Statin Wars - British Style!

[Rianne]

Regarding cardiac calcium check, I had 2 CT scans last year due to a small bowel obstruction. There were a few other things the docs noted in that CT scan. If they're doing the CT scan for other reasons, wouldn't they note or see high calcification in the arteries? I'm sure if they saw a tumor somewhere else they'd tell you. If you're going through a CT scan anyways, don't you get a 2fer if something else is wrong?

[Teacher Terry]

Sen, that’s really sad about your FIL. Too bad he didn’t listen to you.

[msieweke]

Not an expert, but... I understand the CAC test requires a special CT scan that works super-fast to catch an image of a beating heart. A standard CT scan probably gives a blurry picture.


I remembered a few more tests to indicate cardiovascular risk. Hope this is interesting:

C-reactive protein (hsCRP) is a marker for inflammation. This is a well-known indicator of cardiovascular risk, so your MD may have requested hsCRP at some point. I think it may not be widely used because most people don't seem to know what to do with it. This link has several suggestions for lowering inflammation and hsCRP.

Serum ferritin is an indicator of body iron stores. One of the reasons why pre-menopausal women have lower heart attack risk than men is due to lower iron stores. One study showed that men who donated blood within the previous 24 months had an 88% reduction in heart attack risk vs. non-donors. From what I've read: you want serum ferritin to be 100 or less. If yours is high, donate blood and re-test.

Visceral fat is fat that deposits around internal organs - also known as abdominal fat. Visceral fat causes inflammation, and it may be a marker for fatty liver. You can have a DEXA scan (expensive) or just measure your waist/hip ratio. You want w/h to be less than 1, but the ideal is probably a bit lower - ~.8 for women or ~.9 for men. This is the old "apple" vs "pear" body shape, where apple-shaped people have higher risk.

[threegoofs]

Quote:

Originally Posted by sengsational I've told this story of my FIL before, but warrants repeating. He was active and healthy and one day in the garden he wanted help getting up. I was set aback because he would be the one to lift, carry, pull and push to the extreme. He said he had pain and weakness in his muscles and when I found out the doctor* has him on a statin, I said to stop taking it. He said "what about my numbers?" I said your numbers don't matter if you're dead! This sales job that the big pharma has done had him so confused, he kept taking that stuff, poisoning himself literally into a wheelchair before coming off the statin. I didn't know how bad it was getting due to infrequent contact. Anyway he lost a bunch of weight, got more frail and hasn't ever really recoveed. As to the tactics of the companies selling statins, 3g seems not to be addressing the topics of selective release of trials, misleading marketing and the business practices that they used to bolster usage. * We had the same PCP at the time, and when he mailed me a prescription for a statin, without even talking to me about it, and based on a calculated LDL-C of 102, I fired his ass.

Oh, please... enlighten me on which large statin trials were not published.

Marketing and business practices are irrelevant. No one is selling statins. No one.

[6miths]

I would ask what the difference would be between entire trials not being published and raw data from the published trials not being released. The effect is potentially the same. Threegoofs you don't really come across as an unbiased source. The money may have largely been already made on statins but selling the idea that LDL-C or a similar indicator is the holy grail will pave the way for the next generation of patent protected drugs. Medicine is business after all, and business is well... business.

[threegoofs]

Quote:

Originally Posted by 6miths I would ask what the difference would be between entire trials not being published and raw data from the published trials not being released. The effect is potentially the same. Threegoofs you don't really come across as an unbiased source. The money may have largely been already made on statins but selling the idea that LDL-C or a similar indicator is the holy grail will pave the way for the next generation of patent protected drugs. Medicine is business after all, and business is well... business.

Eh..... no. The effect is not the same. The raw datasets are good for hypothesis generating publications and ideas, and also pretty abusable if you have the motive. The primary and secondary endpoints of these trials- and these are generally published before the trial is finished nowadays- is the important thing. And a registrational trial for labeling is fully open to the FDA for independent analysis. And believe me... they do it.

The issue now isn’t what a drug does to LDL... it’s what effect it has on cardiovascular events. Surrogate markers are old news- 1990s medicine.

And the bar for effectiveness has been set by the statins.

True. I’m not an unbiased source. I’m trained in clinical pharmacy, so I’m biased toward evidence.

Fluffy LDL talk is fine, HDL speculation is great... but where the rubber hits the road, follow outcome trials.

[Helen]

Quote:

Originally Posted by Rianne Regarding cardiac calcium check, I had 2 CT scans last year due to a small bowel obstruction. There were a few other things the docs noted in that CT scan. If they're doing the CT scan for other reasons, wouldn't they note or see high calcification in the arteries? I'm sure if they saw a tumor somewhere else they'd tell you. If you're going through a CT scan anyways, don't you get a 2fer if something else is wrong?

I had a CT and angiogram because of a brain aneurysm (I opted for the endovascular coiling). It wasn't until I asked the neurosurgeon about my arteries that he said mine looked better than 95% of his patients. I was surprised he didn't tell me that up front.

[tfudtuckerpucker]

Threegoofs, would you comment on this article? https://annals.org/aim/article-abstract/2717730/finding-balance-between-benefits-harms-when-using-statins-primary-prevention?doi=10.7326%2fM18-1279
I don't have access to the full text, but there's a summary here https://www.ajmc.com/newsroom/new-st...to-prevent-cvd

[threegoofs]

Quote:

Originally Posted by tfudtuckerpucker Threegoofs, would you comment on this article? https://annals.org/aim/article-abstract/2717730/finding-balance-between-benefits-harms-when-using-statins-primary-prevention?doi=10.7326%2fM18-1279 I don't have access to the full text, but there's a summary here https://www.ajmc.com/newsroom/new-st...to-prevent-cvd

I won’t go through it in detail, but it shows what we know. The higher the risk of CVD you have, the more pronounced the benefits of statins are.

But even with low risk.. if you have no adverse effects, you’ll get benefit. It may take a decade, but given negligible cost, it’s a no brainer decision.

[bmcgonig]

Quote:

Originally Posted by threegoofs I won’t go through it in detail, but it shows what we know. The higher the risk of CVD you have, the more pronounced the benefits of statins are. But even with low risk.. if you have no adverse effects, you’ll get benefit. It may take a decade, but given negligible cost, it’s a no brainer decision.

It says that the 7.5 risk threshold is too low and that it should be raised to at least 14. In some cases 22. Below that the harm could outweigh the benefits.

It's fundamentally saying that the new guidelines for primary care are wrong.

[zedd]

Quote:

Originally Posted by bmcgonig It says that the 7.5 risk threshold is too low and that it should be raised to at least 14. In some cases 22. Below that the harm could outweigh the benefits. It's fundamentally saying that the new guidelines for primary care are wrong.

That's my interpretation as well.


The full text of the study is behind a paywall, true, but that doesn't mean one can't learn something meaningful by researching other studies that cite that text.


Google

"Finding the Balance Between Benefits and Harms When Using Statins for Primary Prevention of Cardiovascular Disease: A Modeling Study"

And find references such as:


https://www.jwatch.org/na48090/2019/...ary-prevention


"
This model recommends statins less frequently than the American College of Cardiology guideline does.

There is substantial disagreement on which patients without known cardiovascular disease (CVD) should take statins. In this latest effort to address potential benefits and harms of statins for primary prevention, a Swiss team created a complex model based on data from randomized trials and observational studies. The model also incorporated competing risks for non–CV-related death and results of a survey of patients' preferences for avoiding adverse CV outcomes and statin side effects.
The 10-year predicted CVD risk above which the model predicted net benefit ranged from 14% (for men in their 40s) to 21% (for 70- to 75-year-old men), and from 17% (for women in their 40s) to 22% (for 70- to 75-year-old women)."




https://www.medpagetoday.com/cardiol...ipidemia/76673


"

Statins may be overprescribed for the primary prevention of cardiovascular disease (CVD), according to a modeling analysis of benefits and harm.
Statins are likely to provide net benefits at substantially higher 10-year CVD risk thresholds than the 7.5% to 10% thresholds noted by most guidelines, according to Milo A. Puhan, MD, PhD, of the University of Zurich, and colleagues.
Probability of net benefit from statin therapy decreased as age increased."




https://pace-cme.org/2018/12/17/for-...10-year-risks/


"Statins are recommended for primary prevention of CVD if 10-year risk exceeds 7.5-10.0%, often in addition to other criteria such as high cholesterol or presence of at least one specific risk factor [1-5]. None of the current guidelines, however, used a systematic assessment of the benefit-harm balance of statins [6], and it remains unclear whether the currently recommended thresholds for initiation of statin therapy are justified."


"Editorial comment Richman and Ross note that the recommendation to use statins for primary prevention of CVD in adults with 10-year risk of at least 7.5% in the 2013 update of the ACC/AHA guidelines was particularly controversial. In the 2018 update of these guidelines, the approach was affirmed, albeit with emphasis on the importance of patient preference. The U.S. Preventive Services Task Force released guidelines in 2016, in which statins for primary prevention was recommended for adults with 10-year CVD risk of at least 10%, or at lower risk thresholds (starting at 7.5%) considering individual circumstances.
Yebyo and colleagues now challenge these risk thresholds, ‘through a careful accounting of long-term risks and benefits of statins’, according to Richman and Ross. ‘The authors assigned weights to treatment outcomes so that benefits and harms could be quantified on a single scale and summed over a 10-year horizon to determine the risk threshold at which benefits outweighed harms.’ Richman and Ross express their surprise that the authors consistently found that harms outweighed benefits until 10-year CVD risk thresholds substantially exceeded those recommended in current guidelines. That raises the question whether physicians should reconsider implementing the guideline recommendations into practice. Richman and Ross consider why the estimates in this article differ from those in current guidelines. Firstly; different methodological approaches were used to estimate net benefit, with a more elaborate method used in the article. Especially taking into account competing mortality risk contributed to the decreasing probability of net benefit of statins with increasing age.
Yebyo et al. included a long list of potential adverse events, derived from an as yet unpublished network meta-analysis by the same authors, which inevitably tips the balance further away from net benefit and toward harm. Opinions may differ as to whether or not it is justified to include these harms. Richman and Ross conclude that it is the patient who has to decide on the CVD risk threshold for initiation of statin therapy. It is up to ‘physicians to fairly summarize the evidence and guide patients through the decision-making process’."


And the list goes on.

[threegoofs]

Quote:

Originally Posted by zedd That's my interpretation as well. The full text of the study is behind a paywall, true, but that doesn't mean one can't learn something meaningful by researching other studies that cite that text. Google "Finding the Balance Between Benefits and Harms When Using Statins for Primary Prevention of Cardiovascular Disease: A Modeling Study" And find references such as: https://www.jwatch.org/na48090/2019/...ary-prevention " This model recommends statins less frequently than the American College of Cardiology guideline does. There is substantial disagreement on which patients without known cardiovascular disease (CVD) should take statins. In this latest effort to address potential benefits and harms of statins for primary prevention, a Swiss team created a complex model based on data from randomized trials and observational studies. The model also incorporated competing risks for non–CV-related death and results of a survey of patients' preferences for avoiding adverse CV outcomes and statin side effects. The 10-year predicted CVD risk above which the model predicted net benefit ranged from 14% (for men in their 40s) to 21% (for 70- to 75-year-old men), and from 17% (for women in their 40s) to 22% (for 70- to 75-year-old women)." https://www.medpagetoday.com/cardiol...ipidemia/76673 " Statins may be overprescribed for the primary prevention of cardiovascular disease (CVD), according to a modeling analysis of benefits and harm. Statins are likely to provide net benefits at substantially higher 10-year CVD risk thresholds than the 7.5% to 10% thresholds noted by most guidelines, according to Milo A. Puhan, MD, PhD, of the University of Zurich, and colleagues. Probability of net benefit from statin therapy decreased as age increased." https://pace-cme.org/2018/12/17/for-...10-year-risks/ "Statins are recommended for primary prevention of CVD if 10-year risk exceeds 7.5-10.0%, often in addition to other criteria such as high cholesterol or presence of at least one specific risk factor [1-5]. None of the current guidelines, however, used a systematic assessment of the benefit-harm balance of statins [6], and it remains unclear whether the currently recommended thresholds for initiation of statin therapy are justified." "Editorial comment Richman and Ross note that the recommendation to use statins for primary prevention of CVD in adults with 10-year risk of at least 7.5% in the 2013 update of the ACC/AHA guidelines was particularly controversial. In the 2018 update of these guidelines, the approach was affirmed, albeit with emphasis on the importance of patient preference. The U.S. Preventive Services Task Force released guidelines in 2016, in which statins for primary prevention was recommended for adults with 10-year CVD risk of at least 10%, or at lower risk thresholds (starting at 7.5%) considering individual circumstances. Yebyo and colleagues now challenge these risk thresholds, ‘through a careful accounting of long-term risks and benefits of statins’, according to Richman and Ross. ‘The authors assigned weights to treatment outcomes so that benefits and harms could be quantified on a single scale and summed over a 10-year horizon to determine the risk threshold at which benefits outweighed harms.’ Richman and Ross express their surprise that the authors consistently found that harms outweighed benefits until 10-year CVD risk thresholds substantially exceeded those recommended in current guidelines. That raises the question whether physicians should reconsider implementing the guideline recommendations into practice. Richman and Ross consider why the estimates in this article differ from those in current guidelines. Firstly; different methodological approaches were used to estimate net benefit, with a more elaborate method used in the article. Especially taking into account competing mortality risk contributed to the decreasing probability of net benefit of statins with increasing age. Yebyo et al. included a long list of potential adverse events, derived from an as yet unpublished network meta-analysis by the same authors, which inevitably tips the balance further away from net benefit and toward harm. Opinions may differ as to whether or not it is justified to include these harms. Richman and Ross conclude that it is the patient who has to decide on the CVD risk threshold for initiation of statin therapy. It is up to ‘physicians to fairly summarize the evidence and guide patients through the decision-making process’." And the list goes on.

The consequences of reversible muscle pain are not equivalent to a myocardial infarction or stroke.

[Scratchy]

Physician here and feel obliged to say that this thread does one thing, and one thing only, for sure: it demonstrates that permitting medical advice to be given on an open forum is an appallingly bad idea.

lt is honestly shocking to read the falsehoods and bad medical advice blithely dispensed in this otherwise great forum.

Moderators, please please reconsider whether it is responsible policy to allow medical advice to be given here.

[bmcgonig]

Quote:

Originally Posted by Scratchy Physician here and feel obliged to say that this thread does one thing, and one thing only, for sure: it demonstrates that permitting medical advice to be given on an open forum is an appallingly bad idea. lt is honestly shocking to read the falsehoods and bad medical advice blithely dispensed in this otherwise great forum. Moderators, please please reconsider whether it is responsible policy to allow medical advice to be given here.

Probably worth mentioning what the falsehoods are, or else your plea is merely on account of your supposed authority as a physician. Not that you're wrong. You might be correct. But a lot of this thread involves discussions that are highly controversial among members of your field.

[bmcgonig]

Quote:

Originally Posted by threegoofs The consequences of reversible muscle pain are not equivalent to a myocardial infarction or stroke.

I agree with that. But it's really not that simple. How about diabetes?

https://www.diabetes.co.uk/news/2019...-97343893.html

[braumeister]

Quote:

Originally Posted by Scratchy Physician here and feel obliged to say that this thread does one thing, and one thing only, for sure: it demonstrates that permitting medical advice to be given on an open forum is an appallingly bad idea. lt is honestly shocking to read the falsehoods and bad medical advice blithely dispensed in this otherwise great forum. Moderators, please please reconsider whether it is responsible policy to allow medical advice to be given here.

Speaking only for myself, not as a moderator, I see only opinions being given here on the forum, not advice. What is not responsible behavior is for anyone to take these opinions as medical advice.

[threegoofs]

Quote:

Originally Posted by bmcgonig Probably worth mentioning what the falsehoods are, or else your plea is merely on account of your supposed authority as a physician. Not that you're wrong. You might be correct. But a lot of this thread involves discussions that are highly controversial among members of your field.

No... statins are incredibly UNcontroversial in medicine.

Yes, lots of websites and an occasional editorial in the published literature will be critical, but the general consensus as codified in guidelines around the world is pretty solid.

[donheff]

Quote:

Originally Posted by Scratchy Physician here and feel obliged to say that this thread does one thing, and one thing only, for sure: it demonstrates that permitting medical advice to be given on an open forum is an appallingly bad idea. lt is honestly shocking to read the falsehoods and bad medical advice blithely dispensed in this otherwise great forum. Moderators, please please reconsider whether it is responsible policy to allow medical advice to be given here.

I think you are over reacting. Most of our health discussions are rather straight forward and uncontroversial (e.g. knee and hip replacements). Where things get dicey is in areas where the medical opinion is all over the place (e.g. diet). Nothing wrong with people griping and postulating about things there is no consensus on. Statins and PSA tests come to mind.

[joeea]

Quote:

Originally Posted by Scratchy Physician here and feel obliged to say that this thread does one thing, and one thing only, for sure: it demonstrates that permitting medical advice to be given on an open forum is an appallingly bad idea. lt is honestly shocking to read the falsehoods and bad medical advice blithely dispensed in this otherwise great forum. Moderators, please please reconsider whether it is responsible policy to allow medical advice to be given here.

I agree. It's one thing to give misguided financial advice.
It's quite another to encourage uninformed medical advice.

Rather sad.

[threegoofs]

Quote:

Originally Posted by bmcgonig I agree with that. But it's really not that simple. How about diabetes? https://www.diabetes.co.uk/news/2019...-97343893.html

Again, presence or absence of T2DM is not a potentially fatal event like MI or stroke.

It looks like much of this effect is basically nudging people with borderline T2DM to diagnosed T2DM.

But the major risk of death in T2DM (especially late onset T2) is cardiovascular events, and statins unquestionably are beneficial here.