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Old Sat, Jul-06-02, 21:38
alpmartin alpmartin is offline
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Plan: Atkins / Protein Power
Stats: 190/190/145 Male 5 feet 6 inches
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Location: Elizabeth, NJ
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First, did any of you look at the Lancet's site, and get the information on the study from the publication? It is very interesting. Before I put in my own (actually, some doctor's) 2 cents, here is the summary from the source:
http://www.thelancet.com/journal/vo...esearch.21672.1

"Summary

"Background Throughout the usual LDL cholesterol range in Western populations, lower blood concentrations are associated with lower cardiovascular disease risk. In such populations, therefore, reducing LDL cholesterol may reduce the development of vascular disease, largely irrespective of initial cholesterol concentrations.

"Methods 20 536 UK adults (aged 40-80 years) with coronary disease, other occlusive arterial disease, or diabetes were randomly allocated to receive 40 mg simvastatin daily (average compliance: 85%) or matching placebo (average non-study statin use: 17%). Analyses are of the first occurrence of particular events, and compare all simvastatin-allocated versus all placebo-allocated participants. These "intention-to-treat" comparisons assess the effects of about two-thirds (85% minus 17%) taking a statin during the scheduled 5-year treatment period, which yielded an average difference in LDL cholesterol of 1·0 mmol/L (about two-thirds of the effect of actual use of 40 mg simvastatin daily). Primary outcomes were mortality (for overall analyses) and fatal or non-fatal vascular events (for subcategory analyses), with subsidiary assessments of cancer and of other major morbidity.

"Findings All-cause mortality was significantly reduced (1328 [12·9%] deaths among 10 269 allocated simvastatin versus 1507 [14·7%] among 10 267 allocated placebo; p=0·0003), due to a highly significant 18% (SE 5) proportional reduction in the coronary death rate (587 [5·7%] vs 707 [6·9%]; p=0·0005), a marginally significant reduction in other vascular deaths (194 [1·9%] vs 230 [2·2%]; p=0·07), and a non-significant reduction in non-vascular deaths (547 [5·3%] vs 570 [5·6%]; p=0·4). There were highly significant reductions of about one-quarter in the first event rate for non-fatal myocardial infarction or coronary death (898 [8·7%] vs 1212 [11·8%]; p<0·0001), for non-fatal or fatal stroke (444 [4·3%] vs 585 [5·7%]; p<0·0001), and for coronary or non-coronary revascularisation (939 [9·1%] vs 1205 [11·7%]; p<0·0001). For the first occurrence of any of these major vascular events, there was a definite 24% (SE 3; 95% CI 19-28) reduction in the event rate (2033 [19·8%] vs 2585 [25·2%] affected individuals; p<0·0001). During the first year the reduction in major vascular events was not significant, but subsequently it was highly significant during each separate year. The proportional reduction in the event rate was similar (and significant) in each subcategory of participant studied, including: those without diagnosed coronary disease who had cerebrovascular disease, or had peripheral artery disease, or had diabetes; men and, separately, women; those aged either under or over 70 years at entry; and--most notably--even those who presented with LDL cholesterol below 3·0 mmol/L (116 mg/dL), or total cholesterol below 5·0 mmol/L (193 mg/dL). The benefits of simvastatin were additional to those of other cardioprotective treatments. The annual excess risk of myopathy with this regimen was about 0·01%. There were no significant adverse effects on cancer incidence or on hospitalisation for any other non-vascular cause.

"Interpretation Adding simvastatin to existing treatments safely produces substantial additional benefits for a wide range of high-risk patients, irrespective of their initial cholesterol concentrations. Allocation to 40 mg simvastatin daily reduced the rates of myocardial infarction, of stroke, and of revascularisation by about one-quarter. After making allowance for non-compliance, actual use of this regimen would probably reduce these rates by about one-third. Hence, among the many types of high-risk individual studied, 5 years of simvastatin would prevent about 70-100 people per 1000 from suffering at least one of these major vascular events (and longer treatment should produce further benefit). The size of the 5-year benefit depends chiefly on such individuals' overall risk of major vascular events, rather than on their blood lipid concentrations alone"

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Next quote:

This is from my physician's desk reference. It is titled "Primary Prevention". He copied the relevant pages for Statin therapy, but did not get in any other information regarding the publication. I am skipping all of the references. If anyone wants references, I will be glad to give them in a latter posting. This is what this reference says:

"Statins: We found four systematic reviews that considered the effect of HMG-CoA reductase inhibitors (statins) versus placebo on clinical outcomes in people given long term (>= 6 months) treatmetn. All included the two large primary prevention trials using statins (13 200 people). All found similar results. After 4-6 years of treatment for primary prevention, statins compared with placebo did not significantly reduce all cause mortality (OR 0.87, 95% CI 0.71 to 1.06) or CHD mortality (OR 0.73, 95% CI 0.51 to 1.05), but did reduce major coronary events (OR 0.66, 95% CI 0.57 to 0.76) and cardiovascular mortality (OR 0.68, 95% CI 0.50 to 0.93). The absolute risk reduction for CHD events, CHD mortality, and total mortality varied with the baseline risk in the placebo group of each trial.
Other treatments: We found no systematic review specifically in people with low baseline risk (< 0.5% annual risk of CHD events). We found two systematic reviews that looked at statins and non-statin treatments together versus placebo or no treatment, specifically for primary prevention. Both found similar results. The most recent review found four RCTs (2 with statins, one with fibrates, and one with cholestyramine, 21 087 people). It found that cholesterol reduction therapy versus placebo significantly reduced CHD events and CHD mortality, but found no significant effect on overall mortality (OR for therapy v placebo; 0.70, 95% CI 0.62 to 0.79 for CHD events; 0.71, 95% CI0.56 to 0.91 for CHD mortality; 0.94, 95% CI 0.81 to 1.09 for overall mortality)

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My comments:
1) The study selected those people who would be helped by statin therapy, and proved that it helps people at risk for heart disease. Good for it. All those people who do not want to be LCers or do not know about LC, they will be helped and will live longer lives.
2) The Doctors Eades talk about the risks of cholesteral levels that are "too" low. As they say, (I paraphrase) dead is dead, and low choleseral can kill as well as high cholesteral. Thus I suspect that most of us LCer's raise our risk of death by taking statins. Note that the "Other treatment" paragraph starts out by saying that no studies have been done for low risk people (that should be us!)
3) I have no problem with the drug companies spending money for these huge trials in order to prove that the drugs work. First, the trials, in fact, do prove that the drugs work. That is imprtant, because sometimes the drugs do not pass Stage I trials (they are toxic or dangerous or do not work). The drug companies have identified a problem,and have found a solution. The drug companies are not at fault for promoting a low-fat / high carb diet. Nor do they promote low-fat / high carb. But if people are fat, and are getting diabeties and dying of heart attacks, then the drug companies will try to find a drug to cure the problem. And they will look into drugs for the solution. Just as they are trying to find a drug (that can be made into a pill) for almost any other human ailment
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