Statins, side effects and safety

April 1, 2010 by  
Filed under HEART AND STROKE

Statin therapy is the gold standard in lowering cholesterol levels and preventing cardiovascular events. However, the safety of some statins has been questioned lately. Simvastatin (marketed as Zocor by Merck) is currently under safety review by the US FDA due to a potentially serious side effect. The US FDA is currently reviewing data from the SEARCH trial (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) as well as those from other trials.

Statin use can cause muscle myopathy that results in muscle pain and weakness. Higher doses of simvastatin (highest approve is 80 mg) can lead to a serious type of myopathy called rhabdomyolysis which “occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.” Those at risk are the elderly (older than 65), those with hypothyroidism and impaired kidney function.

There have several reported cases of statin-associated muscle problems, especially among women, leading some experts to question the benefits of statin use (see this article in TIME magazine). The US FDA, however, is quick to point out that rhabdomyolysis is a rare side effect of statins. Patients are advised against statin cessation unless explicitly order by a health care professional.

The American Heart Association (AHA) has issued a statement to react to the FDA advisory and to the TIME magazine article. The statement goes:

Because of the well-documented benefit of cholesterol-lowering with statins, the association advises that patients respect the benefit of statin therapy and only consider discontinuation after a discussion with the appropriate healthcare provider. For the person who experiences myopathy with a statin, other alternatives should be discussed with their physician. Patients who are taking statins and not experiencing any side effects should continue to take their medication unless advised for other reasons to stop by their healthcare provider. Only the very rare side effect of rhabdomyolysis (muscle injury), signaled by dark urine, should lead a patient to stop their statin immediately but then talk promptly with their healthcare provider.

As with all therapies, the decision to use statins for primary or secondary prevention must include careful consideration of the risks and benefits, side-effects and cost. Side effects can vary by dose, by individual, and by the presence of other medical conditions or other medications. Awareness of possible side effects and open communication between patient and provider will allow optimal treatment benefit for each patient.

Vytorin, Zetia, Zocor, Confusion and What You Should Do Now

April 1, 2008 by  
Filed under HEALTHCARE

vytorin.jpg

We used to see the ads on TV. Your cholesterol goes out of whack because of two things: cholesterol from the food you eat, and genetic cholesterol problems. So, being the good and wise patient you were, you discussed the subject with your doctor and he or she suggested Vytorin. Why? Because it was said to battle both types of cholesterol. And that can help prevent heart attacks and strokes.

Turns out that those clever marketers at both Shering Plough and Merck — the manufacturers of the components of Vytorin — had us all fooled. Billions of dollars later (yes — I mean billions!) they announced that — oops! Vytorin not only doesn’t work to reduce cholesterol and protect us from heart attacks and strokes, but it might even cause us additional cholesterol problems, worse than we had before we took the drug!

This isn’t really new news — the results of the most recent study were actually released back in January. The point is only raised today because it became official when announced at this week’s meeting of the American College of Cardiologists. But since then, there have been a few aspects of the announcements that most patients don’t understand, or haven’t thought about. So — here’s some food for thought:

What exactly is Vytorin? It is a combination drug. Shering Plough makes one statin (cholesterol-lowering drug) called Zetia. Merck makes another one called Zocor. Their brilliant marketing minds decided to mix them together because two kinds should lower cholesterol even better than one, right? Turns out, that wasn’t always right.

If the drug doesn’t work, then how did it get FDA approval to begin with? Good question. It was approved for sale in 2004, presumably because the FDA bought the argument that the two components, both Zocor and Zetia would work in combination. Fooled the FDA! (nothing new)

Why doesn’t it work? Turns out that the bigger question being asked isn’t so much whether or not any of these statins really lower someone’s cholesterol levels; rather, the question is whether or not lowering someone’s bad cholesterol really prevents heart disease or stroke. Evidently, just because someone’s LDL (bad cholesterol) is lower doesn’t mean they are really protected.

How can that be? We’ve known for years that LDL needs to be low, and HDL should be high for protection. That’s actually what was disproved from this test — that the assumptions about LDL and HDL may be wrong!

Who is most upset at this news? The answer is probably a four way tie:

Doctors are very upset because they were fooled (and who likes to be made a fool?) How will they ever trust Merck or Shering Plough again? (OK — not sure how they trust Merck after the vioxx scam anyway?)

Insurers are very upset because they have been paying big bucks for Vytorin (when it was launched, it cost $2.34/tablet). Generic statins, which would have been more effective for patients would have cost a fraction of the price.

Investors / stockholders of both Merck and Shering Plough are hurting — their stock value has nose-dived.

And the pharmaceutical reps who work for both companies, and sell doctors on the drugs are angry — through no fault of their own, the rug has been pulled out from under their career legs. No doctor will ever prescribe Vytorin again. And anything sold by Merck or Shering Plough will be suspect.

We patients should get mad, too. We should be angry because the FDA allowed itself to be fooled and approved a drug — yet another one — that is not beneficial to patients, and can harm them, too.

What should patients do if they take Vytorin, Zetia, Zocor or any other statin? Don’t change anything until you check with your doctor. The bottom line of the study doesn’t seem to be that any of them are dangerous. Instead they just aren’t effective.

See your doctor. Ask tough questions. And partner with him or her to decide what to do next.

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NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.