As the whole world knows by now, the American College of Cardiology and American Heart Association have announced new guidelines for use of lipid-lowering drugs. The big shocker was that they no longer recommend using cholesterol levels as a therapeutic target. Statins lower risk in patients at risk; that is what we all know, and all you need to know.
Well. Where do we go from there? We need to identify our at-risk patients and put them on statins for the rest of their lives. But who, exactly, is at risk? Ay, there’s the rub. And that is where the ACC/AHA ran afoul of the critics. They used data from the bad old days (when people smoked and didn’t take ACEs and ARBs to control their blood pressure) to calculate (and overestimated) who would have a 7.5% risk of a cardiovascular event in the next 10 years.
Maybe some who read this can remember the bumper stickers from the 1960’s that said: “Question Authority”. The poor guy with a 7.4% risk goes through life statin-less and unprotected, while his 7.5% neighbor has 10 years of clear sailing on 40 mg/day of atorvastatin? That seems a little arbitrary. Throw out ezetimibe, niacin and fibrates? That could turn out to be a little hasty. After the first prescription for a statin, never draw another serum cholesterol? But, doc, how will I know if it’s working?
The next issue of Treatment Guidelines from the Medical Letter (January 2014) will be on Drugs for Lipids. We will mention the new guidelines, of course. But we might also leave a little room for clinical judgement. Watch your newsstand.
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Having studied this quite a bit, and am unawre of any credible controlled clinical trial data to support the use of ezetimibe. It should be thrown out. The data on niacin and fibrates is very thin, suggesting that these agents are probably not particularly helpful in reducing important cardiovascular endpoints. Most people on these agents don’t need them.
A huge concern should also be the new calculator puts at risk (>7.5%/10 years) practically every male in America who is at least 62 years and has a normal BP without drugs, has optimal lipids, and is not diabetic. When the benefits may be really small are the possiblities of harm too great?
@ William Jones – Excellent point you make that I totally agree with. Despite any new Guidelines that the ACC/AHA may have come out with – I believe primary prevention in a 62-year old man as you describe should be decided by shared decision-making with informed consent. What might be perceived by one such 62-year old as worth taking a statin – might not by another. Rather than decree of “statins for all” – shouldn’t the informed patient be presented with NNT (Number-Needed-to-Treat) for potential benefit vs NNH (Number-Needed-to-Harm) by taking a statin or not? How many informed patients would want to take a statin for 5 years if NNT was 1 in 50? (such that only 1 out of 50 patients will benefit from primary prevention by taking a daily statin – whereas the other 49 patients get NO benefit at all, yet are subject to potential for harm from adverse effects + cost of drug). I eagerly await Mark Abramowicz’ next issue with his “take” on this changing subject.
Thanks for the rely.
As I look at this, if a 62 year old white male with optimal lipids (TC 170, HDL 50) who does not smoke, does not have diabetes, is not taking meds for hypertension with a SBP of 120 or 110 has a calculated 10 year risk of 7.9% an 6.9%, respectively. The absolute 10 year difference is obviously 1%, and the RRR is 14%. The NNT is 100! Another way to ask is treatment needed is to look at the rate of being disease free. In this case, the two different scenarios would give 92.1% (SBP 120) and 93.1% (SBP 110). I think most patients would conclude that 92% and 93% are really similar and might not be worth treating. Agree that costs should be factored into this. If a generic drug is used (e.g., pravastatin 40 mg to get moderate lowering of LDL), the patient’s cost might be $48/year since on a “$4 list”. That would mean it would cost $24,000 to treat 100 patients for 5 years at $4/month to prevent ONE CV event. However, in the system I work in, using atorvastatin 20 mg would cost almost $115,000 for the same 100 patients and rosuvastatin 10 mg would cost just over $1,000,000 to prevent one CV event. This should also be factored into whatever decision making occurs.