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Diabetes Care. 2005 Aug;28(8):2082.

Statin neuropathy masquerading as diabetic autoimmune polyneuropathy.

Vaughan TB, Bell DS.

Division of Endocrinology, University of Alabama School of Medicine, Faculty
Office Tower, Suite 758, 510 20th St. S., Birmingham, AL 35294.
brooks@uab.edu.

PMID: 16043768 [PubMed - in process]

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8All:This was a concern of mine, posted immediately upon FDA approval for statinsto be marketed to diabetics.  It is well established that statins CAUSEperipheral neuropathy and polyneuropathy, yet the FDA permitted the statincompanies to market to diabetics, for whom neuropathy is an existing danger.The Cholesterol-lowering Statin Drug Names: Lipitor, Crestor, Mevacor,Pravachol,Zocor, Lescol, and Baycol, aka atorvastatin, rosuvastatin, cerivastatin,fluvastatin,lovastatin, pravastatin, and simvastatin; This class of drugs is also knownas HMG-CoAReductase Inhibitors, short for 3-Hydroxy-3-Methyl-Glutaryl Coenzyme AReductase.Now, there is also a combination drug, Vytorin, with both Zetia (Ezetimibe)and Zocor (simvistatin).The adverse effects of this class of drugs, specific to nerve damage isbelow.  For a full FAQ of statin adverse effects, including muscle,cognitive, ED, and other adverse effects of statins, see:http://www.freewebs.com/stopped_our_statins/StatinFAQ_031305wTOCv4.pdfStatin Adverse Effects FAQ: NERVE DAMAGE & STATINSTo my physician,I believe that my symptoms may be due to the adverse effects associated withcholesterol-lowering statin drugs.  I need your help to understand the causeof my symptoms, treatment options, and the prognosis for my recovery.Please review the references below, published medical studies that showsimilar problems associated with statin drugs.  These are made available viathe National Institutes of Health (NIH, http://www.ncbi.nlm.nih.gov/Entrez/)library of biomedical journal citations and other major repositories ofmedical research.Also, I am respectfully requesting that you file an adverse effects reportwith the FDA (http://www.fda.gov/medwatch/how.htm), and that you please senda copy of the report to the to the NIH-funded Statin Study, attention: Dr.Beatrice Golomb, Principal Investigator.Statin Study website: http://medicine.ucsd.edu/statin/Statin Study contact info: http://medicine.ucsd.edu/statin/contactinfo.htmlUCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.eduMAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995PHONE NUMBER: (858) 558-4950Thank youReferences (updated as of  January 7, 2005):Statin-associated peripheral neuropathy: review of the literature.Chong PH, Boskovich A, Stevkovic N, Bartt RE. Pharmacotherapy. 2004Sep;24(9):1194-203. Review. PMID: 15460180 [PubMed - indexed forMEDLINE]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=15460180"Based on epidemiologic studies as well ascase reports, a risk of peripheral neuropathy associated with statin use mayexist; however, the risk appears to be minimal. On the other hand, thebenefits of statins are firmly established. These findings should alertprescribers to a potential risk of peripheral neuropathy in patientsreceiving any of the statins; that is, statins should be considered thecause of peripheral neuropathy when other etiologies have been excluded."Disorder resembling Guillain-Barre syndrome on initiation of statintherapy.Rajabally YA, Varakantam V, Abbott RJ.  Muscle Nerve. 2004Nov;30(5):663-6. PMID: 15389662 [PubMed - indexed forMEDLINE]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=15389662"We report a disorder resemblingGuillain-Barre syndrome, occurring on initiation of simvastatin, in a58-year-old man, who had experienced a similar but milder episode afterstarting pravastatin 6 months earlier. This case suggests that acutepolyradiculoneuropathy may represent a rare but serious side-effect ofstatin treatment. It also raises the issue of the pathophysiology of acuteneuropathy on statin exposure, with a hypersensitivity reaction resulting inan immune-mediated process being possible instead of the hypothesizedmitochondrial dysfunction in chronic cases."  Simvastatin-inducedmononeuropathy multiplex: case report.Scola RH, Trentin AP, Germiniani FM,Piovesan EJ, Werneck LC. Arq Neuropsiquiatr. 2004 Jun;62(2B):540-2. Epub2004 Jul 20. PMID: 15273860 [PubMed - inprocess]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=15273860"The association between the use of statinsand neuromuscular disease is currently being intensely discussed. We relatea 63 years old man with possible case of statin-induced neuropathy in apatient with dislipidemia in use of simvastatina at high doses. Theelectrophysiologic studies disclosed findings compatible with mononeuropathymultiplex, suggested by clinical prescutation of asymmetrical numbness andweakness. More common causes of mononeuropathy multiplex were excluded andthe patient improved after the discontinuation of the drug."Statins and risk of polyneuropathy, A case-control studyD. Gaist, MD, PhD; U. Jeppesen, MD, PhD; M. Andersen, MD, PhD; L.A. GarcíaRodríguez, MD, MSc;J. Hallas, MD, PhD; and S.H. Sindrup, MD, PhDhttp://213.4.18.135/87.pdf full textFrom the abstract: "The authors verified a diagnosis of idiopathicpolyneuropathy in 166 cases. The cases were classified as definite (35),probable (54), or possible (77). The odds ratio linking idiopathicpolyneuropathy with statin use was 3.7 (95% CI 1.8 to 7.6) for all cases and14.2 (5.3 to 38.0) for definite cases. The corresponding odds ratios incurrent users were 4.6 (2.1 to 10.0) for all cases and 16.1 (5.7 to 45.4)for definite cases. For patients treated with statins for 2 or more yearsthe odds ratio of definite idiopathic polyneuropathy was 26.4 (7.8 to 45.4).CONCLUSIONS: Long-term exposure to statins may substantially increase therisk of polyneuropathy."Are users of lipid-lowering drugs at increased risk of peripheralneuropathy?David Gaist, Luis Alberto García Rodríguez · Consuelo Huerta · Jesper Hallas· Søren H. Sindruphttp://213.4.18.135/75.pdf full texthttp://213.4.18.135/76.2.pdf full texthttp://213.4.18.135/87.pdf full text textPharmacodynamics: Statins and peripheral neuropathyU. 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, DenmarkReceived: 6 July 1998 / Accepted in revised form: 1 October 1998Abstract Volume 54 Issue 11 (1999) pp 835-838http://link.springer-ny.com/link/service/journals/00228/bibs/9054011/90540835.htm"Within the past 3 years seven cases of reversible peripheral neuropathyapparently caused by statins have been reported. Here we report sevenadditional cases associated with long-term statin therapy, in which othercauses of neuropathy were thoroughly excluded. The neuropathy was in allcases axonal and with affection of both thick and thin nerve fibers. Thesymptoms of neuropathy persisted during an observation period lasting from10 weeks to 1 year in four cases after statin treatment had been withdrawn.We suggest that long-term statin treatment may be associated with chronicperipheral neuropathy."Association of HMG-CoA reductase inhibitors with neuropathy.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2549960&dopt=AbstractAnn Pharmacother. 2003 Feb;37(2):274-8.Backes JM, Howard PA.Department of Pharmacy Practice and Lipid, Atherosclerosis, Metabolic andLDL-Apheresis Clinic, University of Kansas Medical Center, Kansas City, KS66160-7231, USA. jbackes@kumc.edu"Epidemiologic studies and case reports suggest an increased risk ofperipheral neuropathy with statin drugs. The majority of cases were at leastpartially reversible with drug cessation." (emphasis added)Selenoprotein synthesis and side-effects of statins.Moosmann B, Behl C.Lancet. 2004 Mar 13;363(9412):892-4. Review. PMID: 15031036 [PubMed -indexed forMEDLINE]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=15031036"We noted that the pattern of side-effects associated with statins resemblesthe pathology of selenium deficiency, and postulated that the mechanism layin a well established, but often overlooked, biochemical pathway--theisopentenylation of selenocysteine-tRNA([Ser]Sec). A negative effect ofstatins on selenoprotein synthesis does seem to explain many of theenigmatic effects and side-effects of statins, in particular, statin-inducedmyopathy."Statin therapy and small fibre neuropathy: a serial electrophysiologicalstudy.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2639733&dopt=AbstractLo 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.sgDescribes 3 patients who developed neuropathy after ONE MONTH of statintherapy. "One patient redeveloped small and large fibre neuropathy when thesimilar drug was readministered."Peripheral Neuropathy and Lipid-Lowering TherapyPaul E. Ziajka, MD, PhD, and Tammy Wehmeier, RN, Orlando, Fla.Abstract: We report a case of peripheral neuropathy induced and excerbatedby several commonly used HMG-CoA reductase inhibitors including lovastatin,simvastatin, pravastatin, and atorvastatin, and the vitamin niacin. A reviewof the literature shows similar cases with individual lipid-lowering drugs,but this case shows the cross-reactivity of the neuropathic process todifferent HMG-CoA reductase inhibitors, and is the first reported case of aperipheral neuropathy exacerbated by the use of niacin.http://www.sma.org/smj1998/julysmj98/ziajka.pdfPeripheral neuropathy associated with simvastatin.Phan T, McLeod JG, Pollard JD, Peiris O, Rohan A, Halpern JP.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=7
745415&dopt=Abstract"Four patients are described who developed sensorimotor neuropathy whilebeing treated with simvastatin and had complete or partial resolution ofclinical abnormalities after withdrawal of treatment. In one case onset waswithin days of commencing treatment, but in two cases symptoms did notdevelop for two years. The electrophysiological and pathological features ofthe neuropathy were those of axonal degeneration. Clinical evidence ofproximal and distal weakness and muscle fasciculations and persistentabnormalities of sensory conduction after recovery suggest the possibilityof toxic damage to anterior horn cells and dorsal root ganglia. Thirty eightother cases with symptoms suggestive of peripheral neuropathy have beenreported to the Australian Adverse Drug Reactions Advisory Committee, 22 ofwhom recovered after cessation of treatment; in five cases there wasrecurrence after re-exposure to the drug. Simvastatin should be consideredamong the causes of peripheral neuropathy, and the drug should be withdrawnif patients receiving it develop muscle weakness or sensory disturbances."Lovastatin and peripheral neuropathy.Ahmad S.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=7
484806&dopt=AbstractVestibular vertigo and lovastatin therapy.Ahmad S.South Med J. 1996 Feb;89(2):257-8. No abstract available.PMID: 8578368 [PubMed - indexed for MEDLINE]http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstra
ct&list_uids=8578368HMG-CoA reductase inhibitor therapy and peripheral neuropathy.Jacobs MB.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=8
172444&dopt=AbstractMedication-induced peripheral neuropathy.http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
2507417&dopt=AbstractCurr Neurol Neurosci Rep. 2003 Jan;3(1):86-92. Review.Weimer LH.Neurological Institute of New York, 710 West 168th Street, Unit 55, NewYork, NY 10032, USA. Lhw1@columbia.eduPMID: 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 toxiccauses of chronic idiopathic neuropathy."Neuropathy due to drugs.Le Quesne PM.In: Dyck PJ, Thomas PK, Griffin JW, et al, eds. Peripheral neuropathy. 3rded. Philadelphia: Saunders, 1993:1571-1581.(Book, no link)