Cholesterol lowering drugs.

reply to post by punterdeb


S+F for a wonderful illumination.
I will keep this in mind if ever. . . . .

Originally posted by unityemissions

Originally posted by ANNED
I don't believe the side effects i had from niacin.

Intense itching from head to toes and i mean bad. Benadryl did nothing for the itching.

This is related to your natural histamine level. If it is high normal or in the high range, you will likely have this itching as the niacin causes the release of excess histamine. It will receed after a few days of your body learning to adapt. Another way of having the itch be minimal while you transition is to take the form: inositol-hexanicotinate. This form has 6 niacin molecules bonded to inositol, and slowly breaks away in your bloodstream as the day progresses.

edit on 20-1-2011 by unityemissions because: worms in me brains!!!!!!!!!!

While they probably won't experience any of the flushing symptoms associated with standard niacin use, it's also very unclear whether this form of niacin, usually marketed as "no-flush niacin" is even effective at achieving the lipid improvements we normally experience with standard niacin therapy (decreased LDL, TG, increased HDL).

Here's one interesting case study: "Flush-Free Niacin": Dietary Supplement may be "Benefit-Free"

Bottom line: if you want to use an OTC niacin supplement you can get the established benefit while also reducing the associated flush by just taking an aspirin ~30mins before your niacin dose. Plus as unity pointed out the reaction usually dissipates after a few days to a week for most patients as they become stabilized.

Originally posted by LuckyOscar
reply to post by punterdeb

 

I'm sorry to hear about your experience. It's always disappointing to hear of someone having to stop drug therapy because of a side effect that was serious or could not be tolerated reasonably.

From your story it sounds like you were generally unaware of the potential side effects, was that the case? I ask because muscle pain/fatigue is the most common side effect of statin medications - occurring in about 2-12% of patients - and I would have assumed (maybe more aptly put hoped) your prescribing physician would have informed you of this and other side effects and would have specifically told you to monitor for signs of muscle pain.

Also, and of course only if you feel comfortable discussing it - might I ask what alternatives your physician offered you when you presented the muscle related side effects to them? Did they want to switch you to another statin (like Lipitor, or simvistatin)? Or did they discuss changing to a different drug class?

Thanks for sharing your story.

hi oscar,

this was the first time i have ever really had a side effect from a prescription drug. i had no idea of the side effects at all. my doctor never ever mentioned it. i did what i usually do when taking a new med. i scanned through the info pamplet but didnt really read it. i know the usual to look for if you have a severe reaction like hives or throat swelling. but my dr never said a word, which was upsetting because he has been the family dr for over 20 years. when he put me on it the second time i told him what had happened before and he really just dismissed it. which is the thing that worries me as if patients go to him with muscle fatigue he is not putting the two and two together.

I haven't read anything that great about using statins to lower cholesterol. I did read that a study conducted in Israel and repeated with similar results showed that 1.5 oz of pomegranate juice a day (preferably before meals) reduced the amount of buildup in the arteries a very significant percentage. This percentage I read even improved after taking it for a whole year. I found a more concentrated brand in Walmart (so many drinks claim they have it but it's often far down the list of ingredients so that is only a small percentage). I don't like the taste too much so I mix it with an equal amount of blueberry juice. I read if you drink it before you eat, it can reduce blood sugar levels. I also read drinking it on a regular basis can reduce LDL levels. I thought I had more energy after drinking it for a few weeks.

Disclaimer: This is not a claim to any medical benefits or advice. It is just my personal opinion about something I read.

Plus I know of a couple people I told this too have experienced lower LDL levels without changing anything else. Now if you don't exercise, gain weight, or start eating worse, your LDL levels may increase anyway. I thought I would share this information. I read something about what someone was claiming was the real risk when it comes to heart attacks but I forgot the information. I plan on checking my emails and finding that information again.

If your doctor is recommending taking statins or you are already using them, I am not recommending changing anything. A relative of mine is taking them after her heart attack. She is also drinking a little bit of the juice I mentioned and she is still getting around.

Oh, I read in the study they drank 1.5 oz a day. I often put a little bit of juice in my glass, then equal part of blueberry juice to change the taste and drink it before breakfast and supper. I'm often at work for lunch so I don't drink any then. I was wondering if you drank more than 1.5 oz a day if that would have bigger benefits. I don't know.

I did an internet search for this. I found results here.
www.livestrong.com...

www.amazing-pomegranate-health-benefits.com...

Oh yeah...Statins work....

They work for MEN who've had previous heart complications and have high cholesterol. Not wormen. And not for generally healthy people with elevated cholesterol levels.

BTW, according to the data, a whopping 1 man out of 100 has his life saved by statins. Pretty weak statistic...

Originally posted by LuckyOscar

Originally posted by unityemissions
reply to post by bozzchem

 

Fully agree with you on this one. Niacin is the only nutrient that not only lowers ldl, and raises hdl, but it also lowers the risk of mortality following a heart attack. Statins actually increase mortality risk!!

edit on 19-1-2011 by unityemissions because: (no reason given)

FALSE - Statins do NOT increase mortality. Please provide a link to a clinical trial that proves this assertion.

I retract my statement. While I see some instances that indicate higher incidences of cancers, it seems these made be idiosyncratic reactions. After going through a meta-analysis report, there doesn't seem to be an increased risk overall.

As a physician, I can assure you that your assumption is correct, and your are a person that should not take statins again. Unfortunately, many other enzyme systems in the body are closely enough related that they are affected by the medications meant to act primarily within the liver. There are a certain number of people whose bodies simply do not toletate statings.

Nevertheless, the statin drugs are wonderful for those people who do not experience these side effects.

Think about Penicillin, for example. It is still an affective drug for Strep, as well as most Gram Positive bacteria. However, if you are a person with a Penicillin allergy, that same medication could cause such a severe reaction that the person's life could be at risk. Because of those with Penicillin allergies, should we take it off the market even for those that have no such allergy?

Look even at peanuts. There are those that are so sensitive to peanuts that even a single teaspoon could cause a severe enough allergic reaction to kill them. Again, should we remove peanuts, everything with peanut oil, and even peanut butter (which I love), from the market? Not likely.

This is but one more example of why the "cookbook" type of medical practice still requires adequate judgment from the physician. There are some who had adverse effects to earlier stating that may tolerate the newer ones, such as Crestor. Still, there are a great many patients who will react to ANY statin drug, and must avoid them all.

Niacin is a wonderful substitute for many. Sadly, there is no perfect medication, though. Flushing of the skin and itching is a FREQUENT side effect, causing most patients to not tolerate the medication in the long term.

Red yeast rice is even an adequate substitute for cholesterol for a small percentage of the population. Omega fatty acids, especially Omega-3, found in fish, fish oil, flax, flax oil, and a number of other sources, can assist in cholesterol control, as well as to decrease "foam cell" formation, which plays a key role in early plaque formation within arteries.

I just wanted to provide a physician's viewpoint to the discussion.

reply to post by Truth1000





i thank you for your reply. i agree with you that it is a drug that can be of use to people who dont have a reaction to it.

my only problem with the drug and the reason that i posted is that the main side effect of this drug is not widely known. until i just happened to hear the doctor on the radio, i had never heard of it. and i work in the medical field. maybe its was just that i wasnt listening, i dont know but i dont think so.

the problem i think is that the side effect of pain and lethergy is so easy to be put down as just age or whatever by the core group of patients that take it. you really dont get many under the age of 40 on statins. in my case, it came on slowly over a period of time. its not like the side effect is something that really stands out. like it doesnt turn your nose green or something like that. its so easy for people in the age group of 40 and 50 to put these symptoms down to, well we are getting older now and that sport we played in our younger years is now catching up with us in the knees and the legs. in my case it was that i thought the physical job that i do was just getting too much for me. how many thousands and thousands of people out there are in the same boat? how many other things are being misdiagnosed because of statins. like the depression that comes from the aches and pains, are these people then put on depression medication?.....i dont know. are there people who have given up their passions like gardening and maybe even boating because they think im too old for this now, the body wont let me do this anymore. maybe im wrong but i can see thousands out there like me who too lie in the bath with salts and radox trying to ease their tired muscles and get relief. are there many people who are having knee and hip replacements because of the pain?......i dont know.

i would love to see a targeted survey on patients who take statins specifically looking for this side effect. i think the figures of those who cant take it would sky rocket through the roof. if you had of asked me while i was on did i have any side effects i would have said no. it was not till i specifically heard that that is what it can cause did i put two and two together.

just one last thing, it seems as though with everyone i have talked to, after ceasing taking the statins, we all seem to pretty much return to normal within about 6 weeks, so would it therefore cause much damage if people ceased taking the statins to see whether they are in this group. under there doctors care of cause. does the benefit outway the risk?????

reply to post by punterdeb


CoQ-10

Statins inhibit CoQ-10 production...which leads to pain and lethargy. If you absolutely have to take a statin, and the only people that should even consider taking them are middle-aged men with a previous cardiac event, supplement with CoEnzyme Q-10.

Originally posted by DevolutionEvolvd
Oh yeah...Statins work....

They work for MEN who've had previous heart complications and have high cholesterol. Not wormen. And not for generally healthy people with elevated cholesterol levels.

INCORRECT - statins have been proven to be effective for Men and Women in not only improving lipid profiles, but also in lowering the incidence of cardiac events like MI and Stroke, and in decreasing cardiac death and all-cause mortality. Furthermore, statins have been shown to be effective even in apparently healthy individuals who weren't even classified as high-risk based on their lipid panels.

Are Statins Effective In Apparently Healthy Individuals With Low LDL-C?

Originally posted by DevolutionEvolvd
BTW, according to the data, a whopping 1 man out of 100 has his life saved by statins. Pretty weak statistic...

edit on 22-1-2011 by DevolutionEvolvd because: (no reason given)

Could you provide a link to what data source you're using for this number? There have been numerous trials done involving statin efficacy, and the resulting Number Needed to Treat (NNT) varies from trial to trial based on MANY different factors.

Furthermore, your comment that it's a "Pretty weak statistic" relays to me a "Pretty weak" understanding of biostatistics. Maybe you should review what it means for something to statistically significant.

Originally posted by LuckyOscar
INCORRECT - statins have been proven to be effective for Men and Women in not only improving lipid profiles,

Sometimes...and in some trials. Not always. Most of the more recent studies are showing a clear trend that Statins work to reduce cardiac events and death by lowering inflammation, not LDL and total cholesterol (especially considering total cholesterol is hardly a predictor of heart attack incidence)

but also in lowering the incidence of cardiac events like MI and Stroke, and in decreasing cardiac death and all-cause mortality.

It's really important, as you've pointed out, to understand the statistical significance of such findings. It's also important not to cherry pick the data or rely on one or two trials. I can go search google scholar for 5 studies that support what you're saying conclusively; however, I can find just as many, if not more, showing just how inconclusive and unclear the data set really is.

Furthermore, statins have been shown to be effective even in apparently healthy individuals who weren't even classified as high-risk based on their lipid panels.

Sometimes...and in some trials. Other research studying the efficacy of the use of statins on relatively healthy individuals show no benefit. So....like I said, cherry picking isn't good. The quality and length of trials is very important, which is why we have systematic reviews...

Statins for the primary prevention of cardiovascular disease

The aim of this systematic review is to assess the effects, both in terms of benefits and harms of statins for the primary prevention of CVD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE until 2007. We found 14 randomised control trials with 16 trial arms (34,272 patients) dating from 1994 to 2006. All were randomised control trials comparing statins with usual care or placebo. Duration of treatment was minimum one year and with follow up of a minimum of six months. All cause mortality.

Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

The Cochrane Collaboration is the best of the best when it comes to research analysis and review.

Shah Ebrahim, co-author of the report, had this to say about it

doctors [should] stop giving patients the drugs unnecessarily.

Just one life is currently saved for every 1,000 people who take them each year, the report says.

Could you provide a link to what data source you're using for this number?

I've read it in multiple places...but I was specifically referring to one drug. Lipitor. I interviewed a health professional, Dr. Jonny Bowden, and he responded with this...

You take a drug like Lipitor, that advertises widely that there's a 33% reduction in Heart Disease risk when you take [it], and you have to look at the fine print. What that really means, first of all, depending on....what statsitics you use, that 33% reduction in heart disease risk is actually in one tiny subset of the population, which is middle-aged men who already had a heart attack. Now, if you look at that subcatagory you'll see a slight reduction in heart disease.

Here's what the actual absolute numbers are: Instead of 3 in 500 people who would have gotten a heart attack, it's 2 in 500. So, that is a 33% reduction, but that's like saying you have a 1 in 10 million chance of winning the lottery and I increase your chances 100% percent, now you've got a 2 in 10 million chance. So depending on what statsitcs you use, and when you use statstics in marketing you can make things sound an awful lot more valuable.

And if you look at the fine print in those Lipitor ads it will tell you exactly what I just said and it will also tell you that it's in that subset of middle-aged men who've had a heart attack. It does absolutely nothing for women. It does absolutely nothing for people who have not had a heart attack.

Originally posted by DevolutionEvolvd

Originally posted by LuckyOscar
INCORRECT - statins have been proven to be effective for Men and Women in not only improving lipid profiles,

Sometimes...and in some trials. Not always. Most of the more recent studies are showing a clear trend that Statins work to reduce cardiac events and death by lowering inflammation, not LDL and total cholesterol (especially considering total cholesterol is hardly a predictor of heart attack incidence)

Can you provide a link to a clinical trial published in a peer-reviewed journal that proves any of the statin drugs are ineffective in improving patient lipid profiles, specifically LDL levels? As far as I'm aware, all of the clinical trials have shown improvements in patient lipid profiles.

As far as an anti-inflammatory link to reduction in cardiac events - yes, there have been studies pointing to this as a possible mechanism (e.g.PROVE IT - TIMI 22, JUPITER), which is promising in further understanding the disease state and formulating future therapies. But it is INCORRECT to state that there is a "clear trend" or that the efficacy of statin drugs is "by lowering inflammation, not LDL and total cholesterol". If you have evidence that proves the contrary, then please provide it.

Also, are you inferring that lipid profile has no correlation to CVD risk?

but also in lowering the incidence of cardiac events like MI and Stroke, and in decreasing cardiac death and all-cause mortality.

It's really important, as you've pointed out, to understand the statistical significance of such findings. It's also important not to cherry pick the data or rely on one or two trials. I can go search google scholar for 5 studies that support what you're saying conclusively; however, I can find just as many, if not more, showing just how inconclusive and unclear the data set really is.

Please provide these studies then. I am not sure how you think I have cherry-picked any data. Furthermore the data available to support the efficacy of statin drugs is not from just one or two trials - there are many. I have provided several links earlier in the thread, I can provide many more if requested.

Furthermore, statins have been shown to be effective even in apparently healthy individuals who weren't even classified as high-risk based on their lipid panels.

Sometimes...and in some trials. Other research studying the efficacy of the use of statins on relatively healthy individuals show no benefit. So....like I said, cherry picking isn't good. The quality and length of trials is very important, which is why we have systematic reviews...

Primary prevention studies have shown CLEAR benefit with statins to reduce non-fatal MI. If you are aware of a study that proves otherwise, please provide a link. Saying that other research shows "no benefit" is incorrect when presented as an absolute, and misleading without specifying which primary or secondary outcomes you are specifically referring to. Additionally other studies HAVE also shown benefit in reducing stoke, cardiovascular death, and all-cause mortality. A great example of this was the JUPITER trial, whose results were presented at the 2008 AHA meeting.
JUPITER trial review

JUPITER Results
The trial was stopped after a median follow-up of 1.9 years (maximum, 5.0 years). Rosuvastatin reduced LDL-C levels by 50% and hsCRP levels by 37%. A total of 142 primary events occurred in the rosuvastatin group compared with 251 in the placebo group, a reduction of 44% with rosuvastatin ( Table 1 ). The number needed to treat to prevent 1 primary event was calculated as 25, "a value if anything smaller than that associated with treating hyperlipidemia in primary prevention," Dr. Ridker remarked. Reductions seen with rosuvastatin were 54% for MI, 48% for stroke, 47% for revascularization or unstable angina, 47% for the combined endpoint of MI, stroke, or death from cardiovascular causes, and 20% for death from any cause.

Interpreting the Results
In terms of the implications of the JUPITER results for public health, Dr. Ridker and his colleagues have calculated that "application of the simple screening and treatment strategy tested in the JUPITER trial over a 5-year period could conservatively prevent more than 250,000 heart attacks, strokes, revascularization procedures, and cardiovascular deaths in the United States alone."

Again, this trial studied PRIMARY prevention in relatively healthy patients.

The concern comes when evaluating the use of statins for primary prevention of FATAL outcomes. Recent meta-analysis does raise questions about the true benefit of statins in preventing cardiovascular death and all-cause mortality. Please note that I am not providing the information from the JUPITER trial above to prove that there is conclusive benefit in these areas. I am merely showing that there are studies that show a benefit, just as there are recent meta-analysis that do not. The fact is that the data as a whole is still inconclusive, and the jury is still out.
New meta-analysis of statins in primary prevention does not suggest significant reduction in all-cause mortality

Still beneficial for nonfatal complications
To heartwire, Seshasai commented: "We didn't find a significant reduction in death despite having such a huge sample size. This is the totality of evidence in primary prevention. So if we can't show a significant reduction with this data, it is unlikely to be there. We are not saying don't use statins in this population, as they do have benefits on other outcomes, such as MI. But we are saying that we should be cautious in prescribing these agents for a mortality reduction. That is, don't expect wonders to happen. If it is for a reduction of all-cause death that you are prescribing a statin, you probably need to reconsider. And our population was primary prevention at high risk of heart disease, so if we extend it to those at lower risk the benefits will be even more modest."

He [Dr Lee Green (University of Michigan Medical School, Ann Arbor)] adds that this analysis "makes it clear that in the short term, for true primary prevention, the benefit, if any, is very small. In the long term, although sincere advocates on both sides will try to convince us otherwise, we really must admit that we do not know."

However, I think it is still important to recognize that even though there may not be any benefit in reducing fatal outcomes, there is still benefit in using statins for primary prevention in apparently healthy individuals.

Nissen: "Not surprising"
Commenting on the meta-analysis for heartwire, Dr Steve Nissen (Cleveland Clinic, OH) said he did not find the results surprising. "Because mortality is low in primary-prevention patients, it is difficult to show a mortality benefit. This has been established previously. The primary benefit in this setting is reduction in nonfatal MI, which remains a worthwhile goal of therapy," he added.

Ultimately the decision must be based on many different patient-specific factors and the clinical judgment of the physician.

Statins for the primary prevention of cardiovascular disease

The aim of this systematic review is to assess the effects, both in terms of benefits and harms of statins for the primary prevention of CVD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE until 2007. We found 14 randomised control trials with 16 trial arms (34,272 patients) dating from 1994 to 2006. All were randomised control trials comparing statins with usual care or placebo. Duration of treatment was minimum one year and with follow up of a minimum of six months. All cause mortality.

Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

The Cochrane Collaboration is the best of the best when it comes to research analysis and review.

I do enjoy the Cochrane Collaboration, as they are non-profit and claim to not accept any commercial funding. However to say that they are the "best of the best" is obviously a matter of opinion (not that I'm disputing the overall quality of their work in general).

I'm glad you provided the new Cochrane review, as it has shaken up some controversy - not only just over the use of statins in primary prevention, but also among researchers who already maintain that the Cochrane reviewers have misrepresented the data.
Cochrane review stirs controversy over statins in primary prevention

But Dr Colin Baigent (Clinical Trials Service Unit, Oxford, UK) commented to heartwire : "I object to the conclusions they have drawn from their review. They say there is not good evidence of benefit, but their own data show significant reductions in deaths and cardiac events." And Baigent further objects to the Cochrane authors' suggestion that harms are not known with statins. "They didn't show any increase in adverse events in their review, but they then say the benefit is not worth the risk. That doesn't make sense."

Furthermore, for someone who has made such a big deal about "cherry-picking" data, you sure have excluded a lot of important information from your quote of the specific Cochrane review in question. The problem here is (as pointed out by Dr. Baigent above) that THE AUTHORS CONCLUSIONS DO NOT MATCH THE RESULTS OF THEIR OWN STUDY. Lets look at the actual data from the Cochrane review.
The Cochrane Library - Statins for the Primary Prevention of Cardiovascular Disease

Main results
Fourteen randomised control trials (16 trial arms; 34,272 participants) were included. Eleven trials recruited patients with specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). All-cause mortality was reduced by statins (RR 0.83, 95% CI 0.73 to 0.95) as was combined fatal and non-fatal CVD endpoints (RR 0.70, 95% CI 0.61 to 0.79). Benefits were also seen in the reduction of revascularisation rates (RR 0.66, 95% CI 0.53 to 0.83). Total cholesterol and LDL cholesterol were reduced in all trials but there was evidence of heterogeneity of effects. There was no clear evidence of any significant harm caused by statin prescription or of effects on patient quality of life.

In addition, it seems that the Cochrane authors did some "cherry-picking" of their own, as they didn't include the latest meta-analysis done by the Oxford group in their data set.

Latest Oxford Meta-Analysis Not Included
The Cochrane review did not include the recent meta-analysis from the Oxford group, published late last year, which showed a clear reduction in events with statin therapy in primary-prevention patients. Baigent noted that this meta-analysis was more reliable than the Cochrane review, as the Oxford researchers used individual patient data from all the trials. "Our 2010 meta-analysis in primary prevention is substantially more complete than the Cochrane review and provides direct and overwhelmingly statistically convincing evidence of a clear reduction in events in all patient groups, right down to those at the lowest risk."
On the possible hazards of taking these drugs, Baigent says: "Statin therapy is very safe. The most serious hazard, rhabdomyolysis, is very rare, and most often seen at high doses. There is a possibility that reducing LDL cholesterol might increase the risk of hemorrhagic stroke, but even in primary prevention these hazards would be much smaller than the benefits, and there is no reliable evidence for other hazards mentioned by the Cochrane authors, such as depression and cognitive impairment."

Here is a link to the Oxford meta-analysis.
Cholesterol Treatment Trialists' Collaboration (CTT)

Results
The results of the updated meta-analysis of the 21 statin vs. control trials were similar to those observed in the first cycle: there was a highly significant 21% (95% CI 19-23;p

Originally posted by punterdeb

hi oscar,

this was the first time i have ever really had a side effect from a prescription drug. i had no idea of the side effects at all. my doctor never ever mentioned it. i did what i usually do when taking a new med. i scanned through the info pamplet but didnt really read it. i know the usual to look for if you have a severe reaction like hives or throat swelling. but my dr never said a word, which was upsetting because he has been the family dr for over 20 years. when he put me on it the second time i told him what had happened before and he really just dismissed it. which is the thing that worries me as if patients go to him with muscle fatigue he is not putting the two and two together.

Thanks for responding and sharing these details with everyone. My interest was because there is evidence that more than 40% of patients who experience muscle pain/fatigue on a statin drug, will not experience those side effects again if switched to another drug within the class. I am surprised he didn't try to switch your drug therapy to a different statin or to a different class when you presented with the muscle pain.

Obviously I do not know your physician personally, but your story to me communicates either a lack of education or communication skills on your physicians part. The fact is that muscle pain/fatigue is the most common side effect of statins (~2-12% of patients experience this) and this is widely known. It is especially troubling because an extremely rare and potentially dangerous side effect called Rhabdomyolysis should be monitored for in patients initiating a statin therapy, and this commonly initially presents as muscle pain. Your doctor should have explained the signs to look for.

Also, were you counselled by the Pharmacist when you filled the Rx your doctor gave you? They should have communicated this side effect to you as well.

If this were my healthcare (based on your story) I would seek care from a different physician.

I think the problem with situations like this in general stems from a lack of communication and education. I fear that patients rely on their physicians judgments without gaining adequate information as to why specific clinical decisions are being made. If your doctor prescribes you a medication, he should be explaining exactly why he is and what exactly to expect from it (most common side effects). If he is not, I would hope that those specific questions would then be asked by you, the patient, before any new drug therapy is started. Also, there is an abundance of drug information available online to help educate patients on how a medication works and what to expect from it. The only caveat is that it is obtained from RELIABLE sources, like the MedlinePlus database provided by the National Institutes of Health: www.nlm.nih.gov... Also, all drug manufacturers are required by law to provide information from clinical trials about the side effect profile and potential adverse reactions. This information is usually easily accessible on the drug manufacturers website.

Obviously side effects like the muscle pain/fatigue you experienced can often be overlooked by persons who already suffer similar problems before initiating therapy - and thus the line becomes grey as to how much is due to the medication, and how much is due to an already present condition. So in these patients it's even more important to closely monitor, and communication between patient and physician is all that more crucial. The bottom line is that with all medications you and your doctor should be assessing the Risk vs Benefit. Some side effects are more common than others, and many can't be avoided for some patients. But if the medication provides a certain level of benefit, and the patient can tolerate the side effects (assuming they themselves aren't detrimental to the patients overall health), then the Benefit is worth the Risk. If not, thats usually when alternative drug therapies (many times 2nd and 3rd line) are considered.

Originally posted by LuckyOscar

Can you provide a link to a clinical trial published in a peer-reviewed journal that proves any of the statin drugs are ineffective in improving patient lipid profiles, specifically LDL levels? As far as I'm aware, all of the clinical trials have shown improvements in patient lipid profiles.

You really have to read carefully. I didn't say statins are ineffective at improving LDL and total serum cholesterol levels in target groups. That's not to say that trials haven't produced results in which study participants showed no improvement in lipid profiles (once again, I would have to search to find them as I'm reading and analyzing multiple studies daily).

My point was that our understanding of how CAD progresses is changing. And while certain biomarkers, within lipid profiles, can indicate heart disease risk, adjusting them directly is, as we've now begun to realize, simply fixing a symptom of the real cause. Inflammation. What I'm saying is that Statins are working through its anti-inflammatory effects.

But it is INCORRECT to state that there is a "clear trend" or that the efficacy of statin drugs is "by lowering inflammation, not LDL and total cholesterol". If you have evidence that proves the contrary, then please provide it.

Actually, yes. There is a clear trend. It may not be fully understood because researchers cling so tightly to the lipid hypothesis....as they "know" it to be true. It's very likely that inflammation is causing dyslipidemia (inflammation that is caused by poor lifestyle choices, but that's another thread topic). Many researchers are concluding that CRP (C-Reactive Protein) is a better predictor of MI than lipid profiles.

www.nejm.org... _NUM=10&resourcetype=HWCIT&resourcetype=HWCIT&andorexacttitleabs=and
www.biomedcentral.com...
www.nejm.org...

There really are a ton of data on the subject.

Also, are you inferring that lipid profile has no correlation to CVD risk?

Parts of the "lipid profile" do. Total LDL is a poor predictor, compared to LDL size. HDL/VLDL (triglyceride) ratio is a good predictor. Total cholesterol is probably the worst predictor of all. Honestly, go pull the actual data from from 40 years ago when the lipid hypothesis was being formed and you'll see how the data and the conclusions don't match. Start with the Frammingham Heart Study.

Please provide these studies then. I am not sure how you think I have cherry-picked any data. Furthermore the data available to support the efficacy of statin drugs is not from just one or two trials - there are many. I have provided several links earlier in the thread, I can provide many more if requested.

I was making a point. You provided one study...(which was unaccessible, mind you). So my point is that we can go back and forth arguing our points and backing them up with studies that we search for in support of our respective side because there are tons of poor quality studies and even more poor quality analyses of studies.

Primary prevention studies have shown CLEAR benefit with statins to reduce non-fatal MI. If you are aware of a study that proves otherwise, please provide a link. Saying that other research shows "no benefit" is incorrect when presented as an absolute, and misleading without specifying which primary or secondary outcomes you are specifically referring to.

Saying "no benefit" may have been misleading. I apologize. Minimally beneficial, which typically means there was a benefit but it was statistically insignificant. That is what the cochrane review found.

A great example of this was the JUPITER trial, whose results were presented at the 2008 AHA meeting.

In actuality, the JUPITER trial is, if anything, in support of what I've been saying, if you look at the DATA.

Basically, the results suggest that men over 50 and women over 60 with normal LDL-C levels and increased C-RP levels show a small but significant benefit when taking Crestor (remember the inflammation thing?). The study says nothing about anyone who has normal C-RP levels, is a male under 50 or is a female under 60. And that's if you trust the reported data.

See, reading your quotes would easily mislead anyone to believe that these study results would apply to anyone of any age or sex. I think it's also worth noting that those in the Crestor group developed diabetes at a much higher rate than did those on the placebo.

Again, we're talking about a slight decrease in risk when we analyze the ACTUAL data.

The fact is that the data as a whole is still inconclusive, and the jury is still out.

Are you saying we may actually have a common stance here? Of course, I think the jury IS out.

However, I think it is still important to recognize that even though there may not be any benefit in reducing fatal outcomes, there is still benefit in using statins for primary prevention in apparently healthy individuals.

$1400 a year to receive a very small benefit, if any at all...(since the jury is still out)?

I'll address the rest in a later post.

Also, to clearify...I believe, based on the data that I've seen, that it's still speculative to assume Statins work solely through anti-inflammatory effects. However, I think it's just as speculative, or wrong, to assume they work through cholesterol lowering effects (not because they don't lower cholesterol, but because most of the epidemiology, and other studies, show their to be no relationship between total cholesterol and heart disease)

Originally posted by LuckyOscar
I'm glad you provided the new Cochrane review, as it has shaken up some controversy - not only just over the use of statins in primary prevention, but also among researchers who already maintain that the Cochrane reviewers have misrepresented the data.
Cochrane review stirs controversy over statins in primary prevention

But Dr Colin Baigent (Clinical Trials Service Unit, Oxford, UK) commented to heartwire : "I object to the conclusions they have drawn from their review. They say there is not good evidence of benefit, but their own data show significant reductions in deaths and cardiac events." And Baigent further objects to the Cochrane authors' suggestion that harms are not known with statins. "They didn't show any increase in adverse events in their review, but they then say the benefit is not worth the risk. That doesn't make sense."

Furthermore, for someone who has made such a big deal about "cherry-picking" data, you sure have excluded a lot of important information from your quote of the specific Cochrane review in question. The problem here is (as pointed out by Dr. Baigent above) that THE AUTHORS CONCLUSIONS DO NOT MATCH THE RESULTS OF THEIR OWN STUDY. Lets look at the actual data from the Cochrane review.

Well, there's a few reasons for that...which were addressed in their conclusion. It makes sense when you read this...

Although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease.

In addition, it seems that the Cochrane authors did some "cherry-picking" of their own, as they didn't include the latest meta-analysis done by the Oxford group in their data set.

They hardly cherry picked. Firstly, the Cochrane criteria for trials is very strict so to avoid low quality studies, selection bias and other confounders that may influence data results and conclusions negatively.

Randomised controlled trials of statins with minimum duration of one year and follow-up of six months, in adults with no restrictions on their total low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD, were included.

Secondly, their was an obvious cut-off date that happened to be before the meta-analysis in question. It wasn't cherry picking...

To avoid duplication of effort, we checked reference lists of previous systematic reviews. We searched the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (2001 to March 2007) and EMBASE (2003 to March 2007). There were no language restrictions.

Okay, first lets address your source. I could not find any peer reviewed studies or journal articles published by someone of that name.

He hasn't published any...and I never claimed he has. You don't have to be a researcher to analyze research.

I did a little digging and the only person I could find was this: jonnybowden.com... Just so everyone reading this thread is clear, this person is NOT a physician. His title of "Dr." comes from his PhD in Nutrition. Why anyone would take serious medical advice on any non-nutrition topic from this person escapes me.

It's not medical advice. It's an analysis of medical research and pharmaceutical ads, which hardly requires one to be a physician. It does, however, require some knowledge of biochemistry and statistics. And if you want to know how foods affect one's body, you kinda have to know a lot about biochemistry. Jonny Bowden is a Board Certified Nutrition Specialists, one of the most respectful certifications in nutrition and definitely one of the most extensively detailed tests, requiring an advanced degree in a nutrition related field.

A CNS is trained to analyze nutrition research and apply that to tailor fitting diets for clients. Seeing how what we eat directly affects lipid profiles, and seeing how certified nurtition specialists are trained to know exactly how those foods affect them and why, it's not a stretch to assume that such a credentialed individual can properly analyze research dealing with Statins. Besides, a CNS should know whether or not a Statin drug is more effective than a proper diet.

Also, most physicians don't have the time, or take the time, to read through medical journals to get a proper understanding of why and how statins work, or if they work at all. They're getting their information directly from drug companies. Not all, of course, but the vast majority. And they certainly don't know much about studies examining the relationship between blood lipids and heart disease.

So trying to qualify his statements on statins by saying he is a "health professional" is a bit misleading.

No, it's really not. Would you consider a Dietitian a health professional? Yes...and CNS is much more advanced than Registered Dietitian.

Also, his website is riddled with products and programs he is trying to sell, this should be an immediate red flag for anyone considering taking his advice on any topic.

True. I've personally avoided his website and his information since I interviewed him for this very reason. I used the information from him because I personally interviewed him, is all.

Second, the information that he was presenting was from the ASCOT-LLA trial, which studied the use of Atorvastatin (Lipitor) for PRIMARY PREVENTION! Results of the study were found in both MEN AND WOMEN. Again, this was studying Primary Prevention - patients who had a previous MI (heart attack) were EXCLUDED from participating in the trial! This person has NO IDEA what they are talking about.

Actually, I believe he was referring to information provdided by Lipitor ads AND information provided by this report which provides the scientific rationale for this executive summary

...the results of the report, which, by the way, included primary and secondary prevention..

Men the age of 65 and under without heart disease but with risk factors (LDL greater than 130mg/dl) of developing heart disease showed no difference in all cause mortality. Those men did, however, show a slight benefit to taking Statins...but nothing that would justify prescription.

In women 65 and under....nothing.

Men and women over 65 showed no evidence of significant decreased risk of developing heart disease.

It was men, of all ages, with heart disease that showed any evidence of real benefit. Women with atherosclerosis showed a decrease in heart disease mortality but not all cause.

Statins to prevent cardiovascular events in hypertensive patients. The ASCOT-LLA study

The safety committee board prematurely discontinued the ASCOT-LLA trial, considering that stopping rules for the primary end-point were significantly exceeded, although no significant reduction in total mortality was shown.