Dr Stephen Sinatra- Restrict Statin Drugs to Men with Known Heart Disease (11)
Now we can summarize the above information. In Women and the Elderly, Statin drugs offer no mortality benefit for primary or secondary prevention of heart disease.
In addition, Statin drugs offer no mortality benefit for men in primary prevention of heart disease (men with no known heart disease).
This leaves us with the remaining group in which statin drugs HAVE BEEN SHOWN to provide a mortality benefit. This group is males with known heart disease, also called secondary prevention.
And now, we can understand the rationale for Dr Stephen Sinatra's position on statin drugs announced in his newsletter.(11) Dr. Sinatra says that statin drugs should be prescribed only to middle aged males with known heart disease. For other groups, Dr Sinatra considers statin drugs unnecessary and potentially harmful. (11)
Secondary Prevention of Heart Disease in Males
Considering the media and marketing hype over statin drugs, one would think there must be something to it, so let's take a look at the statin drug studies in the best case scenario, middle aged men with known heart disease. This is the group with proven mortality benefit and these studies were submitted for FDA approval for this class of drugs. Let's take a closer look at the data from two of the most representative secondary prevention studies with statin drugs, the 4S (12,13) and the LIPID Studies (14).
4S Trial with Simvastatin in Scandinavia (12,13) - 0.6% per year
Here is a quick recap of the 4S-Trial data.
The 4S trial was done on 4444 patients who had known heart disease, randomized to simvastatin or placebo, and followed for 5.5 years. At the end of the follow up, they reported 182 deaths in the statin drug group (8.2 %) and 256 deaths in the placebo group (11.5% ). This provided an absolute mortality benefit of 3.3% over 5.5 years, or 0.6% per year. (12,13) The 6-year probabilities of survival for placebo was 88.5 % and for simvastatin was 91.8%, a difference of 3.3%.
LIPID Pravastatin Study (14) - 0.5% per year
Here is a quick recap of the LIPID Trial data.
9,000 patients with unstable angina and history of myocardial infarction were randomized to either placebo or Pravastatin and followed for 6.1 years.(14)
The statin group had 11% mortality and the placebo group had 14.1 % mortality over 6.1 years. This is a 3.1% mortality benefit over 6.1 years or 0.5% per year. After 6 years probability of survival in the placebo group is 85.9% and in the Statin drug group is 89%, a difference of 3.1 %. (14)
Absolute Mortality Benefit of 0.5% per year in Secondary Prevention
So, as you can see from the above, the absolute mortality benefit in the best case scenario, in secondary prevention trials, is only 0.5% - 0.6% per year. This benefit is underwhelming, and actually quite shocking that it is such a minimal benefit when the drug company marketing would suggest much larger benefits.