Statin drugs like Lipitor (atorvastatin), Zocor (simvastatin), Mevacor (lovastatin) and Pravachol (pravastatin) have been around for almost a decade so I thought that it would be interesting to see what research reports have to say about their effectiveness in combating heart disease.
The 20 year Honolulu Heart Program (Schatz, et al. 2001) report indicated that, “Our data accord with previous findings of increased mortality in elderly people with low serum cholesterol, and show that long-term persistence of low cholesterol concentration actually increases risk of death. Thus, the earlier that patients start to have lower cholesterol concentrations, the greater the risk of death.” Yes, you read that right. They report that low cholesterol levels increase the risk of death. Their report also states that “Those individuals with a low serum cholesterol maintained over a 20-year period will have the worst outlook for all-cause mortality.” I’ll write more about the cholesterol hypothesis in my next blog so come back for more.
The 2001 study “aptly” named MIRACL (Schwartz, et al, 2001) followed 3,086 patients in hospital after angina or non-fatal MI for 16 weeks to test the effect of Lipitor. This study found that the only significant difference between the control group and the group receiving 80 mg/day of Lipitor was a significant reduction in chest pain requiring rehospitalization. There was no significant difference in re-infarction rate or the need for resuscitation from cardiac arrest.
One of the largest North American cholesterol-lowering trials was ALLHAT (2002) which used data from 10,000 participants over a 4-year period. Of the 5,170 participants that received Lipitor, 28 percent showed a reduction in cholesterol levels. The other 5,185 participants used a “usual care” protocol of maintaining proper body weight, no smoking, and regular exercise. Guess what? Both groups showed the same rates of death, heart disease, and heart attack. The mortality rates of the treatment and control groups were identical after three and six years.
PROSPER (Shepherd, et al. 2002) studied the effect of Pravachol compared to a placebo on two older populations. There were no differences between the treatment and control groups in measures of total health impact, total mortality and total serious adverse events. The only overall statistical difference was that the treatment group (those receiving Pravachol) had increased cancer.
The Japanese Lipid Intervention Trial (J-LIT, Matsuzki et al. 2002) was a six year study that followed 47,294 patients treated with Zocor. The participants were divided into three groups, those with no reduction in LDL levels, those with a moderate fall in LDL levels and those with a very-large reduction in LDL levels. There was no correlation between the amount of LDL lowering and death rate at five years. In fact, those with LDL lower than 80 had a death rate just over 3.5 at five years and those with LDL levels above 200 had a death rate of just over 3.5 at five years.
A meta-analysis of 44 trials involving almost 10,000 patients (Hecht and Marmon, 2003) found that the death rate was identical at 1 percent in each of three groups, those taking Lipitor, those taking other statin drugs and those taking nothing.
Another widely publicized meta-analysis (PROVE-IT, Cannon et al., 2004) conducted by researchers at Harvard Medical School was serious flawed because it did not include a control group. Rather it compared the effect of two statin drugs, Lipitor and Pravachol. While those taking Lipitor had a great reduction in LDL levels it is not possible to draw a conclusion about the overall health effect of statin drugs from this study.
If you are taking or are thinking about taking statin drug please read http://www.westonaprice.org/moderndiseases/statin.html. They review some of the same research (and others) and provide a very good explanation of the effects of statin drugs.
I'll be writing about some less expensive, less risky, and more effective approaches to reducing the risk of heart disease in my next post.
References
Schatz IJ and others. Lancet 2001 Aug 4;358:351-355.
Schwartz GG and others. J Am Med Assoc. 2001;285:1711-8.
The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. JAMA 2002;288:2998-3007.
Shepherd J and others. Lancet 2002;360:1623-1630.
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