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Studies cited on the radio program:
If reducing cholesterol levels lowers the risk of heart disease you would assume that people who lower their cholesterol levels will live longer compared to those who do not lower cholesterol levels. The most important statistic of any study is the mortality rate – how many are alive at the end of the study.
Let’s take a close look at the mortality rate of the five studies cited by the American Heart Association.
- Heart Protection Study (2002) Over 20,000 adults in UK age 40-80 who were at a high risk for heart disease were followed for 5 years. They were divided into 2 groups. A placebo group and a group getting simvistatin 40mg/day. At the end of 5 years the placebo group had an 85.4% chance of survival. The statin group had an 87.1% chance of survival. That is not even a 2% difference. In fact the Doctor involved in the study wrote “Low cholesterol concentrations have been related to depression, cognitive impairment, and suppression of the immune system. Does a reduction of 1.7% in mortality balance these risks?” Funny that wasn’t mentioned by the American Heart Association.
- Prosper (2002) 5804 adults were examined to look at the effect of pravastatin versus placebo in the risk of developing heart disease and stroke. At the end of the 3 year trial the placebo group had 89.5% alive compared to the treatment group of 89.7% alive. That is only 2 tenths of a percent difference. This is not even statistically significant. As a side note cancer was significantly increased in the treatment group.
- ALLHAT (2003) 10,355 adults over 55 were randomized to receive either pravastatin or usual care (which means diet and lifestyle changes). At the end of 6 years 84.7% of the “usual care” group was still alive compared to 85.1% of the statin group. That is again less than 1% difference. Not statistically significant.
- ASCOT-LLA 19,342 high blood pressure patients between 40 and 79 with risk factors of cardiovascular disease. The statin group in this case did have reduce the number of cardiac events compared to the placebo group however at the end of 3.3 years 95.9% of the placebo group were still alive compared to 96.4% of the statin group. Only ½ % difference.
- PROVE-IT 4,162 patients who had a heart attack or angina were given either atorvastatin or pravastatin. In this study there was no placebo group. The absolute reduction in death of atorvastatin was 2.2% versus 3.2% from pravastatin.
So when we look at these studies the reduction in the risk of death was insignificant. Does this insignificant change in death rate warrant the increased risks of side effects from statins?
Let’s look at some other studies and what the outcomes of low cholesterol compared to higher cholesterol was:
- In women of all ages and men over 55, higher cholesterol levels may actually result in a decreased mortality (Q J Med 2003;96:927-34)
- One study showed that in the elderly female, a lower cholesterol level (less than 155mg/dl) was associated with 5.2 times higher death rate as compared to a woman with a cholesterol level of 272mg/dl (Lancet 1:868-870. 1989)
- Breast cancer rates in humans that took statins were shown to increase by 1,200% (relative risk)
- JAMA reported on a study of 5,170 subjects taking a statin versus 5,185 subjects treated with "usual care" (lifestyle changes) found that the statin did reduce cholesterol however (not widely reported) the mortality rate between the 2 groups was nearly identical (so why take the statin with all its side effects) also the coronary heart disease rates were not different between the control group and the statin group (JAMA Dec 18, 2002 18;288:2998-3007)
- The Framingham study (one of the longest ongoing studies on heart disease) reports after 30 years of follow up, there is no increased overall mortality with subjects with high cholesterol for those over 50. Furthermore, researchers reported that FALLING cholesterol levels were found to increase the cardiovascular death rate - a 14% increase for every 1mg/dl drop in cholesterol. (JAMA Vol 257. No 16, 4.24.1987)
- A study of 11,563 subjects found that those with cholesterol below 160mg/dl had 49% increases in all-cause mortality as compared to those subjects with a cholesterol level over 160mg/dl. Non cardiac death increased 2.27 times in the low cholesterol group compared to the control group (Eur Heart Journal 1997 18, 52-59)
- In 977 elderly patients (>70 y/o) studied, researchers found no correlation between elevated cholesterol levels and increases in mortality from coronary heart disease, all-cause mortality or hospitalization from heart attacks or angina. (JAMA Vol 272 No 17 Nov 2, 1994)
- Studies have found a correlation with low cholesterol levels and increased risk of mortality from cancer of the lung, liver, pancreas and bone marrow as well as increased risk of death from respiratory, hepatic and digestive disease (Arch. Intern. Med 192;152. 1490=1500)
- A study of 5,491 men aged 45-68 y/o found that falling cholesterol levels from 180-239mg/dl down to less than 180mg/dl were associated with a 30% higher risk of all-cause mortality and a significant increased risk of death from cancers of the esophagus, prostate, and bone marrow (Circulation 1995;92:2396-2403)
So as seen above the overall mortality rate of taking statins compared to placebo is insignificant. Further the increased risk for mortality from other causes is increased in the lowered cholesterol group. So what exactly does statins do and why does it seem to decrease cardiovascular events?
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