg Per Day Of Supplemental Co-Enzyme Ql0 To Reduce The Risk Of Statin-Induced Myopathies (Including Cardiomyopathy And Congestive Heart Failure)," by Dr. Julian Whitaker, MD: http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf or as html: http://216.239.33.100/search?q=cache:4qAiX-YbZLYC:www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf+Statin-Induced+Cardiomyopathy+Introduction+To+The+Ci tizen%27s+Petition+On+Statins&hl=en&ie=UTF-8
Statin Depletion of CoQ10 is linked to heart problems.
Exhibit A of FDA Petition: "The clinical use of HMG CoA-reductase inhibitors (statins) and the associated depletion of the essential co-factor coenzyme Ql0; a review of pertinent human and animal data." by Dr. Peter Langsjoen MD: http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-02-Exhibit_A-vol1.pdf

Examples of the heart problems associated with statin depletion of CoQ10. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2247468&dopt=Abstract
Lovastatin decreases coenzyme Q levels in humans.
Proc Natl Acad Sci U S A. 1990 Nov;87(22):8931-4.
PMID: 2247468 [PubMed - indexed for MEDLINE] A 1990 study showing depletion of CoQ10 by Lovastatin – includes descriptions of cardiac patients. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11479481&dopt=Abstract A 2001 discussion on "The effect of pravastatin and atorvastatin on coenzyme Q10"
http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/C/CellularRespiration.html Primer on how cells breathe normally (Note the role of CoQ10, called "Ubiquinone" in "The Respiratory Chain" section. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11505177&dopt=Abstract (abstract) http://213.4.18.135/70.pdf http://216.239.33.100/search?q=cache:IGxCBJ3vs1kC:213.4.18.135/70.pdf+gaist+statin+myopathy+risk+greater&hl=en&ie=UTF-8 view as html
Lipid-lowering drugs and risk of myopathy: a population-based follow-up study. Dr. Gaist is in Denmark and studies populations of entire countries for epidemiology information.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12011277&dopt=Abstract Dr. Gaist’s study, Statins and risk of polyneuropathy: a case-control study. (more serious than peripheral neuropathy) http://213.4.18.135/87.pdf Dr. Gaist's studies on Statin-induced nerve damage (full text)

Others:
Watts GF, Castelluccio C, Rice-Evans C, Taub NA, Baum H, Quinn PJ. Plasma coenzyme Q (ubiquinone) concentrations in patients treated with simvastatin. J Clin Pathol. 1993;46:1055-7. [PMID: 8254097] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=PMID: 8254097

Mortensen SA, Leth A, Agner E, Rohde M. Dose-related decrease of serum coenzyme Q10 during treatment with HMG-CoA reductase inhibitors. Mol Aspects Med. 1997;18 Suppl:S137-44. [PMID: 9266515] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=9266515

Bargossi AM, Grossi G, Fiorella PL, Gaddi A, Di Giulio R, Battino M. Exogenous CoQ10 supplementation prevents plasma ubiquinone reduction induced by HMG-CoA reductase inhibitors. Mol Aspects Med. 1994;15 Suppl:s187-93. [PMID: 7752830] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=7752830

Ogasahara S, Engel AG, Frens D, Mack D. Muscle coenzyme Q deficiency in familial mitochondrial encephalomyopathy. Proc Natl Acad Sci U S A. 1989;86:2379-82. [PMID: 2928337] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2928337

Baker SK, Tarnopolsky MA. Statin myopathies: pathophysiologic and clinical perspectives. Clin Invest Med. 2001;24:258-72. [PMID: 11603510] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=11603510

Rosenfeldt FL, Pepe S, Ou R, Mariani JA, Rowland MA, Nagley P, et al. Coenzyme Q10 improves the tolerance of the senescent myocardium to aerobic and ischemic stress: studies in rats and in human atrial tissue. Biofactors. 1999;9:291-9. [PMID: 10416043] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=10416043

Reust CS, Curry SC, Guidry JR. Lovastatin use and muscle damage in healthy volunteers undergoing eccentric muscle exercise. West J Med. 1991;154:198-200. [PMID: 2006566] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=2006566

Statin-associated myopathy. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12672737&dopt=Abstract
Thompson PD, Clarkson P, Karas RH.
Preventive Cardiology and Cardiovascular Research, Division of Cardiology, Hartford Hospital, Hartford, Conn 06102, USA. pthomps@harthosp.org
“recent evidence suggests that statins reduce the production of small regulatory proteins that are important for myocyte maintenance”

Statins and myotoxicity.
Curr Atheroscler Rep. 2003 Mar;5(2):96-100. Review.
PMID: 12573193 Farmer JA. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12573193&dopt=Abstract
Baylor College of Medicine, One Baylor Plaza, Room 525D, Houston, TX 77030, USA. jfarmer@bcm.tmc.edu

CARNITINE DEFICIENCY CAUSED BY STATINS

Bhuiyan J, Seccombe DW. The effects of 3-hydroxy-3-methylglutaryl-CoA reductase inhibition on tissue levels of carnitine and carnitine acyltransferase activity in the rabbit. Lipids. 1996;31:867-70. [PMID: 8869889] http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?db=m&form=6&Dopt=r&uid=8869889

JOINT PAIN AND STATINS
Frequently Asked Question: Can statins have something to do with my joint pain?
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11707010&dopt=Abstract Four cases of tendinopathy in patients on statin therapy.
Joint Bone Spine. 2001 Oct;68(5):430-3. PMID: 11707010 [PubMed - indexed for MEDLINE]
Abstract on a report of 4 cases of people with painful tendons & statins. Included to show that the pain and damage shows up in a variety of areas.

QUITTING STATINS
Frequently Asked Question: Can it be dangerous to just stop taking statins?

One study indicates that there are more coronary events when people stop taking statins (Definitely talk with your doctor on this): http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11914253&dopt=Abstract Withdrawal of statins increases event rates in patients with acute coronary syndromes. The dangers of getting off statins. See also: http://www.lipidsonline.org/commentaries/al_abstract.cfm?abs_id=Abs030

VIOLENCE AND LOW CHOLESTEROL
Frequently Asked Questions: Can it be the statins making me so irritable and prone to angry outbursts?

It may be that the angry outbursts are caused by the Low Cholesterol, the result of taking Lipitor or other statins.
Dr. Beatrice Golomb, who is now conducting the NIH funded Statin Study, published 2 articles/studies on the connection between violence and low cholesterol levels.
See:
Low cholesterol and violent crime. Golomb BA, Stattin H, Mednick S. Department of Medicine, University of California, Los Angeles, CA 92093-0995, USA. J Psychiatr Res 2000 Jul-Oct;34(4-5):301-9 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11104842&dopt=Abstract
and
Cholesterol and violence: is there a connection? Golomb BA. Ann Intern Med 1998 Mar 15;128(6):478-87 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9499332&dopt=Abstract

IMMUNE SYSTEM AND STATINS
Frequently Asked Question: Can statins depress my immune system?

It is a tribute to the imaginations of the drug marketers to see how successfully they have put positive “spin” on a very alarming proposition, that statins depress the immune system (or is it just arrogance?). If the known side effect of statins is to depress your immune system, and it is so beneficial to transplant recipients and others with autoimmune disease, what about people with pre-statin 'normal' immune systems
I'm not the only one astonished and disgusted with this, check out Dr. Mercola's comment (scroll down for his response to the article) on http://www.mercola.com/2000/dec/24/statins.htm
Excerpts: "This is an amazing example of positive "spin" put on a very negative result. People with high cholesterol certainly don't need their immune systems suppressed...If suppressing the helper T cells is considered such great benefit then there is a disease going around that does this quite well - AIDS...if the mechanism of action of the drug is not understood, how can the manufacturer or the FDA claim that it is safe"
It sounds like he is talking about this article http://pub.ucsf.edu/today/print.php?news_id=200211062 , but actually he is describing the last time the drug companies tried to feed us a myth about how great it is that statins depress immune systems: (available for online purchase from Nature Medicine: http://www.nature.com/dynasearch/app/dynasearch.taf?sp-w=Exact&_action=search&search_fulltext=&sp-p=All&search_volume=&search_startpage=&search_title=&search_author=&search_abstrac t=statins+as+immunosuppressors&issue_start_month=12&issue_start_year=2000&issue_end_month=01&issue_end_year=2001&pickerCount=You+have+selected+1+journal+to+search.&rolloverMessage= &sp_k=NM
Atorvastatin suppresses interferon-gamma -induced neopterin formation and tryptophan degradation in human peripheral blood mononuclear cells and in monocytic cell lines.
Neurauter G, Wirleitner B, Laich A, Schennach H, Weiss G, Fuchs D.
Summary: Recent findings indicate that statins also have anti-inflammatory properties and can modulate the immune response…statins inhibit T cell activation within the cellular immune response…atorvastatin directly inhibits IFN-gamma-mediated pathways in monocytic cells, suggesting that both immunoreactivity of T cells and of monocyte-derived macrophages are down-regulated by this statin.
Clin Exp Immunol 2003 Feb;131(2):264-7 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12562386&dopt=Abstract

A novel anti-inflammatory role for simvastatin in inflammatory arthritis.
Leung BP, Sattar N, Crilly A, Prach M, McCarey DW, Payne H, Madhok R, Campbell C, Gracie JA, Liew FY, McInnes IB.
J Immunol. 2003 Feb 1;170(3):1524-30.
PMID: 12538717 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12538717&dopt=Abstract

Immunomodulation: a new role for statins?
Wulf Palinski
SUMMARY: Statins reduce the expression of the class II major histocompatibility complex (MHCII) by arterial cells, leading to a decreased T-cell response. This indicates that statins...
Nature Medicine6, 1311 - 1312 (01 Dec 2000) News and Views

HMG-CoA reductase inhibitors as immunomodulators: potential use in transplant rejection.
Raggatt LJ, Partridge NC.
These findings suggest that statins have the potential to regulate an immune response in vivo and that more investigation is essential in order to explain the opposing clinical data.
Drugs. 2002;62(15):2185-91.
PMID: 12381218 [PubMed - in process] http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12381218&dopt=Abstract

Statins as a newly recognized type of immunomodulator
Brenda Kwak, Flore Mulhaupt, Samir Myit, François Mach
SUMMARY: Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, or statins, are effective lipid-lowering agents, extensively used in medical practice. Statins have never been shown to...
Nature Medicine 6, 1399 - 1402 (01 Dec 2000) Article

and could a depressed immune system lead to infection? See: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11936540&dopt=Abstract
Statin-induced fibrotic nonspecific interstitial pneumonia.
Eur Respir J. 2002 Mar;19(3):577-80.
PMID: 11936540 [PubMed - indexed for MEDLINE]

STATINS AND CANCER
Frequently Asked Question: What are the cancer rates for people on statins?

Despite the infomercial-type hype in recent press releases under titles like, “Does Lipitor prevent cancer?” (note it is a question, not an assertion), the numbers from recent studies tell the opposite story:

Statin use and the risk of breast cancer.
Beck P, Wysowski DK, Downey W, Butler-Jones D. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12725884&dopt=Abstract
J Clin Epidemiol. 2003 Mar;56(3):280-5.
PMID: 12725884 [PubMed - in process]
“Stratified analyses revealed increases in risk in short-term statin users and statin users with long-term hormone replacement therapy (HRT) exposure.”

The PROSPER Study (PROspective study of pravastatin in the elderly at risk)
[Article in French]
Kulbertus H, Scheen AJ.
Service de Diabetologie, Nutrition et Maladies metaboliques et deMedecine Interne Generale, CHU Liege.
Rev Med Liege. 2002 Dec;57(12):809-13.
“New cancers were more frequent amongst pravastatin-treated individuals (+25%; p = 0.020).”

Major Outcomes in Moderately Hypercholesterolemic, Hypertensive Patients Randomized to Pravastatin vs Usual Care
The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12479764&dopt=Abstract
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial.

Deaths by cancer during the ALLHAT study: Pravastatin= 163; Usual Care= 148
6-year rate per 100 Participants: Pravastatin= 4.1; Usual Care= 3.7

LUPUS-LIKE SYMPTOMS AND STATINS
Frequently Asked Question: Can statins cause Lupus symptoms?

Drug-induced lupus-like syndrome associated with severe autoimmune hepatitis. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12765306&dopt=Abstract
Graziadei IW, Obermoser GE, Sepp NT, Erhart KH, Vogel W.
Lupus. 2003;12(5):409-12.
PMID: 12765306 [PubMed - in process]

Glossary of some search terms & equivalents:

Lipitor = atorvastatin
Coenzyme Q10 = CoQ10 = Ubiquinone = Ubidecarenone
Statins = hydroxymethylglutaryl coenzyme A reductase inhibitors = HMG-CoA Reductase Inhibitors
Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol = atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin

More to come: FAQs with published medical research on other aspects of statin adverse effects.

****
Sharon H

06-22-2003 at 02:24 AM | Quote Reply

sharon H
Level: Jr. Member
Registered: 06-21-2003
Posts: 97
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Re: Lipitor/Statin Frequently Asked Questions (FAQ) - Adverse Effects (Lines Wrap)
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Updated 21 June 2003
Frequently Asked Questions about Statin Adverse Effects

What are the names of the Statin drugs?

The Cholesterol-lowering Statin Drug Names: Lipitor, Mevacor, Pravachol, Zocor, Lescol, and