Sharon Hope
2005-01-10 02:05:30 UTC
Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS
To my physician,
I believe that my symptoms may be due to the adverse effects a_ssociated
with cholesterol-lowering statin drugs. I need your help to understand the
cause of my symptoms, treatment options, and the prognosis for my recovery.
Please review the references below, published medical studies that show
similar problems a_ssociated with statin drugs. These are made available
via the National Institutes of Health (NIH,
http://www.ncbi.nlm.nih.gov/Entrez/) library of biomedical journal citations
and other major repositories of medical research.
Also, I am respectfully requesting that you file an adverse effects report
with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send
a 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.html
UCSD STATIN STUDY E-MAIL ADDRESS: ***@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858) 558-4950
Thank you
ERECTILE DYSFUNCTION (ED) AND STATINS
References (updated as of January 7, 2005):
Do lipid-lowering drugs cause erectile dysfunction? A systematic review.
Rizvi K, Hampson JP, Harvey JN.
University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK.
Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357
BACKGROUND: Erectile dysfunction (ED) is common although under-reported by
patients. Along with the better known causes of ED, drug-induced impotence
needs to be considered as a cause of this symptom. Lipid-lowering drugs have
been prescribed increasingly. Their relationship to ED is controversial.
OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering
therapy and ED. A secondary aim was to a_ssess the value of the systematic
review procedure in the area of adverse drug reactions. METHODS: A
systematic review was carried out using computerized biomedical databases
and Internet sources. Terms denoting ED were linked with terms referring to
lipid-lowering drugs. Information was also sought from regulatory agencies.
RESULTS: A significant literature was identified, much from obscure sources,
which included case reports, review articles, and information from clinical
trials and from regulatory agencies. Information from all of these sources
identified fibrates as a source of ED. A substantial number of cases of ED
a_ssociated with statin usage have been reported to regulatory agencies.
Case reports and clinical trial evidence supported the suggestion that
statins can also cause ED. Some information on possible mechanisms was
obtained, but the mechanism remains uncertain. CONCLUSIONS: The systematic
review procedure was applied successfully to collect evidence suggesting
that both statins and fibrates may cause ED. More numerous reports to
regulatory agencies complemented more detailed information from case reports
to provide a new perspective on a common area of prescribing.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11818357&dopt=AbstractERECTILE DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULARRISK FACTORS AND DRUG THERAPIESH. Solomon1, J. Man1, Y.P. Samarasinghe2, M.D. Feher2, A.S. Wierzbicki3, G.Jackson11Department of Cardiology, St. Thomas' Hospital, 2Beta Cell Diabetes Centre,Chelsea & Westminster Hospital, 3Department of Chemical Pathology, St.Thomas' Hospital, London UKErectile dysfunction has been a_ssociated with atherosclerotic risk factorsand drugs used in their treatment. This study investigated the relationshipof erectile function with cardiovascular risk factors and specific drugtherapies. International Index of Erectile Function (IIEF) scores measuredin 100 men attending cardiovascular risk clinics. Cardiovascular riskfactors and drug therapies were a_ssessed prior to initation and after 6months of statin therapy. Before statin therapy no correlation was observedbetween IIEF score and any individual cardiovascular risk factor thoughbetter scores were observed in patients on warfarin or angiotensin-IIreceptor blocker therapy (r=0.42; p <0.001). After 6 months of statintherapy, significant correlations were observed between lower IIEF scores(r=0.62; P<0.001) and age, smoking, diabetes and usage of warfarin orangiotensin-2 type 1 receptor blocker (ARB) therapy. Differences in dose,relative efficacy or relative lipophilicity of statin prescribed showed nocorrelation with change in IIEF score. This study suggests impotencefollowing statin therapy is likelier in patients with more severeendothelial dysfunction due to established cardiovascular risk factorsincluding age, and smoking and diabetes. This is complicated by adverseinteractions between statin therapy and concomitant treatment with warfarinor angiotensin-II type I receptor blockers.http://www.kenes.com/73eas/program/abstracts/126.docDrug Information Center: Information on Statin Drugs"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD,PhD, principal investigator of a study on Statin Drugs by the NationalInstitutes of Health. Dr. Golomb noted that the most common problemsreported about statin drugs pertain to muscle pain or weakness, fatigue,memory and cognitive problems, sleep problems, and neuropathy. Erectiledysfunction, problems with temperature regulation (feeling hot or cold, orhaving sweats) are among the other problems reported. "http://www.coloradohealthsite.org/pharmacology/statins.html"Question: What are the common complaints of patients who take statins?Dr. Golomb: The most common problems we hear reported pertain to muscle painor weakness, fatigue, memory and cognitive problems, sleep problems, andneuropathy. Erectile dysfunction, problems with temperature regulation(feeling hot or cold, or having sweats), are among the other problemsreported. "http://www.coloradohealthsite.org/topics/interviews/golomb.htmlBBC News: Wednesday, 15 March, 2000, 19:02 GMTHeart drug impotence warning"Statins prevent heart attacks by reducing the levels of dangerouscholesterol in the bloodstream. However, a small number of men prescribed the life-saving drug havecomplained that they are unable to achieve an erection.""Dr John Harvey, from the Wrexham Maelor Hospital in Wales, identified 220men who appeared to have lost their "virility" after starting to takestatins. "http://news.bbc.co.uk/1/hi/health/678811.stmBailey DG, Dresser GK. Interactions between grapefruit juice andcardiovascular drugs.Am J Cardiovasc Drugs. 2004;4(5):281-97. Review. PMID:15449971 [PubMed - indexed for MEDLINE] Blumentals WA, Brown RR,Gomez-Caminero A. Antihypertensive treatment and erectile dysfunction in acohort of type IIdiabetes patients.Int J Impot Res. 2003 Oct;15(5):314-7.PMID: 14562130 [PubMed - indexed for MEDLINE]
To my physician,
I believe that my symptoms may be due to the adverse effects a_ssociated
with cholesterol-lowering statin drugs. I need your help to understand the
cause of my symptoms, treatment options, and the prognosis for my recovery.
Please review the references below, published medical studies that show
similar problems a_ssociated with statin drugs. These are made available
via the National Institutes of Health (NIH,
http://www.ncbi.nlm.nih.gov/Entrez/) library of biomedical journal citations
and other major repositories of medical research.
Also, I am respectfully requesting that you file an adverse effects report
with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send
a 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.html
UCSD STATIN STUDY E-MAIL ADDRESS: ***@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858) 558-4950
Thank you
ERECTILE DYSFUNCTION (ED) AND STATINS
References (updated as of January 7, 2005):
Do lipid-lowering drugs cause erectile dysfunction? A systematic review.
Rizvi K, Hampson JP, Harvey JN.
University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK.
Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357
BACKGROUND: Erectile dysfunction (ED) is common although under-reported by
patients. Along with the better known causes of ED, drug-induced impotence
needs to be considered as a cause of this symptom. Lipid-lowering drugs have
been prescribed increasingly. Their relationship to ED is controversial.
OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering
therapy and ED. A secondary aim was to a_ssess the value of the systematic
review procedure in the area of adverse drug reactions. METHODS: A
systematic review was carried out using computerized biomedical databases
and Internet sources. Terms denoting ED were linked with terms referring to
lipid-lowering drugs. Information was also sought from regulatory agencies.
RESULTS: A significant literature was identified, much from obscure sources,
which included case reports, review articles, and information from clinical
trials and from regulatory agencies. Information from all of these sources
identified fibrates as a source of ED. A substantial number of cases of ED
a_ssociated with statin usage have been reported to regulatory agencies.
Case reports and clinical trial evidence supported the suggestion that
statins can also cause ED. Some information on possible mechanisms was
obtained, but the mechanism remains uncertain. CONCLUSIONS: The systematic
review procedure was applied successfully to collect evidence suggesting
that both statins and fibrates may cause ED. More numerous reports to
regulatory agencies complemented more detailed information from case reports
to provide a new perspective on a common area of prescribing.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11818357&dopt=AbstractERECTILE DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULARRISK FACTORS AND DRUG THERAPIESH. Solomon1, J. Man1, Y.P. Samarasinghe2, M.D. Feher2, A.S. Wierzbicki3, G.Jackson11Department of Cardiology, St. Thomas' Hospital, 2Beta Cell Diabetes Centre,Chelsea & Westminster Hospital, 3Department of Chemical Pathology, St.Thomas' Hospital, London UKErectile dysfunction has been a_ssociated with atherosclerotic risk factorsand drugs used in their treatment. This study investigated the relationshipof erectile function with cardiovascular risk factors and specific drugtherapies. International Index of Erectile Function (IIEF) scores measuredin 100 men attending cardiovascular risk clinics. Cardiovascular riskfactors and drug therapies were a_ssessed prior to initation and after 6months of statin therapy. Before statin therapy no correlation was observedbetween IIEF score and any individual cardiovascular risk factor thoughbetter scores were observed in patients on warfarin or angiotensin-IIreceptor blocker therapy (r=0.42; p <0.001). After 6 months of statintherapy, significant correlations were observed between lower IIEF scores(r=0.62; P<0.001) and age, smoking, diabetes and usage of warfarin orangiotensin-2 type 1 receptor blocker (ARB) therapy. Differences in dose,relative efficacy or relative lipophilicity of statin prescribed showed nocorrelation with change in IIEF score. This study suggests impotencefollowing statin therapy is likelier in patients with more severeendothelial dysfunction due to established cardiovascular risk factorsincluding age, and smoking and diabetes. This is complicated by adverseinteractions between statin therapy and concomitant treatment with warfarinor angiotensin-II type I receptor blockers.http://www.kenes.com/73eas/program/abstracts/126.docDrug Information Center: Information on Statin Drugs"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD,PhD, principal investigator of a study on Statin Drugs by the NationalInstitutes of Health. Dr. Golomb noted that the most common problemsreported about statin drugs pertain to muscle pain or weakness, fatigue,memory and cognitive problems, sleep problems, and neuropathy. Erectiledysfunction, problems with temperature regulation (feeling hot or cold, orhaving sweats) are among the other problems reported. "http://www.coloradohealthsite.org/pharmacology/statins.html"Question: What are the common complaints of patients who take statins?Dr. Golomb: The most common problems we hear reported pertain to muscle painor weakness, fatigue, memory and cognitive problems, sleep problems, andneuropathy. Erectile dysfunction, problems with temperature regulation(feeling hot or cold, or having sweats), are among the other problemsreported. "http://www.coloradohealthsite.org/topics/interviews/golomb.htmlBBC News: Wednesday, 15 March, 2000, 19:02 GMTHeart drug impotence warning"Statins prevent heart attacks by reducing the levels of dangerouscholesterol in the bloodstream. However, a small number of men prescribed the life-saving drug havecomplained that they are unable to achieve an erection.""Dr John Harvey, from the Wrexham Maelor Hospital in Wales, identified 220men who appeared to have lost their "virility" after starting to takestatins. "http://news.bbc.co.uk/1/hi/health/678811.stmBailey DG, Dresser GK. Interactions between grapefruit juice andcardiovascular drugs.Am J Cardiovasc Drugs. 2004;4(5):281-97. Review. PMID:15449971 [PubMed - indexed for MEDLINE] Blumentals WA, Brown RR,Gomez-Caminero A. Antihypertensive treatment and erectile dysfunction in acohort of type IIdiabetes patients.Int J Impot Res. 2003 Oct;15(5):314-7.PMID: 14562130 [PubMed - indexed for MEDLINE]