By Duane Graveline, M.D., M.P.H.
The purported special benefit of Vytorin is better LDL cholesterol reduction by interfering not only with Zocor's inhibition of cholesterol biosynthesis but by the added reduction of intestinal absorption of cholesterol through Zetia's effect on the small bowel. In reality, then, Vytorin is just another strong statin drug with the same side effect profile of all the other statins in current use.
Go to the Why Enhanced Failed page on this site for my take on the Enhance study. The last thing Merck/Schering-Plough wanted to hear was the truth about cholesterol lowering. None of the drug companies nor even the FDA wanted to hear the truth fifteen years after the multi-billion dollar statin industry began.
Cholesterol strongly appears to be irrelevant to atherosclerosis. I have been saying this for nearly a decade now and finally the drug companies (of all people) were the ones to prove it. They dreamed up this study to pit Zocor against Vytorin at the same dose betting that the Zetia in Vytorin with its extra cholesterol lowering ability would make a difference. It did not make a shred of difference in that the Vytorin group lowered LDL cholesterol some 35 points more than plain Zocor.
Why should it if cholesterol is not the problem in atherosclerosis development? If inflammation is the problem then treatment should be directed towards this inflammation to be effective. Since all statins are powerful anti-inflammatory agents and the statin dose in the Enhance trial was identical (Zocor), the study had to come out the same and it did. Zetia was irrelevant and Vytorin with its higher price tag is irrelevant. All you need is plain Zocor and that's what this study showed.
Since the overwhelming majority of statin side effects result from their well-known interference with the mevalonate pathway for cholesterol synthesis, Vytorin's use inevitably must result in the full range of adverse drug reports of myopathies, neuropathies and emotional factors now being reported for Zocor use alone.
My books discuss in detail these cognitive side effects. Did you know that Muldoon, a bio-researcher of note, reports a 100% incidence of cognitive dysfunction in statin users if sensitive enough testing is done? Drug companies had no idea their particular statin drug would inhibit our brain's glial cell synthesis of cholesterol, reported by Pfrieger to be absolutely vital to memory function. And one drug company found in their early studies that out of every 1,000 people taking their statin, five would experience serious cognitive problems, including amnesia.
These are just a few of the reports I have received from readers regarding their personal experiences of Vytorin side effects.
1.) I had been on Vytorin less than a week when I began having muscle pains. Sometimes it felt like someone were sticking a needle or a knife in my legs. The pain started with my calves and then I noticed I started getting the pain in my thighs. Sometimes the pain was so great I would clutch my leg. My doctor had me reduce my pill taking from one per day to one every other day, but that did not stop the side effects.
I told my doctor I was switching to Policosanol with CQ enzyme. (I took some Policosanol for several days after stopping the Vytorin but it wasn't until I took the Policosanol including the CQ enzyme that the pain in my legs started going away.) I think the CQ enzyme had some positive effect. I go in for a blood test in a week, and I am hoping that the policosanol supplement I am taking from a vitamin store plus better diet and more exercise will prevent me from having to ever consider taking statins again.
2.) I took Vytorin for two months and stopped one week ago because of joint and muscle pain out of the ordinary. I am a 58-year old female who had and LDL of 211 and after taking Vytorin is now in 87. This is good on the side of cholesterol, but too bad for the pain and stiffness left. In fact, according to my doctor, I have rheumatism. I never had that before and my diet is very healthy (lost of fruits and vegetable, nuts, yogurt). I also bought Sytropin (HGH) which gave me much strength and zest; however, I wonder which one (Vytorin or Sytropin) has caused me so much discomfort.
3.) My brother 65 years of age had a mild stroke, he was put on Lipitor, I had high colestoral for a few years, was put on Vytorin, when we chatted about these medicines, we discovered that we both suffered severe muscle pain, his in arms and neck, Mine mostly arms, like no pain I ever felt. He told the doctor about the pain and dr said stick with it for a year then I can take you off, I told mine and he didn't say much of anything. The Vytorin was a new medicine added to a long list of medicines I take for Crest syndrome, mixed connective tissue disease, vascular problems, diabetes predisone induced. I don't think it's worth the excruciating pain.
4.) I have been taking Vytorin since Feb of this year. I am only taking a 1/2 tablet of the 10/20 dosage. At first I seemed to tolerate it pretty well. In about late March I started to experience a muscle ache, sort of like a tooth ache, in my right upper arm. I did not associate this with the drug at this time. I had been remiss and not read about the side affects on the enclosed literature from the pharmacy. Since I was turning 50 this year I just thought I was having a bit of the A-G-E syndrome! I had my yearly exam scheduled for April and thought that I would discuss this with my doctor at that time. When I told my doctor about this ache, he thought that maybe I had hurt myself during one of my workouts.5.) I Have been on Vytorin for 3 months . I am going to my doctor today I can't hardly go I have been having such severe muscle pain and swelling of my hands, feet, legs, and face. I had to take a fluid pill 3 days in a row, which I don't like to do very often. I thought at first It was just my usual aches and pains for I have been diagnosed with possible Dermatomyositis about 5 years ago and with my other meds I have been doing pretty good up until now. It seems to me this started right about the time I started the Vytorin I believe there is a link to the muscle pain and the Vytorin. My energy is just terrible.
6.) When I complained of muscle weakness while taking Zocor the family doctor told me I was just out of shape. (Arthritis of the hip and severe pain in the adductor muscle keep me limited in exercise, fun at 45 ! so much for a simple dislocation of the hip) The family doctor didn't want to hear it when I told her about some of the things I have read concerning Zocor.
I, according to her, was just out of shape. Now they tell me they want me to take Vytorin. I have tried it and I think I shall stop taking it! Since starting on Vytorin my left leg is all pins and needles and my knee feel swollen like a football. I have never experienced such a feeling to such an extent. I guess I will have to live with the high HDL numbers. I'm not making these drugs companies any more richer. The doctors don't know a darn thing about the meds they prescribe!
7.) My doctor prescribed Vytorin for my high cholesterol. I was reluctant to take it but I started regardless (my family has a history of heart attacks). I'm a 40 year old male, 5'10", 175 pounds and exercise regularly. After only 5 days of taking Vytorin I experienced the following side effects: constant headaches, heartburn, excessive thirst (I began drinking 2-3 times my normal daily water intake), dark circles under my eyes, slow recovery form workouts and acne. Those were just the physical side effects. On the emotional side: Anxiety, restlessness, easily agitated, impulsive and vivid dreams.
8.) My mother was recently told by her Doctor to start taking Vytorin, she took it for 19 days, and on that 19th day she literally almost crawled into the house. She was in so much pain, weakened leg muscles and completely exhausted. Since then she has been in therapy, resting (still in pain) not able to walk more than a block at a time, and not able to resume her normal daily functions. There is more but without being long winded where do we go from here. We would like to pursue an avenue for pain and suffering and to alert pushy Doctors about lowering cholestrol and the health of the patient. I am on Lipitor now and wondering if I should go off. I had tried Crestor with horrible results.
9.) I take Vytorin (was originally taking Zetia and Zocor) and also Niaspan - all at the max. doses allowed. I have had muscle pain and major leg cramping since I can remember and it has gotten considerable worse since I was switched to Vytorin. My blood tests show no abnormalities. Now, here is the interesting part - I have also been experiencing menopausal symptoms for the past three to five years but no doctor has been able to explain it. Hot flashes, night sweats, slow thought processing (not easy since I attend college at night), many missed periods, and now, constant cramping in my left ovary that radiates around to my back.
With all of this being said, there is no test that shows anything wrong. I usually only receive a look that tells me the doc thinks I am nuts again. I was even convinced to try therapy to work on being a hypochondriac but the therapist thought I was fine and thought my docs needed therapy. So, you can see my confusion, frustration and stress regarding these medications. In the past, I have stopped all meds for a short while and tried to give my body a break and it would work a bit. Now, I have been off all meds again for two weeks and the symptoms are not subsiding. Here is the deal...I know I need these meds (all of the women in my family have had their first heart attack by 40) but I am not sure what I am compromising by taking them.
So I used different types of medicinal shampoos, put apple cider vinegar on my scalp and started using Scalpicin. My last liver test was better and my cholesterol was down to 150: There was two changes that possibly caused the better liver function tests; I was taking half of the prescribed dosage and I went on a diet to cleanse my liver.
Meantime my prescription was running low and we had changed insurance companies so I had to request a new prescription. The prescription has been really slow arriving and I have been without the Vytorin for about a week now. In this week my scalp has problem is much improved and is almost back to normal. I am wondering if the side effects are worth it.
Vytorin now leads in side effects reported to me.
When I started my research on the statins, Vytorin had yet to be developed. Now the combination of Zocor (simvastatin) and Zetia (ezetimibe) has achieved a major market share. The purported special benefit of Vytorin is better LDL cholesterol reduction by interfering not only with Zocor's inhibition of cholesterol biosynthesis but by the added reduction of intestinal absorption of cholesterol through Zetia's effect on the small bowel.
So the stated reason for the introduction of this new combination pill was improved cholesterol reduction. This came at a time when existing products such as Lipitor, Mevacor and Zocor already were achieving better than 40% reductions in serum cholesterol in most people and researchers were just beginning to tell us of the increasing irrelevance of cholesterol in cardiovascular risk.
Vytorin is just another strong statin drug expected to have at least as many side effects as other strong statins already in use but a new factor now has to be considered - Vytorin is causing far more people to report adverse side effects than Zocor alone ever did. Now, fully a third of my daily e-mails of adverse reports from statin users relate to Vytorin use.
With the possible exception of cognitive reports, there is no change in the content of the reports only the numbers. Because cognitive side effects appear to be based on altered cholesterol availability, it was anticipated that a possible worsening of cognitive side effects reports from Vytorin because of its even greater reduction of cholesterol bio-availability than with Zocor alone.
The "few aches and pains and occasional liver intolerance" of a decade ago has now evolved to a flood of adverse reports involving cognitive, affective and neuromuscular systems and the addition of Zetia to Zocor in the product Vitorin has only made the side effect problem worse.
Merck would have been far better off to have combined their Zocor with ubiquinone (CoQ10), especially since ubiquinone lack is the cause of so many of the side effects of Zocor (just as with Lipitor, Mevacor and Crestor). Myopathy, rhabdomyolysis, neuropathy, chronic fatigue, congestive heart failure and even mitochondrial mutations are secondary to ubiquinone lack and have nothing to do with cholesterol reduction. A combination pill with CoQ10 would have been a helpful addition to the list of medications available for cardiovascular risk reduction.
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. In my judgment the decision to combine Zocor with Zetia in the product, Vytorin, was ill-advised and prescribing physicians deserve to know the true side effect profile of statins.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
Updated July 2011