[77] Do statins have a role in primary prevention? An update.

18 Oct 2010 [77] Do statins have a role in primary prevention? An update.

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Posted at 16:25h in Therapeutics Letter by

77Therapeutics Letter #48 (April-June 2003)1 concluded that “statins have not been shown to provide an overall health benefit in primary prevention trials” based on the 5 RCTs8-12 available at that time. More RCTs are now available and 5 systematic reviews2-6 designed to answer this question have been published since 2003. Unfortunately, these reviews do not answer the question “Do the benefits of statins outweigh the harms in people without proven occlusive vascular disease?” This question is critically important to patients, physicians and health care resource utilization.

The Cochrane Collaboration is regarded as the gold standard of systematic reviews. One of its guiding principles is avoiding unnecessary duplication: any independent reviewer following the proper methodology would include the same trials, extract the same data and come to the same interpretation and conclusions. The review is then updated as new trials are published.

The 5 published systematic reviews2-6 (none of which are Cochrane reviews) vary in the RCTs included, summary effect estimates, conclusions and declared conflicts of interest of the authors (Table 1).

Table 1. Published systematic reviews

77Table1

Two of these reviews report a decrease in total mortality while 3, including the latest, conclude that mortality is not decreased by statins in this setting.

What is the explanation for the different relative risk estimates? In part, it is due to the timing of the review and the trials that were available for inclusion. The 2006 review2 did not have access to 3 RCTs17-19.  The 2007 review3 did not have access to 2 RCTs18,19.  The 2008 review4 did not include 2 RCTs13,19 and included 10 RCTs20-29 not included in any of the other reviews. The 2009 and 2010 reviews5,6 had access to the same RCTs and had very small differences in the RCTs included (Table 1). The reason for the variation in the overall mortality estimate between the 2009 and 2010 reviews is that the 2010 review requested and obtained additional details from authors, allowing exclusion of 3659 secondary prevention patients from 4 large RCTs8,10,11,12.

Why is a new systematic review necessary?

The differences in the interpretation and conclusions of these non-Cochrane reviews are confusing for clinicians. They can be resolved by using Cochrane methodology, including the Cochrane Risk of Bias Tool. Therefore we performed a new systematic review starting with the 22 RCTs included in at least one of these 5 systematic reviews. We excluded 10 of the RCTs20-29 included in the 2008 review because the population studied was largely or entirely people with occlusive vascular disease at baseline. We included the remaining 12 RCTs8-19, which provided data for at least one of 3 outcomes that we judged least subject to bias and most meaningful to patients: total all-cause mortality, total people with at least one serious adverse event (SAE) and total people with at least one major coronary heart disease (CHD) serious adverse event. All-cause mortality is an important outcome, for which we used the more accurate data from the 2010 review. Total SAEs capture overall mortality and all serious morbidity. Major CHD (non-fatal MI and death from coronary heart disease) is the outcome specifically reduced by statins, and less subject to bias than other cardiovascular outcomes such as revascularizations and strokes.

Results. All 12 RCTs report major CHD data, 11 report mortality data and 6 report SAE data. Our meta-analysis demonstrates that the reduction in mortality and major CHD, both SAE outcomes, is not reflected in a reduction in total SAEs (Table 2). The results are similar if they are limited to the 6 RCTs8,9,11,14,16,19 that reported SAEs:  mortality RR 0.90 [0.79-0.98], ARR 0.4%; Major CHD RR 0.70 [0.62-0.79], ARR 1.0%.

However, getting accurate data entered and analysed is insufficient on its own. Cochrane reviews require assessing the risk of bias for each included RCT using the Risk of Bias Tool. Using this tool we found some risk of bias for each of the 12 included RCTs. Table 2.

Table 2. Statins for primary prevention meta-analysis77Table2

*Click here to see the Forest Plots.

Loss of blinding to treatment allocation probably occurred in all 12 RCTs, because statins predictably lower LDL cholesterol and the physicians managing the patients knew the lipid parameters. This loss of blinding likely biased clinical decisions regarding revascularization procedures and how outcomes were categorized (e.g. transient ischemic attack or reversible ischemic neurological deficit). Fewer revascularization procedures in the statin group as a result of loss of blinding would result in fewer complications secondary to the procedures, e.g. myocardial infarctions.

Other risks of bias affected only some RCTs. Of highest risk are the biases due to stopping RCTs early for benefit, affecting 3 RCTs12,14,19, and incomplete outcome reporting bias (not an intention to treat analysis), affecting 1 RCT18. A recent research study demonstrated that the magnitude of the bias effect from stopping RCTs early for benefit is surprisingly large and robust, RR 0.71 [0.66-0.77].7 Testing the effect of this bias estimate on the early terminated JUPITER trial changes the RR for major CHD from 0.54 to 0.76 and completely negates the mortality benefit.

In order to test the effect of the bias from these 4 RCTs we removed them; analysis of the remaining 7 RCTs (Table 2, second row) shows no reduction in mortality. This suggests that the claimed mortality benefit with statins for primary prevention is more likely due to bias than being a true effect. Removing the 4 potentially biased trials also diminished the magnitude of the major CHD relative risk reduction from 26% to 21%.

How can CHD SAEs decrease, but not total SAEs?

All CHD events are SAEs and are counted in both categories. Therefore a reduction in major CHD SAEs should be reflected in a reduction in total SAEs. The fact that it is not suggests that other SAEs are increased by statins negating the reduction in CHD SAEs in this population. A limitation of our analysis is that we could not get total SAE data from all the included RCTs. However, we are confident that the data from the 6 missing RCTs would not change the results, because they represent only 41.2% of the total population and include ALLHAT-LLT10, where one would not expect a reduction in total SAEs; in that trial there was no effect on mortality or cardiovascular SAEs.

Conclusions

  • Systematic reviews and meta-analyses are challenging and require much more than locating RCTs and plugging in the numbers.
  • The claimed mortality benefit of statins for primary prevention is more likely a measure of bias than a real effect.
  • The reduction in major CHD serious adverse events with statins as compared to placebo is not reflected in a reduction in total serious adverse events.
  • Statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.

*Click here for Appendix: Forest Plots.

The draft of this Therapeutics Letter was submitted for review to 45 experts and primary care physicians in order to correct any inaccuracies and to ensure that the information is concise and relevant to clinicians.

References

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7 Comments
  • chrisae
    Posted at 10:10h, 18 April Reply

    Very good, congratulations!

    Once again a thought provoking issue!

    The article is very interesting and very clear. We are going to signal it in the December ISDB Newsletter.

    Again, this is an excellent letter. I like the example at the end of a theoretical benefit of spending less on meds. The public needs to be aware of this as well as physicians.

    Thanks for bringing me up to date via e-mail with the Therapeutics Initiatives.

    I want to tell you how much I have appreciated the letter for the previous years.

    It became the only source of drug information I relied on. Keep up the good work!

    Great article and pertinent to nurse practitioners for sure.

    May I add that physicians are not the only prescribers now in Canada. There are just over 1,200 nurse practitioners and the number is increasing yearly — who will be eligible to prescribe medications as well and it would important to include these folks as well in your message so that collectively physicians and nurse practitioners have to power to address this issue.

    Thank you for sending this. The content is very useful, as is your suggestion to offer a website with costs of prescriptions.

    I was most interested by the sentence: “Canada now spends 25% more on pharmaceuticals than on doctors”, which can be a powerful communication gun towards the physicians. Physicians do not feel concerned by the health expenditures, because it often remains a theoretical concept for them. Such a sentence is a way to make them deeply concerned, if they realise that they can not dissociate their own fees from their drug costs, within a tight national economic constraint. This figure would be even more efficacious if we could give along time the evolution of the ratio drug costs / physician costs: do you have such information?

    It is a constant wonder to me when healthcare spending is discussed in the media as well as among healthcare professionals and providers that we continue to lament the spiralling costs of prescription and OTC drugs while at the same time, look for (ask for) more money to spend on them. If a formula for determining “me too” drugs has been established we need to convince government formularies to reject coverage and/or limit choices in each category of pharmaceutical treatment regimes. Our doctors need to be better trained in healthcare and not depend on the pharmaceutical industry to “cure” their patients. Too often our doctors are graduating with one tool in their treatment arsenal – a prescription pad. Which brings to mind the adage: If the only tool you know how to use is a hammer, pretty soon everything begins to look like a nail. As we all know or should remember to acknowledge there is no “pill for every ill”.

    Please convey to the TI group my congratulations on the content and message of this edition of the Therapeutics Letter. It finally addresses, point-blank, the issue of massive irrelevancy and redundancy in the drug industry. It also points, indirectly, to industry’s ability to manipulate rank-and-file physicians into acting as agents for its sales strategies. Well done!

    I hope one day the penny will drop, and the TI will ask the pointed question: “If not drugs, then what?” If it does so, then I hope it will answer that question on evidentiary grounds alone, using the same rigor, comprehensive approach and attention to detail that have characterized its scrutiny of drug therapy. If it does, I think it will find that true primary prevention (lifestyle change, psychobiological approaches and community-based support for healthy living) are everything that drug therapy is not — inexpensive, replete with corollary benefits, and sustainable for the very long

    term.

    Thank-you for your thoughtful article. There is currently a tool that provides the cost of prescription drugs in BC (and other details such as PharmaCare coverage etc.). Please see below:

    http://www.medi-mouse.com/drug/drugfind.php

    Thank you so much for your Therapeutics Letter!

    Yes, please put my name on the list of those wanting to know drug costs per dose, your new initiative. I suggest you consider sending along with the cost, a recommendation of an equally effective alternative older drug and its cost. It will drive home the message emphatically as numbers speak volumes. You need to find the right carrot to change prescribing patterns of doctors. Perhaps we should have TI reps pay us a visit in our clinics the way drug reps do and then have a system to monitor change by accessing prescribing patterns from the next door pharmacist, just the way drug companies do. Keep up the great work!

    This was an excellent edition of the Therapeutics Letter. I was going to refer to it in our upcoming newsletter and encourage NDs across BC to link to your site for

    more info.

    Congratulation for the excellent article and for performing this analysis.

    I personally believe that the evaluation of the Added Therapeutic Value of new drugs should finally be considered at regulatory level. Until recently, evaluating the quality, safety and efficacy of new drugs made complete sense. Nowadays, new drugs cannot be considered as if they were in a vacuum and drug companies should be required to submit adequate comparative (superiority) trials as part of their applications.

    This is what we lobbied for during the last review of the European Pharmaceutical Legislation. The EU parliament came to agree to this principle but unfortunately the EU Council did not take it into account in the final text of the legislation. I hope this principle will be applied by other countries soon…

    Well done again.

    I appreciated your April-July TI newsletter. However, I have a couple of questions:

    1) How much of our drug costs are incurred by those who have extensive coverage for their medications? Specifically I wonder about employees with supplemental insurance, First Nations, income assistance recipients and government employees with benefits, including RCMP and military.

    2) Is there any plan to provide us physicians with a “classification” like the French one that gives us the scoop on which drugs are “me too” copies?

    My experience over many years has been one of extreme frustration when it comes to prescribing. Those who don’t have to worry about costs (see question 1) are usually the most demanding of expensive and unnecessary prescribing whereas those who pay for all drugs without assistance often deprive themselves of needed therapy due to cost. It’s for this reason that I am virulently opposed to a National Drug Plan! Canadians have become too complacent about medical costs and the addition of such a plan would undoubtedly break the bank.

    We need much more in the way of patient education in order to reduce our unnecessary pharmaceutical costs. You wouldn’t believe the number of times I have had a mother in the ER at night demanding an antibiotic for their child because of a non-bacterial ear infection. And… I have also encountered those who insist on azithromycin because their child is “immune” to amoxil! When I point out the cost differential, their response is “no problem, we’re covered!” Of course, they are completely resistant to any discussion of their child being “immune to amoxil”. And … in the middle of the night, I’m not interested in “education”. All I want to do is get back to sleep to prepare for the day following. At the other end of the spectrum are those who are in their 60’s and 70’s who, having abused their bodies for 50 years, are now reaping the rewards of their lifestyle and demanding medical cures. It simply amazes me how many obese, sedentary folks are on antihypertensives, a statin, metformin and some sort of NSAID to reduce pain. I doubt it will ever change.

    Thanks for your efforts…

    “Yes, I am all in favor of any measure whatsoever which will start raising awareness about the cost of what we prescribe. I understand the annual cost increases for PharmaCare, per day, are sufficient to fund an additional family physician’s fees for a year. Money frivolously wasted on medications is just as important as money we waste on unnecessary or incorrect investigations, tests and procedures.

    To initiate some change many steps could be helpful, in particular:

    – provide accurate drug cost information for commonly prescribed medications in usual quantities and usual doses

    – in a format which would download to my Palm Pilot would be ideal, Internet second choice

    – data from my community would be most useful since price varies geographically, which many probably don’t realize

    – data for specific pharmacies or specific retailers is also needed since there is quite significant price variability from store to store even within a few blocks of each other, another point of which that most patients and many physicians are unaware (10% to 30% or more in my experience)

    – the data collection would need to have provision for frequent updates because the pharmacies or manufacturers will be quick to game any system or create pricing ploys to discredit the process

    Without sounding too paranoid one could easily suspect that there has been a lot of effort put into the current marketplace, so called, to obscure price information and create a world where the prescriber is unaware and feeling no sense of responsibility for the cost issues even while they write the prescriptions.

    My feeling is that there is also a marketplace evolving where some real price competition and transparency about costs would be welcome, and I doubt it will come from our leaders.

    Some interesting “market driving” options could include:

    – allowing/requiring price data to be included in all pharma promotional material and print advertising

    – encouraging or requiring pharmacies to advertise their usual prices and usual dispensing fees for all or a select list of commonly prescribed drugs – patients will quickly identify where they will receive the best price/service for their needs

    – somehow extracting current price data, by specific store, including product cost and dispensing fees from the PharmaCare database (where it all exists now and has done so for a decade) and making that available online for physicians and patients

    – taking serious steps, a la New Zealand, to manage the market place to the benefit of the consumer/payer rather that the sellers/purveyors – many different options

    – Internet pharmacies in Canada to serve US customers are somehow acceptable “competitive business practice” but a similar model could work well in BC for BC customers, should the idea be promoted?

    If there is any group formed to further some of these initiatives I would be pleased to play some sort of a role.

    I like the tone and content of TI 59. One minor quibble, why is it necessary to use a 1996 cost comparison chart for “Me-Too” vs “Vintage” drugs? The spread is probably equal or greater in 2006.

    Thanks for the opportunity to comment.

  • ruinedbystatins
    Posted at 19:13h, 09 October Reply

    Thank-you for reminding us (especially our physicians) that,

    “Statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.”

    Also, according to Dr. Dwight Lundell, a well-known veteran heart surgeon, whom I was fortunate to meet 2 nights ago, free radical damage from smoking and consuming simple carbohydrates like SUGAR are the TRUE causes of heart disease and NOT cholesterol. He said that free radicals WOUND the arteries and causes them to become so inflamed and full of plaque (the body’s way of healing the wound) that it eventually leads to heart disease and heart attacks. Dr. Lundell’s solution to that problem DOES NOT include the use of statins but rather the use of ANTIOXIDENTS (Vit A, B, C, D & E) and fish oil which HE CLAIMS WILL REVERSE HEART DISEASE.
    I think it is time for us to STOP FOOLING OURSELVES about STATINS and STOP HARMING PATIENTS with statin’s DEADLY side effects (CONGESTIVE HEART FAILURE, MUSCLE WASTING, MEMORY LOSS, etc) and call statins what it should be called, A SCAM DRUG INVENTED FOR DRUG COMPANY PROFIT. A drug that can only prevent ONE heart attack out of 100 people taking the drug over a 2 year period is a drug that BELONGS IN THE GARBAGE CAN.
    Sincerely,
    Josephine Keliipio
    Caregiver from Hawaii

  • Pingback:The Great Cholesterol Scam and the Dangers of Statins — Der Friedensstifter
    Posted at 05:25h, 02 July Reply

    […] while the other 2 had also reached a positive conclusion for statin therapy). That assessment instead concluded: “Statins have not been shown to provide an overall health benefit in primary prevention […]

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