I just read A systematic review and meta-analysis on the therapeutic equivalence of statins. This artilce will not make any major U.S. headlines because it is a Taiwanese study from a not very well known journal. However, the methodology is sound and makes an important point to patients who need a statin and are deciding between a generic and more expensive brand name medication.
The study did a systematic review of all the studies which compared the different statins. They found that at comparable doses, statins are therapeutically equivalent in reducing LDL (or bad cholesterol). This would suggest that if statins are essentially equal, provided you use the right dose, then you should always go with a generic. However, the other thing they found was that "the only two statins that could reduce LDL-C more than 40% were rosuvastatin and atorvastatin at a daily dose of 20 mg or higher." In other words, those patients who need cholesterol lowering drugs and have to get their cholesterol down by less than 40% should be OK with generic, but those who need to get their LDL cholesterol by more than 40% should use either Crestor (rosuvastatin) or Lipitor (atorvastain). Though new guidelines should be out by the end of the year, current guidelines suggest that patients with increased risk for heart attack and stroke (all diabetics, mulitple risk factors,etc.), who are generally the patients we use statins in, need their LDL's under 100. This means that if you are at increased risk for heart attack and stroke, and your LDL is 160 or above, you should not take the generic (even if it is cheaper), but take the more expensive branded cholesterol medicines.
Fortunately, as I mentioned in a recent post Are Drug Reps and Free Samples Bad For Patients? It Depends, both companies offer coupons to offset the additional out of pocket costs, so you should not pay much more for Crestor or Lipitor than what you would pay for a generic medication.
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There is a simple and practical approach that is not mentioned here - and rarely mentioned elsewhere.
1. Tell the patient what the goal is (e.g., LDL < 100 or LDL ~ 70) and why.
2. Explain (truthfully) that studies suggest that in large populations, the newer branded and more $ meds are more potent, but that in individuals, the response is less predictable
3. Offer to start the patient on a less expensive generic and set up an appointment to review the results - and discuss changing meds if the response is not optimal - after several monthly stepwise dose increases of the generic.
Advantages: the patient is involved in the decision making and understands the goal and the plan, some patients will be adequately managed with less expensive meds, and only those who stand to benefit the most will be moved to more expensive meds.
I don't see why this isn't the default approach.
pheski,
Thanks for the comment. This approach is not unreasonable. However, I do not recommend it because:
1. Though individual response is variable, it is still relatively predicatable. In other words, it is possible to get a 40% reduction of LDL with simvastatin 40mg, but pretty unlikely.
2. Primary care doctors as a whole, do not titrate. This has been studied many times, and specifically with statins. Once a statin is started it is rarely titrated up. There are probably lots of reasons for this, such as setting up a second appointment, reluctance to try something new, etc.
3. Stepwise dose increase doesn't work. Rules of 6's and 7's state that each doubling of a statin gives you about an additional 6-7% reduction in LDL. In other words, if you give simva 40mg and get a 30% reduction, doubling to 80mg will only get you to 36%.
Now,now,Dr. Mintz, please find me a proper study that having a cholesterol level lower than 180 has any health benefits.
or less than 200.
or less than 220.
Dolev,
There are numerous studies that show the benefits of lower cholesterol. The evidence is staggering. Best place to start would be the
ATPIII Guideline published in 2001 as well as the
Update in 2004
that reviewed 5 large trials between 2001 and 2004 and updated the ATPIII recommendations. The next guideline should be out by the end of the year.
Vitamin C also lowers cholesterol:
VITAMIN C AND CHOLESTEROL - RESEARCH
Annals of the New York Academy of Sciences, Vol 258, Issue 1 410-421
Ascorbic acid in cholesterol and bile acid metabolism
E. Ginter
chronic ascorbic acid deficiency provokes in guinea pigs a metabolic disorder in the liver, causing an impaired cholesterol transformation to its principal catabolic product, bile acids. High doses of ascorbic acid significantly stimulate cholesterol transformation to bile acids in guinea pigs and decrease plasma cholesterol concentration in humans.
International Journal of Vitamin Nutritional Res. 1977;47(2):123-34. PMID: 881295
Effect of ascorbic acid on plasma cholesterol in humans in a long-term experiment.
Ginter E, Cerna O, Budlovsky J, Balaz V, Hruba F, Roch V, Sasko E.
ascorbic acid in a dose of 2 x 500 mg per day was administered to 82 men and women aged 50-75 years…the higher the initial cholesterolemia, the greater the hypocholesterolemic effect of ascorbic acid…In all these time intervals, ascorbic acid was found significantly to depress cholesterolemia and its effects persisted 6 weeks after termination of the experiment…The administration of 2 x 500 mg ascorbic acid daily during one year resulted in … a marked accumulation of ascorbic acid in the leucocytes.
Atherosclerosis. 1976 Jul-Aug;24(1-2):1-18.
The role of ascorbic acid in the regulation of cholesterol metabolism and in the pathogenesis of atherosclerosis.
Turley SD, West CE, Horton BJ
chronic vitamin C deficiency leads to hypercholesterolemia …Ascorbic acid supplementation of the diet of hypercholesterolemic humans and animals generally results in a significant reduction in plasma cholesterol concentration.
Dolev,
You references are so old I do not have access to the full text to read them myself. It appears some of the data is not human data, it is unclear whether these were randomized trials, and most importantly it is not clear what the magnitude of cholesterol lowering Vitamin C showed. Cheerios lowers cholesterol and has proved to do this in a randomized trial. Problem is that the amount that Cheerios lowers cholesterol is so small it is unlikely to be clinically siginficant, i.e. prevent heart attacks or stroke. We do know that when we randomized patients at risk for heart attack and stroke to Vitamin C/E and placebo, the patients on the vitatmins had MORE heart attacks.
I get that you are interested in supplements and vitamins. I am not against their use, but they have not proven to show any benefit in people with adequate nutrition. Statins have shown substantial benefit in preventing heart attacks and strokes, and a small but not insignificant benefit in saving lives.
DR Mintz It isn't how old a study is that matters, What matters is the medical community embraces the findings. It took years for Medicine to promote the use of 2 baby aspirins to save lives and it will take years for medicine to promote Vitamin C as an alternative to RX drugs ... doctors are bombarded by drug reps on a daily basis It is so much easier to pop a pill how about making your patients be responsible for their own health ... no mention by you of diet first life style changes exercise weight control We consume JUNK and clog our arteries and then want a pill to fix it and you supply it shame on you! Humans do not make vitamin C as other animals do we must consume it and it is depleted quickly due to all sorts of internal (diet) and external (toxins) factors so take my challenge put your patients on 500mg of Vitamin C 4 times a day for 2 months and the HDL will rise and the LDL will drop there is no profit to the drug companies if Vitamin C is promoted for high LDL treatment and you can write a paper on your treatment and no one will pay attention because as we all know MONEY MAKES the WORLD GO ROUND and there is no money in it for the drug companies get back to basics I have been a nurse for 39 years and I have seen the lack of diet therapy by doctors for years its too much work My patients want the easy way out if I don't give them a "Magic Pill" they will go to another doctor you need to re educate your patients and other doctors we our killing our bodies and all these Magic pills are only covering the symptoms not solving the problem yours truly getbacktobasics
getbacktobasics here again re reading your response to "dovel" the term people with adequate nutrition how many nutritional evaluations of your patients have you done? Do you even ask your patients what they are eating? science has I repeat has proven that high LDL in directly related to High intake of trans fats in the diet. wake up!! We as humans do not make Vitamin C so we are always lacking , vitamin C acts as a antioxidant we need to promote a healthier life style its not a easier road to travel and patients may be noncompliant at times but I truly believe adding pills and pills and more pills is not the answer to the problem and soon we have a patient with more problems related to side effects then we originally started with so we add more pills When I go to the Doctor at the age of 58 they say you don't take any meds ? no My goal is to stay drug free as long as possible the average american takes a drug for diabetes hypertension high cholesterol and they are all compounded by one another "back to basics DIET we as a people do not have "adequate nutrition" Most people eat fast food sugared drinks way too many fatty foods we have more food in this country than most but are "nutrition" sucks Educate your patient MC Donalds started in the 50's ? so did our rise in heart disease any relationship? Why is the "south" the heart attack capital DIET DIET DIET chew on that
backtobasics suggested reading for you published march 31 2010 in PubMed.gov Diet and Chronic Diseases:INCAP Studies of atherosclerosis and coronary heart disease study showed that fatty diets cause heart disease back to basics give a pill quick cure life is more basic a healthy life is obtainable if you would monitor your patients diet as well as their lab work
back to basics again please read Harvard School of public health 2009 Impact of Genetics,stress and and lifestyle Q&A with Eric Rim director of program in cardiovascular epidemiology you might learn something and add nutrition to your patient protocol yours truly backtobasics
backtobasics Dr Mintz do you tell your patients about the side effects of Lipitor ? kidneys liver and thyroid problems as well as muscular If they had a choice to spend a $100 a month on a magic pill or healthy foods they might choose food if they Knew all the bad thing it could do to them and isn't a Dr Oath first to do no harm? 20 years from now a study will come out that we did more harm then good with many of these drugs instead of teaching our patients about nutrition and lifestyles
ter,
there is no question that diet and exercise is important. In the past 10 years we have almost doubled the number of Americans that are overweight and obese. The same trend is seen with the incidence of type2 diabetes. Our country as a whole needs to "get back to basics" with better nutrition and exercise. This is going to take major public health efforts.
As a physician, I treat patients. Of course, I stress diet and exercise. However, there are certain people who need medication to decrease risk factors (like cholesterol) where unless they lose 100 pounds (which unless they go on "The Biggest Loser" is almost impossible to do without surgery), they are going to need medication. In addition, there are certain patients (diabetics, patients with previous heart attacks) than need statin medications regardless of how great their diet and exercise has been, because their risk of a heart attack is so high.
In other words, any comments I make discussing the benefits of statin medications should in no way be taken to undermine the importance of diet and exercise. However, until our country decides to embrace a major initiative to reverse the national trend of our growing waistlines, I am going to need a lot of medications to keep my patients healthy.
Vitamin C is a different issue because it has been shown to do more harm than good.
can you please be more specific what harm does vitamin c do ter
Ter,
Sorry for lack of precision.
It's vitamin A and vitamin E that can cause harm. Vitamin C actually was not found to cause harm, but not shown to be of any benefit. However, like A and E, C is an antioxidant. Using antioxidants for therapeutic benefits has not shown to provide any benefit, and in this study, A and E showed harm.
http://jama.ama-assn.org/content/297/8/842.abstract
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