Cholesterol Meds For The Youngest Children?
47 CommentsBy Ed Silverman // July 7th, 2008 // 8:31 am
The nation’s pediatricians are recommending wider cholesterol screening for children and more aggressive use of cholesterol meds starting as early as the age of 8 in hopes of preventing adult heart problems, The New York Times reports, adding that new guidelines are expected to be issued today by the American Academy of Pediatrics.
Why do this? The Times writes that proponents say there is growing evidence the first signs of heart disease show up in childhood. And with 30 percent of the nation’s children overweight or obese, many docs fear a rash of early heart attacks and diabetes is on the horizon as these children grow up.
Previously, the academy had said cholesterol drugs should be considered in children older than 10 if they fail to lose weight after a 6-to 12-month effort. The academy estimated that under current guidelines, 30 percent to 60 percent of children with high cholesterol were being missed. And supporters say for some children, statins may be the best hope of lowering their risk of early heart attack, the paper writes.
“We are in an epidemic,” Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta, tells the paper. “The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.” He adds that, while there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.
There is more to read below, but what do you think?
Should the drugmakers have waited to release the SEAS results?
- No (73%, 82 Votes)
- Yes (27%, 31 Votes)
Total Voters: 113
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Surprisingly, the paper published in the medical journal Pediatrics that explains the new guidelines notes that among adolescents, average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000. Here is the paper.
It is not clear how many children would be affected by the new guidelines. The recommendations call for cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women, the Times writes.
Screening is also recommended for children when family history is unknown, or if they have other risk factors, like being at or above the 85th percentile for weight, or have diabetes.
If the child’s cholesterol level is normal, retesting is suggested in three to five years. Although lifestyle changes are still recommended as the first course of action, drugs should be considered for children 8 years and older who have bad cholesterol of 190 milligrams per deciliter and no other risk factors, the new recommendations say (the Times wrote that meds should be considered for kids with a family history of early heart disease or two additional risk factors, but that was incorrect). Here is a useful chart.
The guidelines give no guidance on how long a child should stay on drug treatment, but do say the first goal should be to lower bad cholesterol levels to less than 160 milligrams or possibly as low as 110 milligrams in children with a strong family history of heart disease or other risk factors like obesity.
Because statins have been around since only the mid-1980s, there is no evidence to show whether giving statins to a child will lower the risk for heart attack in middle age.
UPDATE: A loyal reader reminds us that drug therapy was suggested in a paper published last year by Circulation for children with a familial risk for cholesterol. You can read about that here.
Atlex
Ed,
The Times article overplays the role of drugs in the guideline and underplays the role of diet and exercise recommendations. Here is a summary of the recommendations (note that drug treatment is the 7th out of seven recommendations.
1. The population approach to a healthful diet should be recommended to all children older than 2 years according to Dietary Guidelines for Americans. This approach includes the use of low-fat dairy products. For children between 12 months and 2 years of age for whom overweight or obesity is a concern or who have a family history of obesity, dyslipidemia, or CVD, the use of reduced-fat milk would be appropriate.
2. The individual approach for children and adolescents at higher risk for CVD and with a high concentration of LDL includes recommended changes in diet with nutritional counseling and other lifestyle interventions such as increased physical activity.
3. The most current recommendation is to screen children and adolescents with a positive family history of dyslipidemia or premature (less than 55 years of age for men and less than 65years of age for women) CVD or dyslipidemia. It is also recommended that pediatric patients for whom family history is not known or those with other CVD risk factors, such as overweight
(BMI 85th percentile, 95th percentile),
obesity (BMI 95th percentile), hypertension
(blood pressure 95th percentile), cigarette smoking, or diabetes mellitus, be screened with a fasting lipid profile.
4. For these children, the first screening should take place after 2 years of age but no later than 10 years of age. Screening before 2 years of age is not recommended.
5. A fasting lipid profile is the recommended approach
to screening, because there is no currently available noninvasive method to assess atherosclerotic CVD in children. This screening should occur in the context of well-child and health maintenance visits. If values are within the reference range on initial screening, the patient should be retested in 3 to 5 years.
6. For pediatric patients who are overweight or obese and have a high triglyceride concentration or low HDL concentration, weight management is the primary treatment, which includes improvement of diet with nutritional counseling and increased physical activity to produce improved energy balance.
7. For patients 8 years and older with an LDL concentration of less than than 190 mg/dL (or less than 160 mg/dL with a family history of early heart disease or 2 additional risk factors present or less than 130 mg/dL if diabetes mellitus is present), pharmacologic intervention should be considered. The initial goal is to lower LDL concentration to less than 160 mg/dL. However, targets as low as 130 mg/dL or even 110 mg/dL may be warranted when there is a strong family history of CVD, especially with other risk factors including obesity, diabetes mellitus, the metabolic syndrome, and other higher-risk situations.
Marilyn Mann
Atlex, in your paragraph 7, when you discuss the LDL cutpoints, you mean “greater than,” not “less than.”
The Times article is in error. The 190 cutpoint is for kids with no other risk factors. There are lower cutpoints for kids with risk factors.
These guidelines are similar to the AHA guidelines for kids with high-risk lipid abnormalities, published in Circulation last year.
Marilyn
Dan
Ed,
Informative post and comment, so thanks for educating me.
Statins may be appropriate for children if they have an innate lipid disorder. But it’s market expansion for any other reason.
pharma PR hack
Am I missing something here? Isn’t the whole Vytorin /Enhance debacle mainly because there really wasn’t a proven casuality but now we are going to sign kids up for statins?
Atlex
Marilyn,
You are correct. The blog software doesn’t take too kindly to greater than and less then symbols. I tried to convert them to words and mixed myself up. It should read:
7. For patients 8 years and older with an LDL concentration of greater than than 190 mg/dL (or greater than 160 mg/dL with a family history of early heart disease or 2 additional risk factors present or greater than 130 mg/dL if diabetes mellitus is present), pharmacologic intervention should be considered. The initial goal is to lower LDL concentration to less than 160 mg/dL. However, targets as low as 130 mg/dL or even 110 mg/dL may be warranted when there is a strong family history of CVD, especially with other risk factors including obesity, diabetes mellitus, the metabolic syndrome, and other higher-risk situations.
Thanks for noting that.
Atlex
Anne
So…instead of teach people to shop right and eat right, we want to drug the children. Lovely.
Robert McCart
Folks, we (and me personally) have been assaulted by a 20-billion dollar a year propaganda machine based on statins. First, the Oct. 3, 2006 issue of the “Annals of Internal Medicine” concluded that statin therapy to achieve proposed LDL Cholesterol was found to be of “NO BENEFIT” and “Not proved to be SAFE”. Big Pharma owns the FDA, AMA, and over half of our members of Congress. Dr. Stephen Daniels, who is on the nutrition committee of the American Academy of Pediatrics and is advocating for Statin use in in children, has also worked as a consultant for Merck & Co. (Zocor&Vytorin). Statins damage all users to a more or less degree but don’t take my word for it. There is a growing mountain of evidence showing Cholesterol is your body”s friend, not your enemy. Go on line and check it out before you allow your doctor to put you on statins. AND DON’T LET THEM PUT YOUR CHILDREN ON THEM.
Nathan
Robert: Please stop spreading mis-information. The article you refer to (Annals of Internal Medicin, 2006, pg 520) states clearly that “Clear, compelling evidence supports near-universal empirical statin therapy in patients at high cardiovascular risk (regardless of their natural LDL cholesterol values)”
You completely missed the point of the article: The point of the article is that titrating statins in order to bring cholesterol to a specific predetermined level DOES NOT have a proven clinical benifit. Here’s the quote: “No high-quality evidence could be found that suggests that titrating lipid therapy to recommended low-density lipoprotein (LDL) cholesterol targets is superior to empirically prescribing doses of statins used in clinical trials for all patients at high cardiovascular risk.”
Sam
I’m pretty appalled by this news. My own personal experience has been to be put on statin drugs as a result of a life insurance physical (another industry that incorrectly uses cholesterol levels to assign risk), in spite of the fact that my PCP and Cardiologist found me otherwise healthy, don’t smoke, and drink very little, and have no family history of CHD or heart attacks; I simply had higher than “normal” cholesterol levels. It was only after having suffered severe side effects common to statin drugs, along with just “feeling bad”, that I decided to question my medical providers. My PCP’s solutions was to switch me to another statin resulting in more severe side effects and my Cardiologist decided to go to scare tactics in order to keep me on them. I switched PCP’s and cardiologists twice and got the same “party line”. I had to simply accept that fact that all medical opinions are biased as far as this subject is concerned and conducted by own research. I lost a little weight, started taking flush free Niacin, and ate less of certain foods but otherwise continued as I have done throughout my life (i.e. I don’t make myself enjoy life less because of the latest bad news study from the medical industry) for no other purpose than to get my life insurance premiums under control. After about six weeks, my premium was assigned at a standard rate and I feel great. We’re all busy people and these so called experts publish these articles to keep us informed with convenient and easy to access information. But this issue of putting our children on statin drugs is too much for me to keep quiet. We all need to take some control, assume we’re intelligent, care about our own health, and invest the time to research this on our own. If you take the original study and Google each of the cited resources that were used by the authors of this ridiculous information, cross reference them with other reputable sources on the subject, I think you’ll find the connnection to CHD and cholesterol spotty at best and a clear connection with those that support the findings to the industries that stand to benefit financially from this news. Google the term “homocyctine” and “arterial inflammation”. All that’s left for you to figure out is what’s a healthy diet for you and what kind of exercise is the most benefit to you as opinions are vastly different based on what the source is trying to sell here as well. Most of this kind of information has no merit as far as I’m concerned as it follows a “one size fits all” theory and we’re all very different in the way our bodies work. You have to be smart and challenge the info. And I’m with Anne, we don’t need to drug our children even more than we do, especially since I’m of the mind that cholesterol has nothing to do with correctly assessing who dies of CHD. Just quit feeding your children junk and go play outside with them. Someday the medical profession with either come to their senses on this or we’ll see massive Vioxx like lawsuits after we’ve drugged people to death with statins.
Dave M
I am a prescriber and I am weary of the link between heart disease cholesterol levels and children. I am not sure we know how to best use the statins even in adults today? Which patients are the optimal candidates, how low to get your LDLs, what exactly is the “right” HDL to shoot for? These seem to change after each study. When I first started to practice there was no HDL.LDL-and you were WNL if your cholesterol was 260 or under.
We have come a long way and we do know that statins work, they DO keep people alive. They also have side effects.
I would not want to see every child with high cholesterol on a statin. Diet and exercise are much more important in kids and we don’t have the studies yet to show their effectiveness in cholesterol lowering. Those healthy habits have to be taught so kids can grow into healthy adults.
In children with significant history of familial hypercholesterol, I can see treatment. Diet and exercise may not help at all and these people have significant mortality and morbidity that may be able to be significantly decreased with the use of statins.
Dave Mittman, PA
Justice in MI
One of the things that I find impressive in Atlex’s summary of the guidelines that it is, indeed, titrated - not “one size fits all.” Undoubtedly, there are some number of kids with severe lipid disorders / risk factors/ fam hx, who _might_ benefit from statins.
At this point, I don’t think we have more than the barest idea what that number is. The issues of such potentially long-term use, what the benefit/risks really are, and the impact of the pediatric context specifically all remain essentially unknown.
How confident are people that the criteria as Atlex summarizes them under #7 would be strictly followed by docs? (Until and unless reliable studies suggested whatever revision of them.)
Dan
This whole discussion is based on a news story designed for sensationalism.
Many big pharma companies seek a peds indication on thier elderly blockbuster to artifically extend its patent life. Same thing is done with blood pressure drugs, as well as other classes of meds clearly designed for adult health issues that children are exempt from, in large part.
No doctor in thier right mind would prescribe a statin to a child.
Atlex
Justice,
Please note that I pulled the summary directly from the published guidelines except for making an edit to account for the “less than” and “greater than” signs.
I think, in general, pediatricians will likely follow these guidelines. They tend to be relatively conservative and may, in fact, be late to treat relative to the guidelines. Of course, we’ll have to watch this over the next few years to determine exactly what happens.
Atlex
Nathan
Dan,
The patent life extension applies whether or not the drug is APPROVED for pediatric use. The company gets an extension just for a clinical STUDY for pediatric use. It may or may not be in the best interest of the company to actually seek FDA approval for pediatrics.
In general, though, I agree with you: The possibily of a 6-month patent extension is the major driving force behind pediatric studies. But this is largely a GOOD thing! Without this patent life extension, many rare pediatric disorders would be completely without proven treatment.
Atlex
Nathan,
You are, of course, correct abot the 6 month excusivity extension. However, I think that Dan was implying that Big Pharma is behind the effort by the AAP so that they might reap billions of dollars in revenue by endangering unsuspecting fat kids. No one has mentioned, though, that the number of kids who actually need drug treatment according to the guidelines is likely relatively small and that their needs could be handled easily byuse of generic products (pravastatin and simvastatin). Thus, branded manufacturers have little incentive to drive these guidelines, except perhaps in the rare cases of kids suffering from extraordinarily high levels of LDL cholesterol.
Atlex
Justice in MI
Good points, Atlex. I think what will be worth watching is “guideline creep” - both officially, via permitted off-label communications, and everyday rx’ing - as well as whether, in one way or other, branded companies are able to tweak existing non-generics in ways that convince FDA that they are relevantly pediatric-specific.
One of the ironies here (which I also have felt about Gardasil, btw) is that the wider decline of confidence in the industry may hinder what is actually a very positive thing.
The industry itself can’t do much about that, at least as things now stand. But if they contribute to overreaching - which I believe Merck did with Gardasil/Women in Gov., etc. - they will play right into that hand.
Justice in MI
Related to above, I am “impressed” by the results of Ed’s poll. Whatever one says about the biases/assumptions of many Pharmalot readers, I’m not sure I recall a poll that was quite this one-sided.
Chris
The question has bias in it by using the qualifier ’small’ children.
Dr. Sal Giorgianni
I elect not to participate in the Pharmalot poll on this issue because it seeks a black or white answer to a question that can only be answered as “it depends” on the clinical circumstances.
Ed Silverman
Hi Folks,
I don’t pretend to be a professional pollster, but there was no intent to introduce any bias in the question. I used the word small for two reasons - space and because the paper referred to kids 8 and under, who I commonly refer to as small children. Anyway, the poll isn’t scientific or going to resolve a complicated situation. It’s simply an attempt to take a temperature reading.
Cheers
ed
Justice in MI
Agree with both points above. I considered abstraining for precisely the reasons Chris and Sal state. I didn’t, because I reframed the question in terms of what I would do if I had, say, a 10-year-old who met all the conditions that Atlex listed under his point #7.
Of course, that’s still a personal, not a policy, perspective. I answered “no” thinking of my own hypothetical 10-yr-old because I don’t believe we know enough about risk/benefits, long-term use, in pediatric contexts.. That is, as a parent, I would not be convinced that the size of the benefits were worth my child being, inevitably, a “guinea pig” (not fat intended), and understanding there may be a risk (small, in my view of current knowledge) of waiting at least until we had better ways of assessing actual athlerosclerosis in young adults.
This not entirely hypothetical. My wife, thin as a rail and athletic, comes from the wrong genes. Big bad numbers as a young adult. She started tx in her thirties (it was sequestrants and then niacin then). As shown in imaging, there is no sign of althlero at all.
So, based on what I know, and I think we know more generally, I would wait.
Atlex
Ed,
I do also have quibbles with your poll. Now that you have tried to explain it, I have even more concern. The guidelines themselves essentially mower the age group for possible drug treatment from 10 to 8. I don’t think that the guidelines address drug treatment below the ago of 8. Thus, your use of the term “small children” is misleading since your definition is below the age of 8.
Atlex
Just A Thought
My doctor keeps bringing up statins because my number is over 200. That number is really a bad basis for suggesting these drugs when my HDL is nearly 1/3 of my total. It is far too simplistic to pick an overall number and run with it. HDL to LDL ratios need careful consideration. As for fatty foods- I eat a much leaner diet than my hunny does yet I have the higher cholesterol and a MUCH better HDL/LDL ratio. I’m slim and weight is no contributing factor to my elevated overall number. A chubby kid needs cholesterol testing? Pleaseeee, how many kids have heart attacks? Baby fat is not evil and there is a good likelihood that it will be outgrown. Get them involved in some activities.
I believe that to give statins to kids would block needed cholesterol from doing it’s intended job of aiding nerve tissue, bile, and hormones. Cholesterol does serve many purposes (which is why every body produces it). It is a defense mechanism. Statins do nothing to cure the underlying cause of elevated cholesterol. If your bile ducts are blocked (you could be a redne…) statins are not going to do a thing to cure the problem, for instance.
Do kids need more cholesterol for the developement of their bodies?
This is not what I was looking for but close enough:
http://www.wellness-monitor-online.com/food-and-cholesterol.html
Ed Silverman
Sorry Atlex,
I misspoke before, or miswrote a few minutes ago. Yes, the papers refers to children between 8 and 10. What I meant to write in my last comment is that I refer to kids who are 10 and younger. Sorry about that.
ed
snugpharma
Dave M, we can see that diet and exercise is not having the desired effect on a significant amount of children. Got to try to be preventive. A cholesterol drug in a child’s dosage deserves consideration. How many docs do you know who have acceptable cholesterol levels insist on taking some sort of statins. Medicine will always have risk/reward ratio. Let’s face reality, the diet in the western world for us all including the children is unhealthy. You have to be practical about these facts.
Lisa Van S
Ahhhhh,… another Grand Marketing Plan,.. Yes?
Dr. Sal Giorgianni
Ed
I accept your coment that you are not a professional polster but I am sure you appreciate that in this IM-Generation the kind of poll you are doing as a well recognized journalist could be picked up by someone who doen’t really look at the finer points.
To those who criticize the suggestion of using statins in children as a mearly a marketing plan may I professionally suggest you need to look at the evolving data. It is very scary.
The need for these medicines in certian children may be for genetic dyslipidemias and dyslipiemias cause by poor eating and living habbits.
I venture an educated guess that 1000 years ago and likely 300 years ago diabetes or diabesity was not as rampant in childrend as it is now, nor was asthma. The fact of the matter is as our society changes the health care conditions we must treat change. Should children with type-2 diabetes not be treated because they are children (small or large)?
Justice in MI
I don’t think anyone disagrees with the notion of weighing risks/benefits in the context of what we know in general and what we know about a particular pt., (child or otherwise).
For me, rx’ing a statin to kids that young (8-10), even if they have all the relevant risk factors and bad numbers, seems fairly clearly dicier than not doing so. Once again, relative benefit/risk numbers, pediatric unknowns, and the unknowns of long-term use tip the scales for me that way.
Obviously, I could be wrong. But since my ten-year-old wouldn’t know enough to make such a decision for themselves, it is up to me to do so.
More broadly, I think the case _for_ such interventions needs to be considerably stronger than current data supports. Obviously, some parents will opt otherwise, and some docs will push otherwise.
We place our bets and take our chances.
For Just a Thought - I won’t “play doctor,” but it does sound like another opinion might be in order.
Justice in MI
Quick note to Sal - I think treating kids who already have a dx of diabetes 2 is a different issue than hyperlipdemia. There are immediate and present dangers in the first instance; there are, _relatively speaking_, potential dangers in the second. I am aware this is not an absolute distinction, but I believe it is a relevant one.
Also, this bit from the NYT article:
“Surprisingly, the paper published in the medical journal Pediatrics that explains the new guidelines notes that among adolescents, average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000.”
The decline in triglycerides in particular seems to suggest that a more complex picture of where we are than is often suggested.
Lisa Van S
Dr. Sal,
“look at evolving data”
Look and see how many children are on antipsychotics, then look at the antipsychotic adverse effects(Insulin resistant Diabetes, High Cholesterol). I call it an epidemic..
Ed Silverman
Hi Dr. Sal,
Point taken.
ed
Ed Silverman
Hi again,
Just to clarify any inadvertent confusion caused by my previous comments, the poll question, as I intended the wording, refers to children who 8 years old to 10 years old, which was clearly discussed in the story in the newspaper and in the medical journal.
Hope that helps,
ed
Anne
It’s been about 5 years since I’ve been on a statin. (I was in my 20s at the time and fairly slim, with a total in the 400s - it’s hereditary.)
If I remember correctly, statins showed an increased likelihood of birth defects if taken by women of childbearing age. This was a shaky link, since so few studies were conducted on females in their 20s and 30s. But it was enough for several doctors to recommend I stop taking it.
If that is still a concern, wouldn’t it also apply to girls in their 0s and 10s? I’m hesitant to increase risk of birth defects while the mothers themselves are still babies.
Vince
“We are in an epidemic,” Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta, tells the paper. “The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.” He adds that, while there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.
No data on the long term effects of giving statins to kids. Talk about test subjects. The severe financial conflicts on the board that came up with the original guidelines on LDL targets for adults has been well documented. Any idea of the financial conflicts on this group.
Ed Silverman
Hi Vince,
I’m aware that Stephen Daniels is or has been a consultant and advisory board member for Abbott Labs, which markets a cholesterol med. You can look here…
http://www.circ.ahajournals.org/cgi/content/full/111/15/1999/TBL4
Regards
ed
Laurie
This whole line of thinking is unbelievable. What about the livers of these small children? What does years of statin use do to the liver function that ADULTS are warned about? Again…no long term studies, no pediatric studies. Yes, the “recommended” guideline is for those with serious lipid problems, but we all know that off label use will result in a quick prescription for a kid who’s “screening” is slightly abnormal. Hopefully parents will have some common sense in this situation, but sadly we don’t see common sense all that often when it’s a doctor making a recommendation.
Marilyn Mann
I want to modify my comment from this morning where I said the AAP guidelines were similar to the AHA guidelines. The AAP guidelines discuss circumstances where “pharmacologic intervention should be considered,” but don’t specify what drugs should be used preferentially. The AHA guidelines, in contrast, endorse statins as first-line treatment. I agree with the AHA approach. Statins are the best drugs we have for dyslipidemia, so they should be used as first-line therapy.
In addition, I am disappointed that the AAP guidelines speak favorably of ezetimibe (Zetia). I do not think it is appropriate to use ezetimibe in kids when we do not even know if it works in adults.
Justice in MI
Whatever else, interesting that this was the lead story on ABC evening news tonight and one of the featured stories on PBS.
In general, my sense is that response to it has been a kind of Rorschach re: assumptions about the industry more generally. Even with all the reminders that the recs are not mainly about drug tx, that (as Atlex notes) name brands would probably not play a central role, the “conspiracy narrative” arises.
I genuinely doubt that this would have happened even twelve years ago (pre-97). If anything, the stories would have been greeted as interesting, and potentially important, good news.
Times, indeed, have changed.
Vince
From a Follow up article in todays Times
http://www.nytimes.com/2008/07/08/health/08well.html?th&emc=th 8-Year-Olds on Statins? A New Plan Quickly Bites Back ……….
“To be frank, I’m embarrassed for the A.A.P. today,” said Dr. Lawrence Rosen of Hackensack University Medical Center in New Jersey, vice chairman of an academy panel on traditional and alternative medicine. He added: “Treatment with medications in the absence of any clear data? I hope they’re ready for the public backlash.”
Doc
I think that the AAP has lost its mind. These children are growing and have not yet gone through puberty.
Lili
The problem with Ststins or any medication is that doctors are not monitoring the side effects. Statins are a very dangerous medication and the pharmaceuticals could not care less if you have serious side effects. The doctors do not report the side effects and statins cause organ failure that leads to death. Rhbadomyloysis! Beacuse doctros do not report and not subject too, there is not any evidence of how many people have Rhbadomyolysi and Peripheral Neuropathy from Statins. Clinicial Trials does not account for long term use with Statins or any other medications. We need relieable research and truth and honesty in medicine.
Atlex
Lilli,
There is absolutely no data to support your position. The supposed lack of physician reporting doesn’t make a difference. There are many long-term clinical and, probably more important, numerous retrospective analyses that of very large patient databases that demonstrate the general safety of statins and the significant benefits of treatment. One might be able to argue about which patients types are appropriate for treatment, but there is no doubt about the general safety of the statins currently on the market, particularly when compared to their benefits.
Atlex
Justice in MI
Atlex - At core I agree with what you write. But how do _you_ understand the Baycol saga? Clearly (so it seems to me), Bayer was able to run the string for a few years through spin, delay, denial, and suppressed internal studies. Eventually, they ran out of places to hide. But it took a few years, and it took a few people with them.
So, while I would not generalize to statins as a whole, there are clearly instances that support Lilli’s contention that “truth and honesty” really do make a difference, and all those studies are _not_ enough - in themselves - to keep us/docs informed.
They make a helluva difference if your life happens to be part of someone else’s “cost of doing business.”
Atlex
JiM,
Note that I specifically stated “statins currently on the market.” Except, perhaps, for Crestor, all statins on the have long term safety records worldwide. Certainly Bayer did its best to hide data, but the product was still relatively new to the market when it became evident to outsiders that something was amiss. The other products have been scrutinize by many, many 3rd parties which have continued to demonstrate broad general safety.
Atlex
Justice in MI
Atlex - Yes, I was aware of your phrasing which is why I framed my comment as did — those circumstances (specific but, in my view, not trivial) when Lilli’s perspective was, indeed, of direct relevance.
DaisyPatch
On another topic - wish the guidelines contained a reference to supplementing the children’s statin dosage with coenzyme Q10.
DaisyPatch
Margaret
Anyone bother to look at their evidence for these guidelines?
What these bozos have done is make the wild assed assumption that if you use measures used in adults for secondary prevention of CVD in children it will prevent future CVD without shred of evidence that the proposed strategy has more benefit than harm. All of the evidence cited in their report was either from studies on adults or children with FH (genetic familial hypercholesterolemia) and none on norml healthy children.
Primary prevention strategies in adults haven’t proven very successful so - what the hell - let’s try it on our children anyway?
The people who wrote these guidelines are nuts, and any doc that follows them is braindead.