Letter to National Academy

Project Title: Review of the Process to Update the Dietary Guidelines for Americans


I recently reviewed the UP TO DATE chapter on Low Carbohydrate diet.

 I was surprised to see Meta-analysis data misrepresented.

Dr. Bonnie Brehm's 2 year head to head trial and Shai's 2 year head to head trials showed LCHF diet had better weight loss results than low fat diet. 
These long term trials are very important .

I am certified by the American Board of Obesity Medicine.
 I am shocked to see the latest text(2016) of Nutrition Concepts and Controversies state on p 136:
"several times this minimum (130 grams CHO/d) is recommended to maintain health and glycogen stores."

Insulin resistance is a major consideration in treating obesity and metabolic syndrome.
 It should always be a footnote in these discussions just as
LDL particle number or apoB or non-HDL cholesterol level must replace the old LDLc data because of the discordance that occurs between particle data and calculated LDLc.

Please choose  Obesity clinicians and Lipidologists who understand the new science of obesity.

See reviews
 by Frank Greenway and May 2015 and
Christopher N Ochner Feb 2015

What Docs read about low carbohydrate diets

I paid $500 to get the latest information on medical science.  

This is what I got for my money on Low Carbohydrate Diets. 

Obesity in adults: Dietary therapy

Author
George A Bray, MD

Section Editors
F Xavier Pi-Sunyer, MD, MPH
Timothy O Lipman, MD

Deputy Editor
Jean E Mulder, MD

All topics are updated as new evidence becomes available and our peer review process is complete.

Literature review current through: Jul 2016. | 

   This topic last updated: Jun 15, 2016.

Low-carbohydrate diets —  

Proponents of low-carbohydrate diets have argued that the increasing obesity epidemic may be in part due to low-fat, high-carbohydrate diets. 

But this may be dependent upon the type of carbohydrates that are eaten, such as energy dense snacks and sugar or high fructose containing beverages.

The carbohydrate content of the diet is an important determinant of short-term (less than two weeks) weight loss.

Low- (60 to 130 grams of carbohydrates) and

very-low-carbohydrate diets (0 to less than 60 grams) <60 grams="" span=""> have been popular for many years [20].

Restriction of carbohydrates leads to glycogen mobilization

 and, if carbohydrate intake is less than 50 g/day, ketosis will develop.

 Rapid weight loss occurs, primarily due to
1- glycogen breakdown and
2-fluid loss
rather than fat loss.


Low- and very-low-carbohydrate diets are more effective for short-term weight loss than low-fat diets,
 although probably not for long-term weight loss. 

A meta-analysis of five trials found that the difference in weight loss at six months, favoring the low-carbohydrate over low-fat diet,
was not sustained at 12 months [27]. (See 'Choice of diet' below.)

I looked up this (27)reference and found this chart:

 Then I looked up the original Brehm trial which went out to 2 years:

 I then went to a more recent head to head 2 year Shai Trial:

 I must say I don't think I am getting my $500 worth of UP TO DATE material.

Back to UP TO DATE article:

Low-carbohydrate diets may have some other beneficial effects with regard to
1- risk of developing type 2 diabetes mellitus,
2- coronary heart disease, and
3-some cancers,
particularly if attention is paid to the type as well as the quantity of carbohydrate.

A low-carbohydrate diet can be implemented in two ways,
 either by
1-reducing the total amount of carbohydrate or by
2- consuming foods with a lower glycemic index or glycemic load (table 3).

Glycemic index and load are reviewed separately.
 (See "Dietary carbohydrates", section on 'Glycemic index'.)

If a low-carbohydrate diet is chosen,
healthy choices for fat (mono- and polyunsaturated fats) and protein (fish, nuts, legumes, and poultry) should be encouraged because of the association between saturated fat intake and risk of coronary heart disease.

During 26 years of follow-up of women in the Nurses' Health Study and

20 yrs of follow-up of men in the Health Professionals’ Follow-up Study,

low carbohydrate diets in the highest versus lowest decile for vegetable proteins and fat
were associated with
1- lower all-cause mortality  and
2-cardiovascular mortality  [28].

 In contrast, low-carbohydrate diets in the highest versus lowest decile for animal protein and fat were associated with
1- higher all-cause and
2-cardiovascular  mortality.
(See "Dietary fat" and "Overview of primary prevention of coronary heart disease and stroke", section on 'Healthy diet'.)


ADA guideline 2013  

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

Jackie Boucher, MS, RD, LD, CDE, Vice President for Education, Minneapolis Heart Institute Foundation,  noted that the scientific evidence is still limited related to various eating patterns and their impact on health outcomes in individuals with diabetes. Current evidence does not strongly support one eating pattern over another. “Whether you prefer a Mediterranean, vegetarian or lower-carbohydrate eating plan is less important than finding an eating pattern that fits your food preferences and lifestyle, can be consistently followed  and that provides you with the nutrition you need for good health,” she said.
In choosing an appropriate eating plan, people with diabetes should be sure to consider individual metabolic goals, such as their glucose and lipid levels and blood pressure, the statement notes.
The new guidelines also note that there is no conclusive evidence of an ideal amount of carbohydrate intake for people with diabetes. However, the authors suggest that whatever carbohydrates are eaten should come from vegetables, whole grains, fruits, legumes and dairy products, over other sources that contain added fats, sugar or sodium. Likewise the evidence remains inconclusive for an ideal amount of total fat intake. Fat quality (eating monounsaturated and polyunsaturated fats and avoiding trans fats and saturated fats) appears to be  more important than quantity, the authors note. Although individuals working to manage their weight should still eat  even good fats in moderation.
- See more at: http://www.diabetes.org/newsroom/press-releases/2013/american-diabetes-association-releases-nutritional-guidelines.html?referrer=https://www.google.com/#sthash.rWP7ahS2.dpuf

130 grams Carbohydrate/day still advised

 

The above is from a 2016 Nutrition textbook

Dr. Ludwig has a different viewpoint in Always Hungry 
seen below:

Below from ADA guidelines 2013

Using Bioelectric Impedance Scale in Reduced obese

Bioelectrical Impedance analysis

"BIA is considered reasonably accurate for measuring groups, or for tracking body composition in an individual over a period of time,
but is not considered sufficiently accurate for recording of single measurements of individuals."

"Two-electrode foot-to-foot measurement is less accurate than 4-electrode (feet, hands) and eight-electrode measurement."

 I  am on 5 diet medications!

I am not losing weight.

However, I lost 40 lbs since I started Invokana and stopped Insulin and Actos.

Now the challenge is to maintain weight lose in the reduced obese state as demonstrated in THE BIGGEST LOSER by Gina Kolata

 Yesterday when I went to my Obesity Clinic at Stormont, the Nurse Practitioner who takes care of me was please with my body composition results.
Compare 5-16-16 when I weighed in at my lowest at 217.3 lbs to
8-17-16 at 222.5 lbs.

Without the benefit of Bioelectric Impedance Scale, one might say the five diet medications are failing.

However, in the last two months I began a high protein (2.4 mg/kg lean body weight) and circuit weight lifting of 25 repetitions to preserve muscle mass.( How to preserve muscle while losing weight)

My muscle mass increased by 1.8 lbs.
My body fat decreased by1.1%.
My fat free mass increased by 1.2%
My body water increased by 1.6%

I did this with an AD LIBITUM ADKINS DIET.   I am never hungry and I drink 2-4 oz ETOH almost everyday.

This is the Bon Vivant diet

The guidelines advise the National Weight Control Registry aspects of success.

1- weigh themselves every day

and then if 3-5 pounds heavier, they had a plan what to do about it immediately

2-they tended to have little variety in their food

3-they splurged less on food on holidays.

4-they ate 1,385 calories/day but the facilitator said they are under reporting

5-they ate 4.87 meals a day

6-they linked behaviors to something more than just losing weight.

For example they use walking as their social time.  They linked good behaviors to something they want to do.

7-they often had a life changing event such as divorce or new job.

8- they walk about five miles a day or exercise equivalent

It's also reported in Medical Clinics of North America Sept 2011 V 95 #5
on page 945:

Now compare the NWCR program to The Great Starvation Experiment done by Ancel Keys at the end of World War 2.

He put about 32 men on 24 weeks of a "starvation diet" that they had a very difficult time staying on.
It was about 1550 calories a day and they walked one hour a day.

The reduced obese are told to do this do the rest of their life.

Very few can do this for the rest of their life due to the low Leptin in the billions of shrunken fats cells that never go away.  I call this the
 Sponge Syndrome

At a Saxenda presentation I found the rules of use were CRAZy

I went to a Saxenda presentation last night and to my amazement I learned I am supposed to increase the dose every week without fail till the maximum dose.
If the patient cannot tolerate the maximum dose I have to give up on the drug. 
I can't go back to the lower dose that may have had an effective weight loss of 5%.
However if the patient tolerates the high dose and loses weight, I can cut Saxenda down to a lower dose if I wish.

10 year data on Bariatric surgery Feb 2016

52 cases over 10 years

RESULTS:

"A mean maximum percent excess weight loss of 71±25% (percent total weight loss: 28±15%) was reached at a median of 12 (range 12-120) months after SG.

 At 10 years, a mean percent excess weight loss of 53±25% was achieved by 32 patients, corresponding to a percent total weight loss of 26.3±13.4%.

Nineteen of the 53 patients (36%) were converted to Roux-en-Y gastric bypass (n = 18) or duodenal switch (n = 1) due to
1- significant weight regain (n = 11), 
2-reflux (n = 6), or
3-acute revision (n = 2)
at a median of 36 months.

Two patients died at 3 and 101 months postoperatively, unrelated to SG.

A total of 31 patients (59%) suffered from weight regain
of 10 kg or more,
among them 24 patients (45%) with 15 kg or more,
16 patients (30%) with 20 kg or more,
 and 7 patients (13%) with 25 kg or more weight regain from nadir.

 Mean BAROS  (Bariatric Analysis and Reporting Outcome System) score was 2.4±2.2 at 10 years follow-up, classifying SG as "fairly efficient."

I have two questions.
1-How many patients gained all their weight back after 10 years?  

2-Was diet medication considered in the treatment of the regain? 

The best way to maintain weight loss

NHLBI "Guideline"
 suggests adding diet medicine to maintain weight loss.

My Blogs on using Diet Medications

Guidelines choose drugs without head to head trials?

"In the absence of high quality head-to-head drug comparison trials to determine the relative efficacy of the individual drugs, choice of therapy should be based upon
1- efficacy,
2-safety,
3-cost, 
4-convenience,
5-and other patient-related factors [30,31]."

The above is from Up To Date on choosing drugs for Osteoporosis.



Below is criteria for choosing drugs from a Consensus Committee
 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk.

The process employed in the creation of the ECDP document was supported by the ACC without external funding - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.cv2ZMPed.dpuf

 "The process employed in the creation of the ECDP document was supported by the ACC without external funding"

the value of patient-provider interaction in clinical decision making when non-statin therapies are considered, examining the extent of available scientific evidence for net clinical benefit, safety and tolerability, potential for drug-drug interactions, efficacy of additional LDL-C lowering, cost, convenience and medication storage, pill burden, route of administration, and patient preferences; - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.cv2ZMPed.dpuf

"the value of patient-provider interaction in clinical decision making when non-statin therapies are considered,
1-examining the extent of available scientific evidence for net clinical benefit,
2- safety and
3- tolerability,
4- potential for drug-drug interactions,
5-efficacy of additional LDL-C lowering, 
6-cost, 
7-convenience and
8-medication storage,
9-pill burden,
10-route of administration, and
11-patient preference"


 NEJM article Head to Head trial

"As compared with ezetimibe, niacin had greater efficacy regarding the change in mean carotid intima–media thickness over 14 months (P=0.003), leading to significant reduction of both mean (P=0.001) and maximal carotid intima–media thickness
Paradoxically, greater reductions in the LDL cholesterol level in association with ezetimibe were significantly associated with an increase in the carotid intima–media thickness (R=–0.31, P<0 .001="" p="">
Interestingly there are head to head trials with Niacin.
Most famous is the Coronary Drug Project 
in which
"Mortality in the niacin group was 11% lower than in the placebo group (52.0 versus 58.2%; p = 0.0004)" after 15 years.

Yet somehow Niacin failed to make the list of non-statin drugs allowed on the list yet PCSK9 which is $1,000 a month, has no outcome studies and is given intravenously is on the list?

Niacin was dropped from guidelines because of  AIM-HIGH and HPS-THRIVE were stopped early.


These were not LDLc lowering trials.  LDLc was already at goal with statins.
These were HDLc and triglyceride trials.

Why then are they used against Niacin in a guideline that has in its criteria:
5-"efficacy of additional LDL-C lowering," 

This is the result of Niacin's effect on LDLc in AIM-HIGH

aa

IMPROVE Trial quote :

"It took 7 years of follow-up for us to reach that many events, so some investigators were wondering if this would be the eternal trial," Cannon said. "But that was really good news because it meant that the treatment was working: we were actually doing good for our patients."
It should, however, be noted that 42% of patients, regardless of treatment, stopped the study drug before the end of the trial.

Zetia was added to the list by the consensus committee because it had the IMPROVE-IT positive outcome.

If AIM-HIGH went out to 7 years it may also have had a positive outcome.  It was a government study however.
There were some illnesses in patients on Niacin and AIM-HIGH was stopped early.  Later these illnesses were found not to be statistically significant but I believe it is the reason the committee left Niacin off the list of advised drugs. 

<0 .001="" p="">

Point Counterpoint on Saturated Fats from Nutrition text

From text 14th edition, Feb 26, 2016

Nutrition: Concepts and Controversies by Frances Sizer and Ellie Whitney


page 199

 

It take 14 years for a new idea to be accepted

Finally after the Biggest Loser Data,  science is being accepted and believed.

What’s All This Talk About Slow Metabolism?



The Reduced obese state has been well known for many years.
 I learned about it at The Obesity Society Meeting In Orlando in 2011.

Gina Kolata wrote about Rosenbaum and Liebel's work in her excellent book Re-Thinking Thin from April 2008.

 I learned from these sources and developed the The Sponge Syndrome.
 When the Obese become the Reduced obese they retain the billions of excess fat cells in the form of shrunken fat cells that are low in Leptin.
This deficiency makes the brain believe the body is starving and will not stop believing it is starving until the billions of excess fat cells are replenished with fat.
For years the reduced obese have been told to exercise 40-60 minutes a day and eat 1200 to 1500 calories a day to maintain weight.  Interestingly, this is this the same program Ancel Keys put 32 volunteers on to test a Starvation diet for 24 weeks.  

 This is why the reduced obese regain weight despite exercise and relatively low calorie intake.

Joint British Societies' consensus JBS3

1.2.4 Lifetime risk for CVD

Age and gender, which are not modifiable, are such powerful determinants of absolute CVD risk over the relatively short 10-year period, that individuals only cross the pre-set threshold of risk (currently 20%) that mandates drug treatment at an older age, despite having important modifiable CVD risk factors from much earlier in life. 

In the USA, it has been estimated that up to half of the adult population (predominantly young individuals and women) have a low 10-year CVD risk (<10 b="">but nevertheless have a high risk of a future event (>39%) over their lifetime.13

 

 With the current approach to risk stratification, such individuals do not get effective risk factor reduction until late in the evolution of their disease, potentially missing the opportunity to influence favourably CVD evolution. 

Recent risk factor guidelines have attempted to overcome this important problem by ‘extrapolating risk from elderly patients back to younger patients’ but these projections are not easy to understand and are subject to many assumptions.14 

There is considerable scope for improvement in the communication of CVD risk to patients and the public.

Most surveys suggest that the majority of the public underestimate their lifetime risk of developing and dying of CVD, considering cancer to be a greater threat despite robust evidence to the contrary.

1.2.5 JBS3 lifetime risk approach

A key change in the new JBS3 Guidelines is the adoption of a ‘lifetime risk’ approach to assess and communicate CVD risk, in addition to 10-year absolute risk estimates.

 This change is based upon several lines of evidence. 

 Although most CVD events occur after the age of 50 years,

 the atherosclerotic process begins many years earlier, 

often from the first decade of life.

Studies have confirmed a steady increase in the presence of atherosclerosis with age in individuals dying from non-cardiac causes.15 

Exposure to CVD risk factors occurs from early life and this has been shown to promote the progression of this long preclinical phase of arterial disease.

 In large observational trials, levels of classical CVD risk factors in adolescents (including LDL-c, BMI, smoking, and BP) have been associated with increased carotid intima–medial thickness measurements in adulthood, a marker of emerging arterial disease. 

The epidemic of obesity and the resulting increase in type 2 diabetes in the young is likely to accelerate disease progression and is predicted to have a substantial adverse impact on the prevalence of CVD in the population over the next 20 years.16

The emergence of CVD appears to be related to long term and cumulative exposure to causal and modifiable risk factors. 

The Framingham Heart study examined the relationship between CVD risk profiles at the age of 50 years in men and women and the risk of subsequent CVD events, and showed a large difference in outcomes dependent on risk profiles at this age.17 

This emphasised the importance of the interaction between risk factors and the arterial wall in early life, suggesting that prevention efforts need to begin earlier. 

The importance of this risk factor exposure for future CVD was confirmed in a meta-analysis of studies which included more than a quarter of a million men and women, and showed a strong influence of CVD risk factors on lifetime risk of CVD.18 

This suggests that there is an opportunity to modify the evolution of disease by earlier intervention.

All studies on the impact of CVD risk factors in the young and the potential benefits of early treatments have been observational and use surrogate measures of CVD. 

Prospective randomised trials to evaluate the impact of risk factor lowering from a young age on CVD event rates in later life would need to be very long and are not feasible.

 Indirect evidence from genetic studies, however, and more direct evidence from intervention trials support the concept that a longer period of cholesterol lowering (and other risk factor lowering) could leverage larger reductions in later CVD risk.

 The Atherosclerosis Risk In Communities (ARIC) study reported that a rare genetic variant in the population resulted in lower PCSK9 values (now an important target for drug treatment), 

with 28% lowering of lifetime LDL-c concentrations.19 

This was associated with an 88% reduction in future CVD events.

More recent work has confirmed that genetic variants which are associated with lower LDL-c values over life are associated with substantially better outcomes than those which can be achieved by equivalent LDL-c lowering with statins in later life.20 

 FH is perhaps the best example of a monogenic disorder which elevates a causal risk factor, LDL-c, and which results in rapid early manifestations of atherosclerosis and premature CVD morbidity and mortality. 

 In this context, the concept of statin treatment from a young age to reduce lifetime risk is already universally accepted.

 The benefits of early statin use have been shown on progression of carotid intima–media thickness (cIMT), even in prepubertal children.

Up to Date not very Up to Date on Lipid therapy

This Consensus statement  below
 came out before the last review of the literature by UP TO DATE

A Consensus Approach to the Use of Non-Statin Therapy for Atherosclerotic Cardiovascular Disease Prevention - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.anm24eQB.dpuf

A Consensus Approach to the Use of Non-Statin Therapy for Atherosclerotic Cardiovascular Disease Prevention

A Consensus Approach to the Use of Non-Statin Therapy for Atherosclerotic Cardiovascular Disease Prevention - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.anm24eQB.dpuf

"Unlike the ACC/AHA Blood Cholesterol Guideline, but consistent with the NLA Recommendations Part II,4
the ECDP gives recommendations
on the order in which specific non-statin therapies should be considered, providing a perspective that is useful to the practicing clinician.

 Generally, ezetimibe is recommended as the initial add-on agent, based upon its demonstrated efficacy in ASCVD risk reduction, tolerability, safety and low pill burden.

Bile acid resins are generally reserved for those who require additive therapy, but are unable to tolerate ezetimibe.

PCSK9 inhibitors are recommended for consideration solely in high risk individuals with ASCVD or LDL-C ≥190 mg/dL after therapy with the previously mentioned agents fail to provide sufficient additional LDL-C lowering, but these agents are not recommended in those with these conditions who are pregnant or imminently contemplating pregnancy."

 My opinion.
It's outrageous to not include Niacin at 1,000 mg as an alternative drug. 
It has many trials of success behind it. 
It can be purchased over the counter very inexpensively. 
It is very safe at low dose. 
Used with low dose statin it is very effective at lowering LDLc. 

PCSK9 inhibitors cost $1,000 a month and have no outcome studies. 

AIM-HIGH trial was stopped after 3 years for non-significant bad side effects. 
 If trial continued as long as the Zetia trial it would probably have had a positive trial.  
AIM-HIGH data from Dr Terry Jacobson slide from Masters Program NOLA, NLA 2016

Unlike the ACC/AHA Blood Cholesterol Guideline, but consistent with the NLA Recommendations Part II,4 the ECDP gives recommendations on the order in which specific non-statin therapies should be considered, providing a perspective that is useful to the practicing clinician. Generally, ezetimibe is recommended as the initial add-on agent, based upon its demonstrated efficacy in ASCVD risk reduction, tolerability, safety and low pill burden. Bile acid resins are generally reserved for those who require additive therapy, but are unable to tolerate ezetimibe. PCSK9 inhibitors are recommended for consideration solely in high risk individuals with ASCVD or LDL-C ≥190 mg/dL after therapy with the previously mentioned agents fail to provide sufficient additional LDL-C lowering, but these agents are not recommended in those with these conditions who are pregnant or imminently contemplating pregnancy. - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.rZvrT124.dpuf

Unlike the ACC/AHA Blood Cholesterol Guideline, but consistent with the NLA Recommendations Part II,4 the ECDP gives recommendations on the order in which specific non-statin therapies should be considered, providing a perspective that is useful to the practicing clinician. Generally, ezetimibe is recommended as the initial add-on agent, based upon its demonstrated efficacy in ASCVD risk reduction, tolerability, safety and low pill burden. Bile acid resins are generally reserved for those who require additive therapy, but are unable to tolerate ezetimibe. PCSK9 inhibitors are recommended for consideration solely in high risk individuals with ASCVD or LDL-C ≥190 mg/dL after therapy with the previously mentioned agents fail to provide sufficient additional LDL-C lowering, but these agents are not recommended in those with these conditions who are pregnant or imminently contemplating pregnancy. - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.rZvrT124.dpuf

Unlike the ACC/AHA Blood Cholesterol Guideline, but consistent with the NLA Recommendations Part II,4 the ECDP gives recommendations on the order in which specific non-statin therapies should be considered, providing a perspective that is useful to the practicing clinician. Generally, ezetimibe is recommended as the initial add-on agent, based upon its demonstrated efficacy in ASCVD risk reduction, tolerability, safety and low pill burden. Bile acid resins are generally reserved for those who require additive therapy, but are unable to tolerate ezetimibe. PCSK9 inhibitors are recommended for consideration solely in high risk individuals with ASCVD or LDL-C ≥190 mg/dL after therapy with the previously mentioned agents fail to provide sufficient additional LDL-C lowering, but these agents are not recommended in those with these conditions who are pregnant or imminently contemplating pregnancy. - See more at: http://www.acc.org/latest-in-cardiology/articles/2016/04/07/14/32/a-consensus-approach-to-the-use-of-non-statin-therapy-for-atherosclerotic-cardiovascular-disease-prevention#sthash.rZvrT124.dpuf

Interesting when experts disagree

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Naturally, when I found the authors of this section disagree with 2014 guidelines I thought how bold of them to Update guidelines.   Just what I am looking for.   

We disagree with the 2014 American Heart Association and American Stroke Association (AHA/ASA) guidelines that recommend...