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  #1   ^
Old Mon, Sep-11-17, 03:52
teaser's Avatar
teaser teaser is offline
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Default statins vs. heart disease death

https://www.sciencedaily.com/releas...70906170427.htm

Quote:
Statins reduce deaths from coronary heart disease by 28 per cent in men, according to longest ever study

The study, by Imperial College London and University of Glasgow, focused on men with high levels of 'bad' cholesterol and no other risk factors or signs of heart disease.

Previous research has shown the benefit of statins for reducing high cholesterol and heart disease risk amongst different patient populations. However, until now there has been no conclusive evidence from trials for current guidelines on statin usage for people with very high levels of low density lipoprotein (LDL) cholesterol (above 190mg/dL) and no established heart disease.

After studying mortality over a 20-year period, researchers led by Professor Kausik Ray at Imperial showed that 40mg daily of pravastatin, a relatively weak type of statin, reduced deaths from heart disease in participants by more than a quarter.

Senior author Professor Ray from Imperial's School of Public Health said: "For the first time, we show that statins reduce the risk of death in this specific group of people who appear largely healthy except for very high LDL levels. This legitimises current guidelines which recommend treating this population with statins."

In addition, the findings challenge current approaches on treating younger patients with LDL elevations with a 'watch and wait' approach. Instead, the authors say even those with slightly elevated cholesterol are at higher long term risk of heart disease, and that the accumulation of modest LDL reductions over time will translate into large mortality benefits.

Professor Ray added: "Our findings provide the first trial-based evidence to support the guidelines for treating patients with LDL above 190mg/dL and no signs of heart disease. They also suggest that we should consider prescribing statins more readily for those with elevated cholesterol levels above 155 mg/dl and who also appear otherwise healthy."

The paper is published in the journal Circulation. It follows on from a five-year 1995 study in which researchers observed the long-term effects of statins on patients involved in the West of Scotland Coronary Prevention Study (WOSCOPS) trial. The researchers took into account the original five-year study and followed the patients for a further 15 years.

The WOSCOPS study provided the first conclusive evidence that treating high LDL in men with pravastatin for five years significantly reduces the risk of heart attack or death from heart disease compared with placebo. Statins were subsequently established as the standard treatment for primary prevention in people with elevated cholesterol levels.

Now, researchers have completed analyses of the 15-year follow up of 5,529 men, including 2,560 with LDL cholesterol above 190 mg/dL of the original 6,595, chosen because they had no evidence of heart disease at the beginning of the present study.

Participants were aged 45-64 years. During the five-year initial trial they were given pravastatin or placebo. Once the trial ended the participants returned to their primary care physicians, and an additional 15-year period of follow-up ensued.

The 5,529 men were split into two groups: those with 'elevated' LDL (between 155 and 190mg/dL) and those with 'very high' LDL (above 190mg/dL). The standard 'ideal' level of LDL for high risk patients is below 100mg/dL, but this varies depending on individual risk factors.

The researchers found that giving pravastatin to men with 'very high' LDL reduced twenty year mortality rates by 18 per cent. Statins also reduced the overall risk of death by coronary heart disease by 28 per cent, and reduced the risk of death by other cardiovascular disease by 25 per cent among those with very high LDL cholesterol.

The 15-year follow up also meant the researchers could compare patients' original predicted risk of heart disease with actual observed risk. According to the risk equations to for cardiovascular disease, 67 per cent of patients included in the WOSCOPS trial with LDL above 190mg/dL would have less than a 7.5 per cent risk of heart disease by year ten, and thus would not have been treated with statins based on that risk. However, the present study shows that in fact, this group actually had a 7.5 per cent risk by year five, and meaning their ten year risk was 15 per cent. Following statin therapy, this group's ten year risk was reduced compared with those that were given placebo during the trial.

The authors say today's findings provide the first direct randomised trial evidence to confirm that current guidelines should stand as they are for those with very high LDL, and those with LDL levels above the 190mg/dL threshold should be considered for statin therapy without risk assessment, as the LDL elevation provides enough risk on its own.

Professor Ray said: "This is the strongest evidence yet that statins reduce the risk of heart disease and death in men with high LDL. Our study lends support to LDL's status as a major driver of heart disease risk, and suggests that even modest LDL reductions might offer significant mortality benefits in the long-term. Our analysis firmly establishes that controlling LDL over time translates to fewer deaths in this population."


http://circ.ahajournals.org/content...NAHA.117.027966

Quote:
Abstract

Background—Patients with primary elevations of LDL-C ≥190 mg/dL are at a higher risk of atherosclerotic cardiovascular disease as a result of long-term exposure to markedly elevated LDL-C levels. Therefore, initiation of statin therapy is recommended for these individuals. However, there is a lack of randomised trial evidence supporting these recommendations in primary prevention. In the present analysis we provide hitherto unpublished data on the cardiovascular effects of LDL-C lowering among a primary prevention population with LDL-C ≥190 mg/dL.

Methods—We aimed to assess the benefits of LDL-C lowering on cardiovascular outcomes among individuals with primary elevations of LDL-C ≥190 mg/dL without pre-exiting vascular disease at baseline. We carried out post-hoc analyses from the West Of Scotland Coronary Prevention Study (WOSCOPS) randomised, placebo-controlled trial, and observational post-trial long-term follow-up, after excluding individuals with evidence of vascular disease at baseline. WOSCOPS enrolled 6595 men aged 45-64 years, who were randomised to pravastatin 40 mg/d or placebo. In the present analyses, 5529 participants without evidence of vascular disease were included, stratified by LDL-C levels into those with LDL-C <190 mg/dL (n=2969; mean LDL-C 178±6 mg/dL) and those with LDL-C ≥190 mg/dL (n=2560; mean LDL-C 206±12 mg/dL).The effect of pravastatin versus placebo on coronary heart disease (CHD) and major adverse cardiovascular events (MACE) were assessed over the 4.9-year randomised-controlled trial phase and on mortality outcomes over a total of 20-years of follow-up.

Results—Among 5529 individuals without vascular disease, pravastatin reduced the risk of CHD by 27% (p=0.002) and MACE by 25% (p=0.004) consistently among those with and without LDL-C ≥190 mg/dL (p-interaction >0.9). Among individuals with LDL-C ≥190 mg/dL, pravastatin reduced the risk of CHD by 27% (p=0.033) and MACE by 25% (p=0.037) during the initial trial phase and the risk of CHD death, cardiovascular death and all-cause mortality by 28% (p=0.020), 25% (p=0.009) and 18% (p=0.004), respectively, over a total of 20-years of follow-up.

Conclusions—The present analyses provide robust novel evidence for the short and long-term benefits of lowering LDL-C for the primary prevention of cardiovascular disease among individuals with primary elevations of LDL-C ≥190 mg/dL.


Okay, so you do a five year study with statins. Over the five years, there's less heart disease. You return patients to their family doctors. The intervention is over.

You now have two groups, one has been established to have a higher rate of heart disease. One thing that's very predictive of future heart disease is pre-existing heart disease. Once you've established these groups, one with higher heart disease than the other--even if the intervention ends, even if their treatment going forward is likely to be roughly the same, the family doctor is likely to put them on statins, not continue their placebo treatment, if that's what they had before. It seems to me that once a group with higher heart disease is established, the probability that that pattern will continue is high. Less cardiovascular disease in five years being followed by less cardiovascular death going forwards isn't really astonishing.
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  #2   ^
Old Mon, Sep-11-17, 06:27
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JEY100 JEY100 is online now
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Study was funded by Sanofi S.A. A French multinational pharmaceutical company and was originally funded by Bristol-Myers Squibb and Sankyo, also producers of statins. Not that I want to delve into it, but believe this is relative risk, though still has an absolute risk of 2%....as long as you can tolerate the side effects for 20 years. And you have to be a man with "very high" LDL.
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  #3   ^
Old Mon, Sep-11-17, 06:37
teaser's Avatar
teaser teaser is offline
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Thanks Janet. Not shocked. One thing I found funky;

Quote:
"For the first time, we show that statins reduce the risk of death in this specific group of people who appear largely healthy except for very high LDL levels. This legitimises current guidelines which recommend treating this population with statins."


I know it's in his best interest to make the study seem as significant as possible--but in doing so, he's pretty much bashed the idea that outside of this one study, there's much of anything to "legitimize" current statin guidelines. This is actually quite the admission.
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  #4   ^
Old Mon, Sep-11-17, 09:57
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GRB5111 GRB5111 is offline
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What is alarming is that the studies (initial 5-year and subsequent 15-year) are based on the assumption that anyone with LDL-C above 190 mg/dL is at risk. And over time, the level of LDL-C considered dangerous is being lowered. More and more we're learning that LDL-C is not a valid health marker for CHD. Just as we've learned that total cholesterol is no longer a valid health marker. So, you generate data based on a questionable health marker from studies funded by the very pharmaceutical companies who have a vested interest in an outcome for promoting statins. Sorry for stating the obvious, but we live in a crazy world when no one is willing to challenge these findings, other than those of us who have interest in reading and researching this stuff. And the physicians who can prescribe these medications fall in line and continue to do so based on relative risk data. Unbelievable, but true.

Yesterday, I was again in the car listening to Doctor Radio on XM (yes, I am a glutton for punishment), and I heard a cardiologist describing the dangers of high blood pressure and how it causes stroke, heart disease, and other bad health situations, and all I could do is wonder, well, what causes high blood pressure, and isn't it simply another symptom correlated with stroke, heart disease, and other bad health situations? We no longer seek to find the root cause that could be the reason for a variety of symptoms. Again, I'm stating the obvious, but we've lost our ability to think about how all these symptoms being much more frequent and common since the late 1970s came to be. What has changed since then? I believe a few of us know or at least have a reasonable hypothesis.
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  #5   ^
Old Mon, Sep-11-17, 13:14
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JLx JLx is offline
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Quote:
I heard a cardiologist describing the dangers of high blood pressure and how it causes stroke, heart disease, and other bad health situations, and all I could do is wonder, well, what causes high blood pressure, and isn't it simply another symptom correlated with stroke, heart disease, and other bad health situations? We no longer seek to find the root cause that could be the reason for a variety of symptoms.


A friend and I used to walk our dogs together every day and when I moved she said she had to go back on her blood pressure meds because she didn't walk as far or as fast without me. It's too bad that doctors don't "prescribe" a half hour of somewhat brisk walking daily - for various reasons. Simple walking also compared favorably with Zoloft for depression in a Duke University a while back, for instance.

I joined a weight loss group last year and was rather shocked to find that most members do no form of exercise and ALL of them still eat sugar! Including the diabetics.
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  #6   ^
Old Sun, Oct-29-17, 05:12
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JEY100 JEY100 is online now
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Uffe Ravnskov rips this one to shreds...that is, if he could penetrate the obfuscated data. Good links in the article. Can also find rebuttals in the BMJ.

http://www.ravnskov.nu/october-2017...d-us-purposely/

Quote:
Yet Another Proof that the Statin Supporters Mislead us Purposely


KasteThere is an increasing understanding among medical researchers that statin treatment of healthy people with high cholesterol, so-called primary prevention, is without any benefit. The first trial that only included healthy people was WOSCOPS, the outcome of which was published in 1995. Since then millions of healthy people with high cholesterol have been treated with statins because its results were highly exaggerated. In the summary of the paper for example you can read that the number, who have died after five years treatment was 22 % lower among the treated than the untreated.

This figure, the relative risk reduction, is misleading, to put it mildly. As 106 of 3302 participants (3.2%) died in the treatment group and 135 of 3293 participants (4.1%) died in the control group after five years treatment, the absolute risk reduction was only 0.9 percentage points. You could also say that to prolong the life of one individual during five years, you have to treat 114 healthy people. The difference of 0.9% (4.1-3.2) was not even statistically significant, which means that it could have been a coincidence.

However, as the difference of 0.9% is 22% of 4.1 (the number of deaths among the untreated), the authors used that figure, the relative risk reduction, instead.

Recently a 20-year-follow-up study of the participants in the WOSCOPS trial was published. Here the authors claimed that their analysis had provided “robust evidence” for the short and long-term benefits of lowering LDL-cholesterol (the “bad” one) in healthy men; in particular among those with high LDL-cholesterol. For instance, during these twenty years all causes of mortality were lowered by up to 28% and with statistical significance.

They had of course, as almost all authors of the statin trials do, calculated the relative risk. The absolute risk reduction was only a few percentage points, and in most types of mortality without statistical significance.

But to find the relevant figures in that study is difficult, because its design is utterly complicated, Together with a supplement the paper consists of more than 60 pages filled with dozens of complicated figures and tables including thousands of statistical calculations; an effective method to prevent readers to continue after having read the abstract.

Hitherto many reports about the follow-up study have been published all over the world in various newspapers or on scientific websites, and with optimistic comments. In Telegraph for insyace (“Millions of people in their 20s and 30s should be offered statins”), in The Times (“Statins Cut Heart Deaths by 28%”) and in Daily Mail (“Statins DO work”). You can read more about that in Justin Smith´s newsletter. (Justin is one of the few medical journalists who have realized that the cholesterol campaign is the greatest medical scandal in modern time He has just started a campaign – Dont let STATINS break your heart).

Obviously none of the many optimistic reporters of the follow-up study have understood the difference between relative and absolute risk. And there was even a more serious error.

To evaluate the possible benefit of a drug in a trial it is necessary to compare two groups of participants. One of the groups receive the drug under investigation; the other group receive a placebo; a pill without any effect. And when it is time for evaluation of the result, you must of course know to which group the participants belong and whether they have taken the drug. The latter is of particular importance if you are studying the effect of a statin drug, because due to its many unpleasant side effects, many patients stop the treatment. This has been documented in a Canadian study including more than 140,000 elderly patients. Two years after they had been prescribed the statin drug, more than half of them had discontinued the treatment

But the authors of the follow-up study have ignored these elementary preconditions. On page 4 in the supplement you can read that…

Following the final randomised trial visit, pravastatin and placebo were withdrawn and patients returned to their primary care physicians. At 5 years after the completion of the randomised trial 38.7% and 35.2% of patients originally allocated to pravastatin and placebo arms, respectively, were taking statins. No later data on the proportion of individuals taking statin therapy were available for the subsequent years of follow-up,

Thus, the authors did not know whether the participants had been on statin treatment or not during the follow-up period. There is no “robust evidence”. The paper is simply an attempt to fool the medical world.

But of course, the authors are well paid by the drug industry. With one exception (the main author) all of them have several financial conflicts with Big Pharma. One of them has been supported financially by 21 various drug companies.

The reason why fewer had died among those with the highest LDL-cholesterol is hardly due to statin treatment, because, as we have documented in a recent study, elderly people with the highest LDL-cholesterol live the longest; even longer than those on statin treatment. The reason is most likely that LDL partake in the immune system by inactivating all kinds of bacteria and virus.

Evidently, no one seems to have observed the authors´ deliberately misleading information. Together with ten international experts I therefore sent a short comment to British Medical Journal, and Professor David Diamond sent a more detailed comment together with Dr. Malcolm Kendrick and Dr. Luca Mascitelli, all of whom are members of THINCS.

Those of you who have read my previous newsletters know that statin treatment is just as ineffective when used by patients who ave suffered from heart disease or stroke (secondary prevention) , and many researchers have also realized that. But as long as the ”experts” do not change their mind, nothing will happen, and the health of millions of people on statin treatment all over the world is in danger.
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  #7   ^
Old Sun, Oct-29-17, 08:54
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GRB5111 GRB5111 is offline
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Excellent analysis by Dr. Ravnskov. These finding should be ripped, and people must be made aware of this travesty. My doctors either are not aware of this issue (most likely because unless one is a statistician, there is no way someone is willing to wade through this and identify the fallacies and they'll happily take the results from the drug companies) or they're ignoring it and going with the medical expert status quo due to their flocking mentality. I'll give my doctors the benefit of the doubt, and it all means the as individual patients, we must double down on doing our own research and increasing our own awareness to protect our own good health.

Dr. Uffe Ravnskov's book, "The Cholesterol Myths: Exposing the Fallacy that Saturated Fat and Cholesterol Cause Heart Disease" is a great resource for those interested in a deeper dive on this issue. The great news? It's now selling for just $0.99 in Kindle version on Amazon!!!
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  #8   ^
Old Sun, Oct-29-17, 09:51
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Ambulo Ambulo is online now
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Thank you, I have just bought this book from Amazon UK for £0.99
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  #9   ^
Old Fri, Dec-29-17, 04:56
JEY100's Avatar
JEY100 JEY100 is online now
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Plan: P:E/DDF
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In older adults (>65..it's science...I’m officially old ) there is no benefit to statin treatment vs usual care, with even a non-significant increase in all cause mortality. This was for primary prevention, no evidence of CVD at start.

Yet, if you run the current risk calculator most men over 65 and many women will end up with a "risk factor" that results in a statin prescription.

Quote:
Effect of Statin Treatment vs Usual Care on Primary Cardiovascular Prevention Among Older Adults
The ALLHAT-LLT Randomized Clinical Trial

Key Points
Question Are statins beneficial when used for primary cardiovascular prevention in older adults?

Findings In this post hoc secondary analysis of older adults in the randomized clinical trial Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial–Lipid-Lowering Trial (ALLHAT-LLT), there were no significant differences in all-cause mortality or cardiovascular outcomes between pravastatin sodium and usual care for primary prevention for adults 65 years and older.

Meaning No benefit was found when a statin was given for primary prevention to older adults. Treatment recommendations should be individualized for this population.

Abstract
Importance While statin therapy for primary cardiovascular prevention has been associated with reductions in cardiovascular morbidity, the effect on all-cause mortality has been variable. There is little evidence to guide the use of statins for primary prevention in adults 75 years and older.

Objectives To examine statin treatment among adults aged 65 to 74 years and 75 years and older when used for primary prevention in the Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).

Design, Setting, and Participants Post hoc secondary data analyses were conducted of participants 65 years and older without evidence of atherosclerotic cardiovascular disease; 2867 ambulatory adults with hypertension and without baseline atherosclerotic cardiovascular disease were included. The ALLHAT-LLT was conducted from February 1994 to March 2002 at 513 clinical sites.

Interventions Pravastatin sodium (40 mg/d) vs usual care (UC).

Main Outcomes and Measures The primary outcome in the ALLHAT-LLT was all-cause mortality. Secondary outcomes included cause-specific mortality and nonfatal myocardial infarction or fatal coronary heart disease combined (coronary heart disease events).

Results There were 1467 participants (mean [SD] age, 71.3 [5.2] years) in the pravastatin group (48.0% [n = 704] female) and 1400 participants (mean [SD] age, 71.2 [5.2] years) in the UC group (50.8% [n = 711] female). The baseline mean (SD) low-density lipoprotein cholesterol levels were 147.7 (19.8) mg/dL in the pravastatin group and 147.6 (19.4) mg/dL in the UC group; by year 6, the mean (SD) low-density lipoprotein cholesterol levels were 109.1 (35.4) mg/dL in the pravastatin group and 128.8 (27.5) mg/dL in the UC group. At year 6, of the participants assigned to pravastatin, 42 of 253 (16.6%) were not taking any statin; 71.0% in the UC group were not taking any statin. The hazard ratios for all-cause mortality in the pravastatin group vs the UC group were 1.18 (95% CI, 0.97-1.42; P = .09) for all adults 65 years and older, 1.08 (95% CI, 0.85-1.37; P = .55) for adults aged 65 to 74 years, and 1.34 (95% CI, 0.98-1.84; P = .07) for adults 75 years and older. Coronary heart disease event rates were not significantly different among the groups. In multivariable regression, the results remained nonsignificant, and there was no significant interaction between treatment group and age.

Conclusions and Relevance No benefit was found when pravastatin was given for primary prevention to older adults with moderate hyperlipidemia and hypertension, and a nonsignificant direction toward increased all-cause mortality with pravastatin was observed among adults 75 years and older.


https://jamanetwork.com/journals/ja...1?redirect=true

Ted Naiman shared this and a chart from the full text at Twitter.
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  #10   ^
Old Wed, Jan-24-18, 06:37
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JEY100 JEY100 is online now
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Plan: P:E/DDF
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More on the Statin Wars.

MaryAnne Demasi has a new article in the BMJ, which is behind a paywall, but Michael West has interpreted it in lay terms.

https://www.dietdoctor.com/statin-w...lucrative-drugs

Quote:
Cholesterol-lowering statins are among the most profitable drugs ever. They can help protect people with heart disease from new heart attacks. But should they be taken even by healthy people, hundreds of millions of people without heart disease? That’s what the guidelines currently say, but there are some serious issues involved.

Should we simply trust statin studies, when most are paid and conducted by the pharmaceutical companies who sell the drugs? Studies where the raw data on effects and side effects are being kept secret, to stop independent researchers from seeing it? And finally, when these studies are interpreted and judged by expert panels, full of people that are paid by the same pharmaceutical companies?

Here’s a new narrative review by science journalist Maryanne Demasi, followed by a two-part adaptation of the paper in lay terms:

British Journal of Sports Medicine: Statin wars: have we been misled about the evidence? A narrative review
Statin Wars: secrecy and the world’s most lucrative drugs
Statin Wars: how Big Pharma infiltrates governments and the medical profession
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  #11   ^
Old Mon, Jan-29-18, 18:04
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Merpig Merpig is offline
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When I'm out and about I usually listen to NPR radio in the car. If it's a Sunday afternoon I sometimes catch the program "Dr. Zorba Pastor on your Health". Most of the time I enjoy it but some things make me freak - like the episode where he said Dr. Atkins died of a heart attack when someone called asking about a LC diet.

So I know he's low fat devotee based on his weekly recipes, but I ignore that part of the show. But yesterday he had a woman call in who has 2 children who are both T1 diabetics - a boy of 17 and a girl of 12. Her doctor wanted to put them both on statins as they each had elevated cholesterol, but she was worried about something like that for such young children.

Well Dr. Zorba did feel the evidence was not in to start someone as young as her daughter on statins. But he was totally on-board with the son going on statins as soon as he turned 18. He went on for quite some time about what a "wonder drug" statins are, and that heart attacks/deaths (? can't recall exactly) have dropped by 75% since statins came into common use. The mother was worried about such young children being on such drugs for life - but he seemed to feel this was the absolute best thing they could do, and that EVERY diabetic, regardless of cholesterol levels, should be on statins. He finally seemed to have convinced the mom that this would be in her childrens' regimens forever and what a blessing that would be.

I may have to start turning off the radio when his program comes on in the future!
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  #12   ^
Old Sun, Dec-09-18, 04:47
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JEY100 JEY100 is online now
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Another new study from the statinators at Imperial College London, and response by the producer of "Statin Nation" film.
https://forum.lowcarber.org/showthread.php?t=481689

Both the Statin Nation films are available on DietDoctor to members.
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