Today, most of the non-cognitive side effects we are seeing from statins such as Advicor are due to ubiquinone and dolichol deprivation; collateral damage in our war on cholesterol, made worse each year due to the relentless trend toward higher and higher doses as the target levels for acceptable cholesterol have been progressively lowered.
Our "few aches and pains" have evolved to rising numbers of patients with debilitating muscle pain persisting for years despite cessation of the statin drug involved. Even more importantly, we have learned that lovastatin and all other statins lower cardiovascular risk not by cholesterol manipulation but by reducing arterial wall inflammation through inhibition of our immune system.
Until recently most of these observations were anecdotal, based on case reports that were forwarded to the FDA's Medwatch, to Dr. Golomb of the UCSD statin study or to my own study of statins. Now medical journals are beginning to bring them to the attention of prescribing physicians. No longer can physicians claim ignorance of the many adverse side effects of the statin drugs.
Prescribing physicians must now wake up to the reality that what they have been told by overzealous pharmaceutical "reps" over the past decade may not have been the whole truth. I wish only to present the true legacy of the combination drug, Advicor, for prescribing physicians and their patients.
The following are a few of the adverse reports Advicor users have shared with me and are edited down from the original messages:
1) I have been taking Advicor for about 1.25 years and developed a case of Peyronie's disease about 3 months ago. There was no injury or trauma or over vigorous sexual activity that may have caused this. Additionally I was exeriencing muscle cramping in my calfs until I started taking some Cal / Mag / Zinc tablets. My guess is that there is a internal unbalance in my body but is it related to Advicor Ans: Unknown. My Doc says no but ???
2) I have recently been experiencing some health problems that I believe may be related to Advicor. I have been taking Advicor for approximately 4 months. My doctor quickly elevated me to the maximum dosage per day of 2000/40mg.
I have experienced flushing that I now control by taking two 325mg aspirin thirty minutes before Advicor. The 80mg of aspirin recommended by my doctor is ineffective in controlling the flushing. Previous to my Advicor use, I was taking lipitor 20mg for several years. I am male, 41 yrs, caucasian, 5'11'', 210 lbs.
3) In the past two months I have noticed changes in my skin. I have suffered yeast infections in my groin area and underarms that have progressed to bacterial infections. Most recently, I have noticed brown patches of skin on my knees, legs, arms, elbows, back, and underarms. Also, I have noticed significant wrinkling of my skin in the elbow and knee areas. Upon examination by a dermatologist, I have been diagnosed with Acanthosis Nigricans.
The dermatologist noted siginificant skin thickening on my hands and upper back as well as hyper-pigmented areas. My primary care doctor has tested my blood for high insulin levels, Glucose levels, thyroid levels, white blood cells, platelets. All results have returned as normal. I am also experiencing a moderate level of fatigue.
My primary care doctor has suggested that additonal testing may be required to rule out cancers and tumors as a cause of the Acanthosis Nigricans. I have expressed to my doctor that Advicor may play a role in these synptoms. The patient information leaflet included with the Advicor, specifically mentions Acanthosis Nigricans as a rare side-effect. So far, my doctor still has me taking the Advicor.
4) I've only taken Advicor for a few days, and stopped for another few. However, I have been feeling weak and dizzy, definitely not myself. I have had no other changes in meds, or anything. I also have little to no appetite. Could this happen on just a small dosage, and have such lingering side effects? On a side note, I am an insulin dependent Diabetic of 15 years, on an insulin pump. My age: 36. Female. No other significant diagnoses except the high fats, poor healthy cholesterol.
5) Hi, since taking Advicor for 3 yrs. I get out of bed in the morning and am in extreme pain trying to walk. I have gotten used to not being able to sleep because of the niacin sweats. I have gained 35 pounds in 2 yrs. and believe it is because of losing all energy, plus all the pain associated with whatever has happened to me. I have had tests which said I have high tryglicerides, which runs in my family. I am 61 yrs old. I always was very active and even taught exercise classes. I have retired because of this. I am out of breath, in pain, and getting fatter by the week. PS. I have a ruptured disk that I found about many yrs ago. This affected my one leg. My problems now are my ankles and feet joints, which make it very hard to walk. ALSO......... cramps whenever I try to exercise or reach for something. I feel like an invalid at an early age !!!
6) I have been taking Advicor for over two years and have been experiencing fatigue for about the same length of time. I wake up every morning and feel as though I have had about two to three hours of sleep when I have actually had about six hours of sleep. The feeling is about the same all day long. If I take a nap I wake up feeling tired. Two doctors that I have been going to for about three years have told me that none of the drugs that I have been using-diovan, norvasc, Advicor, aspirin 325 mg (aspirin as I had a TIA about 5 years ago)-could be responsible for the fatigue either individually or in combination. Blood panels show everything normal. Thyroid levels are low normal and I have been also taking Armour Thyroid in ever increasing doses for the past 6 months. Armour Thyroid has not helped the fatigue. My primary physician told me just over a year ago to have a sleep study as he could not figure out why I was feeling fatigued. I was diagnosed with moderate to severe sleep apnea and have been wearing a CPAP machine ever since. Oygen levels in the blood are almost 100% after being checked on several occasion. This has not had any effect on my fatigue as I still feel as tired as ever. Yesterday I went to see an endocrinologist for the fatigue and he has me scheduled for some blood work in about six weeks. He has me scheduled for several specific blood tests as he wanted to look at some things. He talked about a CK muscle enzyme problem that could be a result of the Advicor and he told me to stop taking the thyroid medication. I of course told him that the fatigue started long before I began taking the thyroid medication about six months ago. I have no other medical problems that I am aware of. My heart was checked by a specialist about a year and a half ago and was in great shape.
7) I have recently been diagnosed with hypertension and high cholesterol, for which my doctor prescribed Benicar HCT 20mg/12.5mg and Advicor 500mg/20mg with an aspirin each night. This was on 7/21/2005. Everything seemed okay, but starting last Thursday (7/28/2005) , I started noticing muscle pain in my jaw, neck, back & kidney areas, very similar to really bad lactic acid buildup after working out too much, but I have not exercised at all since starting the medication just over a week ago. Friday, I left work early, and I was experiencing the severe muscle pain, along with chills and cold sweats. I thought it was a flu, so we called the Dr's office and asked about taking flu medicine such as Theraflu, which we were told would be okay. However, today is Saturday, and I am still so stiff & sore that It is really painful to even bend over to flush the toilet. I have been taking 3 Advil @ a time probably every 4-6 hours just to help with the soreness & stiffness.
8) I have been taking Advicor 1000mg/20mg for about 18 months. I have been complaining about extreme fatigue and memory loss especially short term to my family physician. I was told that it is a secondary type of report and the FDA has to include them even though there not substantiated. My cholesterol before taking Advicor was higher than normal but not extremely high. My doctors concern was my mothers medical history. With Advicor cholesterol is 144,hdl 33 and ldl 85. I am tired almost all the time and drink coffee to keep moving. Memory loss is a real pain in the neck. My memory before Advicor was exceptional. Now I have to grope for information that I always had at my fingertips. Remembering details is now a chore. My doctor blames the symptoms on stress and lack of sleep. I get about 6.5 hours of sleep a night. Same as the last 20 years. At first my doctor said that my symptoms were not due to my medication in any way. When printed out other reported symptoms he told me about them being not reliable. I am a diabetic and taking Metformin 1,000 mg twice a day and sugar level is under control. I do not like the way I feel every day with fatigue and memory problems. What can I do?
9) I am a 36 year old male. Just recently my PCP has prescribed me to take Advicor 500/22, because my LDL is 272 and HDL is 36 also high triglyceride. Just before I went for my physical I was eating badly for at least 3/4 months (I also was exercising regularly...false sense of security). Anyhow, I started to take Advicor 3 days ago and going through extreme fatigue right after lunch, even though I take the pill before I go to bed. Do you think that PCPs over prescribe these cholesterol lowering drugs. I believe that I can bring down my numbers if I follow strict diet (I'm not overweight) along with my daily exercise ( which I have been doing it for a while), without using any medications. I'm not sure whether to continue using Advicor or not.
10) I started taking Advicor about 1½ months ago and I went back for blood tests last week to have my triglyceride level checked. My previous test had my cholesterol at 212 and my triglycerides at 390. After 6 weeks on Advicor my new blood test came back with my cholesterol at 273 and my triglycerides at 847! How is this possible? My Dr. seems to be taking a no worry stance and has asked that I return in 6 weeks for another test and to keep taking the Advicor. I had been on Lipitor for 3 years when the triglycerides started to climb. There is a family history of heart disease. Frankly, I am terrified and am thinking I should get another opinion.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor