SEAS them! Statins vs. Stenosis: No Contest

[tobagotwo]

This from The Philadelphia Inquirer July 22, 2008; SECTION: BUSINESS; P-com Biz; Pg. C01; By Stacey Burling; Inquirer Staff Writer (Boldings mine)

Vytorin Misses Primary End Point in SEAS Study from Heartwire — a professional news service of WebMD

July 22, 2008 — Merck and Schering-Plough presented interim results of the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study today, a randomized, multicenter, placebo-controlled study evaluating the effects of combination ezetimibe/simvastatin (Vytorin) on clinical outcomes in roughly 1800 patients with aortic stenosis, and the results showed that the controversial cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events.
The combination was significantly more effective than placebo in reducing the risk of ischemic events, a secondary composite end point of nonfatal MI, coronary artery bypass graft (CABG) surgery, PCI, hospitalization for unstable angina, nonhemorrhagic stroke, and cardiovascular death. Vytorin failed to meet a secondary goal of improving aortic-valve disease events, which included valve-replacement surgery, hospitalization because of heart failure, and cardiovascular mortality.

"The SEAS study has given a clear-cut answer to the question of whether intensive lipid lowering will influence the course of aortic-stenosis disease. I think we can conclude that it does not," announced Dr Terje Pedersen (Ulleval University Hospital, Oslo, Norway), chair of the steering committee, during a conference call today with the media.

These results from yet another four-year statins-vs.-aortic-stenosis study shows that statins again have no effect on the growth of aortic valve calcification, and do not extend the time before surgeries, nor reduce other AS-related cardiac mortality events.

But they sure sold a bundle of statins by making doctors think it might in the meantime. It's surprising that the myth had lingered after the last big study (Lipitor) showed absolutely no beneficial effects on aortic valve calcification as well.

Let's hope it's finally been put to rest now. False hopes fed from others' greed are a sad waste of time and resources that could have been trying to help the actual problem.

Best wishes,

 

[Dina]

Thanks for the information. I tried it for a couple weeks when my cholesterol
was high because of low thyroid, but I had side effects(joint pain) and
stopped taking it. I would rather take herbs like garlic and ginger to lower mild or moderately high cholesterol.

 

[Mary]

Thanks for bringing the results to our attention. You're right; it's time to move on and look elsewhere.

 

[khawkk]

Help me here

Help me here

So lets be very clear.
Is the lovastatin that I am taking a waste of time and money?

????????????????????????????????????????????????????????????????

I guess there are other reasons for lowering cholesterol.

 

[epstns]

Thanks for the update!

My take is that if statins are well-tolerated, and if a condition of high cholesterol exists, then they may still be a viable treatment to reduce cholesterol. Purely for the intent of slowing the progression of aortic stenosis, they have no proven value.

I tried them for a couple of weeks when the first studies showed some effect on aortic stenosis, but I could not tolerate them at all. Too much muscle pain, we were afraid of permanent damange. Guess I didn't lose anything (with respect to the stenosis) after all. . .

 

[ruthienc1]

in a nutshell (from the American College of Cardiology eNewsletter):


"Other studies have shown that a high LDL (bad cholesterol) level is a risk factor for developing aortic stenosis. High LDL is also associated with an increased risk of coronary artery disease, peripheral vascular disease, and stroke.

The SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) Study was designed to investigate whether aggressive cholesterol lowering with simvastatin/ezetimibe (Vytorin) was associated with improved outcomes in patients with AS, especially in terms of reducing the long term need for aortic valve surgery. The study enrolled 1873 patients with mild to moderate aortic stenosis across multiple countries in Europe. Half of the patients received a daily 40/10 mg Vytorin tablet and half received a placebo pill.

The patients who received Vytorin attained very low LDL levels (76 mg/dL on average). After following the subjects for several years, the investigators found that even this aggressive LDL lowering did not reduce the number of people who went on to require valve surgery, developed heart failure or died due to valve disease. However, in those who took Vytorin, there was a significant 22% reduction in the need for bypass surgery, angioplasty, development of a heart attack, or development of a stroke.

Of interest, there was a slight increased incidence of cancer deaths in the group which was receiving the simvastatin/ezetimibe combination. This did not seem to be related to any particular type of cancer and was not related to duration of treatment.

Editor?s Comment: So what does this all mean? It suggests that lowering LDL cholesterol is unlikely to impact aortic stenosis progression and use of statins for this purpose is not currently indicated. The findings add to the body of knowledge supporting LDL lowering for the prevention of coronary disease and stroke. The cancer findings are intriguing but inconclusive, and may represent a chance occurrence. Much more data will be required before these findings can be put in context. Ongoing large clinical trials with simvastatin/ezetimibe will shed further light on this topic, although interim analysis does not suggest an association.
Sources:

Press conference, Dr. Terje Pederson on behalf of the SEAS investigators, July 21, 2008, London

Khumbani, D. http://www.cardiosource.com/clinicaltrials/trial.asp?trialID=1721"

 

[KristyW]

So lets be very clear.
Is the lovastatin that I am taking a waste of time and money?

????????????????????????????????????????????????????????????????

I guess there are other reasons for lowering cholesterol.

Khawkk,

The study is saying that if you're taking the statin to help improve or steady an aortic stenosis condition, then the statins are not effective for that purpose. BUT if you've been placed on statins to lower your cholesterol, then they are effective.

Hope that answers your question.

 

[bird lady50]

Acorrding to this post I am waiting my time taking satatins. As they will nill not prevent the outcome or stop my bav getting califieied. Thanks for all the info I am just waiting money in precrisption charges which £7.00 per item here in the u.k.

 

[tobagotwo]

Kristy restated it well. My initial post was directed at the aortic valve calcification portion of the results only.

They (statins) still work to reduce cholesterol, if your levels are too high. They reduce cholesterol-related heart problems.

They do not work to slow or stop aortic stenosis or calcification.

If the ONLY reason you're taking them is to slow calcification of your valve, then you are wasting your money.

Best wishes,

 

[PairoDocs]

Just remember that the statins act as plaque stabilizers, so also reduce the risk of stroke and PAD. There are some recent studies that show that Lipitor (and possibly other statins) lower the risk of colon cancer. Not that I would recommend stopping aspirin for anything short of allergy, but aspirin has been shown to increase (slightly) the risk of pancreatic cancer in women. Obviously, the risk of stroke or heart attack is very much higher than the risk of pancreatic cancer.

Many with aortic stenosis have comorbid circulatory conditions and/or elevated cholesterol.

Not that I am a pill pusher! I always recommend the usual conservative treatment for elevated lipids (diet, exercise), plus some "natural" treatments which may have some effect. I have seen some nasty side effects from natural treatments, not the least of which is a much lighter pocketbook. Lovastatin is $4/month here, so cheaper even than garlic pills. I make sure my patients know about the side effects.

Tired in Idaho,
-Laura

 

[bird lady50]

satains and sise effects

satains and sise effects

one thing I am worried about is the effect the statains have on the liver. I also have liver problems and very elevated liver tests. the lfts keep coming back adnormal. I am wondering if taking satains are doing more harm than good in my case.

 

[tobagotwo]

As with all drugs, statins don't work well in some people's systems. That's something that you and your doctor should determine, and something you should decide.

The basis of drugs is their risk-benefit profile. Any drug that's potent enough to have a beneficial effect on someone is also capable of having a negative effect on someone else. And a drug's method of correcting one problem may cause other problems to occur.

Drugs are approved based on the level of risk of these adverse events occuring, vs. the benefits the drugs can provide for the majority of people who do tolerate them well.

You may fall on either side of that equation for any prescription you happen to take. As such, it makes sense to understand what you're taking and a little something about how it works and what other drugs it may interact with. Enjoy the benefits of those that help you, and don't be afraid to push back to your doctor to help you get off of those that affect you badly.

Be well,

 

[bird lady50]

thank you for all the info

thank you for all the info

Thank you for all the info I think I shall stop taking them and hope for the best.I dont know which is the worst the liver or the valve

 

[KristyW]

Thank you for all the info I think I shall stop taking them and hope for the best.I dont know which is the worst the liver or the valve

Lady50,

Please don't stop taking these medications without first speaking with your physician. We supply information like this so that we may all be informed patients. So that we may ask intelligent questions. That does not mean that we encourage you to make medical and pharmacological decisions without consulting with your physician and getting his/her take on things.

 

[tobagotwo]

...don't be afraid to push back to your doctor to help you get off of those that affect you badly.

Yes, please consult your doctor to help you get off any prescription if you feel it is wrong for you. Some prescriptions can't be simply stopped: they must be tapered off to avoid bad results.

Best wishes,