March 19th, 2014
New Statin Guidelines Recommend Therapy for 12.8 Million More Adults Than The Prior Guideline
Larry Husten, PHD
Millions more people are now eligible for statin therapy under the new cholesterol guideline published last year, according to a new estimate published in the New England Journal of Medicine.
Under the earlier guideline statins were indicated for primary and secondary prevention based largely on LDL cholesterol levels. The new guideline, announced last year, places much less emphasis on LDL and instead puts a much greater emphasis on the future risk of individuals for heart disease and stroke. The most important change is in primary prevention. Now, patients who have LDL cholesterol levels as low as 70 mg dl and no established cardiovascular disease are eligible for statin therapy if they have diabetes or a 10-year estimated risk of CV disease of 7.5%.
There have been many attempts to quantify just how many more people are now eligible for statin therapy under the new guideline. In the new paper in NEJM, Michael Pencina and his colleagues estimate that the new guideline results in a net increase of 12.8 million people presently eligible for statins. Most of the newly eligible people are older adults without cardiovascular disease.
The researchers extrapolated from data from a representative sample of the US population (the National Health and Nutrition Examination Surveys, or NHANES) and calculated the number of adults 40-75 years of age who would be eligible for statin therapy under the old guideline and the new guideline:
- Under the old guideline 43.2 million adults, or 37.5% of the population, were eligible for statins.
- Under the new guideline this increases to 56 million (48.6%). Three out of 5 of the newly eligible patients would be men and their median age would be 63.4 years.
- The net increase in 12.8 million comes mostly from primary prevention– 10.4 million.
- Most of the increase occurs in older adults, between 60 and 75 years. Just under half (47.8%) of this population was eligible for statins in the earlier guideline. Now more than three-quarters (77.3%) of this age group are eligible.
- Lowering the treatment threshold to a 10-year risk starting at 5%, which the guidelines deem “reasonable,” would increase eligibility to 38.4% of adults between 40 and 60 and 87.4% of adults between 60 and 75.
- By increasing the number of people eligible for treatment, the new guideline has increased sensitivity— that is, it will result in more people being treated who would otherwise have gone on to have a cardiovascular event– but also decreased specificity— more people will receive treatment who would not have had an event.
- The authors estimated that the increased number of people taking statins would result in 475,000 fewer events– nearly all (90%) coming from the group of older adults.
In an email interview, Allan Sniderman, one of the senior authors of the paper, said that the increase in the population eligible for treatment “has major consequences for cost and medicalization.” He agreed with other observers that the 7.5% threshold cutoff “is arbitrary.” “The way out is to better define risk. That is where we need to move forward,” he said.
An alternative to the “risk-based approach” of the new guideline, Sniderman said, is “a cause-based approach in which we identify and treat the causes in order to prevent the intramural atherosclerotic disease that will produce the clinical events.” But this approach, he acknowledged, will require more research before being adopted by future guidelines.
The NEJM paper fails to take into account the more subjective side of the new guideline, said Harlan Krumholz in an email. “The guideline recommendation is intended to be just that – a recommendation about a threshold that might make sense to use in a treatment decision. The guidelines are clear that the patient’s preference is what matters most. So it is really impossible to know if more people will be taking statins.”
9 Responses to “New Statin Guidelines Recommend Therapy for 12.8 Million More Adults Than The Prior Guideline”
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The guidelines do not define who is eligible for statins. They state that among those who are eligible for primary prevention, they recommend statins based on a risk assessment – but say clearly that the ultimate decision is based on the patient’s preference. So they are not defining eligibility – some may consider this nitpicking or a difference without a distinction – but I think that the words do matter.
Here is what the guidelines say:
Conclusion
On the basis of the above tenets and its review of the evidence, this guideline recommends initiation of moderate or intensive statin therapy for patients who are eligible for primary CVD prevention and have a predicted 10-year “hard” ASCVD risk of ≥7.5%. This guideline recommends that initiation of moderate-intensity statin therapy be considered for patients with predicted 10-year “hard” ASCVD risk of 5.0% to <7.5%.
and
Assessment of the potential for benefit and risk from statin therapy for ASCVD prevention provides the framework for clinical decision making incorporating patient preferences.
I have long been telling my colleagues, statins and ace’s should be in the water, along with low dose asa
It is reasonable to let the patients decide themselves provided that they are informed about the benefits and risks. As I wrote in a letter to BMJ: In case you have a healthy patient with high cholesterol, tell him/her the following: Your chance to prolong your life is minimal. Your chance not to get a non-fatal heart event during the next five years according to Cochrane is 97.1 per cent. You can increase your chance to 98.1 per cent if you take a statin every day. But then your risk of suffering muscle problems is about 25 per cent unless you never exercise (1); your risk of becoming sexually impotent is about 20 per cent (2); your risk of suffering from diabetes is almost 4 per cent (3), and you also run a risk of memory loss, liver damage, peripheral neuropathy, cataract, and also cancer (4), but we do not yet know how large these risks are. And don´t forget that many non-fatal heart events may heal with minor health consequences or none at all.
1. Sinzinger H, Wolfram R, Peskar BA. Muscular side effects of statins. J Cardiovasc Pharm 2002;40:163-71.
2. Solomon H1, Samarasinghe YP, Feher MD, Man J, Rivas-Toro H, Lumb PJ, et al.. Erectile dysfunction and statin treatment in high cardiovascular risk patients. Int J Clin Pract. 2006;60:141-5.
3. Culver A, Ockene IS, Balasubramanian R, Olendzki BC, Sepavich DM, Wactawski-Wende J et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s Health Initiative. Arch Intern Med. 2012;172:144-52
4.Ravnskov U. Rosch PJ, McCully KS. The statin-low cholesterol-cancer conundrum. QJM doi:10.1093/qjmed/hcr243
Side effects of statins is overrated. I believe that patients benefit from statin therapy. We do not have more weapons for the treatment of ASCVD. However difficult to persuade patients to use statins. Nevertheless, we need to work on this issue. I believe it is sensible of the recommendations in the new guidelines.
The largest increase in eligible patients for statin use would be among people over 60 years old, otherwise free of previous CVD. The authors argue that since cardiovascular events affect increasingly more people over 60, such a strategy might be provén adequate. It is worth remembering, however, that for the same age group, the same organizations – ACC and AHA – havê releases new hypertension guidelines that accept higher treatment targets for systolic blood pressures. Would the adoption of such guidelines have the potential of neutralizing the expected benefits of a widespread statin prescription for primary prevention in seniors?
For prevention, patient preference is paramount.
One way to express it is that, for an average man over 35, taking a statin is more likely to prevent death as wearing a seatbelt when driving (which almost everyone is happy to do). By the age of 60, the statin is 47 times more likely to prevent death than a seatbelt is.
http://www.sciencedirect.com/science/article/pii/S016752731001017X
Meanwhile, although symptoms are commonly reported when statins are taken, they are almost all equally commonly reported when a placebo is taken in a randomized blinded trial environment.
http://cpr.sagepub.com/content/21/4/464
To help patients make choices that are genuinely right for them, we can keep looking for reliable information, and conveying it to them in a way that is easily interpreted.
Dr. Ravnskov – the ‘risk discussion’ that I had with my patients in clinic yesterday was entirely different than what you recommend. For one thing, I do not emphasize side effects to the extent that you do. I agree with Dr. Altunkan on that point. I would submit that we should consider the totality of literature and not cherry pick studies. For example, for systematic reviews on the question of memory and cognition, see: Mayo Clin Proc. 2013;88:1213-21 and Ann Intern Med. 2013;159:688-97. The 2013 ACC/AHA guidelines state, “The panel did not find evidence that statins had an adverse effect on cognitive changes or risk of dementia”
Our completely different approaches to a patient-centered risk discussion tells me that it could be helpful if the next versions of the ACC/AHA guidelines and other guidelines around the world include even more explicit recommendations on what should and should not be included in such a discussion.
Dr. Kaiser – I think you pose a very important question. But to be clear – the ACC/AHA did not release the latest hypertension guidelines calling for an increase in the SBP treatment threshold from 140 to 150. They were released independently by the expert group appointed to JNC8. They were not endorsed by any professional societies. My understanding is the the ACC/AHA is developing its own hypertension guidelines.
With these new guides a lot of patients over 60 will require statins for prevention of CVD. Many of my patients wonder if old age is not only a risk factor but a incurable disease. I agree 100% patient’s preference is fundamental, but how do they choose? Are we inadvertently transmitting fear or a wrong message to the public. I am in favor of tailored medicine. How many people surfing the internet will understand the new message? Not many. Do we have the man power to educate all of them? It will take time, in the mean time if we are not careful many unscrupulous people will use this in an unethical way, taking advantage and transmitting fear to grow old and many other things. If in the medical community we have conflicting opinions and for the moment this is a very controversial topic imagine how bad is the situation in the community.
The 2013 Nobel Prize laureates James E. Rothman, Randy W. Schekman and Thomas C. Südhof “for their discoveries of machinery regulating vesicle traffic, a major transport system in our cells”
The important thing in this respect is that all vesicle traffic and transport heavily relies on lipid rafts in the cell membrane. Those lipid rafts are required for transmembrane transport. Those lipid rafts are very high in cholesterol and they do not work without a high cholesterol concentration.
So by reducing cholesterol synthesis by statins the patient will have side effects due to cholesterol deficiency. To name a few
The neurotransmittors in the brain are depending on lipid rafts and cholesterol, less cholesterol means less neurotransmitter release and slower thinking. Is called “natural ageing” by your doctor when you are 50 years old.
The neurotransmittors between peripheral nerves and muscle cells are depending on lipid rafts and cholesterol, less cholesterol means less neurotransmitter release and muscle weakness and muscle aches. Is called “natural ageing” by your doctor when you are 50 years old.
The release of insulin is depending on lipid rafts and cholesterol, less cholesterol means less release of insulin and more symptoms of diabetes.
This is the reason patients fare ill when they start statins.
So stop prescribing statins as they have not been shown to increase survival