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Medical Forum / General / General / January 2005Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS
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: statinstudy@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=1 1818357&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] >Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS > [quoted text clipped - 3 lines] >with cholesterol-lowering statin drugs. I need your help to understand the >cause of my symptoms, treatment options, and the prognosis for my recovery. Gee, Sharon, do you really think your erectile dysfunction is due to your use of statins? I bet your doctor would be fascinated. -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always correct. "If I have not seen as far as others, it is because giants were standing on my shoulders." (Hal Abelson, MIT) Several months ago there was a request on the smc newsgroup, asking if anyone had heard of statins causing ED. Since I was researching statin adverse effects anyway, I decided to check into it, and found those study results. On the assumption that if one person asks, others may have the same question, I make the results available. As for myself, I suffer from a different adverse effect - the damage to the family. You have no idea how horrifying it is to watch your spouse of 30+ years experiencing constant excruciating neuromuscular pain, losing short-term memory, and experiencing amnesia. I am constantly researching statin adverse effects, in hopes of finding something that will help my husband, disabled from 4 years of Lipitor at 10 mg per day, resulting in muscle pain, muscle wasting, peripheral neuropathy, chronic excruciating pain, fatigue, exhaustion, extreme exercise intolerance, short-term memory loss (measured at below the 1 percentile), multiple witnessed episodes of transient global amnesia, aphasia, and CK that continued elevating for 1 year off the drug. Three years later he is still disabled, with most of the symptoms continuing, and hundreds of tests and specialist consultations (52 the first year) serving to rule out all other causes. To date, my husband's Lipitor disability appears in a couple of studies, a book, an article in Smart Money Magazine, and an article in the Los Angeles Times Sunday Magazine. This public exposure of a very private sorrow is permitted in hopes that no other family need go through what we have. Thank you for asking. >>Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS >> [quoted text clipped - 13 lines] > "If I have not seen as far as others, it is because giants > were standing on my shoulders." (Hal Abelson, MIT) Are there any double blind controlled studies addressing this issue? Statin use and ED may be a correlation, not causal. If the ED resolved after discontinuance of statins, that would be more interesting.  SignatureChuck Forsberg caf@omen.com www.omen.com 503-614-0430 Developer of Industrial ZMODEM(Tm) for Embedded Applications Omen Technology Inc "The High Reliability Software" 10255 NW Old Cornelius Pass Portland OR 97231 FAX 629-0665 I have posted the studies that I could find. Our internist did say once a few years ago that she was seeing a problem with younger men on statins. She said that the testosterone needs a cholesterol/lipid base to do its normal job. She had asked about it at a medical convention, and the popular wisdom was to just prescribe viagra. Her response: Testosterone controls much more in a male - up to and including drive to succeed in business. These guys were losing ground in their jobs, something viagra wouldn't fix. No citation - just a quick conversation in the hallway, leaving an appointment. I haven't seen that in any studies, and it would have caught my eye because of that conversation. And I'm not sure how you would devise the study to pick up the drive for success and masculinity factors in a measurable way. There are, however, lots of studies on low cholesterol and violence. Again, if there hadn't been a few questions posted over the last few years, to the degree that it seemed to be something people were concerned about, I wouldn't have added it to the FAQ. Then again, I had left out the "obvious" - muscle damage and rhabdomyolysis - because there had been so much publicity that it was the one area of statin adverse effects where doctors seemed to be informed. But lately there have been several questions posted (not necessarily on this ng) from people asking if their muscle pain could possibly be related to statins, that I decided to go ahead and add those, too. But that made the original all-inclusive statin adverse effects FAQ go more than 77 pages. Thus, the breakout. And it seems to be more effective that way - certainly the individual FAQs have generated far more comments than the big 77 pager with the same info. > Are there any double blind controlled studies addressing this issue? > Statin use and ED may be a correlation, not causal. > > If the ED resolved after discontinuance of statins, that would be > more interesting. So the answer to the question "Are there any double blind controlled studies addressing this issue? Statin use and ED may be a correlation, not causal." is no? Or we could say, other than a brief, anectdotal conversation with an internist you have not found any controlled studies to support your contention. Would *that* be correct? L. > I have posted the studies that I could find. > [quoted text clipped - 36 lines] >> If the ED resolved after discontinuance of statins, that would be >> more interesting. The answer is: I spend my research time on things that might help my Lipitor-disabled husband, and the rest of my time earning our income. This Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS faq was a bit of a diversion for my purposes, but I collected the articles on ED and statin adverse effects because people suffering statin adverse effects asked for information, and it was somewhat congruent. You have drifted well past my area of interest, purpose or curiosity, so.... Go for it! You, too, can do RESEARCH! Find the answer for all of us! http://www.ncbi.nlm.nih.gov/entrez/query.fcgi "PubMed, a service of the National Library of Medicine, includes over 15 million citations for biomedical articles back to the 1950's. These citations are from MEDLINE and additional life science journals. PubMed includes links to many sites providing full text articles and other related resources. " Just put in your search terms and you may be able to find out. Varying the search terms with synonyms in different combinations helps. Some search terms & equivalents: Lipitor = atorvastatin Coenzyme Q10 = CoQ10 = Ubiquinone = UbidecarenoneS tatins = hydroxymethylglutaryl coenzyme A reductase inhibitors = HMG-CoAReductase Inhibitors Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol = atorvastatin,cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin plus all the ED synonyms you can come up with. When you find what you are looking for, remember the search terms with the right 'hits' and repeat them monthly to keep up with new publications. Good luck, and don't forget to share what you learned with the rest of the newsgroup. Another interesting data point would be to keep track of the time you spend in searching, reviewing, selecting, documenting, quoting, summarizing, etc., plus posting and responding to ng questions, and then maintaining the info to keep it current. > So the answer to the question "Are there any double blind controlled > studies addressing this issue? Statin use and ED may be a correlation, [quoted text clipped - 44 lines] >>> If the ED resolved after discontinuance of statins, that would be >>> more interesting. Chuck here are some anecdotal comments I pulled off the rxlist Lipitor board. The second anecdote talks about testosterone. Zee One of the lesser known side effects of statins. All from: http://www.rxlist.com/rxboard/lipitor.pl "Took lipitor 8/97 thru 10/03...noticed decline in lower leg muscle stamina, increasing pain, etc...but had other problem I never connected until recently...Please listen with care....Over the past few years, I have noticed a decline in one area of sexual performance...No problem with ED, no discomfort during sex, but the climaxes have become less and less...it seems that the muscles that should produce ejaculation just...don't....evrything else is normal, but instead of a regular ejaculation, almost nothing comes out...no pulsing or spurting at all...then shortly later, fluid gradually leaks out...I feel this lack of muscular contractions may be the result of 6 yrs of lipitor...any similar experiences? any thoughts? I'm 55 and otherwise very youthful..." ~~~~~~~~~~` My husband was on 20mg. of Lipitor for 3 years. It nearly wrecked our marriage! Go and have your testosterone level checked. Lipitor destroys your ability to make that wonderful male hormone. My husband had to be given NATURAL testosterone by injection for about 2 months as well as using the NATURAL testosterone cream for his level to rise where he felt normal. After quiting the Lipitor he started taking Zocor... after only 2 weeks on this statin drug the testosterone level dropped once again to that of an 11 year old boy. He still has to use the cream daily. I would advise all men on statin drugs to get their testosterone serum checked! ~~~~~~~~~~~~~~ Don't stay on this drug - if you ever want to return to a normal life - get off it now. There are alternatives - such as diet, exercise, niacin. The side effects are awful and this is not the only one that is unacceptable. Believe me, my poor husband totally lost his "abilities" over a year ago - and he was only 52 at the time. Because of all the other negative side effects he has experienced, this one is on the bottom of the list. He's lost the ability to use his left arm, his right eye is suffering from occular hemorrhaging, his right leg is swollen with edema from foot to hip - which sometimes spreads to the genitals, he's lost a lot of his hair, he has had rashes on his body that suddenly just start bleeding, and the pain - constant pain that never ever stops, muscle loss - to the point of not being able to move, dress himself, get up from a chair, get into or out of a bathtub, up or down stairs, drive a car. he has a swollen liver and digestive disorders too long to list. You name it - it's been there and still is there. This drug kills... ." ~~~~~~~~~~~~~~~~ I took myself off Lipitor a little over a week ago. Before that, I took the drug for a little over a month. During that time I experienced severe cramping in my calves, and stiffness, soreness, and cramping in my shoulders. Worst of all, I began experiencing erectile dysfunction--semi-flacid erections, a lack of sensation, and sometimes outright impotence--something I had never experienced in my life. Since the only thing that had changed in my lifestyle was taking Lipitor, and since the problem had never occurred before I took it, I thought maybe the drug was the problem. While the erectile dysfunction is somewhat improved after a week off Lipitor, it is still severe enough that my wife and I are as yet unable to have sexual relations. The leg cramps have subsided, but the stiffness, soreness, and cramping in my shoulders is still a problem. My doctor insists that Lipitor has no sexual side effects. However, I never had this problem when I took Pravachol, although I did have leg cramps. Can anyone give me some idea of how long one has to be off Lipitor before erectile dysfunction/impotence symptoms go away? As you may be able to tell, I'm really pretty spooked by all this. At age 43, I'm not at all ready to give up my sexual relationship with my wife." ~~~~~~~~~~~~~~~~~~~~~~ > Are there any double blind controlled studies addressing this issue? > Statin use and ED may be a correlation, not causal. [quoted text clipped - 6 lines] > Omen Technology Inc "The High Reliability Software" > 10255 NW Old Cornelius Pass Portland OR 97231 FAX 629-0665 For Canadian healthcare consumers. Canadian Adverse Events reporting: Health Canada: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_report_e.html PharmaWatch: http://www.pharmawatch.net PharmaWatch: Working for Consumer Rights and Safe Medicines PharmaWatch is a non-profit advocacy group that believes patients/consumers must play a central role in prescription drug safety in Canada. All prescription drugs have side effects, and it is up to patients, in consultation with their physician, to determine if the benefits outweigh the risks. One of the main ways we are able to learn about the risks is when patients tell us if and when they have had an adverse drug reaction (ADR), especially (but not only) ADRs that are serious or unexpected. Patients who know about a drug's side effects can make more informed choices about what medicines they will use. But if no one reports ADRs, it is impossible to know whether the benefits continue to outweigh the risks. Canadians rely on safe medicines to help them manage chronic conditions like asthma or diabetes or to overcome a temporary or long-term illness. The job of Health Canada is to make sure these drugs are safe and effective when they make it on to the market. It also is Health Canada's job to ensure that patient experiences with approved prescription drugs are monitored. This is called "post-market surveillance" and it is the early warning system that allows us to know what the potentially dangerous side effects of prescription drugs might be. People who experience adverse reactions to prescription medicine are often left alone to search for information about the drug they may be having problems with, as well as the problems themselves. They often lack the support they need to connect with others who may have similar experiences. As patients, people are often isolated and made to feel at fault for adverse reactions. PharmaWatch believes that consumers and patients have unique perspectives and experiences. They can provide information and insight that contributes to the effective and safe use of medicines. Reporting by patients and consumers can provide an early warning signal to regulators, manufacturers, physicians, health professionals and other consumers. The goal of PharmaWatch is to highlight and validate consumer experiences and heighten consumer involvement in adverse drug reaction reporting. In addition to documenting these experiences, we aim to facilitate networking among individual patients/consumers and advocacy groups who share our concerns about the lack of adequate post-market monitoring by the pharmaceutical industry and Health Canada. PharmaWatch aims to raise public awareness about the role of consumers/patients in reporting their own adverse drug reactions - or those experienced by their children, a spouse, a brother or sister, or a parent. The group plans to teach people how to report an ADR, how to encourage others to report, and what role ADR reporting has played or can play to help ensure the medicine we take is right for us. ~~~~~~~~~~~~~~~ > Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS > [quoted text clipped - 54 lines] > 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=1 1818357&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] |
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