Statin Induced Rhabdomyolysis or Myositis Disorder

Oh man, I forgot about that with the NY Times. Here is the print of what was posted.

Do Statins Really Cause Muscle Aches?
People taking cholesterol-lowering statin drugs often report muscle pain, but the pain may be the same when they take a look-alike placebo pill.

Many people who take the cholesterol-lowering statin drugs report that they cause muscle pain, but a randomized trial suggests that the pain is no different when they take a placebo pill.

In rare cases, statins are known to cause a severe muscle condition called rhabdomyolysis, in which skeletal muscle tissue is destroyed, leading to serious complications. But much more frequently, people complain that the drugs simply cause muscle pain.

Whether statins are responsible for the muscle pain, however, remains uncertain. Muscle pain has many causes and is common in the older age group using statins, so determining whether statins are causing the pain is not easy. Results from observational studies, along with many media reports, may have led some to unnecessarily discontinue a treatment that is potentially lifesaving.

This new study, published in BMJ, involved a series of what is known as n-of-1 clinical trials, a methodology that allows researchers to examine the results of treatment and placebo in individual patients, rather than studying them as a group. In effect, each patient serves as his or her own control.

Researchers assembled 200 people in England and Wales who had either stopped or planned to stop taking statins because of intolerable muscle pain. For a year, each patient randomly took either a statin or a placebo pill over six two-month periods. Half the time they received 20 milligrams of Lipitor, and the other half they got a look-alike dummy pill. Until the end of the study, neither the researchers nor the patients knew when they were taking the statin and when they were taking the placebo.

During the last seven days of each two-month phase, the researchers measured each patient’s pain daily using a validated 10-point visual pain scale, with 10 indicating the worst possible pain. They also tracked other aspects of daily life, including the patient’s general activity level, mood, comfort in walking, ability to pursue normal work activities, social relationships, sleep and enjoyment of life.

The study found no differences between the statin and placebo periods in either muscle pain or reports on daily life activities and moods. Nine percent withdrew because of pain while they were on statins, but so did 7 percent who were taking placebos, an insignificant difference.

“These studies are difficult to do,” said Dr. Henry N. Ginsberg, a professor of medicine at Columbia who was not involved in the work. “This one is done as well as you can, and it’s a nice one to talk about with patients. You can tell your patients, ‘They’ve done studies in people like you, and these people couldn’t tell the difference between placebo and medicine.’”

Three months after the final treatment, when the patients had been informed of their results, the researchers asked them whether they had restarted statins, or intended to, and whether they found their own trial result helpful in making their decision. Most of the patients said that the trial was helpful, and more than two-thirds reported that they planned to start taking statins again.

The lead author, Dr. Liam Smeeth, a primary care physician and professor of clinical epidemiology at the London School of Hygiene and Tropical Medicine, said that when people stop statins because of muscle pain “they’re missing out on the huge benefits — reducing the risk of heart attack or stroke by about a third. What we’ve shown is that among these people who gave up their medicine because of pain — and their pain was real — it wasn’t made worse by statins.”

Yikes! This study is misleading and biased! What it doesn't identify is the very small percentage of patients that develop Rhabdomyolysis and the possibility of Liver Damage, Kidney Damage, and Death. If a provider read this study and did not research further, they would be careless in correctly monitoring patients on Lipitor. I wonder who paid for this study..

Study Criteria:
"Researchers assembled 200 people in England and Wales who had either stopped or planned to stop taking statins because of intolerable muscle pain.
For a year, each patient randomly took either a statin or a placebo pill over six two-month periods. Half the time they received 20 milligrams of Lipitor, and the other half they got a look-alike dummy pill. Until the end of the study, neither the researchers nor the patients knew when they were taking the statin and when they were taking the placebo."

Comments:
First it only includes 200 people who had been already been on Statins. That's not a large enough baseline to make conclusions. I think it's been proved that Statins definitely can cause muscle pain. From the research I've done, serious symptoms may not appear for 6+ months. If they only monitored for 6 months then switched to placebo they missed the grouping of patients that would potentially develop serious symptoms. Plus that, if muscle cramps can continue up to 3-4 months after stopping Statins, then they would be reporting muscle aches/pains during the placebo period. Trended CK's would also be important during the placebo period. Also, Many people can successfully restart a different statin. Did they change the drug or dose?

My bad symptoms didn't start until 6 months out. during that time they were masked by long Covid symptoms. Then they got significantly worse when Cyclosporine was added.
It doesn't say if they monitored CK levels routinely and matched the levels to the persons social and physical routine. Without that data this means nothing. The tipping point for me was that I had progressed to Renal failure due to the Rhabdomyolysis (GFR 14). After stopping Lipitor for 3 weeks my GFR increased to 35. It is now in the 40's. No other changes to meds were made.

This is a good article on statin associated myopathy.
https://www.uspharmacist.com/article/statin-associated-myopathy

I have to have a referral for a Rheumatologist. And.. it takes about 3 months to get a "New Patient" appointment with almost every doctor I tried. Even to get a decent new PCP.

Update: I'm 9 weeks out from stopping the Lipitor and the muscular pain has slowly reduced to tolerable if I'm just staying in bed. If I have to get up and do anything more than a trip to the bathroom or kitchen a pain pill will get me enough relief to accomplish simple chores. I refuse to take more than 1- 10mg Norco a day to reduce chances of addiction so I mostly stay in bed.
Unfortunately last week my Angioedema cranked up to intolerable again. I've been sleeping 16 hours a day. It could be related to the statins or the auto-immune skin disorder that caused my hives which are now controlled by Xolair injections.
Basically I'm going to end up sitting in my bed until the 3-4 month period to resolve the Rhabdomyolysis - to see if it does resolve.. because no providers want to address this... or because I need a new PCP appointment to get a Rheumatologist referral. I have an appointment at the end of September with a new PCP. Unfortunately my CK levels wont be high enough to support a referral by that time. So.. I start over.

Have you checked your Creatnine Kinase (CK) levels during a blood test. While on statins I had muscle ache and found that my CK levels were elevating which indicated possible muscle damage. My cardiologist diagnosed it as statin-related mypathy. When I stopped Crestor for a month my CK levels cane right down to normal although my LDL increased. I am back on a lower dose of Crestor (5mg) which is managing CK levels better while keeping my LDL at a safe level. I am also on a low carb Mediterraen diet which is helping my HDL and Triglyceride levels. Hope you are able to find a solution to your muscle cramps.

@marinab - Believe it or not no provider has checked my CK. My PCP should have done that especially in January when I got really sick. Instead he turfed me to my allergist. That's when the Rhabdomyolysis started and my kidney function started to decline. We didnt figure out it was a Statin adverse reaction until mid July. The Nephrologist diagnosed the Rhabdomyolysis/Statin Adverse reaction.. but didn't run a CK. I followed up with my Allergist and asked him to run one but the tech ordered a CK-MB instead of a CK. That was 2 weeks ago. I finally just gave up. Now that I'm off Lipitor the muscle pain is starting to resolve and I'm getting some mobility back so my CK levels are probably going back down. If it flares up again I'll go to a walk in lab and have them run myself.

Thank you for the post. I did have creatine checked but don't remember the result. I tried a all of the statins on the market, over time, and they all triggered really painful (and I thought dangerous) leg cramping so I don't take any of them. I still have elevated cholesterol but mostly of the larger molecule size which is also less likely to clump or cause arterial buildup so my cardiologist is less concerned about the statins now.

That's surprising. I though tit was part of the follow up blood test cardiologists do after prescribing statins. - they check lipids, kidney, liver and CK. I would love to go off statins but my cardiologist tells me there is a biiger danger from not controlling my lipids than the likelihood of me developing severe muscle damage. He did say that PCSK9 (injections) was an alternative to statin that would not cause muscle damage, but they are very costly and my insurance company will not cover that cost so I am hoping that between a low dose statin and proper diet will manage my condition satisfactorily. Please keep us posted with your progress.

Glad to hear that your cholesterol is manageable. Best to avoid statins unless there is no alternative. Wishing you good health!

Hello everyone, there is so much to learn about cholesterol and statins, and side effects. I've posted my own concerns recently. It's amazing to me that doctors don't run more tests. Especially since so much blood is drawn out of you! I was prescribed a statin and will only go on it after an advanced lipid test is run. As someone mentioned, you have to know if it is the larger or smaller dense particles of ldl. Let's all keep demanding our doctors do better. And really give us the level of care we deserve. And if I need meds at least I know I have done my work. And can then be more comfortable taking the statins.