Sept 18, 2012 | Justin Smith
An estimated 40 million people take a statin to lower their cholesterol levels. These are one of the most widely prescribed medications in history and, of course, one of the most profitable.
We are led to believe that the benefits associated with statins far outweigh any risks. However, when it comes to primary prevention (accounting for around 75 percent of all the people who take a statin), no clinical trial has been able to conclusively show any net benefit.
This is one of the issues discussed in the documentary film STATIN NATION: The Great Cholesterol Cover Up.
If we look at the history of primary prevention clinical trials involving statins, we find that none of the major trials were able to demonstrate a significant reduction in the number of deaths from all causes. The AFCAPS, ASCOT, CARDS, PROSPER and WOSCOPS clinical trials all failed to show a statistically significant reduction in all cause mortality.
This data for deaths from all causes is, of course, important because it is the only measure we can use to determine if the statin is going to extend life expectancy or not.
Whilst some statin clinical trials have shown a very slight reduction in cardiac events, this has always been counter-acted by deaths from other causes. The net result being that people did not live any longer after taking the statin.
In fact, a meta-analysis of primary prevention clinical trials published in 2001 suggested that statins increase mortality when taken over a ten year period for both men and women.
More recently, pharmaceutical companies and much of the world's media have been touting the results of the JUPITER trial. However, if we take a closer look at the data for this trial, we can see that the statin and the placebo group had exactly the same number of cardiovascular related deaths - a fact that is highlighted by Dr Malcolm Kendrick in the new documentary.
In addition, an article published in the Archives of Internal Medicine in 2010 questioned the validity of the data from the JUPITER trial and raised concerns about the role of the company sponsoring the trial. Another article published in the journal Cardiology in 2011 raised similar concerns.
In 2010, a meta-analysis of 11 statin trials was published in the Archives of Internal Medicine. Professor Kausik Ray and colleagues concluded that statins provided no benefit in terms of deaths from all causes. It is worth mentioning that this analysis had the 'cleanest' dataset of any analysis completed to date - the researchers were able to exclude patients with existing heart disease (secondary prevention) and only include data associated with primary prevention.
In 2011, the highly respected Cochrane Collaborative conducted a review of statin clinical trials. Based on this review, lead authors Dr Shah Ebrahim and Dr Fiona Taylor said that they could not recommend the use of statins for primary prevention. The absolute benefit was so small that it could have been down to chance, and even if it was a real benefit, 1000 people would have to be treated for one year to prevent one death.
Thus, even before we start to assess the risks associated with statins, we can see that there is no meaningful net benefit where primary prevention is concerned.
We are told that the adverse effects of statins are only experienced by a very small number of people. This is said with confidence despite the fact that many of the trials did not report the adverse effects at all. For example, in the Cochrane review, the researchers noted that eight of the 14 randomized controlled primary prevention trials of statins analyzed did not report on adverse events.
It is very difficult to obtain a realistic overall percentage for the rate of adverse effects, however, GreenMedInfo.com has compiled what is probably the most extensive database of published studies documenting statin adverse effects. This body of evidence shows that there are more than 300 documented adverse effects of statins. This document can be accessed here: Statin Toxicity Research.
In summary, it is clear from the clinical evidence that for at least 75 percent of people who are taking a statin, there is no net benefit; only a strong possibility of significant adverse effects.
In my next article, I will focus on the use of statins for people who already have a diagnosed heart problem.
- Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr,. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998; 279:1615-22
- Sever PS, Dahlöf B, Poulter NR et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003; 361:1149-1158
- Clhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atovastatin Diabetes Study (CARDS). Lancet 2004; 364:685-96
- Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360:1623-1630
- Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia (WOSCOPS). N Engl J Med 1995; 333:1301-7
- Jackson PR, Wallis EJ, Haq IU, Ramsay LE. Statins for primary prevention: at what coronary risk is safety assured? Br J Clin Pharmacol 2001; 52:439-46
- Ridker PM, Danielson, E, Fonseca F, et al, for the JUPITER Study Group. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008; 359:2195-207
- de Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036
- Serebruany VL. Extreme all-cause mortality in JUPITER requires reexamination of vital records. Cardiology. 2011; 120:84-8
- Ray KK, Seshasai SR, Erqou S, Sever P, Jukema JW, Ford I, Sattar N. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010; 170:1024-31