Are Cholesterol Lowering Drugs Right For You?

Written by Dr. Steve Chaney on . Posted in Drugs and Health, Issues

Do Statins Really Work?

Author: Dr. Stephen Chaney

Do statins really work?Statins – those ubiquitous drugs used to lower cholesterol levels – are big business!

Over 20 million Americans are currently being treated with statin drugs at a cost that runs into billions of dollars every year. And cardiologists have just recommended that another 20 million Americans consider using cholesterol lowering drugs. 44% of the men and 22% of the women in this country are now being told that they should be using statin drugs.

Some of my cardiologist friends are so convinced that statin drugs prevent death from heart attacks that they have said, only half-joking, that we should just add statins to the water supply.

Are Cholesterol-Lowering Drugs Right For You?

Is the faith of doctors in the power of statin drugs to prevent death from heart disease justified? To answer that question in full we need to look at people who have already survived a heart attack and people who have never had a heart attack separately.

If you’ve already had a heart attack the evidence is clear cut.

  • If you have had a heart attack, there is good evidence that statins will reduce your risk of dying from a second heart attack.
  • In the technical jargon of the scientific world that is referred to as secondary prevention.

But what about those millions of Americans who are being prescribed statin drugs who have never had a heart attack? This is something we scientists refer to as primary prevention.

What Do The Studies Actually Say About Statins And Primary Prevention?

Here the evidence is not clear at all. Two major reports have cast doubt on the assumption that statins actually do prevent heart attacks in people who have not already had a first heart attack.

In the first study, Dr. Kausik Ray and colleagues from Cambridge University in England performed a meta-analyis of 11 clinical studies involving over 65,000 participants (Ray et al, Arch. Int. Med., 170: 1024-1031, 2010). They focused on those participants in the studies who had not previously had a heart attack (primary prevention).

  • They found that the use of statins over an average of 3.7 years had no statistically significant effect on mortality. In short, statins had no effect on the risk of dying from heart disease or any other cause.
  • Dr. Sreenivasa Sechasai, one of the doctors involved in the study, said “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 reduction with this data, it is unlikely to be there.”

The second study was a Cochrane Systemic Review of statins published January 19th, 2011.  It stated that there was not enough scientific evidence to recommend the use of statins in people with no previous history of heart disease with some caveats (see below).

To help you understand the significance of that conclusion, let me give you a bit of background:

  • First you need to understand that the Cochrane Collaboration is an independent, non-profit organization that carefully reviews the scientific evidence behind medical treatments and proposed medical treatments.
  • Cochrane Reviews are considered the “Holy Grail” of evidence-based medicine (ie. medicine based on the best scientific evidence rather than what the pharmaceutical companies would have you believe).
  • So when a Cochrane Review concludes that there isn’t enough evidence to recommend use of statins in patients with no prior history of heart disease that is pretty big news in the medical world.

How Should These Studies Be Interpreted?

Please don’t misinterpret what I am saying. The Cochrane Review said that statin drugs are overprescribed, but it did not say that everyone who has not had a heart attack will not benefit from statins. It said that there are a number of risk factors that need to be considered in evaluating individual patients for statin use.

  • Simply put, that means that it is not as simple as saying that everyone with no previous history of heart disease should not be on statin drugs.
  • If you are currently taking statin drugs and you have no previous history of heart disease, you may want to discuss with your physician whether the Cochrane Review of statin drugs changes their opinion of whether se of those drugs is still warranted for you.
  • But the bottom line is that only your physician is trained to take into account all of the factors that increase your risk of heart disease and the best therapeutic approach for reducing your risk of heart attack.

There Is A Double Standard In The Medical Community

More importantly, these studies highlight the difficulty in showing that anything works when you start out with a healthy group of adults with no prior evidence of disease (primary prevention).

And, the way that doctors have responded to primary prevention studies shows that there is a double standard in how primary prevention trials are interpreted in the medical community. For example:

  • There is no good evidence that statins prevent fatal heart attacks in healthy people.
  • However, because statins do work in high risk patients, most doctors recommend their use by millions of Americans who have never had a heart attack.
  • There is also no good evidence that nutrients like vitamin E and omega-3 fatty acids prevent fatal heart attacks in healthy people.
  • However, there is evidence that both vitamin E and omega-3 fatty acids prevent heart attacks in high risk patients, yet most doctors will tell you they are a waste of money.

It is food for thought.

The Bottom Line

1)    Statin drugs clearly save lives when used by people who have already had a heart attack.

2)    On the other hand, there is no proof that statin drugs prevent heart attacks in people who have not previously had a heart attack

3)    Statin drugs do have side effects. Increased risk of diabetes, liver damage, muscle damage and kidney failure are the best documented, although memory loss has also been reported.

4)    I am not recommending that you stop using statin drugs without consulting your doctor. I am suggesting that you discuss the benefits and risks of statin drug use with your doctor.

5)    Perhaps the most important poin tto come out of these studies is that it almost impossible to prove the benefit of any intervention in a primary prevention trial. If you can’t prove that statins work in healthy people, it is not surprising that it is difficult to prove that other interventions work.

6)   Finally, the way that these studies have been interpreted shows that there is a clear double standard in how the medical community evaluates primary intervention trials.

  • Statin drugs don’t show any benefit in a primary prevention setting, yet most doctors still recommend them.
  • Vitamin E and omega-3 fatty acids don’t show any benefit in a primary prevention setting, and most doctors recommend against them.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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Comments (14)

  • Lyle Yoder

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    Thank you for the thoughtful article; I am a layman and student of healthy living, a Shaklee user for over forty years. In that pursuit I came across a certain Dr. Russell Blaylock a 30 year veteran brain surgeon; who is diametally opposed to the use of any type of statin drugs. He claims tha cholesterol build up in the arteries comes from inflammation and not from excess cholesterol. He further states that cholesterol amounts now recommended are far to low and is very dangerous to our brain which approximately eighty-five percent cholesterol the lack of iwhich may well contribute to early dimensia and other electrical parts of our annatoamy.

    Lyle Yoder

    FOOD FOR THOUGHT.

    Reply

  • Sharon Hill

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    Very timely and important article, Steve. I appreciate it very much.

    Reply

  • Karen

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    Great article!! Interesting yet not really surprising about the double standard. Medical community has their own agenda. Money! What would you tell someone whose father died very young from a heart attack? I don’t really know if its a history of genetics or the lifestyle of smoking and drinking that was the culprit but the history is there. I would much rather see the natural supplementation route but there is a lot of fear in NOT taking the statins placed by the physician. Hard to go up against the one with all credentials.

    Reply

    • Dr. Steve Chaney

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      Dear Karen,
      I just came across an interesting article on the subject by Joe & Terry Graedon (You may be familiar with their “People’s Pharmacy talk show on NPR and their web site http://www.PeoplesPharmacy.com). They referenced a recent study that concluded: “A healthy Mediterranean-style diet could be as effective as statins without the side effects” (JAMA Internal Medicine, Oct. 28, 2013).
      Dr. Chaney

      Reply

  • David Norby

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    Great article. I have a question regarding blood cholesterol levels. High levels are supposed to be a risk factor for heart attacks, so statins are given to lower those levels, which they usually do. So, are the studies implying that cholesterol levels are not a risk factor for heart disease? Or the recommended levels are incorrect, as implied by Blaylock? There are two issues, I think – statins and heart disease plus cholesterol and heart disease. This has probably already been written about.

    Reply

    • Dr. Steve Chaney

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      Dear David,

      Great question, but there is not a simple answer. Elevated cholesterol is one risk factor. Inflammation, LDL/HDL ratio, particle size, triglycerides, high blood pressure, and diabetes are also all important risk factors. Statins are favored by many cardiologists because they lower both cholesterol and inflammation.

      My point was not to say that statins were ineffective in people at risk of heart disease. They might well be. My point was that it was impossible to prove that they were effective for people who have not yet had a heart attack. And, if you can’t prove that stains prevent heart attacks in healthy people, why should it surprise anyone that it is difficult to prove that vitamin E, B vitamins or omega-3 fatty acids prevent heart attacks in healthy people.

      Dr. Chaney

      Reply

  • Shirley

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    I, too, have read and heard about the statin controversy. I have diabetes and heart disease in my family history. I have tried all different statins with serious side effects. Crestor doesn’t seem to cause any problems. Before starting medication, my chloresterol was 363, now it’s under 200. I am reluctant to stop taking the drug.

    Reply

    • Dr. Steve Chaney

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      Dear Shirley,

      Most experts agree that someone with a cholesterol level of 363 should be taking a statin if they can tolerate it. The new guidelines include many people with cholesterol levels in the 200 range or less. It is this recommendation that has stirred controversy among the experts.

      D Chaney

      Reply

  • JoAn

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    Dr. Chaney, please comment on red yeast rice for reducing cholesterol ratio, inflammation, etc. Are there two kinds: One made in China (don’t take because it is like a statin) and one in the USA? What about 5-HTP?

    Reply

    • Dr. Steve Chaney

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      Dear JoAn,
      The active ingredient in red yeast is a natural statin. It can have the same effectiveness and the same potential side effects as the synthetic statin drugs. But, you put your finger on the most important concern. Red yeast rice is sold as a food supplement, and most food supplement companies don’t perform the same quality control tests that the drug companies employ. If you are using a red yeast rice supplement, make sure you are getting it from a reputable company that employs rigorous quality control tests.
      Dr. Chaney

      Reply

  • Carol E.

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    I have taken all the statins for different periods of time and then stopped because they cause muscle problems in my arms in particular.

    My nephrologist/internist gets very angry with me because I stop. He says “ok you will get a heart attack or stroke and die”. I cannot help it that my muslces hurt….BUT he doesn’t listen to me.

    Reply

    • Dr. Steve Chaney

      |

      Dear Bunny,
      You probably already know that there is no magic “ab cruncher” that gets rid of body fat. But a well designed exercise program couple with a high protein diet (with moderate amounts of healthy carbs & fats) will slowly get rid of that belly fat. It won’t happen overnight, bur it also didn’t develop overnight.
      Dr. Chaney

      Reply

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Latest Article

A Low Carb Diet and Weight Loss

Posted January 15, 2019 by Dr. Steve Chaney

Do Low-Carb Diets Help Maintain Weight Loss?

Author: Dr. Stephen Chaney

 

low carb dietTraditional diets have been based on counting calories, but are all calories equal? Low-carb enthusiasts have long claimed that diets high in sugar and refined carbs cause obesity. Their hypothesis is based on the fact that high blood sugar levels cause a spike in insulin levels, and insulin promotes fat storage.

The problem is that there has been scant evidence to support that hypothesis. In fact, a recent meta-analysis of 32 published clinical studies (KD Hall and J Guo, Gastroenterology, 152: 1718-1727, 2017 ) concluded that low-fat diets resulted in a higher metabolic rate and greater fat loss than isocaloric low-carbohydrate diets.

However, low-carb enthusiasts persisted. They argued that the studies included in the meta-analysis were too short to adequately measure the metabolic effects of a low-carb diet. Recently, a study has been published in the British Medical Journal (CB Ebbeling et al, BMJ 2018, 363:k4583 ) that appears to vindicate their position.

Are low carb diets best for long term weight loss?

Low-carb enthusiasts claim the study conclusively shows that low-carb diets are best for losing weight and for keeping it off once you have lost it. They are saying that it is time to shift away from counting calories and from promoting low-fat diets and focus on low-carb diets instead if we wish to solve the obesity epidemic. In this article I will focus on three issues:

  • How good was the study?
  • What were its limitations?
  • Are the claims justified?

 

How Was The Study Designed?

low carb diet studyThe investigators started with 234 overweight adults (30% male, 78% white, average age 40, BMI 32) recruited from the campus of Framingham State University in Massachusetts. All participants were put on a diet that restricted calories to 60% of estimated needs for 10 weeks. The diet consisted of 45% of calories from carbohydrate, 30% from fat, and 25% from protein. [So much for the claim that the study showed low-carb diets were more effective for weight loss. The diet used for the weight loss portion of the diet was not low-carb.]

During the initial phase of the study 161 of the participants achieved 10% weight loss. These participants were randomly divided into 3 groups for the weight maintenance phase of the study.

  • The diet composition of the high-carb group was 60% carbohydrate, 20% fat, and 20% protein.
  • The diet composition of the moderate-carb group was 40% carbohydrate, 40% fat, and 20% protein.
  • The diet composition of the low-carb group was 20% carbohydrate, 60% fat, and 20% protein.

Other important characteristics of the study were:

  • The weight maintenance portion of the study lasted 5 months – much longer than any previous study.
  • All meals were designed by dietitians and prepared by a commercial food service. The meals were either served in a cafeteria or packaged to be taken home by the participants.
  • The caloric content of the meals was individually adjusted on a weekly basis so that weight was kept within a ± 4-pound range during the 5-month maintenance phase.
  • Sugar, saturated fat, and sodium were limited and kept relatively constant among the 3 diets.

120 participants made it through the 5-month maintenance phase.

 

Do Low-Carb Diets Help Maintain Weight Loss?

low carb diet maintain weight lossThe results were striking:

  • The low-carb group burned an additional 278 calories/day compared to the high-carb group and 131 calories/day more than the moderate-carbohydrate group.
  • These differences were even higher for those individuals with higher insulin secretion at the beginning of the maintenance phase of the study.
  • These differences lead the authors to hypothesize that low-carb diets might be more effective for weight maintenance than other diets.

 

What Are The Pros And Cons Of This Study?

low carb diet pros and consThis was a very well-done study. In fact, it is the most ambitious and well-controlled study of its kind. However, like any other clinical study, it has its limitations. It also needs to be repeated.

The pros of the study are obvious. It was a long study and the dietary intake of the participants was tightly controlled.

As for cons, here are the three limitations of the study listed by the authors:

#1: Potential Measurement Error: This section of the paper was a highly technical consideration of the method used to measure energy expenditure. Suffice it to say that the method they used to measure calories burned per day may overestimate calories burned in the low-carb group. That, of course, would invalidate the major findings of the study. It is unlikely, but it is why the study needs to be repeated using a different measure of energy expenditure.

#2: Compliance: Although the participants were provided with all their meals, there was no way of being sure they ate them. There was also no way of knowing whether they may have eaten other foods in addition to the food they were provided. Again, this is unlikely, but cannot be eliminated from consideration.

#3: Generalizability: This is simply an acknowledgement that the greatest strength of this study is also its greatest weakness. The authors acknowledged that their study was conducted in such a tightly controlled manner it is difficult to translate their findings to the real world. For example:

  • Sugar and saturated fat were restricted and were at very similar levels in all 3 diets. In the real world, people consuming a high-carb diet are likely to consume more sugar than people in the other diet groups. Similarly, people consuming the low-carb diet are likely to consume more saturated fat than people in the other diet groups.
  • Weight was kept constant in the weight maintenance phase by constantly adjusting caloric intake. Unfortunately, this seldom happens in the real world. Most people gain weight once they go off their diet – and this is just as true with low-carb diets as with other diets.
  • The participants had access to dietitian-designed prepared meals 3 times a day for 5 months. This almost never happens in the real world. The authors said “…these results [their data] must be reconciled with the long-term weight loss trials relying on nutrition education and behavioral counseling that find only a small advantage for low carbohydrate compared with low fat diets according to several recent meta-analyses.” [I would add that in the real world, people do not even have access to nutritional education and behavioral modification.]

 

low carb diet and youWhat Does This Study Mean For You?

  • This study shows that under very tightly controlled conditions (dietitian-prepared meals, sugar and saturated fat limited to healthy levels, calories continually adjusted so that weight remains constant) a low-carb diet burns more calories per day than a moderate-carb or high-carb diet. These findings show that it is theoretically possible to increase your metabolic weight and successfully maintain a healthy weight on a low-carb diet. These are the headlines you probably saw. However, a careful reading of the study provides a much more nuanced viewpoint. For example, the fact that the study conditions were so tightly controlled makes it difficult to translate these findings to the real world.
  • In fact, the authors of the study acknowledged that multiple clinical studies show this almost never happens in the real world. These studies show that most people regain the weight they have lost on low-carb diets. More importantly, the rate of weight regain is virtually identical on low-carb and low-fat diets. Consequently, the authors of the current study concluded “…translation [of their results to the real world] requires exploration in future mechanistic oriented research.” Simply put, the authors are saying that more research is needed to provide a mechanistic explanation for this discrepancy before one can make recommendations that are relevant to weight loss and weight maintenance in the real world.
  • The authors also discussed the results of their study in light of a recent, well-designed 12-month study (CD Gardener et al, JAMA, 319: 667-669, 2018 ) that showed no difference in weight change between a healthy low-fat versus a healthy low-carbohydrate diet. That study also reported that the results were unaffected by insulin secretion at baseline. The authors of the current study noted that “…[in the previous study] participants were instructed to minimize or eliminate refined grains and added sugars and maximize intake of vegetables. Probably for this reason, the reported glycemic load [effect of the diet on blood sugar levels] of the low-fat diet was very low…and similar to [the low-carb diet].” In short, the authors of the current study were acknowledging that diets which focus on healthy, plant-based carbohydrates and eliminate sugar, refined grains, and processed foods may be as effective as low-carb diets for helping maintain a healthy weight.
  • This would also be consistent with previous studies showing that primarily plant-based, low-carb diets are more effective at maintaining a healthy weight and better health outcomes long-term than the typical American version of the low-fat diet, which is high in sugar and refined grains. In contrast, meat-based, low-carb diets are no more effective than the American version of the low-fat diet at preventing weight gain and poor health outcomes. I have covered these studies in detail in my book “Slaying The Food Myths.”

Consequently, the lead author of the most recent study has said: “The findings [of this study] do not impugn whole fruits, beans and other unprocessed carbohydrates. Rather, the study suggests that reducing foods with added sugar, flour, and other refined carbohydrates could help people maintain weight loss….” This is something we all can agree on, but strangely this is not reflected in the headlines you may have seen in the media.

The Bottom Line

 

  • A recent study compared the calories burned per day on a low-carb, moderate-carb, and high-carb diet. The study concluded that the low-carb diet burned significantly more calories per day than the other two diets and might be suitable for long-term weight control. If confirmed by subsequent studies, this would be the first real evidence that low-carb diets are superior for maintaining a healthy weight.
  • However, the study has some major limitations. For example, it used a methodology that may overestimate the benefits of a low-carb diet, and it was performed under tightly controlled conditions that can never be duplicated in the real world. As acknowledged by the authors, this study is also contradicted by multiple previous studies. Further studies will be required to confirm the results of this study and show how it can be applied in the real world.
  • In addition, the kind of carbohydrate in the diet is every bit as important as the amount of carbohydrate. The authors acknowledge that the differences seen in their study apply mainly to carbohydrates from sugar, refined grains, and processed foods. They advocate diets with low glycemic load (small effects on blood sugar and insulin levels) and acknowledge this can also be achieved by incorporating low-glycemic load, plant-based carbohydrates into your diet. This is something we all can agree on, but strangely this is not reflected in the headlines you may have seen in the media.
  • Finally, clinical studies report averages, but none of us are average. When you examine the data from the current study, it is evident that some participants burned more calories per hour on the high-carb diet than other participants did on the low carb diet. That reinforces the observation that some people lose weight more effectively on low-carb diets while others lose weight more effectively on low-fat diets. If you are someone who does better on a low-carb diet, the best available evidence suggests you will have better long-term health outcomes on a primarily plant-based, low-carb diet such as the low-carb version of the Mediterranean diet.

For more details read the article above.

 

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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